左归丸加减联合培哚普利叔丁胺片治疗气阴两虚夹瘀证早期糖尿病肾病临床观察

Efficacy of Modified Zuoguiwan Combined with Perindopril Tert-butylamine Tablets on Early Diabetic Kidney Disease Patients of Qi-Yin Deficiency with Blood Stasis Syndrome

目的:观察左归丸加减联合培哚普利叔丁胺片治疗早期糖尿病肾病气阴两虚夹瘀证的疗效。方法:选择2020年9月至2021年11月广西中医药大学附属瑞康医院收治的气阴两虚夹瘀证早期糖尿病肾病患者77例,随机分为观察组(39例)和对照组(38例)。所有患者均接受基础治疗,对照组在此基础加用培哚普利叔丁胺片治疗,观察组在对照组的基础上加用左归丸加减治疗,疗程为3个月,观察治疗前后两组症状评分、血糖[空腹血糖(FBG)、餐后2 h血糖(2 h PBG)、糖化血红蛋白(HbA1c)、葡萄糖在目标范围内时间(TIR)]、肌酐(SCr)、尿素、预估肾小球率过滤(eGFR)、血清胱抑素-C(Cys-C)、血β_(2)-微球蛋白(Sβ_(2)-MB)、尿系列微量蛋白[24 h尿蛋白定量(24 h UmAlb)、24 h尿微量白蛋白定量(24 h MTP)及尿β_(2)-微球蛋白(Uβ_(2)-MB)]。结果:两组治疗前各项指标差异无统计学意义。治疗后,对照组总有效率为84.2%(32/38),观察组总有效率为94.9%(37/39),观察组疗效优于对照组(Z=6.03,P<0.05)。与本组治疗前比较,两组患者的症状评分均显著降低(P<0.01);治疗后与对照组比较,观察组患者症状评分显著降低(P<0.01)。与本组治疗前比较,两组患者治疗后的TIR水平均有明显升高(P<0.05);两组患者FBG、2 h PBG和HbA1c水平均显著降低(P<0.01);治疗后与对照组比较,观察组患者TIR水平显著升高(P<0.01)。与本组治疗前比较,两组患者治疗后的Cys-C含量均显著降低(P<0.01);观察组Sβ_(2)-MB水平明显降低(P<0.05);对照组Sβ_(2)-MB水平有所下降,但差异无统计学意义;治疗后与对照组比较,观察组患者Cys-C水平显著降低(P<0.01);观察组患者Sβ_(2)-MB水平明显降低(P<0.05)。与本组治疗前比较,两组患者治疗后24 h UmAlb、Uβ_(2)-MB均明显降低(P<0.05);观察组24 h MTP水平明显降低(P<0.05);对照组24 h MTP水平有所下降,差异无统计学意义;治疗后与对照组比较,观察组患者24 h UmAlb、24 h MTP、Uβ_(2)-MB水平显著降低(P<0.01);SCr及eGFR变化不明显。结论:左归丸加减联合培哚普利叔丁胺片可降低早期糖尿病肾病气阴两虚夹瘀证患者的血糖波动和尿白蛋白排泄,临床疗效优于西药基础治疗。

Objective:To observe the effect of modified Zuoguiwan combined with perindopril tertbutylamine tablets on early diabetic kidney disease(DKD)of Qi-Yin deficiency with blood stasis syndrome.Method:A total of 77 patients with early DKD of Qi-Yin deficiency with blood stasis syndrome,who were treated in the Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine from september 2020 to november 2021,were randomized into the control group(38 cases)and observation group(39 cases).The control group received basic treatment and perindopril tert-butylamine tablets,and the observation group was treated with modified Zuoguiwan and perindopril tert-butylamine tablets in addition to the basic treatment.The treatment lasted 3 months for both groups.The symptom scores,blood glucose[fasting blood glucose(FBG),2 h postprandial blood glucose(2 h PBG),glycosylated hemoglobin(HbA1c),time in range(TIR)],serum creatinine(SCr),urea,estimated glomerular filtration rate(eGFR),cystatin-C(Cys-C),serum beta 2-microglobulin(Sβ_(2)-MB),and urinary microproteins[24 h urinary microalbumin(24 h UmAlb),24 h micrototal protein(24 h MTP),urine beta 2-microglobulin(Uβ_(2)-MB)]were observed in two groups.Result:The two groups showed no significant difference in the various indexes before treatment.After treatment,the total effective rate of the control group was 84.2%(32/38),as compared with the 94.9%(37/39)in the observation group(Z=6.03,P<0.05).After treatment,the symptom scores were lower than those before treatment in both groups(P<0.01)and lower in the observation group than in the control group(P<0.01).TIR level was higher(P<0.05)and levels of FBG,2 h PBG,and HbA1c(P<0.01)were lower than those before treatment in both groups.After treatment,the TIR level in the observation group was significantly increased as compared with that in the control group(P<0.01).After treatment,the level of Cys-C was lower than that before treatment in both group(P<0.01)and lower in the observation group than in control group(P<0.01).The level of Sβ_(2)-MB in both the observation group(P<0.05)and control group decreased as compared with that before treatment.The 24 h UmAlb and Uβ_(2)-MB of two groups were decreased after treatment as compared with those before treatment(P<0.05).Moreover,24 h MTP in observation group(P<0.05)was lower than that before treatment.After treatment,the levels of 24 h UmAlb,24 h MTP and Uβ_(2)-MB in observation group were lower than those in control group(P<0.01),and levels of SCr and eGFR in observation group did not change significantly as compared with those in the control group.Conclusion:Modified Zuoguiwan combined with perindopril tert-butylamine tablets can reduce blood glucose fluctuations and urinary albumin excretion in early DKD patients of Qi-Yin deficiency with blood stasis syndrome.The efficacy is better than that of basic western medicine.