【摘要】 目的观察珍枣胶囊治疗老年阴虚火旺型失眠患者的临床疗效和安全性。方法将66例老年阴虚火旺型失眠患者随机分为治疗组和对照组各33例。治疗组服用珍枣胶囊,每日1次,每次1.9g;对照组服用舒眠胶囊,每日1次,每次2.0g;两组患者睡前30min口服,疗程4周。通过多导睡眠图监测,观察治疗前后两组患者总睡眠时间、睡眠潜伏期时间、觉醒次数和非快速眼动睡眠各分期时间并记录两组患者中医证候积分。治疗后评价临床疗效和中医证候疗效,并观察不良反应。结果治疗组总有效率为87.88%,对照组为81.82%,两组比较差异无统计学意义(P>0.05);中医证候疗效比较,治疗组总有效率为90.90%,对照组为75.76%,治疗组明显优于对照组(P<0.05)。治疗后两组患者中医证候积分均比治疗前明显下降(P<0.05),治疗组治疗后中医证候积分明显低于对照组(P<0.05)。治疗后两组患者总睡眠时间、睡眠潜伏期时间、觉醒次数和非快速眼动睡眠各分期时间均较治疗前明显改善(P<0.05或P<0.01);治疗组睡眠潜伏期时间、觉醒次数、入睡期时间和中度+深度睡眠期时间改善明显优于对照组(P<0.05)。两组患者均未发现不良反应。结论珍枣胶囊治疗老年阴虚火旺型失眠患者疗效确切,安全可靠,其可以调整患者的睡眠结构、增加总睡眠时间和缩短睡眠潜伏期时间。更多还原

【Abstract】 Objective To observe the efficacy and safety of Zhenzao Capsule [capsule of Suanzaoren( Semen Ziziphi Spinosae,酸枣仁) and Zhenzhumu( Concha Margaritifera,珍珠母) ] for elderly patients with insomnia of effulgent yin deficiency fire pattern. Methods Totally 66 elderly patients with insomnia of effulgent yin deficiency fire pattern were randomized into the treatment group and control group,with 33 in each. The treatment group and control group was given 1. 9 g of Zhenzao Capsule and 2. 0 g of Shumian Capsule( capsule for insomnia) respectively 30min before bedtime. The treatment lasted for 4 weeks. The total sleep time,sleep latency time,numbers of awakenings and non-rapid eye movement( REM) sleep time were observed before and after treatment according to polysomnography. The TCM pattern scores were recorded before and after treatment. The therapeutic effect and TCM pattern efficacy were evaluated and the adverse reactions were recorded after treatment. Results The total effective rate of the treatment group and control group was 87. 88% and 81. 82% respectively,with no significant difference between groups( P > 0. 05). The total TCM pattern efficacy in the treatment group and control group was 90. 90% and 75. 76% respectively,with significant difference between groups( P < 0. 05). The TCM pattern scores in both groups were significantly decreased after treatment( P < 0. 05),especially in the treatment group( P < 0. 05). The total sleep time,sleep latency time,numbers of awakenings and non-REM sleep time were significantly improved in both groups after treatment( P < 0. 05 or P < 0. 01),especially sleep latency time,numbers of awakenings,sleep time,moderate + deep sleep time in the treatment group( P < 0. 05). There was no adverse reaction in both groups. Conclusion Zhenzao Capsule is effective and safe for insomnia with effulgent yin deficiency fire pattern in elderly. It can regulate the sleep structure,increase the total sleep time and shorten the sleep latency time.更多还原