325例屈螺酮炔雌醇(Ⅱ)不良反应报告分析

doi:10.19803/j.1672-8629.2020.07.08

中国药物警戒 ›› 2020, Vol. 17 ›› Issue (7): 418-424.
DOI: 10.19803/j.1672-8629.2020.07.08

325例屈螺酮炔雌醇(Ⅱ)不良反应报告分析

周博雅¹, 袁偲偲¹, 林京玉², 周应群², 冯欣^1,*

¹首都医科大学附属北京妇产医院药事部,北京 100006;
²北京市药品不良反应监测中心,北京 100054

收稿日期:2020-01-31 修回日期:2020-06-22 出版日期:2020-07-15 发布日期:2020-06-22
通讯作者: ^*冯欣,女,主任药师,临床药理学。E-mail:fengxin1115@sohu.com
作者简介:周博雅,女,硕士,临床药学。
基金资助:
北京市属医院科研培育计划（PG2019028）

325 Cases of Adverse Drug Reactions Induced by Drospirenone and Ethinylestradiol Tablets (II)

ZHOU Boya¹, YUAN Sisi¹, LIN Jingyu², ZHOU Yingqun², FENG Xin^1,*

¹Department of Pharmacy, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100006, China;
²Beijing Center for ADR Monitoring, Beijing 100054, China

Received:2020-01-31 Revised:2020-06-22 Online:2020-07-15 Published:2020-06-22

摘要/Abstract

摘要： 目的通过屈螺酮炔雌醇（Ⅱ）的药品不良反应数据分析,了解不良反应发生特点,提示临床用药可能存在的安全性风险,为临床合理应用屈螺酮炔雌醇（Ⅱ）提供依据。方法对2015年1月1日至2018年12月31日期间北京市药品不良反应监测中心收集到的屈螺酮炔雌醇（Ⅱ）不良反应/事件报告进行回顾性分析。结果屈螺酮炔雌醇（Ⅱ）临床表现以生殖系统疾病、胃肠疾病和神经系统疾病多见。结论屈螺酮炔雌醇引起的一般不良反应通常可以耐受,虽然低剂量屈螺酮炔雌醇不良反应更少,但仍存在发生静脉血栓栓塞的风险;在用药前仔细评估用药风险,并为用药患者建立长期、系统的随访关系;鼓励不良反应的报告并及时更新循证证据,将新的不良反应修订到药品说明书中,以降低患者的用药风险、更好地促进屈螺酮炔雌醇（Ⅱ）的长期合理使用。

关键词: 屈螺酮炔雌醇（II）, 药品不良反应, 药品不良反应报告, 合理用药

Abstract: Objective To analyze the data on adverse drug reactions caused by of drospirenone and ethinylestradiol tablets (II) in order to contribute to clinical rational application of this drug and to make recommendations for clinical application. Methods Case reports on adverse reactions associated with drospirenone and ethinylestradiol tablets (II) in Beijing between 2015 and 2018 were analyzed retrospectively. Results The adverse reactions caused by drospironone and ethinylestradiol tablets (II) were mainly manifested as reproductive system diseases, gastrointestinal diseases and nervous system diseases. Conclusion The adverse reactions induced by drospirenone and ethinylestradiol tablets are generally tolerable. Although low-dose drospironone and ethinylestradiol tablets cause fewer adverse reactions, the risk of venous thromboembolism remains. It is recommended that the risk of medication be assessed before use, a long-term, systematic follow-up be maintained with the patients, and high-quality reporting of adverse reactions be encouraged. In order to reduce the risk of drug use and promote the long-term rational use of drospirenone and ethinylestradiol (II), evidence should be updated and new adverse reactions should be added to the drug instructions.

Key words: drospirenone and ethinylestradiol tablets (II), adverse drug reactions(ADR), ADR reporting, rational clinical use

中图分类号:

R994.11

周博雅, 袁偲偲, 林京玉, 周应群, 冯欣. 325例屈螺酮炔雌醇(Ⅱ)不良反应报告分析[J]. 中国药物警戒, 2020, 17(7): 418-424.

ZHOU Boya, YUAN Sisi, LIN Jingyu, ZHOU Yingqun, FENG Xin. 325 Cases of Adverse Drug Reactions Induced by Drospirenone and Ethinylestradiol Tablets (II)[J]. Chinese Journal of Pharmacovigilance, 2020, 17(7): 418-424.

参考文献

[1] 复方口服避孕药临床应用中国专家共识专家组.复方口服避孕药临床应用中国专家共识[J]. 中华妇产科杂志,2015,50(2): 81-91.
[2] Sullivan H, Furniss H, Spona J, et al.Effect of 21-day and 24-day oral contraceptive regimens containing gestodene (60 microg) and ethinyl estradiol (15 microg) on ovarian activity[J]. Fertil Steril, 1999, 72(1): 115-120.
[3] Rosenberg MJ, Meyers A, Roy V.Efficacy, cycle control, and side effects of low- and lower-dose oral contraceptives: a randomized trial of 20 micrograms and 35 micrograms estrogen preparations[J].Contraception,1999,60(6): 321-329.
[4] Akerlund M, R de A, Westergaard J. Comparative profiles of reliability, cycle control and side effects of two oral contraceptive formulations containing 150 micrograms desogestrel and either 30 mic-rograms or 20 micrograms ethinyl oestradiol[J]. Br J Obstet Gynaecol,1993,100(9): 832-838.
[5] Gallo MF, Nanda K, Grimes DA, et al.20 µg versus >20 µg estrogen combined oral contraceptives for contraception[J].Cochrane Database Syst Rev,2013 (8): CD003989.
[6] Rosenberg MJ, Waugh MS, Meehan TE.Use and misuse of oral contraceptives: risk indicators for poor pill taking and discont-inuation[J]. Contraception,1995,51(5): 283-288.
[7] Frost JJ, Darroch JE.Factors associated with contraceptive choice and inconsistent method use, United States, 2004[J]. Perspect Sex Reprod Health,2008,40(2): 94-104.
[8] Frost JJ, Darroch JE, Remez L.Improving contraceptive use in the United States[J]. Issues Brief (Alan Guttmacher Inst),2008(1):1-8.
[9] Westhoff CL, Heartwell S, Edwards S, et al. Oral contraceptive discontinuation: do side effects matter[J]. Am J Obstet Gynecol,2007,196(4): 412.e1-412.e7.
[10] Bakhru A, Stanwood N.Performance of contraceptive patch compared with oral contraceptive pill in a high-risk population[J].Obstet Gynecol,2006,108(2): 378-386.
[11] Brynhildsen J.Combined hormonal contraceptives: prescribing patterns, compliance, and benefits versus risks[J]. Ther Adv Drug Saf,2014,5(5): 201-213.
[12] Rosenberg MJ, Waugh MS.Oral contraceptive discontinuation:a prospective evaluation of frequency and reasons[J]. Am JObstet Gynecol,1998,179(3 Pt 1): 577-582.
[13] Loder EW, Buse DC, Golub JR.Headache as a side effect of combination estrogen-progestin oral contraceptives: a systematic review[J]. Am J Obstet Gynecol,2005,193(PT1):636-649.
[14] Lidegaard,Lokkegaard E, Svendsen AL, et al. Hormonal cont-raception and risk of venous thromboembolism: national follow-up study[J]. BMJ,2009,339(7720): b2890.
[15] Vinogradova Y, Coupland C, Hippisley-Cox J.Use of combined oral contraceptives and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases[J].BMJ,2015,350: h2135.
[16] van Hylckama Vlieg A, Helmerhorst FM, Vandenbroucke JP, et al.The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study[J]. BMJ,2009,339: b2921.
[17] Heit JA, Kobbervig CE, James AH, et al.Trends in the incidence of venous thromboembolism during pregnancy or postpartum: a 30-year population-based study[J]. Ann Intern Med,2005,143(10): 697-706.
[18] Heinemann LA, Dinger JC.Range of published estimates of venous thromboembolism incidence in young women[J]. Contraception,2007,75(5): 328-336.
[19] Bork K, Fischer B, Dewald G.Recurrent episodes of skin angio-edema and severe attacks of abdominal pain induced by oral contraceptives or hormone replacement therapy[J]. Am J Med,2003,114(4): 294-298.
[20] ACOG Practice Bulletin No. 110: noncontraceptive uses of horm-onal contraceptives[J]. Obstet Gynecol,2010,115(1): 206-218.
[21] Grimes DA, Jones LB, Lopez LM, et al.Oral contraceptives for functional ovarian cysts[J]. Cochrane Database Syst Rev,2014 (4):CD006134.
[22] Marshall LM, Spiegelman D, Goldman MB, et al.A prospective study of reproductive factors and oral contraceptive use in relation to the risk of uterine leiomyomata[J]. Fertil Steril,1998,70(3): 432-439.
[23] Wise LA, Palmer JR, Harlow BL, et al.Reproductive factors, hormonal contraception, and risk of uterine leiomyomata in African-American women: a prospective study[J]. Am J Epidemiol, 2004,159(2): 113-123.
[24] Alexander GM, Sherwin BB, Bancroft J, et al.Testosterone and sexual behavior in oral contraceptive users and nonusers: a pros-pective study[J]. Horm Behav,1990,24(3): 388-402.
[25] Schaffir J.Hormonal contraception and sexual desire: a critical review[J]. J Sex Marital Ther,2006,32(4): 305-314.
[26] Graham CA, Ramos R, Bancroft J, et al.The effects of steroidal contraceptives on the well-being and sexuality of women: a double-blind, placebo-controlled, two-centre study of combined and progestogen-only methods[J]. Contraception,1995,52(6): 363-369.
[27] Pastor Z, Holla K, Chmel R.The influence of combined oral contraceptives on female sexual desire: a systematic review[J]. Eur J Contracept Reprod Health Care,2013,18(1): 27-43.
[28] Lindh I, Ellstr m AA, Milsom I. The long-term influence of combined oral contraceptives on body weight[J]. Hum Reprod,2011,26(7): 1917-1924.

325例屈螺酮炔雌醇(Ⅱ)不良反应报告分析

325 Cases of Adverse Drug Reactions Induced by Drospirenone and Ethinylestradiol Tablets (II)

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