Steiner T J, Voelker M
Division of Neuroscience and Mental Health, Imperial College London, London, UK.
J Clin Pharm Ther. 2009 Apr;34(2):177-86. doi: 10.1111/j.1365-2710.2008.00989.x.
For the management of common disorders producing short-lasting pain, there is very good evidence of the efficacy of aspirin. Yet paracetamol is often preferred, despite that evidence of its efficacy is much less sound. The reason for this appears to be a concern over gastrointestinal (GI) toxicity. If this concern is misplaced, so may be the preference for paracetamol, with the consequence of widespread sub-optimal treatment. Our purpose in this analysis of pooled individual patient data from clinical studies of aspirin is to adduce the evidence that will show whether or not this is so, for the benefit of consumers and health-care professionals who advise them.
The frequencies of all and GI adverse events (AEs) and adverse drug reactions (ADRs) were calculated from the pooled individual patient data of nine similar randomized, double-blind, placebo controlled clinical trials of single-doses of aspirin 1000 mg in the treatment of acute migraine attacks, episodic tension-type headache and dental pain. Absolute differences between active and placebo AE and ADR rates, and numbers-needed-to-harm (NNH), were calculated.
Of 2852 patients included in the analysis, 1581 were treated with aspirin and 1271 with placebo. Reported AE rates were 14.9% and 11.1% amongst patients allocated to aspirin and placebo respectively (NNH: 26), with the GI system most frequently affected (aspirin: 5.9%; placebo: 3.5%; NNH: 42). Reported ADR rates were much lower (aspirin: 6.3%; placebo: 3.9%; NNH: 42), especially for the GI system (aspirin: 3.1%; placebo: 2.0%; NNH: 91). Most of the AEs and ADRs were mild or moderate, and none was serious.
The GI ADR differences between aspirin and placebo are not great enough to support decision choices for short-lasting acute pain based on tolerability: these are better based on efficacy.
对于治疗产生短期疼痛的常见病症，有充分证据表明阿司匹林具有疗效。然而，尽管对乙酰氨基酚的疗效证据远不如阿司匹林充分，但它却常常更受青睐。出现这种情况的原因似乎是对胃肠道（GI）毒性的担忧。如果这种担忧没有依据，那么对乙酰氨基酚的偏好可能也是不合理的，其结果将是广泛的治疗效果欠佳。我们对阿司匹林临床研究中汇总的个体患者数据进行分析的目的，是为了找出证据，以表明情况是否如此，从而造福消费者以及为他们提供建议的医疗保健专业人员。
从九项类似的随机、双盲、安慰剂对照临床试验的汇总个体患者数据中，计算单剂量1000毫克阿司匹林治疗急性偏头痛发作、发作性紧张型头痛和牙痛时所有不良事件（AE）和药物不良反应（ADR）的发生频率。计算活性药物组与安慰剂组AE和ADR发生率的绝对差异以及伤害所需人数（NNH）。
纳入分析的2852名患者中，1581名接受阿司匹林治疗，1271名接受安慰剂治疗。分配到阿司匹林组和安慰剂组的患者报告的AE发生率分别为14.9%和11.1%（NNH：26），其中胃肠道系统受影响最为频繁（阿司匹林组：5.9%；安慰剂组：3.5%；NNH：42）。报告的ADR发生率要低得多（阿司匹林组：6.3%；安慰剂组：3.9%；NNH：42），尤其是在胃肠道系统方面（阿司匹林组：3.1%；安慰剂组：2.0%；NNH：91）。大多数AE和ADR为轻度或中度，无一为严重事件。
阿司匹林与安慰剂之间的胃肠道ADR差异不足以支持基于耐受性来选择治疗短期急性疼痛的药物：这些选择最好基于疗效。
