百令胶囊、大黄蛰虫丸联合基础治疗对早期糖尿病性肾病蛋白尿的疗效观察

Clinical Observation of Bailing Capsule and Dahuang Zhechong Pill Combined with Basic Treatment for Proteinuria of Early Diabetic Nephropathy

目的:观察百令胶囊、大黄蛰虫丸联合基础治疗对早期糖尿病性肾病蛋白尿患者的临床疗效。方法:选择符合纳入标准的早期糖尿病性肾病蛋白尿患者150例,采用随机数字表法随机分为对照组、治疗1组(联用百令胶囊+大黄蛰虫丸)、治疗2组(联用百令胶囊)各50例,比较三组患者治疗后的临床疗效及治疗前后BUN、Cr、CHOL、TG、Hb Alc、Hs-CRP、ALB含量变化和肾损伤标志性蛋白的改变情况。结果:三组患者在改善患者肾功能、血脂、糖化血红蛋白方面无明显统计学差异(P>0.05),但在减少患者超敏C反应蛋白及提高血清白蛋白方面,两个治疗组具有明显疗效(P<0.05),其中以治疗1组疗效最明显(P<0.01);治疗1组、治疗2组对DN早期的β2微球蛋白、尿微量白蛋白及24小时尿蛋白定量改善情况均优于对照组(P<0.05),其中治疗1组的疗效最明显(P<0.01),相对其他两组均具有统计学意义(P<0.05)。结论:两药联合使用具有补虚扶正,破瘀消瘕的协同作用,恰中糖尿病肾病的中医病机,故能取得较满意的临床疗效。

Objective： To observe the clinical efficacy of Bailing capsule and Dahuang with basic treatment for proteinuria due to diabetic nephropathy（DN）. Methods： 150 Zhechong pill combined cases of inpatients and outpatients（January 2012- April 2016）, were randomly divided into the control group, medication group A （ Basic treatment ＋ Bailing capsule ＋ Dahuang Zhechong pill）, medication group B （ Basic treatment ＋ Bailing capsule）, with 50 cases in each group. The clinical efficacy, the levels of BUN, Cr, CHOL, TG, HbAlc, Hs - CRP and ALB, and the changes of the specific protein were compared among the groups. Results ： There were no significant statistical difference among the three groups in improving patients renal function, blood lipids, and glycosylated hemoglobin （P 〉 0.05 ） ; but the medication groups had obvious effect in reducing hy- persensitive c - reactive protein and increase the serum albumin （ P 〈 0.05 ）, of which medication group A had the most obvious curative effect （P 〈 0. 01 ） ; The improvements of 132 microglobulin, urine microalbumin, and 24 hours urinary protein were all better in the medication groups compared to those in the control group （P 〈 0. 05 ）, of which medication group A had the most significant improvements （ P 〈 0.01, P 〈 0.05 ）. Conclu- sion： The combination of the two medications has the functions of supplementing deficiency and removing blood stasis, which just fits in the TCM pathogenesis of DN, and therefore it can obtain satisfactory curative effect. However, it lacks of specific pharmacological mechanism and large clinical data, which needs further in- depth study. It is worth exploring to decrease administration times and developing the compound prepara- tions of these two formulae.