甘麦芪仙磁石汤联合艾司唑仑片治疗老年慢性失眠心脾两虚证临床观察

Clinical Observation of Ganmai Qixian Cishi Decoction Combined with Estazolam Tablets in Treating Chronic Insomnia in Elderly with Xin-Pi Deficiency

目的观察甘麦芪仙磁石汤联合艾司唑仑片对心脾两虚证老年人慢性失眠的疗效及安全性。方法选择慢性失眠心脾两虚证老年患者90例,按照随机数字表法分为西医组(15例)、中医组(30例)、中西医结合组(45例)。西医组睡前口服艾司唑仑片1 mg,中医组口服甘麦芪仙磁石汤,中西医结合组采用以上疗法联合治疗,疗程均为4周。比较各组匹兹堡睡眠质量指数(PSQI)评分、有效率、中医证候积分、睡眠潜伏期、睡眠效率、N3期睡眠比例、血清5-羟色胺(5-HT)表达水平,观察不良反应。结果与本组治疗前比较,西医组和中西医结合组治疗1、2、4周PSQI评分、中医证候积分降低(P<0.01,P<0.05),中医组治疗4周后PSQI评分、中医证候积分降低(P=0.000);治疗4周后,各组有效率、睡眠效率、N3期睡眠比例、血清5-HT表达水平均升高,睡眠潜伏期缩短(P<0.01,P<0.05)。与西医组比较,中医组和中西医结合组治疗4周后有效率、睡眠效率、N3期睡眠比例、血清5-HT表达水平升高,PSQI评分、中医证候积分、睡眠潜伏期降低(P<0.01,P<0.05)。与中医组比较,中西医结合组有效率、睡眠效率、N3期睡眠比例、血清5-HT表达水平升高,PSQI评分、中医证候积分、睡眠潜伏期下降,但差异无统计学意义(P>0.05)。结论甘麦芪仙磁石汤联合艾司唑仑片治疗老年慢性失眠症有效,可缩短药物起效时间。单用甘麦芪仙磁石汤也可达到良好的治疗效果,未见严重不良反应。

Objective To observe the efficacy and safety of Ganmai Qixian Cishi Decoction combined with Estazolam tablets on chronic insomnia in elderly with Xin-Pi deficiency.Methods Totally 90 elderly chronic in-somnia patients with Xin-Pi deficiency were randomly assigned to Western medicine group(15 cases),Chinese medicine group(30 cases)and combination group(45 cases),according to the random number table.The Western medicine group took 1 mg of Estazolam tablets orally before bedtime,Western medicine group received Ganmai Qixian Cishi Decoction,combination group received Ganmai Qixian Cishi Decoction and Estazolam tablets.After 4 weeks,Pittsburgh Sleep Quality Index(PSQI)score,the effective rate,TCM syndrome score,sleep latency,sleep efficiency,N3 sleep proportion,serum 5-HT and adverse reactions were observed.Results Compared with before treatment,PSQI score and TCM syndrome score decreased after treatment for 1,2 and 4 weeks in the Western medicine group and the combination group(P<0.01,P<0.05),PSQI score and TCM syndrome score in Chinese medicine group decreased at 4 week treatment(P=0.000).After 4 weeks of treatment,the effective rate,sleep efficiency,N3 sleep proportion and the concentration of serum 5-HT increased,meanwhile,the sleep latency decreased(P<0.01,P<0.05).Compared with the Western medicine group,the effective rate,sleep efficiency,N3 sleep proportion,serum 5-HT expression level,and PSQI score,TCM syndrome score,and sleep latency decreased after 4 weeks of treatment in the Chinese medicine group and the combination group(P<0.01,P<0.05).Compared with Chinese medicine group,the effective rate,sleep efficiency,N3 sleep proportion and the concentration of serum 5-HT of the combination group increased,meanwhile,the PSQI score,TCM syndrome score and sleep latency decreased,but the difference was not statistically significant(P>0.05).Conclusions Ganmai Qixian Cishi Decoction combined with Estazolam tablets in treating chronic insomnia in elderly is effective and can shorten the onset time.Ganmai Qixian Cishi Decoction alone has good curative effects in treating insomnia without serious adverse reactions.