摘要
目的:采用Meta分析方法评价维药祖卡木颗粒治疗上呼吸道感染的疗效及安全性。方法:根据检索关键词,通过计算机检索中英文数据库(中国期刊全文数据库、中文科技期刊数据库、万方数据库和SCIFINDER),搜集单独或联合使用祖卡木颗粒(试验组)对比常规药物(对照组)治疗上呼吸道感染的随机对照试验(RCTs);根据纳入排除标准筛选文献,对符合标准的临床研究进行资料提取,并按照Cochrane系统评价员手册5.1.0进行偏倚风险评价,采用Rev Man 5.3软件进行Meta分析。结果:共纳入10项RCTs,合计1 506例患者。Meta分析结果显示,试验组的总有效率(OR=1.97,95%CI:1.47~2.65,P<0.000 01)、痊愈率(OR=2.07,95%CI:1.67~2.58,P<0.000 01)、改善流涕(OR=-0.90,95%CI:-1.37^-0.43,P=0.000 2)、鼻塞(OR=-0.43,95%CI:-0.60^-0.26,P<0.000 01)、咳嗽(OR=-1.31,95%CI:-1.54^-1.08,P<0.000 01)、咽喉肿痛(OR=-0.49,95%CI:-0.71^-0.27,P<0.000 1)、头痛(OR=-0.75,95%CI:-1.16^-0.34,P=0.000 3)、发热(OR=-2.94,95%CI:-3.39^-2.49,P<0.000 01)等结果均优于对照组,其差异均有统计学差异意义;另外,3项研究分别报道了在治疗期间出现皮疹、恶心呕吐或轻微不良反应,所有症状均不影响治疗。结论:单独或联用祖卡木颗粒治疗上呼吸道感染具有一定的疗效,且未增加不良反应风险。但由于本Meta分析纳入研究质量不高,有必要开展更多设计严谨、大样本、多中心RCTs加以验证。
Objective： To systematically review the effectiveness and safety of Zukamu granules in treatment of upper respiratory infection with Meta-analysis method. Methods： Retrieved from CJFD,VIP Database,Wanfang Database,and SCIFINDER,clinical trials about alone or combined with Zukamu granules（ test group） versus other conventional medicines（ control group） in the treatment of upper respiratory infection were collected. Meta-analysis was performed using Rev Man 5. 3 software after data extracting and assessing risk of bias using Cochrane system evaluation manual 5. 1. 0. Results： Totally 10 RCTs were enrolled,involving 1 506 patients. Results of Meta-analysis showed total effective rate（ OR =1. 97,95% CI： 1. 47-2. 65,P 0. 000 01）,total cure rate（ OR = 2. 07,95% CI： 1. 67-2. 58,P 0. 000 01）,clinical signs such as runny nose（ OR =-0. 90,95% CI：-1. 37--0. 43,P = 0. 000 2）,stuffy nose（ OR =-0. 43,95% CI：-0. 60--0. 26,P 0. 000 01）,cough（ OR =-1. 31,95% CI：-1. 54--1. 08,P 0. 000 01）,sore throat（ OR =-0. 49,95% CI：-0. 71--0. 27,P 0. 000 1）,headache（ OR =-0. 75,95% CI：-1. 16--0. 34,P = 0. 000 3）,fever（ OR =-2. 94,95% CI：-3. 39--2. 49,P 0. 000 01） in test group were sigitificantly better than control group,the differences were statistically significant between two groups; three studies reported a rash,nausea and vomiting or mild adverse reactions during treatment,respectively. Conclusion： The effectiveness of Zukamu granules alone or in combination with other particles shown better curative effection on upper respiratory infection,and less adverse reactions. Given that the only several low-quality cases were included in this Meta-analysis,more RCTs with rigorous design,large scale and multi-center were needed for further corroboration of this tendency.
出处
《药物流行病学杂志》
CAS
2018年第2期73-77,84,共6页
Chinese Journal of Pharmacoepidemiology
基金
国家中医药管理局科技项目(编号:ZYBZH-C-XJ-56)
关键词
祖卡木颗粒
上呼吸道感染
疗效
安全性
系统评价
META分析
Zukamu granules
Upper respiratory infection
Effectiveness
Safety
Systematic review
Meta-analysis
