摘要
目的系统评价雷美替胺治疗成人慢性失眠的疗效和安全性。方法计算机检索CENTRAL、PubMed、EMbase、ISI、CNKI、CBMdisc、VIP和WanFang Data,检索时间均从建库至2010年11月,纳入有关雷美替胺治疗成人慢性失眠的随机对照试验,按照Cochrane系统评价方法进行文献数据提取和质量评价后,采用RevMan 5.0软件进行Meta分析。结果最终纳入5个RCT,共计1 772例患者。Meta分析结果显示:①疗效:治疗1周后在持续睡眠潜伏期[MD=18.36,95%CI(11.55,25.18),P<0.000 01]、总睡眠时间[MD=–15.47,95%CI(–22.50,–8.43),P<0.000 1]、睡眠效率[MD=–3.39,95%CI(–5.32,–1.46),P=0.000 6]、睡眠质量[MD=0.14,95%CI(0.03,0.25),P=0.01],以及治疗1个月后在持续睡眠潜伏期[MD=13.02,95%CI(6.01,20.03),P=0.000 3]方面雷美替胺均优于安慰剂,而在治疗1个月后的入睡后觉醒时间[MD=–8.79,95%CI(–17.24,–0.35),P=0.04]上效果差于安慰剂,但在其他指标上两组差异均无统计学意义;②安全性:两组仅在女性体内催乳素浓度[MD=5.50,95%CI(2.02,8.98),P=0.002]和男性体内游离睾酮浓度[MD=15.30,95%CI(0.62,29.98),P=0.04]方面差异有统计学意义,而在其他激素水平、反跳性失眠、停药综合征、次日残留效应和不良反应发生率方面差异无统计学意义。结论雷美替胺治疗成人慢性失眠1周后效果显著,1个月后疗效不明显。不良反应主要表现为嗜睡、男性游离睾酮浓度和女性催乳素浓度升高。
Objective To evamate me exlecuveJl~ 7 otis The following databases as CENTRAL, PubMed, EMbase, ISI, CNKI, CBMdisc, VIP and WanFang Data were searched from the date of their establishment to November 2010. The randomized controlled trials （RCTs） meeting the inclusion criteria were included, qqae data extraction and quality assessment were conducted according to the methods of Cochrane Reviewers＇ Handbook recommend by The Cochrane Collaboration, and meta-analysis was performed with Key- MartS.0 software. Results A total of 5 RCTs involving 1 772 patients were included. The results of meta-analyses showed that： a） Effectiveness： In the effectiveness, ramelteon was superior to placebo in latency to persistent sleep （MD=18.36, 95%CI 11.55 to 25.18, P〈0.000 01）, total sleep time （MD= -15.47, 95%CI -22.50 to -8.43, P〈0.000 I）, sleep efficiency （MD= -3.39, 95%CI -5.32 to -1.46, P=0.000 6）, sleep quality （MD=0.14, 95%CI 0.03 to 0.25, P=0.01） after one week treatment and latency to persistent sleep （MD=13.02, 95%CI 6,01 to 20.03, P=0.000 3） except for wake after sleep onset （MD= -8.79, 95%CI -17.24 to -0.35, P=0.04） after one month treatment, b） Safety： significant differences were only found in the female prolactin （MD=5.50, 95%CI 2.02 to 8.98, P=0.002） and male free testosterone （MD=15.30, 95%CI 0.62 to 29.98, P=0.04） between the two groups, rather than in all the other hormones concentration, rebound insomnia, withdrawal syndrome, next-day residual effects and incidence rate of adverse reactions. Conclusion Ramelteon has marked effects on adults＇ chronic insomnia after 1-week treatment, but its effect is not obvious after 1-month treatment. The adverse reactions are mostly the somnolence, rising of male free testosterone and female prolactin concentration.
出处
《中国循证医学杂志》
CSCD
2012年第3期314-319,共6页
Chinese Journal of Evidence-based Medicine
