Nettis E, Colanardi M C, Di Paola R, Mangialardi G, Ferrannini A, Tursi A
Department of Internal Medicine, Immunology and Infectious Diseases, Section of Allergy and Clinical Immunology, University of Bari, Bari, Italy.
Immunopharmacol Immunotoxicol. 2003 Aug;25(3):365-75. doi: 10.1081/iph-120024504.
Macrolides are considered one of the safest anti-infective groups in clinical use and are well-tolerated as alternative antibiotics in patients with a previous adverse reaction to other classes of antibiotics. However there is scarce information in the literature about their long-term tolerability. The present study was performed to determine whether the results of a challenge test with rokitamycin could predict the response to ingestion of rokitamycin during illness. The study was carried out on 335 patients, who experienced adverse reactions to one or more antibiotics. All patients received peroral challenges with rokitamycin (granules or capsules). On the first day patients received a number of placebo doses equivalent to the rokitamycin doses. One week later, the test was administered by increasing doses of rokitamycin at 60 min intervals until the common daily therapeutic dose of 406.25mg was reached (31.25-93.75-125-156.25mg). A questionnaire was distributed to all subjects. In particular, subjects were asked to clarify any reactive symptom they had developed after ingestion of the drug. It was found that only 3.1% (4/129) of subjects, who used this drug, reported adverse reactions: three experienced urticaria/angioedema and one patient experienced erythema multiforme during treatment. This study, points out a low percentage of adverse reactions to rokitamycin after a negative challenge test, thus, emphasizing both safety and good predictive value as a challenge test.
大环内酯类药物被认为是临床使用中最安全的抗感染药物类别之一，对于先前对其他类抗生素有不良反应的患者而言，作为替代抗生素耐受性良好。然而，文献中关于其长期耐受性的信息却很少。本研究旨在确定用罗他霉素进行激发试验的结果是否能预测患病期间服用罗他霉素的反应。该研究针对335名对一种或多种抗生素有不良反应的患者开展。所有患者均接受了罗他霉素（颗粒剂或胶囊）的口服激发试验。第一天，患者接受了与罗他霉素剂量相当的安慰剂剂量。一周后，每隔60分钟递增罗他霉素剂量进行试验，直至达到406.25mg的常用每日治疗剂量（31.25 - 93.75 - 125 - 156.25mg）。向所有受试者发放了一份问卷。特别地，要求受试者阐明服用药物后出现的任何反应性症状。结果发现，使用该药物的受试者中只有3.1%（4/129）报告有不良反应：3人在治疗期间出现荨麻疹/血管性水肿，1名患者出现多形红斑。这项研究指出，激发试验呈阴性后，罗他霉素的不良反应发生率较低，因此，既强调了其安全性，也突出了激发试验良好的预测价值。
