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基于Meta分析的清开灵注射剂治疗急性上呼吸道感染临床评价研究

Meta analysis of Qingkailing Injection in the Treatment for Acute Upper Respiratory Tract Infection

DOI：

中文关键词: 清开灵注射剂急性上呼吸道感染系统评价 Meta分析

英文关键词:Qingkailing injection Acute upper respiratory tract infection Systematic review Meta analysis

基金项目:国家自然科学基金项目（编号：81473547）

作者	单位
蔺梦娟^①吴嘉瑞^① 张晓朦^①刘施^①张冰^①	①北京中医药大学中药学院（北京 100102）

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中文摘要:

摘要目的：探讨清开灵注射剂治疗急性上呼吸道感染的有效性及安全性。方法：通过计算机检索中英文数据库等途径全面收集清开灵注射剂治疗急性上呼吸道感染的临床随机对照试验，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研究质量，通过RevMan 5.3进行统计分析。结果：共纳入42项研究，累计患者5 905例。Meta分析结果显示：①“清开灵（+西医对症治疗）”较“利巴韦林（+西医对症治疗）”可提高临床疗效总有效率（RR=1.19，95%CI：1.16~1.22，P<0.000 01）；②“清开灵（+西医对症治疗）”较“抗菌药（+西医对症治疗）”显著提高临床疗效总有效率（RR=1.34，95%CI：1.25~.44，P<0.000 01）；③“清开灵+西医对症治疗”较“利巴韦林+抗菌药+西医对症治疗”明显提高临床疗效总有效率（RR=1.31，95%CI：1.23~1.40，P<0.000 01）；④“清开灵+西医常规治疗”较“西医常规治疗”可提高临床疗效总有效率（RR=1.17，95%CI：1.10~1.25，P<0.000 01）。清开灵注射剂还可缩短发热、鼻塞流涕、咽部不适、咳嗽、头痛、扁桃体肿大的持续时间。对于药品不良反应/事件，19项研究未报道，11项研究报道无不良反应，11项研究报道试验组21例、对照组34例，1项研究仅报道试验组22例。结论：清开灵注射剂治疗急性上呼吸道感染可提高临床总有效率，缩短临床主要症状、体征持续时间，但在安全性方面尚不能得出确切结论。

英文摘要:

ABSTRACT Objective:To evaluate the efficacy and safety of qingkailing injection (QKLI) for acute upper respiratory tract infection (AURTI). Methods:Randomized controlled trials (RCTs) regarding QKLI for the treatment of AURTI were collected through comprehensive searches of many Chinese and English databases and so on. Related RCTs were selected according to the inclusion and exclusion criteria. Then, data were extracted and the methodological quality of included studies were assessed by the Cochrane Collaboration’s tool for assessing risk of bias. Data analysis especially meta analysis was conducted with Review Manager 5.3 software. Results:42 RCTs involving 5 905 patients were included. Meta analysis and subgroup analysis showed,①“QKLI(+western medicine symptomatic treatment, WMST)” compared with “ribavirin(+WMST)” could improve the clinical total effective rate (RR=1.19, 95%CI: 1.16-1.22, P<0.000 01); ②“QKLI(+WMST)” was significantly superior to “antibiotics(+WMST)” in the improvement of clinical total effective rate (RR=1.34, 95%CI:1.25-1.44,P<0.000 01); ③“QKLI+WMST” had an obviously higher clinical total effective rate than “ribavirin+ antibiotics+ WMST” (RR=1.31, 95%CI: 1.23-1.40,P<0.000 01); ④“QKLI(+western medicine routine treatment, WMRT)” was better than “WMRT” in clinical curative effect (RR=1.17, 95%CI: 1.10-1.25, P<0.000 01). Also, QKLI could shorten the duration of the main clinical signs and symptoms (fever, nasal congestion and rhinorrhea, throat discomfort, cough, headache, adenoids). Adverse drug reactions/adverse drug events (ADRs/ADEs) were not mentioned in 19 studies, were not observed in 11 studies and were reported in 12 studies. Among these 12 studies, 11 studies separately reported the occurrence of 21 cases ADRs/ADEs in experimental groups and 34 cases ADRs/ADEs in control groups, one trial merely reported 22 cases ADRs/ADEs in experimental group but did not mentioned the occurrence of ADRs/ADEs in control group.Conclusion:QKLI for the treatment of AURTI could improve the clinical total effective rate and shorten the duration of the main clinical signs and symptoms, however, there was no exact conclusion concluded on safety.

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