A systematic review and meta-analysis assessing adverse event profile and tolerability of nicergoline.
A systematic review and meta-analysis assessing adverse event profile and tolerability of nicergoline.
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评估尼麦角林不良事件概况和耐受性的系统评价和荟萃分析
DOI：
10.1136/bmjopen-2014-005090
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发表时间：
2014-07-30
期刊：
影响因子：
2.9
通讯作者：
Garg A
中科院分区：
文献类型：
--
作者：
Fioravanti M;Nakashima T;Xu J;Garg A
目的评价尼麦角林与安慰剂及其他活性药物的安全性。设计尼麦角林与安慰剂和其他活性药物在不同适应症中的系统评价和荟萃分析。数据来源MEDLINE、Medline-in-process、科克伦、EMBASE、EMBASE alerts、科克伦对照试验中心（CENTRAL）、科克伦系统性综述数据库（CDSR）和科克伦方法学登记库（CMR），适用于所有在接受尼麦角林治疗的成人中开展的开放标签或设盲随机对照试验。纳入了截至2013年8月发表的研究。审查方法29项研究纳入数据提取。本综述纳入的研究主要来自欧洲国家，主要涉及脑血管疾病（n=15）和痴呆（n=8）。结果尼麦角林组的停药率低于安慰剂组（RR=0.92; 95%CI 0.7 ~ 1.21）和其他活性对照药物组（RR=0.45; 95%CI 0.10 ~ 1.95），但差异无统计学意义。与安慰剂组相比，尼麦角林组任何不良事件（AE）的发生率略高（RR=1.05; 95% CI 0.93 - 1.2），而严重AE的发生率较低（RR=0.85; 95% CI 0.50 - 1.45）。尼麦角林组的焦虑频率显著低于安慰剂组（p=0.01）。与安慰剂/活性药物相比，尼麦角林组的其他AE（包括腹泻、胃部不适、头晕和嗜睡）发生率较低，但差异不显著。尼麦角林组低血压和潮热的频率略高，但差异不显著。这些研究均未报告尼麦角林治疗的纤维化或麦角中毒发生率。结论尼麦角林为麦角衍生物，但其安全性优于麦角胺和麦角毒碱。该系统性综述和荟萃分析表明，尼麦角林具有良好的安全性特征。本系统性综述中纳入的研究均未报告尼麦角林的任何纤维化或麦角中毒发生率。
Objective To evaluate the safety profile of nicergoline compared with placebo and other active agents from published randomised controlled trials. Design Systematic review and meta-analysis of nicergoline compared with placebo and other active agents across various indications. Data sources MEDLINE, Medline-in-process, Cochrane, EMBASE, EMBASE alerts, Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews (CDSR) and Cochrane Methodology Register (CMR) for all the randomised controlled trials, open-label or blinded, in adults treated with nicergoline. Studies published until August 2013 were included. Review method 29 studies were included for data extraction. The studies included in this review were majorly from European countries and mostly in cerebrovascular disease (n=15) and dementia (n=8). Results The treatment withdrawals were comparatively lower in the nicergoline group as compared with the placebo group (RR=0.92; 95% CI 0.7 to 1.21) and other active comparators (RR=0.45; 95% CI 0.10 to 1.95), but the difference was non-significant. Incidence of any adverse events (AEs) was slightly higher (RR=1.05; 95% CI 0.93 to 1.2) while incidence of serious AEs was lower (RR=0.85; 95% CI 0.50 to 1.45) in the nicergoline compared with placebo group. Frequency of anxiety was significantly lower in nicergoline as compared with placebo (p=0.01). Other AEs including diarrhoea, gastric upset, dizziness and drowsiness were less frequent in the nicergoline group when compared with placebo/active drugs, but the difference was non-significant. Frequency of hypotension and hot flushes was slightly higher in the nicergoline group but the difference was non-significant. None of the studies reported any incidence of fibrosis or ergotism with nicergoline treatment. Conclusions Nicergoline is an ergot derivative, but its safety profile is better than other ergot derivatives like ergotamine and ergotoxine. This systematic review and meta-analysis suggests that nicergoline has a good safety profile. None of the studies included in this systematic review reported any incidence of fibrosis or ergotism with nicergoline.
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影响因子：
2.9
作者：
Alvarez-Guerra, M;Bertholom, N;Garay, RP
通讯作者：
Garay, RP
影响因子：
2.5
作者：
Kim, MJ;Chang, JH;Bang, BK
通讯作者：
Bang, BK
DOI：
10.1016/0197-2456(95)00134-4
发表时间：
1996-02-01
期刊：
CONTROLLED CLINICAL TRIALS
影响因子：
--
作者：
Jadad, AR;Moore, RA;McQuay, HJ
通讯作者：
McQuay, HJ
影响因子：
14.2
作者：
BOUSQUET, J;RIVORY, JP;MION, C
通讯作者：
MION, C
影响因子：
3.2
作者：
Felisati, G;Battaglia, A;Pignataro, O
通讯作者：
Pignataro, O