河北工业科技2026，Vol.43Issue(3)：263-269,7.DOI:10.7535/hbgykj.2026yx03008
乌梅丸加减治疗T2DM合并早醒型失眠的临床研究
Clinical research on modified Wumei pill for the treatment of Type 2 Diabetes Mellitus complicated with early awakening insomnia
摘要
Abstract
In order to verify the effectiveness of traditional Chinese medicine(TCM)prescriptions in treating type 2 diabetes mellitus(T2DM)combined with early-wake insomnia,a clinical observation was conducted to examine the intervention effects of modified Wumei pill on the insomnia symptoms including early-awakening,blood glucose metabolism levels,and depressive emotions in patients with T2DM.100 eligible patients were selected and divided into two groups randomly:a control group(49 patients completed in the end)and a study group(48 patients completed in the end).Patients in the control group took oral eszopiclone tablets(3mg per time)before bedtime,while patients in the study group took modified Wumei pill decocted herbal medicine.The study lasted for two consecutive courses of treatment.The objective quantifiable improvement in sleep quality[Athens Insomnia Scale(AIS)scores across various dimensions]was considered as the primary efficacy standard,and blood glucose control levels[fasting blood glucose(FBG),2-hour postprandial plasma glucose(2hPPG),glycated haemoglobin(HbA1c)]and depression status[Patient Health Questionnaire-9(PHQ-9)score]as secondary efficacy standards.These are used to evaluate the therapeutic effect.The result shows that fistly,the values of FBG,2hPPG,and HbA1c in the research group were significantly lower than those in the control group,and the differences were statistically significant(P＜0.05);secondly,The PHQ-9 scores in the study group were also lower than those of the control group,and the difference was statistically significant(P＜0.05);thirdly,the scores of all dimensions of AIS of the two sets of Insomnia Severity Index(ISI)are significantly improved compared to baseline,and the difference was statistically significant(P＜0.05).The improvement effects of the study group are significantly superior to those of the control group in terms of number of nocturnal awakenings,early morning awakening time,sleep latency after awakening,total sleep time,sleep quality,daytime mood,daytime physical function and daytime sleepiness,with statistically significant differences(P＜0.05),except the sleep onset time.The modified Wumei pill is effective in treating insomnia with early awakening insomnia complicated by T2DM.It lowers patients' blood glucose control levels,improves their the scores of all dimensions of AIS and PHQ-9 scores,and optimizes clinical outcomes of early morning awakening insomnia.The research results can provide safe and effective TCM treatment plans and evidence-based basis for the clinical treatment of T2DM complicated with early awakening insomnia.关键词
中药学其他学科/乌梅丸/T2DM/早醒型失眠Key words
other disciplines of traditional chinese medicine/Wumei pill/T2DM/early awakening insomnia分类
医药卫生引用本文复制引用
吴文霞,魏芯芯,杨洁文,刘明晓,韩青青..乌梅丸加减治疗T2DM合并早醒型失眠的临床研究[J].河北工业科技,2026,43(3):263-269,7.基金项目
邯郸市科学技术研究与发展计划项目(23422083089ZC) （23422083089ZC）
