Bookman M A, Kloth D D, Kover P E, Smolinski S, Ozols R F
Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, PA 19111, USA.
Semin Oncol. 1997 Dec;24(6 Suppl 19):S19-13-S19-15.
Severe hypersensitivity reactions to paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) were reported during early phase I trials. A premedication regimen consisting of oral steroids 12 and 6 hours before treatment with paclitaxel as well as immediate infusion of diphenhydramine and cimetidine (or ranitidine) before paclitaxel markedly decreased the incidence of hypersensitivity reactions. Subsequently, investigators at the Fox Chase Cancer Center used intravenous dexamethasone, diphenhydramine, and cimetidine immediately before paclitaxel in an effort to obviate the inconvenience of oral steroid administration. Two prospective clinical trials that use carboplatin and paclitaxel were performed in patients with ovarian cancer and in patients with non-small cell lung cancer. In both these trials, all premedication for hypersensitivity reactions was administered intravenously immediately before paclitaxel. No significant hypersensitivity reactions were reported in these two trials, and, subsequently, a large retrospective search of a computerized pharmacy database concluded that a single-dose regimen of intravenous dexamethasone, diphenhydramine, and cimetidine is a safe and convenient alternative for prevention of hypersensitivity reactions associated with outpatient paclitaxel administration.
在I期临床试验早期，有报告称患者对紫杉醇（泰素；百时美施贵宝公司，新泽西州普林斯顿）出现严重过敏反应。一种预处理方案为在使用紫杉醇治疗前12小时和6小时口服类固醇，以及在使用紫杉醇前立即输注苯海拉明和西咪替丁（或雷尼替丁），这显著降低了过敏反应的发生率。随后，福克斯蔡斯癌症中心的研究人员在使用紫杉醇前立即静脉注射地塞米松、苯海拉明和西咪替丁，以避免口服类固醇带来的不便。针对卵巢癌患者和非小细胞肺癌患者进行了两项使用卡铂和紫杉醇的前瞻性临床试验。在这两项试验中，所有针对过敏反应的预处理均在使用紫杉醇前立即静脉给药。这两项试验均未报告显著的过敏反应，随后，一项对计算机化药房数据库的大型回顾性检索得出结论，静脉注射地塞米松、苯海拉明和西咪替丁的单剂量方案是预防与门诊使用紫杉醇相关的过敏反应的一种安全且便捷的替代方法。
