| Objective1. Based on the theory of EBM as well as the principle and methods of systematic review, to do critical appraisal for clinical study literature on COPD at stable phase and bronchial asthma in chronic persistent period treated by TCM in China, analyze the problems of the two diseases and provide beneficial reference for further study in treatment.2. By means of the ancient and modern theoretical study of treating different diseases with the same method, to analyze the current situation of the theory in China and provide reference for further study of the theory.3. To analyze the data collected through rigorous clinical randomized controlled trial in order to obtain the curative effect of Wen Run Xin Jin Pei Ben method in treating wheezing and suffocating of lung disease, and prove the effectiveness, safety and feasibility of treating different diseases with the same method in wheezing and suffocating of lung disease with airway tension.Methods1. Theoretical study1.1Critical literature appraisalLiterature of clinical study on COPD at stable phase and bronchial asthma in chronic persistent period in recent ten years was collected and screened according to the inclusion and exclusion criteria. Related study characteristic data of the literature were extracted. Literature in accord with selected criteria was appraised in quality of methodology and reports.1.2Theoretical study of treating different diseases with the same methodLiterature related to the theory of treating different diseases with the same method in all ages was collected and sorted out. Literature information extraction form was drafted. Excel software was applied to statistically analyze the source, prescription, medicine composition and disease referred in the literature.2. Clinical study2.1The study of curative effectClinical case report form was drafted on the basis of literature and theoretical study. The276cases collected in accordance with the inclusion and exclusion criteria of COPD at stable phase and bronchial asthma in chronic persistent period, with TCM diagnosis of deficiency of lung, spleen and kidney were randomly divided into the treatment group and the control group. Western medicine conventional treatment plus TCM placebo was adopted by the control group, and western medicine conventional treatment plus TCM decoction treatment was adopted by the treatment group. Clinical symptoms and signs before and after the treatment, SGRQ and changes in lung function were mainly compared between the two groups.2.2The study of treating different diseases with the same methodPatients in the treatment group were divided into71cases of COPD at stable phase and65cases of bronchial asthma in chronic persistent period. SPSS17.0software was applied to compare the curative effect between the groups. Results1. Results of the theoretical study1.1Results of the literature studyA total of129qualified articles on COPD at stable phase were collected, including123RCT articles,2non-RCT articles and4narrative study articles.29qualified articles on bronchial asthma in chronic persistent period were collected, including24RCT articles,3non-RCT articles and2narrative study articles. The quality of methodology and reports in the literature obtained was relatively low.42RCT articles on COPD at stable phase were of high quality level in jadad grade, and81articles were of low quality level. Articles on bronchial asthma in chronic persistent period were all of low quality level in jadad grade, and had high possibility of selective bias and measuring bias. Mixed factor was identified incompletely in CCT articles, having high possibility of selective bias and measuring bias. It was uncertain whether the same measure could obtain the same curative effect due to research data interfered by bias and mixed factor in narrative articles only for reference.It was found that in the study on COPD at stable phase and bronchial asthma in chronic persistent period treated by TCM, the pathogenesis of the two diseases was deficient root with overdo superficial, treating by syndrome differentiation were more than disease identification, the mostly used law was invigorating lung and kidney while depressing qi and relieving asthma, and tonifying deficiency drugs, preventing phlegm from forming and stopping cough and asthma drugs as well as qi-regulating drugs were most frequent drugs although there were no unified standards in pathogenesis, syndrome differentiation, treatment, patients’ condition or course of treatment.1.2Results of treating different diseases with the same method theoretical study1.2.1Results of treating different diseases with the same method theoretical study in ancient timesAlthough there were not specific description of treating different diseases with the same method in the Internal Canon of Medicine, treating the same disease with different methods reflected the idea of treatment. So treating different diseases with the same method stemmed from the Internal Canon of Medicine.There were31prescriptions and99articles related to treating different diseases with the same method in Treatise on Febrile Diseases and Synopsis of Golden Chamber.There were53prescriptions and147articles related to treating different diseases with the same method in Treatise on Three Categories of Pathogenic Factors, mainly reflected in treating different diseases with the same prescription. But attention should be paid that there were different medicine with the same prescription name.Many doctors inherited the medical achievements from their predecessors and carried forward, such as Qian Jin Yi Fang written by Sun Simiao, Su Wen Xuan Ji Yuan Bing Shi and Xuan Ming Lun Fang written by Liu Wansu, Treatise on Febrile Diseases with Notes and Shang Han Ming Li Lun written by Cheng Wuji and so on. Finally, treating different diseases with the same method was definitely put forward by Chen Shiduo and further explained by Cheng Wenyou. Hence, treating different diseases with the same method was often quoted by doctors and became a unique feature of TCM treatment.1.2.2Results of treating different diseases with the same method theoretical study in modern times A total of360qualified articles were collected, including3RCT articles,2non-RCT articles17observational trial articles, and the other articles were case reports, summaries of experience and theoretic exploration. The quality of methodology and reports in the literature obtained was relatively low, severely influencing the credibility of the results.A total of177prescriptions and17related syndromes were involved in the qualified articles. Targeted treatment was mainly adopted, including TCM decoction, single ingredient, Chinese patent drug, external treatment such as cupping, acupuncture and moxibustion.2. Results of clinical study2.1Results of curative effectA total of272qualified cases were collected, including142cases of COPD at stable phase and130cases of bronchial asthma in chronic persistent period.2.1.1Results of primary symptoms curative effectThe effectual rate and effective rate of the overall curative effect of wheezing and suffocating, the primary symptom and rhonchus, the sign in the treatment group were respectively14.71%and54.41%, apparently higher than the control group (P<0.0001). After stratification, the effectual rate and effective rate of the overall curative effect of COPD at stable phase in the treatment group were respectively12.68%and52.11%, apparently higher than the control group (P=0.002), and those of bronchial asthma in chronic persistent period in the treatment group were respectively16.92%and56.92%, apparently higher than the control group(P=0.001).2.1.2Results of subsidiary symptoms curative effectThe effectual rate and effective rate of SGRQ in the treatment group were respectively14.71%and54.41%, and there were statistically significant difference between the two groups(P=0.001). After stratification, the effectual rate and effective rate of SGRQ of COPD at stable phase in the treatment group were respectively64.79%and76.06%, apparently higher than the control group (P=0.001), and those of bronchial asthma in chronic persistent period in the treatment group were respectively67.69%and81.54%, apparently higher than the control group (P=0.005).2.2Results of efficacy evaluation of treating different diseases with the same methodThe difference of curative effect between the patients of COPD at stable phase and bronchial asthma in chronic persistent period in the treatment group was not statistically significant in the evaluation of the effectual rate and effective rate of wheezing and suffocating, the primary symptom and rhonchus, the sign (P=0.485>0.05; P=0.574>0.05). The difference of curative effect between the patients of COPD at stable phase and bronchial asthma in chronic persistent period in the treatment group was not statistically significant in the evaluation of the effectual rate and effective rate of SGRQ (P=0.721>0.05; P=0.436>0.05).Conclusion1. The basic status of clinical study on patients of COPD at stable phase and bronchial asthma in chronic persistent period treated by TCM has been obtained by means of critical appraisal. 2. Initial understanding of how the ancients applied treating different diseases with the same method has been acquired by theoretical study. That is, the same treatment can be applied when the same syndrome appears in the course of genesis and development of different diseases. While modern clinical study shows that there is not intensive study on the theory of treating different diseases with the same method, and it is necessary to carry out clinical study on the theory.3. The clinical trial design methods of multi-center, randomized block, parallel comparison (1:1) and double blind have been applied in this study. The curative effect of TCM relieving asthma prescription combining western medicine conventional treatment is superior to western medicine conventional treatment from the view of either major and minor curative effect index, or overall and delamination. The curative effect of S-COPD and bronchial asthma in chronic persistent period has been compared. It is found that treating patients of wheezing and suffocating of lung disease with airway tension with relieving asthma prescription has achieved the goal of treating different diseases with the same method, and its advantage has been proved from the aspect of curative effect. |
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