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目的评价中医药非劣效/等效性随机对照试验(RCTs)的质量。方法检索中医药研究中采用非劣效/等效性试验设计的RCTs报告,参照CONSORT声明的扩展——非劣效/等效性随机对照试验报告清单的条目,对纳入的RCTs进行质量评价。结果共纳入中医药非劣效/等效性RCTs 13篇,发现此类试验在试验设计和统计分析方面存在一些问题,如:①阳性对照药物选择的依据不足;②未确定非劣效/等效性界值;③未进行样本含量估算,或未提供样本含量估算的依据;④未采用正确的非劣效/等效性检验方法,而是在显著性检验无统计学意义的情况下得出非劣效/等效性合格的结论,或只是简单的说明采用非劣效/等效性试验,而实际并未按照其方案执行。结论随着中药新药研发的深入,采用非劣效/等效性试验设计的临床研究逐步增多,这就要求研究者对非劣效/等效性试验的理论基础有更深入的认识,明确此类试验在设计和统计分析方面与传统优效性试验的不同。只有采用科学、合理的试验设计和正确的统计分析方法,才能得到可信的非劣效/等效性结论。
Objective To evaluate the quality of RCTs in Chinese medicine noninferiority / equivalence. METHODS: RCTs reporting in non-inferiority / equivalence trials in TCM studies were searched, and the quality of RCTs included in the RCTs was evaluated with reference to the CONSORT statement of entries in the extended-nof / equivalent RCT report list. Results A total of 13 non-inferior / equivalent TCM RCTs were included and found that there were some problems in experimental design and statistical analysis such as: (1) Insufficient basis for selection of positive control drugs; (2) Undetermined non-inferiority / equivalent Validity threshold; ③ did not estimate the sample size, or did not provide a basis for estimation of sample size; ④ did not use the correct non-inferiority / equivalence test method, but in the significance test was not statistically significant Non-inferiority / equivalency conclusions, or simply a non-inferiority / equivalency test, are not actually implemented according to their program. Conclusion With the deepening of new drug research and development of traditional Chinese medicine, clinical research using non-inferiority / equivalence test design gradually increases, which requires researchers to have a deeper understanding of the theoretical basis of non-inferiority / equivalence test. Class trials differ from traditional superiority tests in design and statistical analysis. Only credible non-inferiority / equivalence conclusions can be obtained using a scientific and rational trial design and proper statistical analysis.