Open-label study of ultra low-dose mifepristone for the treatment of uterine leiomyomata

Objective

To assess the effect of ultra low-dose mifepristone on uterine size, pain, bleeding and quality of life among women with symptomatic leiomyomata.

Study design

Open-label cohort study of 2.5 mg mifepristone orally among adult women with at least moderately severe symptoms related to leiomyomata and total uterine volume of greater than 160 cm³, or at least one myoma of greater than 2.5 cm diameter. Assessments of leiomyomata and uterine size (ultrasound), pain (McGill Pain Questionnaire), bleeding (daily log duration), quality of life (Uterine Fibroid Symptom and Quality of Life) and health status (SF-36) were conducted at baseline, three months and six months. Endometrial sampling was done at baseline and six months.

Results

Seventeen (74%) participants completed the entire six-month trial. Each of the measures showed significant improvement at six months compared to baseline (p < 0.001). Uterine volume decreased by 11% and anemia, bleeding, pain, health status and fibroid-related quality of life improved during the course of the trial. Endometrial sampling showed cystic glandular dilatation, but no evidence of endometrial hyperplasia or cellular atypia.

Conclusion

Treatment of women with symptomatic leiomyomata with ultra low-dose mifepristone for six months is associated with modest reduction in uterine size, appreciable improvements in symptoms and quality of life and no evidence of endometrial hyperplasia.     

Patient satisfaction and disease specific quality of life after uterine artery embolization

OBJECTIVES: This study was undertaken to evaluate changes in fibroid specific symptom severity and health-related quality of life (HRQOL) after uterine artery embolization (UAE) and to consider the impact of these changes on satisfaction with the procedure. STUDY DESIGN: A validated, fibroid specific, symptom, and HRQOL questionnaire was mailed to 80 women who had undergone UAE from 1998 through 2002. Pre- and postprocedure symptom severity and HRQOL scores were obtained. The primary outcome measure was change in fibroid symptoms and HRQOL after UAE. Secondary outcomes included objective measures of patient satisfaction, and the decrease in uterine volume after UAE. RESULTS: Questionnaires were completed by 64 women (80.0%) at a mean of 32.1 months from UAE (range: 57.5-6 months). After UAE, mean uterine volume decreased by 26.3% (95% CI 19.6-33.0), and 17 of 79 women (21.5%) underwent an additional procedure after a mean of 18.6 months. Symptom severity scores decreased by a mean of 35.2% (95% CI 29.3-41.1) and HRQOL scores increased by a mean of 35.7% (95% CI 28.9-42.4). Satisfaction with UAE was correlated with the change in symptom severity and HRQL scores (P <.0001 and P=.0004, respectively) and the decrease in uterine volume after UAE (P=.0196). CONCLUSION: Women who undergo UAE have a significant decrease in symptom severity and increase in HRQOL, associated with high levels of satisfaction with the procedure, even when subsequent therapies are pursued.     

促性腺激素释放激素激动剂与米非司酮治疗子宫肌瘤的临床对照研究

目的比较促性腺激素释放激素激动剂（ＧｎＲＨ－ａ）与米非司酮治疗子宫肌瘤的临床疗效及副作用。方法将７５例根据临床症状、妇科检查及Ｂ超诊断为子宫肌瘤患者,随机分为两组,ＧｎＲＨ－ａ组３０例,每天用ＧｎＲＨ－ａ１５０μｇ肌内注射或皮下注射３个月;米非司酮组４５例,用米非司酮每天１２．５ｍｇ口服３个月,比较两组治疗的疗效与副反应。结果两组患者临床症状均有明显改善。肌瘤体积,ＧｎＲＨ－ａ组缩小２０．０％以上者有２７例,占９０．０％;米非司酮组肌瘤缩小２０．０％以上者有４１例,占９１．１％。复发率,ＧｎＲＨ－ａ组为４０．０％,米非司酮组为１７．８％。结论米非司酮较ＧｎＲＨ－ａ对子宫肌瘤有更好的治疗效果     

米非司酮对子宫肌瘤间隙连接蛋白43表达的影响

目的 :研究间隙连接蛋白 4 3(Cx4 3)在子宫肌瘤中的表达及米非司酮作用后Cx4 3蛋白表达的改变 ,探讨子宫肌瘤的生长及治疗的相关机制。方法 :用免疫组化法检测 30例子宫肌瘤组织 ,2 0例术前 3d给予米非司酮的子宫肌瘤及 2 0例正常子宫肌组织中Cx4 3蛋白的表达。结果 :子宫肌瘤Cx4 3蛋白表达高于正常子宫肌组织 (P <0 .0 5 )。子宫肌瘤Cx4 3蛋白表达增生期高于分泌期 (P <0 .0 5 )。米非司酮作用后Cx4 3蛋白表达在增生期无明显改变 (P >0 .0 5 ) ,分泌期明显增高 (P <0 .0 5 )。结论 :子宫肌瘤中Cx4 3蛋白表达水平与月经周期相关 ,米非司酮对Cx4 3蛋白表达的上调可能是其治疗子宫肌瘤的机制之一。     

Characterization of therapy and costs for patients with uterine fibroids in Utah Medicaid

Objectives To determine in an eligible Utah Medicaid population (1) medical and drug costs associated with treating uterine fibroids (UFs) and (2) the cost and incidence of hysterectomy complications. Methods Medical and drug cost analyses were based on data from 897 premenopausal patients with UFs included in the Utah Medicaid database from 1996 to 2004. UF-related medical and pharmacy costs were determined from first diagnosis of UFs until a related procedure or until estimated menopause. Outcomes for patients treated with a procedure (hysterectomy, myomectomy, or embolization), medication, and watchful waiting (no procedure, no UF-related drug) were compared. When determining hysterectomy complication rates for the population of women in the Medicaid database, a total of 1,323 pre- or postmenopausal patients with UFs were included. Results Overall, 20% of patients were treated with medication, 33% with a procedure, and 47% with watchful waiting. Mean total UF costs were: $11,996 (procedure), $2,703 (medication), and $2,118 (watchful waiting). Mean eligibility months were 8.8, 28.8, and 14.1, respectively. Costs/eligible month were: $1,358 (procedure), $151 (watchful waiting), and $94 (medication). The mean hysterectomy cost was $12,107. Conclusion Treatment for UFs is expensive with a mean cost of $5,504 per study patient. The highest costs are seen in patients receiving procedures, which can lead to complications; 15% in this study. Costs for watchful waiting are similar to costs in patients receiving UF-related drugs. Consideration should be given to using non-surgical therapies for the treatment of UFs before procedures are performed.     

Chronic pelvic pain and quality of life after laparoscopy

OBJECTIVES: To examine the long-term relationship between chronic pelvic pain (CPP) and quality of life and see if this is affected by a negative laparoscopy result. STUDY DESIGN: A postal questionnaire survey of CPP and quality of life in 63 women who underwent a diagnostic laparoscopy 12-18 months previously. RESULTS: Women with CPP still reported pain 12-18 months after laparoscopy and a significantly poorer quality of life than UK norms for women of a similar age. Factor analysis showed that reports of pain symptoms clustered into two dimensions: (1) pain associated with menstruation and (2) pain associated with sexual intercourse and bladder and bowel function. Most dimensions of quality of life were significantly associated with pain. However, 'role limitation due to emotional problems' and 'mental health' were only associated with pain due to sexual intercourse and bladder and bowel function. Pain and quality of life were not affected by laparoscopy result or follow-up appointment. CONCLUSIONS: Women with CPP continue to have pain and a low quality of life 12-18 months after laparoscopy. Laparoscopy results and follow-up appointments do not appear to affect either pain symptoms or quality of life in the long term, although this may be confounded by women obtaining treatment elsewhere.     

A new hypothesis about the origin of uterine fibroids based on gene expression profiling with microarrays

This article will discuss some recent insights based on our microarray studies that have emphasized the role the extracellular matrix, transforming growth factor beta, and collagen structure in fibroid formation. These studies led to appreciation of molecular similarities between fibroids and keloids. Collectively, these observations suggest a model of fibroid development based on an abnormal response to tissue repair, resulting in disordered healing and formation of an altered extracellular matrix.     

米非司酮治疗异位妊娠后宫内再孕率分析

目的　探讨米非司酮 (RU4 86 )治疗异位妊娠成功后的宫内再孕率。方法　回顾性分析我院1 996年 1月～ 2 0 0 2年 1月之间收治的 98例有生育要求的、药物保守治疗成功的异位妊娠患者的临床资料 ,其中5 8例为米非司酮 (RU4 86 )治疗成功 ,4 0例为甲氨蝶呤 (MTX)全身治疗成功 ,并经门诊及电话随诊。结果　RU4 86治疗者宫内再孕率 5 1 7% ,MTX治疗者宫内再孕率 5 2 5 % ,两者比较差异无显著性 (P >0 0 5 )。结论　RU4 86保守治疗的宫内再孕率和MTX保守治疗的宫内再孕率比较无明显差异 ,而且前者无明显副作用 ,血 β -hCG下降明显 ,患者更易接受     

妊娠滋养细胞肿瘤患者化疗后生命质量的相关因素分析

目的 采用自设计的量表描述妊娠滋养细胞肿瘤(GTN)患者经化疗获得完全缓解后的生命质量情况,寻找影响生命质量的可干预的相关因素.方法 自制的生命质量调查量表是在综合多个权威量表及GTN特点的基础上设计的,经检验具有较好的信度和效度.选取2008年12月至2009年5月期间在北京协和医院随诊的100例经化疗已完全缓解的GTN患者,采用自设计的量表描述并统计分析患者化疗后生命质量的相关影响因素.结果 经化疗获得完全缓解3个月以上的GTN患者具有较好的生命质量,只有16%(16/100)的患者自觉总体生命质量"一般",无总体生命质量"差"的反馈.70%(70/100)的患者对目前的性生活感到满意.分别有47%(47/100)和45%(45/100)的患者存在不同程度的性欲减低和阴道干燥的问题.有66%(66/100)的患者表现出不同程度的抑郁情绪,50%(50/100)的患者存在焦虑情绪.相关性分析发现,GTN患者生命质量的影响因素包括躯体功能(r=0.609,P＜0.01)、性功能(r=0.473,P＜0.01)及情绪心理(r=0.294,P＜0.01).结论 GTN患者经化疗获得完全缓解后具有较好的生命质量,化疗后影响生命质量的因素主要表现在躯体功能、性功能、情绪心理方面.患者的性功能障碍主要表现为性欲减低和阴道干燥症状,但大多数患者对性生活满意.     

Treatment of uterine myoma with 5 or 10mg mifepristone daily during 6 months, post-treatment evolution over 12 months: double-blind randomised clinical trial

Objectives

To evaluate the efficacy and safety of 5 and 10 mg doses of mifepristone for 6 months for the treatment of uterine fibroids and to check those results at 1 year post-treatment.

Study design

Randomised double-blind clinical study carried out at the “Eusebio Hernández” Hospital, Havana, Cuba. One hundred and seventy-six women with symptomatic uterine fibroids received one daily capsule of 10 mg mifepristone orally or one daily capsule of 5 mg mifepristone orally, over 6 months. Up to two endometrial biopsies were performed. Reduction in fibroid volume was used to evaluate efficacy.

Results

The 5 and 10 mg dose had a similar efficacy in reducing the fibroid volume, 48.1% and 39.1%, p = 0.07, and that of the uterus, 30.3% and 27.2%, p = 0.63, respectively. Twelve months after treatment the majority of the subjects were asymptomatic with symptom prevalence similar to that at the end of treatment, except for hypermenorrhea and metrorrhagia, although the intensity of hypermenorrhea was much less, p < 0.01.

Conclusions

(1) Both doses obtain similar results in reducing fibroid size. (2) Administering 6 months’ treatment achieves symptomatic improvement lasting 1 year in a high percentage of cases. (3) More studies need to be carried out with longer treatment and follow-up periods.     

Prolapse severity, symptoms and impact on quality of life among women planning sacrocolpopexy.

OBJECTIVES: To explore the relationship between severity of pelvic organ prolapse (POP), symptoms of pelvic dysfunction and quality of life using validated measures. METHOD: Baseline data from 314 participants in the Colpopexy And Urinary Reduction Efforts (CARE) trial were analyzed. Pelvic symptoms and impact were assessed using the Pelvic Floor Distress Inventory (PFDI) and the Pelvic Floor Impact Questionnaire (PFIQ). PFDI and PFIQ scores were compared by prolapse stage and history of incontinence or POP surgery. Regression analyses were performed to identify other predictors of symptoms and impact. RESULTS: Women were predominantly (90%) Caucasian and had mean age of 61 years. Women with stage II POP, especially those with prior surgery, reported more symptoms and impact than women with more advanced POP. There were no other significant predictors of symptoms or life impact. CONCLUSIONS: Women planning sacrocolpopexy with stage II prolapse and prior pelvic surgery reported more symptoms and quality of life impact than those with more advanced prolapse.     

Women's quality of life and sexual function after transvaginal anterior repair with mesh insertion

Objective

Current evidence about the impact of pelvic floor surgery on sexual function is conflicting. Only a few studies have reported with validated questionnaires on sexual function after transvaginal mesh repair, with a discrepancy in reported outcomes. The aim of this study was to prospectively explore the impact of anterior repair (AR) with mesh insertion on sexual function, quality of life and dyspareunia.

Study design

69 women with symptomatic stage II or greater prolapse exclusively of the anterior compartment participated in a prospective study on safety and efficacy of two mesh implantation techniques for anterior vaginal wall prolapse repair between September 2007 and May 2009. They were invited to complete the validated condition-specific short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and quality of life (QoL) questionnaires (Pelvic Organ Prolapse (POP) Distress Inventory (POPDI), Urinary Distress Inventory (UDI), POP Impact Questionnaire (POPIQ), and Urinary Impact Questionnaire (UIQ)) pre-operatively and 6 months post-operatively. All data were processed and analyzed in Statistical Computing Environment R, version 2.9.1.

Results

A significant decrease of Qol scores and a significant increase of PISQ-12 scores occurred after surgery. All sexually active women resumed sexual activity postoperatively. The majority of non-sexually active women remained sexually inactive. Postoperatively the frequency of pain during intercourse increased in 31% of cases and decreased or stayed unchanged in 69% of cases. The incidence of de novo dyspareunia after mesh repair was 4% while the incidence of dyspareunia slightly increased from 25% to 29% postoperatively.

Conclusions

The results of this study suggest no deterioration in sexual function, a significant improvement in quality of life and a low incidence of de novo dyspareunia six months after AR with mesh insertion. Despite these findings, the majority of non-sexually active women remain sexually inactive postoperatively. These conclusions should be confirmed in a longer follow-up.     

米非司酮对保守性手术后子宫内膜异位症临床治疗效果的观察

目的:探讨子宫内膜异位症患者保守性手术后服用米非司酮巩固治疗的临床疗效及其对内分泌的影响。方法:选择2003年1月至2005年1月行保守性手术的盆腔子宫内膜异位症患者70例,随机分为3组。米非司酮组30例,给予米非司酮12.5mg口服,每天1次,于手术后第1次月经来潮5天内开始用药,疗程为6个月。GnRH-a组20例,于手术后第1次月经来潮5天内,腹部皮下注射戈舍瑞林(商品名:诺雷得)3.6mg,28天注射1次,共6次。对照组20例患者手术后不用药物巩固治疗。比较分析应用米非司酮和GnRH-a治疗子宫内膜异位症的疗效、副反应及对垂体-卵巢轴内分泌的影响。结果:3组患者痛经症状都得到不同程度的缓解,米非司酮组和GnRH-a组的完全缓解率分别为87%和90%,明显高于对照组的55%,差异有统计学意义(P<0.05)。米非司酮组和GnRH-a组累积复发率分别为7%和5%,显著低于对照组(P<0.05)。米非司酮组和GnRH-a组之间的完全缓解率和累积复发率均无统计学差异(P>0.05)。结论:米非司酮用于盆腔子宫内膜异位症患者保守性手术后的巩固治疗有效,可预防和减少复发,而且副反应小,对内分泌代谢及骨密度无明显影响。     

Effect of autogenic training on quality of life and symptoms in people living with HIV: A mixed method randomized controlled trial

ObjectiveQuality of life of people living with HIV is strongly affected by sleep problems, fatigue, pain, anxiety, and depression symptoms. This study set out to evaluate the effects of autogenic training (AT) on quality of life and symptoms within this population.MethodsA mixed method randomized controlled trial was conducted. Participants were randomly assigned to either the AT group (n = 32) or the control group (CG) (n = 31). Quality of life and symptoms were measured in both groups three times: prior to intervention (T0), immediately after intervention (T3), and three months after intervention (T6). Fourteen individual interviews were conducted.ResultsResults show a significant improvement in social and mental dimensions of quality of life for the two groups at T6. They also show a significant improvement in sleep for AT participants at T3. Qualitative results are consistent with quantitative ones.ConclusionAT seems to improve sleep quality and could improve some dimensions of quality of life and other symptoms among people living with HIV. Further studies are needed to confirm these results.Trial registration numberNCT01901016.     

盆腔脏器脱垂患者阴道封闭术后生活质量调查分析

目的:评价阴道封闭手术对盆腔脏器脱垂患者生活质量的影响。方法:2003年3月至2009年5月北京大学人民医院妇产科为27例POP-Q分期Ⅱ～Ⅳ期的盆腔脏器脱垂患者实施了阴道封闭手术。患者填写术前及术后生活质量调查问卷。术后定期复查,判定主客观复发情况。结果:可进行生活质量评价的阴道封闭手术患者27例,均为联合盆腔缺陷。随访时间7～79个月,平均35.5个月,主观满意率96.3%,客观治愈率100%。术前及术后生活质量自评分有显著统计学差异(χ2=60,P<0.01)。术后患者性功能完全丧失,1例患者随访79个月,仍有下腹部及会阴部坠胀感。结论:老年女性特别是有合并症不能耐受较大手术的患者阴道封闭术疗效肯定,可显著改善患者术后生活质量,但术后患者完全失去性功能,且部分患者术后有下腹部及会阴部坠胀感,应引起重视。     

子宫动脉栓塞术治疗有症状子宫肌瘤术后患者生存质量的评估

目的评估腹腔镜辅助下经阴道全子宫切除术(LAVH)和子宫动脉栓塞术(UAE)对有症状、无生育要求的子宫肌瘤患者术后的生存质量影响。方法选择2000年12月至2003年12月中日友好医院和海淀医院妇科住院有症状、无生育要求的子宫肌瘤患者56例,随机选择治疗方案。各组患者皆于入院时、术后2月、术后2年进行问卷调查,独立填写WHOQOL-BREF表。比较不同治疗方式在术后不同时间的生存质量评分。结果在生理、心理、社会关系、环境和主观感受4个方面,两组术后都有显著改善。但是,LAVH组在术后2年生存质量才显现显著的差异。UAE组则在术后2月即有了显著改变。结论两组都明显地提高了患者术后的生存质量,在远期效应中无明显差异(除了心理层面),UAE组在提高患者生存质量上有明显的优势。     

Impact of HTLV-I in quality of life and urogynecologic parameters of women with urinary incontinence

Objective

To assess the impact of urinary incontinence in quality of life, epidemiological data, symptoms, findings of gynecological/neurological examination and urodynamic of HTLV-I seropositive women compared with HTLV-I negative women.

Study design

43 incontinent women were divided in two groups: 24 seropositives and 19 seronegatives for HTLV-I. We used King's Health Questionnaire (KHQ), standardized recorded data and urodynamics. Data were compared using Mann–Whitney test or Chi-squared test.

Results

Quality of life was significantly worse in seropositive incontinent women in the following parameters: general perception of health, impact of incontinence, limitation of daily life activities, social relations, sleep and disposition. Also, the following gynecological/neurological symptoms were more prevalent in seropositives: pain on vesical filling, dyspareunia, parestesis in inferior members, increased perineal sensitivity, pain in vaginal palpation, increased vaginal tonus, gait alteration, increased patellar reflex, Babinski reflex positive and increased tonus in inferior members.

Conclusion

Poor quality of life and physical abnormalities were identified in incontinent HTLV-I seropositive women when compared with incontinent HTLV-I seronegative women.     

Quality of life evaluations in patients with ovarian cancer during chemotherapy treatment

OBJECTIVES: To examine the impact of treatment- and disease-related factors on the quality of life of patients with ovarian cancers undergoing chemotherapy. PATIENTS AND METHODS: Over 18 months period, all patients with ovarian cancer receiving chemotherapy at the Saskatoon Cancer Center were recruited. The Functional Assessment of Cancer Therapy-Ovarian (FACT-O) questionnaire was used to assess patients' quality of life before each chemotherapy cycle. Platinum-based chemotherapy was used initially or in patients with a platinum-free interval of more than 6 months in a recurrence setting. After progression on the platinum-based regimens, liposomal doxorubicin, topotecan, and cisplatinum/etoposide were used as salvage chemotherapy pending on drug availability and convenience of administration to patients. Regression analysis was used to identify significant disease and treatment-related factors that can significantly affect patients' quality of life measures. RESULTS: Seventy-two patients participated in the study providing 270 separate observations. The mean age was 57.81 years with a standard deviation of 13.40. The median duration of chemotherapy-free interval for patients with recurrent disease was 7 months. All patients had stage 3 or 4 disease. About half (52.2%) of the patients had optimal surgical resection with small (<1 cm) residual cancer masses before primary adjuvant chemotherapy. Seventy percent of the patients had either a first diagnosis or a first recurrence of cancer with the other 30% previously treated with two or more chemotherapy regimens. Sixty-two percent had an initial complete response to platinum-based chemotherapy. Multivariate regression analysis showed the use of topotecan or cisplatinum/etoposide, patients' poor responses to chemotherapy, experience with two or more previous line of chemotherapy treatment, and younger ages were significant predictors of poor quality of life during chemotherapy. CONCLUSION: There were significant differences in side effects of commonly used chemotherapy regimens on patients' quality of life. Quality of life assessments should be routinely incorporated in selecting specific chemotherapy to be used. Future research should be carried out to identify the best strategies to further integrate the results of quality of life assessments in cancer treatment protocols and to examine the long-term effects of cancer and its treatment on patients and their families.