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首页> 外文期刊>Clinical drug investigation >Effect of a Simple Dose-Escalation Schedule on Tramadol Tolerability Assessment in the Clinical Setting
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Effect of a Simple Dose-Escalation Schedule on Tramadol Tolerability Assessment in the Clinical Setting

机译:简单的剂量递增时间表对临床环境中曲马多耐受性评估的影响

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Objective: To assess the effect of a very simple dose-escalation schedule on tramadol tolerability in clinical practice. This schedule consists of starting treatment with sustained-release tramadol 50mg twice daily, and escalating the dose around 7 days later to l00mg twice daily.Methods: Data from 1925 outpatients with non-malignant chronic pain were collected in this multicentre, prospective, comparative, non-randomised, open, observational study.Results: A total of 1071 patients (55.6%) were included in the dose-escalation group (50mg group) and 854 patients (44.4%) in the control group (sustained-release tramadol lOOmg twice daily; lOOmg group). The proportion of patients who interrupted tramadol treatment due to the occurrence of adverse reactions was significantly lower in the 50mg group (5.6%) than in the lOOmg group (12.6%) [p = 0.001]. In line with this, the proportion of patients who experienced at least one adverse reaction was significantly lower in the 50mg group (18.4%) than in the lOOmg group (30.4%) [p = 0.001] and, interestingly, the two most frequently reported adverse reactions, nausea and dizziness, were found with a significantly lower frequency in the 50mg group (p < 0.001). Multivariate analysis showed that the risk of safety-related treatment cessations was 2.3 times higher in the l00mg group than in the 50mg group, and 2.2 times higher in females than in males. The two treatments were equally effective in reducing pain intensity (p = 0.121), measured as a reduction in pain score obtained by means of a visual analogue scale.Conclusion: The instauration of tramadol treatment, starting with sustained-release 50mg capsules twice daily and escalating the dose some days later to l00mg twice daily, was shown to be an effective and easy way to improve tramadol tolerability in clinical practice, whilst maintaining its analgesic efficacy.
机译:目的:在临床实践中评估非常简单的剂量递增时间表对曲马多耐受性的影响。该时间表包括以每天两次50mg的持续释放曲马多开始治疗,然后在7天后将剂量逐步增加至每天两次100mg。方法:在该多中心,前瞻性,比较性,多中心,多中心,多中心收集1925名非恶性慢性疼痛门诊患者的数据结果:剂量递增组(50mg组)中包括1071例患者(55.6%),对照组(缓释曲马多100mg两次)中包括854例患者(44.4%)。每天; 100mg组)。由于发生不良反应而中断曲马多治疗的患者比例在50mg组(5.6%)显着低于100mg组(12.6%)[p = 0.001]。与此相符,在50 mg组中发生至少一种不良反应的患者比例(18.4%)明显低于100 mg组中的比例(30.4%)[p = 0.001],有趣的是,这两个报告频率最高的患者在50mg组中,不良反应,恶心和头晕的发生率显着降低(p <0.001)。多变量分析表明,100 mg组中与安全相关的戒烟风险比50mg组高2.3倍,女性比男性高2.2倍。两种疗法在减轻疼痛强度方面均有效(p = 0.121),这是通过视觉模拟量表得出的疼痛评分降低的结论。结论:曲马多治疗的恢复方法是,从每天两次缓释50mg胶囊开始,几天后将剂量增加至每天两次200mg,已被证明是在临床实践中改善曲马多耐受性的有效且简便的方法,同时保持其镇痛效果。

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