双黄连注射剂不良反应发生率的Meta分析  

Meta-analysis on incidence of adverse drug reaction induced by Shuanghuanglian injection

作　　者：唐伟[1] 石庆平[1,2] 马涛[1] 姜晓东[2] 刘诗娴 王永新[4] 

机构地区：[1]蚌埠医学院药学系,安徽蚌埠233000 [2]蚌埠医学院第一附属医院药剂科,安徽蚌埠233000 [3]广州医科大学临床医学系,广东广州510000 [4]蚌埠医学院第一附属医院风湿免疫科,安徽蚌埠233000

出　　处：《中国中药杂志》2016年第14期2732-2742,共11页China Journal of Chinese Materia Medica

基　　金：国家“重大新药创制”科技重大专项(2009ZX09502-030);安徽省教育厅2014年度高等教育振兴计划人才项目[皖教秘人(2014)181号]

摘　　要：系统评价双黄连注射剂临床使用的安全性。计算机检索Pubmed,Embase,the Cochrane Library,CNKI,VIP和WanFang Data,根据纳入与排除标准筛选文献、提取资料并评价纳入研究的方法学质量后,采用R3.2.3软件进行Meta分析。最终纳入56篇文献,双黄连注射剂用药者共计11 001例,累计发生不良反应585例。Meta分析结果显示：总不良反应发生率为6.5%[95%CI（0.051;0.082）]。亚组分析显示：儿童和成人发生率分别为4.8%[95%CI（0.032;0.067）],8.1%[95%CI（0.054;0.112）];5%~10%葡萄糖注射液和0.9%氯化钠注射液发生率分别为7.2%[95%CI（0.049;0.095）],6.6%[95%CI（0.036;0.104）];粉针剂和注射液发生率分别为6.3%[95%CI（0.047;0.082）],7.0%[95%CI（0.044;0.099）];≤7 d和﹥7d发生率分别为5.8%[95%CI（0.043;0.075）],8.9%[95%CI（0.049;0.140）];单用药和联合用药发生率分别为4.2%[95%CI（0.027;0.059）],8.4%[95%CI（0.059;0.113）]。不良反应症状报道最多的3个表现类型依次为皮肤及粘膜、消化系统、体温中枢反应,发生率分别为4%[95%CI（0.03;0.04）],3%[95%CI（0.02;0.03）],1%[95%CI（0.00;0.01）]。该系统评价提示双黄连注射剂不良反应发生的影响因素与年龄、溶媒、使用时间和联合用药等存在关联性,且不同损害类型之间的不良反应发生率差异较大。临床使用时应遵循中医辨证施治原则,尽量单独使用,勿与其他药物配伍使用;严格按说明书合理用药,特别是儿童和老年人应按体重计算给药;加强用药后不良反应监测,评估长期使用可能发生不良反应的风险,并做好相应的防治措施,确保其安全使用。To conducted a systematic review on the safety of Shuanghuanglian injection in clinical use. In this paper, data from Pubmed, Embase, the Cochrane Library, CNKI, VIP and WanFang Data were retrieved. After extracting information and evaluatingresearch methodological quality according to inclusion and exclusion criteria, Meta-analysis was conducted by using R3.2. 3 software. A total of 56 individual studies were included, in which 585 cases showed adverse reactions in a total of 11 001 patients with Shuang- huanglian injections. Meta-analysis showed that the total incidence of adverse reactions was 6. 5% （95% CI 0. 051 to 0. 082）. Sub- group analysis showed that the incidence of adverse reactions was 4. 8% （95% CI （0. 032 to 0. 067） and 8. 1% （95% CI 0. 054 to 0. 112） respectively in children and adults; 7. 2% （95% CI 0. 049 to 0. 095 ） and 6. 6% （95% CI 0. 036 to 0. 104 ） respectively in 5% -10% glucose injection and 0.9% sodium chloride injection; 6. 5% （95% CI 0. 047 to 0. 082） and 7.0% （95% CI 0. 044 to 0. 099 ） respectively in powder injection and liquid injection; 5.8 % （95 % CI 0. 043 to 0. 075 ） and 8.9 % （95 % CI 0. 049 to 0. 140） respectively in cases with duration of ~〈7 d and 〉 7 d ; 4. 2% （95% CI 0. 027 to 0. 059） and 8.4% （95% CI 0. 059 to 0. 113） respec- tively in single use and combined medication. Three most frequent types of adverse reaction symptoms reported were in skin and muco- sa, digestive system, and body temperature center, with an incidence of 4% （95 % C I 0. 03 to 0.04）, 3% （95 % CI 0. 02 to 0. 03）, and 1% （95% CI 0. 00 to 0. 01 ）, respectively. The systemic evaluation demonstrated that the occurrence of adverse reaction of Shuan- ghuanglian injection was related to age, menstruum, duration of medication and combined medication. Incidence of adverse reactions differed considerably among different damage types. From the study demonstrated above, this paper concludes that we should follow the principles of evidence-based medicat

关 键 词：双黄连注射剂 不良反应 发生率 META分析 亚组分析 

分 类 号：R286[医药卫生—中药学]