中医药辅助治疗围绝经期失眠研究的Meta分析

目的:系统评价中医药辅助治疗围绝经期失眠的疗效及安全性。方法:计算机检索Pub Med,The Cochrane Library,OVID,EMbase,CBM,CNKI,Wan Fang Data及VIP数据库,检索时限均从2010年至2014年12月,纳入有关中医药结合西药(中西医结合)对照单纯西药治疗围绝经期失眠的RCT研究。设计文献资料提取表,由2名研究者按纳排标准独立对文献进行筛检、提取资料、评价文献偏倚风险,并结合Rev Man5.2.6软件进行Meta分析。结果:共纳入21个RCTs,包括1 608例患者。Meta分析结果显示:中医药辅助治疗其临床有效率高于对照组[OR=3.26,95%CI(2.50,4.26),P0.000 01];治疗后其复发率较对照组低[OR=4.21,95%CI(2.46,7.22),P0.000 01];在PSQI总评分测评方面比较,中医药辅助治疗组优于对照组[MD=-2.28,95%CI(-2.78,-1.78)];在患者睡眠状况改善方面,中医药辅助治疗组在睡眠质量[MD=-0.40,95%CI(-0.73,-0.06)],入睡时间[MD=-0.54,95%CI(-0.91,-0.16)],睡眠时间[MD=-0.41,95%CI(-0.60,-0.22)],睡眠效率[MD=-0.38,95%CI(-0.56,-0.20)],睡眠障碍[MD=-0.37,95%CI(-0.55,-0.19)],催眠药物[MD=-0.32,95%CI(-0.47,-0.18)],日间功能障碍[MD=-0.29,95%CI(-0.47,-0.10)],Kupperman评分[MD=-5.48,95%CI(-9.87,-1.09),P=0.01]方面测评均优于对照组;在证候评价方面,中医药辅助治疗组在改善患者潮热汗多[MD=-1.65,95%CI(-1.84,-1.45)],烦躁易怒[MD=-0.99,95%CI(-1.13,-0.85)],头晕心悸[MD=-2.18,95%CI(-2.92,-1.43)],精神倦怠[MD=-1.89,95%CI(-2.07,-1.72)]等症状其效果均优于常规治疗组;在内分泌激素水平测评层面,中医药辅助组较常规治疗组可促进患者血清中雌二醇(E2)水平[MD=17.70,95%CI(1.89,33.52)],降低卵泡刺激素(FSH)水平[MD=-11.51,95%CI(-20.49,-2.53)],但在黄体生成素(LH)水平比较其差异无统计学意义[MD=-5.85,95%CI(-13.01,1.30)];纳入研究均未报告由中医药辅助治疗所引起的频繁或严重不良反应。结论:本研究Meta分析表明,中医药辅助干预可改善患者睡眠障碍,提高睡眠质量,且不良反应少;但现有研究方法学及报道质量偏低,以上结果仍需进行设计严谨的大样本研究予以证实。

Meta-analysis on Randomized Controlled Trials of Adjuvant Therapy with Traditional Chinese Medicines for Perimenopausal Insomnia

Objective: To systematically evaluate the efficacy and safety of the adjuvant therapy with traditional Chinese medicines (TCM) in treating perimenopausal insomnia. Method: The PubMed, Cochrane Library, OVID, EMbase, CNKI, WanFang Data and VIP databases between 2010 and December 2014 were searched through computer to collect all RCTs on the comparison of the combined therapy of TCM and western medicines and the simple therapy of western medicines in treating perimenopausal insomnia. The data extraction form was designed. Two researchers independently screened the littérateurs, extracted data and evaluated the literature bias risk according to the inclusion standards. The Meta-analysis was operated by using RevMan 5.2.6 software. Result: A total of 21 RCTs involving 1 608 patients were included. The result of Meta-analysis indicated t hat the TCM adjuvant therapy group was superior to the control group in terms of clinical effectiveness[OR=3.26, 95%CI(2.50, 4.26), P<0.000 01], recurrence rate[OR=4.21, 95%CI(2.46, 7.22), P<0.000 01]and total scale of PSQI[MD=-2.28, 95%CI(-2.78, -1.78)]. With respect to the sleep improvement, the TCM adjuvant therapy group was also better than the control group in quality of sleep[MD=-0.40, 95%CI(-0.73, -0.06)], time of sleeping[MD=-0.54, 95%CI(-0.91, -0.16)], hour of sleep[MD=-0.41, 95%CI(-0.60, -0.22)], efficiency of sleep[MD=-0.38, 95%CI(-0.56, -0.20)], disorders of sleep[MD=-0.37, 95%CI(-0.55, -0.19)], application of hypnotic drugs[MD=-0.32, 95%CI(-0.47, -0.18)], daytime dysfunction[MD=-0.29, 95%CI(-0.47, -0.10)]and scale of Kupperman[MD=-5.48, 95%CI(-9.87, -1.09), P=0.01]. With respect to the syndrome evaluation, the TCM adjuvant therapy group showed a better effect than the conventional treatment group in relieving patients' hot flash and sweating[MD=-1.65, 95%CI(-1.84, -1.45)], irritability[MD=-0.99, 95%CI(-1.13, -0.85)], dizziness and palpitation[MD=-2.18, 95%CI(-2.92, -1.43)]and mental burnout[MD=-1.89, 95%CI(-2.07, -1.72)]. At the level of endocrine hormone, the TCM adjuvant therapy group can better improve the estradiol (E₂) level[MD=17.70, 95%CI(1.89, 33.52)]and reduce the level of follicle-stimulating hormone (FSH)[MD=-11.51, 95%CI(-20.49, -2.53)], but with no statistical significance in difference in luteinizing hormone (LH)[MD=-5.85, 95%CI(-13.01, 1.30)]. No serious or frequent adverse effect was reported for the two groups. Conclusion: The Meta-analysis suggests that the adjuvant intervention with TCM can improve patients' sleep disorders, enhance the quality of sleep, with less adverse effect. However, there are only a few research methodologies and reports in a low quality. The above results shall be further proved by well-designed large-sample-size studies.