紫杉醇和多西紫杉醇超敏反应的快速脱敏疗法:一种成功应用于77例患者的新标准方案

Objective. Administration of paclitaxel is associated with hypersensitivity reactions (HSRs) in up to 9% of patients despite premedication. The purpose of this study was to evaluate the effectiveness of a standardized desensitization protocol in patients with HSRs to taxanes, based on our experience with carboplatin desensitization. Methods. We analyzed seventeen consecutive patients with documented HSRs to taxanes who required continued treatment with a taxane agent. The patients were treated with either paclitaxel or docetaxel using the 6- to 7- h standard desensitization protocol. Results. Seventeen patients who previously had severe taxane HSRs successfully completed 77 planned cycles of desensitization to paclitaxel or docetaxel, 72 of which were without reactions. Four patients developed HSRs during the desensitization protocol that were much less severe than their original HSRs and tolerated the re- administration of infusions without further reactions. Of these four patients, the first had palmar erythema 8 h after her 1st desensitization. The second patient had mild abdominal pain during her 1st cycle, and the third patient developed mild chest burning during her 2nd and 4th cycles. These three patients also completed subsequent desensitization cycles without reactions. The fourth patient developed a delayed urticaria reaction and gastrointestinal symptoms 6 h after completing her 1st desensitization. She elected to be treated with an alternative chemotherapy and did not receive additional courses of desensitization. Conclusion. The rapid standard desensitization protocol provides a safe and effective strategy for the re- administration of paclitaxel or docetaxel even after severe HSRs.

测量不确定度评定——单向轴心受力强度

本文依据我国现行《测量不确定度评定与表示》标准的基本规定,应用B类不确定度的分析方法,推导了常温下单向轴心受力试验强度不确定度评定的一般数学模型,并就建筑工程中常用材料强度试验为例,在现行检验方法标准的基础上,分析计算了它们的B类相对不确定度。

大鼠皮肤类过敏试验评定标准的探讨

该研究通过对大鼠皮肤类过敏试验各项特征指标的研究,选定同只动物给药部位皮肤蓝斑OD与对照部位皮肤蓝斑OD比值(K)作为新的评定标准。并以有临床类过敏反应报道的常用造影剂、中药注射剂和注射剂原料药或辅料为受试药物进行大鼠皮肤类过敏试验,以对K进行界定:K>2为类过敏反应阳性;1.2≤K≤2为类过敏性可疑;K<1.2为类过敏反应阴性。以此标准对受试药物的类过敏性进行评定。评定结果与经典标准的评定结果进行比较,以考察K的适用性。比较结果显示,以K作为大鼠皮肤类过敏试验的评定标准,可更真实地反映皮肤蓝染的实际情况,同时将因动物个体因素造成的误差降到最低。其阳性、可疑、阴性3级标准相对蓝斑直径阳性、阴性2级标准,具有更为客观、准确的特点,建议尝试选择K作为药物致大鼠皮肤类过敏反应的评定标准。

小鼠全身类过敏试验方法及其评价标准的研究

药物类过敏性检测是一个国际性的难题,至今尚无一个成熟而可靠的动物模型或试验方法。为探索和建立一种适用于注射类药物临床前类过敏性评价的试验方法和评定标准,该研究根据静脉注射C48/80或聚氧乙烯脱水山梨醇单油酸酯(Tween 80)导致的小鼠类过敏反应症状,整理出小鼠全身类过敏反应症状表,通过引入能表证类过敏症状强弱的症状强度系数(K)及其计算公式,制订了小鼠全身类过敏症状强度评定标准。以此评定标准为对照,筛选出组胺、类胰蛋白酶和Ig E等3个血液生物标志物作为评定药物类过敏性的实验室检测指标,建立了症状评定与血液指标检测联合评价小鼠全身类过敏性的试验方法。该试验方法评定类过敏性的特征:K值、血液组胺水平与C48/80或Tween 80静注剂量呈高度相关;血液组胺对数值升高与K值呈高度正相关;类胰蛋白酶水平表现为升高、持平或下降,其变化状态可能与受试物特性和取血时间有关;Ig E水平表现为持平或下降,但不会升高,此可明显区别于Ⅰ型过敏反应。在此基础上,选用碘海醇、碘普罗胺、紫杉醇以及血塞通注射液、注射用双黄连、生脉注射液等进行适用性考察,检测结果与临床实际用药后情况呈现高度的一致性。结果提示,小鼠全身类过敏试验方法敏感性高,特异性强,与临床一致性好,建议进一步验证和推广使用。