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 foll...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.展开更多
CaproF is a biodegradable subcutaneous contraceptive implant of releasing levonorgestrel (LNG), which is expected to provide an effective contraception for 2 years. This study was undertaken to assess the one year pr...CaproF is a biodegradable subcutaneous contraceptive implant of releasing levonorgestrel (LNG), which is expected to provide an effective contraception for 2 years. This study was undertaken to assess the one year preliminary clinical results of using CaproF in 19 subjects. All subjects (n=19) completed the 1 year study, and the contraceptive effectiveness and follow up rate were both 100%. The incidence of side effects was low. The major side effects were menstrual disorder, but bleeding patterns tended to be improved and restored to be the same as pre implantation ones with time. There were no significant increase in weight (P>0.05) and no changes in blood pressure. In the 3 rd , 6 th and 12 th months after using CaproF, the cervical mucus became scanty and viscous without fern like crystals. The amount of menstrual blood loss decreased from 49.38 ml of pre implantation to 33.23 ml of the 12 th month of using the implant (P<0.05). Hemoglobin concentrations showed no changes, but serum ferritin concentrations were slightly increased. No changes in liver function, kidney function, glucose tolerance test and lipoprotein levels were found. Determinations of sex hormones (FSH, LH, E 2 and progesterone) levels, ultrasonography of ovary, and endometrial biopsy in observed group (n=9) showed that all had normal ovulation before insertion. But ovulation was suppressed and endometrium development was inhibited after insertion. All basal body temperatures were single phase patterns during the 1 year follow up. This study suggested that CaproF is an effective, safe and acceptable long acting contraceptive method. It is likely to reach its contraceptive effectiveness through suppressing ovulation, inhibiting endometrium development and influencing cervical mucus characteristics.展开更多
In this study,a new class of biodegradable contraceptive implants was prepared via the UV irradiation molding method,among which,progestin levonorgestrel(LNG)was used as a model drug.Photo-cross-linked aliphatic polyc...In this study,a new class of biodegradable contraceptive implants was prepared via the UV irradiation molding method,among which,progestin levonorgestrel(LNG)was used as a model drug.Photo-cross-linked aliphatic polycarbonates(APCs),namely,poly(trimethylene carbonate-co-2,2′-dimethyltrimethylene carbonate)[P(TMC-co-DTC)]elastomers,were used as the drug delivery matrix.The results obtained from the degradation experiments carried out in Sprague-Dawley(SD)rats showed that the cross-linked elastomer had the degradation characteristics of the surface erosion degradation mechanism,with no generation of acid degradation products,and excellent form-stability,which met the performance requirements of the matrix for a long-acting sustained-release delivery system.The in vitro cytotoxicity tests and histological and immunohistochemical evaluations showed good biocompatibility and biosafety of the elastomer matrix material and contraceptive implants.Subsequently,the implant formulations were screened by in vitro release experiments,and their release kinetics were explored.Finally,in the evaluation study of the in vivo anti-fertility effect,the implants exhibited excellent dimensional stability and were degraded by a surface erosion mechanism.LNG achieved a stable and sustained release in female SD rats,maintaining a long-acting contraceptive duration of up to 4 months.The contraceptive implants obtained in this study could be used to address the limitations of currently available formulations,which required secondary surgical removal and a single means of regulating drug release kinetics.Therefore,these implants could provide a new option for birth control needs and may be of significance in reducing the incidence of induced abortion and protecting female fertility.展开更多
文摘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.
文摘CaproF is a biodegradable subcutaneous contraceptive implant of releasing levonorgestrel (LNG), which is expected to provide an effective contraception for 2 years. This study was undertaken to assess the one year preliminary clinical results of using CaproF in 19 subjects. All subjects (n=19) completed the 1 year study, and the contraceptive effectiveness and follow up rate were both 100%. The incidence of side effects was low. The major side effects were menstrual disorder, but bleeding patterns tended to be improved and restored to be the same as pre implantation ones with time. There were no significant increase in weight (P>0.05) and no changes in blood pressure. In the 3 rd , 6 th and 12 th months after using CaproF, the cervical mucus became scanty and viscous without fern like crystals. The amount of menstrual blood loss decreased from 49.38 ml of pre implantation to 33.23 ml of the 12 th month of using the implant (P<0.05). Hemoglobin concentrations showed no changes, but serum ferritin concentrations were slightly increased. No changes in liver function, kidney function, glucose tolerance test and lipoprotein levels were found. Determinations of sex hormones (FSH, LH, E 2 and progesterone) levels, ultrasonography of ovary, and endometrial biopsy in observed group (n=9) showed that all had normal ovulation before insertion. But ovulation was suppressed and endometrium development was inhibited after insertion. All basal body temperatures were single phase patterns during the 1 year follow up. This study suggested that CaproF is an effective, safe and acceptable long acting contraceptive method. It is likely to reach its contraceptive effectiveness through suppressing ovulation, inhibiting endometrium development and influencing cervical mucus characteristics.
基金sponsored by the Natural Science Foundation of Liaoning Province(Nos.2022-YGJC-69,2021-BS-110)the support program for excellent young scholars of China Medical University.
文摘In this study,a new class of biodegradable contraceptive implants was prepared via the UV irradiation molding method,among which,progestin levonorgestrel(LNG)was used as a model drug.Photo-cross-linked aliphatic polycarbonates(APCs),namely,poly(trimethylene carbonate-co-2,2′-dimethyltrimethylene carbonate)[P(TMC-co-DTC)]elastomers,were used as the drug delivery matrix.The results obtained from the degradation experiments carried out in Sprague-Dawley(SD)rats showed that the cross-linked elastomer had the degradation characteristics of the surface erosion degradation mechanism,with no generation of acid degradation products,and excellent form-stability,which met the performance requirements of the matrix for a long-acting sustained-release delivery system.The in vitro cytotoxicity tests and histological and immunohistochemical evaluations showed good biocompatibility and biosafety of the elastomer matrix material and contraceptive implants.Subsequently,the implant formulations were screened by in vitro release experiments,and their release kinetics were explored.Finally,in the evaluation study of the in vivo anti-fertility effect,the implants exhibited excellent dimensional stability and were degraded by a surface erosion mechanism.LNG achieved a stable and sustained release in female SD rats,maintaining a long-acting contraceptive duration of up to 4 months.The contraceptive implants obtained in this study could be used to address the limitations of currently available formulations,which required secondary surgical removal and a single means of regulating drug release kinetics.Therefore,these implants could provide a new option for birth control needs and may be of significance in reducing the incidence of induced abortion and protecting female fertility.
