清肝补脾降糖饮结合西医常规疗法治疗成人2型糖尿病肝旺脾虚证的临床研究  

Clinical study of Qinggan Bupi Jiangtang Decoction combined with western medicine in the treatment of adult type 2 diabetes mellitus with liver hyperactivity and spleen deficiency syndrome

作　　者：高文澜[1] 王静[2] 王文艳[1] 李斯斯[1] 王雪菲 黄慧 陈易 陶枫[1] 蔡淦[3] Gao Wenlan;Wang Jing;Wang Wenyan;Li Sisi;Wang Xuefei;Huang Hui;Chen Yi;Tao Feng;Cai Gan(Department of Endocrinology,Shanghai Municipal Hospital of Traditional Chinese Medicine,Shanghai 200071,China;Department of Internal Medicine,Shanghai Municipal Hospital of Traditional Chinese Medicine,Shanghai 200071,China;Department of Internal Medicine,Shuguang Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai 200071,China)

机构地区：[1]上海中医药大学附属市中医医院内分泌科,上海200071 [2]上海中医药大学附属市中医医院内科,上海200071 [3]上海中医药大学附属曙光医院大内科,上海200071

出　　处：《国际中医中药杂志》2023年第1期31-36,共6页International Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金项目(81774237);上海申康医院发展中心临床科技创新项目(SHDC12018X27、SHDC12020623)。

摘　　要：目的评价清肝补脾降糖饮结合西医常规疗法治疗成人T2DM肝旺脾虚证临床疗效。方法前瞻性队列研究。将符合入选标准的2020年2月-2021年2月上海中医药大学附属市中医医院内分泌科T2DM肝旺脾虚证患者103例,按随机数字表法分为观察组52例、对照组51例。2组均给予西医常规疗法治疗,在此基础上对照组加用磷酸西格列汀,观察组加用清肝补脾降糖饮。2组均治疗12周。分别于治疗前后进行中医证候评分;采用干化学法和罗氏电发光法检测空腹血糖(FPG)、2 hPG、HbA1c、空腹胰岛素(FINS),并计算胰岛素抵抗指数(HOMA-IR);实时监测动态血糖,包括葡萄糖在目标范围内时间(TIR)百分比、葡萄糖高于目标范围内时间(TAR)百分比、葡萄糖低于目标范围内时间(TBR)百分比;观察平均血糖波动幅度(MAGE);评价临床疗效。结果观察组总有效率为92.3%(48/52)、对照组为56.9%(29/51),2组比较差异有统计学意义(χ^(2)=15.32,P<0.01)。观察组治疗后中医证候评分低于对照组(t=6.30,P<0.01)。观察组治疗后HbA1c达标率为46.2%(24/52)、对照组为23.5%(12/51),2组比较差异有统计学意义(χ^(2)=5.80,P=0.016)。与同组治疗前比较,2组治疗后MAGE、TAR、TBR降低,TIR升高(P<0.01),但2组治疗后比较差异无统计学意义(t值分别为0.78、1.06、0.22、1.45,P>0.05)。与同组治疗前比较,2组治疗后FPG、2 hPBG、HbA1c水平降低(P<0.01),但2组治疗后比较差异无统计学意义(t值分别为1.32、0.18、1.50,P>0.05)。与同组治疗前比较,2组治疗后FINS水平和HOMA-IR降低(P<0.01),但2组治疗后比较差异无统计学意义(t值分别为1.25、0.51,P>0.05)。治疗期间,观察组未发生不良反应,对照组发生轻度恶心2例、一过性腹泻1例,2组比较差异无统计学意义(χ^(2)=3.15,P=0.118)。结论清肝补脾降糖饮可改善成人T2DM肝旺脾虚证患者的血糖水平,提高TIR和血糖达标率,疗效与磷酸西格列汀相当。Objective To evaluate the efficacy of Qinggan Bupi Jiangtang Decoction combined with western medicine in the treatment of adult type 2 diabetes mellitus(T2DM)with with liver hyperactivity and spleen deficiency syndrome.Methods Prospective cohort study.A total of 103 T2DM patients with liver hyperactivity and spleen deficiency syndrome in the Department of endocrinology of Shanghai Municipal Hospital of Traditional Chinese Medicine from February 2020 to February 2021 were randomly divided into the observation group(52 cases)and the control group(51 cases)according to random number table method.Both groups were treated with conventional western medicine,the control group was treated with sitagliptin phosphate on the basis of routine treatment,and the observation group was treated with Qinggan Bupi Jiangtang Decoction on the basis of routine treatment.Both groups were treated for 12 weeks.TCM symptom scores were performed before and after treatment.The FPG,2hPBG,HbA1c and fasting insulin(FINS)were detected by dry chemistry method and Roche electroluminescence method,and insulin resistance index(HOMA-IR)was calculated.The clinical efficacy was evaluated by dynamic blood glucose monitoring indexes TIR(percentage of time when glucose was in the range of 3.9-10.0 mmol/L),TAR(percentage of time when glucose was higher than the target range≥11.1 mmol/L)and TBR(percentage of time when glucose was lower than the target range<3.9 mmol/L).Results The total effective rate was 92.3%(48/52)in the observation group and 56.9%(29/51)in the control group(χ^(2)=15.32,P<0.01).The score of TCM syndrome in the observation group was significantly lower than that of the control group(t=6.30,P<0.01).The compliance rate of HbA1c in the observation group was 46.2%(24/52)and that of the control group was 23.5%(12/51).There was significant difference between the two groups(χ^(2)=5.80,P=0.016).Compared with the groups before treatment,MAGE,TAR,TBR significantly decreased and TIR significantly increased in both groups after treatment(P<0.01)

关 键 词：糖尿病 2型 清肝补脾降糖饮 葡萄糖在目标范围内时间 肝旺脾虚证 

分 类 号：R587.2[医药卫生—内分泌]