Lee K M, Dorr R T, Robertone A
Invest New Drugs. 1987;5(1):31-5. doi: 10.1007/BF00217666.
A retrospective analysis was performed on the medical charts of 160 cancer patients who received esorubicin (ESO or 4'deoxydoxorubicin) in a Phase I clinical trial. The purpose of the review was to characterize the incidence of local venous reactions to this investigational doxorubicin (DOX) analog. The impact of prophylactic pretreatments of post-treatment using antihistamines and glucocorticosteroids was also assessed. There were 58 episodes of local reactions to ESO injections (14.3%). These reactions were characterized by local swelling, itching and erythema. Like DOX-induced venous reactions, ESO complications resolved spontaneously after several hours and did not predispose patients to skin ulceration or subsequent general hypersensitivity reactions. Indeed, ESO reactions were more common with initial treatments at low drug doses of only 10-15 mg/M2 (p less than .05 by Chi-square analysis). One case of ESO extravasation (about 5mg) was successfully managed with topical cooling. The use of antihistamines and corticosteroids was ineffective at preventing local reactions. However, when these drugs were administered after a reaction had ensued, symptoms were lessened significantly in half of the patients treated (p less than .05). The results of this review suggest that ESO causes a four-fold greater incidence of local venous reactions than with the parent DOX.
对160例在I期临床试验中接受表柔比星（ESO或4'-脱氧阿霉素）治疗的癌症患者的病历进行了回顾性分析。该综述的目的是描述这种研究性阿霉素（DOX）类似物局部静脉反应的发生率。还评估了使用抗组胺药和糖皮质激素进行预防性预处理或治疗后处理的影响。ESO注射有58次局部反应发作（14.3%）。这些反应的特征为局部肿胀、瘙痒和红斑。与DOX引起的静脉反应一样，ESO并发症在数小时后自发消退，并未使患者易患皮肤溃疡或随后的全身过敏反应。实际上，ESO反应在初始治疗药物剂量仅为10 - 15mg/M2时更为常见（经卡方分析p小于0.05）。1例ESO外渗（约5mg）通过局部冷敷成功处理。使用抗组胺药和皮质类固醇预防局部反应无效。然而，当在反应发生后给予这些药物时，接受治疗的患者中有一半症状明显减轻（p小于0.05）。该综述结果表明，ESO引起的局部静脉反应发生率比母体DOX高四倍。
