Garbett N D, Currie D C, Cole P J
Department of Thoracic Medicine, Brompton Hospital, London, UK.
Clin Exp Immunol. 1989 Apr;76(1):1-7.
A prospective, randomized, cross-over study was performed to evaluate the safety and clinical efficacy of an immunoglobulin preparation for intravenous use (Intraglobin F) in comparison with the standard intra-muscular preparation. Twelve patients with idiopathic adult-onset panhypogammaglobulinaemia received intravenous Intraglobin F infusions of 300 mg/kg body weight every 4 weeks, or standard intramuscular injections of 25 mg/kg body weight every week (following a 4-week loading phase of 50 mg/kg/week) in random order for 24 weeks each with a 'washout' period between. At the end of this comparative trial eight of the patients received a further 24 weeks treatment with Intraglobin F at 300 mg/kg body weight every 3 weeks. Patients were assessed by diary cards, interview, laboratory screening (including assessment of serum opsonic capacity), chest and sinus radiographs, and full lung function tests. There were statistically significant, favourable changes in clinical parameters and trough serum IgG levels using the intravenous preparation but no other significant differences with respect to the two preparations. The eight patients who subsequently received the 3-weekly intravenous regimen improved further in these parameters, including serum IgG levels and serum opsonic capacity. Thirty per cent of infusions were associated with mild adverse reactions related to the rate of administration but one patient was withdrawn due to anaphylactoid reaction to her fifth infusion. Ten of the eleven remaining patients elected to continue intravenous therapy at the end of the trial. We conclude that Intraglobin F is preferable to the standard intramuscular preparations for control of idiopathic adult-onset panhypogammaglobulinaemia but that infusion intervals should be tailored to the individual's clinical response and results of appropriate functional in vitro assays, eg. opsonization.
进行了一项前瞻性、随机、交叉研究，以评估静脉用免疫球蛋白制剂（Intraglobin F）与标准肌内制剂相比的安全性和临床疗效。12例特发性成人起病的全血细胞减少性低丙种球蛋白血症患者，随机接受每4周静脉输注300mg/kg体重的Intraglobin F，或每周肌内注射25mg/kg体重（在50mg/kg/周的4周负荷期之后），每种治疗各24周，期间有一个“洗脱期”。在这项对比试验结束时，8例患者接受了进一步的治疗，每3周静脉输注300mg/kg体重的Intraglobin F，持续24周。通过日记卡、访谈、实验室筛查（包括血清调理能力评估）、胸部和鼻窦X光片以及全肺功能测试对患者进行评估。使用静脉制剂时，临床参数和谷值血清IgG水平有统计学上显著的有利变化，但两种制剂在其他方面无显著差异。随后接受每3周一次静脉治疗方案的8例患者在这些参数方面进一步改善，包括血清IgG水平和血清调理能力。30%的输注与与给药速度相关的轻度不良反应有关，但有1例患者因对第5次输注发生类过敏反应而退出。其余11例患者中有10例在试验结束时选择继续静脉治疗。我们得出结论，对于控制特发性成人起病的全血细胞减少性低丙种球蛋白血症，Intraglobin F比标准肌内制剂更可取，但输注间隔应根据个体的临床反应和适当的体外功能试验结果（如调理作用）进行调整。
