雌激素防治LNG皮下埋植剂所致不规则阴道流血的临床观察

目的 :观察长效雌激素尼尔雌醇及短效雌激素炔雌醇对使用 L NG皮下埋植剂半年内不规则阴道流血的防治效果。方法 :L NG皮下埋植剂使用者 6 5人 ,长效组、短效组各2 0人、对照组 2 5人。长效组及短效组分别给予尼尔雌醇 ( CEE3 ,5mg,每月一次 )、炔雌醇 ( EE,0 .0 5mg,qd× 2 0 d,月经 d5开始服用 )治疗半年 ,对照组不用药 ,研究结束时Doppler超声检查。结果 :与短效组比 ,长效组出血次数减少 ( P<0 .0 5) ,最长流血天数减少 ( P<0 .0 5)而出血天数并未减少。使用雌激素治疗后卵巢动脉阻力下降 (长效组 P<0 .0 5,短效组 P<0 .0 5) ,但不影响子宫和卵巢的大小以及子宫的血供 ,对子宫内膜的厚度也无影响。结论 :雌激素对防治皮埋剂使用后不规则阴道流血有效。     

日释10μg18－甲基炔诺酮钥匙形宫内节育器和TCu200对比性临床研究

日释１０μｇ１８－甲基炔诺酮（ＬＮＧ）钥匙形宫内节育器（ＩＵＤ）进行临床初试１０１例，观察５７８．５个妇女月与ＴＣｕ２００对照。未发现失败，续用率为９３．０７％，无宫外孕发生，闭经率很低（０．９９％），且能自然恢复月经。主要副反应为经期延长和月经淋漓。经３例置器前后月经中期连续测定晨尿ＬＨ和宫颈粘液，提示对排卵可能无影响。使用者经血量明显减少．血红蛋白相应上升，痛经改善。本器使用５年或５年以上。为月经过多、贫血和痛经妇女提供了合适的ＩＵＤ，为我国计划生育提供了一种新的工具。     

Evaluation and Management of Abnormal Uterine Bleeding

Abnormal uterine bleeding (AUB) is a common condition that leads to increased health care costs and decreased quality of life. A systematic approach to AUB evaluation can simplify management and enhance women’s well-being. Abnormal uterine bleeding describes any variation from normal bleeding patterns in nonpregnant, reproductive-aged women beyond menarche lasting for at least 6 months. Ambiguous and inconsistent use of terminology and definitions to characterize AUB in the past decades necessitated a new, consensus-based approach to nomenclature and AUB evaluation. This led to the International Federation of Gynecology and Obstetrics (FIGO) System 1 in 2007, which standardized nomenclature, set parameters, and defined normal and abnormal bleeding based on the 5th to 95th percentile data from available large-scale epidemiologic studies. FIGO System 1, endorsed by several national and international societies, improved worldwide communication among educators, clinicians, and researchers. FIGO System 2, published in 2011, focused on classifications of AUB etiology into structural and nonstructural entities using the PALM-COEIN (polyp[s], adenomyosis, leiomyoma, malignancy, coagulopathy, ovulatory dysfunction, endometrial disorders, iatrogenic, and not yet classified) classification system. The PALM-COEIN classification is facilitated by a complete patient history combined with appropriate imaging, histopathologic analysis, or laboratory evaluation to ensure accurate diagnostic and treatment approaches to AUB. Herein we present the systematic evaluation of AUB.     

Regulation of matrix metalloproteinase-9 in endometrium during the menstrual cycle and following administration of intrauterine levonorgestrel

Remodelling of endometrial tissues is fundamental to the cyclical changes that occur during the menstrual cycle, implantation and, in the absence of pregnancy, at menstruation. The enzyme matrix metalloproteinase-9 (MMP-9) is recognized as important in these processes but its regulation is not well defined. These studies have demonstrated that MMP-9 activity is present in the endometrium and exhibits cyclical changes in its distribution in the glandular and stromal cells. MMP-9 protein is present throughout the cycle with highest expression, as determined by semiquantitative analysis of specific MMP-9 immunoreactivity, in glandular cells during the mid secretory phase. A similar distribution was observed in first trimester decidua. In women with a levonorgestrel intrauterine system (LNG-IUS), which delivers high local concentrations of progestagen to the uterine cavity, MMP-9 is highly expressed in both endometrial glandular and stromal cells, and in the vasculature (in endothelial and perivascular cells). It can be concluded that MMP-9 is stimulated directly or indirectly by progesterone. Furthermore, MMP-9 may play a role in the remodelling of the endometrium that occurs during the menstrual cycle and in the aetiology of the morphological changes and breakthrough bleeding associated with long-term progestagen administration via a LNG-IUS.     

女性避孕的精密给药系统研究 Ⅱ.释放左炔诺孕酮宫内节育器的制备及体外释药

制备一种每天释放左炔诺孕酮Levonorgestrel(LNG)2μg的宫内节育器(IUD),并对之进行体外释药速度的研究。本IUD选用乙烯醋酸-乙烯共聚物(EVA)材料,T型纵臂为贮药管,内装LNG、硫酸钡及硅油所组成的混悬剂,EVA管壁为释药限速膜。本释药系统在“漏槽”状态下测定其稳态释药速度,表明在长时期内可维持零级速度。释药速度是管壁厚度及(或)药管内外径比的线性函数,说明本系统属于骨架控制释放机理。温度与标化速度关系符合Arrhenius方程,可以估算温度每升高1℃,本系统释药速度增加约16％。     

Ease of insertion, contraceptive efficacy and safety of new T-shaped levonorgestrel-releasing intrauterine systems

OBJECTIVE: The objective of the study was to evaluate ease of insertion, contraceptive performance and safety, in parous and nulliparous women, of two new T-shaped levonorgestrel (LNG)-releasing intrauterine systems (LNG-IUS), Femilistrade mark (parous women) and Femilis Slim (nulliparous women), releasing 20 mug of LNG per day. An ancillary objective was to evaluate expulsion and user continuation. DESIGN AND METHODS: An open, prospective, noncomparative study (interim analysis). Two hundred thirty-five insertions were performed in fertile women seeking contraception. Of these, 143 (60.8%) parous women were fitted with Femilis and 92 (39.2%) nulliparous women were fitted with Femilis Slim. The LNG-IUS was inserted using a simplified push-in technique (without folding the cross-arms in the insertion tube). RESULTS: This paper is the first report with the Femilis LNG-IUS. The push-in technique of insertion was considered simple and safe. Insertion was reported "easy" in virtually all women (97.9%). Pain at insertion was absent in 24.7% and "mild" in 67.7% of women. With respect to pain, there were no statistical differences between the parous and nulliparous group. At the time of study analysis, the total number of women-months of use was 1769.7. Seventy-six women had the Femilis IUS in place for periods in excess of 1 year. The study was well followed up with lost to follow-up of only two women. No pregnancies were observed. There was one expulsion in the nulliparous and one in the parous group. Ten removals were performed for medical reasons (mainly bleeding and pain). One pelvic infection occurred in a nulliparous woman caused by Chlamydia trachomatis, which was resolved without removing the IUS. There were no other serious adverse events reported. Both Femilis and Femilis Slim were well tolerated, which resulted in a high continuation rate (94.04%). CONCLUSION: The Femilis LNG-IUS is an effective contraceptive and is easily inserted. The simple and safe insertion procedure could be an advantage for use by nonspecialist providers such as nurses, midwives, general practitioners, and for those not inserting intrauterine devices regularly. Femilis Slim could be an attractive long-term contraceptive option in young and adolescent women.     

米非司酮治疗皮下埋植避孕剂阴道出血的疗效研究

本研究采用双盲法随机分组,应用米非司酮和安慰剂进行药物临床试验,以了解服用米非司酮是否能改善左炔诺孕酮(LNG)皮下埋植剂使用妇女阴道异常出血的情况。结果;研究组与对照组的出血/滴血天数、出血/滴血平均时间均短于服药前参照期;出血/滴血间歇天数均大于服药前参照期(P<0.01)。服药参照期中,研究组的出血/滴血平均长度短于对照组,且服药4～6个月内出血/滴血天数小于对照组,而其出血/滴血间歇天数大于对照组(P<0.01)。疗效自我评估满意率研究组明显高于对照组。研究中共测试600份尿HCG无一例阳性,测定了520份尿孕激素值,研究组与对照组无明显差异(P>0.05)。提示每月一次50mg米非司酮口服对皮下埋植避孕剂后阴道异常出血有一定疗效,而不影响埋植剂的避孕效果。对照组也有疗效,说明心理咨询也是皮下埋植避孕后阴道异常出血的重要对策之一,临床应予以重视。     

可生物降解的PELA微球优化工艺的研究

本文报道了可生物降解的ＰＥＬＡ微球的优化工艺，制得平均球径为３２．５μｍ，平均包封率为７５％以上，临界相对湿度约７８％以及流动性好的白色球形粉末。体外释放药物符合零级释放规律，达到了肌内注射用的缓释微球的要求。