Xiong Lian, Chen Ling, Wang Chengqiong, Yue Jianbo, Li Yuqin, Zhou Weijing, Yuan Yang, Liu Quanxian, Xiao Zheng
1 The Second Department of Respiratory Medicine (Center for Evidence-Based and Translational Medicine of Major Infectious Diseases), Affiliated Hospital of Zunyi Medical College , Zunyi, China .
2 Evidence-Based Medicine Center, MOE Virtual Research Center of Evidence-based Medicine at Zunyi Medical College, Affiliated Hospital of Zunyi Medical College , Zunyi, China .
J Altern Complement Med. 2018 Nov;24(11):1051-1062. doi: 10.1089/acm.2018.0020. Epub 2018 Aug 20.
Tanreqing injection (TRQ) is often used in the treatment of pulmonary infection in patients with tuberculosis (TB). But its efficacy and safety are still unclear; to further reveal its efficacy and safety, the authors systematically evaluated all relevant trials.
The authors searched published trials using the search strategy as (Tanreqing OR "Tanreqing injection") AND ("Tuberculosis" [MeSH] OR Tuberculosis OR TB) in Embase, PubMed, CNKI, VIP, Wanfang Database, CBM and CENTRAL, and ongoing trials in Chinese and U.S. clinical trials and World Health Organization International Clinical Trials Registry Platform (WHO-ICTRP) (established to January 2017). The authors evaluated the methodological bias risk of all included trials using the Cochrane evaluation handbook of randomized controlled trials (RCTs) (5.1.0), extracted data following the PICO principles, and synthesized the data using meta-analysis.
Twenty-six RCTs involving 2404 patients were included. In TRQ alone versus antibiotics, the merged risk ratio (RR) values and their confidence interval (95% CI) of meta-analysis for overall efficacy, lesion absorption, and bacterial clearance were as follows: 1.05 (0.99-1.10), 0.98 (0.89-1.08), and 1.36 (1.09-1.70). All differences were not statistically significant. In TRQ plus antibiotics versus antibiotics, the RR values and their 95% CI of overall efficacy, lesion absorption, and bacterial clearance were as follows: 1.17 (1.10-1.25), 1.24 (1.11-1.38), and 1.61 (1.36-1.90). All differences were statistically significant. Except for the bacterial clearance, sensitivity analyses showed that the overall efficacy had good stability.
TRQ may have the same overall efficacy as antibiotics in pulmonary infection in patients with TB. TRQ plus antibiotics may improve the clinical efficacy. TRQ may have synergistic effect to antibiotics through bacteriostatic activity and eliminating inflammatory mediators. Its antibacterial activity may be better than some antibiotics and does not increase adverse drug reaction. But all these need new evidences for further investigation.
痰热清注射液（TRQ）常用于治疗肺结核（TB）患者的肺部感染。但其疗效和安全性仍不明确；为进一步揭示其疗效和安全性，作者系统评价了所有相关试验。
作者在Embase、PubMed、中国知网（CNKI）、维普资讯（VIP）、万方数据库、中国生物医学文献数据库（CBM）和考克兰系统评价数据库（CENTRAL）中，使用检索策略（痰热清或“痰热清注射液”）与（“结核”[医学主题词]或结核或TB）检索已发表的试验，并检索中国和美国临床试验以及世界卫生组织国际临床试验注册平台（WHO-ICTRP）（截至2017年1月）中的正在进行的试验。作者使用考克兰随机对照试验（RCT）评价手册（5.1.0版）评估所有纳入试验的方法学偏倚风险，按照PICO原则提取数据，并采用Meta分析对数据进行综合分析。
纳入26项RCT，涉及2404例患者。单独使用TRQ与使用抗生素相比，Meta分析的总体疗效、病灶吸收和细菌清除率的合并风险比（RR）值及其置信区间（95%CI）如下：1.05（0.99-1.10）、0.98（0.89-1.08）和1.36（1.09-1.70）。所有差异均无统计学意义。TRQ联合抗生素与抗生素相比，总体疗效、病灶吸收和细菌清除率的RR值及其95%CI如下：1.17（1.10-1.25）、1.24（1.11-1.38）和1.61（1.36-1.90）。所有差异均有统计学意义。除细菌清除率外，敏感性分析显示总体疗效具有良好的稳定性。
TRQ在肺结核患者肺部感染中的总体疗效可能与抗生素相当。TRQ联合抗生素可能提高临床疗效。TRQ可能通过抑菌活性和消除炎症介质与抗生素产生协同作用。其抗菌活性可能优于某些抗生素，且不增加药物不良反应。但所有这些都需要新的证据进一步研究。
