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中医辨证治疗慢性肾脏病蛋白尿的多中心前瞻性临床研究
引用本文:王东,吴同茹,谢婷婷,彭文,王怡,袁敏,米秀华,毕月萍,何立群. 中医辨证治疗慢性肾脏病蛋白尿的多中心前瞻性临床研究[J]. 南方医科大学学报, 2013, 33(4): 502-506
作者姓名:王东  吴同茹  谢婷婷  彭文  王怡  袁敏  米秀华  毕月萍  何立群
作者单位:1. 上海中医药大学附属曙光医院,上海,200021
2. 上海中医药大学附属普陀医院,上海,200118
3. 上海中医药大学附属岳阳中西医结合医院,上海,200437
4. 复旦大学附属中山医院,上海,200032
5. 上海杨浦区中医院,上海,200090
6. 上海殷行社区卫生服务中心,上海,200438
7. 上海中医药大学附属曙光医院,上海200021;上海市中医临床重点实验室,上海200021
基金项目:国家自然科学基金,科技部中医药行业科研专项,教育部高等学校博士点专项科研基金,上海市科委创新行动计划项目,上海高校创新团队建设项目
摘    要:目的研究中医辨证组方联合基础治疗与氯沙坦联合基础治疗对慢性肾脏病蛋白尿的临床疗效。方法对入组人群采用
多中心、前瞻性、随机、对照研究的方法,将符合方案的81例患者分为中药组(60例),按脾肾气阴两虚、脾肾气阳两虚予中医辨
证组方内服;西药组(21例)予氯沙坦50 mg/d口服。总疗程24周,观察两组临床疗效。结果中药组临床总有效率93.33%,优于
西药组76.20%(P<0.05);两组患者治疗后的中医证候积分值均较基线时明显改善(P<0.01或P<0.05),中药组较西药组下降更
为明显(P<0.05)。中药组用药后8周血肌酐、肾小球滤过率估算值下降值以及24周血血胱抑素C和24 h尿蛋白定量、尿微量白
蛋白/尿肌酐比值下降值均有统计学意义(P<0.05),而西药组无明显变化(P>0.05)。结论中医辨证组方联合基础治疗对慢性肾
脏病蛋白尿在改善症状、降低证候积分值、减少尿蛋白、保护肾功能方面显示了良好的临床疗效。


关 键 词:慢性肾脏病  蛋白尿  中医辨证组方  氯沙坦

Syndrome differentiation-based treatment with traditional Chinese medicine for proteinuria in patients with chronic kidney disease: a randomized multicenter trial
WANG Dong,WU Tongru,XIE Tingting,PENG Wen,WANG Yi,YUAN Min,MI Xiuhua,BI Yueping,HE Liqun. Syndrome differentiation-based treatment with traditional Chinese medicine for proteinuria in patients with chronic kidney disease: a randomized multicenter trial[J]. Journal of Southern Medical University, 2013, 33(4): 502-506
Authors:WANG Dong  WU Tongru  XIE Tingting  PENG Wen  WANG Yi  YUAN Min  MI Xiuhua  BI Yueping  HE Liqun
Affiliation:1,7 1Shuguang Hospital,Shanghai University of TCM,Shanghai 200021,China;2Putuo Hospital Affiliated to Shanghai University of TCM, Shanghai 200118,China;3Yueyang Hospital of Integrated Chinese & Western Medicine Affiliated to Shanghai University of TCM,Shanghai 200437,China;4Zhongshan Hospital Affiliated to Fudan University,Shanghai 200032,China;5Yangpu District Hospital of TCM,Shanghai 200090,China;6Yinhang Community Health Center,Shanghai 200438,China;7Shanghai Municipal Clinical Key Laboratory of TCM, Shanghai 200021,China
Abstract:Objective To evaluate the clinical efficacy of syndrome differentiation-based treatment with traditional Chinese
medicine (TCM) versus losartan therapy in addition to basic treatment for management of proteinuria in patients with chronic
kidney disease. Methods This multicenter, randomized, and case-controlled clinical trial was conducted among 81 consecutive
patients meeting the inclusion criteria. The patients were randomized consecutively to receive TCM treatments according to
the syndrome patterns in TCM (spleen and kidney Qi and Yin deficiency, and spleen and kidney Qi and Yang deficiency, n=60)
or oral losartan therapy (50 mg/day, n=21) in addition to the basic treatments. All the patients were followed up for 24 weeks to
observe the clinical effects. Results The patients in TCM group showed a significantly higher overall response rate (93.33%)
than those in losartan group (76.20%, P<0.05). The TCM score in the two groups were all decreased at week 24 as compared
with baseline (P<0.01 or P<0.05). The TCM scores in both groups decreased significantly after the treatments as compared with
the baseline scores (P<0.05). After a 8-week-long treatment, Scr, eGFR and Cys-C, U-Pro/24 h, and MA/Cr all decreased
significantly in TCM group (P<0.05) but showed no significant changes in losartan group (P>0.05). Conclusion Syndrome
differentiation-based TCM treatment in addition to basic treatments can produce satisfactory therapeutic effects on proteinuria
in patients with chronic kidney disease by improving the clinical symptoms, reducing TCM symptom scores and proteinuria,
and protecting the renal functions.
Keywords:
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