舒眠胶囊与艾司唑仑治疗失眠症的临床疗效比较

目的：对比观察舒眠胶囊与艾司唑仑治疗失眠症的临床疗效和不良反应。方法将96例失眠症患者随机分为舒眠胶囊组和艾司唑仑组，两组患者分别给予舒眠胶囊和艾司唑仑治疗失眠症，疗程均为4周。2组患者在治疗前和治疗结束后分别测定PSQI评分和血清5-羟色胺（5-HT）水平，以PSQI评分的减分率作为疗效判定指标，计算2组的治疗有效率。治疗过程中每周测定一次患者的呼吸频率、心率及血、尿常规等，随时记录患者出现的不良反应，比较两种药物的不良反应发生率。结果舒眠胶囊组和艾司唑仑组患者药物治疗有效率分别为89．36％和91．83％；两组患者PSQI评分分别由治疗前的（15．1±2．5）和（14．7±2．1）降低为（9．5±2．9）和（8．6±3．2）（ P＜0．01）；舒眠胶囊组患者血清5-HT含量由治疗前的（1499．88±113．44）nmol· L－1升高至治疗后的（1786．75±116．22）nmol· L－1（P＜0．01），而艾司唑仑组该指标则未见明显改变；舒眠胶囊和艾司唑仑不良反应发生率分别为4．26％和12．24％，舒眠胶囊显著低于艾司唑仑（P＜0．05）。结论舒眠胶囊和艾司唑仑治疗失眠症的有效率和PSQI评分下降程度均差异无显著性，但舒眠胶囊的不良反应少而轻，安全性高，耐受性好，值得推广。

Comparison of the therapeutic effects of Shumian capsule and estazolamin the treatment of insomnia

Objective To compare the therapeutic effects and adverse reactions of Shumian capsule and estazolam in the treatment of in-somnia.Methods 96 patients with insomnia were included in the study and randomly divided into Shumian capsule group (n=47) and estazolam group (n=49).The two groups were given Shumian capsule and estazolam for 4 weeks respectively.PSQI score and serum 5-HT content were evaluated before and at the end of the course of treatment.The reducing rate of total PSQI score was used for judging the therapeutic efficacy and calculating the effectiveness rate.Respiratory frequency and heart rate were recorded and routine blood and urine examinations were taken every week.Adverse reactions were recorded anytime during the treatment, the incidence rates of adverse drug reactions were compared.Results The effective rates of Shumian capsule group and estazolam group were 89.36%and 91.83%respec-tively;the PSQI scores in the two groups were declined from (15.1 ±2.5) and (14.7 ±2.1) to (9.5 ±2.9) and (8.6 ±3.2) (P<0.01) respectively;the serum 5-HT content was increased from (1 499.88 ±113.44) to (1 786.75 ±116.22) (P<0.01) in the Shumi-an capsule group after treatment, whereas no significant difference in estazolam group was found.The incidence of adverse drug reaction in Shumian capsule group was 4.26%, which was significantly lower than 12.24%of estazolam group (P<0.05).Conclusions The total effective rate and the reducing rate of total PSQI score had no statistical significance between Shumian capsule group and estazolam group.However, Shumian capsule had less adverse reactions and better tolerability.It is worth of promotion and application in clinical practice.