杞黄降糖胶囊对二甲双胍控制不佳2型糖尿病疗效和安全性一项240例多中心、随机、双盲、安慰剂对照临床研究  

Efficacy and Safety of Qihuang Jiangtang Capsules(杞黄降糖胶囊) for Type 2 Diabetes Mellitus Patients with Poor Glycemic Control after Metformin Treatment:A Multicenter,Randomized,Double-Blind,Placebo-Controlled Trial of 240 Cases

作　　者：赵能江[1] 杨叔禹[1] 王秀阁[2] 方朝晖[3] 王燕燕[4] 李树才 刘福强[6] 冯晓 张谦平 胡爱民[9] 高天舒[10] 朱章志[11] 周晖[12] 苗林艳 ZHAO Nengjiang;YANG Shuyu;WANG Xiuge;FANG Zhaohui;WANG Yanyan;LI Shucai;LIU Fuqjiang;FENG Xiao;ZHANG Qianping;HU Aimin;GAO Tianshu;ZHU Zhangzhi;ZHOU Hui;MIAO Linyan(The First Affiliated Hospital of Xiamen University,Xiamen 361003,Fujiang,China;Affiliated Hospital of Changchun University of Chinese Medicine,Changchun 130021,Jilin,China;The First Affiliated Hospital of Anhui University of Chinese Medicine,Hefei 230031,Anhui,China;Yueyang Integrated Traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200437,China;Yantai Baishi Traditional Chinese Medicine Hospital,Yantai 264013,Shandong,China;QiluHospital of ShandongUniversity,Jinan 250012,Shandong,China;Dezhou Hospital of Traditional Chinese Medicine,Dezhou 253054,Shandong,China;Dezhou Municipal Hospital,Dezhou 253012,Shandong,China;Wuhan Hospital of Traditional Chinese Medicine,Wuhan 430010,Hubei,China;Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang 110032,Liaoning,China;The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405,Guangdong,China;Oriental Hospital of Beijing University of Chinese Medicine,Beijing 100078,China;Weihai Hospital of Traditional Chinese Medicine,Weihai 264200,Shandong,China)

机构地区：[1]厦门大学附属第一医院,福建厦门361003 [2]长春中医药大学附属医院,吉林长春130021 [3]安徽中医药大学第一附属医院,安徽合肥230031 [4]上海中医药大学附属岳阳中西医结合医院,上海200437 [5]烟台白石中医医院,山东烟台264013 [6]山东大学齐鲁医院,山东济南250012 [7]德州市中医院,山东德州253054 [8]德州市立医院,山东德州253012 [9]武汉市中医医院,湖北武汉430010 [10]辽宁中医药大学附属医院,辽宁沈阳110032 [11]广州中医药大学第一附属医院,广东广州510405 [12]北京中医药大学东方医院,北京100078 [13]威海中医院,山东威海264200

出　　处：《中华中医药学刊》2022年第11期227-230,共4页Chinese Archives of Traditional Chinese Medicine

基　　金：福建省中医药科研项目(2021zyg178);福建省名中医工作室项目(2018-216)。

摘　　要：目的 观察中成药杞黄降糖胶囊对二甲双胍单药控制不佳的2型糖尿病患者的临床疗效和安全性。方法 按照随机、双盲、安慰剂对照方法,纳入全国14家医院240例二甲双胍控制不佳的糖尿病患者,随机分别为试验组和对照组(各120例),在原治疗基础上分别加用杞黄降糖胶囊和模拟剂。干预12周后评估疗效,观察降糖效果[糖化血红蛋白(glycosylated hemoglobin, HbA1c)、空腹血糖(fasting blood sugar, FPG)、餐后2 h血糖(two-hour postprandial blood glucose, 2 h PPG)]、中医气阴两虚证候和临床症状评分,并评估安全性。结果 最终共完成205例(试验组97例、对照组108例),12周后试验组HbA1c降低了0.28%±0.60%,空腹血糖下降0.14±1.56 mmol/L;而对照组HbA1c则增高了0.03%±0.62%,空腹血糖上升(0.83±1.58) mmol/L;两组有明显差别(P<0.01)。试验组口苦咽干,手足心热等症状及气阴两虚兼热证候明显改善(P<0.05),未见严重不良反应。结论 对单纯二甲双胍疗效不佳的患者,加用杞黄降糖胶囊安全有效,可协同控糖,改善患者症状。Objective To observe the clinical effects and safety of Qihuang Jiangtang Capsules(杞黄降糖胶囊)for type 2 diabetes mellitus patients with poor glycemic control after metformin treatment.Methods Randomized,double blind,placebo controlled clinical trial design was adopted,and 240 patients with poor glycemic control after metformin treatment were enrolled in 14 parallel hospitals.The patients were divided into experimental group and control group randomly with 120 cases in each group,and recerived Qihuang Jiangtang Capsules+metformin and simulant+metformin respectively.The treatment course was 12 weeks.The levels of glycosylated hemoglobin(HbA1 c),fasting blood sugar(FPG)and two-hour postprandial blood glucose(2 h PPG),the symptoms of Qi and Yin deficiency syndrome and diabetes symptom score were evaluated,and security was assessed.Results A total of 205 cases completed the trial(97 cases in experimental group,108 cases in control group).After 12 weeks,HbA1 c decreased 0.28%±0.60%,FPG decreased(0.14±1.56)mmol/L in the experimental group.HbA1 c increased 0.03%±0.62%and FPG increased(0.83±1.58)mmol/L in control group,and there were statistically significant differences between the two groups(P<0.01).The symptoms of bitter taste and dry throat,feverish feeling in palms and soles,and Qi and Yin deficiency syndrome with heat improved greatly in the experimental group(P<0.01),and no serious adverse reactions were found.Conclusions Qihuang Jiangtang Capsules could reduce blood glucose and improve clinical symptoms for patients with poor glycemic control after metformin treatment.

关 键 词：杞黄降糖胶囊 2型糖尿病 气阴两虚兼热证 

分 类 号：R259.681[医药卫生—中西医结合]