媽富隆與敏定偶避孕效果及安全性比較的系統評價_《中國循證醫學雜志》

作者：

1. 四川大學華西臨床醫學院（成都 610041）2. 四川大學華西醫院中國循證醫學中心（成都 610041);

關鍵詞：

口服避孕藥/媽富隆，敏定偶避孕隨機對照試驗系統評價

DOI：

10.7507/1672-2531.20080055

視頻：

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摘要 全文 圖表 視頻 參考文獻 施引文獻 補充材料

目的　系統評價口服避孕藥物媽富隆（30g炔雌醇+150g去氧孕烯）與敏定偶（30g炔雌醇+75g孕二烯酮）的避孕效果和安全性。
方法　計算機檢索MEDLINE（1990～2007），POPLINE（1990～2007），Cochran Central Register of Controlled Trials（CENTRAL）（2007年第2期），EMbase（1990～2007）和Cochrane圖書館（2007年第2期），并手工檢索4種相關雜志，納入媽富隆與敏定偶比較的隨機對照試驗。由兩名評價員獨立進行質量評價和資料提取。采用RevMan4.2進行Meta分析。
結果　共納入6篇符合納入標準的已發表文獻，包括3143例受試者。Meta分析結果顯示，媽富隆和敏定偶避孕有效性的差異無統計學意義（P gt;0.05）；隨訪6個月媽富隆不規則出血率高于敏定偶，其差異有統計學意義［RR=1.50，95%CI（1.27，1.78）；P lt;0.00001］；隨訪6個月媽富隆除嘔吐不良反應率較低外［RR =0.18，95%CI（0.04，0.78）；P=0.02］，其余不良反應率（頭痛、乳房脹痛、緊張、靜脈曲張、性交不適、黃褐斑、水腫）均高于敏定偶；隨訪6個月兩者停藥率差異無統計學意義。
結論　媽富隆和敏定偶避孕有效性相當，但使用后者對月經的影響和其他不良反應相對較少。由于觀察例數和時間有限，上述結論仍需高質量的隨機對照試驗來證實。

引用本文： 彭麗樺,王莉,蔡林芮,孟月,李幼平. 媽富隆與敏定偶避孕效果及安全性比較的系統評價. 中國循證醫學雜志, 2008, 08(4): 252-260. doi: 10.7507/1672-2531.20080055 復制

1.	ACOG Technical Bulletin. Hormonal contraception. International Journal of Gynecology and Obstetrics, 1995, 48: 115-126.
2.	Stone SC. Desogestrel. Clin Obstet Gynecol, 1995, 34(4): 821-828.
3.	Human Reproduction Update, Vol.12, No.2 pp. 169-178, 2006; Advance Access publication November 16, 2005.
4.	Cullberg G, Samsioe G, Andersen RF, et al. Two oral contraceptives, efficacy, serum proteins, and lipid metabolism. A comparative multicentre study on a triphasic and a fixed dose combination. Contraception, 1982, 26(3): 229-243.
5.	Foidart JM, Wuttke W, Bouw GM, et al. A comparative investigation of contraceptive reliability, cycle control and tolerance of two monophasic oral contraceptives containing either drospirenone or desogestrel. Eur J Contracept Reprod Health Care, 2000, 5(2): 124-134.
6.	Huber J, Foidart JM, Wuttke W, et al. Efficacy and tolerability of a monophasic oral contraceptive containing ethinylestradiol and drospirenone. Eur J Contracept Reprod Health Care, 2000, 5(1): 25-34.
7.	Aerlund, Mats Clinical experience of a combined oral contraceptive with very low dose ethinyl estradiol; Proceedings of the Baltic Conference On Obstetrics And Gynecology; Malm Sweden 25-27 May 1995.
8.	Hugh Allen, H. Clinical assessment of a low-dose estrogen low-dose progestogen combined oral contraceptive. Curr Med Res Opin, 1974, 2: 101-108.
9.	Kaplan B. Desogestrel, norgestimate, and gestodene: the newer progestins. Ann Pharmacother, 1995, 29(7-8): 736-742.
10.	WHO Tech Rep Ser 619. Geneva: World Health Organization, 1978: 47.
11.	Halbe HW, de Melo NR, Bahamondes L, et al. Efficacy and acceptability of two monophasic oral contraceptives containing ethinylestradiol and either desogestrel or gestodene. European Journal of Reproductive health, 1998, 3(3): 113-120.
12.	王今錦, 劉搏, 王德靜, 等. 左炔諾孕酮三相片在女性避孕中的作用. 中國婦幼保健, 2006, 21: 2842-2843.
13.	Clinical comparison of monophasic oral contraceptive preparations of gestodene/ethinyl estradiol and desogestrel/ethinyl estradiol. Latin American Oral Contraceptive Study Group. Contraception, 1994, 50(3): 201-214.
14.	Koetswang S, Charoenvisal C, Banharnsupawat L, et al. Multicenter trial of two monophasic oral contraceptives containing 30 mcg ethinylestradiol and either desogestrel or gestodene in Thai women. Contraception, 1995, 51(4): 225-229.
15.	Zichella L, Sbrignadello C, Tomassini A, et al. Comparative study on the acceptability of two modern monophasic oral contraceptive preparations: 30 microgram ethinyl estradiol combined with 150 microgram desogestrel or 75 microgram gestodene. Adv Contraception, 1999, 15(3): 191-200.
16.	Benagiano G. Comparison of two monophasic oral contraceptives: gestodene/ethinyl estradiol versus desogestrel/ethinyl estradiol. Int J Fertil, 1989, 34 Suppl: 31-39.
17.	Brill K, Muller C, Schnitker J, et al. The influence of different modern low-dose oral contraceptives on intermenstrual bleeding. Advances in Contraception, 1991, 7: 51-61.
18.	Lexchin J, Bero LA, Djulbegovic B, et al. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ, 2003, 326: 1167-1170.
19.	Rosenberg MJ, Waugh MS. Oral contraceptive discontinuation: a prospective evaluation of frequency and reasons. American Journal of Obstetrics and Gynecology, 1998, 179: 577-582.
20.	Maitra N, Kulier R, Bloemenkamp KWM, et al. Progestogens in combined oral contraceptives for contraception (Cochrane Review). In: The Cochrane Library, Issue 1, 2006.
21.	Gallo MF, Lopez LM, Grimes DA, et al. Combination contraceptives: effects on weight. In: The Cochrane Library, Issue 1, 2006.
22.	Foidart JM, Wuttke W, Bouw GM, et al. Heithecker A comparative investigation of contraceptive reliability, cycle control and tolerance of two monophasic oral contraceptives containing either drospirenone or desogestrel. The European Journal of Contraception and Reproductive Health Care, 2000, 5: 124-134.
23.	Endrikat J, Mijller U, Dijsterberg B. A Twelve-Month Comparative Clinical Investigation of Two Low-Dose Oral contraceptives containing 20 mg ethinylestradiol/75mg gestodene and 30mg ethinylestradiol/75mg gestodene with respect to efficacy,cycle control and tolerance. Contraception, 1997, 55: 131-137.
24.	Bruni V, Croxatto H, De La Cruz J, et al. A comparison of cycle control and effect on well-being of monophasic gestodene-, triphasic gestodene- and monophasic desogestrel-containing oral contraceptives. Gestodene Study Group. Gynecol Endocrinol, 2000, 14: 90-98.
25.	Holt VL, Daling JR, McKnight B, et al. Functional ovarian cysts in relation to the use of monophasic and triphasic oral contraceptives. Obstetrics and Gynecology, 1992, 79: 529-533.
26.	Marchbanks PA, McDonald JA, Wilson HG, et al. Oral contraceptives and the risk of breast cancer. New England Journal of Medicine, 2002, 346: 2025-2032.
27.	Corvol P, Elkik F, Feneant M, et al. Effect of progesterone and progestins on water and salt metabolism. In: CW Bardin,E Milgrom, P Mauvais-Jarvis, editor(s). Progesterone and Progestins. New York: Raven Press, 1983.
28.	Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Lancet, 2001, 357: 1191-1194.

1. ACOG Technical Bulletin. Hormonal contraception. International Journal of Gynecology and Obstetrics, 1995, 48: 115-126.
2. Stone SC. Desogestrel. Clin Obstet Gynecol, 1995, 34(4): 821-828.
3. Human Reproduction Update, Vol.12, No.2 pp. 169-178, 2006; Advance Access publication November 16, 2005.
4. Cullberg G, Samsioe G, Andersen RF, et al. Two oral contraceptives, efficacy, serum proteins, and lipid metabolism. A comparative multicentre study on a triphasic and a fixed dose combination. Contraception, 1982, 26(3): 229-243.
5. Foidart JM, Wuttke W, Bouw GM, et al. A comparative investigation of contraceptive reliability, cycle control and tolerance of two monophasic oral contraceptives containing either drospirenone or desogestrel. Eur J Contracept Reprod Health Care, 2000, 5(2): 124-134.
6. Huber J, Foidart JM, Wuttke W, et al. Efficacy and tolerability of a monophasic oral contraceptive containing ethinylestradiol and drospirenone. Eur J Contracept Reprod Health Care, 2000, 5(1): 25-34.
7. Aerlund, Mats Clinical experience of a combined oral contraceptive with very low dose ethinyl estradiol; Proceedings of the Baltic Conference On Obstetrics And Gynecology; Malm Sweden 25-27 May 1995.
8. Hugh Allen, H. Clinical assessment of a low-dose estrogen low-dose progestogen combined oral contraceptive. Curr Med Res Opin, 1974, 2: 101-108.
9. Kaplan B. Desogestrel, norgestimate, and gestodene: the newer progestins. Ann Pharmacother, 1995, 29(7-8): 736-742.
10. WHO Tech Rep Ser 619. Geneva: World Health Organization, 1978: 47.
11. Halbe HW, de Melo NR, Bahamondes L, et al. Efficacy and acceptability of two monophasic oral contraceptives containing ethinylestradiol and either desogestrel or gestodene. European Journal of Reproductive health, 1998, 3(3): 113-120.
12. 王今錦, 劉搏, 王德靜, 等. 左炔諾孕酮三相片在女性避孕中的作用. 中國婦幼保健, 2006, 21: 2842-2843.
13. Clinical comparison of monophasic oral contraceptive preparations of gestodene/ethinyl estradiol and desogestrel/ethinyl estradiol. Latin American Oral Contraceptive Study Group. Contraception, 1994, 50(3): 201-214.
14. Koetswang S, Charoenvisal C, Banharnsupawat L, et al. Multicenter trial of two monophasic oral contraceptives containing 30 mcg ethinylestradiol and either desogestrel or gestodene in Thai women. Contraception, 1995, 51(4): 225-229.
15. Zichella L, Sbrignadello C, Tomassini A, et al. Comparative study on the acceptability of two modern monophasic oral contraceptive preparations: 30 microgram ethinyl estradiol combined with 150 microgram desogestrel or 75 microgram gestodene. Adv Contraception, 1999, 15(3): 191-200.
16. Benagiano G. Comparison of two monophasic oral contraceptives: gestodene/ethinyl estradiol versus desogestrel/ethinyl estradiol. Int J Fertil, 1989, 34 Suppl: 31-39.
17. Brill K, Muller C, Schnitker J, et al. The influence of different modern low-dose oral contraceptives on intermenstrual bleeding. Advances in Contraception, 1991, 7: 51-61.
18. Lexchin J, Bero LA, Djulbegovic B, et al. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ, 2003, 326: 1167-1170.
19. Rosenberg MJ, Waugh MS. Oral contraceptive discontinuation: a prospective evaluation of frequency and reasons. American Journal of Obstetrics and Gynecology, 1998, 179: 577-582.
20. Maitra N, Kulier R, Bloemenkamp KWM, et al. Progestogens in combined oral contraceptives for contraception (Cochrane Review). In: The Cochrane Library, Issue 1, 2006.
21. Gallo MF, Lopez LM, Grimes DA, et al. Combination contraceptives: effects on weight. In: The Cochrane Library, Issue 1, 2006.
22. Foidart JM, Wuttke W, Bouw GM, et al. Heithecker A comparative investigation of contraceptive reliability, cycle control and tolerance of two monophasic oral contraceptives containing either drospirenone or desogestrel. The European Journal of Contraception and Reproductive Health Care, 2000, 5: 124-134.
23. Endrikat J, Mijller U, Dijsterberg B. A Twelve-Month Comparative Clinical Investigation of Two Low-Dose Oral contraceptives containing 20 mg ethinylestradiol/75mg gestodene and 30mg ethinylestradiol/75mg gestodene with respect to efficacy,cycle control and tolerance. Contraception, 1997, 55: 131-137.
24. Bruni V, Croxatto H, De La Cruz J, et al. A comparison of cycle control and effect on well-being of monophasic gestodene-, triphasic gestodene- and monophasic desogestrel-containing oral contraceptives. Gestodene Study Group. Gynecol Endocrinol, 2000, 14: 90-98.
25. Holt VL, Daling JR, McKnight B, et al. Functional ovarian cysts in relation to the use of monophasic and triphasic oral contraceptives. Obstetrics and Gynecology, 1992, 79: 529-533.
26. Marchbanks PA, McDonald JA, Wilson HG, et al. Oral contraceptives and the risk of breast cancer. New England Journal of Medicine, 2002, 346: 2025-2032.
27. Corvol P, Elkik F, Feneant M, et al. Effect of progesterone and progestins on water and salt metabolism. In: CW Bardin,E Milgrom, P Mauvais-Jarvis, editor(s). Progesterone and Progestins. New York: Raven Press, 1983.
28. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Lancet, 2001, 357: 1191-1194.

《中國循證醫學雜志》

媽富隆與敏定偶避孕效果及安全性比較的系統評價

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《中國循證醫學雜志》

媽富隆與敏定偶避孕效果及安全性比較的系統評價

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