CN102552473A - New application of Keke preparation - Google Patents
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Abstract
The invention discloses new application of a Keke preparation for treating cough due to pathogenic wind-heat in preparation of medicines for treating cold cough and cold and phlegm wet cough. A Chinese medicinal composition consists of 360 parts of ephedra, 360 parts of poppy capsule, 360 parts of liquorice, 360 parts of bitter almond, 112.5 parts of balloon flower, 112.5 parts of radish seed and 112.5 parts of gypsum. The Chinese medicinal composition can be prepared into oral formulations, including tablets, capsules, granules, an oral solution preparation, powder or pills. The invention overcomes the technical bias in the traditional pharmacy and medication, opens up the new application of the Chinese medicinal composition including Keke capsules and Keke tablets in the preparation of medicines for treating cold cough and cold and phlegm wet cough, and has good social and economic benefits.
Description
Technical field
The present invention relates to field of traditional Chinese medicine pharmacy, especially a kind of new purposes that is used to treat cough due to pathogenic wind-heat's Chinese medicine composition.
Background technology
The tradition traditional Chinese medical science is thought lung being a delicate viscus, is subject to the exopathogen invasion and attack, if receive the invasion and attack of wind, cold, summer-heat, wet, dry, fiery six climate exopathogens, causes impairment of dispersing and descending function of the lung, and abnormal rising of lung-QI causes cough.Cough has the branch of wind and cold and wind heat by pathogenic factor character.The cough due to wind and cold, how by the heresy invasion and attack of wind and cold, in strongly fragrant lung qi, lung qi obstruction and cause that cardinal symptom is low voice speaking for cough, the thin color of coughing up phlegm is white, aversion to cold, or heating is arranged is lossless, itching throat, nasal obstruction watery nasal discharge, or with headache general pain, arthralgia, thin white fur of tongue, floating and tense pulse.Wind and cold holds concurrently that productive cough due to phlegm-damp refers to that the cough due to wind and cold has that expectorant is sticky concurrently, lack of appetite, loose stool, tongue are greasy in vain, rolling pulse or moisten cunning.The cough due to pathogenic wind-heat, many because heresy of wind heat are violated lungs, impairment of purifying and descending function of the lung and cause that cardinal symptom is cough, it is slightly high to cough sound, yellowish thick sputum, it is not well to cough up phlegm, with fever and aversion to wind, the headache sweating, dry throat and mouth, nose flow yellow thick nasal discharge, red tongue with thin and yellow fur, floating and rapid pulse etc.
By each 360 parts of Herba Ephedrae, Pericarpium Papaveris, Radix Glycyrrhizae and Semen Armeniacae Amarums, the prescription of each 112.5 parts of composition of Radix Platycodonis, Semen Raphani and Gypsum Fibrosum derives from name side's MAXINGSHIGAN TANG of Zhang Zhongjing " Treatise on Febrile and Miscellaneous Disease " treatment dyspnea and cough due to lung-heat.The descendant according to " make mutually with material, abnormal smells from the patient is in harmony mutually ", changes its original intention on the basis of Maxing Ganshi Tang, deposits it and becomes second nature, and adds Radix Platycodonis, Pericarpium Papaveris, Semen Raphani three flavor medical materials, thereby has widened the scope of application.All medicines share plays altogether that heat clearing away is eliminated the phlegm, the effect of relieving cough and asthma, and its indication is the cough due to pathogenic wind-heat.
Guizhou Yibai Pharmaceutical Co., Ltd is developed into the Chinese patent medicine KEKE JIAONANG with above-mentioned prescription, records
In" Drug Standard of Ministry of Public Health of the Peoples Republic of China Chinese traditional patent formulation preparation " (the 17th), and be put into nonprescription drugs.At present, domestic enterprise has gone out the Chinese patent medicine of multiple dosage forms such as cough-relieving tablets, cough-relieving syrup through the change formulation development according to this prescription.For example good effect is obtained according to the cough-relieving tablets of above-mentioned prescription production in the Zhongshan Zhongzhi Pharmaceutical Group Co., Ltd.The present invention is referred to as cough stopping formulation to the preparation of the various dosage forms of being processed by above-mentioned prescription.
According to " Pharmacopoeia of People's Republic of China clinical application notice " record, KEKE JIAONANG is clinical to be used for expectorant heat and to accumulate the cough due to lung or the phlegm-damp heat-transformation, the disease that dyspnea with rapid respiration is breathed hard, and wind-cold affecting lung person should not use.This also is the generally understanding of present the world of medicine to KEKE JIAONANG (sheet) indication.Domestic have a document announcement; KEKE JIAONANG is to the respiratory system commonly encountered diseases; The cough that frequently-occurring disease causes, cough up phlegm, symptom such as asthma, uncomfortable in chest, chest pain, itching throat has obvious curative effects; Especially to cough, expectorant, to breathe heavily three primary symptom effects remarkable, the above-mentioned symptom total effective rate that acute/chronic bronchitis, asthma etc. is caused reaches 76.2%.Its indication all points to cough due to pathogenic wind-heat's symptom, and report is to some extent never seen in the effect that KEKE JIAONANG or cough-relieving tablets etc. can be used to treat the cough due to wind and cold.
Summary of the invention
For expanding the application of Chinese medicine; Research worker of the present invention is passed through long term studies and is groped; Proof is according to the Chinese medicine composition (following abbreviation " Chinese medicine composition ") of the related prescription preparation of KEKE JIAONANG (sheet); Also be applicable to the treatment cough due to wind and cold, and have good effect and safety.
Thus, the object of the present invention is to provide the pharmaceutic usage of above-mentioned Chinese medicine composition.Specifically be that said composition is used to prepare the new application of productive cough due to phlegm-damp medicine of holding concurrently of treatment cough due to wind and cold's medicine and wind and cold.The prescription of said Chinese medicine composition is by each 360 parts of Herba Ephedrae, Pericarpium Papaveris, Radix Glycyrrhizae and Semen Armeniacae Amarums, and Radix Platycodonis, Semen Raphani and Gypsum Fibrosum be 112.5 parts of compositions respectively.The source of above Chinese crude drug is consistent with China pharmacopeia.
Described Chinese medicine composition can be made into and is fit to oral dosage form, comprises tablet, capsule, granule, oral liquid, powder or pill.
To the cough due to wind and cold; The present invention through multicenter, at random, double blinding, the clinical trial of positive drug parallel control; The result shows; After above-mentioned Chinese medicine composition (tablet) treatment, main curative effect index is coughed symptom score, the score of nocturnal cough's symptom, cough degree (VAS) in the daytime all than having clear improvement before the treatment; And can obviously improve clinical symptoms, signs such as amount of expectoration, expectorant matter, heating, itching throat, aversion to cold, nasal obstruction watery nasal discharge, clinical efficacy is preferably arranged.Compare the difference not statistically significant with Tongxuanlifei sheet matched group.
Compare with positive drug parallel control group, the improvement rate of coughing in the daytime after the test group treatment is 89.0%, and the improvement rate of coughing in the daytime after the treatment of control group is 93.8%, the difference not statistically significant.Test group treatment back nocturnal cough's improvement rate 87.0%, nocturnal cough's improvement rate 89.3% after the treatment of control group, difference not statistically significant.
Two groups of treatment back cough degree score improvement degree compare, and the score of test group treatment back cough degree changes
Kind rate 86.4%, cough degree score improvement rate 93.8% after the treatment of control group, difference not statistically significant.
Test group is disappearance of cough rate 35.8% in the daytime, and matched group is disappearance of cough rate 41.1% in the daytime; Test group nocturnal cough's disappearance rate 49.3%, matched group nocturnal cough disappearance rate 46.8%; Test group cough degree score disappearance rate 27.2%, matched group cough degree score disappearance rate 24.1%.Therapeutic effect difference not statistically significant.
Tcm syndrome curative effect treatment group cure rate is 21.4%, and obvious effective rate is 30.7%, and effective percentage is 41.7%, and cure rate and obvious effective rate are 52.1%, and total effective rate is 93.9%; The matched group cure rate is 18.8%, and obvious effective rate is 28.6%, and effective percentage is 46.4%, and cure rate and obvious effective rate are 47.4%, and total effective rate is 93.7%.Two groups relatively, and difference does not have the significance meaning.
The symptom of coughing up phlegm all has clear improvement after two groups of treatments, and test group amount of expectoration improvement rate is 74.5%, expectorant matter improvement rate is 73.6%, and matched group is 71.4%, expectorant matter improvement rate is 71.4%.Two groups of improvement degree compare the difference not statistically significant.
Part patient blood, urine appear in the therapeutic process, just routine, renal function, electrocardiogram testing result surpass the range of normal value that each center provides, and according to the analysis and the judgement of researcher, all do not think relevant with trial drug, meet the drug safety requirement.
Above-mentioned clinical effectiveness proves, above-mentioned Chinese medicine composition is used for the treatment cough, and the for example cough that causes of acute tracheobronchitis, chronic bronchitis belongs to cough due to wind and cold, the wind and cold productive cough due to phlegm-damp of holding concurrently and has clinical therapeutic efficacy and drug safety preferably.
The present invention has overcome the technological prejudice of traditional pharmacy medication, has opened up above-mentioned Chinese medicine composition and has comprised that KEKE JIAONANG, cough-relieving tablets in preparation treatment cough due to wind and cold and the wind and cold new purposes aspect the productive cough due to phlegm-damp medicine of holding concurrently, have good society and economic benefit.
The specific embodiment
Present embodiment 1 through 480 routine clinical case multicenters, at random, double blinding, positive drug parallel check experiment, according to optimal efficiency check clinical trial design, objective evaluation cough-relieving tablets treatment cough belongs to the hold concurrently clinical efficacy of productive cough due to phlegm-damp of cough due to wind and cold, wind and cold.And through blood, urine, the just observation of routine, darling renal function and adverse events, the safety of objective evaluation cough-relieving tablets.
One, clinical trial method: adopt optimal efficiency check, multicenter, at random, double blinding, positive drug parallel control clinical trial method.
Two, clinical trial observation index: the main effects index comprises the score of cough symptom (night in the daytime), cough degree (VAS).The secondary efficacy index comprises cough remission time, cough recurrent number; Simultaneous phenomenons such as expectoration; The tcm syndrome curative effect.
Three, test crowd and experimenter go into the group situation:
Qualified experimenter's inclusion criteria, cough due to wind and cold's symptom is low voice speaking to cough, and the thin color of coughing up phlegm is white, aversion to cold, or heating is arranged, and lossless, itching throat, the nasal obstruction watery nasal discharge, or with headache general pain, arthralgia, thin white fur of tongue, floating and tense pulse are standard.The wind and cold productive cough due to phlegm-damp of holding concurrently, with the cough due to wind and cold have that expectorant is sticky concurrently, lack of appetite, loose stool, tongue are greasy in vain, rolling pulse or to moisten cunning be standard.18 years old to 65 years old age.
Screen pro rate to test group and the matched group of qualified experimenter with 3:1, the observation patient is the outpatient, strict control variable factor.Clinical trial is carried out in 6 tame hospitals simultaneously.Go into to organize case 480 examples altogether, test group 360 examples wherein, matched group 120 examples; Run counter to inclusion criteria case 8 examples, test group 6 examples wherein, matched group 2 examples; Come off or drop by the wayside case 23 examples, test group 13 examples wherein, matched group 10 examples; Accomplish altogether in the eligibility and observe 449 examples, test group 341 examples wherein, matched group 108 examples.
Four, dosage regimen:
Test group: cough-relieving tablets, oral, 4 of 2+placebo (magneta colour), 2 times on the one.
Matched group: Tongxuanlifei sheet (Film coated tablets), oral, 2 of 4+placebo (blueness), 2 times on the one.7 days courses of treatment.
Wherein, the test group cough-relieving tablets is produced by intelligence Pharmaceutical group in the middle mountain and is provided.Its prescription is by each 360g of Herba Ephedrae, Pericarpium Papaveris, Radix Glycyrrhizae and Semen Armeniacae Amarum; Each 112.5g of Radix Platycodonis, Semen Raphani and Gypsum Fibrosum forms.Matched group Tongxuanlifei sheet is provided by Guangdong Boluo Pioneer Medicinal Group Co., Ltd., and this medicine is made up of Radix Platycodonis, Pericarpium Citri Reticulatae, Radix Peucedani, Herba Ephedrae, Semen Armeniacae Amarum etc.The function cold expelling that induces sweat, the lung qi dispersing antitussive is used for diseases such as cough due to wind and cold.Be clinical generally acknowledged treatment cough due to wind and cold, the cough due to wind and cold nonprescription drugs of phlegm-damp of holding concurrently.
Five, drug combination requires:
During clinical trial, must not use the anti-microbial type medicine; Must not use has therapeutical effect or cures mainly similar Chinese medicine decoction, Chinese patent medicine and Western medicine etc. with the trial drug function cough; If in experimenter's therapeutic process; Merge the bacterial infection person; To routine blood test WBC >=normal value upper limit 20%, the experimenter patient more than 37.5 ℃ that generates heat; Visual clinical setting is taken the circumstances into consideration to add and is used antibiotic therapy, uses oral or quiet of levofloxacin, as selecting secondary or third-generation cephalosporin for use to the levofloxacin allergy sufferers.If the experimenter meets qualified subject enrollment standard; Need in clinical trial, to continue medication person and merge other disease; Or due to illness the feelings treatment needs; Or the treatment unsatisfactory curative effect, really need add with other medicines or treatment means person, answer title (or treatment means), dosage, medication number of times, administration time of medicament that itemized record make etc.
Six, clinical trial step:
That main clinic symptoms, picture of the tongue, pulse condition, sign, auscultation of lung all need be treated is preceding, treatment back the 3rd day, the 7th day each observed and recorded in treatment back once.
Heating (oxter is more than 37 ℃), every day the early, middle and late body temperature of respectively measuring 1 time, the soprano is as body temperature on the same day in measuring with 3 times.
Inspection before the treatment of chest X line.
Routine blood test, routine urinalysis, stool routine examination, electrocardiogram, liver function (ALT), renal function (BUN, Cr) inspection must be before treatments, treatment back the 7th day each detect once.
Seven, evaluation criterion:
(1) main effects index therapeutic evaluation:
The score of cough symptom, cough degree are carried out comparing before and after two groups of treatments, and the improvement degree and the disappearance rate of statistics symptom.
1. cough symptom point system does, the cough symptom integral be divided into into integration in the daytime and night integration two parts, every part all is divided into 0-3 fens 4 grades (seeing table 1) according to different light and heavy degrees.This scoring system has reflected affected situation of cough frequency, intensity and quality of life.
Table 1
| Score | In the daytime the symptom of coughing score | The score of nocturnal cough's symptom |
| 0 minute | There is not cough | There is not cough |
| 1 minute | Idol has of short duration cough | Of short duration cough or idol have the nocturnal cough when sleeping |
| 2 minutes | Frequent cough, the slight effect daily routines | Because of cough slight effect nighttime sleep |
| 3 minutes | Frequent cough has a strong impact on daily routines | Because of cough has a strong impact on nighttime sleep |
2. cough degree point system:
Inspection method: visual analogue scale (visual analogue scale; VAS) adopt the linear gauge point-score, be the subjective cough of experimenter grading, promptly prepare the Vertical surveyors' staff of 100mm; 0 dial compass is decided to be minimum does not promptly have cough; The 100mm dial compass is decided to be maximum and intolerable cough, lets the experimenter think at him and can reflect that the horizontal part of cough does a labelling, keeps the score as the cough degree with the mark reading.Numerical value is big more, and expression cough degree is heavy more.
The standard of keeping the score.
Do not have (0 minute): keep the score 0 for there not being cough.
Slightly (1 minute): keep the score 1～3 for slightly coughing.
Moderate (2 minutes): keeping the score 4～6 is the moderate cough.
Severe (3 minutes): keeping the score 7～10 is the severe cough.
(2) secondary efficacy index therapeutic evaluation.
1. cough remission time:
The patient reaches in the daytime and the score of nocturnal cough's symptom≤1 minute or 1 grade that descends, and continues 48 hours persons, is called " alleviation ".The patient reaches the time that cough is alleviated in the record observation period.Be in the daytime and nocturnal cough's symptom score≤1 minute (annotate: what the cough symptom was scored assessment is the preceding 24 hours status of cough of patient) if the cough symptom of patient's diary card was scored continuous two days, then " cough remission time " is designated as one day after.For example on the 5th day and the 6th day patient's diary card in the daytime and the score of nocturnal cough's symptom all≤1 minute, the remission time of then coughing is designated as " 6 days ".
2. cough recurrent number:
After patient's cough reaches above " alleviation " standard, occur in the daytime again or the score of nocturnal cough's symptom >=2 minutes or 1 grade that rises, get rid of respiratory tract infection person is taken place once more, be called " recurrence ".The patient's number of times and order of severity of recurrence that occur coughing in the record observation period.
3. simultaneous phenomenon such as expectoration.
1) amount of expectoration.
Do not have (0 minute): do not have and cough up phlegm.
Slightly (1 minute): expectoration 10-50ml round the clock.
Moderate (2 minutes): expectoration 51-100ml round the clock.
Severe (3 minutes): expectoration＞100ml round the clock.
2) expectorant matter.
Do not have (0 minute): do not have and cough up phlegm.
Slightly (1 minute): the thin color of expectorant matter is white.
Moderate (2 minutes): in the expectorant matter or matter sticking, be prone to bring up.
Severe (3 minutes): thick sputum brings up effort.
4. heating: do not have heating meter 0 minute; 37～38 ℃ of meters of axillaty temperature 1 minute.
5. itching throat: do not have meter 0 minute, meter 1 minute is arranged.
6. aversion to cold: do not have meter 0 minute, meter 1 minute is arranged.
7. nasal obstruction watery nasal discharge: do not have meter 0 minute, meter 1 minute is arranged.
8. a general pain: do not have meter 0 minute, meter 1 minute is arranged.
9 lack of appetite: do not have meter 0 minute, meter 1 minute is arranged.
10 loose stools: do not have meter 0 minute, meter 1 minute is arranged.
11. tcm syndrome criterion of therapeutical effect.
1) recovery from illness: the tcm syndrome clinical symptoms all disappears, and the total score value in treatment back is 0 minute, and promptly therapeutic index is 100%.
2) produce effects: the tcm syndrome clinical symptoms is obviously improved, 75%≤therapeutic index＜100%.
3) effective: the tcm syndrome clinical symptoms is improved, 30%≤therapeutic index＜75%.
4) invalid: the tcm syndrome clinical symptoms does not have improvement, therapeutic index＜30%.
Annotate: tcm syndrome therapeutic index=(the total score value of tcm syndrome symptom before the total score value of tcm syndrome symptom before the treatment-total score value of treatment back tcm syndrome symptom/treatment) * 100%.
Main tcm syndrome scoring value=cough symptom score+cough degree (amount of expectoration, expectorant matter)+heating+itching throat+aversion to cold+nasal obstruction watery nasal discharge+general pain+lack of appetite+loose stool of scoring+cough up phlegm.
(3) safety evaluatio: laboratory checking index (blood, urine, just routine, the heart, hepatic and renal function) and clinicing symptom observation (general and local untoward reaction).
1. evaluation criterion.
One-level: safety, there is not any untoward reaction; The safety indexes inspection is no abnormal.
Secondary: compare safety, mild adverse effects is arranged, need not do any processing and can continue administration; The safety indexes inspection is no abnormal.
Three grades: safety issue is arranged, moderate untoward reaction is arranged, or safety indexes has mile abnormality, can continue administration after processing.
Level Four: because of serious adverse reaction is ended test; Or the safety indexes inspection is obviously unusual.
2. the record of adverse events, untoward reaction and method for reporting:
Adverse events (Adverse Event) definition: patient or clinical trial experimenter accept the bad medical events that occurs behind a kind of medicine, but might not cause effect relation be arranged with treatment.
Serious adverse events (Serious Adverse Event) definition: refer to that " adverse drug reaction report and monitoring management way " refers to causing that because of taking medicine the reaction of one of following infringement situation takes place: cause death; Carcinogenic, teratogenesis, cause birth defect; Dangerous and can cause the permanent or significant permanent disability of human body to life; Organ dysfunction is produced permanent damage; Cause being in hospital or the hospital stays prolongation.
The adverse events record
Adverse events to the duration of test appearance; Should its kind, degree, time of occurrence, persistent period, treatment measures, processing process and lapsing to etc. be recorded in CRF; And taking all factors into consideration complication; On the basis of drug combination, estimate the dependency of itself and trial drug, and by doctor's itemized record.Case to because of adverse events, untoward reaction drug withdrawal should be carried out follow up survey, its result of itemized record.
Safety detection index (routine blood test, routine urinalysis, stool routine examination, electrocardiogram, liver function, renal function) is if appearance is unusual in the treatment, after the treatment; Check between must be in due course; Record faithfully; And carry out analysis-by-synthesis with situation such as experimenter's morbidity, treatments, relevant to determine whether with trial drug.
The criterion of adverse events and trial drug relation
Confirm whether adverse events and trial drug exist cause effect relation, can judge according to the standard (Gao Dongchen etc. " adverse effect supervision guide ", Chinese Medicine science and technology publishing house version in 1996) that work out at Ministry of Public Health adverse drug reaction supervision center.Judge to divide Pyatyi: cause effect relation judge divide certainly, probably, possible, suspicious and impossible.
Untoward reaction grading standard:
Gently: slight reaction, symptom does not develop, and generally need not treatment;
In: the ADR symptom is obvious, and vitals and tissue have certain damage, is prone to recover;
Heavy: vitals damage, disable, teratogenesis, carcinogenic, threat to life, can cause sequela, or cause patient to need hospitalization, and the inpatient need prolong hospital stay.
Eight, statistical analysis technique:
This test adopts two groups of the optimal efficiency check to compare.Each continuous variable carries out test of normality in case of necessity.According to the character (metering, classification and ranked data) of clinical testing data, select suitable statistical analysis technique.Group data is with X2 check or accurate probabilistic method.Measurement data satisfies normality and homogeneity of variance claimer two sample means are relatively checked with t; The relatively Wilcoxon rank test of backlog demand person's two sample means is relatively matched rank test with Wilcoxon before and after self.Ranked data are with the Wilcoxon rank test (correction) relatively of two samples.The significance level of statistical test is 0.05.The Cochran-Mantel-Haenszel method is adopted in the center effect analysis.There is lack of uniformity if influence the Clinical symptoms of main effects index between group in the baseline, adopts chromatographic analysis to organize a curative effect relatively.Independent variable (or covariant), dependent variable are that quantitative variable adopts covariance analysis; Independent variable, dependent variable are that qualitative variable adopts the Logistic regression analysis.Main analysis type comprise ITT analyze (intention-to-treat analysis, ITT) with comply with the scheme experimenter analyze (per-protocol subjects analysis, PPA).
Nine, clinical efficacy result:
(1) main curative effect index analysis: the score of cough symptom, cough degree
In the daytime minimizing value before and after the symptom of the coughing score test, the test group mean is 1.49 ± 0.78 (branches); The matched group mean is 1.50 ± 0.70 (branches).Difference compares between group, the difference not statistically significant.And compare before and after the treatment, difference has the significance meaning.
Minimizing value before and after nocturnal cough's symptom score test, the test group mean is 1.40 ± 0.82 (branches); The matched group mean is 1.35 ± 0.71 (branches).Difference compares between group, the difference not statistically significant.And compare before and after the treatment, difference has the significance meaning.
Minimizing value before and after cough degree (VAS) the scoring test, the test group mean is 4.19 ± 2.10 (cm); The matched group mean is 4.13 ± 2.13 (cm).Difference compares between group, the difference not statistically significant.And compare before and after the treatment, difference has the significance meaning.
In the daytime cough the improvement degree relatively after two groups of treatments, the difference not statistically significant.In the daytime the improvement rate 89.0% (307/345) of coughing after the test group treatment, the improvement rate 93.8% (105/112) of coughing in the daytime after the treatment of control group.Two groups of treatment back nocturnal cough's improvement degree compare the difference not statistically significant.Test group treatment back nocturnal cough's improvement rate 87.0% (300/345), nocturnal cough's improvement rate 89.3% (100/112) after the treatment of control group.Two groups of treatment back cough degree score improvement degree compare the difference not statistically significant.Test group treatment back cough degree score improvement rate 86.4% (298/345), cough degree score improvement rate 93.8% (105/112) after the treatment of control group.
In the daytime cough after two groups of treatments, nocturnal cough, cough degree score disappearance rate compare, and difference does not have the significance meaning.Test group is disappearance of cough rate 35.8% in the daytime, and matched group is disappearance of cough rate 41.1% in the daytime; Test group nocturnal cough's disappearance rate 49.3%, matched group nocturnal cough disappearance rate 46.8%; Test group cough degree score disappearance rate 27.2%, matched group cough degree score disappearance rate 24.1%.
(2) secondary efficacy index analysis
The tcm syndrome curative effect compares: tcm syndrome curative effect treatment group cure rate is 21.4%, and obvious effective rate is 30.7%, and effective percentage is 41.7%, and cure rate and obvious effective rate are 52.1%, and total effective rate is 93.9%; The matched group cure rate is 18.8%, and obvious effective rate is 28.6%, and effective percentage is 46.4%, and cure rate and obvious effective rate are 47.4%, and total effective rate is 93.7%.Two groups relatively, and difference does not have the significance meaning.
Cough remission time, cough recurrent number curative effect compare: treat back cough remission times relatively for two groups, difference does not have the significance meaning.Test group cough remission time be 3.90 ± 2.08 (day), matched group cough remission time be 4.05 ± 1.77 (my god).Two groups of treatment back cough recurrent numbers compare, and difference does not have the significance meaning.Test group cough recurrent number is 0.02 ± 0.13 (inferior), matched group cough recurrent number be 0.01 ± 0.10 (my god).
(amount of expectoration, the expectorant matter) symptom of coughing up phlegm after two groups of treatments all has clear improvement; Test group amount of expectoration improvement rate is 74.5% (257/345), expectorant matter improvement rate is 73.6% (254/345), and matched group is 71.4% (80/112), expectorant matter improvement rate is 71.4% (80/112).But two groups of improvement degree relatively, the difference not statistically significant.Test group amount of expectoration disappearance rate is 52.7%, expectorant matter disappearance rate is 53.4%; The heating disappearance rate is 82.1%, the itching throat disappearance rate is 67.4%, the aversion to cold disappearance rate is 95.2%, nasal obstruction watery nasal discharge disappearance rate is 95.6%, a general pain disappearance rate is 94.8%, the lack of appetite disappearance rate is 76.5%, the loose stool disappearance rate is 83.8% disappearance rate.Matched group amount of expectoration disappearance rate is 49.5%, expectorant matter disappearance rate is 48.5%; The heating disappearance rate is 77.8%, the itching throat disappearance rate is 63.8%, the aversion to cold disappearance rate is 94.5%, nasal obstruction watery nasal discharge disappearance rate is 87.5%, a general pain disappearance rate is 76.7%, the lack of appetite disappearance rate is 77.8%, the loose stool disappearance rate is 83.3% disappearance rate.Except that a general pain test group treatment back transference cure rate is higher than the matched group, two groups of treatment back clinical symptom disappearance rates compare, and difference does not have the significance meaning.
Ten, safety results:
(1) lab testing
Part patient blood, urine, the just range of normal value that provides above each center of routine, renal function, electrocardiogram testing result are all arranged after two groups of tests; Researcher has carried out explanation, analysis and cause effect relation and has judged; Be mainly: 1, treatment back exceptional value is near the normal value critical level, and researcher is thought normally or do not had clinical meaning unusually; 2, treatment back unusual with treatment before relatively, alleviate, no significant change or amplitude of variation be less; 3, treatment back unusually maybe be because due to the patient physiological, pathologic condition etc.Thereby be not judged as relevant with trial drug.
(2) adverse events/reaction is observed
Adverse events appears in test group totally 5 examples, and wherein 2 examples are slight hepatic injury (ALT slightly raises), and 1 routine cause effect relation is judged as possibility, 1 example is suspicious.Suspicious untoward reaction appears in 2 examples, dizzy, 1 routine mild skin pruritus that 1 example is slight.Adverse events does not appear in matched group.
11, sum up
Can judge that from above-mentioned clinical test results it is suitable that cough-relieving tablets is used to treat the hold concurrently effect of effect and positive drugs compared Tongxuanlifei sheet of productive cough due to phlegm-damp of cough due to wind and cold or wind and cold, difference does not have the significance meaning.Therefore, we think that cough-relieving tablets can be used for preparation treatment cough due to wind and cold and the wind and cold productive cough due to phlegm-damp medicine of holding concurrently, and its curative effect is good, and safety indexes meets the medication requirement.
Can know by inference according to Chinese traditional medicine principle, the Chinese medicine compositions such as oral formulations KEKE JIAONANG, cough-relieving syrup, decoction that come from the different dosage form of same prescription also have the hold concurrently effect of productive cough due to phlegm-damp of treatment cough due to wind and cold and wind and cold and can be used for preparing treatment cough due to wind and cold and the wind and cold purposes of productive cough due to phlegm-damp medicine of holding concurrently equally.
Claims (4)
1. Chinese medicine composition that is used to treat the cough due to pathogenic wind-heat, its prescription are by each 360 parts of Herba Ephedrae, Pericarpium Papaveris, Radix Glycyrrhizae and Semen Armeniacae Amarums, and each 112.5 parts of composition of Radix Platycodonis, Semen Raphani and Gypsum Fibrosum, above-mentioned composition are used to prepare the new purposes of treatment cough due to wind and cold medicine.
2. Chinese medicine composition as claimed in claim 1 is used to prepare the treatment wind and cold new purposes of productive cough due to phlegm-damp medicine of holding concurrently.
3. new purposes as claimed in claim 1 is characterized in that, the dosage form of described Chinese medicine composition is to be fit to oral dosage form.
4. new purposes as claimed in claim 3 is characterized in that, described suitable oral dosage form is tablet, capsule, granule, oral liquid, powder or pill.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110414604.7A CN102552473B (en) | 2011-11-15 | 2011-12-13 | New application of Keke preparation |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110361319 | 2011-11-15 | ||
| CN201110361319.3 | 2011-11-15 | ||
| CN201110414604.7A CN102552473B (en) | 2011-11-15 | 2011-12-13 | New application of Keke preparation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102552473A true CN102552473A (en) | 2012-07-11 |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1557431A (en) * | 2004-01-18 | 2004-12-29 | 贵州益佰制药股份有限公司 | Cough resisting prescription and its preparing process |
| CN1733112A (en) * | 2004-12-02 | 2006-02-15 | 贵州益佰制药股份有限公司 | Cough stopping preparation and process for preparing the same |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1557431A (en) * | 2004-01-18 | 2004-12-29 | 贵州益佰制药股份有限公司 | Cough resisting prescription and its preparing process |
| CN1733112A (en) * | 2004-12-02 | 2006-02-15 | 贵州益佰制药股份有限公司 | Cough stopping preparation and process for preparing the same |
Non-Patent Citations (1)
| Title |
|---|
| 征文通知: "中智牌克咳片临床应用征文", 《中国处方药》, no. 102, 30 September 2010 (2010-09-30), pages 6 * |
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