玉蚕颗粒联合氯沙坦钾片治疗气虚湿瘀型糖尿病肾病的临床观察  

Clinical observation of Yucan Granules combined with losartan potassium tablets in treatment of diabetic kidney disease with qi deficiency and damp stasis syndrome

作　　者：余振杰 李慧 张亚亨 宋婷 俞菁鉴 杨涛[1] 杨雪军[1] YU Zhenjie;LI Hui;ZHANG Yaheng;SONG Ting;YU Jingjian;YANG Tao;YANG Xuejun(Department of Nephrology,Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)

机构地区：[1]上海中医药大学附属曙光医院肾病科,上海201203

出　　处：《上海中医药杂志》2024年第7期53-57,共5页Shanghai Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金项目(8227153004);上海市科委2022年度“科技创新行动计划”项目(22Y31920200);上海市浦东新区卫健委科研项目(PW2021E-02)。

摘　　要：目的观察玉蚕颗粒联合氯沙坦钾片治疗糖尿病肾病的临床疗效及其安全性。方法将90例气虚湿瘀型糖尿病肾病患者随机分为治疗组、对照组,每组45例。在常规治疗基础上,治疗组加用玉蚕颗粒、氯沙坦钾片,对照组加用玉蚕颗粒安慰剂、氯沙坦钾片,两组疗程均为12周。观察临床疗效,比较治疗前后24 h尿蛋白定量、尿蛋白-肌酐比值(UACR)以及实验室指标[血肌酐(Scr)、尿素氮(BUN)、估算肾小球滤过率(eGFR)、总胆固醇(TC)、低密度脂蛋白(LDL)、C反应蛋白(CRP)、血清淀粉样蛋白A(SAA)、白介素-6(IL-6)]的变化情况,并进行安全性评价。结果①最终完成试验者治疗组、对照组各44例。②治疗组、对照组临床总有效率分别为79.55%、56.82%,中医证候总有效率分别为86.36%、72.73%,差异均有统计学意义(P<0.05),治疗组疗效优于对照组。③治疗前后组内比较,两组24 h尿蛋白定量、UACR降低(P<0.05);组间治疗后比较,治疗组24 h尿蛋白定量、UACR低于对照组(P<0.05)。④治疗前后组内比较,两组Scr、BUN、eGFR、TC、LDL、CRP、SAA、IL-6水平降低(P<0.05);组间治疗后比较,治疗组Scr、TC、LDL、CRP、SAA、IL-6水平低于对照组(P<0.05)。⑤试验期间两组均未出现明显不良反应。结论玉蚕颗粒联合氯沙坦钾片治疗糖尿病肾病疗效满意,可有效改善患者蛋白尿水平和机体炎症状态,延缓疾病进展,且安全性良好。Objective To observe the clinical efficacy and safety of Yucan Granules combined with losartan potassium tablets in treating diabetic kidney disease(DKD).Methods Ninety DKD patients with qi deficiency and damp stasis syndrome were randomly divided into a treatment group(n=45)and a control group(n=45).Besides conventional treatment,the treatment group received additional Yucan Granules and losartan potassium tablets,while the control group received Yucan placebo and losartan potassium tablets.Both groups were treated for 12 weeks.Clinical efficacy was observed,and the 24-hour urinary protein quantification,urine albumin to creatinine ratio(UACR),and laboratory indicators[serum creatinine(Scr),blood urea nitrogen(BUN),estimated glomerular filtration rate(eGFR),total cholesterol(TC),low-density lipoprotein(LDL),C-reactive protein(CRP),serum amyloid A(SAA),and interleukin-6(IL-6)]were compared before and after treatment,along with a safety assessment.Results①Forty-four patients in both treatment and control groups completed the trial.②The total clinical effective rate was 79.55%in the treatment group and 56.82%in the control group,and the total effective rate of traditional Chinese medicine syndromes was 86.36%and 72.73%,respectively,with statistically significant differences(P<0.05),indicating better efficacy in the treatment group.③Intra-group comparisons before and after treatment showed reductions in 24-hour urinary protein quantification and UACR in both groups(P<0.05).Inter-group comparisons after treatment showed that 24-hour urinary protein quantification and UACR were lower in the treatment group(P<0.05).④Both groups showed reductions in the levels of Scr,BUN,eGFR,TC,LDL,CRP,SAA,and IL-6 after treatment(P<0.05);Inter-group comparisons after treatment showed that levels of Scr,TC,LDL,CRP,SAA,and IL-6 were lower in the treatment group compared to those in the control group(P<0.05).⑤No significant adverse reactions were observed in either group during the trial.Conclusions The efficacy of Yucan Granul

关 键 词：糖尿病肾病 慢性肾脏病 玉蚕颗粒 蛋白尿 中西医结合疗法 临床试验 

分 类 号：R587.2[医药卫生—内分泌] R692.9[医药卫生—内科学]