低剂量地塞米松预处理方案防治老年人多西紫杉醇过敏反应的临床研究

Clinical research of low dose dexamethasone pretreatment regimen in prevention of hypersensitive reaction related to docetaxel in elderly tumor patients

目的探讨在多西紫杉醇周疗法的老年患者中用低剂量地塞米松防治其过敏反应的疗效和安全性。方法对用多西紫杉醇（25mg／m^2，第1、8、15天静脉滴注，28d重复）或多西紫杉醇＋顺铂（多西紫杉醇25mg／m^2，第1、8、15天静脉滴注＋顺铂20mg／m^2，第1～5天静脉滴注，28d重复）治疗的老年患者，采用非等量随机对照方法，按入院顺序以3：2比例分为试验组和对照组，共91例，年龄65～82岁，中位年龄68岁。其中试验组54例，预处理方案为地塞米松4．5mg，每日1次；对照组37例，预处理方案为地塞米松8mg 2次／d，均为多西紫杉醇用药前1d、用药当天和用药后连续3d口服。所有患者均按照改良疾病累积评分表（MCIRS）进行评分。不良反应评价参照美国国立癌症研究所的常规毒性判定标准NCI-CTCAE3．0版。结果91例患者中发生过敏反应7例（7．7％），其中试验组发生过敏反应4例（7．4％），对照组发生过敏反应3例（8．1％），差异无统计学意义（P=1．000），主要症状为皮疹或瘙痒3．3％（3／91）、血管性水肿2．2％（2／91）、发热或寒战1．1％（1／91）和胸部不适1．1％（1／91）。不良反应主要为中性粒细胞减少、血红蛋白减少、恶心呕吐、疲劳、肌痛、兴奋或失眠和胃部烧灼感。结论低剂量地塞米松预处理方案安全有效，与常规剂量比较，过敏反应的发生率无明显增高。

Objective To evaluate the efficacy and safety of low-dose dexamethasone pretreatment regimen in prevention of hypersensitive reaction （HR） related to docetaxel in elderly tumor patients. Methods According to the order for admission and the ratio of 3：2, 91 elderly patients with docetaxel weekly therapy were randomly divided into two groups： experimental group and control group. All patients aged from 65 to 82 years with a median age of 68 years old. There were 54 patients in the experimental group and 37 patients in the control group. In the experimental group, patients received oral dexamethasone 4.5 mg once daily on 1 day before treatment, the day of treatment and continuing for 3 days after treatment, while patients received 8 mg twice daily in the control group. All patients were scored according to MCIRS by the physician. The side effects were evaluated by NCI-CTCAE3.0. Results Four cases in the experimental group （7.4%） and three cases in the control group （8.1 %） occurred HR, and there was no significant statistical difference （P=1. 000）. Conclusions The low dose dexamethasone is efficient and safe compared with the conventional dose dexamethasone, and there is no significant difference in HR incidence between two groups.