水陆二仙丹联合抵挡汤加减方对早中期糖尿病肾病患者的临床疗效  

Clinical effects of Shuilu Erxian Pills combined with Modified Didang Decoction on patients with early and middle stage diabetic nephropathy

作　　者：郭建恩 张佳华[2] 张园 纪品川 高志旭 高占华 安丽萍[3] 杨佳琦 常柏[4] GUO Jian-en;ZHANG Jia-hua;ZHANG Yuan;JI Pin-chuan;GAO Zhi-xu;GAO Zhan-hua;AN Li-ping;YANG Jia-qi;CHANG Bai(Graduate School,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;Chengde Medical University,Chengde 067000,China;Chengde Municipal Hospital of Traditional Chinese Medicine,Chengde 067000,China;Tianjin Medical University ZHU Xianyi Memorial Hospital,Tianjin 300070,China)

机构地区：[1]天津中医药大学研究生院,天津301617 [2]承德医学院,河北承德067000 [3]承德市中医院,河北承德067000 [4]天津医科大学朱宪彝纪念医院,天津300070

出　　处：《中成药》2024年第5期1514-1519,共6页Chinese Traditional Patent Medicine

基　　金：国家自然科学基金项目(81973614);河北省自然科学基金资助项目(H2022406069);河北省中医药管理局科研计划项目(2023139)。

摘　　要：目的探讨水陆二仙丹联合抵挡汤加减方对早中期糖尿病肾病患者的临床疗效。方法83例患者随机分为对照组(42例)和观察组(41例),对照组给予厄贝沙坦片,观察组在对照组基础上加用水陆二仙丹联合抵挡汤加减方,疗程12周。检测临床疗效、中医证候评分、血糖指标(FBG、HbA1c)、血脂指标(TC、TG)、肾功能指标(BUN、Scr、24 h UTP、eGFR)、炎症因子(IL-1β、hs-CRP、IL-6、TNF-α、IL-18、TGF-β1)、免疫功能指标(淋巴细胞、中性粒细胞、CD8^(+)、CD3^(+)、CD4^(+)、CD4^(+)/CD8^(+))、不良反应发生率变化。结果观察组总有效率高于对照组(P<0.05)。治疗后,观察组中医证候评分、血糖指标、血脂指标、BUN、Scr、24 h UTP、炎症因子、CD8^(+)降低(P<0.05),淋巴细胞、中性粒细胞减少(P<0.05),eGFR、CD3^(+)、CD4^(+)、CD4^(+)/CD8^(+)升高(P<0.05),并比对照组更明显(HbA1c、TG、SCr、24 h UTP、淋巴细胞、中性粒细胞除外)(P<0.05)。2组不良反应发生率比较,差异无统计学意义(P>0.05)。结论水陆二仙丹联合抵挡汤加减方可安全有效地改善早中期糖尿病肾病患者临床症状,其机制可能与降低炎症水平、改善机体免疫功能有关。AIM To explore the clinical effects of Shuilu Erxian Pills combined with Modified Didang Decoction on patients with early and middle stage diabetic nephropathy.METHODS Eighty-three patients were randomly assigned into control group(42 cases)for 12-week administration of Irbesartan Tablets,and observation group(41 cases)for 12-week administration of Shuilu Erxian Pills,Modified Didang Decoction and Irbesartan Tablets.The changes in clinical effects,TCM syndrome scores,blood glucose indices(FBG,HbA1c),blood lipid indices(TC,TG),renal function indices(BUN,Scr,24 h UTP,eGFR),inflammatory factors(IL-1β,hs-CRP,IL-6,TNF-α,IL-18,TGF-β1),immune function indices(lymphocyte,neutrophil,CD8^(+),CD3^(+),CD4^(+),CD4^(+)/CD8^(+))and incidence of adverse reactions were detected.RESULTS The observation group demonstrated higher total effective rate than the control group(P<0.05).After the treatment,the observation group displayed decreased TCM syndrome scores,blood glucose indices,blood lipid indices,BUN,Scr,24 h UTP,inflammatory factors,CD8^(+)(P<0.05),reduced lymphocyte,neutrophil(P<0.05),and increased eGFR,CD3^(+),CD4^(+),CD4^(+)/CD8^(+)(P<0.05),which were more obvious than those in the control group(except for HbA1c,TG,SCr,24 h UTP,lymphocyte,neutrophil)(P<0.05).No significant difference in incidence of adverse reactions was found between the two groups(P>0.05).CONCLUSION For the patients with early and middle stage diabetic nephropathy,Shuilu Erxian Pills combined with Modified Didang Decoction can safely and effectively improve clinical symptoms,whose mechanism may contribute to the reduction of inflammatory levels and improvement of immune functions.

关 键 词：水陆二仙丹 抵挡汤加减方 厄贝沙坦片 早中期糖尿病肾病 

分 类 号：R287[医药卫生—中药学]