中药治疗结核病临床评价的Meta分析

Meta-analysis of clinical evaluation of traditional Chinese medicine in treatment of tuberculosis

目的 采用Meta分析综合评价基于随机对照临床试验中药治疗结核病临床疗效,研究中药治疗与结核病治疗结局的相关性。方法 在中国期刊全文数据库(CNKI)、万方数据库(Wanfang Data)、PubMed、EMBASE、The Cochrane Library数据库中,采用主题词检索的方式检索有关中药治疗结核病的随机对照临床试验(randomized controlled clinical trials, RCTs)检索时间为建库截至2022年1月30日。采用改良Jadad评分对纳入文献的质量进行评价,以比值比(odds ratio, OR)及95%可信区间(confidential interval, CI)比较试验组和对照组治疗效果,采用漏斗图和Begg检验评价发表偏倚。应用Revman5.4和Stata12.0软件统计分析。结果 对10项RCTs文献进行定性分析,其中, 4篇RCT报道芩部丹治疗,样本量共517例,试验组261例,对照组256例。4篇RCT报道芪甲利肺治疗,样本量共473例,试验组239例,对照组234例。2篇RCT报道益肺通络辅助治疗,样本量共有325例,试验组174例,对照组151例。对8项RCTs进行定量分析,Meta分析结果显示芩部丹治疗明显提高痰菌转阴率[OR=2.21, 95%CI(1.47~3.33),P=0.000 1],促进病灶吸收[OR=1.61, 95%CI(1.05~2.46),P=0.03],未改善空洞闭合[OR=2.22,95%CI(0.78~6.29),P=0.13]。芪甲利肺治疗显著提高痰菌转阴率[OR=2.24, 95%CI(1.13~4.40),(P=0.02)],促进病灶吸收[OR=2.15, 95%CI(1.44~3.20), P=0.000 2]和空洞闭合[OR=1.99, 95%CI(1.30~3.07), P=0.002]。漏斗图对称和Begg检验(P=0.216)提示不存在发表偏倚。结论 中药辅助治疗可能提高抗结核治疗的效果,但安全性指标需进一步评价。

ObjectiveTo systematically evaluate the efficacy of Traditional Chinese Medicine for the outcome of antituberculosis using a meta-analysis, to investigate the association between Chinese medicine treatment and tuberculosis treatment outcome.Methods antituberculosis therapy were searched using MeSH in electronic databases including China Journal Full-text Database(CNKI), Wanfang Data Database(Wanfang Data), PubMed, EMBASE and the Cochrane Library, and the time limit was set during the period from the start of the database until 30th Jan 2022. The methodological quality of the included studies was assessed using the modified Jadad score, and the effect size of outcome were compared between the experimental and control groups using the odds risk(OR) and 95% confidential interval(CI). The publication bias of the included studies was evaluated using a funnel plot and Begg test. Revman5.4 and Stata12.0 were used for statistical analysis.Results were included in the qualitative analysis. There were four studies involving 517 patients reported Qinbudan as adjunctive therapy, including 261 patients in the experimental group and 256 in the control group. Four studies involving 473 patients reported Qijialifei as adjunctive therapy, including 239 patients in the experimental group and 234 in the control group. Other two studies involving 325 patients reported Yifeitongluo as adjunctive therapy, including 174 patients in the experimental group and 151 in the control group. A total of 8 RCTs were included in the quantitative analysis. Meta-analysis revealed Qinbudan add-on therapy could improve the sputum-culture negative convention rate [OR=2.21, 95%CI(1.47-3.33), P=0.000 1], lesions absorption [OR=1.61, 95%CI(1.05-2.46), P=0.03], but not improve cavity closure [OR=2.22, 95%CI(0.78-6.29), P=0.13].Qijialifei add-on therapy significantly improve smear negative convention rate [OR=2.24, 95%CI(1.13-4.40), P=0.02], lesions absorption [OR=2.15, 95%CI(1.44-3.20), P=0.000 2] and cavity closure [OR=1.99, 95%CI(1.30-3.07), P=0.002]. The funnel plot and Begg test(P=0.216) suggesting there was no publication bias.Conclusions Medicine with antituberculosis drug may improve efficacy outcome in patients with pulmonary tuberculosis, the safety outcome remains further studies to evaluate.