Wüster C, Schurr W, Scharla S, Raue F, Minne H W, Ziegler R
Department of Internal Medicine I, University of Heidelberg, FRG.
Eur J Clin Pharmacol. 1991;41(3):211-5. doi: 10.1007/BF00315432.
Possible local and systemic adverse effects following administration of salmon (sCT) and human (hCT) calcitonin (CT) have been evaluated in a double-blind, within-subject, comparative trial in 30 young, healthy volunteers. Each subject received 0.25 and 0.5 mg hCT and 100 IU sCT s.c.. Adverse effects and hypocalcaemia were recorded 1, 3 and 6 h after each injection. Significantly fewer local adverse reactions were observed after hCT (20 or 33%) than after sCT (80%), possibly due to the different vehicles employed (mannitol solution and acetic acid). The most frequent systemic adverse effects were gastrointestinal (nausea, vomiting), which occurred in 80% after 1 h, independently of the CT--preparation used. Hypocalcaemic changes were generally small and lasted longer after sCT. It is concluded that the hCT preparations were better tolerated locally than sCT in young, healthy volunteers, and that there were no differences in the systemic side effects or hypocalcaemic activity.
在一项针对30名年轻健康志愿者的双盲、受试者自身对照的比较试验中,对注射鲑鱼降钙素(sCT)和人降钙素(hCT)后的局部和全身不良反应进行了评估。每位受试者皮下注射0.25毫克和0.5毫克的hCT以及100国际单位的sCT。每次注射后1小时、3小时和6小时记录不良反应和低钙血症情况。与sCT(80%)相比,hCT后观察到的局部不良反应明显较少(20%或33%),这可能是由于所使用的赋形剂不同(甘露醇溶液和乙酸)。最常见的全身不良反应是胃肠道反应(恶心、呕吐),1小时后发生率为80%,与所使用的降钙素制剂无关。低钙血症变化通常较小,且sCT后的持续时间更长。得出的结论是,在年轻健康志愿者中,hCT制剂在局部的耐受性优于sCT,且全身副作用或低钙血症活性方面没有差异。