Dang Jiao-Jiao, Lyu Jian, Sun Meng-Hua, Wang Lian-Xin
Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences Beijing 100700,China Experimental Research Center,China Academy of Chinese Medical Sciences Beijing 100700,China.
Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences Beijing 100700,China.
Zhongguo Zhong Yao Za Zhi. 2019 Dec;44(24):5294-5302. doi: 10.19540/j.cnki.cjcmm.20191008.501.
To systematically review the effectiveness and safety of Reduning Injection in the treatment of acute tracheal-bronchitis.Four Chinese databases( CNKI,VIP,Wan Fang,Sino Med) and three English databases( Cochrane Library,Medline,Web of Science) were systematically and comprehensively retrieved. The retrieval time was from the establishment of each database to April 2019.Randomized controlled trials( RCTs) for the treatment of acute tracheal-bronchitis with Reduning Injection were collected. Two researchers independently conducted literature screening,data extraction and risk assessment for bias. Rev Man 5.3 software was used for data analysis. Fourteen studies were included,and the total sample size was 1 652 at last. Meta-analysis results show that in the aspect of total clinical effective rate,Reduning Injection was superior to ribavirin( RR = 1. 37,95%CI[1. 28,1. 47],P<0. 000 01); Reduning Injection combined with conventional therapy was better than conventional therapy alone( RR = 1. 14,95% CI[1. 09,1. 19],P <0. 000 01); Reduning Injection combined with azithromycin was better than azithromycin therapy alone( RR = 1. 21,95% CI[1. 07,1. 37],P = 0. 002). In the aspect of clinical symptoms,the time in average fever disappearance of Reduning Injection therapy was shorter than that of ribavirin therapy( MD =-1.68,95%CI[-1. 72,-1. 49],P<0. 000 01); the time in cough disappearance of Reduning Injection therapy was shorter than that of ribavirin therapy( MD =-2. 57,95%CI[-2. 91,-2. 24],P<0. 000 01); the time in lung rales disappearance,Reduning Injection therapy was superior to ribavirin therapy( MD =-2. 26,95% CI[-2. 71,-1. 80],P<0. 000 01),and Reduning Injection combined with conventional therapy was superior to conventional therapy( MD =-1. 77,95% CI[-1. 95,-1. 59],P<0. 000 01). Based on the findings,Reduning Injection can improve the total effective rate,reduce the average time of disappearance in fever,cough and lung rales,with mild adverse reactions and a low incidence. However,the quality of the literatures included is not high,it is necessary to adopt large-sample-size,rigorously designed clinical trial protocols in line with the international standards,in a bid to improve the quality of evidence.
系统评价热毒宁注射液治疗急性气管 - 支气管炎的有效性和安全性。系统全面地检索了4个中文数据库（中国知网、维普、万方、中国生物医学文献数据库）和3个英文数据库（考克兰图书馆、医学期刊数据库、科学引文索引数据库）。检索时间为各数据库建库至2019年4月。收集使用热毒宁注射液治疗急性气管 - 支气管炎的随机对照试验。两名研究人员独立进行文献筛选、数据提取和偏倚风险评估。采用Rev Man 5.3软件进行数据分析。最终纳入14项研究，总样本量为1652例。Meta分析结果显示，在总临床有效率方面，热毒宁注射液优于利巴韦林（RR = 1.37，95%CI[1.28，1.47]，P<0.00001）；热毒宁注射液联合常规治疗优于单纯常规治疗（RR = 1.14，95%CI[1.09，1.19]，P<0.00001）；热毒宁注射液联合阿奇霉素优于单纯阿奇霉素治疗（RR = 1.21，95%CI[1.07，1.37]，P = 0.002）。在临床症状方面，热毒宁注射液治疗平均退热时间短于利巴韦林治疗（MD = -1.68，95%CI[-1.72，-1.49]，P<0.00001）；热毒宁注射液治疗咳嗽消失时间短于利巴韦林治疗（MD = -2.57，95%CI[-2.91，-2.24]，P<0.00001）；热毒宁注射液治疗肺部啰音消失时间优于利巴韦林治疗（MD = -2.26，95%CI[-2.71，-1.80]，P<0.00001），且热毒宁注射液联合常规治疗优于常规治疗（MD = -1.77，95%CI[-1.95，-1.59]，P<0.00001）。基于这些发现，热毒宁注射液可提高总有效率，缩短发热、咳嗽及肺部啰音的平均消失时间，不良反应轻微且发生率低。然而，纳入文献的质量不高，有必要采用符合国际标准的大样本、严格设计的临床试验方案，以提高证据质量。
