益气化聚方联合常规疗法治疗代谢综合征糖调节受损患者的随机双盲安慰剂对照研究  

Clinical Study of Yiqi Huaju Formula Combined with Routine Therapy for The Treatment of Metabolic Syndrome Patients with Impaired Glucose Regulation: A Randomized, Double-blinded and Placebo Controlled Trial

作　　者：张曾[1] 何燕铭[1] 郑敏[1] 范朝华[1] 张丹[1] 杨宏杰[1] 王文健 ZHANG Zeng;HE Yan-ming;ZHENG Min;FAN Zhao-hua;ZHANG Dan;YANG Hong-jie;WANG Wen-jian(Endocrinology Department,YueYang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai,200437;Clin-ical Research Institute of Integrated Traditional Chinese and Western Medicine,Shanghai Academy of Traditional Chinese Medicine,Shanghai,200437)

机构地区：[1]上海中医药大学附属岳阳中西医结合医院内分泌科,上海200437 [2]上海中医药研究院中西医结合临床研究所,上海200437

出　　处：《中国中西医结合杂志》2020年第8期908-913,共6页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：上海市中西医结合重点病种建设项目(No.zxbz2012-01);国家“重大新药创制”科技重大专项(No.2017ZX09301006);上海市科委“科技创新行动计划”生物医药领域科技支撑项目(No.17401902700);上海市科委医学引导类中医科技支撑项目(No.17401935400)。

摘　　要：目的观察益气化聚方联合常规疗法治疗代谢综合征糖调节受损患者的临床疗效。方法采用随机双盲安慰剂对照法,将120例代谢综合征糖调节受损患者随机分为治疗组与对照组,每组60例。治疗组在常规西医治疗基础上加用益气化聚方,对照组在常规西医治疗基础上加用安慰剂。两组疗程均为20周,观察糖尿病发生率,比较糖脂代谢指标(FPG、2 hPPG、HbA1c、FINS、HOMA-IR、TC、TG、HDL-C、LDL-C)、形体体征指标(BMI、WHR、SBP、DBP、MAP)的变化情况。结果最终治疗组58例,对照组57例完成试验。治疗组糖尿病发生率为5.17%(3/58)优于对照组14.04%(8/57,χ^2=6.973,P<0.05);与本组治疗前比较,治疗后对照组体重、BMI、WHR及治疗组FPG、2 hPPG、HbA1c、FINS、HOMA-IR、体重、腹围、BMI、WHR、SBP、DBP、MAP水平降低,同时治疗组FPG、2 hPPG、HbA1c、HOMA-IR、SBP、DBP及MAP水平低于对照组(P<0.05)。结论益气化聚方联合常规疗法治疗代谢综合征糖调节受损患者,可有效改善胰岛素抵抗,减轻中心性肥胖,降低患者血压水平,控制血糖、预防和延缓糖尿病的发生。Objective To observe the clinical effect of Yiqi Huaju Formula combined with routine therapy in treating metabolic syndrome patients with impaired glucose regulation.Methods Adopting the randomized,double-blinded and placebo controlled design,120 patients with metabolic syndrome and impaired glucose regulation were randomly assigned to treatment group and control group,60 cases in each group.The treatment group was treated with Yiqi Huaju Formula on the basis of conventional Western medicine treatment,while the control group was treated with placebo on the basis of conventional Western medicine treatment.The treatment lasted for 20 weeks.The incidence of diabetes was observed and the changes of glycolipid metabolism indexes(FPG,2 hPPG,HbA1 c,FINS,HOMA-IR,TC,TG,HDL-C,LDL-C),body sign indexes(BMI,WHR,SBP,DBP,MAP)were compared.Results Fifty-eight cases of treatment group and 57 cases of control group completed the experiment.The incidence of diabetes in the treatment group was 5.17%(3/58)while that in the control group was 14.04%(8/57,χ^2=6.973,P<0.05).After treatment,the levels of body weight,BMI,WHR in the control group and the levels of FPG,2 hPPG,HbA1 c,FINS,HOMA-IR,body weight,abdominal circumference,BMI,WHR,SBP,DBP and MAP in the treatment group were lower than those before treatment(P<0.05).The levels of FPG,2 hPPG,HbA1 c,HOMA-IR,SBP,DBP and MAP in the treatment group were lower than those in the control group(P<0.05).Conclusion In the patients with impaired glucose regulation of metabolic syndrome,Yiqi Huaju Formula combined with routine therapy can effectively improve insulin resistance,reduce central obesity and the blood pressure level,control blood glucose,prevent and delay the occurrence of diabetes.

关 键 词：益气化聚方 代谢综合征 糖调节受损 

分 类 号：R589[医药卫生—内分泌]