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首页> 外文期刊>Reproductive Biology and Endocrinology >A prospective, single-centre, single-arm, open label study of the long term use of a gonadotropin releasing hormone agonist (Triptorelin SR, 11.25?mg) in combination with Tibolone add-back therapy in the management of chronic cyclical pelvic pain
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A prospective, single-centre, single-arm, open label study of the long term use of a gonadotropin releasing hormone agonist (Triptorelin SR, 11.25?mg) in combination with Tibolone add-back therapy in the management of chronic cyclical pelvic pain

机译：一项潜在，单中心，单臂，开放标签研究，长期使用促性腺激素释放激素激动剂（Triptorelin Sr，11.25×mg）与龙源性骨盆疼痛管理中的紫龙加压治疗组合

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Chronic cyclic pelvic pain (CCPP) affects women’s quality of life and pituitary downregulation is often used for symptomatic relief. However, prolonged suppression of ovarian function is associated with menopausal side effects and can lead to osteoporosis. Currently, the use of gonadotropin releasing hormone agonists (GnRHa) for treatment of CCPP is usually restricted to 6–9?months, limiting their efficacy. There is limited information regarding safety and efficacy with longer-term use. The aim of this study is to examine the safety and efficacy of long-term (24?months) pituitary down-regulation with the GnRHa (Triptorelin SR) with add-back therapy (ABT) using Tibolone for symptom relief in women with CCPP. A single-arm, prospective clinical trial at a Tertiary University Teaching Hospital of 27 patients receiving Triptorelin SR (11.25?mg) and Tibolone (2.5?mg). Outcomes measures were the safety of treatment assessed by clinical examination, haematological markers, liver and renal function tests and bone mineral density (BMD) at 12, 18 and 24?months as well as at 6?months post-treatment. Pain and health-related quality of life (HR-QoL) assessed using the endometriosis health profile (EHP-30) and chronic pain grade (CPG) questionnaires. There was no evidence for any significant harmful effects on any of the measured haematological, renal or liver function tests. Although results regarding the effect on BMD are not conclusive there is an increased risk of development of osteopaenia after 12?months of treatment. Pain and HRQoL assessments showed significant improvement during medication, but with deterioration after treatment cessation. Long- term Triptorelin plus Tibolone add-back therapy in women suffering from CCPP does not appear to be associated with significant serious adverse events apart from the possibility of deterioration in the BMD that needs to be monitored. This mode of therapy appears to be effective in pain relief and in improving quality of life over a 24-month period. Clinical trials database NCT00735852.
机译：慢性循环骨盆疼痛（CCPP）影响女性的生活质量和垂体下调通常用于症状性浮雕。然而，延长抑制卵巢功能与绝经副作用有关，可以导致骨质疏松症。目前，使用促性腺激素释放激素激素激动剂（GnRHA）用于治疗CCPP通常限制为6-9个月，限制了它们的疗效。有限的信息有关安全性和疗效与长期使用。本研究的目的是审查长期（24？月）垂体下调的安全性和有效性，用加入治疗（ABT）使用Tibolone用于CCPP妇女的症状缓解。 27名患者的三级大学教学医院的单臂，前瞻性临床试验，接受曲素素SR（11.25×mg）和蒂龙（2.5？mg）。结果措施是通过临床检查，血液学标志物，肝脏和肾功能试验和12,18和24个月的骨矿物密度（BMD）评估的治疗安全性的安全性。治疗后6岁及6个月。使用子宫内膜异位症卫生概况（EHP-30）和慢性疼痛等级（CPG）问卷评估疼痛和健康相关的生活质量（HR-QOL）。对任何测量的血液学，肾病或肝功能试验没有任何显着有害影响的证据。虽然关于对BMD的影响的结果并非决定性，但在12个月治疗后，骨败病的发展风险增加。疼痛和HRQOL评估在药物治疗过程中表现出显着的改善，但治疗后止血后会发生恶化。长期血糖素加紫罗隆加紫罗隆加回疗法在患有CCPP的妇女中，除了需要监测的BMD的恶化可能性之外，患有严重严重的不良事件。这种疗法模式似乎有效地疼痛缓解，并在24个月内提高生活质量。临床试验数据库NCT00735852。

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