摘要
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 investigate a simple and reliable premedication regimen against paclitaxel induced allergy. METHODS A total of 208 oneology patients treated with paclitaxel were enrolled from January 2013 to April 2014 in our hos- pital. Of these patients, 196 received two circles of paclitaxel-based chemotherapy and showed no allergic symptom. These pa- tients were divided into test group and control group in hospitalization sequence. Ninety six patients in test group received sim- plified premedication regimen （dexamethasone, 4. 5 mg） ; 100 patients in control group received routine premedication regimen. The primary endpoint was to estimate incidence o{ rescue medication against paclitaxel infusion hypersensitivity from dose 3 to 12 for patients receiving simplified paclitaxel premedication. RESULTS During paclitaxel-based chemotherapy, no patients showed infusion hypersensitivity in the two groups. Except for hypersensitivity, there were other adverse reactions including neutropenia, nausea, vomiting, myalgia, excitement, insomnia, fatigue, gastric burning sensation and hypertension. Control group had significantly increased hypertension （P = 0. 004）, excitement or insomnia （P = 0. 010）. CONCLUSION For patients who have no infusion hypersensitivity reaction in the past, hypersensitivity can not be completely avoided by routine premedica- tion for the first two doses of paclitaxel infusion. For patients without hypersensitivity at the first two doses of paclitaxel, sim- plified premedication of paclitaxel may be considered safe and effective in the subsequent therapy.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2016年第4期312-314,338,共4页
Chinese Journal of Hospital Pharmacy
关键词
紫杉醇
过敏反应
预处理
paclitaxel
hypersensitivity reaction
premedication regimen
作者简介
[作者简介]杨雅茹，女，硕士，主管药师，研究方向：抗肿瘤药物专业，临床药学实践，电话：13866729433，E-mail：ayefyyyr@126．com，
[通信作者]刘丽萍，女，主任药师，电话：0551-63869649，E-mail：ayfyllp@126．com
