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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 in the treatment of pneumonia by Meta analysis. Methods: Qingkailing injection was collected through computer search of CNKI, VIP, Wanfang Database, SinoMed, PubMed, Springer, Web of Science, Cochrane Central Register of Controlled Trials, Randomized controlled trials of treatment for pneumonia were screened for inclusion in an exclusionary standard, data were extracted and evaluated for quality using the Cochrane Risk Bias Rating Table and statistically analyzed using RevMan 5.3 and Stata 13.1 software. Results: A total of 17 studies were included, with a total of 1 702 cases. Meta-analysis showed that the total effective rate (RR = 1.23, 95% CI: 1.14-1.33, P <0.05) was significantly higher than that of “Qing Kai Ling + Antimicrobial + symptomatic treatment” <0.000 01), shorten the fever time (MD = -1.41, 95% CI: -1.60 ~ -1.21, P <0.000 01); “Qingkailing + antibacterial + symptomatic treatment” Lin + antibacterial + symptomatic treatment "group in the total effective rate was no significant difference (RR = 1.09,95% CI: 0.99 ~ 1.20, P = 0.07). Qing Kai Ling injection can also shorten the cough, lung rales of the time, inhibit the patient’s inflammatory response. In terms of safety, 4 studies reported a total of 91 adverse drug reactions / adverse events, including 27 in the test group and 64 in the control group, all without serious adverse reactions. Conclusion: Qingkailing injection can improve the clinical curative effect, shorten the recovery time of the main symptoms and signs and inhibit the inflammatory reaction. There is no significant difference in the clinical efficacy between the combined ribavirin group and the safety. However, Still require further validation of high quality clinical evidence.