A multicenter comparative clinical study of sino-levonorgestrel-releasing impants-No. I and No. II with Norplant.
Journal of Reproduction and Contraception(2004)
摘要
The objective was to compare the efficacy side effects and acceptability of two Sino-implants with Norplant A randomized prospective multicenter comparative clinical study was conducted in 10 clinical centers in China. Totally 1 001 1 000 and 998 cases were recruited for Sino-implant No. I No. II and Norplant respectively in 1993. The follow-up rate was 99.8% totally in 5 years. Three and five pregnancies occurred respectively in Sino-implant No. I and No. II group while no pregnancy occurred in the Norplant group. The cumulative pregnancy rate was 0.4 0.7 and 0 per 100 women respectively in implant No.I No. II and Norplant group for five years meaning that there was no statistical difference. There was no ectopic pregnancy in the three groups. The cumulative discontinuation rates at the end of five years were not significantly different among the three groups either. Menstrual problems were the main reason for termination. The menstrual blood loss decreased significantly and no serious health problems arose from implants use. The two Sino-implants provided similar high efficacy and safety to Norplant therefore they can be used by women at reproductive age who are from different areas different of races educational background and occupation. (authors)
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关键词
clinical research,treatment,health,developing countries,comparative studies,medicine,population,research methodology
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