A benefit-risk review of systemic haemostatic agents: part 2: in excessive or heavy menstrual bleeding.

The first part of this benefit-risk review examined the efficacy and adverse effect profiles of systemic haemostatic agents commonly used in major surgery. The second part of this review examines the efficacy and adverse effect profiles of systemic haemostatic agents commonly used in the treatment of excessive or heavy menstrual bleeding, and provides individual benefit-risk profiles that may assist clinicians in selecting appropriate pharmacological therapy in this setting. Historically, surgery has played a dominant role in treatment; however, pharmacological therapy is increasingly popular, especially in women who wish to retain their fertility. When selecting the appropriate treatment, patient preference should be considered, as well as the benefits and risks associated with each agent. Recommended pharmacological therapies that are effective and generally well tolerated include the levonorgestrel-releasing intrauterine system and the oral agents tranexamic acid, NSAIDs (e.g. mefenamic acid) and combined estrogen/progestogen oral contraceptives. In patients with an underlying bleeding disorder (e.g. von Willebrand disease), an additional option is intranasal desmopressin.     

Estimating a meaningful reduction in menstrual blood loss for women with heavy menstrual bleeding

Abstract

Objective:

A dichotomy exists within the treatment of heavy menstrual bleeding (HMB); guidelines and expert opinion recommend that clinical management be guided by subjective, patient-centered measures, yet clinical trials often describe treatment efficacy in terms of objective reductions in menstrual blood loss (MBL). The purpose of this investigation was to correlate subjective and objective aspects of HMB treatment by identifying the minimum change in MBL that would be considered meaningful to women.     

Management of heavy menstrual bleeding in general practice

Abstract

Background:

Heavy menstrual bleeding (HMB) is a common symptom that leads women to seek medical treatment. Sources of HMB are variable; patients may present with obvious uterine pathology, systemic disease, or even localized hemostatic dysregulation that defies clinical measurement. Whereas surgical intervention even in the absence of overt pathology had historically been the most common route of treatment for HMB, an expanding therapeutic armamentarium provides greater options and the possibility of maintaining fertility in affected women.     

Tranexamic acid therapy for heavy menstrual bleeding

Introduction: Heavy menstrual bleeding (HMB, also known as menorrhagia) is an important health problem that interferes with women's quality of life. It is one of the most common reasons why women are seen by their family doctors in primary care and is a condition frequently treated by surgery.

Areas covered: This review covers the pharmacology of tranexamic acid in brief and concentrates on its use in the treatment of HMB. Papers published in the English language between January 1985 and November 2010 were reviewed using Medline, Embase, Cinahl and the Cochrane Database of Systematic Reviews. Search terms were ‘heavy menstrual bleeding’, ‘tranexamic acid’ and ‘menorrhagia’.

Expert opinion: Tranexamic acid, a competitive inhibitor of plasminogen activation, has been used to treat HMB for well over four decades. Although several treatment options are available for HMB, tranexamic acid is particularly useful in women who either desire immediate pregnancy or for whom hormonal treatment is inappropriate. Tranexamic acid is a well-tolerated, cost-effective drug that reduces menstrual blood loss in the range of 34 – 59%. It improves the health-related quality of life in women in HMB.     

左炔诺孕酮宫内缓释系统治疗子宫腺肌症的临床观察

目的 探讨左炔诺孕酮官内缓释系统(LNG-IUS)治疗子官腺肌症的临床疗效.方法 44例子宫腺肌症患者官内放置LNG-IUS治疗,随访12个月,观察其临床疗效、生活质量和不良反应.结果 放置LNG-IUS后经量PBAC评分明显减少[(167.43±170.88)分vs.(10.25±11.87)分](P＜0.05).痛经程度VAS评分[(80.23±29.21)分vs.(12.33±22.02)分]和VRS评分[(1.95±1.26)分vs.(0.14±0.52)分]均明显减少(P＜0.05).B超显示放置后子宫体积稍有缩小.置环后不良反应发生率为95.5%(阴道点滴出血率88.6%,闭经率18.2%).81.8%的患者生活质量明显提高,总体满意度为90.9%.结论 LNG-IUS治疗子宫腺肌症疗效显著,无严重不良反应.     

左炔诺孕酮宫内缓释系统治疗子宫腺肌症的疗效观察

目的探讨左炔诺孕酮宫内缓释系统（曼月乐）治疗子宫腺肌症的临床疗效。方法选择2008年2月～2011年2月在本院妇科门诊诊断为子宫腺肌症患者46例,在月经后3～5d子宫内放置左炔诺孕酮宫内缓释系统环,术后3、6个月观察痛经、月经量、子宫内膜厚度变化。结果放置左炔诺孕酮宫内缓释系统环前痛经程度（78±16）、月经量（212±53）mL、子宫内膜厚度（11.1±1.8）mm,放置后3个月后痛经程度（28±12）、月经量（48±15）mL、子宫内膜厚度（16.8±1.2）mm,放置后6个月后痛经程度（20±9）、月经量（31±12）mL、子宫内膜厚度（14.7±1.0）mm,放置前后差异具有统计学意义（P〈0.05）。结论左炔诺孕酮宫内缓释系统治疗子宫腺肌症效果明显,使用安全、有效、简捷,价格相对便宜,相对适合基层医院。     

左炔诺孕酮宫内缓释系统治疗子宫腺肌病中远期临床观察

目的 观察子宫腺肌病(AM)患者放置左炔诺孕酮宫内缓释系统(LNG-IUS)后的中远期临床疗效和安全性.方法 对36例子宫腺肌病患者放置LNG-IUS,记录放置前1个月、放置后第1～5年的痛经评分、月经量、子宫内膜厚度变化,同时阴道超声测量子宫及双侧卵巢体积并抽取晨血查生殖激素水平、血红蛋白含量、血清CA125水平及肝...     

左炔诺孕酮宫内缓释系统治疗子宫内膜异位症的安全性研究

目的：观察和评估子宫内膜异位症患者应用左炔诺孕酮宫内缓释系统（1evonorgestrel-releasing intrauterinesystem，LNG—IUS）的安全性。方法：共59例子宫内膜异位患者纳入研究。将LNG—IUS放置在患者子宫腔内，LNG—IUS放置前与放置后6个月及12个月对患者的痤疮、面部色素沉着、月经前乳房胀痛、体重及生活质量进行评分及比较，并观察LNG—IUS不良反应发生情况。结果：LNG．IUS放置前和放置后6个月痤疮评分分别为1．00（0．00，3．00）和0．00（0．00，2．00），差异无统计学意义（P〉0．05），而放置后12个月痤疮评分为0．00（0．00，1．00），差异有统计学意义（P〈0．01）。放置前和放置后6个月及12个月的面部色素沉着评分均为1．00（0．00，1．00），差异无统计学意义（均P〉0．05）。放置前和放置后6个月及12个月的月经前乳房胀痛评分分别为2．20（0．00，4．00），1．50（0．00，4．00）及1．00（0．00，3．00），差异均有统计学意义（P〈0．05，P〈0．01）。放置前和放置后6个月及12个月的体重分别为59．00（55．00，64．00）b，59．50（55．00，64．00）kg及59．00（54．00，64．00）妇，差异均无统计学意义（均P〉0．05）。放置前和放置后6个月及12个月的生活质量评分差异均有统计学意义（均P〈0．01）。放置前和放置后6个月及12个月月经间期出血分别为4例（6．78％），16例（27．12％）及14例（23．73％）。其他不良反应有脱发（1例）和全身肿胀感（2例）。结论：LNG—IUS是一种治疗子宫内膜异位症的安全疗法。     

左炔诺孕酮宫内缓释系统治疗子宫内膜增生症的临床观察

目的探讨左炔诺孕酮宫内节育系统(LNG-IUS)对子宫内膜增生症的治疗作用。方法 2011年1月至2012年1月我院收治的100例子宫内膜增生症患者,随机分为对照组(孕激素组)和试验组(LNG-IUS组)各50例。对照组于诊断性刮宫术后第5天给予孕激素(醋酸甲羟孕酮),试验组于诊断性刮宫术后第5天宫腔内置入LNG-IUS,比较两组治疗前、后月经量改变情况、血红蛋白水平、子宫内膜厚度及不良反应发生情况。结果对照组治疗1个疗程后,月经量过多者21例,治愈率58%;试验组月经过多者4例,治愈率92%,两组比较差异具有统计学意义(P<0.05)。试验组治疗1个疗程后,血红蛋白水平高于对照组,且子宫内膜厚度低于对照组。对照组不良反应为体重增加、恶心、头晕及肝肾功能损害,而试验组仅有子宫不规则的点状出血。结论左炔诺孕酮宫内缓释系统对子宫内膜增生症的治疗效果优于常规口服孕激素,且不良反应少。     

左炔诺孕酮宫内缓释系统治疗子宫腺肌病的临床观察

目的探讨子宫腺肌症患者放置左炔诺孕酮宫内缓释系统(LNG-IUS,商品名:曼月乐)后的临床疗效及副反应。方法观察38例子宫腺肌症的患者,放置LNG-IUS前、1个月、3个月、6个月月经情况、痛经程度、子宫体积内膜变化。结果放置LNG-IUS后,痛经显著缓解,疼痛评分从75±15降到22±7(P<0.05)。经量评分置环前、置环后1个月、3个月、6个月分别为(197±65)、(53±22)(、42±13)、(25±13)。6个月内子宫内膜明显变薄,差异显著。子宫体积在置环前后没有明显的变化。有4例患者出现卵巢生理性囊肿。结论LNG-IUS是治疗子宫腺肌症的一种较为有效且安全的方法。     

LNG-IUS 12: a 19.5 levonorgestrel-releasing intrauterine system for prevention of pregnancy for up to five years

Introduction: Globally, intrauterine devices (IUDs) are the second most commonly used form of reversible contraception because of their high efficacy, safety, convenience and cost effectiveness. The levonorgestrel releasing intrauterine system with daily average release of 20 mcg (LNG-IUS 20) is the popular choice because of its favorable bleeding patterns and many noncontraceptive benefits. A three year (LNG-IUS 8) became available three years ago. More recently, the LNG-IUS 12 was added. This new IUD shares a smaller frame, narrow inserter and lower rate of amenorrhea with the LNG-IUS 8, but it offers the five years of contraceptive protection of the LNG-IUS 20.

Areas covered: This article provides information on the contraceptive efficacy, safety and tolerability of this new IUS based on approximately 60,000 cycles of use. Where available, the impacts of subject age, parity and body mass index (BMI) on study outcomes are reported.

Expert opinion: This new LNG-IUS 12 with mid-dose hormone levels, smaller frame and longer effective life fills a niche that may better meet the needs of women who might appreciate the narrow insertion tube and/or the lower rates of amenorrhea. Cost will ultimately help determine success.     

负压吸宫术后立即放置左炔诺孕酮宫内缓释系统临床研究

目的探讨人工流产术后立即放置左炔诺孕酮宫内缓释系统的临床效果,观察其是否优于延迟放置。方法 2009年7月～2010年6月,将符合本研究纳入标准的人工流产70例患者分成两组,各35例,研究组在人工流产后立即放置曼月乐,对照组在流产后月经复潮后放置,比较其放置后阴道流血时间、脱落率、因症取出率。结果研究组放置后阴道流血时间显著短于对照组(P<0.05),随访期内(放置后1年)自然脱落率研究组为5.7%(2/35),对照组为2.9%(1/35),差异无统计学意义(P>0.05)。因症取出率研究组为2.9%(1/35),对照组为17.1%(6/35),差异有统计学意义(P<0.05)。结论人工流产术后立即放置曼月乐优于延迟放置,可以有效减少放置后出血时间,适合于人工流产后要求避孕女性。     

左炔诺孕酮宫内缓释系统对子宫腺肌病患者痛经的影响

目的观察左炔诺孕酮宫内缓释系统治疗子宫腺肌病痛经的临床效果。方法选择我院2015年3月~2016年3月68例子宫腺肌病痛经患者,根据治疗方法分为观察组(36例)与对照组(32例),对照组以孕三烯酮进行治疗,观察组以左诀诺孕酮宫内缓释系统进行治疗,观察两组患者的子宫内膜厚度、子宫体积、痛经评分、月经经期时间、血红蛋白、血清CA125、激素水平以及临床疗效和不良反应。结果观察组患者子宫内膜厚度以及子宫体积改善情况明显优于对照组(P<0.05);观察组患者痛经评分、月经经期时间改善情况明显优于对照组(P<0.05);两组血红蛋白较治疗前上升(P<0.05),并渐至正常水平,血清CA125水平治疗后明显下降(P<0.05),且观察组优于对照组。结论以左炔诺孕酮宫内缓释系统对子宫腺肌病痛经进行治疗,能够使患者子宫内膜厚度以及子宫体积得到显著改善,改善痛经症状,安全性好。     

Menorrhagia Impact Questionnaire: assessing the influence of heavy menstrual bleeding on quality of life

Abstract

Objective:

Menorrhagia, or heavy menstrual bleeding (HMB), has a negative impact on women’s quality of life (QOL). The objective was to develop, validate, and assess the performance of a disease-specific patient-reported outcome (PRO) measurement instrument for HMB (the Menorrhagia Impact Questionnaire [MIQ]).     

Retrospective analysis of variation in heavy menstrual bleeding treatments by age and underlying cause

Abstract

Objective:

To describe treatment patterns associated with heavy menstrual bleeding (HMB) in US practice.     

左炔诺孕酮宫内缓释系统在子宫内膜异位症术后患者中的应用效果

目的：探讨左炔诺孕酮宫内缓释系统（LNG-IUS）在子宫内膜异位症术后患者中的应用效果。方法选取2010年1月~2012年1月因子宫内膜异位症在本院行腹腔镜保守性手术治疗的患者60例随机分为两组,A组30例采用LNG-IUS治疗,B组30例采用孕三烯酮治疗。随诊两年,比较术前及治疗后的血清CA125、E2水平、VAS和治疗后2年的两组复发率。结果两组治疗后的CA125水平与术前比较差异有统计学意义（P〈0.01）;两组治疗后2年的CA125水平比较差异有统计学意义（P〈0.05）。 B组治疗后6个月、1年的血清E2水平与术前比较差异有统计学意义（P〈0.05）。治疗后6个月,两组血清E2水平比较差异有统计学意义（P〈0.05）。两组治疗后VAS与术前比较差异有统计学意义（P〈0.01）;治疗后1、2年,两组VAS比较差异有统计学意义（P〈0.05）。治疗后2年,A组复发率明显低于B组,差异有统计学意义（P〈0.05）。结论 LNG-IUS用于子宫内膜异位症术后辅助治疗,对卵巢功能影响较小,患者满意度高、依从性好、复发率低,阴道不规则流血是其主要副反应。