三才连梅颗粒治疗2型糖尿病疗效及对胃饥饿素、胰高血糖素样肽-1的影响

Efficacy of Sancai Lianmei granules on type 2 diabetes mellitus and its effects on ghrelin and glucagon-like peptide-1

目的观察三才连梅颗粒治疗2型糖尿病气阴两虚证患者的疗效及对胃饥饿素、胰高血糖素样肽-1(GLP-1)的影响。方法纳入2022年1—12月成都中医药大学附属医院内分泌科收治的糖化血红蛋白(HbA1c)在6.5%~10%间的60例2型糖尿病气阴两虚证患者,随机分为对照组和试验组,每组30例。在给予个体化的基础干预同时,对照组给予盐酸二甲双胍片口服,试验组给予三才连梅颗粒口服,2组均连续治疗8周。比较2组治疗前后糖代谢相关指标[体重、体质指数(BMI)、HbA1c、口服糖耐量试验(OGTT)血糖水平、胰岛素释放试验胰岛素水平、C肽水平、胰岛素抵抗指数(HOMA-IR)、胰岛素分泌指数(HOMA-β)]及血清酰基化胃饥饿素(AG)、去酰基化胃饥饿素(DAG)、GLP-1水平和中医证候积分、三因子饮食量表R21评分,并记录研究过程中的不良事件。结果治疗后,2组体重、BMI、HbA1c、OGTT各时间点血糖水平、HOMA-IR、血清AG水平及中医证候积分、三因子饮食量表R21评分均明显降低(P均<0.05);试验组胰岛素释放试验中1 h、3 h时的胰岛素水平均明显低于治疗前(P均<0.05),HOMA-β及血清GLP-1、DAG水平均明显高于治疗前(P均<0.05);对照组胰岛素释放试验中0 h,2 h,3 h时的胰岛素水平和0 h时的C肽水平均明显低于治疗前(P均<0.05)。治疗后试验组血清DAG水平明显高于对照组(P<0.05),中医证候积分、三因子饮食量表R21评分均明显低于对照组(P均<0.05),2组其他指标比较差异均无统计学意义(P均>0.05)。研究期间2组均未出现不良事件。结论三才连梅颗粒能够降低2型糖尿病气阴两虚证患者血糖与体重,改善胰岛素抵抗与胰岛β细胞功能,有效减轻患者症状,降低患者食欲,这些作用可能是通过降低血清AG水平、上调GLP-1水平实现的。

Objective It is to observe the efficacy of Sancai Lianmei granules in the treatment of patients with type 2 diabetes mellitus with syndrome of Qi-Yin deficiency and its effect on ghrelin and glucagon-like peptide-1(GLP-1).Methods Sixty patients with type 2 diabetes mellitus of syndrome of Qi-Yin deficiency with glycated hemoglobin(HbA1c)between 6.5%and 10%treated in the Department of Endocrinology of the Affiliated Hospital of Chengdu University of Chinese Medicine from January to December 2022 were included,and were randomly divided into control group and experimental group,with 30 cases in each group.Based on the individualized basic intervention,the control group was given metformin hydrochloride tablets orally,while the experimental group was given Sancai Lianmei granules orally,both groups were treated continuously for 8 weeks.The glucose metabolism-related indexes[body weight,body mass index(BMI),HbA1c,blood glucose level of oral glucose tolerance test(OGTT),insulin level of insulin release test,C-peptide level,insulin resistance index(HOMA-IR),insulin secretion index(HOMA-β)]and serum levels of acylated ghrelin(AG),deacylated ghrelin(DAG),GLP-1 and scores of Chinese medicine syndromes and three-factor diet scale R21 of the two groups before and after treatment were compared,and the adverse events during the trial were recorded.Results After treatment,the body weight,BMI,levels of HbA1c and blood glucose at each time point of OGTT,HOMA-IR,serum level of AG and scores of Chinese medicine syndromes and three-factor diet scale R21 of the two groups were all significantly decreased(all P<0.05);the levels of insulin at 1 h and 3 h in the insulin-release test in the experimental group were significantly lower than those before treatment(both P<0.05),while HOMA-βand serum levels of GLP-1 and DAG were all significantly higher than those before treatment(both P<0.05);the levels of insulin at 0 h,1 h and 3 h in the insulin-release test and the level of C peptide in the control group were significantly lower than those before treatment(all P<0.05).After treatment,the serum level of DAG of the experimental group was significantly higher than that of the control group(P<0.05),and the scores of Chinese medicine syndromes and three-factor diet scale R21 were significantly lower than those of the control group(all P<0.05),there was no significant differences in other indexes between the two groups(all P>0.05).No adverse events occurred in both groups during the trial period.Conclusion Sancai Lianmei granules can reduce blood glucose and body weight,improve insulin resistance and pancreaticβ-cell function,effectively alleviate patients’symptoms,and reduce patients’appetite in patients with type 2 diabetes mellitus with syndrome of Qi-Yin deficiency,and these effects may be achieved by down-regulating the serum level of AG and up-regulating the level of GLP-1.