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口服抗组胺药对自行注射醋酸格拉替雷所致局部注射部位反应的影响。

Effect of oral antihistamine on local injection site reactions with self-administered glatiramer acetate.

机构信息

MS Center of Oklahoma, Mercy's NeuroScience Institute, Oklahoma City, OK USA.

出版信息

J Neurosci Nurs. 2010 Feb;42(1):40-6. doi: 10.1097/jnn.0b013e3181c71ab7.

DOI:10.1097/jnn.0b013e3181c71ab7
PMID:20187348
Abstract

Patients with multiple sclerosis often use injectable medication such as glatiramer acetate or interferons to treat their disease. Subcutaneous injections may be associated with local injection site reactions (LISRs), which can include itching, pain, swelling, or redness. Although not serious, these side effects are bothersome and can have a negative impact on adherence to the therapeutic regimen, particularly in early phases of treatment. This randomized parallel group study of 83 patients with multiple sclerosis who had recently begun glatiramer acetate therapy investigated whether administration of an oral antihistamine (cetirizine hydrochloride; Zyrtec, 10 mg) prior to each daily subcutaneous injection of glatiramer acetate would lower the incidence of LISRs compared with an oral placebo. Data for the outcome measures were derived from patient diaries and from the clinic during the baseline and the treatment periods. The primary outcome measure comparing the number of LISRs at 5 minutes after injection over 2 weeks was slightly but not significantly lower in patients who received cetirizine compared with patients who received placebo. Within-group comparisons showed that there was a significant reduction in mean LISR score from the 2-week baseline period to the 2-week cetirizine treatment period (0, 2, and 5 minutes after treatment). Both groups showed decreases in the average bothersome ratings from the baseline to treatment periods. Use of cetirizine did not affect the type of LISRs that was reported at any time point. There were no safety concerns with the concurrent administration of cetirizine with glatiramer acetate. Because there were no statistically significant differences on the primary end point between patient groups taking cetirizine and those taking placebo prior to glatiramer acetate injections, cetirizine use as a strategy to reduce LISRs in patients on glatiramer acetate therapy cannot be recommended at this time.

摘要

多发性硬化症患者常使用注射用药物(如醋酸格拉替雷或干扰素)来治疗疾病。皮下注射可能会引起局部注射部位反应(LISRs),包括瘙痒、疼痛、肿胀或发红。虽然这些副作用并不严重,但却令人烦恼,并可能对治疗方案的坚持产生负面影响,尤其是在治疗的早期阶段。这项针对 83 名多发性硬化症患者的随机平行组研究,这些患者最近开始接受醋酸格拉替雷治疗,研究了在每天皮下注射醋酸格拉替雷之前给予口服抗组胺药(盐酸西替利嗪;仙特明,10 毫克)是否会降低 LISRs 的发生率与口服安慰剂相比。结果测量数据来自患者日记和诊所,在基线和治疗期间。主要结果是比较 2 周内注射后 5 分钟内 LISRs 的数量,接受西替利嗪治疗的患者略低于接受安慰剂的患者,但无统计学意义。组内比较显示,与 2 周基线期相比,西替利嗪治疗期(治疗后 0、2 和 5 分钟)的 LISR 评分显著降低。两组患者的平均 LISR 评分均从基线期降至治疗期。在任何时间点,西替利嗪的使用都不会影响报告的 LISR 类型。西替利嗪与醋酸格拉替雷同时使用没有安全性问题。由于在接受醋酸格拉替雷注射之前服用西替利嗪和安慰剂的患者在主要终点上没有统计学上的显著差异,因此目前不能推荐在接受醋酸格拉替雷治疗的患者中使用西替利嗪作为减少 LISRs 的策略。

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