水合氯醛口服溶液用于儿童镇静催眠安全性的系统评价
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篇名: 水合氯醛口服溶液用于儿童镇静催眠安全性的系统评价
TITLE: Safety on Chloral Hydrate Oral Solution for Sedative and Hypnotic in Children :A Systematic Review
摘要: 目的:系统评价水合氯醛口服溶液用于儿童镇静催眠的安全性,为其临床应用提供循证参考。方法:检索文献数据库9个(PubMed、Cochrane图书馆、Embase、CINAHL、InternationalPharmaceuticals、中国期刊全文数据库、中国生物医学文献数据库、万方数据库和维普网)、临床试验注册平台3个(ClinicalTrials、Cochrane临床试验数据库、世界卫生组织临床试验数据库)和不良反应监测网站18个(如世界卫生组织、美国、瑞士、中国等国家/地区/组织的不良反应检测网站),检索时限均为建库起至2019年3月,收集水合氯醛对比其他干预措施(空白对照、安慰剂或其他镇静催眠药物)用于儿童镇静催眠安全性的随机对照试验、队列研究、病例对照研究、病例系列研究、病例报告、横断面调查研究和不良反应监测网的报告。对符合纳入标准的文献进行资料提取,并采用Cochrane偏倚风险评价手册(随机对照试验)、纽卡斯尔-渥太华量表评价工具(队列研究和病例对照研究)、澳大利亚JBI质量评价工具(病例系列研究和病例报告)等对纳入研究进行质量评价后,采用RevMan5.3软件进行Meta分析,或进行描述性分析。结果:共纳入研究54项,其中随机对照试验13项、队列研究9项、病例系列研究17项、病例报告13项、不良反应监测网报告2项。基于随机对照试验和队列研究结果显示,水合氯醛口服溶液不良事件发生率为7.25%。水合氯醛口服溶液与咪达唑仑在消化系统[RR=0.87,95%CI(0.14,5.42),P=0.88]、神经系统[RR=0.13,95%CI(0.01,2.41),P=0.17]和心血管系统[RR=2.12,95%CI(0.08,56.57),P=0.65]的不良事件发生率比较差异均无统计学意义,但水合氯醛口服溶液呼吸系统的不良事件发生率高于咪达唑仑[RR=3.07,95%CI(1.94,4.86),P<0.01]。水合氯醛口服溶液与地西泮的消化系统不良事件发生率比较,差异无统计学意义[RR=0.71,95%CI(0.47,1.10),P=0.13]。水合氯醛口服溶液与巴比妥类药物在消化系统、神经系统、心血管系统的不良事件发生率比较,差异均无统计学意义(P>0.05)。结论:水合氯醛口服溶液在消化系统、神经系统、心血管系统不良事件发生率与咪达唑仑、地西泮和巴比妥类药物相当,但其呼吸系统不良事件发生率高于咪达唑仑。
ABSTRACT: OBJECTIVE:To systematically evaluate the safety of Chloral hydr ate(CH)oral solution for sedative and hypnotic in children,and to provide evidence-based reference for clinical use. METHODS :Retrieved from 9 electronic databases (PubMed, Cochrane Library ,Embase,CINAHL,International Pharmaceuticals ,CNKI,CBM,Wanfang Database ,VIP),3 clinical trial registry platforms (Clinical Trials ,Cochrane Clinical Trial Database ,WHO Clinical Trial Database )and 18 adverse drug reaction (ADR)monitoring systems (ADR monitoring websites of WHO ,USA,Switzerland,China and other countries/areas/international organizations),during the date of database establishment to March 2019,the reports of randomized controlled trials ,cohort studies,case-control studies ,case series studies ,case reports , cross-sectional studies and adverse reactions monitoring network of chloral hydrate versus other interventions (blank 85503205。E-mail:chenzhehx@163.com control,placebo or other sedative hypnotics )for children ’s sedative and hypnotic safety were collected. After data extraction of included literatures met inclusion criteria ,quality mail:zhanglingli@scu.edu.cn evaluation of included s tudies with Cochrane bias risk evaluation manual (RCT),Newcastle-Ottawa scale evaluation tool (Cohort study and case control study ),Australian JBI quality assessment tool (case series study and case report study ),Meta-analysis was performed by Rev Man 5.3 software,or descriptive analysis was conducted. RESULTS :A total of 54 studies were included ,among which there were 13 RCTs,9 cohort studies ,17 case series studies ,13 case reports ,and 2 reports from ADR monitoring network. Based on the results of RCT and cohort studies , the incidence of Chloral hydrate oral solution adverse events was 7.25%. There was no statistical significance in the incidence of digestive system [RR =0.87,95% CI(0.14,5.42),P=0.88],nervous system [RR =0.13,95% CI(0.01,2.41),P=0.17], cardiovascular system [RR =2.12,95% CI(0.08,56.57),P=0.65] adverse event between Chloral hydrate oral solution and midazolam. The incidence of respiratory system adverse events induced by Chloral hydrate oral solution was higher than that of midazolam [RR =3.07,95%CI(1.94,4.86),P<0.01]. There was no statistical significance in the incidence of digestive system adverse events between Chloral hydrate oral solution and diazepam [RR =0.71,95%CI(0.47,1.10),P=0.13]. There was no statistical significance in the incidence of digestive system ,nervous system and cardiovascular system adverse events between Chloral hydrate oral solution and barbiturates (P>0.05). CONCLUSIONS :Chloral hydrate oral solution is similar to midazolam , diazepam and barbiturates in terms of digestive ,nervous and cardiovascular systems adverse events ,but the incidence of respiratory system adverse events is higher than midazolam.
期刊: 2020年第31卷第09期
作者: 陈哲,林茂,曾力楠,黄亮,俞丹,张伶俐
AUTHORS: CHEN Zhe,LIN Mao,ZENG Linan,HUANG Liang,YU Dan,ZHANG Lingli
关键字: 水合氯醛;口服溶液;儿童;镇静催眠;安全性;系统评价
KEYWORDS: Chloral hydrate ;Oral solution ;Child;Sedative and hypnotic ;Safety;Systematic review
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