前列环素类似物治疗肺动脉高压安全性与耐受性的Meta分析

Meta-analysis of safety and tolerability of prostacyclin analogues for pulmonary arterial hypertension

目的系统评价前列环素类似物(prostacyclin analogues,PA)治疗肺动脉高压(pulmonary arterial hypertension,PAH)的安全性与耐受性。方法在线检索中国知网、万方、维普、PubMed、Embase等数据库,查找PA治疗PAH的随机对照试验(randomized controlled trial,RCT),进行文献筛选、数据提取及偏倚评估后,使用RevMan5.3和Stata V 12.0软件进行Meta分析。结果共纳入16个RCT,3726例患者。Meta分析结果示:试验组至少出现一次不良反应(AE)[RR=1.05,95%CI(1.00,1.10),P=0.04]和停药不良反应的发生率[RR=1.81,95%CI(1.08,3.05),P=0.02]均较对照组高,差异有统计学意义,各具体AE发生趋势前者也较后者高;而至少出现一次严重不良反应的发生率[RR=0.93,95%CI(0.83,1.04),P=0.20],差异无统计学意义。结论应用PA治疗PAH患者安全性尚可,但仍存在一定的耐受性风险。

Objective To evaluate the safety and tolerability of prostacyclin analogues(PA) in the treatment of pulmonary arterial hypertension(PAH).Methods Such databases as CNKI, WanFang Data, VIP, PubMed and Embase were searched for randomized controlled trials(RCTs)in which PAs were used in the treatment of PAH. Literature was screened, data was extracted and the quality of the study was assessed. RevMan5.3 and StataV12.0 software were used for meta-analysis.Results Sixteen RCT studies involving 3,726 patients were included in this research. The result of meta-analysis showed that the incidence of at least one adverse events(AEs)[RR=1.05, 95%CI(1.00, 1.10), P=0.04] and discontinuation [RR=1.81, 95%CI(1.08, 3.05), P=0.02] in the test group was higher than that in the control group, and the difference was statistically significant. The chance of specific AEs in the test group was also higher than in the control group. The incidence rates of at least one serious adverse event [RR=0.93, 95%CI(0.83, 1.04), P=0.20] was not significantly different between the two groups.Conclusions PAs are relatively safe, but there is still the risk of tolerability in PAH patients.