• 1. 北京協(xié)和醫(yī)院婦產(chǎn)科,北京,1000372. 四川大學(xué)華西第二醫(yī)院婦產(chǎn)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(shù)據(jù)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(fù)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(zhì)量進行方法學(xué)評價,并用RevMan 4.2軟件進行Meta 分析.
結(jié)果 　最終納入6個RCT,但其方法學(xué)質(zhì)量均不高,且采用不同的中藥或?qū)φ?故進行單獨描述.結(jié)果發(fā)現(xiàn):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(zhuǎn)陰湯單用與宮腔內(nèi)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(zhuǎn)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(zhuǎn)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(zhuǎn)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(zhuǎn)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(jié)論 　現(xiàn)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(dǎo)致其療效及安全性尚無充分的證據(jù).在以后的研究中需要設(shè)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(tǒng)評價. 中國循證醫(yī)學(xué)雜志, 2004, 04(9): 609-614. 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

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(diào)查[J]. 中華婦產(chǎn)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(zhuǎn)陰湯配合宮腔內(nèi)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(jié)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(jié)合治療免疫性不孕26例臨床觀察[J]. 中國中西醫(yī)結(jié)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(chǎn)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(diào)查[J]. 中華婦產(chǎn)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(zhuǎn)陰湯配合宮腔內(nèi)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(jié)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(jié)合治療免疫性不孕26例臨床觀察[J]. 中國中西醫(yī)結(jié)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(chǎn)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.