ORAL CYCLOPHOSPHAMIDE VS ORAL PLACEBO IN SYSTEM SCLEROSIS PULMONARY AVEOLITIS

口服环磷酰胺与口服安慰剂治疗系统性硬化性肺泡炎

• 批准号: 7376113
• 负责人: VIRGINIA D STEEN
• 金额: $ 0.77万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376113
• 关键词: ORAL; CYCLOPHOSPHAMIDE; VS; PLACEBO; SYSTEM

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. This study has been designed to evaluate whether cyclophosphamide (a strong anti-inflammatory and immunosuppressant medication, trade named Cytoxan) is better than placebo (an inert, no effective treatment) in preventing lung damage from scleroderma from getting worse. This rail will compare 2 milligrams per kilogram per day of cyclophosphamide (approximately 100-150 mg in tablet form) with a placebo that looks like cyclophosphamide but is inert, with allowances for dose adjustments for toxicity. In previous studies from several centers, improvement in lung function was reported to have occurred after starting cyclophosphamide. In one recent study, lung function improved by greater than 10% in 3/4 of the cyclophosphamide patients and in 1/4 of the non-treated patients. This study is designed toexamine in a scientific fashion whether cyclophosphamide does actually improve lung function in people with scleroderma with early lung involvement.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。这项研究旨在评估环磷酰胺（一种强效抗炎和免疫抑制药物，商品名为环磷酰胺）在预防硬皮病肺损伤恶化方面是否优于安慰剂（一种惰性，无效的治疗方法）。这条轨道将比较每天每公斤2毫克的环磷酰胺（片剂形式约100-150 mg）与安慰剂，安慰剂看起来像环磷酰胺，但是惰性的，允许剂量调整毒性。在几个中心的既往研究中，报告称开始环磷酰胺治疗后肺功能改善。在最近的一项研究中，3/4的环磷酰胺治疗患者和1/4的未治疗患者的肺功能改善超过10%。本研究旨在以科学的方式检验环磷酰胺是否真的能改善硬皮病早期肺部受累患者的肺功能。