五味消渴方治疗气阴两虚证2型糖尿病患者临床观察
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摘要
目的:观察五味消渴方治疗2型糖尿病气阴两虚证的临床疗效,并探讨其作用机制。方法:选取128例2型糖尿病气阴两虚证患者,随机分为治疗组(64例)和对照组(64例),治疗组采用五味消渴方+基础治疗,对照组采用安慰剂+基础治疗,观察治疗前后患者症状、体征变化,检测空腹血糖(FBG),餐后2 h血糖(P2 hBG),糖化血红蛋白(HbA1c),空腹血清胰岛素(FINS),安全性指标(血、尿、便常规,肝、肾功能),计算胰岛素抵抗指数(HOMA-IR),中医证候评分。结果:两组患者分配均衡,基线状况良好,可比性强。中医证候方面,两组患者口渴喜饮、多食易饥、气短懒言、倦怠乏力、心悸失眠、五心烦热、舌红少津、脉细数无力均明显改善,治疗组优于对照组(P<0.05);治疗组和对照组中医疗效总有效率分别为93.55%,76.19%,治疗组优于对照组(P<0.05);两组患者治疗后FBG,P2 hBG,HbA1c,FINS,HOMA-IR均较治疗前改善,治疗组改善更明显(P<0.05)。结论:五味消渴方治疗2型糖尿病气阴两虚证疗效显著且安全,值得推广应用。
Objective: To observe the effect of Wuwei Xiaoke decoction in treatment of type 2 diabetes with Qi and Yin deficiency. Method: A total of 128 patients with type 2 diabetes were selected and randomly divided into two groups: treatment group( 64 cases) and control group( 64 cases). Two groups were both treated with the basic therapy; the treatment group was additionally given Wuwei Xiaoke decoction,and control group was additionally given placebo. Clinical symptoms,sign changes,fasting blood glucose( FBG),postprandial 2 h blood sugar( P2 h BG),glycosylated hemoglobin( HbA1c),fasting insulin level( FINS),insulin resistance index( HOMA-IR),traditional Chinese medicine( TCM) syndrome score of two groups were observed after treatment.Result: Two groups were evenly distributed,with a good baseline status and strong comparability. In the aspect of TCM syndrome scores,treatment group was significantly better than control group in the alleviation of clinical symptoms( P < 0. 05). The total clinical effective rate was 93. 55% in treatment group was significantly higher than control group( P < 0. 05). After treatment,two groups showed alleviations in FBG and P2 h BG,HbA1c,FINS and HOMA-IR,particularly the treatment( P < 0. 05). Conclusion: Wuwei Xiaoke decoction has a significant efficacy and safety in treating type 2 diabetes with Qi and Yin deficiency syndrome,and thus is worth clinical popularization.
Objective: To observe the effect of Wuwei Xiaoke decoction in treatment of type 2 diabetes with Qi and Yin deficiency. Method: A total of 128 patients with type 2 diabetes were selected and randomly divided into two groups: treatment group( 64 cases) and control group( 64 cases). Two groups were both treated with the basic therapy; the treatment group was additionally given Wuwei Xiaoke decoction,and control group was additionally given placebo. Clinical symptoms,sign changes,fasting blood glucose( FBG),postprandial 2 h blood sugar( P2 h BG),glycosylated hemoglobin( HbA1c),fasting insulin level( FINS),insulin resistance index( HOMA-IR),traditional Chinese medicine( TCM) syndrome score of two groups were observed after treatment.Result: Two groups were evenly distributed,with a good baseline status and strong comparability. In the aspect of TCM syndrome scores,treatment group was significantly better than control group in the alleviation of clinical symptoms( P < 0. 05). The total clinical effective rate was 93. 55% in treatment group was significantly higher than control group( P < 0. 05). After treatment,two groups showed alleviations in FBG and P2 h BG,HbA1c,FINS and HOMA-IR,particularly the treatment( P < 0. 05). Conclusion: Wuwei Xiaoke decoction has a significant efficacy and safety in treating type 2 diabetes with Qi and Yin deficiency syndrome,and thus is worth clinical popularization.
引文
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[4]陈威妮,刘志龙,张弛,等.中药治疗2型糖尿病随机对照试验的系统评价[J].中国中医药信息杂志,2012,19(1):21-24,28.
[5]李渊何.糖尿病中医病机再探——试论“五脏皆柔弱”为糖尿病基本病机[J].天津中医药,2004,21(3):216-217.
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[10]张娜.不同胰岛素及联合用药方案对于糖尿病治疗的临床效果[J].吉林医学,2015,36(4):667-668.
[11]周欢.平陈汤对肥胖痰湿型2型糖尿病前期患者胰岛素抵抗指数干预的临床研究[D].兰州:甘肃中医药大学,2016.
[12]Matthews D R,Hosker J P,Rudenski A S,et al.Homeostasis model assessment:insulin resistance and beatcell funncaion from fasting plasmaglucose and insulin concentrations in man[J].Diab Etologia,1985,28(7):412-419.
[13]美国糖尿病学会(ADA)2016指南:糖尿病血糖控制诊疗标准[J].中国全科医学,2016,19(13):1555.
[14]黄皓月,张园.《黄帝内经》养生理论在消渴病防治中的应用[J].中国中医药现代远程教育,2012,10(21):3.
[15]单亮亮,邓小敏,郭超峰,等.邓小敏应用五味消渴方治疗糖尿病经验[J].中医药临床杂志,2017,29(5):631-633.
[16]赵心华,王庆其,李海峰.河洛理数与《黄帝内经》[J].南京中医药大学学报:社会科学版,2011,12(4):195-197,219.
[2]XU Y,WANG L M,HE J,et al.Prevalence and control of diabetes in Chinese adults[J].JAMA,2013,310(9):948-959.
[3]张意,王淼,何颂华,等.中医药治疗2型糖尿病胰岛素抵抗的研究进展[J].辽宁中医杂志,2015,42(6):1385-1388.
[4]陈威妮,刘志龙,张弛,等.中药治疗2型糖尿病随机对照试验的系统评价[J].中国中医药信息杂志,2012,19(1):21-24,28.
[5]李渊何.糖尿病中医病机再探——试论“五脏皆柔弱”为糖尿病基本病机[J].天津中医药,2004,21(3):216-217.
[6]World Health Organization.Definition,diagnosis and classification of diabetes mellitus and its complication,report of a WHO consultation[M].Geneva:World Health Organization,1999:1.
[7]中华人民共和国卫生部.中药新药临床研究指导原则[M].北京:中国医药科技出版社,2002:233-237.
[8]中华医学会糖尿病学分会.中国2型糖尿病防治指南(2013年版)[J].中国糖尿病杂志,2014,22(8):2-42.
[9]唐旭东,卞立群,高蕊,等.中药临床试验安慰剂制作探讨[J].中国中西医结合杂志,2009,29(7):656-658.
[10]张娜.不同胰岛素及联合用药方案对于糖尿病治疗的临床效果[J].吉林医学,2015,36(4):667-668.
[11]周欢.平陈汤对肥胖痰湿型2型糖尿病前期患者胰岛素抵抗指数干预的临床研究[D].兰州:甘肃中医药大学,2016.
[12]Matthews D R,Hosker J P,Rudenski A S,et al.Homeostasis model assessment:insulin resistance and beatcell funncaion from fasting plasmaglucose and insulin concentrations in man[J].Diab Etologia,1985,28(7):412-419.
[13]美国糖尿病学会(ADA)2016指南:糖尿病血糖控制诊疗标准[J].中国全科医学,2016,19(13):1555.
[14]黄皓月,张园.《黄帝内经》养生理论在消渴病防治中的应用[J].中国中医药现代远程教育,2012,10(21):3.
[15]单亮亮,邓小敏,郭超峰,等.邓小敏应用五味消渴方治疗糖尿病经验[J].中医药临床杂志,2017,29(5):631-633.
[16]赵心华,王庆其,李海峰.河洛理数与《黄帝内经》[J].南京中医药大学学报:社会科学版,2011,12(4):195-197,219.