CN102764371A - Traditional Chinese medicine compound prescription for relieving radiotherapy side reactions and preparation method and application thereof - Google Patents
Traditional Chinese medicine compound prescription for relieving radiotherapy side reactions and preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine compound prescription for relieving radiotherapy side reactions. The traditional Chinese medicine compound comprises, by weight, 10 parts to 30 parts of heterophylly falsestarwort roots, 10 parts to 30 parts of cochinchinese asparagus roots, 10 parts to 30 parts of dwarf lilyturf roots, 5 parts to 10 parts of Chinese magnoliavine fruit, 10 parts to 15 parts of rehmannia roots, 10 parts to 30 parts of barbary wolfberry fruit, 10 parts to 30 parts of pulp of dogwood fruit, 15 parts to 30 parts of hedyotis diffusa willd, 10 parts to 15 parts of poria cocos, 10 parts to 30 parts of yam and 6 to 12 parts of papermulberry fruit. The invention further discloses a preparation method and an application of the traditional Chinese medicine compound for relieving radiotherapy side reactions. Aiming at basic pathogenesis of 'ablaze heat toxin and qi and yin deficiency' of radiotherapy side reactions, the traditional Chinese medicine compound prescription for relieving radiotherapy side reactions clears away heat and toxic materials, nourishes qi and yin, plays a role of relieving radiotherapy side reactions, and is provided with clinical exact effects.
Description
Technical field
The invention belongs to technical field of Chinese medicines, be specifically related to a kind of Chinese medicine compound that alleviates radiotherapy side effect.
Background technology
Radiotherapy is one of malignant tumor most common therapeutic method, and most of clinically tumor patient all will be accepted radiotherapy.But because lonizing radiation have tangible aggressivity to human body; And the specificity selection function to the tumor cytotoxicity effect is relatively poor; Lonizing radiation damage surrounding tissue and normal cell inevitably in killing tumor cell; No matter cause a series of whole bodies of body and partial toxicity, still be on the health, to have caused injury in various degree to the patient again psychologically therefore.
The main side reaction of radiotherapy has: (1) nasopharynx part, oral mucosa and skin injury; (2) heart radiation injury; (3) radiation pneumonia; (4) radioactivity bone marrow injury; (5) other: Brain Radiation Injury, radiation rectitis, injury of bladder etc.Wherein the damage meeting of mouth and nose mucosa and skin occurs at radiation period; Diseases such as dry mouth and throat, oral ulcer, skin pigment deposition can appear in the patient; And after some damage can appear at radiotherapy several weeks and even several months, for example induced lung injury was divided in early days, mid-term, late period.Mostly occurring in early days occurs in several weeks after radiotherapy, and clinical manifestation is the acute radiation pneumonia; Then possibly appear at back 6 months of irradiation or longer time late period.
Chinese medicine is as one of malignant tumor Therapeutic Method commonly used; It is cooperated radiotherapy, not only can alleviate the toxicity of body, can also strengthen the curative effect of radiotherapy; Improve patient's tolerance and quality of life; Thereby strengthen patient's immunologic function, reduce the chance of tumor recurrence and transfer, to prolong patient's life-span.
The traditional Chinese medical science thinks that lonizing radiation belong to the heresy of fire-toxin, and lonizing radiation are in killing tumor cell, and are also cloudy as " pyretic toxicity " damage people bromhidrosis.The clinical article of supplementing QI and nourishing YIN, removing pathogenic heat from blood and toxic substance from the body of often selecting for use are alleviated caused by radiation interior-heat caused by deficiency of YIN symptom, common drug such as Radix Adenophorae (Radix Glehniae), Radix Ophiopogonis, Rhizoma Polygonati Odorati, Radix Arnebiae (Radix Lithospermi), Cortex Moutan, the Radix Rehmanniae etc.In addition, blood-activating and stasis-removing can be prevented and treated pulmonary fibrosis, myocardial damage, radioactivity esophagitis and radiation pneumonia.The Chinese medicine external can also be alleviated radiotherapy and the skin and the mucosa injury that cause.Blood-activating and stasis-removing can change the alleviating vascular spasm, kind microcirculation, and the oxygen content of increase diseased region cancerous cell, anticoagulant is regulated connective tissue metabolism, makes weary oxygen cancer carefully responsive to lonizing radiation, thereby strengthens radiotherapeutic effect.Clinical Semen Persicae, Flos Carthami, triangular, Rhizoma Curcumae, Radix Notoginseng powder etc. often selected for use.
Summary of the invention
Technical problem to be solved by this invention provides a kind of Chinese medicine compound that alleviates radiotherapy side effect, and this can significantly reduce radiotherapy side effect.
The technical problem that the present invention also will solve provides the method for preparing of above-mentioned compound recipe.
The technical problem that the present invention will solve at last provides the application of above-mentioned compound recipe.
For solving the problems of the technologies described above, the technical scheme that the present invention adopts is following:
A kind of Chinese medicine compound that alleviates radiotherapy side effect, it comprises the component of following parts by weight: Radix Pseudostellariae 10-30 part, Radix Asparagi 10-30 part, Radix Ophiopogonis 10-30 part; Fructus Schisandrae Chinensis 5-10 part, Radix Rehmanniae 10-15 part, Radix Notoginseng 3-5 part, Fructus Ligustri Lucidi 10-30 part; Herba Ecliptae 10-30 part, Fructus Lycii 10-30 part, Fructus Corni 10-30 part, Herba Hedyotidis Diffusae 15-30 part; Poria 10-15 part, Rhizoma Dioscoreae 10-30 part, Fructus Broussonetiae 6-12 part.
The above-mentioned method for preparing that alleviates the Chinese medicine compound of radiotherapy side effect; Radix Pseudostellariae, Radix Asparagi, Radix Ophiopogonis, Fructus Schisandrae Chinensis, the Radix Rehmanniae, Radix Notoginseng, Fructus Ligustri Lucidi, Herba Ecliptae, Fructus Lycii, Fructus Corni, Herba Hedyotidis Diffusae, Poria, Rhizoma Dioscoreae, the Fructus Broussonetiae of formula ratio are mixed; Decocting with 8 ~ 10 times of weight of total medical material weight boils 2 ~ 3 times, each 30 ~ 60 minutes, merges the water extract; The water extract obtains extract at 60 ° of C concentrating under reduced pressure, promptly gets the Chinese medicine compound extract.
The above-mentioned Chinese medicine compound that alleviates radiotherapy side effect alleviates the application in the radiotherapy side effect medicine in preparation.
Wherein, described medicine comprises the medicine of the various dosage forms that the Chinese medicine compound that alleviates radiotherapy side effect is combined with pharmaceutically acceptable carrier to process, and described dosage form is tablet, capsule or granule.
The traditional Chinese medical science is thought; Lonizing radiation also can cause damage to people's bromhidrosis the moon as a kind of treatment means when killing tumor cell, its side effect can be regarded as the heresy of pyretic toxicity, so the pathogenesis of radiotherapy side effect can be reduced excessive noxious heat; Deficiency of both QI and YIN; Chinese traditional treatment is when being the rule of treatment with the strengthening vital QI to eliminate pathogenic factors, and with heat-clearing and toxic substances removing, supplementing QI and nourishing YIN is concrete method of treatment.Prescription of the present invention has merged the medication consideration of famous YIN nourishing prescriptions such as SHENGMAI SAN, ERZHI WAN, LIUWEI DIHUANG WAN; The article that cooperate heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling; Number Fang Qiyong nourishes cloudy Tianjin, holds up solid healthy energy to decrease originally with nourishing YIN, and heat clearing and blood circulation promoting is with the mark of the pyretic toxicity of dispelling; Can effectively reduce radiotherapy toxic side effect, improve patients ' life quality.With the Radix Rehmanniae clearing away heat and cooling blood of promoting production of body fluid with drugs sweet in flavor and cold in nature, with the Radix Pseudostellariae supplementing QI and nourishing YIN of sweet profit tonify deficiency, both 5 are all monarch drug mutually, play heat-clearing and toxic substances removing altogether, the merit of supplementing QI and nourishing YIN in the side.Lung covering other viscera, delicate rapid wear, stomach liking moistness and disliking dryness, the heresy of pyretic toxicity is outer invades hyperactivity of deficient fire; The lung stomach stands in the breach, and damage and exhaustion of lung-YIN is the few expectorant of dry cough then, silent chest pain, and deficiency of stomach-Yin is body fluid cannot flow upwards then; Dry mouth and throat, the red few tongue of dry tongue, the lung stomach both decreased, and water channel is cloth not; Not only the article of common YIN nourishing fluid infusion can't be filled up body fluid, help humidogene expectorant on the contrary, make cloudy wound deadlocked with phlegm-damp, and the state of an illness is complicated.Chinese medicine compound of the present invention is chosen the same usefulness of Radix Asparagi, Radix Ophiopogonis and Radix Pseudostellariae, gets the meaning that Maimendong Tang nourishes the lung stomach, makes water liquid fail and often be furnished with that body fluid fortuneization has, and has only the logical accent of lung stomach the way to be arranged body fluid biochemistry; The compatibility convergence is astringent or styptic treatment for spontaneous sweating, the Fructus Schisandrae Chinensis of supplementing QI for promoting the production of body fluid, and invigorating middle warmer has receipts, prevents that cloudy liquid from further consuming.Fructus Ligustri Lucidi, Herba Ecliptae nourishing the liver and kidney, the two equal portions has the effect of foster vigour, tonifying deficiency, nourishing YIN to lower pathogenic fire with being ERZHI WAN.Herba Hedyotidis Diffusae is assisted Radix Rehmanniae heat-clearing and toxic substances removing, and can eliminating carbuncle eliminating stagnation, be anticancer key medicine, again can promoting urination to remove dampness, invigorating middle warmer has rushes down, and prevents that Yin-nourishing drug from helping humidogene expectorant.More than six medicines be ministerial drug altogether, strengthen the effect of monarch drug nourishing YIN and clearing away heat.Adjuvant drug Fructus Corni, Poria, Rhizoma Dioscoreae and Radix Rehmanniae compatibility have the rhythm of LIUWEI DIHUANG WAN, nourishing kidney yin; The sweet cold yin nourishing of Fructus Broussonetiae, but strengthening bone and muscle, tonify deficiency labor helps the waist knee joint, share with the training the congenital foundation the moon of profit the whole body; Fructus Lycii can be strengthened the power of ERZHI WAN nourishing liver and kidney, has immune, the anticancer modern pharmacology effect of regulating again; The pseudo-ginseng blood-circulation-invigovating analgesic therapy can be alleviated on the one hand the causalgia of caused by radiation local skin, on the other hand can microcirculation improvement, strengthen radiation sensitivity, the recovery of the skin that promotes to burn.The complete square radiotherapy side effect deficiency of YIN that links closely is that this, pyretic toxicity are the target pathogenic characteristic, and the Drug therapy direction is clear and definite, gives prominence to the key points, and the dispenser prescription is well arranged, and clinical use prevents and treats irradiation complications such as radiation pneumonia, radiation esophagitis and obtains special effect repeatly.
Beneficial effect: the Chinese medicine compound that alleviates radiotherapy side effect of the present invention adopts scientific matching, can coordinate each other between each component, mutually promote, and plays the effect of Synergistic.The traditional Chinese medical science thinks that lonizing radiation also can cause damage to people's bromhidrosis the moon as a kind of treatment means when killing tumor cell, and its side effect can be regarded as the heresy of pyretic toxicity; So the pathogenesis of radiotherapy side effect can be reduced excessive noxious heat, deficiency of both QI and YIN, it is the rule of treatment that Chinese traditional treatment is worked as with the strengthening vital QI to eliminate pathogenic factors; Chinese medicine compound heat-clearing and toxic substances removing of the present invention; Supplementing QI and nourishing YIN plays the effect that alleviates radiotherapy side effect, and clinical have a definite effect.And taking convenience, patient tolerability is good, takes for a long time and does not find untoward reaction, can promote Chinese medicine standardization treatment after processing the Chinese patent medicine preparation of standard.
The specific embodiment
According to following embodiment, can understand the present invention better.Yet, those skilled in the art will readily understand that the described content of embodiment only is used to explain the present invention, and the present invention that should also can not limit in claims to be described in detail.
Embodiment 1:
A kind of Chinese medicine compound that alleviates radiotherapy side effect, it comprises the component of following parts by weight: 20 parts of Radix Pseudostellariaes, 20 parts of Radix Asparagis, 20 parts of Radix Ophiopogonis; 8 parts of Fructus Schisandrae Chinensis, 12 parts in the Radix Rehmanniae, 4 parts of Radix Notoginseng, 20 parts of Fructus Ligustri Lucidi; 20 parts of Herba Ecliptaes, 20 parts of Fructus Lycii, 20 parts of Fructus Corni, 20 parts of Herba Hedyotidis Diffusaes; 12 parts in Poria, 20 parts of Rhizoma Dioscoreaes, 10 parts of Fructus Broussonetiaes.
Method for preparing:
Formula ratio Radix Pseudostellariae, Radix Asparagi, Radix Ophiopogonis, Fructus Schisandrae Chinensis, the Radix Rehmanniae, Radix Notoginseng, Fructus Ligustri Lucidi, Herba Ecliptae, Fructus Lycii, Fructus Corni, Herba Hedyotidis Diffusae, Poria, Rhizoma Dioscoreae, Fructus Broussonetiae are mixed; Decocting with 8 ~ 10 times of weight of total medical material weight boils 2 ~ 3 times; Each 30 ~ 60 minutes; Merge the water extract, the water extract obtains extract at 60 ° of C concentrating under reduced pressure, promptly gets the Chinese medicine compound extract.
The present invention have alleviate radiotherapy side effect Chinese medicine compound when processing tablet, the extract of Chinese medicine compound raw material and carrier lactose or corn starch, granulate, drying adds magnesium stearate lubricant when needing, mix homogeneously, tabletting is processed tablet then.
The present invention have alleviate radiotherapy side effect Chinese medicine compound when processing capsule, the extract of Chinese medicine compound raw material and carrier lactose or corn starch mix homogeneously, granulate, the encapsulated then capsule of processing.
The present invention have alleviate radiotherapy side effect Chinese medicine compound when processing granule, the extract of Chinese medicine compound raw material and carrier lactose or corn starch mix homogeneously, granulate, drying is processed granule.
Embodiment 2:
A kind of Chinese medicine compound that alleviates radiotherapy side effect, it comprises the component of following parts by weight: 10 parts of Radix Pseudostellariaes, 10 parts of Radix Asparagis, 10 parts of Radix Ophiopogonis; 5 parts of Fructus Schisandrae Chinensis, 10 parts in the Radix Rehmanniae, 3 parts of Radix Notoginseng, 10 parts of Fructus Ligustri Lucidi; 10 parts of Herba Ecliptaes, 10 parts of Fructus Lycii, 10 parts of Fructus Corni, 15 parts of Herba Hedyotidis Diffusaes; 10 parts in Poria, 10 parts of Rhizoma Dioscoreaes, 6 parts of Fructus Broussonetiaes.
Method for preparing is with embodiment 1.
Embodiment 3:
A kind of Chinese medicine compound that alleviates radiotherapy side effect, it comprises the component of following parts by weight: 30 parts of Radix Pseudostellariaes, 30 parts of Radix Asparagis, 30 parts of Radix Ophiopogonis; 10 parts of Fructus Schisandrae Chinensis, 15 parts in the Radix Rehmanniae, 5 parts of Radix Notoginseng, 30 parts of Fructus Ligustri Lucidi; 30 parts of Herba Ecliptaes, 30 parts of Fructus Lycii, 30 parts of Fructus Corni, 30 parts of Herba Hedyotidis Diffusaes; 15 parts in Poria, 30 parts of Rhizoma Dioscoreaes, 12 parts of Fructus Broussonetiaes.
Method for preparing is with embodiment 1.
Embodiment 4: alleviate the radiotherapy side effect clinical research.
1 clinical data
1.1 case source
Selected 71 routine breast tumors are all come the patient of comfortable Yixing City tumour hospital treatment, choose the case that meets the standard of including in and get rid of treatment with chemotherapy person and fasting simultaneously or oppose to take Chinese medicine the person, are divided into treatment at random and organize 33 examples, matched group 38 examples.
1.2 the standard of including in
(1) clinical clarifying a diagnosis is breast tumor, and confirms to carry out the patient of radiotherapy;
(2) physical function state scoring (KPs) is more than 60 minutes;
(3) expect life cycle>6 months.
1.3 exclusion standard:
(1) while treatment with chemotherapy medicine person;
(2) fasting or the opposition person that takes Chinese medicine.
1.4 rejecting standard:
(1) because with irrelevant former of test of cure thereby interrupt radiotherapy or cut out Chinese medicine the person;
(2) owing in the course of treatment other diseases takes place, possibly cause bias person as a result.
1.5 the diagnostic criteria of radiation pneumonia
The diagnostic criteria of radiation pneumonia is according to " diagnostic criteria of acute radiation pneumonia " in the national occupational health standard of Ministry of Public Health issue (GBZll0-2002):
(1) pulmonary's radioactive dose is 8Gy above (containing 8Gy);
(2) clinical symptoms such as cough, uncomfortable in chest, chest pain, dyspnea and low grade fever are arranged;
(3) sign: but the lighter's Non Apparent Abnormality, and weight person's respiratory murmur reduces, and dried, moist rales occur.
(4) X-ray examination finds that netted, the irregular fuzzy shape shade in edge appears in exposure pulmonary, and perhaps ground-glass-like change and patch shape high density shadow appear in CT scan.
1.6 group technology
To accept the patient of radiotherapy to the chest between in August, 2009-2010 year December in the ward, the court, choose the case that meets the standard of including in and get rid of simultaneously treatment with chemotherapy person and prohibit the trencherman, adopt the digital watch method to be divided into treatment group and matched group at random.
1.7 physical data
33 examples are organized in treatment, male 25 examples, women 8 examples, 56 ~ 79 years old age, average (67.30 ± 7.36) year.Histological type: pulmonary carcinoma 10 examples, the esophageal carcinoma 23 examples.Average (59.33 ± 6.99) Gy of radiological dose.
Matched group 38 examples, male 32 examples, women 6 examples, 54 ~ 86 years old age, average (69.60 ± 10.20) year.Histological type: pulmonary carcinoma 6 examples, the esophageal carcinoma 32 examples.Average (58.69 ± 7.49) Gy of radiological dose.
Two groups of patient's sexes, sick kind, age, exposure doses are relatively seen table 1-1, and two groups of patient disease are relatively seen table 1-2 by stages, and through statistical analysis, two groups of patient clinical datas distribute and are similar to, and have comparability.
Table 1-12 group sex, sick kind, age ratio be
Annotate: 1. 2 groups of sexes are through X 2 test, χ
2=0.79, P＞0.05; 2. 2 groups of sick kinds X 2 test, χ
2=2.13, P＞0.05; 3. 2 groups of ages are checked through t, t=1.07, P＞0.05; 4. 2 groups of ages are checked through t, t=1.07, P＞0.05; 5. 2 groups of exposure doses are checked through t, t=0.37, P＞0.05.
Two groups of patient tumors of table 1-2 compare by stages
Annotate: 1. 2 groups of patient with esophageal carcinoma are by stages through X 2 test, χ
2=1.57, P＞0.05; 2. 2 groups of patients with lung cancer are by stages through X 2 test, χ
2=1.33, P＞0.05.
2 methods
2.1 Therapeutic Method
Treatment group and matched group all give radiotherapy (radioactive source high energy x line: 23EX high energy two-photon accelerator, produced by U.S. VARIAN company) treatment protopathy.Divide into radical radiation therapy and the radiotherapy of appeasing property according to conditions of patients.Radical radiation therapy: for T1-3N0M.Case, the target area wraps into clinical foci, need not preventive radiation lymphatic drainage district; For T1-4NI-3M.Case, irradiation field comprise the internal organs of primary lesion and hilus pulumonis or mediastinum metastatic lymph node and tumor invading.After the radical radiation therapy dose,tumor reached TD40Gy/20 time/4w, adjustment irradiation field and treatment plan changed oblique open country into and avoid spinal cord or radiotherapy planning system design multifield radiation.Appeasing property radiotherapy: only alleviate recent symptom, the far case of MET occurs to local late tumor or oneself.The chest irradiation field only wraps into the focus that produces symptom.Expection 6-12 month person life cycle, TD30Gy/10 time/2w, or TD45Gy/15 time/3w.
In the experimentation according to state of an illness needs give oxygen uptake, eliminate the phlegm, bronchodilator etc.; Concurrent infection give antibiotic medicine with the preventative use antibiotic person of needs; Do expectorant antibacterial culturing and drug sensitive test in case of necessity with the adjustment antibiotic; And itemized record patient other medicines treatment information, comprise medicine name, method and dosage.
The treatment group adds with Chinese medicine compound decoction of the present invention (embodiment 1) at radiotherapy simultaneously.Medical material is provided by Chinese medicine pharmacy of Jiangsu Province's Yixing City tumour hospital, and it is fried to use Korea S's product DHJ one Dl type boiling machine by Chinese medicine pharmacy, vacuum packaging, and 4 ℃ of refrigerators storages, the storage life is no more than 7 days.Provide to the patient by researcher.Instructions of taking: 1 dose/day, 6 doses/week, serveing on for 4 weeks was 1 course of treatment, obeyed 2 courses of treatment altogether, and per 4 weeks are carried out therapeutic evaluation 1 time.
The follow-up observation phase is 6 months; Respectively before treatment, treatment beginning back carries out in the time of 1st month, 2 months, 3 months, 6 months; Observe patient's radioactivity lung damage overall state, patient body functional status, cardinal symptom etc.; The patient checks if any change of illness state at any time, and review time and result are in time carried out record.
2.2 put and observation index observing time
The follow-up observation phase is 6 months; Respectively before treatment, treatment beginning back carries out in the time of 1st month, 2 months, 3 months, 6 months; Observe patient's radioactivity lung damage overall state, patient body functional status, cardinal symptom etc.; The patient checks if any change of illness state at any time, and review time and result are in time carried out record.
2.2.1 incidence of radioactive pneumonia
The radiation pneumonia diagnostic criteria: the diagnostic criteria of radiation pneumonia is according to " diagnostic criteria of acute radiation pneumonia " (GBZll0-2002) in the national occupational health standard of Ministry of Public Health issue:
(1) pulmonary's radioactive dose is 8Gy above (containing 8Gy);
(2) clinical symptoms such as cough, uncomfortable in chest, chest pain, dyspnea and low grade fever are arranged;
(3) sign: but the lighter's Non Apparent Abnormality, and weight person's respiratory murmur reduces, and dried, moist rales occur.
(4) X-ray examination finds that netted, the irregular fuzzy shape shade in edge appears in exposure pulmonary, and perhaps ground-glass-like change and patch shape high density shadow appear in CT scan.
2.2.2 evaluation scale
The physical function state evaluation is an index with the scoring of KPS muscle power situation, treatment finish the back before the treatment KPS scoring increase >=20 and be divided into produce effects, increase by 10 and be divided into improvement, do not have increase or reduce >=10 be divided into invalid; The dyspnea situation takes the Watters methods of marking to quantize scoring; It is the rank scores standard of RTOG/EORTC system that the acute radiation lung damage adopts European cancer research and treated tissue tumour radiotherapy group; Tcm symptom is observed the method improvement design that scale is provided with reference to Xu Dihua " traditional Chinese medical science quantizes diagnosis ", and the cardinal symptom scoring comprises cough, breathes hard, weak classification is scored; Safety indexes is taked the acute and subacute toxicity reaction calibration standard of WHO antitumor drug.
2.3 statistical method
Adopt SPSS17.0 software, enumeration data is used chi-square criterion, and measurement data is checked with t.
3 results
3.1 incidence of radioactive pneumonia
Behind the chest radiation treatment, treatment is organized 13 routine patients radiation pneumonia is taken place, and incidence of radioactive pneumonia is 39.39%; Radiation pneumonia takes place in matched group 38 routine patients, and incidence of radioactive pneumonia is 76.32%, and treatment group patient incidence of radioactive pneumonia is starkly lower than matched group (P＜0.01); Difference has statistical significance; See table 3-1, results suggest Chinese medicine compound of the present invention can obviously reduce the incidence rate of radiation pneumonia after the chest radiotherapy, has the effect of prevention radiation pneumonia.
Two groups of radiation pneumonia sickness rate of table 3-1 relatively
Annotate: behind 2 groups of patient's radiotherapy to the chest incidence of radioactive pneumonia through X 2 test, χ
2=9.96, P＜0.01.
3.2 two groups of patients ' life qualities improve situation
Treat preceding two groups of patient Ka Shi scoring no difference of science of statistics (P＞0.05), have comparability, behind radiotherapy, physical function slightly descends the treatment group 1 ~ March after treatment, treats the more preceding improvement of physical function state in back 6 months, even before being superior to radiotherapy; And the matched group patient is in 6 carrying out property of physical function situation declines in the middle of the month of following up a case by regular visits to, and the two groups of result differences in each monitoring point are obvious, sees table 3-2, explains that Chinese medicine compound of the present invention can improve patients ' life quality with obvious raising patient body function.
Table 3-2 physical function state scoring (KPS scoring)
Annotate: 1. 2 groups of preceding KPS scorings of patient treatment are through t check, t=0.92, P＞0.05; 2. behind 2 groups of patient treatments 1 month, the KPS scoring was through t check, t=2.39, P＜0.05; 3. behind 2 groups of patient treatments 2 months, the KPS scoring was through t check, t=3.43, P＜0.01; 4. behind 2 groups of patient treatments 3 months, the KPS scoring was through t check, t=3.19, P＜0.01; 5. behind 2 groups of patient treatments 6 months, the KPS scoring was through t check, t=4.48, P＜0.01.
3.3 dyspnea situation Watters scoring
Treat preceding two groups of patient respiratories difficulty situation no significant difference; Treatment group 1 month, 2 months, 3 months dyspnea situations behind radiotherapy have slightly and increase the weight of; In 6th month investigation, treatment group patient's dyspnea situation is obviously improved, and breath state takes a turn for the better before than radiotherapy; And the dyspnea situation of matched group follow up a case by regular visits to 6 the middle of the month carrying out property increase the weight of, the two groups of symptom score differences in each monitoring point have statistical significance, see table 3-3, explain that Chinese medicine compound of the present invention can reach obviously to improve the patient respiratory function.
Table 3-3 dyspnea situation Watters scoring
Annotate: 1. 2 groups of preceding dyspnea situation Watters scorings of patient treatment are through t check, t=1.71, P＞0.05; 2. behind 2 groups of patient treatments 1 month, dyspnea situation Watters scoring was through t check, t=2.64, P＜0.05; 3. behind 2 groups of patient treatments 2 months, dyspnea situation Watters scoring was through t check, t=2.90, P＜0.05; 4. behind 2 groups of patient treatments 3 months, dyspnea situation Watters scoring was through t check, t=3.18, P＜0.01; 5. behind 2 groups of patient treatments 6 months, dyspnea situation Watters scoring was through t check, t=4.42, P＜0.01.
3.4 acute radiation lung damage RTOG/EORTC rank scores
Overall state RTOG/EORTC rank scores no significant difference (P＞0.05) before two groups of patient treatments; Have comparability, the treatment group radioactivity lung damage occurred on the 1st to 2 months behind radiotherapy, peak at 2nd month damage; Begin subsequently to make moderate progress; Treated back 6 months, pulmonary infringement obviously alleviates, before the radiotherapy lung symptoms be improved significantly; And matched group radioactivity lung damage in follow-up period continues to exist; And carrying out property increases the weight of; Time after the extent of damage and the treatment is proportionate; Two groups of induced lung injury incidence rates in each monitoring point and degree of injury have notable difference, see table 3-4, and Chinese medicine compound side of the present invention determined curative effect aspect prevention and radiotherapy property injury of lung is described.
Table 3-4 acute radiation lung damage RTOG/EORTC rank scores
Annotate: 1. 2 groups of preceding acute radiation lung damage RTOG/EORTC rank scores of patient treatment are checked t=1.71, P＞0.05 through t; 2. behind 2 groups of patient treatments 1 month, acute radiation lung damage RTOG/EORTC rank scores was checked through t, t=2.29, P＜0.05; 3. behind 2 groups of patient treatments 2 months, acute radiation lung damage RTOG/EORTC rank scores was checked through t, t=3.22, P＜0.05; 4. behind 2 groups of patient treatments 3 months, acute radiation lung damage RTOG/EORTC rank scores was checked through t, t=4.02, P＜0.01; 5. behind 2 groups of patient treatments 6 months, acute radiation lung damage RTOG/EORTC rank scores was checked through t, t=6.69, P＜0.01.
3.5 traditional Chinese medical science cardinal symptom scoring
Tcm symptom no significant differences (P＞0.05) such as before the treatment, two groups of patients cough, breathe hard, weak have comparability, see table 3-5.Treatment group cough symptom behind radiotherapy 1st month the most obvious, symptom is progressively alleviated subsequently, patient's cough shape alleviates before than radiotherapy after 6 months; The symptom of breathing hard was obviously alleviated before the treatment after radiotherapy in 1st month, had slightly in 2 to 3 months to increase the weight of, and alleviated the obviously improvement of breathing hard before the treatment after 6 months subsequently; Weak symptom is the fluctuation downward trend in 6 middle of the month of following up a case by regular visits to, and treats after 6 months weak than making moderate progress before the treatment.Matched group is between follow-up period, and carrying out property of each item tcm symptom increases the weight of no improvement trend; And the time is proportionate behind sx and the radiotherapy; The treatment group is starkly lower than matched group in each monitoring point tcm symptom order of severity, and difference has statistical significance, sees table 3-6 to 3-9.
Before the table 3-5 traditional Chinese medical science cardinal symptom scoring treatment
Annotate: 1. the 2 groups of preceding cough of patient treatment symptom score are checked t=0.21, P＞0.05 through t; 2. the symptom score of breathing hard before 2 groups of patient treatments is checked t=0.29, P＞0.05 through t; 3. weak symptom score is checked t=0.02, P＞0.05 before 2 groups of patient treatments through t.
Back 1 month of table 3-6 traditional Chinese medical science cardinal symptom scoring treatment
Annotate: 1. 1 month cough symptom score is checked t=1.21, P＞0.05 behind 2 groups of patient treatments through t; 2. 1 month symptom score of breathing hard is checked t=2.01, P＜0.05 behind 2 groups of patient treatments through t; 3. 1 month weak symptom score is checked t=2.53, P＜0.05 behind 2 groups of patient treatments through t.
Back 2 months of table 3-7 traditional Chinese medical science cardinal symptom scoring treatment
Annotate: 1. 2 months cough symptom score are checked t=2.99, P＜0.01 behind 2 groups of patient treatments through t; 2. 2 months symptom score of breathing hard are checked t=2.36, P＜0.05 behind 2 groups of patient treatments through t; 3. 2 months weak symptom score are checked t=3.97, P＜0.01 behind 2 groups of patient treatments through t.
Back 3 months of table 3-8 traditional Chinese medical science cardinal symptom scoring treatment
Annotate: 1. 3 months cough symptom score are checked t=4.61, P＜0.01 behind 2 groups of patient treatments through t; 2. 3 months symptom score of breathing hard are checked t=3.01, P＜0.01 behind 2 groups of patient treatments through t; 3. 3 months weak symptom score are checked t=3.54, P＜0.01 behind 2 groups of patient treatments through t.
Back 6 months of table 3-9 traditional Chinese medical science cardinal symptom scoring treatment
Annotate: 1. 6 months cough symptom score are checked t=4.96, P＜0.01 behind 2 groups of patient treatments through t; 2. 6 months symptom score of breathing hard are checked t=4.10, P＜0.01 behind 2 groups of patient treatments through t; 3. 6 months weak symptom score are checked t=5.71, P＜0.01 behind 2 groups of patient treatments through t.
3.6 untoward reaction
Untoward reaction such as anemia, thrombocytopenia, transaminase's rising, blood urea nitrogen rising, nausea and vomiting, diarrhoea, cardiac insufficiency all do not appear in follow-up period behind two groups of patient treatments; Leukopenia in various degree appears in small number of patients, and table 3-10 is relatively seen in two groups of safeties.
Two groups of safeties of table 3-10 are (example) relatively
Annotate: two groups of patient safeties compare through the Wilcoxon rank test P＞0.05
As show shown in the 3-10; Two groups of untoward reaction are through the Wilcoxon rank test; Leukopenia difference does not have obvious statistical significance (P＞0.05), explains that Chinese medicine compound of the present invention do not have toxic and side effects such as obvious gastrointestinal reaction, bone marrow depression, cardiac toxicity, but the leucocyte level that can not effectively prevent to correct after patient's radiotherapy descends; Prompting clinical application we can add when preventing and treating radiation pneumonia as one sees fit has the Chinese medicine that stimulates the bone marrow hematogenesis effect, improves clinical efficacy.
4 conclusions
The clinical research of this instance shows, Chinese medicine compound prevention of the present invention is obvious and safe with radiotherapy property pneumonia integral body curative effect, can effectively prevent the generation of radiation pneumonia after the chest radiotherapy; Improve respiratory function, reduce induced lung injury, alleviate that the patient coughs, breathes hard, weak symptom; Improve the patient body function; Improve patients ' life quality,, the trend of improving the whole prognosis of disease is arranged for successive treatment provides good basis.
Above-mentioned visible, Chinese medicine compound life-time service provided by the invention, untoward reaction is few, can be developed into to a new generation to alleviate the radiotherapy side effect Chinese medicine preparation.
Claims (4)
1. a Chinese medicine compound that alleviates radiotherapy side effect is characterized in that, it comprises the component of following parts by weight: Radix Pseudostellariae 10-30 part, Radix Asparagi 10-30 part; Radix Ophiopogonis 10-30 part, Fructus Schisandrae Chinensis 5-10 part, Radix Rehmanniae 10-15 part, Radix Notoginseng 3-5 part; Fructus Ligustri Lucidi 10-30 part, Herba Ecliptae 10-30 part, Fructus Lycii 10-30 part, Fructus Corni 10-30 part; Herba Hedyotidis Diffusae 15-30 part, Poria 10-15 part, Rhizoma Dioscoreae 10-30 part, Fructus Broussonetiae 6-12 part.
2. the described method for preparing that alleviates the Chinese medicine compound of radiotherapy side effect of claim 1; It is characterized in that, the Radix Pseudostellariae of formula ratio, Radix Asparagi, Radix Ophiopogonis, Fructus Schisandrae Chinensis, the Radix Rehmanniae, Radix Notoginseng, Fructus Ligustri Lucidi, Herba Ecliptae, Fructus Lycii, Fructus Corni, Herba Hedyotidis Diffusae, Poria, Rhizoma Dioscoreae, Fructus Broussonetiae are mixed, boil 2 ~ 3 times with the decocting of 8 ~ 10 times of weight of total medical material weight; Each 30 ~ 60 minutes; Merge the water extract, the water extract obtains extract at 60 ℃ of concentrating under reduced pressure, promptly gets the Chinese medicine compound extract.
3. the described Chinese medicine compound that alleviates radiotherapy side effect of claim 1 alleviates the application in the radiotherapy side effect medicine in preparation.
4. application according to claim 3 is characterized in that, described medicine comprises the medicine of the various dosage forms that the Chinese medicine compound that alleviates radiotherapy side effect is combined with pharmaceutically acceptable carrier to process, and described dosage form is tablet, capsule or granule.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103142891A (en) * | 2013-04-02 | 2013-06-12 | 石欣 | Medicine for preventing and treating adverse reactions after radiotherapy on head and neck tumors |
| CN103142851A (en) * | 2013-04-02 | 2013-06-12 | 袁宏 | Traditional Chinese medicine for preventing and treating adverse reactions after radiation on head and neck tumors |
| CN103908520A (en) * | 2014-04-12 | 2014-07-09 | 陈欣 | Spleen-invigorating and kidney-nourishing preparation for relieving postoperative radiotherapy reaction of tumor patients and preparation method thereof |
| CN104274681A (en) * | 2014-09-19 | 2015-01-14 | 邓立华 | Formula of traditional Chinese medicinal diet for regulating and nourishing after radiotherapy and preparation method of traditional Chinese medicinal diet |
| CN104857276A (en) * | 2015-05-22 | 2015-08-26 | 崔鹏 | Traditional Chinese medicine for treating both qi and yin deficiency caused by radiotherapy-chemotherapy for malignant tumor |
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| CN1586253A (en) * | 2004-07-10 | 2005-03-02 | 宁夏科锐兰天科技有限公司 | Jinqi selenium tea and its producing process |
| CN100998769A (en) * | 2006-12-25 | 2007-07-18 | 隋丽红 | A Chinese medicinal decoction for resisting cancer and strengthening body resistance |
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| CN1138480A (en) * | 1996-01-23 | 1996-12-25 | 田振典 | "Weixuekang", a medicine for blood health |
| CN1586253A (en) * | 2004-07-10 | 2005-03-02 | 宁夏科锐兰天科技有限公司 | Jinqi selenium tea and its producing process |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103142891A (en) * | 2013-04-02 | 2013-06-12 | 石欣 | Medicine for preventing and treating adverse reactions after radiotherapy on head and neck tumors |
| CN103142851A (en) * | 2013-04-02 | 2013-06-12 | 袁宏 | Traditional Chinese medicine for preventing and treating adverse reactions after radiation on head and neck tumors |
| CN103908520A (en) * | 2014-04-12 | 2014-07-09 | 陈欣 | Spleen-invigorating and kidney-nourishing preparation for relieving postoperative radiotherapy reaction of tumor patients and preparation method thereof |
| CN104274681A (en) * | 2014-09-19 | 2015-01-14 | 邓立华 | Formula of traditional Chinese medicinal diet for regulating and nourishing after radiotherapy and preparation method of traditional Chinese medicinal diet |
| CN104857276A (en) * | 2015-05-22 | 2015-08-26 | 崔鹏 | Traditional Chinese medicine for treating both qi and yin deficiency caused by radiotherapy-chemotherapy for malignant tumor |
| CN104857276B (en) * | 2015-05-22 | 2018-07-06 | 崔鹏 | A kind of Chinese medicine for treating syndrome of deficiency of both qi and yin after malignant tumour Radiotherapy chemotherapy |
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| CN102764371B (en) | 2014-04-09 |
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