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化疗治疗的儿科患者口腔黏膜炎的预防;比较两种口腔护理方案的随机交叉试验

Prevention of oral mucositis in paediatric patients treated with chemotherapy; a randomised crossover trial comparing two protocols of oral care.

作者信息

Cheng K K F, Chang A M, Yuen M P

机构信息

Nethersole School of Nursing, Faculty of Medicine, Room 804A, Esther Lee Building, Chung Chi College, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong.

出版信息

Eur J Cancer. 2004 May;40(8):1208-16. doi: 10.1016/j.ejca.2003.10.023.

DOI:10.1016/j.ejca.2003.10.023
PMID:15110885
Abstract

This study compared the efficacy of two protocols for oral care using either chlorhexidine or benzydamine as oral rinses to alleviate mucositis in children undergoing chemotherapy. Eligible participants were randomised to receive either protocol for 3 weeks in a two-period crossover design. The occurrence of ulcerative lesions and severity of mucositis were measured at baseline and twice weekly, using the modified Oral Assessment Guide (OAG). Data were continuously analysed by plotting them directly on predefined sequential charts. According to this sequential analysis, the study could be terminated at the 34th within subject comparison, with a statistically significant reduction in ulcerative lesions (P<0.05) and severity of mucositis (P<0.05) in children on the chlorhexidine protocol. These findings suggest that chlorhexidine together with oral care might be helpful in alleviating mucositis when given prophylactically to children on chemotherapy, but the therapeutic benefit needs to be confirmed in a larger trial.

摘要

本研究比较了两种口腔护理方案的疗效,这两种方案分别使用洗必泰或苄达明作为口腔含漱液,以缓解接受化疗的儿童的粘膜炎。符合条件的参与者被随机分配接受其中一种方案,为期3周,采用两阶段交叉设计。在基线时以及每周两次使用改良口腔评估指南(OAG)测量溃疡性病变的发生情况和粘膜炎的严重程度。通过将数据直接绘制在预定义的序贯图表上进行连续分析。根据这种序贯分析,该研究可在第34次受试者内比较时终止,使用洗必泰方案的儿童的溃疡性病变(P<0.05)和粘膜炎严重程度(P<0.05)有统计学意义的降低。这些发现表明,在对接受化疗的儿童进行预防性给药时,洗必泰与口腔护理一起可能有助于缓解粘膜炎,但治疗益处需要在更大规模的试验中得到证实。

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