氨磺必利预防术后恶心呕吐的有效性与安全性Meta分析

Efficacy and Safety of Amisulpride in Preventing Postoperative Nausea and Vomiting: A Meta-analysis

目的系统评价氨磺必利预防术后恶心呕吐(PONV)的有效性和安全性。方法计算机检索PubMed、Embase、The Cochrane Library、CNKI、VIP、Wanfang Data和CBM数据库,收集氨磺必利预防PONV的随机对照试验(RCTs),检索时限为建库至2018年8月。由2位评价员独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.3版进行Meta分析。结果纳入RCTs4个,患者2548例。Meta分析结果显示,与对照组比较,氨磺必利可降低PONV发生率[RR=0.83,95%CI(0.78,0.89),P<0.000 01]、术后24 h呕吐发生率[RR=0.78,95%CI(0.68,0.90),P=0.000 9]、术后24 h有意义恶心发生率[RR=0.81,95%CI(0.75,0.88),P<0.000 01]和术后24 h止吐救治药物使用率(术后24 h内需要给予止吐救治药物的例数比例)[RR=0.81,95%CI(0.76,0.88),P<0.000 01]。与对照组比较,氨磺必利可减少术后7 d不良事件发生率(术后7 d内至少发生1次不良事件的例数比例)[RR=0.84,95%CI(0.77,0.92),P=0.000 1],术后7 d严重不良事件发生率[RR=0.91,95%CI(0.56,1.50),P=0.72]与对照组差异无统计学意义。结论当前证据显示,氨磺必利预防PONV有效性和安全性较好,有潜力作为预防PONV用药。受纳入研究数量和质量的限制,上述结论尚待开展更多高质量研究予以验证。

Objective To systematically evaluate the efficacy and safety of amisulpride in preventing postoperative nausea and vomiting(PONV). Methods PubMed,Embase,The Cochrane Library,CNKI,VIP,WanFang Data and CBM databases were electronically searched to collect randomized controlled trials(RCTs) for amisulpride in preventing PONV from inception to August 2018.Two reviewers independently screened literature,extracted data and assessed the risk bias of included studies,and then,meta-analysis was performed by RevMan 5.3 software. Results A total of 4 RCTs were included,involving 2548 patients.Meta-analysis showed amisulpride reduced the PONV incidence [RR=0.83,95%CI(0.78,0.89), P<0.000 01],the PO(postoperative)-24 h-vomiting incidence [RR=0.78,95%CI(0.68, 0.90),P=0.000 9], PO-24 h-significant nausea incidence [RR=0.81,95%CI(0.75,0.88),P<0.000 01] and PO-24 h-antiemetic drug use rate(the proportion of people who need antiemetic therapy within 24 hours postoperative)[RR=0.81,95%CI(0.76, 0.88),P<0.000 01] when comparing with those of the control group.In term of safety, amisulpride reduced the PO-7 d-adverse event incidence(the proportion of people who had at least one adverse event within 7 days postoperative) compared with the control group [RR=0.84,95%CI(0.77, 0.92),P=0.000 1], and the PO-7 d-serious adverse event incidence [RR=0.91,95%CI(0.56,1.50),P=0.72] was not statistically different from the control group. Conclusion The current evidence shows that amisulpride has potential as a drug for preventing PONV with good efficacy and safety.Due to limited quality and quantity of the included studies, more high-quality studies are required to verify above conclusion.