抗纤灵二号方干预慢性肾脏病肾小管间质损伤的临床研究

Clinical Research of No.2 Kangxianling Decoction on Tubulointerstitial Injury in Chronic Kidney Disease

目的：观察中药复方-抗纤灵二号方对CKD1~3期、存在肾小管间质损伤、中医辨属脾肾阳（气）虚兼血瘀证患者的临床疗效。方法：将77例患者随机分为治疗组为36例,对照组为41例。在基础治疗的同时,治疗组加服抗纤灵二号方,每日1剂,分2次服;对照组加服百令胶囊,每日3次,每次1.5 g,两组均治疗90 d后分别于治疗前后对比观察研究对象的中医证候积分,尿常规、尿α_1微球蛋白（α_1-MG）、尿β_2微球蛋白（β_2-MG）、尿N-乙酰β-D-葡萄糖苷酶（NAG）、尿视黄醇结合蛋白（RBP）、肾功能等指标变化。结果：治疗组总有效率75%,对照组总有效率56.1%,治疗组临床疗效明显优于对照组（P〈0.05）。两组治疗后中医证候总积分均有不同程度的改善,且治疗组明显优于对照组（P〈0.01）。治疗组治疗后尿α_1-MG、尿β_2-MG及尿RBP的排泄降低（P〈0.05或P〈0.01）。结论：抗纤灵二号方能显著改善肾小管间质损伤患者的临床症状,保护肾小管功能。

Objective： To observe the clinical effect of traditional Chinese medicine＂No. 2 Kangxianling Decoction＂in the treatment of Tubular- interstitial Lesion in patients who belong to CKD1- 3 period. Methods： Seventy- seven patients were randomly divided into two groups,treatment group in wich 36 cases were given＂No. 2 Kangxianling Decoction＂and control group in wich 41 cases were given Bailing capsule,with a course of 90 days. The changes of Chinese clinical symptoms,urine α_1- MG,urine β_2- MG,urine NAG,urine RBP,renal function were observed before and after treatment to analyse and compare the differences between the two groups. Results： The total effective rate was 75% in treatment group,and the total effective rate was 56. 1% in control group,there are different between the two groups（ P 0. 05）. The total score of TCM syndromes in the two groups were improved after treatment. Conclusion： The treatment group was significantly better than the control group. The excretions of α_1- MG,β_2- MG,RBP were reduced evidently in treatment group（ P 0. 05 or P 0. 01）.