Sang G W, Shao Q X, Ge R S, Ge J L, Chen J K, Song S, Fang K J, He M L, Luo S Y, Chen S F
WHO CCR for Human Reproduction, Family Planning Research Institute of Zhejiang, Zhejiang Academy of Medical Sciences, Hangzhou, China.
Contraception. 1995 Mar;51(3):167-83. doi: 10.1016/0010-7824(95)00013-z.
A phase III clinical study was carried out among 5680 fertile Chinese women to evaluate efficacy and side effects of three monthly injectable contraceptives: Mesigyna, Cyclofem and Chinese Injectable No. 1. When used in a once-a-month treatment schedule (part 1 of study), the effectiveness of Chinese Injectable No. 1 was unacceptably low; 36 pregnancies occurred during the first 1743 women-months of use, 16 before the second injection. The study was restarted with a revised injection schedule for Injectable No. 1: two injections separated by 9 +/- 1 days during the first month and subsequent injections given 10-12 days after the onset of bleeding, or if no bleeding occurred, 28 days after previous injection. In part 2 of the study, 988, 990 and 992 subjects were provided Mesigyna, Cyclofem and Injectable No. 1, respectively. Life-table pregnancy rates at one year were 0.41%, 0% and 0.77% (p < 0.05), respectively; the overall discontinuation rates at one year were 13.9%, 19.1% and 20.4% (p < 0.001). Discontinuation rates for bleeding problems were significantly different between the groups: discontinuation rates for amenorrhea were 0.58%, 3.71% and 0.68% (p < 0.001) for Mesigyna, Cyclofem and Injectable No. 1; for other bleeding problems, the rates were 4.88%, 8.38% and 12.64% (p < 0.001). There were no significant differences between the groups regarding discontinuation for other medical or non-medical reasons. Mean weight changes after one year of use were small: 0.73, 0.86 and 0.17 kg for the three groups, respectively. Both Mesigyna and Cyclofem were very effective for contraception, but Mesigyna appeared to be tolerated slightly better with regard to cycle control; the modified dose regimen for Injectable No. 1 also gave a low pregnancy rate but was associated with higher rates of discontinuation.
一项针对5680名有生育能力的中国女性进行的III期临床研究，旨在评估三种每月注射用避孕药（美施孕、环孕芬和1号国产避孕针）的疗效和副作用。当按照每月一次的治疗方案使用时（研究的第1部分），1号国产避孕针的有效性低得令人无法接受；在最初的1743名女性-月的使用期间发生了36次妊娠，其中16次发生在第二次注射之前。该研究重新启动，对1号避孕针的注射方案进行了修订：第一个月内分两次注射，间隔9±1天，随后的注射在出血开始后10 - 12天进行，或者如果没有出血，则在先前注射后28天进行。在研究的第2部分中，分别为988名、990名和992名受试者提供了美施孕、环孕芬和1号避孕针。一年的生命表妊娠率分别为0.41%、0%和0.77%（p<0.05）；一年的总体停药率分别为13.9%、19.1%和20.4%（p<0.001）。各组因出血问题导致的停药率有显著差异：美施孕、环孕芬和1号避孕针因闭经导致的停药率分别为0.58%、3.71%和0.68%（p<0.001）；因其他出血问题导致的停药率分别为4.88%、8.38%和12.64%（p<0.001）。在因其他医疗或非医疗原因停药方面，各组之间没有显著差异。使用一年后的平均体重变化很小：三组分别为0.73千克、0.86千克和0.17千克。美施孕和环孕芬在避孕方面都非常有效，但在月经周期控制方面，美施孕似乎耐受性稍好一些；1号避孕针的改良剂量方案也有较低的妊娠率，但停药率较高。
