CN109091455A - A kind of clinical research methods of paravertebral point injection Vidarabine Monophosphate - Google Patents

A kind of clinical research methods of paravertebral point injection Vidarabine Monophosphate Download PDF

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CN109091455A
CN109091455A CN201811016678.3A CN201811016678A CN109091455A CN 109091455 A CN109091455 A CN 109091455A CN 201811016678 A CN201811016678 A CN 201811016678A CN 109091455 A CN109091455 A CN 109091455A
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于希军
刘白雪
王秀艳
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Affiliated Hospital Of Inner Mongolia Medical University
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    • A61P31/22—Antivirals for DNA viruses for herpes viruses

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Abstract

The invention discloses a kind of clinical research methods of paravertebral point injection Vidarabine Monophosphate, sample is specifically included to choose, treat, observation index, the present invention is while reducing drug to the injury of patient's body, patient is early set to get rid of the puzzlement of pain, significantly improve the subjective feeling and life quality of patient, valuable time is saved, so that patient is restored physically and mentally healthy as soon as possible, there is positive social effect；And this law medical treatment cost is low, therefore have good economic benefits；These are all very important advantage of the paravertebral point drug injection therapy in treatment HZ.

Description

A kind of clinical research methods of paravertebral point injection Vidarabine Monophosphate
Technical field
The present invention relates to herpes zoster fields, more particularly, to a kind of facing for paravertebral point injection Vidarabine Monophosphate Bed research method.
Background technique
Shingles zoster (Herpes-zoster, HZ) is with severe pain, gathering phlysis, unilateral peripheral nerve distribution The common acute herpes dermatoses of the one kind being characterized, by varicella virus (varicella-zoster Virus, VZV) it invades caused by neuromere and skin；Chinese medicine is known as " herpes zostor ", " herpes zoster ", " herpes zoster ", mostly occurs In trunk.Since some patientss cannot be treated timely and effectively, neuralgia is often left, Patients with Herpes Zoster loses mind after occurring Dysmenorrhoea (Postheptic Neuralgia, PHN) be shingles zoster after still have neuralgia or recurrent pain, probability within 1 month It is 10%~70%, seriously affects minimal invasive treatment and work quality, therefore many scholars more pay attention to the research to this disease.
Pathogenic factors: malignant tumour, cytotoxic chemotherapy, immunosuppressor or the glucocorticoid for receiving large dosage are controlled It treats, these are all the most common pathogenic factors of this disease to infected by HIV, in addition, wound, overwork, various infection and the certain arsenicals of application Equal heavy metals drug etc. is the common risk factor of this disease, these can all make body reduce the immunocompetence of VZV, virus easily quilt A large amount of activation, lead to the generation of forerunner's pain and fash.This disease summer disease incidence is higher, and elderly and infirm is easy to fall ill.
Doctor trained in Western medicine thinks that shingles zoster causes with varicella for same varicella virus (VZV).When primary infection, It is showed with varicella or Invisible infection to be main, immediately VZV nerve fibre of root or three after sensory nerve ending is along spinal cord Neural neuromere is pitched gradually to center movement, and permanent remains in the neuron of spinal cord posterior root ganglion；Work as immunity of organisms When decline, latent VZV is had activated, makes its mass propagation, causes the neuromere of involvement to be inflamed, necrosis, generates neuralgia； And blister specific to the segmental disease is generated on the skin, it is the skin institute for reaching the nerve by movable VZV again and being dominated It causes.
Doctor trained in Western medicine is mainly using analgesic, antiviral, trophic nerve, immunological regulation, corticosteroid hormone, nerve block as principle [7~9].With the methods of for oral administration, external application, physiotherapy.But doctor trained in Western medicine is still undesirable on rehabilitation duration and rehabilitation degree, most Drug is larger to old and frail patient's side effect, therefore seeks a kind of more excellent scheme and changed with alleviating neuralgia caused by this disease Kind life in patients, it is very necessary and urgent.
Motherland's medicine thinks shingles zoster often because year height is weak, and healthy energy is insufficient, and liver and spleen is accumulate in the heresy of damp and hot fire toxin, accumulates flesh outside Skin, QI-blood circulation is unsmooth, and channels and collaterals check, not general rule pain, therefore symptoms include scorching hot severe pain；Must not catharsis be then in tufted bleb；It is scorchingly hot it Heresy is accumulate in blood system then rubescent spot.
Treatment of the Chinese medicine to this disease, mainly relieving heat toxin, dampness removing heat, Removing Blood Stasis, degrading the channel, swelling and pain relieving；According to dialectical It is divided into spleen deficiency type of latent damp, liver gallbladder damp-heat type, qi stagnation and blood stasis type etc. by controlling.Conventional Chinese medicine is for oral administration, external application, the methods of acupuncture, clinical On achieve preferable curative effect.
Consult treat in recent years this disease pertinent literature discovery, many scholars with acupuncture needle, acupoint injection therapy, fire needle, cupping, The methods of bloodletting, acusector, moxa-moxibustion carry out treatment at paravertebral point and Ashi Point and achieve preferable curative effect, especially acupoint injection therapy Analgesic, only blister, reduce post herpetic neuralgia incidence on be better than other methods, be clinically a kind of more mature technology.
In document report, drug injection therapy certainly, but can report document not to the curative effect of shingles zoster It is more, and lack the overall merit of multi objective.Patient of this research to meet the standard of being included in passes through observation pain as research object The overall merits paravertebral point acupoint injection therapy monophosphate arabinoses such as situation, bleb situation, incrustation decrustation time, comprehensive therapeutic effect Score index The clinical efficacy and advantage of adenosine treatment shingles zoster, for type Treated with Point-injection Therapy shingles zoster clinical application provide it is objective according to According to.
Summary of the invention
The present invention is intended to provide a kind of clinical research of paravertebral point acupoint injection therapy Vidarabine Monophosphate treatment shingles zoster.
A kind of clinical research methods of paravertebral point injection Vidarabine Monophosphate, specifically includes the following steps:
S1, sample are chosen, and select the Patients with Herpes Zoster that certain amount is qualified according to screening technique screening, are divided into two Group, one group is control group, and one group is treatment group；
S2, treatment, control group use intravenous infusion: with 0.9% physiological saline 150ml intravenous infusion Vidarabine Monophosphate, 200mg/ It is secondary, 1 times/day；Treatment group selects the syringe of 10ml, and the syringe needle of 1ml syringe carries out acupoint injection therapy drug, and drug includes single phosphorus Sour arabinosy ladenosine 200mg, 0.9% physiological saline 4ml, lidocaine 4ml；Specific injection is the following steps are included: 1. acupoint selection: Jiaji The paravertebral point of the corresponding segment in morbidity side is chosen in cave according to the cutaneous lesion of patient；Ashi Point, two acupuncture points in skin lesion part；2. root Corresponding position is taken according to lesions of patients position, extracts 0.9% physiological saline 4ml for 200mg monophosphate arabinose with 10ml syringe 2% lidocaine 4ml is being extracted in adenosine dissolution, and mixing is made into 8ml liquid, affected part is sufficiently exposed, by infused paravertebral point and skin lesion After surrounding Ashi Point routine disinfection, the syringe needle for exchanging 1ml syringe for is quickly stabbed diagonally to backbone direction into skin (25~35 degree), is taken out No blood back is slowly infused drug in cave again, presses pin hole after needle out.The two paravertebral point drawn game up and down of corresponding disease damage is injected every time Two, portion Ashi Point, every cave 2ml, the next day 1 time；Control group is oral with treatment group simultaneously: acyclovir, and 0.4g/ times, 2 times/ It；Ibuprofen and codeine, 0.2g/ times, 3 times/day；Vitamin B complex tablet, 10mg/ times, 3 times/day；Two groups of courses for the treatment of: 10 days 1 courses for the treatment of, Amount to 1 course for the treatment of.
S3, observation index, including following index item:
(1) bleb evaluation index, to there is bleb as initial time；1. only blister time (day): bleb termination increases Time；2. scab forming time (day): bleb forms a scab time of the area greater than more than half；3. the decrustation time (day): crust thoroughly takes off The time fallen；The above items are observed and recorded between test the 1st~10 day；It can not be recorded such as in the course for the treatment of, in follow-up Record；
(2) pain measurement index, 1. visual analogue scales (VAS scoring): " 0 " indicates painless, and " 100 " indicate that patient can The maximum pain (unit: mm) of the imagination, the scale that can most represent pain degree at that time is said by patient；2. pain relieving time (day): from pain is begun with to pain relief time needed for 30% or more；3. durante dolors (day): aching from beginning with Pain thoroughly disappears the required time to pain；On durante dolors, such as more than 30 days persons are included in post herpetic neuralgia；1. item is in examination It tests before treating, recorded after treatment；3. 2. item in test the 1st~10 day between and treatment end after record；After treatment end It can not record, then be recorded in follow-up；
(3) post-herpetic neuralgia records on the the 30th, 60 day respectively in test；
(4) shingles zoster comprehensive therapeutic effect scores, and topoalgia is itched, burn feeling, generates heat, regional glandular enlargement, blister number Mesh, number of clusters, character, ulcer, papule, the total mark of skin lesion area etc..It before test treatment in the 1st day, records within the 11st day, in test 0th, 11 day shooting photo.
Beneficial effects of the present invention: the present invention early puts patient while reducing drug to the injury of patient's body The puzzlement of pain is taken off, hence it is evident that the subjective feeling and life quality for improving patient save valuable time, make patient as early as possible Recovery it is physically and mentally healthy, there is positive social effect；And this law medical treatment cost is low, therefore have good economic benefits；These are all It is very important advantage of the paravertebral point drug injection therapy in treatment HZ.
Additional aspect and advantage of the invention will be set forth in part in the description, and will partially become from the following description Obviously, or practice through the invention is recognized.
Detailed description of the invention
Fig. 1 is that two groups of VAS scorings are compared；
Fig. 2 is two groups of pain relief >=30% and the time completely disappeared to compare (d)；
Fig. 3 be two groups stop blister, incrustation, decrustation time compare (d)；
Fig. 4 is that two groups of comprehensive therapeutic effect scorings are compared and (divided)；
Fig. 5 is efficacy analysis after two groups of treatments；
Specific embodiment
Following will be combined with the drawings in the embodiments of the present invention, and technical solution in the embodiment of the present invention carries out clear, complete Site preparation description, it is clear that described embodiments are only a part of the embodiments of the present invention, instead of all the embodiments.It is based on Embodiment in the present invention, it is obtained by those of ordinary skill in the art without making creative efforts every other Embodiment shall fall within the protection scope of the present invention.
The clinical research methods of paravertebral point injection Vidarabine Monophosphate, tool are further interpreted below with reference to real case Body includes following corresponding contents.
1 materials and methods
1.1. research object
In dermatology of affiliated hospital of Inner Mongolia Medical University and Inner Mongolia Autonomous Region institute of traditional Chinese medicine department of acupuncture and moxibustion, acquire 2013 6 The Patients with Herpes Zoster of first visit qualification is as research object totally 60 during the moon~in December, 2014, all research objects and family members Equal informed consent.It is treatment group that 30 Patients with Herpes Zoster are randomly selected from first visit patient, in the same time, with the first visit of group It is control group that 30 Patients with Herpes Zoster are randomly selected in patient.
1.1.1. diagnostic criteria:
(1) Western medicine diagnostic criteria: (the world book publishing company Xi'an " Cecil Textbook of Medicine " is referred to " the Xi Shi that the company Goldman and Bennett by the U.S. published in 2004 is translated as the Wang virtuous person of total chief editor China as master Clinical practice " the 21st edition the 10th fascicle " flesh and connective tissue disease ") and " skin cypridology " (the 8th edition, People's Health Publisher goes out Version, Zhang Xuejun chief editor) diagnostic criteria HZ is formulated.
There is unilateral burning sensation, pain or shouting pain in particular body portion before the onset of 1., and pain and burning sensation can be very strong It is strong；
2. skin lesion ordinary wave and along spinal nerve root distribution several adjacent dermatotomes；
It, can be to go out 3. blister is harder omphalos shape, blister wall, close, cluster, can have an exudation, and substrate flush, gos deep into skin Hemorrhagic warts or blister erythema can occur after blister occurs therewith.
(2) tcm diagnosis standard
With reference to " 22 professions, 95 disease Chinese medicine diagnosis and treatment schemes-dermatology's Chinese medicine diagnosis and treatment scheme-herpes zoster "
Diagnosis basis:
1. skin lesion is mostly the blister of mung bean size, substrate is partially red, and in groups, arrangement becomes band gathering, and blister wall is more nervous, mostly singly Side distribution, blister liquid are in limpid liquid or suppuration liquid, notably may occur in which blood blister.Bleb is sent out in Head And Face person, and degree is usually heavier.2. skin Before rash issues, often first there are cutaneous acupuncture thorn or burning heat sensation, notably with the slight uncomfortable, do not feel like eating of whole body.3. being often insufferable Shouting pain and conscious pain is significant, still leaves pain after serious person's deflorescence.
1.1.2 being included in standard:
(1) bleb appeared in one week, without any curer；
(2) male or female, the age 16~80 years old patient；
(3) in meeting, doctor trained in Western medicine diagnosis of herpes zoster standard person；
(4) voluntarily receive this therapeutic scheme and sign informed consent form.
1.1.3. exclusion criteria:
Exclude following situations:
(1) except post-herpetic neuralgia；
(2) shingles zoster of abnormal type, such as ear, external eyes, internal organs portion, meninx shingles zoster, herpes zoster generalisatus；
(3) hypoimmunity or Long-term Oral immunosuppressor or glucocorticoid person；
(4) 1 weeks inherent parts or system used antiviral agent person；
(5) gestation, lactation and quasi- gravid woman；
It (6) include mental disease and hemopoietic system and liver, kidney, Cardial or cerebral vascular diseases etc. with serious primary disease person；
(7) state of an illness is heavier, it is difficult to the safety and efficacy person of accurate evaluation treatment；
(8) it does not meet and is included in standard person.
1.1.4. efficacy determination rules the evaluation of clinical curative effect research for treating shingles zoster and national Chinese medicine by law according to fiery needle repeated shallow puncture Medicine management board Eleventh Five-Year Plan Pivot Subjects cooperative groups herpes zoster diagnosis and treatment scheme:
Therapeutic index: VAS × 100% before n=(VAS after VAS- treatment before treating)/treatment is calculated with Nimodipine method.
Recovery from illness: pain completely disappears, whole skin lesion incrustations, n >=95%；
Effective: pain is significantly alleviated, most of skin lesion incrustation, n >=70%；
It is effective: pain relief, part skin lesion incrustation, 30%≤n < 70%；
It is invalid: pretherapy and post-treatment substantially unchanged, n < 30%.
1.1.5 standard and the processing that falls off are rejected
1.1.5.1 standard is rejected
1. the discovery person that belongs to exclusion criteria in treatment；
2. without being completed by experimental design scheme, efficacy determination or safe sex determination due to obviously interfering element by Influencer.
1.1.5.2 the standard that falls off and the processing that falls off
(1) fall off standard
Meet this disease to be included in standard and at least received treatment as defined in a deuterzooid research institute, but does not complete entire treatment side Case and the patient not fully recovered.
1. it is worse off during treatment, it need to the person of giveing first-aid measures for dangerous situation；
2. because sb.'s illness took a turn for the worse or died for the cause of certain reason during treatment；
3. because serious adverse reaction or accident can not continual cure persons during treatment；
4. requiring the patient for continuing to stop treatment during treatment.
(2) fall off processing
1. researcher should contact patient as early as possible after research object falls off, have friendly relations as far as possible with research object ditch simultaneously Its reason is solved, the assessed information that can be arranged, including last time treatment time are collected；
2. become research object after, no matter later treatment whether complete and diagnose how, needed after treatment end to all take off The person of falling carries out intentional analysis；
3. discovery overall treatment effect is undesirable in research, or even invalid, without value of clinical studies.
1.1.6 quality controls
Basic clinical research data is obtained from experimental study table, and is united to the personnel that will participate in this clinical research One training, skillfully grasps operative skill, uniformly records and saves every original data, conscientiously fill in clinical research table, really Protect the authenticity and accuracy of data.
1.17 compliance is evaluated
Treatment number of times counting method can be used in the compliance of evaluation studies object.
Compliance=research object, which has received treatment number of times/research object, should receive to treat total degree × 100%
1.1.8 key instrument and drug
Instrument: injection room worktable for preparing medicine；Hospital bed after disinfection；10ml, 1ml asepsis injector；Disinfecting cotton swab
Drug: Vidarabine Monophosphate (Guangdong Long Fu pharmaceutical Co. Ltd, drug batch number: 0.1g national drug standard H20057494)；0.9% physiological saline；Lidocaine；Ibuprofen and codeine；Acyclovir；Vitamin B complex tablet；75% alcohol
1.2 experimental method
Using the method for random controls, standard compliant patient is randomly divided into treatment group and control group, treatment group: cave Position injection Vidarabine Monophosphate；Control group: intravenous infusion Vidarabine Monophosphate；Two groups add Primary Care: oral acyclovir, Ibuprofen and codeine, vitamin B complex tablet treatment.Two groups of Genders, age, the course of disease and pretherapy and post-treatment VAS scoring, pain are recorded respectively The clinical datas such as pain alleviation >=30% and the time completely disappeared, bleb situation, comprehensive therapeutic effect scoring.
1.2.1 method
Control group
Intravenous infusion: with 0.9% physiological saline 150ml intravenous infusion Vidarabine Monophosphate, 200mg/ times, 1 times/day；
Treatment group:
(1) acupoint injection therapy drug: Vidarabine Monophosphate 200mg, 0.9% physiological saline 4ml, lidocaine 4ml；
(2) needle set selects: the syringe of 10ml, the syringe needle of 1ml syringe；
(3) acupuncture point positions: being sent out referring to " National Standard of the People's Republic of China, through cave position " by State Bureau of Technical Supervision Cloth: paravertebral point: 0.5 cun of Ashi Point is opened by the small of the back, spinal crest of Rauber: depending on cutaneous lesion.
(4) operating method: 1. acupoint selection: paravertebral point chooses the Jiaji of the corresponding segment in morbidity side according to the cutaneous lesion of patient Cave；Two acupuncture points in Ashi Point skin lesion part；2. taking corresponding position according to lesions of patients position, 0.9% is extracted with 10ml syringe Physiological saline 4ml 200mg Vidarabine Monophosphate is dissolved, extract 2% lidocaine 4ml, mixing be made into 8ml liquid, Sufficiently exposure affected part, after infused paravertebral point and skin lesions circumferece Ashi Point routine disinfection, exchange for the syringe needle of 1ml syringe quickly to Backbone direction is stabbed diagonally into skin (25~35 degree), and pumping is slowly infused drug in cave again without blood back, presses pin hole after needle out.Every time Inject corresponding disease damage two paravertebral points up and down and part two Ashi Points, every cave 2ml, the next day 1 time；
Two groups are oral: acyclovir, and 0.4g/ times, 2 times/day；Ibuprofen and codeine, 0.2g/ times, 3 times/day；Multi-vitamins B piece, 10mg/ times, 3 times/day；
Two groups of courses for the treatment of: 10 days 1 courses for the treatment of amount to 1 course for the treatment of；
Points for attention: operation need are sterile, take and answer cave precisely, safely, and prevent generation of having a fainting spell during acupuncture treatment；Patient is advised to keep skin lesion local Cleaning, prevention infection；The same day does not have a bath, and does not scratch during treatment, does not eat pungent irritable food.
1.2.2 observation index
Overview project
Gender, age, the course of disease were recorded in on-test the 0th day.
Criterion of therapeutical effect
Main indicator:
(1) bleb evaluation index
To there is bleb as initial time.
1. only blister time (day): bleb terminates the time increased.
2. scab forming time (day): bleb forms a scab time of the area greater than more than half.
5. the decrustation time (day): the time that crust thoroughly falls off.
The above items are observed and recorded between test the 1st~10 day；It can not record such as in the course for the treatment of, remember in follow-up Record.
(2) pain measurement index
1. visual analogue scales (VAS scoring): " 0 " indicate it is painless, " 100 " indicate patient it is envisioned that maximum pain (unit: mm) is said the scale that can most represent pain degree at that time by patient.
2. pain relieving time (day): from pain is begun with to pain relief time needed for 30% or more.
3. durante dolors (day): thoroughly disappearing to pain the required time from pain is begun with；Durante dolors On, such as more than 30 days persons are included in post herpetic neuralgia.
1. item records before test of cure, after treatment.3. 2. item in test the 1st~10 day between and treatment end postscript Record.As that can not be recorded after treatment end, then recorded in follow-up.
(3) post-herpetic neuralgia
It is recorded respectively within the 30th, 60 day in test.
(4) shingles zoster comprehensive therapeutic effect scores
Topoalgia is itched, burn feeling, fever, regional glandular enlargement, blister number, number of clusters, character, ulcer, papule, skin Damage the total mark of area etc..It before test treatment in the 1st day, records within the 11st day, in the 0th, 11 day shooting photo of test.
Secondary index:
Tolerance
Indicate very dissatisfied with 0 point, 100 points of expressions are felt quite pleased, in order to indicate the satisfaction for the treatment of that patient receives it Property, allow patient voluntarily to give a mark.
It was recorded in treatment the 11st day.
1.2.3 follow-up
In test follow-up in the 22nd, 30,60 day.
1.2.4 safety indexes
The adverse events occurred in observation treatment group and control group therapeutic process, and record and analyze.
1.2.5 adverse events
During research, researcher should advise patient (or family members) to reflect the situation after treatment strictly according to the facts, can not leading question； Pay attention to observing result, the adverse events of anomalous variation；No matter whether this research method is related with adverse events, should all record in detail A situation arises for adverse events, treating method and process, result etc., and judges with using the causality of therapy.
2 results
2.1 general information
According to Clinical Study Protocol, is collected in June, 2013 in December, 2014 and come from the attached doctor of Inner Mongolia Medical University Patients with Herpes Zoster 60 of Out-patient Department and Inner Mongol institute of traditional Chinese medicine department of acupuncture and moxibustion qualification, are randomly divided into treatment group, control group.Two groups equal No specimen falls off, and age, gender, course of disease etc. between group, and difference is not statistically significant (P > 0.05).
2.1.1 the age
In treatment group 30, the age is 14 years old minimum, 77 years old, average age 50.77 ± 15.99 years old maximum；Control group 30 In, the age is 22 years old minimum, and it is 78 years old maximum, average age 55.27 ± 12.38 years old, it is shown in Table 1.
1 two groups of age distribution situations of table (example/%)
Because different age group Rehabilitation ability is variant, therefore two groups of patient age distribution situations are analyzed, through χ2It examines, χ2 =1.336, P=0.513, P > 0.05, there was no significant difference, shows in age distribution, and two groups of patients are comparable.
2.1.2 gender
In two groups 60, in treatment group 30, male 13 accounts for 43.33%, female 17, accounts for 56.67%；Control group 30 In, male 14 accounts for 46.67%, female 16, accounts for 53.33%, be shown in Table 2.
2 two groups of sex composition distribution situations of table (example/%)
Through χ2It examines, χ2=0.067, P=0.795, P > 0.05, there was no significant difference for two groups of Genders (P > 0.05), It is comparable.
2.1.3 the course of disease
Two groups of 60 patient's courses of disease day are differed from 1 day to 11, wherein treatment group's average course of disease 7.10 ± 1.70 days；Control group Average course of disease 7.00 ± 1.72 days, it is shown in Table 3.
3 two groups of courses of disease of table compare (d)
It is examined through t, t=0.226, P=0.822, P > 0.05, illustrates two groups of patient's course of disease no difference of science of statistics, having can Compare property.
2.2 pain measurement data
2.2.1 pain intensity VAS scoring is compared:
Treatment group VAS scoring is up to 95mm, minimum 30mm, average 66.67 ± 17.49mm before treating；
Control group is up to 90mm, minimum 30mm, 62.33 ± 16.01mm of average out to；
VAS scoring treatment group is up to 10mm after treatment, minimum 0mm, 4.83 ± 3.82mm of average out to；Control group highest For 20mm, minimum 0mm, 10.17 ± 5.49mm of average out to.
Treatment group pretherapy and post-treatment difference highest 90mm, minimum 20mm, average 61.83 ± 17.09mm；Before control group treatment Difference highest 75mm, minimum 25mm afterwards, average 52.50 ± 12.98mm, are shown in Fig. 1 and table 4.
(mm) is compared in 4 two groups of VAS scorings of table
VAS scoring is compared, and is examined between treating first two groups through t, t=1.001, P=0.321, P > 0.05, difference is without statistics Meaning is learned, is comparable between group.On this basis, it tests respectively to before each group treatment with the VAS scoring after treatment.It controls The pretherapy and post-treatment VAS scoring for the treatment of group is compared, and is examined through t, t=19.812, P=0.000, P < 0.01, difference is statistically significant. The pretherapy and post-treatment VAS scoring of control group is compared, and t=22.017, P=0.000, P < 0.01, difference is statistically significant.Two groups are controlled The VAS scoring difference comparsion for treating front and back, is examined, t=2.382, P=0.021, P < 0.05, the statistically significant (P of difference through t < 0.05).It can be seen that two groups in the pain for alleviating HZ patient effectively, but the analgesic effect for the treatment of group is substantially better than pair According to group.
2.2.2 pain relief and extinction time
The time of pain relief >=30%, treatment group up to 8 days, most short is 2 days, and average time is 4.87 ± 1.38 It；Control group up to 10 days, most short was 4 days, and average time is 6.73 ± 1.53 days.Pain completely disappears time, treatment group Up to 33 days, most short was 7 days, and average time is 15.60 ± 1.10 days；Control group up to 32 days, most short was 9 days, average Time is 21.26 ± 1.15 days, sees Fig. 2 and table 5.
5 two groups of pain relief >=30% of table and the time completely disappeared compare (d)
The time of two groups of pain relief >=30% compares, and examines through t, t=-4.958, P=0.000, and P < 0.01 has aobvious Write sex differernce；Two groups of pain completely disappear the time and compare, and examine through t, t=-3.564, P=0.001, P < 0.01, have significant Statistical difference.Therefore treatment group can be obviously shortened pain relief >=30% time and pain disappearing time compared with control group.
2.3 bleb situations
Only blister time: it is 1 day that it is most short, which to stop the blister time, for treatment group, up to 7 days, average out to 3.33 ± 1.58 days；Control group It is 1 day that only the blister time is most short, up to 9 days, average out to 4.60 ± 1.85 days.
Scab forming time: it is 2 days that treatment group's scab forming time is most short, up to 9 days, average out to 6.00 ± 1.88 days；Control group It is 6 days that scab forming time is most short, up to 18 days, average out to 12.07 ± 2.89 days.
The decrustation time: it is 9 days that treatment group's decrustation time is most short, up to 25 days, average out to 16.90 ± 4.11 days；Control The most short group decrustation time is 12 days, up to 36 days, average out to 24.20 ± 6.16 days, sees Fig. 3 and table 6.
6 two groups of table stop blister, incrustation, decrustation time compare (d)
Two groups are stopped the blister time and compared, and are examined through t, t=-2.85, P=0.006, P < 0.01；Two groups of incrustation > 50% when Between compare, examined through t, t=-9.65, P=0.000, P < 0.01；Two groups of decrustation times compare, and examine through t, t=-5.404, P =0.000, P < 0.01.
Illustrate two groups in only blister, incrustation and on the decrustation time, significant difference (P < 0.05) infuses HZ patient using acupuncture point Penetrate therapy can be obviously shortened blister stop increasing, bleb incrustation and time for falling off of bleb skinning.
The scoring of 2.4 comprehensive therapeutic effects
Comprehensive therapeutic effect scoring before treating, treatment group is up to 15, and minimum 9, average out to 12.00 ± 1.80；Control group is most A height of 15, minimum 9, average out to 11.83 ± 1.82.
Comprehensive therapeutic effect scores after treatment, and treatment group is up to 3, and minimum 1, average out to 2.00 ± 0.70；Control group highest It is 6, minimum 2, average out to 4.00 ± 0.87.
The difference of two groups of pretherapy and post-treatment comprehensive therapeutic effect scorings, treatment group's highest 15, minimum 7, average 10.00 ± 1.76；It is right According to group highest 11, minimum 2, average 7.83 ± 2.09, see Fig. 4 and table 7.
7 two groups of comprehensive therapeutic effect scorings of table are compared and (are divided)
Comprehensive score compares before two groups of treatments, examines through t, t=0.356, P=0.723, and P > 0.05, indifference has Comparativity.Before the treatment for the treatment of group's comprehensive score compared with after treatment, t=31.091, P=0.000, P < 0.01 have significance difference It is different.Before the treatment of control group comprehensive score compared with after treatment, t=20.57, P=0.000, P < 0.01 have notable difference.Two groups Pretherapy and post-treatment comprehensive score difference comparsion, is examined, t=4.347, P=0.000, P < 0.01 has significant difference through t.
As the result is shown, it is believed that two kinds of therapies can significantly improve HZ general symptom, but drug injection therapy is controlled compared with dead point It treats more significant in terms of improving HZ patient's general symptom.
2.5 post herpetic neuralgia incidences
This research records the incidence of post herpetic neuralgia on the 30th, 60 day in test, is shown in Table 8.
The incidence (example/%) of 8 two groups of post herpetic neuralgias of table
It tests the 30th day and compares two groups of post herpetic neuralgia incidences, through χ2It examines, χ2=1.667, P=0.197, P > 0.05, there was no significant difference；Compare two groups of post herpetic neuralgia incidences within 60th day, through χ2It examines, χ2=2.069, P=0.492, P 0.05 no significant difference of >.Therefore there was no significant difference for 30,60 days two groups of PHN incidences after first visit.
It follows that the 30th, 60 day two groups of post herpetic neuralgia incidences of test compare no difference of science of statistics.
The evaluation of 2.6 tolerances
Treatment group is up to 100mm, minimum 65mm, 85.50 ± 9.22mm of average out to；Control group highest 100mm is minimum 9 are shown in Table for 40mm, 70.00 ± 14.80mm of average out to.
9 two groups of patient for treatment's tolerances of table compare and (divide)
Two groups of tolerance evaluation comparisons, are examined, t=4.869, P=0.000 through t, and P < 0.01 has significant statistics poor Different, patient is higher than control group for the satisfaction for the treatment of group.
The analysis of Herpes Zoster after 2.7 treatments
Total effective rate is equal to recovery from illness the sum of number of cases and effective number of cases divided by total number of cases × 100%, sees Fig. 5 and table 10.
10 Herpes Zoster of table compares (example/%)
Total effective rate after two groups of treatments is identical, but the cure rate for the treatment of group is higher than control group；Curative effect after two groups of treatments Determine, through rank sum test, Z=-2.095, P=0.036, P < 0.05, there were significant differences, and it is bright to illustrate that treatment group has compared with control group Aobvious curative effect.
2.8 adverse events incidences
Treatment group, in control group 30, adverse events occur has 0, and two groups occur without serious adverse events.
2.9 rejectings or fall off analysis and compliance evaluation
In treatment group 30, no rejecting case falls off 0, compliance 100%；In control group 30, no rejecting case, It falls off 0, compliance 100%.
3 discuss
The analysis of 3.1 treatment methods
3.1.1 medicine foundation is selected:
Related document selects prednisone acetate, vitamin B1、B12Mixed liquor, virazole and vitamin B12Mixed liquor, Mixed liquor of compound Clary injection and lidocaine etc. is as this disease of the drug therapy of acupoint injection therapy, mainly since acupuncture point is infused Penetrating this special administration route has very big advantage on treatment HZ.This research is that a kind of comparison is new because of Vidarabine Monophosphate The antiviral drugs of type, which enters generates triphosphoric acid arabinosy ladenosine and diphosphonic acid arabinosy ladenosine in vivo, they are by inhibiting disease Poison duplication and the synthesis for terminating DNA play antivirus action.Caring for the drug is both inhibitors of viral replication and viral DNA synthesis Terminator, it is safer effective in clinical treatment HZ with preferable anti-herpesvirus effect, therefore choose this product and carry out acupuncture point note It penetrates.
3.1.2 the foundation of acupoint injection therapy is selected
Drug injection therapy is to make the mechanical irritation effect of needle thorn and drug to the pharmacology of body according to theory of traditional Chinese medical science With the special administration route for being integrated as preferably performance drug and the Therapy characteristics at acupuncture point and being formed.Local cave note is antiviral Medicine can stimulate meridian point and guarantee that locally enough drug concentrations reach the effect of quickly easing pain to lesion, to sufficiently send out The synergistic therapeutic action at drug and acupuncture point is waved.
Acupoint injection therapy can make needle pierce information some structures related with acupuncture analgesia along opposite side funiculus lateralis uplink, Stimulation of The Brain, It is suppressed the afferent message of noxious stimulus, to generate analgesic effect.There is research to think that people and animal all exist to follow through low Phenomenon is hindered, illustrates acupuncture point point as medicine-feeding part and is more advantageous to drug absorption, to improve therapeutic effect.Therefore cave note treatment HZ is got over In time, to alleviating inflammation, prevent nerve fibre and ganglionic toxicity and destruction should be more advantageous, and it more can be reduced PHN incidence.
Because varicella virus is hidden in spinal cord posterior root ganglion, many treatment methods are all with quiet at present Arteries and veins instils based on treatment, but intravenous infusion first has to this link by blood circulation and gets to disease institute, this process may The concentration of disease damage topical remedy is influenced, and many scholars use cave note treatment HZ, because cave note has the characteristics that efficiently and rapidly. By in relation to studies have shown that the drug effect of acupoint injection therapy is better than oral, intramuscular injection.Therefore drug is passed through acupoint injection therapy to Jiaji by this project Cave makes drug directly reach sick institute and pierce to give full play to needle, the addition of drug and acupuncture point.Compared with western medicine therapy, acupuncture point This disease is treated in injection to have rapid-action, short treating period, good effect, saves the unique advantages such as drug, Small side effects.
3.1.3 cave foundation is selected:
Paravertebral point: bilateral symmetry is distributed, and is opened at 0.5 cun by the posterior median line of back.According to the related of Jiang Yongxia[33] Paravertebral point can be considered as to the other cave zone for opening 0.3~1 cun under spinous process.1~2 cun of depth is stabbed diagonally to backbone direction when action of acupuncture Jiaji points, Needle sense is part electric shock sample sense, acid is swollen, diffuses sometimes to chest and abdomen or four limbs, and acupuncture curative effect is definite, and operation is more conveniently, safely.
Paravertebral point has the function of Yin Yang balancing, strengthening vital QI to eliminate pathogenic factors, the promoting flow of qi and blood circulation, dredging the channel.Segment of the spinal cord to skin Property dominate[37]And modern anatomy confirms[38], have posterior ramus of spinal nerve distribution around paravertebral point, therefore have the corresponding nerve segment for the treatment of The effect of distributed areas disease.What paravertebral point was located at intervertebral spinal cord and nerve roots emerges position, can inhibit the excitement of spinal conduction The dual analgesic activity of acquisition maincenter and periphery.
Ashi Point: " bitterly be defeated ", or " knot muscle lesion point ", are the Ashi Points on narrow scope；It is distributed across whole body, it can It to put farther away reflecting point apart from slight illness or can also be sensu lato Ashi Point through cave, extra-point to be located at ailing point.Ye Yongming It has carried out analysis to 694 Ashi Point pertinent literatures to find, the Ashi Point of numerous diseases is all in local correlation diseased region.
Ashi Point is reflecting point of the ailing part in body surface, and needle pierces Ashi Point, bootable focal arrival of acu-esthesia, and activating microcirculation and removing stasis medicinal is led to Channels and activating collaterals, directly inhibition pain reaction；Doctor trained in Western medicine, which thinks that its mechanism may is that, enhances local metabolic, and pathological tissues inflammatory is situated between Matter, which absorbs, to be accelerated.
It selects paravertebral point and Ashi Point for injection point, the effect of the collaterals and relieving pain at acupuncture point can be played；And pass through drug It is injected directly into around injured nerve, increases local drug concentration, and the therapeutic effect of drug can be given full play to, and then play cave Position, needle thorn, the synergistic effect of drug, effectively releasing patient suffering.
3.2 interpretation of result
3.2.1 the age
This disease can fall ill in all age group, and elderly and infirm is common, and the health after the crowd of different age group treatment There is individual differences for reactivation power.And the study find that, age bigger crowd easier leaves post herpetic neuralgia.There is research aobvious Show that post herpetic neuralgia easily occurs for 50 years old or more HZ patient about 62%.Analyze reason: the elderly's healthy tendency is weak, often because of blood deficiency and sthenic liver-energy, Damp and hot poison accumulates, cause qi depression to blood stasis, channels and collaterals blocking barrier, therefore sharp ache, protracted course of disease；And gerontal patient's immunologic hypofunction, Institutional framework is degenerated, and the ability for repairing nerve reduces, and nerve fiber restores slower, is easy for a long time there are post herpetic neuralgia, That is the morbidity of shingles zoster and post herpetic neuralgia is related to age factor, the research of this observation result and Hai Fengwei professor As a result consistent.
3.2.2 pain measurement
3.2.2.1VAS scoring
Due to pain intensity (VAS rating method) be record point of observation before in 24 hours patient oneself it is envisioned that most pain Point.This is it is possible that select deviation, due to individual perception level, judgment criteria, psychological quality and hormonal readiness, fat or thin journey Difference in terms of each subjectiveness and objectiveness such as degree, skin thin and thick and stimulating method, people produce different journeys to same stimulation The pain perception of degree, therefore there is individual differences for tolerable pain degree[48].And for there may be grind between two groups of this research The different selection deviation of the tolerance degree of object pain is studied carefully, thus the comparativity between influence group.It is included in reduce selection deviation Sample size can be increased before research object or carry out the assessment of tolerable pain situation, filter out similar qualified subject.
It is obtained by comparing two groups of VAS scoring, two groups are effective in the pain for alleviating HZ patient, but treatment group Analgesic effect is substantially better than control group.Analysis result may be that can not only be played acupuncture point clearing and activating the channels and collaterals due to Point research, be adjusted With the comprehensive function of qi and blood and Antiviral Effect, moreover it is possible to extend the needles sense such as swollen, numb at acupuncture point by gradually absorbing for drug, keep The acupoint stimulation of relatively long time, this lasting stimulation can guarantee the extension of analgesic effect.
3.2.2.2 for the influence of pain time
It is obtained by clinical research, treatment group completely disappears the time in pain relief >=30% time and pain and is considerably less than Control group (P < 0.01).This explanation, acupoint injection therapy can be obviously shortened pain relief and the extinction time of patient.(P < 0.01). Consider that this result may be to have played the synergistic effect of paravertebral point centralizing qi degrading the channel Yu the clear residual poison of Ashi Point energy stasis-dispelling and pain-killing, leads to Then not bitterly.Meanwhile research has shown that, action of acupuncture Jiaji points, it can be by improving the body threshold of pain, to reinforce body to the tolerance journey of pain Degree, moreover it is possible to adjust autonomic nerves system and sensory nervous system, block the conduction of pain sensation fiber excitement, make to play analgesia With.Body systemic immunity function also can be improved in this external stimulus paravertebral point, so that lesion local nerve blood vessel adjacent tissue generates Benign reaction, to reach diminish inflammation reaction and analgesic effect.Certainly, the benefit card being injected directly into around injured nerve Because that may also play a role, which can improve local microcirculation, while can also pierce by the conduction path of blocking pain nerve Swash nerve cell and discharge endorphin, plays analgesic effect similar with morphine, the pain for alleviating patient early.Thus it can mention Show, treatment group is more advantageous than control group in terms of shortening pain time, can accelerate the disappearance of pain symptom, solve patient faster Pain.
3.2.3 skin lesion improves situation
Treatment group and control group, which increase time, scab forming time and decrustation time to the stopping of shingles zoster blister, has conspicuousness poor Different (P < 0.01).This may be by carrying out at paravertebral point and Ashi Point acupoint injection therapy can make drug along channels and collaterals it is straight in sick institute, The metabolism for accelerating local organization, promotes the absorption process of drug, inhibits viral mass propagation, make injured nerve obtain and When reparation；Affected part qi and blood is set to reconcile simultaneously, train of thought is unobstructed, promotes the heresy of wet poison to walk from table, to significantly improve part Skin lesion situation shortens only blister, incrustation and decrustation time.
3.2.4 post herpetic neuralgia incidence
A situation arises for the post herpetic neuralgia recorded when by comparing follow-up in 30,60 days, not can prove that paravertebral point acupuncture point still The incidence (P > 0.05) of PHN can be effectively reduced in injection Vidarabine Monophosphate.The former estimated this law of this research is on preventing PHN It is treated compared with conventional western medicine intravenous infusion advantageous.Because being shown according to correlative study, the generation of PHN is related with immunologic dysfunction.Exempt from Epidemic disease Imbalance, the IL-2 that Th1 cell generates are gradually decreased, and the IL-10 of Th2 secretion increases, and leads to antiviral ability Decline, and acupoint injection therapy can by promote cytotoxic T lymphocyte and bone-marrow-derived lymphocyte differentiation and proliferation, induce lymph because The interferon and LAK cell of son activation, and enhance NK cell activity, and then reinforce lymphocyte, LAK cell and NK cell to entering The lethality of pathogen is invaded simultaneously according to the characteristic of acupoint injection therapy, drug can be made to guide drugs to illness station, give full play to drug and acupuncture point Coordinative role.It analyzes this result and is expected not being inconsistent mainly to consider that this research sample size is small, the finiteness of sample size makes to PHN A situation arises cannot make accurate judgement.The disease incidence decline of 60 days post herpetic neuralgias of this research, there may be can not for analysis Predictive factors: patient's successive treatment, nursing, diet, living habit etc., such as may patient occur after 30 days after pain from Row carries out drug or other intervening measures, so that the disease incidence decline of 60 days post herpetic neuralgias, this is that this research is uncontrollable.
3.2.5 tolerance is analyzed
Tolerance evaluation is that satisfaction property of the treatment method that research object after the treatment receives it records, wherein Very dissatisfied to be indicated with 0mm, feeling quite pleased is indicated with 100mm, and patient is allowed voluntarily to give a mark.That is patient's expiring for type Treated with Point-injection Therapy Meaning degree be better than control group, consider there may be following reasons: on 1. treatment times, due to acupoint injection therapy treatment time and control It treats number and is considerably less than control group, the personal time of patient is greatly saved.2. the medical expense of patient has been saved, because of acupuncture point The dosage of injection is the half of the dosage of conventional western medicine dead point treatment, can reach relatively satisfactory treatment with smaller dose Effect, not only reduces side effect, also significantly reduces the financial burden of patient.3., can be timely and effective because this law relative efficacy is good Ground improves the state of an illness of patient and releases the slight illness of patient, therefore is easy to be received by masses.
3.2.6 the analysis of curative effect
This result of study show that the cure rate for the treatment of group is higher than control group, and both methods curative effect is variant, and explanation is controlled The curative effect for the treatment of group is better than control group (P < 0.05).But two groups of total effective rates compare (P > 0.05), and there was no significant difference, illustrates two Group is effective to the treatment of HZ patient, not can prove that the total effective rate for the treatment of group still better than control group, this may be few with sample size It is related.And the preferable analysis of causes for the treatment of group's curative effect is as follows: an intravenous infusion first has to this link by blood circulation and gets to Lesion part, this process may will affect the concentration of disease damage topical remedy.Two caves note can not only be timely with its unique advantage The pain degree of effective reduction of patient shortens pain relieving time, improves skin lesion situation, to improve therapeutic effect, moreover it is possible to Patient is shifted to the attention of local pain by the stimulation to paravertebral point, and each of which increases patients to the letter of rehabilitation The heart.Because of the presence of feeling of pain, people can be worn down to disease to confidence more, timely and effectively alleviate slight illness, patient can be made by coke The psychological conditions such as worry, depression turn to positive psychological condition, so that positive partner treatment, promotes disease to process more.
In summary several points are it is found that this research early puts patient while reducing drug to the injury of patient's body The puzzlement of pain is taken off, hence it is evident that the subjective feeling and life quality for improving patient save valuable time, make patient as early as possible Recovery it is physically and mentally healthy, there is positive social effect；And this law medical treatment cost is low, therefore have good economic benefits；These are all It is very important advantage of the paravertebral point drug injection therapy in treatment HZ.
4 conclusions
(1) Point research and sessile drop method treatment can effectively mitigate patient pain, but acupoint injection therapy group is relieving pain Degree and on the time it is obviously more advantageous than intravenous infusion group；
(2) pass through the comparison to different time index, it was demonstrated that acupoint injection therapy group can be shortened each timeliness index, so as to bright It is aobvious to shorten the course for the treatment of；
(3) Point research and sessile drop method treatment can reduce the scoring of shingles zoster comprehensive therapeutic effect, but acupoint injection therapy group is excellent In control group；
(4) acupoint injection therapy therapy is opposite saves medicine source and medical expense, and Small side effects, safer, reliable, is worth It furthers investigate and is widely popularized.
The working principle of the invention is:
It is obvious to a person skilled in the art that invention is not limited to the details of the above exemplary embodiments, Er Qie In the case where without departing substantially from spirit or essential attributes of the invention, the present invention can be realized in other specific forms.Therefore, no matter From the point of view of which point, the present embodiments are to be considered as illustrative and not restrictive, and the scope of the present invention is by appended power Benefit requires rather than above description limits, it is intended that all by what is fallen within the meaning and scope of the equivalent elements of the claims Variation is included within the present invention.

Claims (3)

1. a kind of clinical research methods of paravertebral point injection Vidarabine Monophosphate, which is characterized in that specifically includes the following steps:
S1, sample are chosen, and the Patients with Herpes Zoster that certain amount is qualified according to screening technique screening is selected, and are divided into two groups, and one Group is control group, and one group is treatment group；
S2, treatment, control group use intravenous infusion: with 0.9% physiological saline 150ml intravenous infusion Vidarabine Monophosphate, 200mg/ times, and 1 Times/day；Treatment group selects the syringe of 10ml, and the syringe needle of 1ml syringe carries out acupoint injection therapy drug, drug include monophosphate Ah Sugared adenosine 200mg, 0.9% physiological saline 4ml, lidocaine 4ml；Specific injection is the following steps are included: 1. acupoint selection: paravertebral point, The paravertebral point of the corresponding segment in morbidity side is chosen according to the cutaneous lesion of patient；Ashi Point, two acupuncture points in skin lesion part；2. according to trouble Person's cutaneous lesion takes corresponding position, extracts 0.9% physiological saline 4ml for 200mg Vidarabine Monophosphate with 10ml syringe 2% lidocaine 4ml is being extracted in dissolution, and mixing is made into 8ml liquid, affected part is sufficiently exposed, by infused paravertebral point and skin lesions circumferece After Ashi Point routine disinfection, the syringe needle for exchanging 1ml syringe for is quickly stabbed diagonally to backbone direction into skin (25~35 degree), is taken out nothing and is returned Blood is slowly infused drug in cave again, presses pin hole after needle out.Two paravertebral points up and down and the part two of corresponding disease damage are injected every time A Ashi Point, every cave 2ml, the next day 1 time；Control group is oral with treatment group simultaneously: acyclovir, and 0.4g/ times, 2 times/day；Lip river Sweet smell is to because of 0.2g/ times, 3 times/day；Vitamin B complex tablet, 10mg/ times, 3 times/day；Two groups of courses for the treatment of: 10 days 1 courses for the treatment of amount to 1 A course for the treatment of.
S3, observation index, including following index item:
(1) bleb evaluation index, to there is bleb as initial time；1. only blister time (day): bleb terminates the time increased； 2. scab forming time (day): bleb forms a scab time of the area greater than more than half；3. the decrustation time (day): crust thoroughly fall off when Between；The above items are observed and recorded between test the 1st~10 day；It can not record such as in the course for the treatment of, be recorded in follow-up；
(2) pain measurement index, 1. visual analogue scales (VAS scoring): " 0 " indicate it is painless, " 100 " indicate patient it is envisioned that Maximum pain (unit: mm), the scale that can most represent pain degree at that time is said by patient；2. pain relieving time (day): From pain is begun with to pain relief time needed for 30% or more；3. durante dolors (day): from begin with pain to Pain thoroughly disappears the required time；On durante dolors, such as more than 30 days persons are included in post herpetic neuralgia；1. item is controlled in test It is recorded before treatment, after treatment；3. 2. item in test the 1st~10 day between and treatment end after record；As can not after treatment end Record, then record in follow-up；
(3) post-herpetic neuralgia records on the the 30th, 60 day respectively in test；
(4) shingles zoster comprehensive therapeutic effect scores, and topoalgia is itched, burn feeling, generates heat, regional glandular enlargement, blister number, cluster Number, character, ulcer, papule, the total mark of skin lesion area etc..In test the 1st day treatment before, the 11st day record, in test the 0th, 11 days shooting photos.
2. the clinical research methods of paravertebral point injection Vidarabine Monophosphate according to claim 1, which is characterized in that step It includes: that (1) bleb appeared in one week that sample in rapid S1, which is included in standard, without any curer；(2) male or female, year Age 16~80 years old patient；(3) in meeting, doctor trained in Western medicine diagnosis of herpes zoster standard person.
3. the clinical research methods of paravertebral point injection Vidarabine Monophosphate according to claim 1, which is characterized in that step Except sample exclusion criteria in rapid S1 includes: (1) post-herpetic neuralgia；(2) shingles zoster of abnormal type, such as Ear, external eyes, internal organs portion, meninx shingles zoster, herpes zoster generalisatus；(3) hypoimmunity or Long-term Oral immunosuppressor Or glucocorticoid person；(4) 1 weeks inherent parts or system used antiviral agent person；(5) gestation, lactation and quasi- gravid woman； It (6) include mental disease and hemopoietic system and liver, kidney, Cardial or cerebral vascular diseases etc. with serious primary disease person；(7) state of an illness is heavier, It is difficult to the safety and efficacy person of accurate evaluation treatment；(8) it does not meet and is included in standard person.
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