美安颗粒辅助治疗肝阴亏虚型失眠症的随机双盲、安慰剂平行对照试验研究

Adjuvant treatment of insomnia of liver-yin deficiency pattern by "Mei'an Granule":A randomized double-blind and placebo-controlled trial

目的观察美安颗粒辅助治疗肝阴亏虚型失眠症的临床疗效及安全性。方法采用随机双盲、安慰剂平行对照的临床研究设计方案,收集60例肝阴亏虚型轻中度失眠病例,随机分为治疗组和对照组,每组30例。两组均给予西医基础治疗(按需服用艾司唑仑),治疗组同时加服美安颗粒,对照组加服美安颗粒安慰剂。两组临床试验疗程均为14天,观察睡眠质量疗效、中医证候疗效以及匹兹堡睡眠质量指数(PSQI)评分变化情况和安全性。结果①治疗组治疗后及停药第7天睡眠质量总有效率分别为86.7%、66.7%,对照组分别为23.3%、16.7%,治疗组睡眠质量临床疗效优于对照组(P<0.01)。②治疗组、对照组中医证候总有效率分别为100%、83.3%,治疗组中医证候疗效优于对照组(P<0.05)。③治疗组治疗第7天、治疗后及停药第7天PSQI总分较治疗前均明显降低(P<0.01),对照组治疗后、停药第7天PSQI总分较治疗前明显降低(P<0.01);治疗组治疗第7天、治疗后及停药第7天PSQI总分均低于对照组(P<0.01)。④治疗组治疗后PSQI各因子评分与治疗前比较均明显降低(P<0.05,P<0.01),对照组治疗后主观睡眠质量、催眠药物、日间功能障碍评分较治疗前明显降低(P<0.05,P<0.01);治疗组主观睡眠质量、入睡时间、睡眠效率、睡眠障碍、日间功能障碍治疗前后评分差值大于对照组(P<0.05)。⑤两组观察期间均未见明显的与药物有关的不良反应。结论美安颗粒辅助治疗失眠症(肝阴亏虚型)安全有效。

Objective To observe the clinical efficacy and safety of ＂ Mei＇ an Granule＂ in the adjuvant treatment of insomnia of liver-yin deficiency. Methods According to a randomized, double-blind and placebo-controlled trial, 60 cases with mild or moderate insomnia were randomized into two groups： treatment group in which 30 eases were treated with western medicine and ＂Mei＇ an Granule＂ ; control group in which 30 cases were treated with western medicine and placebo, with the course of 14 days. The sleep quality, Pittsburgh Sleep Quality Index （PSQI）, TCM syndrome and safety were evaluated. Results ① In treatment group, the total effective rate of sleep quality was 86.7% after 14-day treatment and 66.7% after drug withdrawal for 7 days respectively; in control group, the total effective rate was 23.3% after 14-day treatment and 16.7% after drug withdrawal for 7 days. The clinical effects of sleep quality in treatment group was better than that of the control group （P 〈0.01 ）. ②The overall effective rate of TCM syndrome was 100% in the treatment group and 83.3% in the control group, with a difference between the two groups （P 〈0.05）. ③ In treatment group, the PSQI total score was decreased markedly at the 7th day, after treatment, after drug withdrawal for 7 days （ P 〈 0.01 ）, and in control group, the PSQI total score was decreased markedly after treatment, after drug withdrawal for 7 days （ P 〈0.01 ） ; the PSQI total scores at the 7th days treatment, after treatment, after drug withdrawal for 7 days in treatment group were lower than that in control group （ P 〈 0.01 ）. ④ In treatment group, the PSQI score after treatment were decreased than that before treatment （ P 〈 0.05, P 〈 0.01 ）, and in control group, the subjective sleep quality, hypnotic and daytime dysfunction were decreased after treatment （ P 〈 0.05, P 〈 0.01 ） ; Before or after treatment, there were significant differences in sleep quality, going sleep time, sleep efficiency, daytime dysfunction in treatment group were higher than that of the control group （ P 〈 0.05 ）. ⑤ No adverse events were found and no difference in the indexes of security were found in both of the groups. Conclusion ＂Mei＇ an Granule!＇ is safe and effective for adjuvant treatment of insomnia of liver-yin deficiency pattern.