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目的:探讨简便可靠的紫杉醇预处理方法。方法:收集2013年1月-2014年4月某肿瘤中心符合入组标准患者208例,所有患者最初两次使用紫杉醇均给予常规预处理,未出现过敏反应症状的患者纳入本研究,采用非等量随机对照方法,按入院顺序分为试验组和对照组。试验组96例,使用简化预处理方案(地塞米松4.5 mg,qd);对照组100例,使用常规预处理方案(在给予紫杉醇12 h和6 h前口服地塞米松20 mg、给药前30~60 min给予苯海拉明50 mg口服和西咪替丁300 mg静脉注射)。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-CTCAE4.0版。观察随后紫杉醇治疗过程中2组的过敏反应及其他药物治疗反应的发生率、严重程度。结果:纳入本试验的患者随后的紫杉醇治疗过程中,简化预处理组和常规预处理组均没有发生过敏反应。2组除过敏反应外,其他不良反应主要表现为中性粒细胞减少、恶心,呕吐、肌痛、兴奋或失眠、疲劳、胃部烧灼感和血压升高。其中,对照组在血压升高(P=0.004)和兴奋或失眠(P=0.010)的发生率高于试验组,差异有统计学意义。结论:对于既往无紫杉醇药物过敏史的患者,最初两次使用紫杉醇过程中,使用常规预处理不能完全避免过敏反应的发生;最初两次未发生过敏反应的患者,在随后紫杉醇治疗过程中使用简化预处理是安全有效的。
Objective: To explore a simple and reliable method of paclitaxel pretreatment. Methods: A total of 208 patients were enrolled in this study from January 2013 to April 2014. All the patients were treated with paclitaxel for the first two times, and patients without any allergic reaction were included in this study. The amount of randomized controlled method, according to the admission sequence is divided into experimental group and control group. The experimental group (n = 96) was treated with simplified preconditioning regimen (dexamethasone 4.5 mg qd) and control group (n = 100). The control group was treated with paclitaxel at 12 h and 6 h before oral administration of dexamethasone 30 to 60 min diphenhydramine 50 mg orally and cimetidine 300 mg intravenously). Adverse reaction evaluation reference to the United States National Cancer Institute routine toxicity criteria NCI-CTCAE4.0 version. Observe the subsequent paclitaxel treatment in the two groups of allergic reactions and other drug treatment response rates, severity. RESULTS: During the subsequent paclitaxel treatment in patients enrolled in this study, no allergic reactions occurred in both the simplified preconditioning group and the conventional preconditioning group. In addition to allergic reactions, the other adverse reactions in group 2 were mainly neutropenia, nausea, vomiting, myalgia, excitement or insomnia, fatigue, stomach burning sensation and high blood pressure. Among them, the incidence of hypertension (P = 0.004) and excitement or insomnia (P = 0.010) in the control group was higher than that in the experimental group, the difference was statistically significant. CONCLUSIONS: For the first time there was no history of paclitaxel drug allergy in patients with the first two paclitaxel, the use of conventional pretreatment can not completely avoid the occurrence of allergic reactions; the first two patients without allergic reactions in the subsequent paclitaxel treatment simplified Pretreatment is safe and effective.