健脾清胃化痰法联合右佐匹克隆片治疗焦虑性失眠的临床疗效及对血清5-羟色胺、25-羟维生素D3水平的影响

目的] 观察健脾清胃化痰法联合右佐匹克隆片治疗焦虑性失眠的临床疗效及对血清5-羟色胺（5-HT）、25-羟维生素D₃25（OH）D₃]水平的影响。方法] 选取2018年10月—2020年5月就诊于河北中医学院第一附属医院失眠门诊的114例符合痰热内扰型焦虑性失眠患者，按随机数字表法随机分为3组，每组38例。西药组口服右佐匹克隆片，每次2 mg，睡前口服1次；中药组口服基于健脾清胃化痰法拟定的中药免煎颗粒，每日1剂；联合组同时服用基于健脾清胃化痰法的中药免煎颗粒和右佐匹克隆片。疗程为4周。比较3组患者治疗前，治疗2、4周后的匹兹堡睡眠质量指数评定量表（PSQI）评分、汉密尔顿焦虑量表（HAMA）评分、睡眠潜伏期时间、睡眠维持时间、血清5-HT、25（OH）D₃水平及不良反应情况，并于停药后4周重复观察睡眠潜伏期时间、睡眠维持时间情况。结果] 治疗4周后，3组均取得良好疗效果。治疗4周后，3组PSQI评分、HAMA评分均低于治疗前，且联合组显著低于中药组和西药组，差异有统计学意义（P<0.05）；3组睡眠潜伏期时间均低于治疗前，且联合组低于中药组和西药组（P<0.05），中药组和联合组睡眠维持时间均高于治疗前，且联合组明显优于西药组和中药组（P<0.05）；3组血清5-HT、25（OH）D₃水平较治疗前提高，且联合组高于西药组及中药组（P<0.05）。联合组不良反应发生率为2.63%，明显低于西药组和中药组的21.05%和7.89%，差异有统计学意义（P<0.05）。停药后4周，联合组睡眠潜伏期时间及睡眠维持时间均优于西药组和中药组，差异有统计学意义（P<0.05）。结论] 健脾清胃化痰法联合右佐匹克隆片可有效改善痰热内扰型焦虑性失眠患者的失眠、焦虑症状，能进一步提高患者血清5-HT、25（OH）D₃水平，临床疗效确切，不良反应小，且远期疗效好。

Clinical observation on the treatment of anxiety insomnia by invigorating spleen and clearing stomach and resolving phlegm combined with ezopiclone and its effect on serum 5-hydroxytryptamine and 25-hydroxyvitamin D3 levels

Objective] To observe the clinical efficacy and safety of invigorating spleen and clearing stomach and removing phlegm method combined with ezopiclone tablets in treating anxiety insomnia and its effect on serum 5-hydroxytryptamine and 25-hydroxyvitamin D3 levels. Methods] From October 2018 to May 2020,114 patients with anxiety insomnia in insomnia clinic of The First Affiliated Hospital of Hebei College of Traditional Chinese Medicine were randomly divided into 3 groups,38 cases in each group according to random digital table method. The western medicine group took ezopiclone tablets orally,2 milligram before bedtime;the traditional Chinese medicine group took the traditional Chinese medicine granule based on invigorating spleen and clearing stomach and removing phlegm method,1 dose per day;combined group took the traditional Chinese medicine free decoction granule based on invigorating spleen and clearing stomach and removing phlegm method and the ezopiclone tablets simultaneously. The course of treatment was 4 weeks. Before treatment,the PSQI scores,HAMA scores,sleep time,sleep maintenance time,serum 5-hydroxytryptamine and 25-hydroxyvitamin D₃ levels,and adverse reactions were compared before and after 2 weeks and 4 weeks of treatment,and the sleep time and sleep maintenance time were observed 4 weeks after withdrawal. Results] After 4 weeks all groups received good effect. After 4 weeks of treatment,the PSQI scores,HAMA scores and sleep time of the combined group were significantly lower than that of the traditional Chinese medicine group and the western medicine group (P<0.05),and the sleep maintenance time was significantly longer than that of the traditional Chinese medicine group and the western medicine group (P<0.05);the levels of serum 5-HT and 25(OH) D₃ in the three groups were higher than those before treatment,and the levels in the combined group were higher than those in western medicine group and traditional Chinese medicine group (P<0.05);the incidence of adverse reactions in western medicine group and traditional Chinese medicine group was 21.05% and 7.89% respectively,which was significantly higher than 2.63% in the combined group,the difference was statistically significant (P<0.05). Four weeks after withdrawal,the sleep time and sleep maintenance time of the combined group were better than that of the western medicine group and the traditional Chinese medicine group (P<0.05). Conclusion] Invigorating spleen and clearing stomach and removing phlegm methods combined with ezopiclone tablets can effectively improve insomnia and anxiety symptoms,and can further improve the serum levels of 5-HT and 25(OH)D₃ in patients. The clinical effect is accurate,the adverse reaction is small,and the long-term effect is good.