中医杂志

目的 观察和胃安神方治疗应激性失眠的临床疗效和安全性。方法 将104例应激性失眠男性患者随机分为治疗组和对照组各52例，治疗组口服和胃安神方，每日1剂；对照组口服酒石酸唑吡坦片，每次10 mg，每日1次，两组均治疗4周。分别于治疗前后应用匹兹堡睡眠质量指数量表（PSQI）总分评价睡眠质量，采用福特应激失眠反应量表（FIRST）评分评价失眠易感性，健康调查简表（SF-36）[包括生理健康（PCS）和心理健康（MCS）两个领域，PCS包括一般健康（GH）、生理功能（PF）、生理职能（RP）、躯体疼痛（BP）,MCS包括情感职能（RE）、社会功能（SF）、精力（VT）、精神健康（MH）]评分评价生活质量，疲劳量表-14 (FS-14，包括躯体疲劳、脑力疲劳评分)评价疲劳程度，并采用自拟失眠中医证候调查表进行中医证候评分。治疗后判定临床疗效和中医证候疗效。治疗过程中记录不良事件及不良反应的发生情况。结果 治疗组临床疗效总有效率为90.38%(47/52)，对照组为80.77%(42/52)，两组比较差异无统计学意义（P>0.05）。治疗组中医证候疗效总有效率为80.77%(42/52)，高于对照组的44.23%(23/52)，差异有统计学意义（P<0.01）。两组治疗后中医证候积分，FIRST评分，FS-14评分中躯体疲劳评分、脑力疲劳评分及总分均降低，且治疗后治疗组各评分均低于对照组（P<0.05）。两组治疗后SF-36评分各项转化分均较本组治疗前升高，且在PF、RP、VT、MH四个维度方面优于对照组（P<0.05）。两组患者均未有不良事件及不良反应的发生。结论 和胃安神方能提高应激性失眠男性患者的睡眠质量，有效缓解疲劳、疼痛等临床症状，改善中医证候，提高生活质量，降低失眠易感性，且安全性好。

Objective To observe the clinical effectiveness and safety of Hewei Anshen Formula （和胃安神方） for stress-induced insomnia. Methods A total of 104 male patients with stress-induced insomnia were randomly divided into a treatment group and a control group, with 52 cases in each group. The treatment group was given Hewei Anshen Formula once a day, while the control group was given zolpidem tartrate tablets 10 mg per time and once a day, and both groups were treated for 4 weeks. The Pittsburgh Sleep Quality Index(PSQI) was applied to evaluate sleep quality before and after treatment, Ford Insomnia Response to Stress Test(FIRST) was used to evaluate insomnia susceptibility, MOS 36-tem Short Form Health Survey(SF-36) [which includes the domains of Physical Component Summary(PCS) and Mental Health Component Summary(MCS), with the PCS including the General Health(GH), Physical Functioning(PF), Role Physical(RP), and Body Pain(BP), and the MCS including Role Emotional(RE), Social Functioning(SF), Vitality(VT), Mental Health(MH)] was used to evaluate the quality of life, and Fatigue Scale 14(FS-14) [including somatic fatigue and brain fatigue scores] to evaluate the degree of fatigue, and the traditional Chinese medicine(TCM) syndrome scores using a self-developed TCM syndrome survey for insomnia.Clinical effectiveness and TCM syndrome improvement were determined after treatment. The occurrence of adverse events and adverse reactions was recorded during treatment. Results The total effective rate of clinical effectiveness was 90. 38%(41/52) in the treatment group and 80. 77%(42/52) in the control group, and the difference between the two groups was not statistically significant(P>0. 05). The total effective rate of TCM syndrome effectiveness in the treatment group was 80. 77%(42/52), which was higher than 44. 23%(23/52) in the control group, and the difference was statistically significant(P<0. 01). The TCM syndrome score, FIRST score, brain fatigue scores, brain fatigue score and total score of FS-14 score all reduced after treatment in both groups, and all scores were lower in the treatment group than those in the control group after treatment(P<0. 05). All transformed scores of SF-36scores were higher in both groups after treatment than before treatment in this group, and they were better than the control group in the four dimensions of PF, RP, VT, and MH(P<0. 05). There were no adverse events and adverse reactions in the two groups. Conclusion Hewei Anshen Formula can improve patients' sleep quality, effectively relieve clinical symptoms such as fatigue and pain, alleviate TCM syndromes, enhance the quality of life, reduce the susceptibility to insomnia, and shows good safety.