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首页> 外文期刊>Journal of drug assessment >Randomised, double-blind comparison of efficacy and tolerability of diclofenac mouthwash versus placebo in mucositis of oral cavity by radiotherapy
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Randomised, double-blind comparison of efficacy and tolerability of diclofenac mouthwash versus placebo in mucositis of oral cavity by radiotherapy

机译:双氯芬酸漱口液与安慰剂在口腔黏膜炎中放疗的疗效和耐受性的随机,双盲比较

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摘要

Seventy-seven patients with headeck cancer, who manifested mucositis of oral cavity by radiotherapy, were randomised in a double-blind study to receive either diclofenac or placebo mouthwash, for a minimum of 2 weeks up to a maximum of 6 weeks.At the end of treatment period, no statistical differences were observed when compared to baseline in all the main criteria considered for treatment with diclofenac (15 ml three times a day, at 0.074% w/v). In the placebo group, worsening of score was reported for all the parameters. For all criteria compared, both objective [RTOG/EORTC (Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer) and physician assessment], and subjective parameters (spontaneous pain, odynophagia and dysphagia) between groups were in favour of diclofenac.The only adverse events with some relationship to the drug were burning/ pain of the throat and one case of vomiting. These had similar incidence in both groups.
机译:在一项双盲研究中,将77例头颈癌患者通过放疗表现出口腔粘膜炎,将其随机分配接受双氯芬酸或安慰剂漱口水,至少2周,最多6周。在治疗结束时,与基线相比,在所有考虑用双氯芬酸治疗的主要标准中均未观察到统计学差异(每天15次,每次3毫升,剂量为0.074%w / v)。在安慰剂组中,报告了所有参数的评分恶化。对于所有比较的标准,两组之间的客观[RTOG / EORTC(放射治疗肿瘤学组/欧洲癌症研究和治疗组织)和医师评估]以及组之间的主观参数(自发性疼痛,吞咽困难和吞咽困难)均支持双氯芬酸。与药物有关的唯一不良事件是喉咙烧灼/疼痛和呕吐一例。两组的发生率相似。

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