【摘要】：目的評(píng)價(jià)百樂(lè)眠治療失眠障礙的療效、安全性及與療程的關(guān)系。方法檢索中國(guó)知網(wǎng)(CNKI)、萬(wàn)方數(shù)據(jù)庫(kù)、中國(guó)優(yōu)秀碩士/博士學(xué)位論文數(shù)據(jù)庫(kù)、維普中文科技期刊數(shù)據(jù)庫(kù)(VIP)、Cochrane圖書(shū)館、Pubmed、EMBASE、中國(guó)學(xué)術(shù)會(huì)議論文數(shù)據(jù)庫(kù)中截至到2016年12月的百樂(lè)眠治療失眠的文獻(xiàn),用Jadad量表評(píng)價(jià)文獻(xiàn)質(zhì)量,用Stata 14軟件進(jìn)行Meta分析。結(jié)果納入文獻(xiàn)20篇,共計(jì)2235例(觀(guān)察組1284例,對(duì)照組951例)。百樂(lè)眠組治療失眠的總有效率顯著高于對(duì)照組(RR=1.20,95%CI:1.10~1.31),百樂(lè)眠治療失眠的有效率顯著高于西藥亞組(RR=1.24,95%CI:1.07~1.44)及其他中藥亞組(RR=1.13,95%CI:1.03~1.23)。百樂(lè)眠組治療失眠降低匹茲堡睡眠質(zhì)量指數(shù)(PSQI)評(píng)分優(yōu)于對(duì)照組[標(biāo)準(zhǔn)化均數(shù)差(SMD)=-0.53,95%CI:-0.81~-0.26]。隨著用藥療程的增加(第2、3、4周),百樂(lè)眠治療失眠降低PSQI評(píng)分較西藥亞組的優(yōu)勢(shì)逐漸顯現(xiàn)(SMD2=-0.50,95%CI:0.83~-0.16;SMD3=-0.60,95%CI:-0.97~-0.24;SMD4=-1.67,95%CI:-0.63~-0.05)。百樂(lè)眠組治療失眠的不良反應(yīng)事件發(fā)生率顯著低于對(duì)照組(RR=0.25,95%CI:0.16~0.38)。百樂(lè)眠組不良反應(yīng)事件發(fā)生率顯著低于西藥亞組(RR=0.23,95%CI:0.15~0.36)。隨著用藥療程的增加(第2、3、4、8周),百樂(lè)眠組不良反應(yīng)事件發(fā)生率逐漸低于西藥亞組(RR2=0.45,95%CI:0.22~0.92;RR3=0.23,95%CI:0.04~1.33;RR4=0.16,95%CI:0.08~0.33;RR8=0.19,95%CI:0.06~0.59)。結(jié)論百樂(lè)眠膠囊治療失眠障礙的總體有效率、降低PSQI評(píng)分均優(yōu)于西藥和其他中藥,具有較高的安全性,值得在臨床上進(jìn)一步推廣使用。但是否隨著用藥療程的增加總體有效率及降低PSQI評(píng)分優(yōu)勢(shì)越顯著仍有待進(jìn)一步研究驗(yàn)證。
[Abstract]:Objective to evaluate the efficacy, safety and relationship with the course of treatment of insomnia. Methods (CNKI), Wanfang database and excellent master / doctoral thesis database were searched. The Chinese scientific and technological journal database (VIP), Cochrane library and the Pubmed,EMBASE, China academic conference paper database were used to evaluate the quality of the literature by using Jadad scale to evaluate the quality of the literature. The Meta analysis was carried out with Stata 14 software in the database of Chinese scientific and technological journals and papers in the database of Pubmed,EMBASE, China academic Conference from December 2016 to December 2016. Results A total of 2235 cases were included in 20 articles (1284 cases in the observation group and 951 cases in the control group). The total effective rate of treatment of insomnia was significantly higher than that of the control group (RR=1.20,95%CI:1.10~1.31), and the effective rate of the treatment of insomnia was significantly higher than that of the western medicine subgroup (RR=1.24,95%CI:1.07~1.44) and other Chinese medicine subgroup (RR=1.13,95%CI:1.03~1.23). The score of Pittsburgh sleep quality index (PSQI) in the treatment group with insomnia was better than that in the control group [standardized mean difference (SMD) = -0.5395% -0.81% -0.26]. With the increase of the course of treatment (2 ~ 3 ~ 4 weeks), the advantage (SMD2=-0.50,95%CI:0.83~-0.16;SMD3=-0.60,95%CI:-0.97~-0.24;SMD4=-1.67,95%CI:-0.63~-0.05) of reducing PSQI score in the treatment of insomnia was gradually revealed (SMD2=-0.50,95%CI:0.83~-0.16;SMD3=-0.60,95%CI:-0.97~-0.24;SMD4=-1.67,95%CI:-0.63~-0.05). The incidence of adverse events in the parlurium group was significantly lower than that in the control group (RR=0.25,95%CI:0.16~0.38). The incidence of adverse events in Paramol group was significantly lower than that in western medicine subgroup (RR=0.23,95%CI:0.15~0.36). With the increase of the course of treatment (2nd week, 3rd week, 4 weeks), the incidence of adverse events in the parlomide group was lower than that in the western medicine subgroup (RR2=0.45,95%CI:0.22~0.92;RR3=0.23,95%CI:0.04~1.33;RR4=0.16,95%CI:0.08~0.33;RR8=0.19,95%CI:0.06~0.59). Conclusion the total effective rate of Baile Mian capsule in treating insomnia disorder is better than that of western medicine and other traditional Chinese medicine in reducing PSQI score. It is worth popularizing in clinic. But the more significant the overall effective rate and the lower PSQI score are with the increase of the course of treatment, the further research remains to be done.
【作者單位】： 復(fù)旦大學(xué)公共衛(wèi)生學(xué)院臨床流行病學(xué)研究中心公共衛(wèi)生安全教育部重點(diǎn)實(shí)驗(yàn)室;
【分類(lèi)號(hào)】：R740
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本文編號(hào)：2279706