【摘要】 目的 探究祛热逐湿清毒加减方联合卡格列净治疗湿热证糖尿病肾病(Diabetic nephropathy, DN)患者的临床疗效及对其安全性的影响。方法 选取2022年3月—2023年6月期间于淮北市中医院就诊的92例DN患者，通过简单随机数字表法分为对照组和研究组，每组各46例。常规干预基础上对照组采取卡格列净，研究组在对照组基础上采取祛热逐湿清毒加减方。两组患者均治疗3个月。统计两组患者临床疗效、不良反应，治疗前后中医证候积分、肾功能指标[尿白蛋白排泄率(Urinary albumin excretion rate, UAER)、胱抑素C(Cystatin C,Cys-C)、尿素氮(Blood urea nitrogen, BUN)、血肌酐(Serum creatinine, SCr)]水平、炎症因子[白介素-6(Interleukin-6,IL-6)、肿瘤坏死因子-α(Tumor necrosis factor-alpha, TNF-α)、超敏C反应蛋白(Hypersensitive C-reactive protein, hs-CRP)]水平。结果 治疗后研究组临床总有效率91.30%(42/46)高于对照组76.09%(35/46),差异有统计学意义(P<0.05)。治疗后两组患者口渴多饮、身重困倦、肢体浮肿、心烦恶热及口中黏腻、脘腹胀满、食少纳呆分值均较治疗前降低，差异有统计学意义(P<0.05);且研究组中医证候积分低于对照组，差异有统计学意义(P<0.05)。治疗后两组患者UAER、Cys-C、BUN、SCr水平均较治疗前降低，差异有统计学意义(P<0.05);且研究组肾功能指标低于对照组，差异有统计学意义(P<0.05)。治疗后两组患者IL-6、TNF-α、hs-CRP水平均较治疗前降低，差异有统计学意义(P<0.05);且研究组炎症因子水平低于对照组，差异有统计学意义(P<0.05)。治疗期间，研究组不良反应发生率6.52%(3/46)与对照组2.17%(1/46)比较，差异无统计学意义(P>0.05)。结论 祛热逐湿清毒加减方联合卡格列净治疗DN湿热证，可有效缓解患者临床症状，改善肾功能，下调炎症因子表达，减轻体内炎症反应程度，提升治疗效果，且具有安全性。更多还原

【Abstract】 Objective To explore the clinical effect and safety of modified Qure Zhushi Qingdu prescription combined with canagliflozin in the treatment of damp-heat syndrome of diabetic nephropathy(DN).Methods A total of 92 patients with DN who were treated in Huaibei Hospital of Traditional Chinese Medicine from March 2022 to June 2023 were selected and divided into a control group and a study group by the simple random number table method, with 46 cases in each group.Besides routine intervention, the control group was given canagliflozin, while the study group was administered with modified Qure Zhushi Qingdu prescription on the basis of the control group.Both the two groups were treated for three months.The clinical efficacy and adverse reactions in the two groups were observed.The traditional Chinese medicine(TCM)syndrome scores of the two groups before and after treatment were recorded, and their levels of renal function indexes[urinary albumin excretion rate(UAER),cystatin C(Cys-C),blood urea nitrogen(BUN),and serum creatinine(SCr)]and inflammatory factors[interleukin-6(IL-6),tumor necrosis factor-α(TNF-α),and hypersensitive C-reactive protein(hs-CRP)]were detected.Results After treatment, the total clinical effective rate of 91.30%(42/46)in the study group was higher than that of 76.09%(35/46)in the control group, and the difference was statistically significant(P<0.05).After treatment, the scores of patients in the two groups regarding thirsty and polydipsia, heavy body and drowsiness, limb edema, vexation with aversion to heat and sticky taste in the mouth, fullness in stomach, and eating less and anorexia were all lower than those before treatment, and the differences were statistically significant(P<0.05).Moreover, the TCM syndrome scores in the study group were lower than those in the control group with statistically significant differences(P<0.05).After treatment, the levels of UAER,Cys-C,BUN,and SCr in the two groups were lower than those before treatment with statistically significant differences(P<0.05),and the study group had lower renal function indexes than the control group(P<0.05).After treatment, the levels of IL-6,TNF-α,and hs-CRP in the two groups were lower than those before treatment(P<0.05),and the study group had lower levels of them than the control group(P<0.05).There was no significant difference in the incidence of adverse reactions between the study group(6.52%,3/46)and the control group(2.17%,1/46)(P>0.05).Conclusion Modified Qure Zhushi Qingdu prescription combined with canagliflozin can effectively alleviate clinical symptoms, improve renal function, down-regulate the expression of inflammatory factors, reduce the degree of inflammation in vivo, and enhance the therapeutic effect with safety in the treatment of damp-heat syndrome of DN.更多还原