基于Meta分析的清开灵注射剂治疗肺炎临床评价研究  

Meta-analysis on Randomized Controlled Trials of Qingkailing Injection in the Treatment of Pneumonia

作　　者：蔺梦娟 吴嘉瑞[1] 刘施[1] 张冰[1] 

机构地区：[1]北京中医药大学中药学院,北京100102

出　　处：《药物流行病学杂志》2017年第5期325-331,338,共8页Chinese Journal of Pharmacoepidemiology

基　　金：国家自然科学基金项目(编号:81473547;81673829)

摘　　要：目的:采用Meta分析方法评价清开灵注射剂治疗肺炎的疗效及安全性。方法:通过计算机检索中国期刊全文数据库(CNKI)、中文科技期刊全文数据库(VIP)、万方数据库、SinoMed、PubMed、Springer、Web of Science、Cochrane Central Register of Controlled Trials数据库等途径收集清开灵注射剂治疗肺炎的随机对照试验,根据纳入排除标准筛选研究、提取资料并采用Cochrane风险偏倚评价表评价其质量,通过Rev Man 5.3和Stata 13.1软件进行统计分析。结果:共纳入17项研究,累计患者1 702例。Meta分析显示,"清开灵+抗菌药+对症治疗"组相较"抗菌药+对症治疗"组可提高疗效总有效率(RR=1.23,95%CI:1.14~1.33,P<0.000 01),缩短发热时间(MD=-1.41,95%CI:-1.60^-1.21,P<0.000 01);"清开灵+抗菌药+对症治疗"组对比"利巴韦林+抗菌药+对症治疗"组在疗效总有效率方面差异无统计学意义(RR=1.09,95%CI:0.99~1.20,P=0.07)。清开灵注射剂还可缩短咳嗽、肺部啰音的时间,抑制患者炎症反应等。在安全性方面,有4项研究共报告药品不良反应/不良事件91例,其中试验组27例,对照组64例,均无严重不良反应发生。结论:清开灵注射剂治疗肺炎可提高临床疗效,缩短主要症状体征恢复时间,抑制炎症反应,在临床疗效总有效率方面与联合利巴韦林组差异无统计学意义,安全性尚无定论,仍需要临床高质量证据的进一步验证。Objective：To evaluate the efficacy and safety of Qingkailing Injection （QKLI） for pneumonia. Methods： Randomized controlled trials （RCTs） regarding QKLI for the treatment of pneumonia were collected through searching in CNKI, VIP, WANFANG DATA, SinoMed, PubMed, Springer, Web of Science, Cochrane Central Register of Controlled Trials , etc. Related RCTs were selected according to the inclusion and exclusion criteria. Then, extracting data and assessing the methodological quality of included studies by the Cochrane Collaboration＇ s tool for assessing risk of bias. Data analysis was conducted with Review Manager 5.3 and Stata 13.1 software. Results： 17 RCTs involving 1 702 patients were included. Meta-analysis and subgroup-analysis showed, ＂QKLI ＋ antibiotics ＋ symptomatic treatment （ST）＂ group com- pared with ＂antibiotics ＋ ST＂ group could improve the clinical total effective rate （RR = 1.23, 95% CI： 1.14-1.33, P 〈 0.000 01 ） and shorten the duration of fever （MD = - 1.41,95% CI： - 1.60- - 1.21, P 〈 0. 000 01 ） ; ＂QKLI ＋ antibiot- ics ＋ ST＂ group provided equally effect in the enhancement of clinical curative effect with ＂Rihavirin ＋ antibiotics ＋ ST＂ group, while there was no significant difference between the two groups （ RR = 1.09, 95% CI： O. 99-1.20, P = 0.07 ）. Moreover, QKLI could shorten the duration of cough and rale, and inhibit inflammatory reaction in patients with pneumoni- a. Additionally, 27 cases adverse drug reactions/adverse drug events （ADRs/ADEs） in experimental groups and 64 cases ADRs/ADEs in control groups were reported separately in 4 studies. There were no serious ADRs/ADEs reported. Conclusion： QKLI for the treatment of pneumonia could enhance the clinical total effective rate, shorten the duration of the main clinical signs and symptoms, and inhibit inflammatory reaction. However, there was no significant difference between the QKLI group and Ribavirin group in improving the total effective rate and no exact conc

关 键 词：清开灵注射剂 肺炎 META分析 

分 类 号：R286[医药卫生—中药学]