目的 評價(jià)扶腎祛毒膠囊治療慢性腎功能衰竭（瘀濁阻滯、脾腎氣虛證）的安全性和有效性。
方法 根據(jù)納入和排除標(biāo)準(zhǔn)，選取慢性腎功能不全患者132例，按21隨機(jī)分為扶腎祛毒膠囊組（治療組）88例和腎衰寧膠囊組（對照組）43例，進(jìn)行隨機(jī)雙盲對照臨床試驗(yàn)。治療組口服扶腎祛毒膠囊，對照組口服腎衰寧膠囊，均每次4粒，1日4次，早中晚及臨睡前各服1次。療程8周。所得結(jié)果采用意向性分析。
結(jié)果 試驗(yàn)組疾病療效的顯效率為27.3%（24/88），總有效率為 67.0%（59/88）；對照組疾病療效顯效率和總有效率別為25.6%（11/43）、58.1%（25/43）。兩組間比較差異無統(tǒng)計(jì)學(xué)意義（P lt;0.05）。試驗(yàn)組對瘀濁阻滯、脾腎氣虛證的顯效率為48.9%（43/88），對照組為53.3%（23/43），組間比較差異無統(tǒng)計(jì)學(xué)意義（P lt;0.05）。服藥期間，兩組均發(fā)生輕微的副作用。
結(jié)論 扶腎祛毒膠囊治療慢性腎功能不全療效確切，有穩(wěn)定患者腎功能的作用，不良反應(yīng)發(fā)生率低。
引用本文： 邱紅渝,付 平,周 莉,米緒華,冀 玲,李 孜,鐘 慧,樊均明,唐文富,張瑞明,李廷謙. 扶腎祛毒膠囊治療慢性腎功能衰竭（瘀濁阻滯、脾腎氣虛證）的隨機(jī)雙盲對照試驗(yàn). 中國循證醫(yī)學(xué)雜志, 2006, 06(4): 254-260. doi: 復(fù)制
| 1. | 鄭筱庾.中藥新藥治療慢性腎衰竭的臨床研究指導(dǎo)原則.見：鄭筱庾.主編.中藥新藥臨床研究指導(dǎo)原則. 第1版. 北京: 中國醫(yī)藥科技出版社; 2002. |
| 2. | 葉任高.慢性腎衰竭. 見:葉任高.主編.內(nèi)科學(xué).第5版.北京:人民衛(wèi)生出版社; 1999. 569-579. |
| 3. | 李福鳳，王憶勤. 慢性腎功能衰竭中醫(yī)辨證客觀化研究進(jìn)展. 上海中醫(yī)藥雜志, 2003;37（7）:56-59. |
| 4. | 孫升云; 楊欽河; 肖達(dá)民等. 慢性腎功能衰竭中醫(yī)證候?qū)W的臨床研究.新中醫(yī), 2005; 37(5): 30-31. |
| 5. | 焦安欽, 傅興蘭. 慢性腎衰竭的病機(jī)特點(diǎn)與治療對策. 山東中醫(yī)藥大學(xué)學(xué)報(bào), 2001; 25(2)： 90-92. |
| 6. | 朱偉; 王學(xué)美. 大黃治療慢性腎功能衰竭機(jī)制的研究進(jìn)展.中國中西醫(yī)結(jié)合雜志 , 2005;25(5):471- 475. |
| 7. | Zheng XY. Chinese principle of clinical research for new traditional herbs in treating chronic renal failure. In: Zheng XY. Chief editor. 1st edition. Beijing: Guiding Principles for Clinical Study of New Traditional Chinese Medicines; 2002. |
| 8. | Ye RG. Chronic Renal Failure. In: Ye RG. Chief editor. Internal Medicine. 5th Edition. Beijing: People’s Medical Publishing House; 1999. 569-579. |
| 9. | National Kidney Foundation Kidney:K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification and stratification. Am J Kidney Disease, 2002; 39(suppl 1): S1-S266. |
| 10. | Li FF, Wang YQ. Progress of the objectification of hinese medical syndrome differentiation of chronic renal failure. Shanghai Journal of Traditional Chinese Medicine, 2003; 37(7) 56-59. |
| 11. | Sun SY, Yang QH, Xiao DM, et al. A Clinical Study on TCM Syndrome Patterns of Chronic Renal Failure. New Journal of Traditional Chinese Medicine, 2005; 37(5): 30-31. |
| 12. | Jiao AQ, Fu XL. Mechanism and treatment on chronic renal failure.Journal of Shandong University of Traditional Chinese Medicine, 2001; 25(2):90-92. |
| 13. | Zhu W, Wang XM. Progress in study on mechanisms of rhubarb in treating chronic renal failure. Chinese Journal of Integrated Traditional and Western Medicine, 2005;25(5): 471- 475. |
- 1. 鄭筱庾.中藥新藥治療慢性腎衰竭的臨床研究指導(dǎo)原則.見：鄭筱庾.主編.中藥新藥臨床研究指導(dǎo)原則. 第1版. 北京: 中國醫(yī)藥科技出版社; 2002.
- 2. 葉任高.慢性腎衰竭. 見:葉任高.主編.內(nèi)科學(xué).第5版.北京:人民衛(wèi)生出版社; 1999. 569-579.
- 3. 李福鳳，王憶勤. 慢性腎功能衰竭中醫(yī)辨證客觀化研究進(jìn)展. 上海中醫(yī)藥雜志, 2003;37（7）:56-59.
- 4. 孫升云; 楊欽河; 肖達(dá)民等. 慢性腎功能衰竭中醫(yī)證候?qū)W的臨床研究.新中醫(yī), 2005; 37(5): 30-31.
- 5. 焦安欽, 傅興蘭. 慢性腎衰竭的病機(jī)特點(diǎn)與治療對策. 山東中醫(yī)藥大學(xué)學(xué)報(bào), 2001; 25(2)： 90-92.
- 6. 朱偉; 王學(xué)美. 大黃治療慢性腎功能衰竭機(jī)制的研究進(jìn)展.中國中西醫(yī)結(jié)合雜志 , 2005;25(5):471- 475.
- 7. Zheng XY. Chinese principle of clinical research for new traditional herbs in treating chronic renal failure. In: Zheng XY. Chief editor. 1st edition. Beijing: Guiding Principles for Clinical Study of New Traditional Chinese Medicines; 2002.
- 8. Ye RG. Chronic Renal Failure. In: Ye RG. Chief editor. Internal Medicine. 5th Edition. Beijing: People’s Medical Publishing House; 1999. 569-579.
- 9. National Kidney Foundation Kidney:K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification and stratification. Am J Kidney Disease, 2002; 39(suppl 1): S1-S266.
- 10. Li FF, Wang YQ. Progress of the objectification of hinese medical syndrome differentiation of chronic renal failure. Shanghai Journal of Traditional Chinese Medicine, 2003; 37(7) 56-59.
- 11. Sun SY, Yang QH, Xiao DM, et al. A Clinical Study on TCM Syndrome Patterns of Chronic Renal Failure. New Journal of Traditional Chinese Medicine, 2005; 37(5): 30-31.
- 12. Jiao AQ, Fu XL. Mechanism and treatment on chronic renal failure.Journal of Shandong University of Traditional Chinese Medicine, 2001; 25(2):90-92.
- 13. Zhu W, Wang XM. Progress in study on mechanisms of rhubarb in treating chronic renal failure. Chinese Journal of Integrated Traditional and Western Medicine, 2005;25(5): 471- 475.