精乌胶囊联合艾司唑仑治疗心肾不交型失眠症的临床研究

Clinical study on Jingwu Capsules combined with eszolam in treatment of insomnia of incompatibility between heart and kidney

目的探讨精乌胶囊联合艾司唑仑治疗心肾不交型失眠症的临床疗效。方法选取2021年9月—2023年9月在武汉市中医医院诊治的128例心肾不交型失眠患者,按随机数字法分为对照组(64例)和治疗组(64例)。对照组患者睡前口服艾司唑仑片,1 mg/次,1次/d。在对照组的基础上,治疗组口服精乌胶囊,6粒/次,3次/d。两组连服药30 d。观察两组患者临床疗效,比较治疗前后两组患者症状好转时间,匹兹堡睡眠质量指数(PSQI)评分,血清因子白细胞介素-1β(IL-1β)、前列腺素D2(PGD2)、5-羟色胺(5-HT)和肿瘤坏死因子-α(TNF-α)水平,及不良反应。结果治疗后,治疗组总有效率为98.43%,明显高于对照组(84.38%,P<0.05)。治疗后,治疗组入睡困难、睡眠较浅、容易惊醒、醒后难以入睡好转时间均明显短于对照组(P<0.05)。治疗后,两组患者PSQI评分明显降低(P<0.05),且治疗组患者PSQI评分明显低于对照组(P<0.05)。治疗后,两组患者血清因子IL-1β和TNF-α明显降低,而PGD2和5-HT水平明显升高(P<0.05),且治疗组这些血清因子水平均明显好于对照组(P<0.05)。药物期间,对照组不良反应发生率为12.57%,明显高于治疗组(4.69%,P<0.05)。结论艾司唑仑与精乌胶囊协同治疗,可有效改善临床失眠症状,有效减弱失眠相关因子水平,明显提升睡眠质量。

Objective To explore the clinical effect of Jingwu Capsules combined with eszolam in treatment of insomnia of incompatibility between heart and kidney.Methods Patients(128 cases)with incompatibility between heart and kidney in Wuhan Hospital of Traditional Chinese Medicine from September 2021 to September 2023 were divided into control(64 cases)and treatment(64 cases)group by random numbers.Patients in the control group were po administered with Estazolam Tablets,1 mg/time,once daily.Patients in the treatment group were po administered with Jingwu Capsules on the basis of the control group,6 grains/time,three times daily.Patients in two groups were treated for 30 d.After treatment,the clinical evaluations was evaluated,the symptom relief time,PSQI scores,the levels of serological IL-1β,TNF-α,PGD2 and 5-HT,and adverse reaction in two groups before and after treatment were compared.Results After treatment,the clinical effective rate of the treatment group was 98.43%,which was significantly higher than that of the control group(84.38%,P<0.05).After treatment,the improvement time of difficulty falling asleep,shallow sleep,easy to wake up and difficulty falling asleep after waking in the treatment group was significantly shorter than that in the control group(P<0.05)..After treatment,the PSQI score in two groups was significantly decreased(P<0.05),and the PSQI score of the treatment group was significantly lower than that of the control group(P<0.05).After treatment,the serum levels of IL-1βand TNF-α were significantly decreased,while the levels of PGD2 and 5-HT were significantly increased in two groups(P<0.05),and the levels of these serum factors in the treatment group were significantly better than those in the control group(P<0.05).During the treatment,the incidence of adverse reactions in the control group was 12.57%,which was significantly higher than that in the treatment group(4.69%,P<0.05).Conclusion The synergistic treatment of eszolam and Jingwu Capsules is effective in improving clinical insomnia symptoms,and which effectively reduce the level of insomnia-related factors and significantly improve sleep quality.