TRIPTORELIN FOR OVARY PROTECTION IN CHILDHOOD ONSET LUPUS

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究的长期目标是通过治疗干预开发保护系统性红斑狼疮（SLE）儿童性腺功能的治疗方法，其有益效果已被高质量的临床证据所证实。 环磷酰胺是SLE儿童最常用的免疫抑制剂，但尚无批准的针对环磷酰胺引起的性腺毒性的预防性治疗。 这项研究希望确定药物曲普瑞林作为性腺毒性预防剂的安全性，其剂量和化疗前达到完全卵巢抑制（COS）所需的时间，以及获得其有效性的初步证据，为SLE年轻女性提供卵巢保护。 本申请的中心假设是曲普瑞林可以安全地实现COS，并且可以有效地保护需要环磷酰胺促性腺毒性化疗的患有SLE的青少年女性的卵巢功能。 这一假设是基于对成人SLE患者的支持性研究结果而提出的。 调查的基本原理是，确定更有效的干预措施来保护卵巢功能和避免过早绝经将转化为生育率的增加，心血管疾病，骨质疏松症和其他绝经期长期健康并发症的风险因素的减少;这反过来又会降低与SLE相关的整体社会成本。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The long-term goal of this study is to develop therapies for protecting the gonadal function of children with systemic lupus erythematosus (SLE) through therapeutic interventions whose beneficial effects have been verified by high-quality clinical evidence. Cyclophosphamide is the most frequently used immunosuppressive agent for children with SLE but there are no approved prophylactic treatments against gonadotoxicity caused by cyclophosphamide. This study hopes to determine the safety of the drug triptorelin when used as a prophylactic against gonadotoxicity, its dose and the time necessary to achieve complete ovarian suppression (COS) prior to chemotherapy, as well as obtain preliminary evidence of its efficacy to provide ovarian protection for young females with SLE. The central hypothesis of this application is that triptorelin can safely achieve COS and may effectively preserve ovarian function of adolescent females with SLE requiring gonadotoxic chemotherapy with cyclophosphamide. This hypothesis has been formulated based on the results of supportive studies in adult patients with SLE. The rationale that underlies the investigation is that identification of more effective interventions to preserve ovarian function and avoid premature menopause will translate into increased fertility, fewer risk factors of cardiovascular disease, osteoporosis and other long-term health complications of menopause; this in turn, will lower the overall societal costs associated with SLE.