• 1. 四川省綿陽市解放軍第520醫(yī)院內(nèi)科（綿陽 621000）2. 四川大學(xué)華西醫(yī)院內(nèi)分泌科(成都 610041);

目的 　系統(tǒng)評價中藥黃芪（Astragaulus membranaceus）治療糖尿病腎病 (Diabeticnephropathy,DN) 的療效及安全性。
方法 　應(yīng)用 Cochrane 協(xié)作網(wǎng)系統(tǒng)評價的方法，計算機(jī)檢索 Cochrane 圖書館臨床試驗注冊庫、MEDLINE、EMbase、中國生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫、中文科技期刊全文數(shù)據(jù)庫中黃芪治療DN 的隨機(jī)或半隨機(jī)臨床試驗及所獲文獻(xiàn)的參考文獻(xiàn)。由兩位研究者對符合納入標(biāo)準(zhǔn)的試驗進(jìn)行獨立篩選、質(zhì)量評價和原始資料提取并交叉核對。評價指標(biāo)包括：① 24 h 尿微量白蛋白排泄率; ② 24 h 尿蛋白定量；③ 內(nèi)生肌酐清除率；④ 血清肌酐；⑤ 尿素氮；⑥ 空腹血糖；⑦ 糖化血紅蛋白；⑧ 甘油三酯；⑨ 膽固醇；⑩ 不良反應(yīng)；11癥狀和體征改善的總有效率。
結(jié)果 　33 個 RCT 和 1 個半隨機(jī)試驗包括 2356例DN 患者被納入，試驗地點均在中國。大部分試驗方法學(xué)質(zhì)量較低且樣本含量小。文獻(xiàn)發(fā)表的 “ 漏斗圖 ” 分布不對稱，提示可能有陰性結(jié)果的試驗未發(fā)表，有潛在發(fā)表偏倚。Meta 分析結(jié)果顯示，①黃芪可以減少DN 患者24 h 尿微量白蛋白排泄率和 24 h 尿蛋白，能降低血清肌酐、尿素氮和提高內(nèi)生肌酐清除率，顯示黃芪能改善DN 患者腎功能；②黃芪降低DN 患者的 24 h 尿微量白蛋白排泄率和血清肌酐方面可能與 ACEI 或 ARB 類藥物的療效相似；③黃芪在減少DN患者 24 h 尿蛋白方面，療效可能優(yōu)于其它活血化淤類中藥。治療期間尚未發(fā)現(xiàn)嚴(yán)重的不良反應(yīng)。
結(jié)論 　黃芪治療DN 有一定的療效且相對安全。但由于本系統(tǒng)評價納入的試驗樣本量較小且方法學(xué)質(zhì)量低下，現(xiàn)有的證據(jù)尚不足以推薦臨床常規(guī)應(yīng)用黃芪治療 DN。因此有必要進(jìn)行大樣本的、多中心、隨機(jī)、雙盲對照試驗，以進(jìn)一步證實黃芪的臨床療效。

引用本文： 劉儀紅,田浩明. 黃芪治療糖尿病腎病的系統(tǒng)評價. 中國循證醫(yī)學(xué)雜志, 2007, 07(10): 715-727. doi: 復(fù)制

版權(quán)信息： ?四川大學(xué)華西醫(yī)院華西期刊社《中國循證醫(yī)學(xué)雜志》版權(quán)所有，未經(jīng)授權(quán)不得轉(zhuǎn)載、改編

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  1. 1. Zhang H, Shi X, Ji JL, et al. Effect of astragaulus injection on the urinary protein of diabetic nephropathy. Journal of Traditional Chinese Medicine of He Nan, 2001; 16(6): 36-37.
  2. 2. Zeng F.Effect of astragaulus injection on early diabetic nephropathy and blood plasma endothel in. Journal of Traditional Chinese Medicine of Jiang Xi, 2005; 36(3): 26-27.
  3. 3. Wang QL. Observations of effect of astragaulus injection on diabetic nephropathy. Zhong Yuan Medicine, 2004; 31(23): 6.
  4. 4. Xie BX, Zhang XF. Observations of effect of astragaulus injection and Prostaglandin E1 on diabetic nephropathy. Journal of Hu Nan Traditional Chinese Medical college, 2002; 22(3): 52-53.
  5. 5. Zhao Y. Combined therapeutic effect of astragaulus injection and Enalapril on Diabetic Nephropathy. Guang Xi medical Journal, 2003; 25(7): 1141-1143.
  6. 6. Wang LN. Observations of therapeutic effect of Losartan and astragaulus injection on diabetic nephropathy. Chinese Journal of Intergrated Traditional Chinese and Western Medicine of Nephropathy, 2003; 4(8): 471-472.
  7. 7. Guo QY, Tang CF, Fang XH, et al. Observations of therapeutic effect of astragaulus injection on early diabetic nephropathy. Chinese Journal of Country Medicine and Pharmacy, 2004; 11(3): 10-11.
  8. 8. Jiao QL. Combined therapeutic effect of astragaulus and XieSeTong injection and Irbesartan on early Diabetic Nephropathy. Guang Xi medical Journal, 2004; 26(10): 1484-1485.
  9. 9. An ZM, Dong XG, Deng YY, et al. Observations of therapeutic effect of western medicine and astragaulus injection on thirty cases of early diabetic nephropathy. Practical Journal of Chinese Medicine, 2004; 20(7): 368.
  10. 10. Wang YW. Observations of therapeutic effect of Kai Shi and astragaulus injection on diabetic nephropathy. Chinese Journal of Misdiagnostics, 2005; 5(3): 454-455.
  11. 11. Luo Y. Observations of Combined therapeutic effect of astragaulus and Prostaglandin E1 on Diabetic Nephropathy. Chinese Journal of Intergrated Traditional Chinese and Western Medicine of Nephropathy, 2004; 5(8): 485.
  12. 12. Huang W, Zhang W, Li SY, et al. Cl inical observations of Combined therapeutic effect of astragaulus injection and Lotensin on Diabetic Nephropathy. Shan Dong Journal of Traditional Chinese Medicine, 2004; 23(3): 161-162.
  13. 13. Cheng SH, Hou FY, Zhang LJ, et al. Observations terapeutic effect of astragaulus injection on Diabetic Nephropathy. Journal of Chinese medicine, 2000; 22(3): 207-209.
  14. 14. Ying LH. Observations of therapeutic effect of astragaulus injection on Diabetic Nephropathy. Modern Journal of Intergrated Traditional Chinese and Western Medicine of Nephropathy, 2005; 14(8): 988.
  15. 15. Xie BX. Clinical observations of astragaulus injection on eight-six cases of Diabetic Nephropathy. Journal of Zheng Jiang Medical college, 2001; 11(2): 168-169.
  16. 16. Cheng JH, Huang RG, Shi YX, et al. Observations of therapeutic effect of astragaulus injection on early Diabetic Nephropathy. Chinese Journal of Misdiagnostics, 2003; 3(8): 1156-1158.
  17. 17. .Liu YH, Yang L, Liu J, et al. Clinical observations of Combined therapeutic effect of astragaulus injection and Captopril on Diabetic Nephropathy. Chinese Journal of Intergrated Traditional Chinese and Western Medicine, 2005; 25(11): 993-995.
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