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每月注射一次的避孕药:疗效及停用原因。

Once-a-month injectable contraceptives: efficacy and reasons for discontinuation.

作者信息

Koetsawang S

机构信息

Siriraj Family Planning Health Research Centre, Department of Obstetrics and Gynaecology, Mahidol University, Bangkok, Thailand.

出版信息

Contraception. 1994 Apr;49(4):387-98. doi: 10.1016/0010-7824(94)90034-5.

DOI:10.1016/0010-7824(94)90034-5
PMID:8013221
Abstract

Reports of the phase III clinical trials on four combined progestogen-estrogen once-a-month injectable contraceptives, Deladroxate, Cyclofem, Mesigyna and Chinese Injectable No. 1, are reviewed focussing on efficacy and reasons for discontinuation. Deladroxate, currently used in many Latin American countries has proved to be highly effective and well accepted. However, this combination was withdrawn by the original manufacturer because the progestogen component of this drug induced a high number of breast cancers in dogs and very curious pituitary hyperplasia in rats. Cyclofem and Mesigyna were found to be highly effective and highly acceptable drugs. Side-effects were minimal and were of minor importance. The Chinese Injectable No. 1 had unacceptably high failure rates with a monthly injection schedule. After doubling the dose in the first month of use, the efficacy was satisfactory. It was found that all monthly injectable contraceptives provided better cycle control than the every 3 months depot-medroxyprogesterone acetate, although abnormal bleeding was still the main drug-related complaint and reason for discontinuation. Missed appointment is another reason for discontinuation which might reflect the problem of frequent injection schedule, thus indicating the need for proper selection of the users and good counselling.

摘要

对四种复方孕激素 - 雌激素每月注射一次的避孕针剂(Deladroxate、Cyclofem、Mesigyna和中国1号避孕针)的III期临床试验报告进行了综述,重点关注疗效和停药原因。目前在许多拉丁美洲国家使用的Deladroxate已被证明非常有效且易于接受。然而,该组合被原制造商撤回,因为该药物的孕激素成分在犬类中诱发了大量乳腺癌,在大鼠中引发了非常奇怪的垂体增生。Cyclofem和Mesigyna被发现是非常有效且易于接受的药物。副作用极小且不太重要。中国1号避孕针每月注射一次的方案失败率高得令人难以接受。在使用的第一个月将剂量加倍后,疗效令人满意。结果发现,所有每月注射一次的避孕针剂在月经周期控制方面都比每三个月注射一次的醋酸甲羟孕酮长效针更好,尽管异常出血仍是与药物相关的主要问题和停药原因。错过预约是停药的另一个原因,这可能反映了频繁注射方案的问题,因此表明需要正确选择使用者并提供良好的咨询服务。

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