中药辨证组方联合苯那普利对慢性肾炎CKD3期的肾保护作用——317例多中心、前瞻、双盲、随机对照试验

发布时间：2019-01-17 10:35

【摘要】：目的:观察中药辨证组方联合苯那普利对慢性肾小球肾炎(CGN)CKD3期患者的肾保护作用与安全性。方法:对入组人群中符合方案集(Per-protocol.PP)的317例患者,观察中西药组(160例,基础治疗+中药辨证颗粒剂+苯那普利片10 mg/d)和西药组(157例,基础治疗+中药颗粒模拟剂+苯那普利片10 mg/d)治疗前后症状、证侯积分值、临床综合疗效及尿蛋白定量/24 h(Upr/24 h)、尿蛋白/肌酐比值(Upr/Cr)、血肌酐(Scr)、尿素氮(Bun)、尿酸(UA)、钾(K+)、估测肾小球滤过率(e GFR)、CKD分期和安全性。疗程24周。结果:治后两组的症状、证侯积分值均较基线时明显改善(P0.01),但以中西药组为优(P0.05)。西药组治后尿蛋白减少(P0.05),血肌酐反增高(P0.01),其中31例(19.7%)增幅30%,8例(5.10%)增幅50%;e GFR降低,其中27例(17.2%)由CKD3期进展至CKD4期,而减轻至2期者仅11例(7.00%)。中西药组则尿蛋白显著减少(P0.05),Scr降低(P0.01),e GFR提高(P0.01),由CKD3期进展至4期者12例(7.50%),而减轻至2期者达27例(16.90%)。临床综合疗效亦优于西药组(P0.05)。药物不良反应两组差异无显著性(P0.05)。结论:中药辨证组方联合苯那普利10 mg/d治疗CGN-CKD3期患者24周,较之单用苯那普利的对照组能更好地减少尿蛋白,保护肾功能,延缓病情进展。
[Abstract]:Aim: to observe the renal protective effect and safety of traditional Chinese medicine combined with benazepril in patients with chronic glomerulonephritis (CGN) CKD3). Methods: a total of 317 patients with Per-protocol.PP were enrolled in this study. 160 patients in the Chinese and western medicine group were treated with benazepril tablets for 10 mg/d, and 157 patients in the western medicine group and the traditional Chinese medicine group were treated with benazepril tablets for 10 mg/d. The symptoms, syndromes, clinical efficacy and urinary protein ration / 24 h (Upr/24 h), urine protein / creatinine ratio (Upr/Cr) were measured before and after 10 mg/d treatment with benazepril. Serum creatinine, (Scr), urea nitrogen, (Bun), (UA), potassium (K), were used to estimate glomerular filtration rate (e GFR), CKD) stage and safety. The course of treatment was 24 weeks. Results: after treatment, the symptoms and symptoms of the two groups were significantly improved compared with the baseline (P0.01), but the Chinese and Western medicine group was the best (P0.05). In the western medicine group, urine protein decreased (P0.05), serum creatinine increased (P0.01), in which 31 cases (19.7%) increased 30% (5.10%). E GFR decreased in 27 cases (17.2%) from CKD3 stage to CKD4 stage, but only in 11 cases (7.00%). In Chinese and western medicine group, urinary protein decreased significantly (P0.05), Scr decreased (P0.01), e GFR increased (P0.01), from CKD3 stage to stage 4 in 12 cases (7.50%), and alleviated to 2 stage in 27 cases (16.90%). The clinical comprehensive curative effect was also superior to that of western medicine group (P0.05). There was no significant difference in adverse drug reactions between the two groups (P0.05). Conclusion: compared with the control group treated with benazepril alone for 24 weeks, the combination of traditional Chinese medicine and benazepril for 10 mg/d can reduce urine protein, protect renal function and delay the progress of the disease.
【作者单位】：浙江中医药大学广兴医院(杭州市中医院);上海中医药大学曙光医院;江苏省中医院;浙江省立同德医院;湖北省中医院;黑龙江省中医研究院;南方医科大学珠江医院;天津中医药大学第一附属医院;广东省中医院;浙江省中医院;北京中医药大学东直门医院;北京中日友好医院;杭州市红十字会医院;第三军医大学新桥医院;北京大学第一医院统计室;
【基金】：国家“十一五”科技支撑计划项目(2006BAI04A07)
【分类号】：R692.3

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