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        水合氯醛口服溶液用于兒童鎮靜催眠安全性的系統評價
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        篇名: 水合氯醛口服溶液用于兒童鎮靜催眠安全性的系統評價
        TITLE:
        摘要: 目的:系統評價水合氯醛口服溶液用于兒童鎮靜催眠的安全性,為其臨床應用提供循證參考。方法:檢索文獻數據庫9個(PubMed、Cochrane圖書館、Embase、CINAHL、InternationalPharmaceuticals、中國期刊全文數據庫、中國生物醫學文獻數據庫、萬方數據庫和維普網)、臨床試驗注冊平臺3個(ClinicalTrials、Cochrane臨床試驗數據庫、世界衛生組織臨床試驗數據庫)和不良反應監測網站18個(如世界衛生組織、美國、瑞士、中國等國家/地區/組織的不良反應檢測網站),檢索時限均為建庫起至2019年3月,收集水合氯醛對比其他干預措施(空白對照、安慰劑或其他鎮靜催眠藥物)用于兒童鎮靜催眠安全性的隨機對照試驗、隊列研究、病例對照研究、病例系列研究、病例報告、橫斷面調查研究和不良反應監測網的報告。對符合納入標準的文獻進行資料提取,并采用Cochrane偏倚風險評價手冊(隨機對照試驗)、紐卡斯爾-渥太華量表評價工具(隊列研究和病例對照研究)、澳大利亞JBI質量評價工具(病例系列研究和病例報告)等對納入研究進行質量評價后,采用RevMan5.3軟件進行Meta分析,或進行描述性分析。結果:共納入研究54項,其中隨機對照試驗13項、隊列研究9項、病例系列研究17項、病例報告13項、不良反應監測網報告2項。基于隨機對照試驗和隊列研究結果顯示,水合氯醛口服溶液不良事件發生率為7.25%。水合氯醛口服溶液與咪達唑侖在消化系統[RR=0.87,95%CI(0.14,5.42),P=0.88]、神經系統[RR=0.13,95%CI(0.01,2.41),P=0.17]和心血管系統[RR=2.12,95%CI(0.08,56.57),P=0.65]的不良事件發生率比較差異均無統計學意義,但水合氯醛口服溶液呼吸系統的不良事件發生率高于咪達唑侖[RR=3.07,95%CI(1.94,4.86),P<0.01]。水合氯醛口服溶液與地西泮的消化系統不良事件發生率比較,差異無統計學意義[RR=0.71,95%CI(0.47,1.10),P=0.13]。水合氯醛口服溶液與巴比妥類藥物在消化系統、神經系統、心血管系統的不良事件發生率比較,差異均無統計學意義(P>0.05)。結論:水合氯醛口服溶液在消化系統、神經系統、心血管系統不良事件發生率與咪達唑侖、地西泮和巴比妥類藥物相當,但其呼吸系統不良事件發生率高于咪達唑侖。
        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: 陳哲,林茂,曾力楠,黃亮,俞丹,張伶俐
        AUTHORS: CHEN Zhe,LIN Mao,ZENG Linan,HUANG Liang,YU Dan,ZHANG Lingli
        關鍵字: 水合氯醛;口服溶液;兒童;鎮靜催眠;安全性;系統評價
        KEYWORDS: Chloral hydrate ;Oral solution ;Child;Sedative and hypnotic ;Safety;Systematic review
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