• 1. 國(guó)家人口計(jì)生委科學(xué)技術(shù)研究所,北京1000812. 四川大學(xué)華西醫(yī)院中國(guó)循證醫(yī)學(xué)中心,成都6100413. 四川大學(xué)華西臨床醫(yī)學(xué)院,成都6100414. 第二軍醫(yī)大學(xué)長(zhǎng)征醫(yī)院,上海200043;

目的 　系統(tǒng)評(píng)價(jià)米非司酮配伍米索前列醇行藥物流產(chǎn)的有效性.
方法 　計(jì)算機(jī)檢索中國(guó)生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(kù)(CBM)等9種數(shù)據(jù)庫(kù),手工檢索 lt;生殖醫(yī)學(xué)雜志 gt;等10種雜志,追查已納入文獻(xiàn)的參考文獻(xiàn),納入所有前瞻性臨床對(duì)照研究.兩位系統(tǒng)評(píng)價(jià)員獨(dú)立進(jìn)行文獻(xiàn)篩查、質(zhì)量評(píng)價(jià)和資料提取,并交叉核對(duì),如遇分歧與第三者討論解決.Meta分析采用RevMan 4.2軟件,文獻(xiàn)間經(jīng)異質(zhì)性檢驗(yàn)(α＝0.05),無(wú)異質(zhì)性采用固定效應(yīng)模型合并分析;有異質(zhì)性則分析異質(zhì)性原因,并用敏感性分析、亞組分析或隨機(jī)效應(yīng)模型處理.二分類(lèi)變量用比值比(OR)表示;連續(xù)性變量用加權(quán)均數(shù)差(WMD)表示,二者均計(jì)算95%CI.
結(jié)果 　共納入藥物流產(chǎn)與手術(shù)流產(chǎn)比較的原始研究8篇(3 348例),同種藥物不同孕齡比較的文獻(xiàn)9篇(6 116例);米非司酮分服與頓服比較的文獻(xiàn)5篇(1 934例);米非司酮與米索前列醇不同間隔時(shí)間比較的文獻(xiàn)2篇(2 381例).國(guó)外原始研究的質(zhì)量高于國(guó)內(nèi)文獻(xiàn).藥物流產(chǎn)完全流產(chǎn)率低于手術(shù)流產(chǎn)[OR合并 0.18,95%CI (0.11,0.27)];藥物流產(chǎn)不完全流產(chǎn)率和流產(chǎn)失敗率均高于手術(shù)流產(chǎn),其OR合并值及95%CI分別為3.32(1.79,6.17)和7.36(4.17,12.98); 孕齡＞49天組完全流產(chǎn)率低于孕齡≤49天組, 其OR合并(95%CI)為0.51(0.43,0.61);孕齡＞49天組的不完全流產(chǎn)率和流產(chǎn)失敗率高于孕齡≤49天組,其OR合并(95%CI)分別為1.66(1.32, 2.09)和3.37(2.30,4.94).米非司酮分服與頓服的完全流產(chǎn)率、不完全流產(chǎn)率、流產(chǎn)失敗率、孕囊排除時(shí)間、第一次月經(jīng)恢復(fù)時(shí)間和流產(chǎn)后平均出血時(shí)間的差別無(wú)統(tǒng)計(jì)學(xué)意義.米非司酮與米索前列醇不同間隔時(shí)間比較,間隔＜48 h組完全流產(chǎn)率較高,有統(tǒng)計(jì)學(xué)意義,不完全流產(chǎn)率、流產(chǎn)失敗率的差異均無(wú)統(tǒng)計(jì)學(xué)意義.
結(jié)論 　提高國(guó)內(nèi)原始研究的質(zhì)量非常重要.雖然手術(shù)流產(chǎn)的完全流產(chǎn)率更高,但藥物流產(chǎn)的完全流產(chǎn)率也能達(dá)到91.6%(1 648/1 800),臨床可以接受.孕齡＞49天比≤49天的完全流產(chǎn)率更低,有統(tǒng)計(jì)學(xué)意義,但孕齡＞49天組的完全流產(chǎn)率也能達(dá)到87%(2 590/3 013),故適當(dāng)放寬法定藥物流產(chǎn)適用孕齡值得考慮,尤其是對(duì)有禁忌癥和恐懼手術(shù)的孕婦.米非司酮分服與頓服的效果相似,頓服在給藥程序上更簡(jiǎn)單,可推廣應(yīng)用.縮短用藥間隔的方案因病人更易接受而應(yīng)予以考慮,但確定最佳間隔時(shí)間尚需更多證據(jù).

引用本文： 鄒 燕,李幼平,干昌平,吳 蘭,童 琳,梁 艷,李 濤,唐 瑩,梅 玲,楊 靜,劉逸文. 米非司酮配伍米索前列醇行早期妊娠藥物流產(chǎn)的有效性評(píng)價(jià). 中國(guó)循證醫(yī)學(xué)雜志, 2005, 05(8): 619-631. doi: 復(fù)制

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  1. 1. 葉寒.緊急避孕的研究現(xiàn)狀與發(fā)展方向[J].中國(guó)婦幼保健, 2001; 16(2): 119～211.
  2. 2. 王春玉, 李蔓波, 李學(xué)榮, 董根澤. 藥物流產(chǎn)與人工流產(chǎn)吸宮術(shù)終止早孕的臨床觀察[J]. 寧夏醫(yī)學(xué)雜志, 1999; 21(12): 739～740.
  3. 3. 孫紅珠, 吳尚純, 徐慧穎, 肖碧蓮. RU486藥物流產(chǎn)與手術(shù)流產(chǎn)方法的可接受性比較研究[J]. 生殖醫(yī)學(xué)雜志, 1995; 4(3): 138～141.
  4. 4. 杜明昆, 應(yīng)玉娣, 鄭懷美, 聞?wù)? 倪如鈺. 藥流與負(fù)壓吸宮法的效果和可接受性研究[J]. 生殖與避孕, 1996; 16(3): 194～198.
  5. 5. 李丹,于立君,楊曉波,張經(jīng)營(yíng),王寒梅. 米非司酮配伍米索前例醇和卡前列甲酯栓終止早孕與吸宮流產(chǎn)臨床對(duì)比研究[J]. 中國(guó)計(jì)劃生育學(xué)雜志, 1997; 31(5): 281～284.
  6. 6. 陳建萍. 藥物流產(chǎn)與人工流產(chǎn)終止早期妊娠的比較[J]. 中國(guó)綜合臨床, 2002; 18(10): 954～955.
  7. 7. 韓麗萍,魏振玲,王世花. 人工流產(chǎn)術(shù)與藥物流產(chǎn)215例療效比較[J]. 鄭州大學(xué)學(xué)報(bào)(醫(yī)學(xué)版), 2003; 38(1): 123.
  8. 8. 史益憑,朱泰來(lái),桂幼倫,賀昌海. 停經(jīng)50～70天早孕婦女藥物流產(chǎn)的安全性與有效性臨床研究[J]. 中國(guó)計(jì)劃生育學(xué)雜志, 1998; 6(10): 468～472.
  9. 9. 徐漢,岳維真,馮淑芝. 50 mg米非司酮終止早孕臨床試驗(yàn)[J]. 中國(guó)計(jì)劃生育學(xué)雜志, 1994; 47(3): 123～124.
  10. 10. 賀昌海,高爾生. 米索前列醇和PG05配伍米非司酮終止早孕的臨床多中心隨機(jī)對(duì)照試驗(yàn)[J]. 生殖與避孕, 1994; 14(1): 41～48.
  11. 11. 王慧, 王虹, 胡靜華, 路彤, 孔佳. 陰道用米索前列醇配伍米非司酮終止早孕的臨床觀察[J]. 中國(guó)計(jì)劃生育學(xué)雜志, 1998; 41(4): 412～413.
  12. 12. 李玲玲. 米非司酮不同給藥方法對(duì)早孕藥物流產(chǎn)效果的影響[J]. 吉林醫(yī)學(xué), 2001; 22(6): 347～348.
  13. 13. 周金桃,馮淑芝,曹來(lái)英,劉元姣. 米非司酮兩種用法抗早孕臨床療效比較[J]. 醫(yī)藥導(dǎo)報(bào), 2002;21(4):222～224.
  14. 14. WHO Scientific Group. Medical methods for termination of pregnancy[Z]. World Health Organ Tech Rep Ser. 1997;871: 1-110.
  15. 15. K. Singh,s.s.Ratnam.The influence of abortion legislation on maternal mortality[J]. Int-J-Gynecol-Obstet,1998;63 (suppl 1):s123-129.
  16. 16. Ye H. Study actuality and developing direction of emergency contraception[J]. Maternal and Child Health Care of China, 2001;16(2):119-211.
  17. 17. International Planned Parenthood Federation. Abortion and quality of care. International Planned Parenthood Federation Annual Report[Z]. New York, 1991-1992.
  18. 18. Peyron R, Aubeny E, Targosz V, Silvestre L, Renault M, Elkik F, Leclerc P, Ulmann A, Baulieu EE. Early termination of pregnancy with mifepristone (RU 486) and the orally active prostaglandin misoprostol[J]. N Engl J Med, 1993; 328(21): 1509-1513.
  19. 19. Kahn JG, Becker BJ, MacIsaa L, Amory JK, Neuhaus J, Olkin I, Creinin MD. The efficacy of medical abortion: a Meta-analysis[J]. Contraception, 2000; 61(1): 29-40.
  20. 20. Creinin MD, Schwartz JL, Pymar HC, Fink W. Efficacy of mifepristone followed on the same day by misoprostol for early termination of pregnancy: report of a randomised trial[J]. BJOG, 2001; 108(5):469-473.
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