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Laparoscopic surgical approach for the treatment of piriformis syndrome: Intrapelvic decompression technique 腹腔镜手术治疗梨状肌综合征:盆腔内减压技术
IF 0.5 Q4 OBSTETRICS & GYNECOLOGY Pub Date : 2021-09-11 DOI: 10.1177/22840265211045610
A. Kale, G. Basol, Elif Cansu Gündoğdu, E. Mat, G. Yıldız, Betul Kuru, Y. Aboalhasan, N. Uzun, T. Usta, Mehmet Al tıntaş, R. Demirhan
Introduction: Piriformis syndrome is an uncommon disease resulting from the piriformis muscle’s compression of the sciatic nerve. Pain and numbness in the buttocks and down the leg are the most common symptoms. This study analyzes the laparoscopic surgical treatment of piriformis syndrome. Methods: We report three cases of piriformis syndrome diagnosed in our hospital. The first case was a 40 years old woman with a 7-year history of intermittent low back pain and sciatica on her right side. Hyperesthesia and cutaneous allodynia were observed in the right sciatic nerve dermatome. The second case was a 30 years old woman with a 2-year history of sciatica on her left side. The third case was a 30 years old woman with a 2-year history of sciatica on her right side. All the patients underwent laparoscopic decompression surgery, which was performed to release the sciatic nerve or sacral nerve roots. Results: The patients were reexamined at the postoperative 3rd and 6th months. Their visual analog scale (VAS) scores were found to be decreased from 10/10, 9/10, and 7/10 to 0/10, 1/10, and 0/10, respectively. Conclusion: Due to the very few cases in the literature, pelvic piriformis syndrome is an exclusively clinical diagnosis. If the sciatica is refractory to conservative treatments, laparoscopic exploration and decompression surgery of the pelvic nerves and piriformis muscle could be an option.
梨状肌综合征是由梨状肌压迫坐骨神经引起的一种罕见疾病。臀部和腿部的疼痛和麻木是最常见的症状。本研究分析腹腔镜手术治疗梨状肌综合征。方法:报告我院诊断的梨状肌综合征3例。第一个病例是40 岁女性,有7年间歇性腰痛和右侧坐骨神经痛病史。右坐骨神经皮片出现感觉异常和皮肤异常疼痛。第二个案例是30 岁女性,左侧坐骨神经痛病史2年。第三个案例是30 岁女性,右侧坐骨神经痛病史2年。所有患者都接受了腹腔镜减压手术,该手术是为了释放坐骨神经或骶神经根。结果:术后3、6个月复查。他们的视觉模拟量表(VAS)评分分别从10/10、9/10和7/10降至0/10、1/10和0/10。结论:由于文献中病例很少,盆腔梨状肌综合征是唯一的临床诊断。如果坐骨神经痛对保守治疗是难治的,腹腔镜探查和盆腔神经和梨状肌减压手术可能是一种选择。
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引用次数: 0
Altered eutopic endometrial T-regulatory and T-helper 17 lymphocyte ratio in women with unexplained subfertility. 不明原因不孕妇女异位子宫内膜T调节淋巴细胞和T辅助17淋巴细胞比例的改变。
IF 0.5 Q4 OBSTETRICS & GYNECOLOGY Pub Date : 2021-09-01 Epub Date: 2021-05-28 DOI: 10.1177/22840265211018544
Malavika K Adur, Andrea G Braundmeier-Fleming, Bruce A Lessey, Romana A Nowak

Problem: Perturbations in T-helper lymphocyte profiles have previously been associated with endometriosis related subfertility and conception failure. Hence a retrospective in vitro study was conducted to evaluate the relationship between T-regulatory (Treg) and T-helper 17 (Th17) lymphocytes in the eutopic endometrium of women with unexplained subfertility and correlate these profiles to their conception status.

Method of study: Eutopic endometrial biopsies were collected during the mid-secretory phase of the menstrual cycle, from women with unexplained subfertility. These samples were evaluated immunohistochemically for Treg and Th17 lymphocytes as well as the related proinflammatory cytokine, Interleukin-17 (IL-17). These eutopic endometrial T lymphocyte subpopulations were compared to the patients' conception status in subsequent cycles.

Results: Though Treg cells were not indicative of conception success in subsequent cycles, patients who maintained their subfertile (no conception) status were observed to have a higher Th17 cell count in their eutopic endometrium. The ratio of Treg:Th17 cell counts was significantly correlated to patient conception status as well. These trends stayed consistent irrespective of concurrent endometriosis.

Conclusion: Patients with a high proinflammatory Th17 lymphocyte profile and low Treg:Th17 ratio in their eutopic endometrium during the secretory phase of their menstrual cycle are more likely to not conceive in subsequent cycles.

问题:T辅助淋巴细胞谱的紊乱与子宫内膜异位症相关的不孕症和受孕失败有关。因此,我们进行了一项回顾性体外研究,以评估不明原因不孕妇女异位子宫内膜中 T 调节(Treg)和 T 辅助 17(Th17)淋巴细胞之间的关系,并将这些特征与受孕状况联系起来:研究方法:在月经周期中期分泌期收集不明原因不孕妇女的异位子宫内膜活检样本。对这些样本的 Treg 和 Th17 淋巴细胞以及相关的促炎细胞因子白细胞介素-17(IL-17)进行免疫组化评估。将这些异位的子宫内膜 T 淋巴细胞亚群与患者在后续周期的受孕情况进行比较:结果:虽然 Treg 细胞并不代表后续周期的受孕成功率,但观察发现,保持亚受孕(未受孕)状态的患者异位子宫内膜中 Th17 细胞数量较高。Treg:Th17细胞计数比与患者的受孕状态也有显著相关性。无论是否同时患有子宫内膜异位症,这些趋势都是一致的:结论:在月经周期的分泌期,异位子宫内膜中的Th17淋巴细胞具有较高的促炎症特征,且Treg:Th17比率较低的患者更有可能在随后的月经周期中无法受孕。
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引用次数: 0
Cannabinoids and chronic pelvic pain in women: Focus on endometriosis 大麻素和女性慢性盆腔疼痛:关注子宫内膜异位症
IF 0.5 Q4 OBSTETRICS & GYNECOLOGY Pub Date : 2021-09-01 DOI: 10.1177/22840265211011277
I. Marcu, A. Gee, B. Lynn
Chronic pelvic pain in women is common and frequently difficult to treat. Chronic pelvic pain often develops in the setting of endometriosis, interstitial cystitis/bladder pain syndrome, and vulvodynia. Cannabinoids are a promising treatment modality for non-cancer chronic pain, but have not been studied in women with chronic pelvic pain nor in specific chronic pelvic pain conditions. This review focuses on the interaction of the endocannabinoid system with the menstrual cycles, with endometriotic lesions, and within the bladder. Furthermore, it provides a brief overview of existing literature of the effects of endocannabinoids on chronic pain generally, with a focus on neuropathic pain. Finally, it discusses limited data available regarding the use of cannabinoids in women with chronic pelvic pain conditions. In the opinion of the authors, cannabinoids are a reasonable treatment modality for refractory chronic pelvic pain, especially if a neuropathic component is suspected. Practitioners should expect a modest effect on pain levels with an acceptable safety profile.
女性的慢性骨盆疼痛很常见,而且往往很难治疗。慢性盆腔疼痛通常发生在子宫内膜异位症、间质性膀胱炎/膀胱疼痛综合征和外阴痛。大麻酚类药物是治疗非癌症慢性疼痛的一种很有前途的治疗方式,但尚未在患有慢性骨盆疼痛的女性中进行研究,也未在特定的慢性骨盆疼痛条件下进行研究。这篇综述的重点是内源性大麻素系统与月经周期、子宫内膜异位病变和膀胱内的相互作用。此外,它还简要概述了内源性大麻素对慢性疼痛的影响的现有文献,重点是神经性疼痛。最后,它讨论了关于大麻素在患有慢性盆腔疼痛的女性中的使用的有限数据。在作者看来,大麻素是治疗难治性慢性盆腔疼痛的合理方法,尤其是在怀疑有神经性成分的情况下。从业者应该期望对疼痛水平产生适度的影响,并具有可接受的安全性。
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引用次数: 4
Bilateral ovarian cysts of mature cystic teratoma and Endometrioma: Its surgical challenges and review of literature 成熟囊性畸胎瘤和子宫内膜瘤的双侧卵巢囊肿:手术挑战和文献综述
IF 0.5 Q4 OBSTETRICS & GYNECOLOGY Pub Date : 2021-09-01 DOI: 10.1177/22840265211032115
V. Bindra, Mamatha G. S. Reddy, G. Mohanty, N. Agarwal, Aditya D. Kulkarni
Teratomas are most frequent germ cell tumors of ovary with an incidence of 15%–20% of all ovarian neoplasm while endometriomas are present in 25.5%–45% of women with pelvic endometriosis. In spite of their increased individual incidence, association of cystic teratomas and ovarian endometriomas is extremely rare. Our case is that of a 33-year-old nulligravida who presented with heavy menstrual flow and pain during periods for last few months, ultrasonography revealed 74 × 57 mm mass in right adnexa-likely ovarian dermoid, enlarged left ovary with two small cysts of size 33 × 29 mm and 25 × 20 mm likely endometrioma, managed by laparoscopy, found to have left ovarian endometrioma of 6 × 6 cm and right ovarian dermoid cyst of 10 × 8 cm size, histopathology confirmed the same. This association of teratoma in one ovary and endometrioma in other ovary of same patient poses a surgical challenge, when it affects young and nulliparous women. Further follow up is mandatory for this simultaneous finding of ovarian endometriosis with coincidental dermoid cyst to assess ovarian reserve, recurrence of either of the cysts, and it also presents a challenge to clinicians to predict the post-operative course of such cases.
畸胎瘤是最常见的卵巢生殖细胞肿瘤,发生率为所有卵巢肿瘤的15%-20%,而子宫内膜异位症患者中子宫内膜异位症的发生率为25.5%-45%。尽管个体发病率增加,但囊肿性畸胎瘤和卵巢子宫内膜异位瘤的关联是极其罕见的。我们的案例中是一位33岁的nulligravida面对沉重的月经时期和痛苦在最后的几个月中,超声显示74×57毫米adnexa-likely卵巢皮样的质量,扩大与两个小左卵巢囊肿的大小33×29毫米和25×20毫米可能子宫腺肌瘤,由腹腔镜检查,发现左卵巢子宫内膜瘤6×6厘米和右卵巢皮样囊肿10×8厘米大小、组织病理学确诊是一样的。在同一患者的一个卵巢畸胎瘤和另一个卵巢子宫内膜瘤的关联提出了手术的挑战,当它影响到年轻和未生育的妇女。对于同时发现卵巢子宫内膜异位症并并发皮样囊肿的患者,需要进一步随访,以评估卵巢储备、囊肿复发情况,同时对临床医生预测此类病例的术后病程也提出了挑战。
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引用次数: 0
Bilateral tubal incarceration into the broad ligaments caused by pelvic endometriosis: A case report 盆腔子宫内膜异位症致双侧输卵管嵌顿入宽韧带1例
IF 0.5 Q4 OBSTETRICS & GYNECOLOGY Pub Date : 2021-08-12 DOI: 10.1177/22840265211038197
Francesca Massimello, A. Giannini, L. Tebache, M. Nisolle, T. Simoncini
Introduction: Endometriosis is characterised by the presence of functional endometrial tissue outside the uterus. Salpinges are a common location of endometriotic implants. Endometriosis located into the broad ligament is a rare event. Case description: A 38-year-old infertile woman presented to our attention with moderate left iliac fossa pain after menses and intermenstrual bleeding. Transvaginal ultrasounds and pelvic magnetic resonance evidenced the presence of bilateral haematosalpinges. At the laparoscopic pelvic exploration, fallopian tubes were absent. Opening and dissecting the apical portion of the broad ligaments, we identified bilateral haematosalpinges incarcerated in the homolateral broad ligaments. We performed bilateral salpingectomy. Histological examination confirmed the presence of endometriosis. Conclusion: Care must be taken to the diagnostic assessment, counselling about the surgical programme before the intervention especially in patients during the reproductive period when the possibility of ablative surgery and subsequent need for an assisted reproductive technique exists.
简介:子宫内膜异位症的特征是子宫外存在功能性子宫内膜组织。输卵管是子宫内膜异位症植入的常见部位。子宫内膜异位症位于阔韧带是一个罕见的事件。病例描述:一名38岁不孕妇女,月经后左髂窝疼痛,经间出血。经阴道超声和盆腔磁共振证实双侧血输卵管的存在。腹腔镜盆腔探查,未见输卵管。打开并解剖宽韧带的根尖部分,我们发现了嵌顿在同侧宽韧带中的双侧血鞘。我们进行了双侧输卵管切除术。组织学检查证实子宫内膜异位症。结论:干预前应注意诊断评估和手术方案咨询,特别是育龄期患者,有可能进行消融手术并随后需要辅助生殖技术。
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引用次数: 0
A rare case of left Nuck’s canal cystic endometriosis: Computed Tomography findings 左努克管囊性子宫内膜异位症1例:计算机断层扫描结果
IF 0.5 Q4 OBSTETRICS & GYNECOLOGY Pub Date : 2021-08-06 DOI: 10.1177/22840265211037235
M. Parillo, C. Altomare, A. Bianchi, B. Beomonte Zobel, C. De Cicco Nardone, C. Quattrocchi
Introduction: Endometriosis is a common and chronic gynaecological condition but the implant in the canal of Nuck constitutes a very unusual state with an estimated prevalence of 0.3%–0.6% of all endometriosis cases. The canal of Nuck is an abnormal patent pouch of parietal peritoneum extending anteriorly from the round ligament of the uterus into the labia majora, thus represents a communication between the peritoneal cavity and the female inguinal canal. This condition may permit the seeding of endometriotic tissue in the inguinal soft tissues, becoming a possible cause of inguinal swelling or pain. Case description: A 43-years-old woman presented with painful swelling in her left groin. Ultrasound and a subsequent pelvic computed tomography showed a cystic lesion as for a Nuck’s canal encysted hydrocele. The patient underwent an anterior open surgery and the histologic examination revealed an endometrium-like tissue in the cystic wall. Conclusion: In women presenting with painful swelling of the groin, despite its rarity, endometriosis of the Nuck’s canal must be differentiated from other more common pathologies like hernias, varicoceles, neoplasms, and lymphadenopathies. Imaging can aid in differential diagnosis, but the final diagnosis is entrusted to histology, which enable to exclude an underlying malignancy.
简介:子宫内膜异位症是一种常见的慢性妇科疾病,但Nuck管内的植入物构成了一种非常不寻常的状态,估计患病率为所有子宫内膜异位症的0.3%-0.6%。Nuck管是腹膜壁异常未闭的囊,从子宫圆韧带向前延伸至大阴唇,代表了腹膜腔与女性腹股沟管之间的交通。这种情况可能允许子宫内膜异位症组织在腹股沟软组织中播种,成为腹股沟肿胀或疼痛的可能原因。病例描述:一名43岁女性表现为左腹股沟疼痛肿胀。超声和随后的盆腔计算机断层扫描显示一个囊性病变,如Nuck管囊肿性鞘膜积液。患者行前路开放手术,病理检查发现囊壁有子宫内膜样组织。结论:在表现为腹股沟肿胀疼痛的女性中,尽管罕见,但Nuck管子宫内膜异位症必须与其他更常见的病理如疝气、精索静脉曲张、肿瘤和淋巴结病相区分。影像可以帮助鉴别诊断,但最终的诊断是托付给组织学,它能够排除潜在的恶性肿瘤。
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引用次数: 0
Patient-reported utilization patterns of endometriosis medications in Europe: Real-world results from the non-interventional VIPOS study 欧洲患者报告的子宫内膜异位症药物使用模式:非介入性VIPOS研究的真实结果
IF 0.5 Q4 OBSTETRICS & GYNECOLOGY Pub Date : 2021-08-03 DOI: 10.1177/22840265211035993
K. Becker, K. Heinemann, B. Imthurn, L. Marions, S. Moehner, Sophia von Stockum, C. Gerlinger, M. Serrani, T. Faustmann
Introduction: Women with endometriosis require individualized, long-term treatment. Analyzing prescription choices, medication switches, discontinuations, and breaks can describe real-world treatment patterns and optimize pathways for women. To our knowledge, the Vi sanne P ost-approval O bservational S tudy (VIPOS) is the largest real-world, non-interventional study examining the safety of hormonal treatments for the routine clinical management of endometriosis. We present data from VIPOS on endometriosis drug utilization patterns, including treatment discontinuation due to treatment failure. Methods: VIPOS was a prospective, long-term, controlled, non-interventional cohort study in six European countries (Germany, Switzerland, Russia, Poland, Ukraine, and Hungary) conducted between 2010 and 2018. Women self-reported medical and gynecological history and symptoms and treatment information via comprehensive questionnaires. Results: Overall, 27,840 women were enrolled via gynecologists or specialized centers. Inter-country variance in treatment prescription patterns suggests the influence of differential management strategies and guidelines on prescribing behavior and diagnostic methods. Most enrolled women were receiving combined hormonal contraceptives. Women receiving dienogest 2 mg or gonadotropin-releasing hormone agonists more often had a surgical diagnosis of endometriosis compared to other treatments, while most women receiving combined hormonal contraceptives, other progestins or danazol had a symptom-based diagnosis. Although treatment changes during follow-up were common, only 4733 discontinuations out of 42,342 treatment starts were reported due to side effects or treatment ineffectiveness. Conclusion: VIPOS provides valuable insights into the considerable inter-country variance in endometriosis treatment prescription and potential role of differing management guidelines and practices strategies. Findings presented here suggest the need greater alignment of clinical practice to optimize patient management.
引言:患有子宫内膜异位症的妇女需要个体化的长期治疗。分析处方选择、药物转换、停药和休息可以描述现实世界中的治疗模式,并优化女性的治疗途径。据我们所知,Vi sanne后期批准的观察研究(VIPOS)是最大的现实世界非介入性研究,旨在检查激素治疗对子宫内膜异位症常规临床管理的安全性。我们提供了VIPOS关于子宫内膜异位症药物利用模式的数据,包括因治疗失败而停止治疗。方法:VIPOS是一项前瞻性、长期、对照、非干预性队列研究,于2010年至2018年间在六个欧洲国家(德国、瑞士、俄罗斯、波兰、乌克兰和匈牙利)进行。妇女通过综合问卷自我报告病史和妇科病史、症状以及治疗信息。结果:总共有27840名女性通过妇科医生或专业中心注册。治疗处方模式的国家间差异表明,差异管理策略和指南对处方行为和诊断方法的影响。大多数登记的妇女正在接受激素联合避孕药。女性接受dienogest 2 与其他治疗方法相比,mg或促性腺激素释放激素激动剂更常被手术诊断为子宫内膜异位症,而大多数接受联合激素避孕药、其他孕激素或达那唑的女性都有基于症状的诊断。尽管随访期间的治疗变化很常见,但在42342次治疗开始中,只有4733次因副作用或治疗无效而中断。结论:VIPOS为子宫内膜异位症治疗处方的巨大国家间差异以及不同管理指南和实践策略的潜在作用提供了有价值的见解。本文的研究结果表明,需要更好地协调临床实践,以优化患者管理。
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引用次数: 0
‘My devil womb’: Patients’ perspectives on, and understanding of, endometriosis: An observational cross-sectional study “我的魔鬼子宫”:患者对子宫内膜异位症的看法和理解:一项观察性横断面研究
IF 0.5 Q4 OBSTETRICS & GYNECOLOGY Pub Date : 2021-07-21 DOI: 10.1177/22840265211034092
Nadine Chilton, S. van Oudtshoorn, J. Pontré, K. Karthigasu, B. Mcelhinney
Objective: To gain insight into patients’ understanding of endometriosis, utilised sources of information on endometriosis and perceptions of available treatment options. Design: Observational cross-sectional study. Setting: Data were collected from an outpatient specialist endometriosis clinic within a tertiary hospital. Participants: New patients referred with symptoms suggestive of endometriosis. Methods: A paper based questionnaire was completed by new patients on their first presentation to the clinic. Main outcome measures: Patient understanding of symptoms and causes of endometriosis, types and expectations of treatment, and sources of information utilised by patients in researching endometriosis. Results: Approximately half of all included patients were unsure of the aetiology of endometriosis. Patients who relied on information from specialist gynaecologists were more optimistic about the outcome of surgical treatment, while those who relied on general practitioners were more optimistic about the outcome of medical treatment, when compared to those who sought information from online sources. Conclusions: Endometriosis is a chronic and debilitating condition, yet there is limited data available regarding both the sources of information that patients’ access, and their perceptions of the disease. Given the high proportion of patients in our study who lacked knowledge of endometriosis, and the negative correlation between the use of social media for information and perception of treatment, there is a clear need for improved access to evidence-based resources for patient education.
目的:了解患者对子宫内膜异位症的认识,利用子宫内膜异位症的信息来源和对可用治疗方案的看法。设计:观察性横断面研究。环境:数据收集于一家三级医院的门诊专家子宫内膜异位症诊所。参与者:有子宫内膜异位症症状的新患者。方法:对首次就诊的新患者进行问卷调查。主要结果测量:患者对子宫内膜异位症的症状和原因、治疗类型和期望的了解,以及患者在研究子宫内膜异位症时利用的信息来源。结果:大约一半的患者不确定子宫内膜异位症的病因。与从网上获取信息的患者相比,依赖妇科专家信息的患者对手术治疗的结果更为乐观,而依赖全科医生信息的患者对医疗结果更为乐观。结论:子宫内膜异位症是一种慢性衰弱性疾病,但关于患者可获得的信息来源和他们对疾病的看法的数据有限。考虑到在我们的研究中有很高比例的患者缺乏对子宫内膜异位症的知识,以及使用社交媒体获取信息与对治疗的认知之间的负相关,显然需要改善对患者教育的循证资源的获取。
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引用次数: 1
Characterizing the impact of menstrual and pelvic health disorders in a convenience sample of women in Barbados 在巴巴多斯方便抽样的妇女中描述月经和骨盆健康障碍的影响
IF 0.5 Q4 OBSTETRICS & GYNECOLOGY Pub Date : 2021-06-16 DOI: 10.1177/22840265211024437
Julia S Mandeville, Damian Best, F. Waterman
Objective: To describe the impact of menstrual and pelvic health disorders on a sample of Barbadian women living with one or more disorders. Design and methods: Responses from a survey taken online by a sample of women living in Barbados (⩾18 years) were assessed. Variables collected included, age, disorder(s) diagnosed, and symptoms. The Work Productivity and Activity Impairment (WPAI) Questionnaire: Specific Health Problem, was administered to measure impact on work and other activities. T-tests, chi- square tests, odds ratios, ANOVA, and multivariate analysis were conducted to estimate the associations between patient characterization, disorder characteristics and outcomes. Results: A total of 247 unique responses were received and after data were reviewed 192 responses (77.7%) from this convenience sample were analyzed. Polycystic Ovary Syndrome was the most frequently reported diagnosis (34.7%). The most frequently reported symptom was fatigue (53%). There was an OR of 2.17 (95% CI 0.54–8.74) of missing work due to menorrhagia and 2.60 (95% CI: 1.31–5.17) of missing work if diagnosed with endometriosis. The WPAI revealed endometriosis to be the condition with the most substantial impact on work in the subgroup of persons with one diagnosis, with presenteeism of 49.2%, absenteeism of 13.3% and an impact on other activities of 56.4%. Conclusion: Pelvic and menstrual disorders have a significant impact on productivity and other activities of Barbadian women. More research is necessary to elucidate the impacts of menstrual and pelvic disorders and treatments on patient outcomes.
目的:描述月经和盆腔健康障碍对患有一种或多种疾病的巴巴多斯妇女样本的影响。设计和方法:对居住在巴巴多斯(大于或等于18岁)的女性样本进行的在线调查的回应进行了评估。收集的变量包括年龄、诊断的疾病和症状。工作效率和活动障碍(WPAI)问卷调查:具体健康问题,用于衡量对工作和其他活动的影响。采用t检验、卡方检验、比值比、方差分析和多变量分析来估计患者特征、疾病特征和结果之间的关系。结果:共收到247份独特回复,经过数据审核后,分析了192份回复(77.7%)。多囊卵巢综合征是最常见的诊断(34.7%)。最常见的症状是疲劳(53%)。因月经过多而缺勤的OR为2.17 (95% CI 0.54-8.74),诊断为子宫内膜异位症的缺勤OR为2.60 (95% CI: 1.31-5.17)。WPAI显示子宫内膜异位症是对工作影响最大的疾病,出勤率为49.2%,缺勤率为13.3%,对其他活动的影响为56.4%。结论:骨盆和月经紊乱对巴巴多斯妇女的生产力和其他活动有重大影响。需要更多的研究来阐明月经和盆腔疾病及其治疗对患者预后的影响。
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引用次数: 0
Thromboembolic safety profile of low-dose estradiol (valerate) in combined hormonal preparations: Implications for the development of new hormonal endometriosis and uterine fibroid therapies 低剂量雌二醇(戊酸酯)联合激素制剂的血栓栓塞安全性:对新激素子宫内膜异位症和子宫肌瘤治疗发展的影响
IF 0.5 Q4 OBSTETRICS & GYNECOLOGY Pub Date : 2021-05-27 DOI: 10.1177/22840265211019546
C. Barnett, A. Bauerfeind, Sophia von Stockum, K. Heinemann
Background: Several promising new medications containing low-dose estradiol (E2) in combination with a progestin and an additional component, such as gonadotropin-releasing hormone antagonists, are currently being developed for use in pre-menopausal women. Objective: This pooled analysis was designed to estimate the thromboembolic safety profile of E2 and its ester, estradiol valerate (E2Val), when used in combined hormonal treatments in a pre-menopausal population. Methods: Data regarding users of combined oral contraceptives (COCs) and combined menopausal hormonal therapy (MHT) containing either E2/E2Val or ethinylestradiol (EE) ⩽ 30 µg were retrieved from five large prospective, non-interventional, cohort studies in Europe, US, and Canada with similar study design but differing medication cohorts. Propensity score sub-classification was applied to balance baseline parameters between cohorts and time-to-event analysis of venous thromboembolic events (VTE) was carried out based on the extended Cox model to calculate crude and adjusted hazard ratios (HR). Results: (1) Crude incidence rates of VTE were higher in MHT users compared to pre-menopausal COC users, (2) the VTE risk in menopausal users of E2/E2Val-norethindrone acetate was not higher than that in menopausal users of E2/E2Val-progestin (adjusted HR 0.71; 95% confidence interval, 0.41-1.26) and (3) the VTE risk in pre-menopausal users of E2/E2Val-progestin was similar, or lower, than pre-menopausal users of EE⩽30µg-progestin (adjusted HR 0.49; 95% confidence interval, 0.28–0.84). Conclusion: Our data presents a solid safety assessment of combined hormonal preparations containing E2/E2Val. We conclude that the risk of E2/E2Val-norethindrone acetate in pre-menopausal users is unlikely to be higher than the known risk of COCs containing EE ⩽ 30 µg-progestin.
背景:目前正在开发几种有前景的新药,包括低剂量雌二醇(E2)与孕激素和其他成分,如促性腺激素释放激素拮抗剂,用于绝经前妇女。目的:本汇总分析旨在评估E2及其酯戊酸雌二醇(E2Val)在绝经前人群中用于激素联合治疗时的血栓栓塞安全性。方法:从欧洲、美国和加拿大的五项大型前瞻性、非干预性队列研究中检索关于联合口服避孕药(COCs)和含有E2/E2Val或炔雌醇(EE)30µg的联合更年期激素治疗(MHT)使用者的数据,这些研究设计相似,但药物队列不同。应用倾向评分亚分类来平衡队列之间的基线参数,并基于扩展Cox模型对静脉血栓栓塞事件(VTE)进行时间-事件分析,以计算粗略和调整后的风险比(HR)。结果:(1)MHT使用者的VTE粗发病率高于绝经前COC使用者,与绝经前使用EE⩽30µg-孕激素的人相比(调整后的HR 0.49;95%置信区间,0.28-0.84)。结论:我们的数据对含有E2/E2Val的联合激素制剂进行了可靠的安全性评估。我们得出的结论是,绝经前使用者使用E2/E2Val去甲肾上腺素醋酸酯的风险不太可能高于含有EE⩽30µg-孕激素的COCs的已知风险。
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Journal of endometriosis and pelvic pain disorders
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