自拟祛浊清源汤用于临床期糖尿病肾病患者的 疗效观察.

OBJECTIVE: To observe the therapeutic effects of self-made Quzhuo Qingyuan decoction on patients with diabetic nephropathy (DN) in clinical stage based on the theory of Zhuoyu Shenluo. METHODS: One hundred and twenty cases of clinical DN admitted into the hospital from Sept. 2019 to Mar. 2021 were divided into the observation group and control group by computer random number grouping method, with 60 cases in each group. The control group was treated with conventional western medicine, while the observation group received Quzhuo Qingyuan decoction on the basis of western medicine, with 8 weeks as a course of treatment. After 3 courses of treatment, the clinical efficacy of two groups was evaluated. Traditional Chinese medicine syndrome scores after 8, 16 and 24 weeks of treatment, renal function [serum creatinine (SCr), blood urea nitrogen (BUN) and 24 h urinary protein (24 h UPR)], blood glucose [fasting blood glucose (FBG), 2-hour postprandial blood glucose (2 hBG) and glycosylated hemoglobin (HbA1 c), and blood lipids [ total cholesterol (TC), triglyceride (TG) and low-density lipoprotein cholesterol (LDL-C)] of two groups were observed. Serum inflammatory factors [tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), transforming growth factor-β1 (TGF-β1)] were compared between two groups. The incidence of adverse drug reactions in two groups was recorded. RESULTS: After 3 courses of treatment, the total effective rate of the treatment group was 91. 7% (55/60), significantly higher than 80. 0% (48/60) of the control group, the difference was statistically significant (P < 0. 05). Compared with the control group, traditional Chinese medicine syndrome score, renal function (SCr, BUN and 24 h UPR), blood glucose (FBG, 2 hBG and HbA1 c), blood lipids (TC, TG and LDL-C) and inflammatory factors (IL-6, TNF-α and TGF-β1) in the treatment group decreased significantly, the level of glomerular filtration rate in the treatment group was significantly higher than that of the control group, the differences were statistically significant (P<0. 05). The total incidence of adverse drug reactions in the treatment group was 6. 7% (4/60), significantly lower than 13. 3% (8/60) in the control group, the difference was statistically significant (P < 0. 05). CONCLUSIONS: The efficacy of self-made Quzhuo Qingyuan decoction on patients with DN is significant, which can effectively relieve traditional Chinese medicine syndromes, reduce blood glucose and blood lipid levels, decrease renal function damage and inflammatory state with higher safety. [ABSTRACT FROM AUTHOR]

目的: 基于浊郁肾络理论基础, 观察自拟祛浊清源汤对临床期糖尿病肾病 (DN) 患者的治疗效果。方法: 将 2019 年 9 月 至 2021 年 3 月该院收治的 120 例临床期 DN 患者按计算机随机数字分组法分为治疗组和对照组, 每组 60 例。对照组患者给予常 规西医治疗, 治疗组患者在常规西医治疗基础上加服自拟祛浊清源汤。以 8 周为 1 个疗程, 治疗 3 个疗程后评价两组患者的临床 疗效, 分别观察两组患者治疗 8、16 和 24 周后的中医证候积分, 肾功能[血肌酐 (SCr)、尿素氮 (BUN) 和 24 h 尿蛋白量 (24 h UPR)]、血糖[空腹血糖 (FBG)、餐后 2 h 血糖 (2 hBG) 和糖化血红蛋白 (HbA1 c)] 及血脂 [总胆固醇 (TC)、三酰甘油 (TG) 和低密 度脂蛋白胆固醇 (LDL-C)] 指标水平变化, 比较两组患者血清炎症因子[肿瘤坏死因子 α(TNF-α)、白细胞介素 6(IL-6) 和转化生 长因子-β1(TGF-β1)]水平, 记录两组患者疗程中不良反应发生情况。结果: 3 个疗程结束后, 治疗组患者临床总有效率为 91. 7% (55/60), 较对照组 (80. 0%, 48/60) 明显升高, 差异有统计学意义 (P<0. 05)。与对照组比较, 治疗组患者治疗 8、16 和 24 周后的 中医证候积分、肾功能 (SCr、BUN 和 24 h UPR)、血糖 (FBG、2 hBG 和 HbA1 c)、血脂 (TC、TG 和 LDL-C) 指标及炎症因子 (IL-6、 TNF-α 和 TGF-β1) 水平明显降低, 肾小球滤过率水平显著升高, 差异均有统计学意义 (P<0. 05)。治疗组患者的不良反应总发生 率为 6. 7%(4/60), 明显低于对照组 (13. 3%, 8/60), 差异有统计学意义 (P<0. 05)。结论: 自拟祛浊清源汤用于临床期 DN 患者的 疗效明确, 可有效缓解中医证候, 降低血糖、血脂水平, 减轻肾功能损伤和炎症状态, 同时具有较好的安全性。 [ABSTRACT FROM AUTHOR]