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两种注射用避孕药具(醋酸甲羟孕酮长效避孕针和复方己酸羟孕酮避孕针)在越南女性中的比较性III期临床试验。

Comparative phase III clinical trial of two injectable contraceptive preparations, depot-medroxyprogesterone acetate and Cyclofem, in Vietnamese women.

作者信息

Cuong D T, My Huong N T

机构信息

Institute for the Protection of Mother and Newborn, Hanoi, Viet Nam.

出版信息

Contraception. 1996 Sep;54(3):169-79. doi: 10.1016/s0010-7824(96)00173-4.

Abstract

A multicenter clinical trial was conducted in Viet Nam, comparing two injectable contraceptive preparations: the three-monthly injectable depot-medroxyprogesterone acetate (DMPA) and the once-a-month injectable Cyclofem. A total of 600 volunteers were randomized to the two treatment groups and followed for one year. No pregnancy occurred during the trial. Approximately one quarter of the women in each group discontinued early from the trial. In the DMPA group, this was mostly because of amenorrhea and vaginal bleeding irregularities. In the Cyclofem group, an equal number discontinued because of menstrual problems and personal reasons. These personal reasons are probably related to the inconvenience of having to return to the clinic for injection on a monthly basis. Thus, Vietnamese women experience less side effects with Cyclofem than with DMPA, and once Cyclofem is made more widely available and is more accessible, it may better meet their needs than does DMPA.

摘要

在越南进行了一项多中心临床试验,比较两种注射用避孕制剂:每三个月注射一次的醋酸甲羟孕酮长效避孕针(DMPA)和每月注射一次的复方庚炔诺酮注射液(Cyclofem)。共有600名志愿者被随机分为两个治疗组,并随访一年。试验期间未发生妊娠。每组中约四分之一的女性提前退出试验。在DMPA组,这主要是由于闭经和阴道不规则出血。在Cyclofem组,因月经问题和个人原因退出的人数相等。这些个人原因可能与每月必须返回诊所注射带来的不便有关。因此,越南女性使用Cyclofem比使用DMPA的副作用更少,一旦Cyclofem更广泛地供应且更容易获得,它可能比DMPA更能满足她们的需求。

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