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皮下注射醋酸甲羟孕酮自我给药与临床给药的随机临床试验。

Randomized clinical trial of self versus clinical administration of subcutaneous depot medroxyprogesterone acetate.

作者信息

Beasley Anitra, White Katharine O'Connell, Cremers Serge, Westhoff Carolyn

机构信息

Department of Obstetrics & Gynecology, Baylor College of Medicine, Houston, TX 77030.

Department of Obstetrics & Gynecology, Baystate Medical Center, Springfield, MA 01199.

出版信息

Contraception. 2014 May;89(5):352-6. doi: 10.1016/j.contraception.2014.01.026. Epub 2014 Feb 7.

DOI:10.1016/j.contraception.2014.01.026
PMID:24656555
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4086940/
Abstract

OBJECTIVES

To evaluate feasibility, acceptability, continuation, and trough serum levels following self-administration of subcutaneous (sc) depot medroxyprogesterone acetate (DMPA).

STUDY DESIGN

Women presenting to a family planning clinic to initiate, restart or continue DMPA were offered study entry. Participants were randomized in a 2:1 ratio to self- or clinician administered sc DMPA 104 mg. Those randomized to self-administration were taught to self-inject and were supervised in performing the initial injection; they received printed instructions and a supply of contraceptive injections for home use. Participants randomized to clinician administration received usual care. Continued DMPA use was assessed by self-report and trough medroxyprogesterone acetate levels at 6 and 12 months.

RESULTS

Two hundred fifty women were invited to participate, and 137 (55%) enrolled. Of these, 91 were allocated to self-administration, and 90/91 were able to correctly self-administer sc DMPA. Eighty-seven percent completed follow-up. DMPA use at 1 year was 71% for the self-administration group and 63% for the clinic group (p=0.47). Uninterrupted DMPA use was 47% and 48% for the self and clinic administration groups at 1 year (p=0.70), respectively. Serum analyses confirmed similar mean DMPA levels in both groups and therapeutic trough levels in all participants.

CONCLUSIONS

Sixty-three percent of women approached were interested in trying self-administration of DMPA, even in the context of a randomized trial, and nearly all eligible for enrollment were successful at doing so. Self-administration and clinic administration resulted in similar continuation rates and similar DMPA serum levels. Self-administration of sc DMPA is feasible and may be an attractive alternative for many women.

IMPLICATIONS

Self-administration of sc DMPA is a feasible and attractive option for many women. Benefits include increased control over contraceptive measures and less time spent on contracepting behaviors. Globally, self-administration has the potential to revolutionize contraceptive uptake by increasing the number of women with access to DMPA.

摘要

目的

评估皮下注射醋酸甲羟孕酮长效避孕针(DMPA)后自我给药的可行性、可接受性、持续性及谷血清水平。

研究设计

邀请到计划生育诊所开始、重新开始或继续使用DMPA的女性参与研究。参与者按2:1的比例随机分为自我给药组或临床医生给药组,接受104mg的皮下注射DMPA。随机分配到自我给药组的参与者接受自我注射培训,并在首次注射时接受监督;他们收到了打印的说明和家用避孕针剂。随机分配到临床医生给药组的参与者接受常规护理。通过自我报告以及6个月和12个月时的醋酸甲羟孕酮谷水平评估DMPA的持续使用情况。

结果

邀请了250名女性参与,137名(55%)登记入组。其中,91名被分配到自我给药组,90/91能够正确自我注射皮下DMPA。87%完成了随访。自我给药组1年时DMPA的使用率为71%,临床医生给药组为63%(p = 0.47)。自我给药组和临床医生给药组1年时不间断使用DMPA的比例分别为47%和48%(p = 0.70)。血清分析证实两组的平均DMPA水平相似,且所有参与者的治疗谷水平也相似。

结论

即使在随机试验的背景下,63%接触到的女性有兴趣尝试自我注射DMPA,几乎所有符合入组条件的女性都成功做到了。自我给药和临床医生给药导致的持续使用率和DMPA血清水平相似。皮下注射DMPA自我给药是可行的,对许多女性来说可能是一个有吸引力的选择。

启示

皮下注射DMPA自我给药对许多女性来说是一种可行且有吸引力的选择。好处包括对避孕措施的控制增加,以及在避孕行为上花费的时间减少。在全球范围内,自我给药有可能通过增加获得DMPA的女性数量来彻底改变避孕药具的使用情况。

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