Effects of Standardization of Clinical Research on Results of Evidence-based Medicine Analysis for Yao-tongning Capsules / 中国药房

ABSTRACT

OBJECTIVE:To investigate influential factors of standardization of clinical research on therapeutic efficacy of Yao-tongning capsules,and to provide direction for reasonable and standard development of clinical research. METHODS:Retrieved from CJFD,VIP and Wanfang database,RCTs about Yaotongning capsules in the treatment of related disease were collected. After data extraction and quality evaluation,Meta-analysis was conducted by using Rev Man 5.3 statistical software. The effects of the di-alectical situation,treatment course and route of administration on the evaluation of therapeutic efficacy of Yaotongning capsules were compared;based on this,the concepts of index evidence-based value which reflected clinical standardization were put for-ward,and its effects on Yaotongning capsules were investigated. RESULTS:A total of 71 RCTs were included,involving 11009 patients. Results of Meta-analysis showed therapeutic efficacy of Yaotongning capsules was better than that of other drugs in dialecti-cal case(P=0.02),while therapeutic efficacy of Yaotongning capsules was inferior to that of other drugs in non-dialectical case(P<0.01);therapeutic efficacy of Yaotongning capsules was inferior to that of other drugs when treatment course was shorter than 30 days(P<0.05),while treatment course was longer than 30 days,there was no difference in therapeutic efficacy between Yaotongn-ing capsules and other drugs(P=0.99). When did not take medicine according to the instruction,therapeutic efficacy of Yaotongn-ing capsule was inferior to that of other drugs(P<0.05);when taking medicine according to the instruction,there was no differ-ence in therapeutic efficacy between Yaotongning capsules and other drugs(P=0.94). When evidence-based value was ≥5,thera-peutic efficacy of Yaotongning capsules was better than that of other drugs(P=0.03);when evidence-based value was equal to 4, there was no difference in therapeutic efficacy between Yaotongning capsules and other drugs(P=0.56);when evidence-based val-ue was ≤3,therapeutic efficacy of Yaotongning capsules was inferior to that of other drugs(P<0.05),with statistical significance. CONCLUSIONS:It is an important guarantee of playing therapeutic efficacy of Yaotongning capsules to regularly use drugs strictly according to the principle of dialectical treatment,and take drugs according to treatment course and instructions. Clinical trials should be standardized strictly in accordance with the instructions,so as to provide objective and fair clinical findings.