摘要
目的:评价复方苦参注射液治疗癌性疼痛的有效性和安全性,为临床合理用药和中药注射剂深入研究提供依据。方法:计算机检索复方苦参注射液治疗癌性疼痛的随机对照试验(randomized controlled trials,RCTs),无盲法和语言限制;根据Cochrane中心推荐的方法进行文献质量评价,对随机对照试验进行方法学质量评估;运用Review Manager 5.3软件对复方苦参注射液的安全性及有效性进行Meta分析。结果:共纳入21篇随机对照试验,包括1 903个患者,其中12篇文献按照治疗组联合止痛药的不同分组进行Meta分析。复方苦参注射液联合西药止痛药,与单独使用西药止痛药相比,在疼痛缓解率方面,合并效应量相对危险度(RR)和95%的可信区间(CI)分别为[n=1 115,RR=1.15,95%CI([1.09,1.21),P<0.000 01]。在不良反应方面,合并效应量RR和95%CI分别为便秘[n=481,RR=0.50,95%CI(0.33,0.78),P=0.002],恶心[n=421,RR=0.49,95%CI(0.24,0.99),P=0.05],呕吐[n=208,RR=0.33,95%CI(0.09,1.17),P=0.09],排尿困难[n=268,RR=0.38,95%CI(0.09,1.60),P=0.19]。无严重不良事件发生。结论:复方苦参注射液联合止痛药对于癌痛的疗效优于单纯使用止痛药,且能够辅助降低单纯使用止痛药的不良反应;虽然近年来RCTs研究的数量和质量有逐年提高的趋势,但仍需从临床试验设计的科学性、报告的规范性诸多环节提高研究水平。
Objective： To evaluate the efficacy and safety of compound Kushen injection for cancerrelated pain,and provide information for clinical application and traditional Chinese medicine（TCM） injection research. Method： Computer retrieval of randomized controlled trials（RCTs） on compound Kushen injection for cancer-related pain was done. No language or blinding restriction was used. Quality of the literature and methodological quality of RCTs was assessed According to the methods recommended by Cochrane center. Rev Man5. 3 was used for Meta-analysis on the efficacy and safety of compound Kushen injection. Result： The 21 randomized controlled trials were included in the study,involving 1 903 patients,and 12 literature were used for Meta-analysis according to different treatment groups combined with analgesic. Compared with the western analgesic alone,compound Kushen injection combined with western analgesic had the following relative risk（RR） and 95%CI were [n = 1 115,RR = 1. 15,95% CI（1. 09,1. 21） ],P 0. 000 01]. In respect of adverse effects,the combined effects showed that the RR and CI were as follows： constipation [n = 481,RR = 0. 50,95% CI（0. 33,0. 78）,P = 0. 002],nausea [n = 421,RR = 0. 49,95% CI（0. 24,0. 99）,P = 0. 05],vomit [n = 208,RR =0. 33,95% CI（0. 09,1. 17）,P = 0. 09],dysuria [n = 268,RR = 0. 38,95% CI（0. 09,1. 60）,P = 0. 19].There were no serious adverse events. Conclusion： Compound Kushen injection combined with western analgesic had better efficacy than analgesic alone,and could assisted to reduce the adverse events of analgesic. Although in recent years,the quantity and quality of RCTs have a tendency to increase year by year,the research level remains to be enhanced through scientific design and normative report.
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2016年第2期172-179,共8页
Chinese Journal of Experimental Traditional Medical Formulae
基金
国家自然科学基金项目(81330090)
关键词
复方苦参注射液
癌性疼痛
系统评价
META分析
compound Kushen injection
cancer-related pain
systematic review
Meta-analysis
