Moser K M, Smith R M, Spragg R G, Tisi G M
Pulmonary and Critical Care Division, University of California, School of Medicine, San Diego.
Am J Med. 1988 Jun 24;84(6A):70-4. doi: 10.1016/0002-9343(88)90161-1.
Nine patients with moderate pulmonary emphysema, six of PiZ phenotype and three of PiM phenotype, have received a single intravenous infusion of alpha-1-proteinase inhibitor (human) (A1PI), in a dose of 60 mg/kg over a 30-minute period. They also received a tracer dose (300 microCi) of 131I-labeled A1PI. No active or passive immunization against hepatitis was given. No acute toxicity was observed. Compared with baseline data, significant elevations of serum A1PI (measured both antigenically and as anti-elastase activity) occurred, with a serum half-life approximating 110 hours. Bronchoalveolar lavage fluid, obtained 48 hours after infusion, reflected a significant increase in A1PI concentration versus baseline bronchoalveolar lavage fluid values. Serial gamma camera images of the lungs confirmed persistence of enhanced lung radioactivity for several days. Urinary desmosine excretion did not change following A1PI infusion. During the period of follow-up thus far, no patient has had chronic toxicity, results of liver function tests have been stable, and there has been no development of hepatitis B antigen or antibodies to hepatitis B surface or core antigens.
9名中度肺气肿患者，其中6名PiZ表型，3名PiM表型，接受了单次静脉输注α-1蛋白酶抑制剂（人）（A1PI），剂量为60mg/kg，输注时间为30分钟。他们还接受了示踪剂量（300微居里）的131I标记的A1PI。未进行针对肝炎的主动或被动免疫接种。未观察到急性毒性。与基线数据相比，血清A1PI（通过抗原测定和抗弹性蛋白酶活性测定）显著升高，血清半衰期约为110小时。输注后48小时获得的支气管肺泡灌洗液显示，与基线支气管肺泡灌洗液值相比，A1PI浓度显著增加。肺部的系列γ相机图像证实肺部放射性增强持续了数天。A1PI输注后尿脱氧吡啶啉排泄未改变。在迄今为止的随访期间，没有患者出现慢性毒性，肝功能测试结果稳定，也没有出现乙肝抗原或乙肝表面或核心抗原抗体。
