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蒙药朱如日-6味汤联合二甲双胍治疗2型糖尿病的安全性及有效性:一项多中心、随机、对照研究
Safety and efficacy of Mongolian medicine Zhururi-6 decoction combined with metformin in the treatment of type 2diabetes: a multicenter, randomized, controlled study
【摘要】 目的:观察朱如日-6味汤联合二甲双胍治疗2型糖尿病(Type 2 diabetes)的临床有效性和安全性。方法:采用前瞻、随机对照、多中心研究方法,将2019年1—2021年12月于内蒙古医科大学附属医院、内蒙古自治区人民医院、内蒙古自治区肿瘤医院自愿加入本研究观察的2型糖尿病患者120例,按随机分组法分为治疗组和对照组,各60例。对照组给予西药二甲双胍治疗,治疗组在对照组的基础上给予蒙药朱如日-6味汤,3个月为1个疗程。观察两组治疗前和治疗后的空腹血糖(fasting blood-glucose,FBG)、餐后血糖(Postprandial blood glucose,PBG)、糖化血红蛋白(Glycosylated Hemoglobin, Type A1C(Hb A1C)、血脂[甘油三酯(triglyceride,TG)、低密度脂蛋白(low density lipoprotein,LDL)、总胆固醇(Total Cholesterol,TC)]、尿糖(Glucose In Urine GLU)等指标的组内和组间变化,同时要观察安全性指标(血常规、尿常规、肝功、肾功等),并记录不良事件。结果:(1)两组组间检测指标比较差异无统计学意义(P>0.05)。(2)治疗组餐后2 h血糖和糖化血红蛋白在治疗前后比较差异有统计学意义(P<0.05)。结论:朱如日-6味汤联合二甲双胍片治疗2型糖尿病显著降低PBG和Hb A1C水平,同时降低不良反应的发生率,因此朱如日-6味汤值得临床推广使用。
【Abstract】 Objective:To observe the clinical efficacy and safety of Zhururi-6 decoction combined with metformin in the treatment of Type 2 diabetes. Methods: A prospective, randomized, single-blind, controlled, multicenter study method, A total of 120 patients with type 2 diabetes who were enrolled in the Affiliated Hospital of Inner Mongolia Medical University, The People’s Hospital of Inner Mongolia Autonomous Region and the Cancer Hospital of Inner Mongolia Autonomous Region from2019-01 to 2021-12 were randomly divided into treatment group and control group, with 60 patients in each group. The control group was treated with metformin, and the treatment group was additionally treated with Zhururi-6 decoction, a course of 3 months. The intra-and inter-group changes of FBG, PBG, Hb A1C, TG, TC, LDL, GLU were observed before and after treatment. At the same time, safety indicators(Blood routine test, urine routine test, liver function, kidney function, etc.) were observed, and adverse events were recorded. Results: There was no significant difference between the two groups( P >0.05).Comparison of PBG and Hb A1C in the treatment group before and after treatment( P<0.05). Conclusion: Zhururi-6 decoction combined with metformin tablets in the treatment of type 2 diabetes can significantly reduce the levels of PBG and Hb A1C,and reduce the occurrence of adverse reactions, so Zhururi-6-decoction is worthy of clinical use.
【Key words】 Zhururi-6 decoction; Type 2 diabetes; Safety and efficacy; multicenter,randomized,controlled study;
- 【文献出处】 中国民族医药杂志 ,Journal of Medicine & Pharmacy of Chinese Minorities , 编辑部邮箱 ,2023年04期
- 【分类号】R587.1
- 【下载频次】42