SAFETY, TOLERANCE, AND CLINICAL EFFICACY OF RPR 109413 AND GAMIMUNE-N

在过去的几年里，人们越来越关注 静脉注射丙种球蛋白传播病毒感染的风险。 最初的研究重点是乙肝的风险；当艾滋病病毒 经鉴定，它被证明对用于 静脉注射丙种球蛋白的加工使其从未出现过 1例由丙种球蛋白传播的艾滋病病毒。不幸的是，肝炎 C病毒并不那么敏感，1994年爆发了一场 丙型肝炎由丙种球蛋白的一种许可制剂引起。 已经开发了几种策略来降低感染风险 传播病毒感染。大多数公司都使用了溶剂和 洗涤剂可灭活所有已知的包膜病毒。这一过程 对其他类型的病毒无效。装甲制药公司 已经开发出一种液体静脉注射丙种球蛋白制剂，即加热 巴氏杀菌以灭活多种已知病毒。 这是一项多中心、随机、双盲、II期研究，比较 新的经巴氏灭菌的109413号防腐剂已获许可 Gamimune-N.在前六个月，三名患者中的第二名 随机接收RPR产品，另三分之一接收 Gamimune-N.在后六个月，所有患者都接受了RPR 不致盲的丙种球蛋白。所有患者都在同一时间接受治疗。 他们在研究之前接受治疗的剂量和频率。功效 通过使用患者日记、药物使用和天数进行评估 住院或因工作或学校缺勤的天数。安全受到监控 通过记录临床对输液的反应和测量血清 化验和血细胞计数。

In the past several years there has been increasing concern about the risk of transmitting virus infections by intravenous gammaglobulin. Initial studies focused on the risk of Hepatitis b; when the AIDS virus was identified it proved to be sensitive to the ethanol used in the processing of intravenous gammaglobulin so that there never has been a case a HIV transmitted by gammaglobulin. Unfortunately, the Hepatitis C virus is not so sensitive, and in 1994 there was an outbreak of Hepatitis C caused by one of the licensed preparations of gammaglobulin. Several strategies have been developed to decrease the risk of transmitting virus infections. Most have employed a solvent and detergent step to inactivate all known enveloped viruses. This process is not effective against other types of viruses. Armour Pharmaceuticals has developed a liquid intravenous gammaglobulin preparation that is heat pasteurized to inactivate a wide variety of known viruses. This is a multicenter, randomized double-blind, Phase II study comparing the new heat-pasteurized RPR 109413 to the licensed preparation Gamimune-N. In the first six month phase two of three patients are randomized to receive the RPR product and the other third receives Gamimune-N. In the second six months all patients receive the RPR gammaglobulin without blinding. All patients are treated at the same dose and frequency that they were treated prior to the study. Efficacy is evaluated by use of patient diaries, use of medications, and days of hospitalization or days missed from work or school. Safety is monitored by recording clinical reactions to the infusions and by measuring serum chemistries and blood counts.