医学翻译—不良事件处理
泛瑞翻译
原文:
Adverse events were frequent, including in the supportive therapy group, suggesting that this group of patients is susceptible to major medical problems. Masking was impossible because of the nature of the treatments involved, but we accept that the fact that the study was unblinded might have affected the reporting of adverse effects. In the active intervention groups, the serious adverse effects were predictable from the sideeffect profiles of the drugs-particularly headache, tremor, hypertension, deterioration in renal function, or infection in the ciclosporin group and predominantly haematological (especially leucopenia and anaemia) or metabolic (especially glucose intolerance) effects in the prednisolone and chlorambucil group. Dose adjustment of chlorambucilarose frequently and treatment interruptions were common, both accounting for most of the protocol departures in the prednisolone and chlorambucil group. Similarly, in the ciclosporin group, nephro toxicity was a substantial problem despite the fact that we used target blood concentrations advocated in a previous RCT; dose reductions, treatment interruptions, and reaching of primary end point were frequent in this group.
译文:
研究期间,患者频繁发生不良事件(包括支持疗法组),提示本组患者对主要医学问题很敏感。由于所涉及治疗
方案
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的性质,试验不可能设盲,但我们承认不设盲的研究可能会影响对不良反应的
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。在主动干预组中,严重的不良反应可以由副反应量
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预测,包括环孢素组的药物特异性头痛、震颤、高血压、肾功能恶化或感染,以及泼尼松龙与苯丁酸氮芥组的主要血液病学反应(特别是白细胞减少症和贫血症)或代谢反应(特别是葡萄糖耐受不良)。在泼尼松龙与苯丁酸氮芥组中,由于经常改变苯丁酸氮芥剂量,并中断治疗,所以常与研究方案有所偏颇。与此类似,在环孢素组中,尽管我们使用在之前的随机对照试验(RCT)中所主张的靶血液浓度,但肾毒性仍是一个重大问题;在本组中,减小剂量、中断治疗和达到主要终点都会频繁出现。
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