甘地胶囊联合常规治疗用于糖尿病肾病的疗效和安全性及对相关指标的影响  

Therapeutic Efficacy and Safety of Gandi Capsules Combined with Routine Treatment for Diabetic Nephropathy and Its Effects on Related Indicators

作　　者：魏昕[1] 黄震浩[2] 张琳琳[3] WEI Xin;HUANG Zhenhao;ZHANG Linlin(Dept.of Pharmacy,Xinhua Hospital,Shanghai Jiaotong University School of Medicine,Shanghai 200092,China;Dept.of Cardiology,Dongfang Hospital Affiliated to Tongji University,Shanghai 200123,China;Dept.of Nuclear Medicine,Xinhua Hospital,Shanghai Jiaotong University School of Medicine,Shanghai 200092,China)

机构地区：[1]上海交通大学医学院附属新华医院药学部,上海200092 [2]上海同济大学附属东方医院心内科,上海200123 [3]上海交通大学医学院附属新华医院核医学科,上海200092

出　　处：《中国药房》2018年第22期3134-3138,共5页China Pharmacy

基　　金：国家自然科学基金资助项目(No.51703126);上海交通大学医学院医院药学科研基金项目(No.JDYX2017QW005)

摘　　要：目的:观察甘地胶囊联合常规治疗用于糖尿病肾病(DN)的疗效和安全性及对相关指标的影响。方法:选择2016年10月-2017年10月上海交通大学医学院附属新华医院收治的205例DN患者,按随机数字表法分为对照组(102例)和观察组(103例)。对照组患者给予赖脯胰岛素注射液,皮下注射,每日3次+甘精胰岛素注射液,皮下注射,每日1次,均根据血糖情况调节胰岛素给药剂量;同时给予氯沙坦钾片100 mg,口服,每日1次+硝苯地平控释片30 mg,口服,每日1次;保持蛋白质和能量摄入量恒定,并结合合理饮食及适当运动等。观察组患者在对照组治疗的基础上给予甘地胶囊0.9 g,口服,每日3次。两组均以2个月为1个疗程,共治疗3个疗程。观察两组患者的临床疗效,治疗前后的血糖[空腹血糖、餐后2 h血糖、糖化血红蛋白(HbA1c)]水平、肝功能指标[丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)、总胆红素(TBIL)]、肾功能指标(血尿素氮、血肌酐)、炎症因子[肿瘤坏死因子α(TNF-α)、白细胞介素6(IL-6)、单核细胞趋化蛋白1(MCP-1)、转化生长因子β(TGF-β)]水平及不良反应发生情况。结果:所有患者均完成治疗,无患者脱落。观察组患者的总有效率(63.11%)显著高于对照组(29.41%)(P<0.05)。治疗前,两组患者血糖水平、肝肾功能指标、炎症因子水平比较,差异均无统计学意义(P>0.05)。治疗后,观察组患者HbA1c水平显著低于同组治疗前及对照组同期(P<0.05);两组患者肝肾功能指标、炎症因子水平均显著低于同组治疗前,且观察组显著低于对照组(P<0.05)。两组患者不良反应发生率比较,差异无统计学意义(P>0.05)。结论:在常规治疗的基础上加用甘地胶囊治疗DN可显著提高疗效,降低患者体内血糖及炎症因子水平,改善其肝肾功能,且未增加不良反应的发生。OBJECTIVE:To observe therapeutic efficacy and safety of Gandi capsules combined with routine treatment for diabetic nephropathy(DN)and its effects on related indicators.METHODS:Totally 205 patients with DN admitted to Xinhua Hospital,Shanghai Jiaotong University School of Medicine during Oct.2016-Oct.2017 were divided into control group(102 cases)and observation group(103 cases)according to random number table.Control group was given Recombinant human insulin lispro injection subcutaneoasly,3 times a day+Insulin glargine injection subcutaneoasly,once a day;the dosage of insulin was adjusted according to the blood glucose level.They were also given Losartan potassium tablets orally 100 mg,once a day+Nifedipine controlled-release tablets orally 30 mg,once a day,and received treatment as maintaining a constant intake of protein and energy,proper diet and proper exercise.Observation group was additionally given Gandi capsules orally 0.9 g,3 times a day,on the basis of control group.Both groups received treatment for 3 courses,and a treatment course lasted for 2 months.Clinical efficacies of 2 groups were observed.The levels of blood glucose(fasting blood glucose,postprandial 2 h blood glucose,HbA1c),liver function indexes(ALT,AST,TBIL),renal function indexes(serum creatinine and blood urea nitrogen)and inflammatory factors(TNF-α,IL-6,TGF-β,MCP-1)and the occurrence of ADR were observed in 2 groups before and after treatment.RESULTS:All patients completed the treatment,and no patient withdrew from the study.Total response rate of observation group(63.11%)was significantly higher than that of control group(29.41%)(P<0.05).Before treatment,there was no statistical significance in blood glucose,liver/renal function indexes or inflammatory factors between 2 groups(P>0.05).After treatment,HbA1c level of observation group was significantly lower than before treatment and control group at corresponding period(P<0.05).Liver/renal function indexes and inflammatory factor levels of 2 groups were significantly lower than before

关 键 词：甘地胶囊 糖尿病肾病 疗效 安全性 血糖 炎症因子 肝功能 肾功能 

分 类 号：R587.2[医药卫生—内分泌]