乌梅丸加减治疗T2DM合并早醒型失眠的临床研究OA
Clinical research on modified Wumei pill for the treatment of Type 2 Diabetes Mellitus complicated with early awakening insomnia
为了验证中医方剂治疗2型糖尿病(type 2 diabetes mellitus,T2DM)合并早醒型失眠的有效性,对乌梅丸加减治疗T2DM患者早醒等失眠症状、血糖代谢水平及抑郁情绪的干预效果进行临床观察.选取100例该病患者,随机分为对照组(最终完成49例)与研究组(最终完成48例);对照组睡前口服右佐匹克隆片(3 mg/次),研究组采用乌梅丸加减代煎剂治疗,连续治疗2个疗程;以睡眠质量[阿森斯失眠量表(athens insomnia scale,AIS)各维度评分]的客观量化改善为主要疗效指标,以血糖控制水平[空腹血糖(fasting blood glucose,FBG)、餐后2 h血糖(2 h postprandial plasma glucose,2hPPG)、糖化血红蛋白(HbA1c)]及抑郁状态[健康问卷抑郁量表(PHQ-9)评分]为次要疗效指标,评价治疗效果.结果表明:1)研究组FBG、2hPPG、HbA1c的值均显著低于对照组,差异具有统计学意义(P＜0.05);2)研究组的PHQ-9评分亦低于对照组,差异具有统计学意义(P＜0.05);3)2组AIS各维度评分较治疗前均显著改善,差异具有统计学意义(P＜0.05),除入睡时间维度外,研究组在夜间苏醒次数、早醒时间、醒后入睡时长、总睡眠时间、睡眠质量、白天情绪、白天身体功能及日间思睡维度的改善幅度均显著优于对照组,差异具有统计学意义(P＜0.05).乌梅丸加减治疗T2DM并发早醒型失眠疗效确切,可有效改善患者的血糖控制水平、AIS各维度评分及PHQ-9评分,优化早醒型失眠临床结局,研究成果可为T2DM并发早醒型失眠的临床治疗提供安全有效的中医治疗方案与循证依据.
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.
吴文霞;魏芯芯;杨洁文;刘明晓;韩青青
邯郸市中医院肾病内分泌科,河北邯郸 056001邯郸市中医院肾病内分泌科,河北邯郸 056001邯郸市中医院肾病内分泌科,河北邯郸 056001邯郸市中医院肾病内分泌科,河北邯郸 056001河北中医药大学研究生学院,河北石家庄 050091
医药卫生
中药学其他学科乌梅丸T2DM早醒型失眠
other disciplines of traditional chinese medicineWumei pillT2DMearly awakening insomnia
《河北工业科技》 2026 (3)
263-269,7
邯郸市科学技术研究与发展计划项目(23422083089ZC)
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