米非司酮配伍米索前列醇行早期妊娠藥物流產的有效性評價_《中國循證醫學雜志》

作者：

鄒燕 ¹ , 李幼平 ² , 干昌平 ³ , 吳蘭 ³ , 童琳 ³ , 梁艷 ⁴ , 李濤 ³ , 唐瑩 ³ , 梅玲 ³ , 楊靜 ³ , 劉逸文 ³

1. 國家人口計生委科學技術研究所,北京1000812. 四川大學華西醫院中國循證醫學中心,成都6100413. 四川大學華西臨床醫學院,成都6100414. 第二軍醫大學長征醫院,上海200043;

關鍵詞：

米非司酮米索前列醇藥物流產有效性

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目的　系統評價米非司酮配伍米索前列醇行藥物流產的有效性.
方法　計算機檢索中國生物醫學文獻數據庫(CBM)等9種數據庫,手工檢索 lt;生殖醫學雜志 gt;等10種雜志,追查已納入文獻的參考文獻,納入所有前瞻性臨床對照研究.兩位系統評價員獨立進行文獻篩查、質量評價和資料提取,并交叉核對,如遇分歧與第三者討論解決.Meta分析采用RevMan 4.2軟件,文獻間經異質性檢驗(α＝0.05),無異質性采用固定效應模型合并分析;有異質性則分析異質性原因,并用敏感性分析、亞組分析或隨機效應模型處理.二分類變量用比值比(OR)表示;連續性變量用加權均數差(WMD)表示,二者均計算95%CI.
結果　共納入藥物流產與手術流產比較的原始研究8篇(3 348例),同種藥物不同孕齡比較的文獻9篇(6 116例);米非司酮分服與頓服比較的文獻5篇(1 934例);米非司酮與米索前列醇不同間隔時間比較的文獻2篇(2 381例).國外原始研究的質量高于國內文獻.藥物流產完全流產率低于手術流產[OR合并 0.18,95%CI (0.11,0.27)];藥物流產不完全流產率和流產失敗率均高于手術流產,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天組的不完全流產率和流產失敗率高于孕齡≤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率、不完全流產率、流產失敗率、孕囊排除時間、第一次月經恢復時間和流產后平均出血時間的差別無統計學意義.米非司酮與米索前列醇不同間隔時間比較,間隔＜48 h組完全流產率較高,有統計學意義,不完全流產率、流產失敗率的差異均無統計學意義.
結論　提高國內原始研究的質量非常重要.雖然手術流產的完全流產率更高,但藥物流產的完全流產率也能達到91.6%(1 648/1 800),臨床可以接受.孕齡＞49天比≤49天的完全流產率更低,有統計學意義,但孕齡＞49天組的完全流產率也能達到87%(2 590/3 013),故適當放寬法定藥物流產適用孕齡值得考慮,尤其是對有禁忌癥和恐懼手術的孕婦.米非司酮分服與頓服的效果相似,頓服在給藥程序上更簡單,可推廣應用.縮短用藥間隔的方案因病人更易接受而應予以考慮,但確定最佳間隔時間尚需更多證據.

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的有效性評價. 中國循證醫學雜志, 2005, 05(8): 619-631. doi: 復制

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1. 葉寒.緊急避孕的研究現狀與發展方向[J].中國婦幼保健, 2001; 16(2): 119～211.
2. 王春玉, 李蔓波, 李學榮, 董根澤. 藥物流產與人工流產吸宮術終止早孕的臨床觀察[J]. 寧夏醫學雜志, 1999; 21(12): 739～740.
3. 孫紅珠, 吳尚純, 徐慧穎, 肖碧蓮. RU486藥物流產與手術流產方法的可接受性比較研究[J]. 生殖醫學雜志, 1995; 4(3): 138～141.
4. 杜明昆, 應玉娣, 鄭懷美, 聞珍, 倪如鈺. 藥流與負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. 李丹,于立君,楊曉波,張經營,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臨床對比研究[J]. 中國計劃生育學雜志, 1997; 31(5): 281～284.
6. 陳建萍. 藥物流產與人工流產終止早期妊娠的比較[J]. 中國綜合臨床, 2002; 18(10): 954～955.
7. 韓麗萍,魏振玲,王世花. 人工流產術與藥物流產215例療效比較[J]. 鄭州大學學報(醫學版), 2003; 38(1): 123.
8. 史益憑,朱泰來,桂幼倫,賀昌海. 停經50～70天早孕婦女藥物流產的安全性與有效性臨床研究[J]. 中國計劃生育學雜志, 1998; 6(10): 468～472.
9. 徐漢,岳維真,馮淑芝. 50 mg米非司酮終止早孕臨床試驗[J]. 中國計劃生育學雜志, 1994; 47(3): 123～124.
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對照試驗[J]. 生殖與避孕, 1994; 14(1): 41～48.
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]. 中國計劃生育學雜志, 1998; 41(4): 412～413.
12. 李玲玲. 米非司酮不同給藥方法對早孕藥物流產效果的影響[J]. 吉林醫學, 2001; 22(6): 347～348.
13. 周金桃,馮淑芝,曹來英,劉元姣. 米非司酮兩種用法抗早孕臨床療效比較[J]. 醫藥導報, 2002;21(4):222～224.
14. WHO Scientific Group. Medical methods for termination of pregnancy[Z]. World Health Organ Tech Rep Ser. 1997;871: 1-110.
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. Ye H. Study actuality and developing direction of emergency contraception[J]. Maternal and Child Health Care of China, 2001;16(2):119-211.
17. International Planned Parenthood Federation. Abortion and quality of care. International Planned Parenthood Federation Annual Report[Z]. New York, 1991-1992.
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. 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. 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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24. Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, Moher D, Becker BJ, Sipe TA, Thacker SB. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis of Observational Studies in Epidemiology (MOOSE) group[J]. JAMA, 2000; 283(15): 2008-2012.
25. Clark M, Oxman AD, editors. Cochrane Reviewers’Handbook 4.2 In:Review Manager(Revman)[Computer program]. Oxford: updated December 2003.
26. Wang CY, Li MB, Li XR, Dong GZ. Clinical observation on the termination of early pregnancy with medical abortion and aspiration[J]. Medical Journal of Ningxia, 1999; 21(12): 739-740.
27. Sun HZ, Wu SC, Xu HY, Xiao BL. Study on the acceptability of medical abortion with RU486 and surgical abortion[J]. Journal of Reproductive Medicine,1995; 4(3): 138-141.
28. Du MK, Ying YD, Zheng HM, Wen Z, Ni RY. Study on the efficacy and acceptability of medical abortion and aspiration[J]. Reproduction&Contraception, 1996; 16(3): 194-198.
29. Elul B, Ellertson C, Winikoff B,et al. Side effects of mifepristone- misoprostol abortion versus surgical abortion. Data from a trial in China, Cuba, and India[J]. Contraception,1999; 59(2):107-114.
30. Li D, Yu LJ. Yang XB, Zhang JY, Wang HM. A controlled study on termination of early pregnancy by mifepristone with misoprostol or Carboprost Mehtylate versus surgical abortion[J]. Chinese Journal of Family Planning,1997; 31(5): 281-284.
31. Chen JP. Comparison between the medical and surgical abortion in terminating early pregnancy[J]. China integrated clinical, 2002; 18(10): 954-955.
32. Han LP, Wei ZL, Wang SH. Comparison of efficacy of 215 cases with medical and surgical abortion[J]. Journal of Zhengzhou University(Med Sci), 2003; 38(1): 123.
33. Cabezas E. Medical versus surgical abortion[J]. International Journal of Gynecology & Obstetrics,1999;63 (suppl):141-146.
34. Spitz IM, Bardin CW, Benton L, Robbins A. Early pregnancy termination with mifepristone and misoprostol in the United States[J]. N Engl J Med,1998 ;338(18):1241-1247.
35. Schaff EA, Fielding SL, Eisinger SH, Schaff EA. Fielding SL. Low-dose mifepristone followed by vaginal misoprostol at 48 hours for abortion up to 63 days[J]. Contraception,2000; 61(1): 41-46.
36. Shi YP, Zhu TL, Gui YL, He CH. Study on safety and effectiveness of medical abortion for women menopause for 50-70 days[J]. Chinses Journal of Family Planning,1998; 6(10): 468-472.
37. ICMR Task Force Study. Indian Council of Medical Research. A multicentre randomized comparative clinical trial of 200 mg RU486 (mifepristone) single dose followed by either 5 mg 9-methylene PGE(2) gel (meteneprost) or 600 microg oral PGE(1) (misoprostol) for termination of early pregnancy within 28 days of missed menstrual period[J]. Contraception,2000; 62(3): 125-130.
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《中國循證醫學雜志》

米非司酮配伍米索前列醇行早期妊娠藥物流產的有效性評價

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《中國循證醫學雜志》

米非司酮配伍米索前列醇行早期妊娠藥物流產的有效性評價

摘要 全文 圖表 視頻 參考文獻 施引文獻 補充材料

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