妈富隆与敏定偶避孕效果及安全性比较的系统评价_《中国循证医学杂志》

作者：

1. 四川大学华西临床医学院（成都 610041）2. 四川大学华西医院中国循证医学中心（成都 610041);

关键词：

口服避孕药/妈富隆，敏定偶避孕随机对照试验系统评价

DOI：

10.7507/1672-2531.20080055

视频：

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摘要 全文 图表 视频 参考文献 施引文献 补充材料

目的　系统评价口服避孕药物妈富隆（30g炔雌醇+150g去氧孕烯）与敏定偶（30g炔雌醇+75g孕二烯酮）的避孕效果和安全性。
方法　计算机检索MEDLINE（1990～2007），POPLINE（1990～2007），Cochran Central Register of Controlled Trials（CENTRAL）（2007年第2期），EMbase（1990～2007）和Cochrane图书馆（2007年第2期），并手工检索4种相关杂志，纳入妈富隆与敏定偶比较的随机对照试验。由两名评价员独立进行质量评价和资料提取。采用RevMan4.2进行Meta分析。
结果　共纳入6篇符合纳入标准的已发表文献，包括3143例受试者。Meta分析结果显示，妈富隆和敏定偶避孕有效性的差异无统计学意义（P gt;0.05）；随访6个月妈富隆不规则出血率高于敏定偶，其差异有统计学意义［RR=1.50，95%CI（1.27，1.78）；P lt;0.00001］；随访6个月妈富隆除呕吐不良反应率较低外［RR =0.18，95%CI（0.04，0.78）；P=0.02］，其余不良反应率（头痛、乳房胀痛、紧张、静脉曲张、性交不适、黄褐斑、水肿）均高于敏定偶；随访6个月两者停药率差异无统计学意义。
结论　妈富隆和敏定偶避孕有效性相当，但使用后者对月经的影响和其他不良反应相对较少。由于观察例数和时间有限，上述结论仍需高质量的随机对照试验来证实。

引用本文： 彭丽桦,王莉,蔡林芮,孟月,李幼平. 妈富隆与敏定偶避孕效果及安全性比较的系统评价. 中国循证医学杂志, 2008, 08(4): 252-260. doi: 10.7507/1672-2531.20080055 复制

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.	王今锦, 刘搏, 王德静, 等. 左炔诺孕酮三相片在女性避孕中的作用. 中国妇幼保健, 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. 王今锦, 刘搏, 王德静, 等. 左炔诺孕酮三相片在女性避孕中的作用. 中国妇幼保健, 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.

《中国循证医学杂志》

妈富隆与敏定偶避孕效果及安全性比较的系统评价

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《中国循证医学杂志》

妈富隆与敏定偶避孕效果及安全性比较的系统评价

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