摘要
目的系统评价正清风痛宁缓释片不良反应的发生特征,为开展相关预防与控制工作提供科学依据。方法计算机检索CNKI、VIP、Wan Fang Data数据库,查找2000-2015年国内关于正清风痛宁缓释片不良反应的文献。按照纳入与排除标准独立筛选文献、提取资料和评价纳入研究的方法学质量后,采用Rev Man 5.3软件进行Meta分析。结果最终纳入44篇文献,共收集治疗组病例1 700例,对照组病例1 688例。Meta分析结果显示正清风痛宁缓释片不良反应的发生率为14.2%,发生几率为对照组的0.83倍（RR：0.83,95%CI：0.72-0.96）。亚组分析显示单独应用正清风痛宁缓释片的治疗组不良反应发生率为11.8%,发生几率为对照组的0.83倍（RR：0.83,95%CI：0.62-1.10）;联合应用正清风痛宁缓释片（对照组的治疗方法 ＋正清风痛宁）的治疗组不良反应发生率为14.8%,发生率为对照组的0.91倍（RR：0.91,95%CI：0.74-1.11）;报告的不良反应的类型主要包括皮疹瘙痒反应,发生率为8%,发生几率为对照组的3倍（RR：3.00,95%CI：2.21,4.08）;胃肠道反应发生率为3.8%,发生几率为对照组的0.58倍（RR：0.58,95%CI：0.44,0.76）;其他类不良反应2.4%,发生几率为对照组的0.33倍（RR：0.33,95%CI：0.24-0.44）。结论与未使用正清风痛宁缓释片的对照组相比,应用正清风痛宁缓释片的治疗组具有较高的皮疹瘙痒发生几率,较低的其胃肠道反应和其他类不良反应的发生几率。且从整体上看,应用正清风痛宁缓释片的治疗组的不良反应的发生率也较低。
Objective To systematically review the characteristics of adverse reactions of Zhengqingfengtongning sustained release tablets,and to provide scientific evidence for related control and prevention work. Methods Databases such as CNKI, VIP, WanFang Data were searched for studies investigating the characteristics of adverse reactions of Zhengqingfengtongning sustained release tablets between 2000-2015. According to the inclusion and exclusion criteria, the data were extracted and the methodological quality of included studies was assessed. Then Meta-analysis was performed by using the RevMan 5.3 software. Results Forty-four studies involving 1 700 cases of treatment group and 1 688 cases of control group were included. The results of pooled analysis showed that the overall adverse reaction incidence of Zhengqingfengtongning was 14.2% and the risk was 0.83 times of the control group （ RR： 0.83, 95% CI： 0.72？0.96）. Sub-group analysis showed that the adverse reaction incidence of Zhengqinfengtongning alone group was 11.8%, 0.83 times of the risk for the control group （ RR： 0.83, 95% CI： 0.62-1.10）; the adverse reaction incidence of Zhengqinfengtongning combined use group（the control group treatments ＋ Zhengqingfengtongning） was 14.8%,0.91 times of the risk for the control group （ RR： 0.91, 95% CI： 0.74- 1.11）; the types of adverse reactions mainly included rash reaction（8%）, the risk was three times for the control group （RR： 3.00, 95% CI： 2.21-4.08）; gastrointestinal reaction3.8% ,the risk was 0.58 times for the control group （ RR： 0.58,95% CI： 0.44-0.76）; the other kind of adverse reactions 2.4%, the risk was 0.33 times for the control group （ RR： 0.33, 95% CI： 0.24-0.44）. Conclusion The treatment groups administrated Zhengqinfengtongning had a higher rash itchy reaction rate than
出处
《中国药物警戒》
2016年第9期547-556,共10页
Chinese Journal of Pharmacovigilance
基金
湖南战略性新兴产业科技攻关项目-盐酸青藤碱单体中药制剂质量标准提升核心技术研究及应用(2014GK1058)
关键词
正清风痛宁缓释片
不良反应
META分析
Zhengqingfengtongning sustained release tablet
adverse reaction
Meta-analysis
