Clinical Preliminary Study on Biodegradable Subcuta neous Contraceptive Implant-CaproF

CaproF is a biodegradable subcutaneous contraceptive implant of releasing lev onorgestrel (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 pres sure. In the 3d, 6th and 12th months after using CaproF, the cervical mucus became scanty and viscous without fern-like crystals. The amount of menstrual blood loss de creased from 49. 38 ml of pre-implantation to 33. 23 ml of the 12th 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 hor mones (FSH, LH, E2 and progesterone) levels, ultrasonography of ovary, and en dometrial 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 musus characteristics.     

高原地区紧急避孕临床应用研究

目的 :探讨高原地区分别单独应用米非司酮、左炔诺孕酮及联合用药的紧急避孕效果 ;方法 :将避孕失败或无保护性生活后 72小时内就诊的 782例健康妇女分为 4组。Ⅰ组 2 1 2例 ,口服米非司酮 2 5mg,1 2小时后重复一次 ;Ⅱ组 2 0 5例 ,口服左炔诺孕酮 0 .75mg ,1 2小时后重复一次 ;Ⅲ组 1 82例 ,口服米非司酮 2 5mg一次 ;Ⅳ组 1 83例 ,口服米非司酮 2 5mg及左炔诺酮 0 .75mg;结果 :Ⅰ组、Ⅱ组均无方法失败而妊娠者 ,Ⅲ组、Ⅳ组各有 2例方法失败而妊娠者 ;避孕效率 4组依次为 1 0 0 % ,1 0 0 % ,84.3 % ,84.5 %。服药后月经影响小 ,副反应发生率低 ;结论 :单独服用米非司酮、左炔诺孕酮两次服法均可作为高原地区性生活后 72小时内有效紧急避孕方法。米非司酮与左炔诺孕酮合用 ,未显示出协同作用。     

左炔诺孕酮宫内缓释系统对子宫腺肌症患者肝功能、血脂及性激素水平的影响研究

目的：研究左炔诺孕酮宫内缓释系统对子宫腺肌症患者肝功能、血脂及性激素水平的影响,评估其安全性,以指导临床应用。方法对左炔诺孕酮宫内缓释系统治疗的43例子宫腺肌症患者,检测其治疗前后肝功能(ALT、AST)、血脂(TC、HDL、LDL)、血清性激素水平(FSH、LH、E2)的变化。结果43例子宫腺肌症患者的肝功能(ALT、AST)、血脂(TC、HDL、LDL)及血清性激素水平(FSH、LH、E2)在治疗前后均在正常范围内,且治疗前后差异无统计学意义。结论左炔诺孕酮宫内缓释系统治疗子宫腺肌症对肝功能、血脂代谢及血清性激素水平无影响,安全性高。     

妈富隆与左炔诺孕酮宫内缓释系统治疗围绝经期功能失调性子宫出血的临床疗效比较

目的：探讨和比较妈富隆和LNG-IUS治疗围绝经期功能失调性子宫出血的临床疗效。方法选择2010年12月—2012年12月该院收治的90例无排卵性功血患者,随机分为妈富隆组（n=45）和LNG-IUS 组（n=45）进行治疗,对患者接受治疗前及治疗6个月的性激素水平、血红蛋白、月经情况、体重指数及不良反应等进行统计分析。结果妈富隆组和LNG-IUS 组患者经治疗后月经量明显减少,血红蛋白明显提高（P＜0．01）;LNG-IUS 组比妈富隆组对减少患者的月经量以及提高其血红蛋白的作用更显著（P＜0．05, P＜0．01）;LNG-IUS组性激素测定中,仅雌二醇水平下降,余性激素水平（FSH、LH、PRL、P）无明显变化（P＞0．05）,妈富隆组FSH、LH、PRL、E2、P水平均降低（P＜0．01）;结论 LNG-IUS可抑制雌激素受体在子宫内膜合成,治疗围绝经期功能失调性子宫出血疗效显著,并且对卵巢功能影响较小, LNG-IUS 较妈富隆临床疗效更显著,安全可靠,不良反应小,值得临床推广应用。     

Impact of bodyweight/body mass index on the effectiveness of emergency contraception with levonorgestrel: a pooled-analysis of three randomized controlled trials

Objective:

A pooled analysis of two randomized controlled trials (RCTs) suggested that increased bodyweight and body mass index (BMI) may be associated with a greater probability of pregnancy. To address this issue we investigated whether higher bodyweight and/or BMI negatively impacted the risk of pregnancy in women receiving LNG-EC (levonorgestrel – emergency contraception) after unprotected sexual intercourse in a pooled analysis of three large multinational RCTs conducted by the World Health Organization (WHO).

Methods:

A pooled analysis of three double-blind, multinational RCTs conducted by the WHO to investigate the efficacy of LNG-EC in the general population. All analyses were done on the per-protocol set (PPS) which included 5812 women who received LNG-EC within 72 hours following unprotected sexual intercourse. The analysis was based on logistic regression, with pregnancy as the outcome. BMI and weight were represented in the same model.

Results:

A total of 56 pregnancies were available for analysis in the PPS. Increasing bodyweight and BMI were not correlated with an increased risk of pregnancy in the studied population. A limitation of this study is that despite the large study population in the pooled analysis there were relatively small numbers of women in the high-BMI and high-bodyweight subgroups.

Conclusion:

LNG-EC is effective for preventing pregnancy after unprotected intercourse or contraceptive failure and no evidence was found to support the hypothesis of a loss of EC efficacy in subjects with high BMI or bodyweight. Therefore, access to LNG-EC should not be limited only to women of lower bodyweight or BMI.     

促性腺激素释放激素激动剂联合左炔诺孕酮宫内节育系统用于子宫内膜异位症术后效果

目的探讨促性腺激素释放激素激动剂(GnRH-a)联合左炔诺孕酮宫内节育系统在子宫内膜异位症(EMT)术后患者中的效果观察。方法选取EMT患者56例,均行腹腔镜手术治疗。按随机数字表法分为观察组(n=28)和对照组(n=28),对照组患者接受GnRH-a治疗,观察组患者接受GnRH-a联合左炔诺孕酮宫内节育系统治疗。对两组患者随访1年的痛经评分和血清CA125,同时亦对两组患者的治疗有效率和复发率进行评估和比较。结果两组患者术后痛经评分以及CA125值均低于术前(P0.05),观察组的术后1年与术后3个月、6个月以及9个月比较,差异无统计学意义(P0.05)。而对照组术后1年的痛经评分和CA125值明显高于术后3个月、6个月以及9个月,差异有统计学意义(P0.05)。观察组治疗有效率为82.14%,对照组为64.29%,两组比较差异有统计学意义(P0.05)。观察组复发率为7.14%,远远低于对照组(39.29%),差异有统计学意义(P0.05)。结论 GnRH-a联合左炔诺孕酮宫内节育系统治疗EMT术后患者,可有效改善患者的疼痛程度,并减轻术后复发的情况,提高了临床疗效。     

皮下埋植避孕妇女血清左炔诺酮含量影响因素分析

目的：测定使用Norplant皮下埋植剂妇女血清中左炔诺酮（LNG）水平,分析影响血清LNG水平的因素。方法：应用液相色谱－串联质谱法测定血清中LNG水平。结果：随着使用Norplant时间延长,血清LNG均值缓慢降低;体重〈60kg组血清LNG水平高于体重≥60kg组（P〈0．05）;不规则出血组血清LNG水平明显高于出血规则组（P〈0．01）。多因素分析显示,埋植时间、体重和月经类型是影响血清左炔诺酮水平的独立因素。结论：皮下埋植后妇女血清左炔诺酮含量与皮下埋植时间、体重和月经类型密切相关。     

Serum levonorgestrel levels and endometrial thickness during extended use of the levonorgestrel-releasing intrauterine system

Background

The levonorgestrel-releasing intrauterine system (LNG-IUS) is a contraceptive method approved for five years of use. However, there is some evidence that its life span may be longer. The aim of the study was to evaluate serum levonorgestrel (LNG) and estradiol (E₂) levels and endometrial thickness every 6 months from 7 to 8 1/2 years after insertion.

Study Design

At the end of the approved 5-year life span, no replacement devices were available; therefore, 86 women were allowed to retain the same device for a further 2 years. At the 7-year follow-up visit, the women who consented were again allowed to retain the same device for a further 18 months and were followed-up at six-monthly intervals. At each visit, vaginal sonography was performed to measure endometrial thickness, and a blood sample was taken to measure LNG and E₂.

Results

Eighty-four months after insertion, 67 women aged 34.3±0.8 years (mean±SEM) (range, 25-49 years) returned for follow-up. Mean±SEM LNG levels decreased from an initial 253±27 pg/mL (range, 86-760) during the first 2 months following insertion to 137±12 (range, 23-393) at 84 months and 119±9 pg/mL (range, 110-129) at 102 months of use (±SEM). At 84 months of use, mean±SEM endometrial thickness was 2.8±0.1 mm, increasing to 3.8±0.5 mm at 102 months of use. The incidence of amenorrhea decreased from 41.8% at 84 months to 31.5% at 102 months of use. No correlation was found between LNG levels and bleeding patterns; however, a weak correlation was found between high body mass index (kg/m²), high weight, and low serum LNG levels. E₂ levels were similar to those of the follicular phase of the menstrual cycle of regularly menstruating women.

Conclusions

During extended use of the LNG-IUS, serum LNG levels were nearly half those found in the first 2 months of use (Wilcoxon signed rank test); serum E₂ levels were normal. Despite the very thin endometrium, menstrual bleeding was reinstated in many cases. At the end of its 5-year life span, there is a window for changing the LNG-IUS, and physicians and users should not be concerned about delaying replacement of the device for a short time beyond the approved life span; however, maintaining the same device long after its approved life span cannot be recommended.     

The effect of levonorgestrel-releasing intrauterine device on menorrhagia in women taking anticoagulant medication after cardiac valve replacement

Background

This study was conducted to evaluate the effect of levonorgestrel-releasing intrauterine devices (LNG-IUDs) on menorrhagia in patients receiving anticoagulant therapy after cardiac valve replacement.

Study Design

Forty women with menorrhagia who underwent cardiac valve replacement and were taking anticoagulant medication were enrolled in the study. The women were randomly divided into two groups: LNG-IUDs were inserted into 20 women in Group 1 over the first 3 days of menstrual bleeding, while the women in Group 2 were followed without any intervention. The activated partial thromboplastin time, prothrombin time, international normalized ratio, hematocrit level, hemoglobin level, ferritin level and pictorial bleeding assessments for the quantity of menstrual bleeding were recorded.

Results

Three months after insertion of LNG-IUDs, the women in Group 1 had a significant decrease in blood loss and higher hemoglobin, hematocrit and ferritin values. No difference was detected for these parameters in the control group at the third and sixth months of the study. Coagulation parameters did not differ between the two groups.

Conclusion

LNG-IUDs can be considered as an effective non-surgical treatment for menorrhagia in women receiving anticoagulant therapy after cardiac valve replacement.     

HPLC法测定左炔诺孕酮片中主药的含量

目的:建立以高效液相色谱(HPLC)法测定左炔诺孕酮片中主药含量的方法。方法:色谱柱为Agilent Extend C18,流动相为水-乙腈-甲醇(55∶45∶5),流速为1.0mL·min-1,柱温为30℃,检测波长为240nm,以外标法进行测定。结果:左炔诺孕酮检测浓度线性范围为3.5～55.6μg·mL-1(r=0.9996),低、中、高3个浓度的平均回收率分别为100.8%、99.7%、98.8%,RSD分别为0.97%、0.92%、0.91%。结论:该方法简便、准确、可靠,适用于左炔诺孕酮片中主药的含量测定。