舒血宁注射液不良反应发生率的Meta分析

目的:系统评价舒血宁注射液不良反应发生率,为舒血宁注射液的规范应用提供参考。方法:计算机检索PubMed,EMbase,the Cochrane library,CNKI,VIP,Wanfang Data和CBM。各个数据库检索时间均为建库时间至2017年2月28日。由研究者根据纳入排除标准独立筛选文献、提取资料并交叉核对,采用R3.2.0软件进行Meta分析,并作亚组分析。结果:最终纳入64篇文献,3 222例舒血宁注射液用药者,累计发生213例不良反应。Meta分析结果显示:总不良反应发生率为5.84%95%(0.049 9;0.067 4)],其中严重不良反应发生率为4.36%95%(0.018 8;0.076 0)]。5%葡萄糖注射液和0.9%氯化钠注射液发生率分别为5.10%95%(0.038 7;0.066 2)]、5.60%95%CI(0.038 9;0.075 4)]。疗程≤7 d、7 d<疗程≤14 d以及疗程≥14 d发生率分别是5.14%95%CI(0.030 3;0.077 0)]、5.49%95%CI(0.044 2;0.066 4)]、7.80%95%CI(0.059 3;0.098 6)]。单用药和联合用药发生率分别是6.41%95%CI(0.051 1;0.078 3)]、5.38%95%CI(0.042 9;0.065 7)]。单日用药剂量≤20 mL·d^-1和剂量≥20 mL·d^-1发生率分别是5.57%95%CI(0.046 8;0.065 2)]、10.15%95%CI(0.061 4;0.149 2)]。超适应证治疗和适应证治疗的发生率分别是7.75%95%CI(0.047 4;0.113 1)]、5.66%95%CI(0.047 9;0.066 0)]。其中皮肤及附件不良反应发生率4%95%CI(0.03;0.05)],神经系统不良反应发生率为4%95%CI(0.03;0.05)],循环系统不良反应发生率为4%95%CI(0.03;0.06)],消化系统不良反应发生率为3%95%CI(0.02;0.05)]。结论:该系研究提示舒血宁注射液不良反应发生的影响因素与使用溶媒、疗程长短、单日用药剂量、是否超适应证治疗等有关。

Meta-analysis of incidence rate of adverse drug reactions induced by Shuxuening injection

OBJECTIVE To systematically review the incidence rate of adverse drug reactions induced by Shuxuening injection.METHODS Databases such as the Pubmed,EMbase,the Cochrane Library,CNKI,VIP,WanFang Data and CBM were searched by computer from foundation to February 28,2017.The reviewer independently screened literatures according to the inclusion and exclusion criteria,extracted date and cross-check data.Then,Meta-analysis was performed by using the R3.2.0 software,and subgroup analysis was performed.RESULTS Sixty-four studies involving 3 222 patients were included,213 patients of which had adverse reactions were reported.Meta-analysis showed that the overall incidence rate of adverse reaction was 5.84%95%CI (0.049 9; 0.067 4)],and the incidence rate of severe adverse reaction was 4.36%95%CI (0.018 8; 0.076 0)].The incidence rates of 5% glucose injection and 0.9% sodium chloride injection were 5.10%95%CI (0.038 7; 0.066 2)],5.60%95%CI (0.038 9; 0.075 4)],respectively.The rates of adverse reaction for different durations of treatment were:5.14%95%CI (0.030 3; 0.077 0)] for cases ≤ 7 d; 5.49%95%CI (0.044 2; 0.066 4)] for cases >7 d and ≤ 14 d; 7.80%95%CI (0.059 3; 0.098 6)] for cases >14 d.When Shuxuening injection was used singly,the rate of adverse reaction was 6.41%95%CI (0.051 1; 0.078 3)],while in cases of combined medication,the rate of adverse reaction was 5.38%95%CI (0.042 9; 0.065 7)].When dosage of Shuxuening was less than 20ml/d,the rate of adverse reaction was 5.57%95%CI (0.046 8; 0.065 2)],while in case of the dosage was over 20 mL/d,the rate of adverse reaction increased to 10.15%95%CI (0.061 4; 0.149 2)].When Shuxuening injection was used to treat indications,the incidence rate of ADR was 5.66%95%CI (0.047 9; 0.066 0)].On the contrary,the incidence rate of ADR was 7.75%95%CI (0.047 4; 0.113 1)].The incidence rate of skin and skin structure ADR was 4%95%CI (0.03; 0.05)]; the incidence rate of nervous system ADR was 4%95%CI (0.03; 0.05)]; the circulatory system ADR was 4%95%CI (0.03; 0.06)] and the digestive system ADR was 3%95%CI (0.02; 0.05)].CONCLUSION The system evaluation suggests that the incidence rate of adverse reactions of Shuxuening injection is related to solvents,duration of medication,daily dose and off label medicaiton.