• 1. 北京協和醫(yī)院婦產科,北京,1000372. 四川大學華西第二醫(yī)院婦產科,成都,610041;

目的 　評價中草藥治療女性免疫性不孕的療效與安全性.
方法 　計算機檢索MEDLINE(1966～2002.2)、EMBASE(1984～2002.2)、CBM(1978～2002.2)及Cochrane臨床對照試驗數據庫(2002年第1期),手工檢索納入試驗的所有參考文獻,比較中草藥(包括單劑和復合劑)與安慰劑、未治療、或常規(guī)西藥治療的隨機對照試驗.對納入研究的質量進行方法學評價,并用RevMan 4.2軟件進行Meta 分析.
結果 　最終納入6個RCT,但其方法學質量均不高,且采用不同的中藥或對照,故進行單獨描述.結果發(fā)現:在妊娠率方面,抗免一號片比強的松+避孕套的治療效果好[RR 3.75, 95%CI (1.61,8.75), P=0.002];加味滋腎生肝飲加減比強的松+避孕套的治療效果好[RR 2.48, 95%CI (1.40,4.39), P=0.002];補腎瀉濁湯比抗炎藥的治療效果好[RR 2.97, 95%CI (1.60,5.50), P=0.000 6];貞芪轉陰湯單用與宮腔內人工授精(IUI)比較,其治療效果無顯著性差異[RR 1.80, 95%CI (0.58,5.60), P=0.31],但貞芪轉陰湯+IUI比IUI治療效果好[RR 3.60, 95%CI (1.32,9.85), P=0.01].在抗精子抗體(antisperm antibody, AsAb)轉陰率方面,抗免一號片比強的松+避孕套的治療效果好[RR 1.66, 95%CI (1.23,2.22), P=0.000 8],補腎瀉濁湯比抗炎藥的治療效果好[RR 2.33, 95%CI (1.54,3.54), P lt;0.000 1];貞芪轉陰湯單獨使用比IUI好[RR 9.61, 95%CI (3.22,28.67), P lt;0.000 1],貞芪轉陰湯+IUI與IUI比較,其治療效果比IUI好[RR 8.92, 95%CI (2.98,26.75), P lt;0.000 1].
結論 　現有的臨床資料表明,中草藥治療女性免疫性不孕可能有效,但由于試驗在隨機、雙盲、隨訪等方面還有欠缺,導致其療效及安全性尚無充分的證據.在以后的研究中需要設計良好的隨機、雙盲、安慰劑對照試驗對其療效加以證實.

引用本文： 賀豪杰,許良智,李尚為,李平. 中草藥治療女性免疫性不孕的系統評價. 中國循證醫(yī)學雜志, 2004, 04(9): 609-614. doi: 復制

1. ［1］Gao DL, Chen XF. Investigation of primary pregnancy rate and subfertility rate about 60 000 new married women[J].Chin J Obstet Gyneco ,1989; 24(4):234-235.
2. 高道利,陳霞飛. 六萬新婚婦女初孕率和不孕率調查[J]. 中華婦產科雜志, 1989; 24(4):234～235.
3. ［2］Neville F. Hacker, J.George Moore. Essentials of obstetrics and gonaecology. See: David R. Meldrum: Infertility[M]. 3rd. Philadelphia: W.B. Saunders Company;1998. p. 610-611.
4. ［3］Zhao K. Clinical observation on the effect of applying NO.1 anti-immune tablet to females with positive antisperm antibody in serum[J]. Journal of Sichuan of Traditional Chinese Medicine, 2001;19(4):57-58.
5. 趙凱. 抗免一號片治療女性血清抗精子抗體陽性不孕療效觀察[J]. 四川中醫(yī), 2001; 19(4):57～58.
6. ［4］Zhao R. Clinical Research on the treatment of immune subfertility with Traditional Chinese Medicine[J]. Research of Traditional Chinese Medicine, 2001; 17(3):14,41.
7. 趙瑞. 中藥治療免疫性不孕的臨床研究[J]. 中醫(yī)藥研究,2001; 17(3):14,41.
8. ［5］Liang WZ. Bushen Xiezhuo Soup for 78 patients with immune subfertility[J]. New Journal of Traditional Chinese Medicine,1997; 30(4):44.
9. 梁文珍. 補腎瀉濁湯治療免疫性不孕癥78例[J]. 新中醫(yī), 1997; 30(4):44.
10. ［6］Luo SP, Liang GZ, Zhang YZ, Luo YK. Clinical research on applying NO.1 and NO.2 improving pregnancy pills to patients with positive antisperm antibody in serum[J]. New Journal of Traditional Chinese Medicine,1996; 28(8):46-48.
11. 羅頌平,梁國珍, 張玉珍,羅元愷. 助孕一號、二號丸治療血清抗精子抗體陽性患者的臨床研究[J]. 新中醫(yī),1996; 28(8):46～48.
12. ［7］Lian F, Zhang N. Clinical observation on applying Zhenqi Zhuanyin Soup and IUI to females with positive antisperm antibody subfertility[J]. Chinese journal of integrated traditional and western medicine, 2002; 22(2):95-97.
13. 連方,張寧. 貞芪轉陰湯配合宮腔內人工受精治療女性抗精子抗體陽性脾腎兩虛型不孕癥的臨床觀察[J]. 中國中西醫(yī)結合雜志, 2002; 22(2):95～97.
14. ［8］Liu RF. 26 Clinical Observation on the treatment of immune subfertility with integrated traditional and western medicine[J]. Chinese journal of integrated traditional and western medicine, 2002; 22(1):68-69.
15. 劉瑞芬.中西醫(yī)結合治療免疫性不孕26例臨床觀察[J]. 中國中西醫(yī)結合雜志, 2002; 22(1):68～69.
16. ［9］Wang JL, Lin Z, Zhang YF, Pan BX, Tang CY, Wu ZZ, Ma DF. Clinical observation on the effect of applying Zhugunning to 136 patients with positive antisperm antibody[J]. Journal of Traditional Chinese Medicine, 2001; 42(11):667-669.
17. 王俊玲,林戰(zhàn),張永鋒,潘柏軒,唐春艷,吳正治,馬德芬. 助孕靈治療抗精子抗體陽性患者136例臨床療效觀察[J]. 中醫(yī)雜志, 2001; 42(11):667～669.
18. ［10］Luo SP, Liang GZ, Zhang YZ. Clinical and laboratory study on immune natural abortion and immune subfertility[J]. Journal of Traditional Chinese Medicne,1997;38(6).
19. 羅頌平,梁國珍, 張玉珍. 免疫性自然流產與免疫性不孕的臨床與實驗研究[J]. 中醫(yī)雜志, 1997; 38(6).
20. ［11］Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials[J]. JAMA, 1995; 273(5):408-412.
21. ［12］Vickers A, Goyal N, Harland R, Rees R Do certain countries produce only positive results? A systematic reviews of controlled trials[J]. Control Clin Trials, 1998; 19(2): 159-166.
  1. 1. ［1］Gao DL, Chen XF. Investigation of primary pregnancy rate and subfertility rate about 60 000 new married women[J].Chin J Obstet Gyneco ,1989; 24(4):234-235.
  2. 2. 高道利,陳霞飛. 六萬新婚婦女初孕率和不孕率調查[J]. 中華婦產科雜志, 1989; 24(4):234～235.
  3. 3. ［2］Neville F. Hacker, J.George Moore. Essentials of obstetrics and gonaecology. See: David R. Meldrum: Infertility[M]. 3rd. Philadelphia: W.B. Saunders Company;1998. p. 610-611.
  4. 4. ［3］Zhao K. Clinical observation on the effect of applying NO.1 anti-immune tablet to females with positive antisperm antibody in serum[J]. Journal of Sichuan of Traditional Chinese Medicine, 2001;19(4):57-58.
  5. 5. 趙凱. 抗免一號片治療女性血清抗精子抗體陽性不孕療效觀察[J]. 四川中醫(yī), 2001; 19(4):57～58.
  6. 6. ［4］Zhao R. Clinical Research on the treatment of immune subfertility with Traditional Chinese Medicine[J]. Research of Traditional Chinese Medicine, 2001; 17(3):14,41.
  7. 7. 趙瑞. 中藥治療免疫性不孕的臨床研究[J]. 中醫(yī)藥研究,2001; 17(3):14,41.
  8. 8. ［5］Liang WZ. Bushen Xiezhuo Soup for 78 patients with immune subfertility[J]. New Journal of Traditional Chinese Medicine,1997; 30(4):44.
  9. 9. 梁文珍. 補腎瀉濁湯治療免疫性不孕癥78例[J]. 新中醫(yī), 1997; 30(4):44.
  10. 10. ［6］Luo SP, Liang GZ, Zhang YZ, Luo YK. Clinical research on applying NO.1 and NO.2 improving pregnancy pills to patients with positive antisperm antibody in serum[J]. New Journal of Traditional Chinese Medicine,1996; 28(8):46-48.
  11. 11. 羅頌平,梁國珍, 張玉珍,羅元愷. 助孕一號、二號丸治療血清抗精子抗體陽性患者的臨床研究[J]. 新中醫(yī),1996; 28(8):46～48.
  12. 12. ［7］Lian F, Zhang N. Clinical observation on applying Zhenqi Zhuanyin Soup and IUI to females with positive antisperm antibody subfertility[J]. Chinese journal of integrated traditional and western medicine, 2002; 22(2):95-97.
  13. 13. 連方,張寧. 貞芪轉陰湯配合宮腔內人工受精治療女性抗精子抗體陽性脾腎兩虛型不孕癥的臨床觀察[J]. 中國中西醫(yī)結合雜志, 2002; 22(2):95～97.
  14. 14. ［8］Liu RF. 26 Clinical Observation on the treatment of immune subfertility with integrated traditional and western medicine[J]. Chinese journal of integrated traditional and western medicine, 2002; 22(1):68-69.
  15. 15. 劉瑞芬.中西醫(yī)結合治療免疫性不孕26例臨床觀察[J]. 中國中西醫(yī)結合雜志, 2002; 22(1):68～69.
  16. 16. ［9］Wang JL, Lin Z, Zhang YF, Pan BX, Tang CY, Wu ZZ, Ma DF. Clinical observation on the effect of applying Zhugunning to 136 patients with positive antisperm antibody[J]. Journal of Traditional Chinese Medicine, 2001; 42(11):667-669.
  17. 17. 王俊玲,林戰(zhàn),張永鋒,潘柏軒,唐春艷,吳正治,馬德芬. 助孕靈治療抗精子抗體陽性患者136例臨床療效觀察[J]. 中醫(yī)雜志, 2001; 42(11):667～669.
  18. 18. ［10］Luo SP, Liang GZ, Zhang YZ. Clinical and laboratory study on immune natural abortion and immune subfertility[J]. Journal of Traditional Chinese Medicne,1997;38(6).
  19. 19. 羅頌平,梁國珍, 張玉珍. 免疫性自然流產與免疫性不孕的臨床與實驗研究[J]. 中醫(yī)雜志, 1997; 38(6).
  20. 20. ［11］Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials[J]. JAMA, 1995; 273(5):408-412.
  21. 21. ［12］Vickers A, Goyal N, Harland R, Rees R Do certain countries produce only positive results? A systematic reviews of controlled trials[J]. Control Clin Trials, 1998; 19(2): 159-166.