前列地尔脂微球载体制剂不同给药方式导致静脉炎发生情况的系统评价

Meta-analysis of Phlebitis Caused by Different Administration Methods of Alprostadil Microsphere Carrier Preparation

关键词:  前列地尔脂微球载体制剂  静脉炎  给药途径  meta分析

Key words:  alprostadil microsphere carrier preparation  phlebitis  route of administration  meta analysis

摘要:

目的 使用meta分析系统评价前列地尔脂微球载体制剂不同给药方式导致静脉炎发生率的差异及临床上常见超说明书给药途径的合理性，为临床应用提供循证参考。方法 检索中国知网、维普、万方、中国生物医学文献数据库、Embase、Pubmed、Cochrane Library，收集与前列地尔脂微球载体制剂不同给药方式导致静脉炎发生差异的相关研究文献，制定筛选条件并筛选文献，并按照Cochrane系统评价员手册评价质量后，采用RevMan 5.2统计软件将提取的有效数据进行meta分析。结果 共纳入23项随机对照试验（randomized cotrolled trial，RCT）研究，涉及3 165例患者。按给药方式进行meta分析，前列地尔脂微球载体制剂采用静脉注射方式较小壶静滴方式更易增加静脉炎发生率[RR=1.92，95%CI（1.17，3.17），P=0.01]；采用静脉注射方式和超说明书给药方式导致静脉炎的发生率无差异[RR=1.35，95%CI（0.69，2.64），P=0.38]；采用小壶静滴方式和超说明书给药方式导致静脉炎的发生率无差异[RR=0.52，95%CI（0.17，1.62），P=0.26]；采用静脉滴注较静脉泵入致静脉炎的发生率降低[RR=0.46，95%CI（0.31，0.67），P<0.000 1]。按给药工具进行meta分析，采用普通输液器致静脉炎发生率显著高于采用精细过滤输液器[RR=0.18，95%CI（0.13，0.25），P<0.000 01]，差异均有统计学意义。按给药速度进行meta分析，前列地尔脂微球载体制剂以慢速静注给药静脉炎发生率显著高于快速静注给药[RR=0.37，95%CI（0.21，0.67），P=0.001 0]。结论 前列地尔脂微球载体制剂快速给药或使用精细过滤输液器致静脉炎发生率较低，静脉注射较小壶静滴致静脉炎发生率较高，静脉泵入较静脉滴注致静脉炎发生率较高。按说明书给药方式与超说明书给药方式导致静脉炎的发生率无差异。

Abstract:

OBJECTIVE To evaluate the difference of the occurrence of phlebitis caused by different administration methods of the alprostadil microsphere carrier preparation by using the method of meta-analysis, and to provide evidence-based reference for clinical application. METHODS To search the CNKI, VIP, Wanfang, Chinese Biomedical Literature Database, EMbase, Pubmed, Cochrane Library, collected literatures about phlebitis caused by alprostadil microsphere carrier preparation in different routes. The screening conditions were established and the literature was screened. After evaluating the quality according to the manual of Cochrane system evaluator, the effective data extracted were meta-analyzed by RevMan 5.2 statistical software. RESULTS Twenty three randomized cotrolled trial(RCT) studies involving 3 165 patients were included. Meta analysis showed that intravenous injection of alprostadil microspheres was more likely to increase the incidence of phlebitis than intravenous drip[RR=1.92, 95%CI(1.17, 3.17), P=0.01], but there was no difference in the incidence of phlebitis caused by intravenous injection of alprostadil microspheres and off-lable drug use[RR=1.35, 95%CI(0.69, 2.64), P=0.38]. There was no significant difference in the incidence of phlebitis caused by intravenous infusion of alprostadil microspheres and off-lable drug use[RR=0.52, 95%CI(0.17, 1.62), P=0.26], but the incidence of phlebitis caused by intravenous infusion of alprostadil microspheres was lower than that of intravenous pump[RR=0.46, 95%CI(0.31, 0.67), P<0.000 1]. According to meta analysis, the incidence of phlebitis caused by alprostadil microspheres used common infusion set was significantly higher than that of fine filtration infusion set[RR=0.18, 95%CI(0.13, 0.25), P<0.000 01], and the difference used common infusion set was statistically significant. Meta analysis showed that the incidence of phlebitis by slow intravenous injection of alprostadil microsphere carrier was significantly higher than that of rapid intravenous injection[RR=0.37, 95%CI (0.21, 0.67), P=0.001 0]. CONCLUSION The incidence of phlebitis caused by alprostadil microsphere carrier preparation used rapid intravenous injection or fine filtration infusion set was low, while used intravenous injection is higher than intravenous drip, used intravenous pump is higher than intravenous infusion. There is no difference of the incidence of phlebitis caused by alprostadil microsphere carrier preparation according to the instructions or off-lable drug use.