A Multicenter Comparative Clinical Study of Sino-Levonorgestrel-Releasing Implants— No. I and No. II withNorplant

Objective To compare the efficacy, side effects and acceptability of two Sino-implants with Norplant Methods A randomized, prospective multicenter comparative clinical study was conducted in 10 clinical centers in China. Results 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. Men- strual problems were the main reason for termination. The menstrual blood loss decreased significantly and no serious health problems arose fromimplants use. Conclusion 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.

A Multicentre Study of CLa Implant and Sino-implant──Expanded Application (two-year follow-up)

A multicentre comparative clinical study of CLa implant and Sino-implant was carried out at 100 subcentres in 11 provinces, and α total of 19673 subjects were recruited. Two-year follow-up has been finished. The follow-up rate at the end of two years was 94.29%. Two-year cumulative continuation rate per 100 women for Sino-implant(89.93) was significantly higher than that for CLa implant (88.89). Two-year cumulative pregnancy rates per 100 women were 0.0462(CLa implant) and 0.281(Sino-implant) respectively, there was statistically significant difference between them. No ectopic pregnancy was recorded among CLa implant users and three ectopic pregnancies were reported among Sino-implant users,resulting in an ectopic pregnancy rate of 0.163 per 1000 women-years. The incidence of side effects appeared to diminish with time. The major side-effects were the menstrual disturbances, which accounted for more than 90% of the total sideeffects, and the incidence of frequent menstruation, irregular bleeding and spotting was higher than that of infrequent/scanty menstruation and amenorrhea. Use of CLa implant had higher incidence of amenorrhea and infrequent/scanty menstruation than that of Sino-implant. During two-year follow-up, the number of discontinuation due to menstrual problems contributed 78% of the total number of discontinuation; two year menstrual-related cumulative discontinuation rates were 8.96 per 100 women for CLa implant and 7.84 for Sino-implant, there wasAddress coryespoll(lol,c'c toe D]' Fang ac juan, Shanghai Institute of Planned Pal.cnthood Research, 2140 Xit, 'I'u BOilal. Shanghai. 200032, China. Tel/F..f 86--021 64171432 E ..ill SIPPRms. STN. sh. C Nstatistically significant difference(P< 0.01). Two year study shows that the two types of implant are similar to Norplant in the incidence of side-effects and contraceptive efficacy as well as two year continuation rates.