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首页> 外文期刊>Clinical therapeutics >Efficacy and tolerability of paracetamol/tramadol (325 mg/37.5 mg) combination treatment compared with tramadol (50 mg) monotherapy in patients with subacute low back pain: a multicenter, randomized, double-blind, parallel-group, 10-day treatment stu
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Efficacy and tolerability of paracetamol/tramadol (325 mg/37.5 mg) combination treatment compared with tramadol (50 mg) monotherapy in patients with subacute low back pain: a multicenter, randomized, double-blind, parallel-group, 10-day treatment stu

机译：对乙酰氨基酚/曲马多（325 mg / 37.5 mg）联合治疗与曲马多（50 mg）单药治疗亚急性下腰痛的疗效和耐受性：多中心，随机，双盲，平行组，10天治疗研究

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BACKGROUND: In various pain studies, the single-dose combination of paracetamol/tramadol (PIT) was found to be more effective than either agent alone. PIT could provide benefit in patients with subacute low back pain (LBP). OBJECTIVE: This study compared the efficacy and tolerability of PIT with tramadol alone (T) in patients with subacute LBP and assessed whether, under comparable analgesic conditions, PIT would be better tolerated. METHODS: This was a multicenter, randomized, double-blind, parallel-group study. Patients were enrolled if they suffered from nonspecific LBP lasting 10 to 42 days and experienced at least moderate pain (> or =40 mm on a 100-mm visual analog scale). Patients were randomized and treated for 10 days with PIT (325 mg/37.5 mg) or T (50 mg). The study outcomes were treatment efficacy (pain intensity, pain relief, patient satisfaction, physicians' assessment of pain control) and tolerability (adverse events [AEs], patients' tolerability judgment). RESULTS: A total of 119 patients were enrolled (PIT, n = 59; T, n = 60). Demographic characteristics of patients were comparable between the PIT and T groups in regard to age (mean, 56.5 vs 54.1 years, respectively), sex (women/men, 38121 vs 31129), race (white, 96.1% vs 94.2%), and body mass index (24.9 vs 26.1 kg/m2). Pain intensity (mean [SD] percentage of worst imaginable pain) improved from nearly identical levels at baseline (P/T, 67.5 [13.0] vs T, 65.3 [14.6]; P = NS) to similarly low levels at the final visit (P/T, 27.9 [22.7] vs T, 24.8 [21.6]; P = NS). The reduction in pain intensity was significant in both treatment groups (P < 0.001). Adequate pain relief (ie, "moderate," "important," or "complete") was observed in 81.6% (40149) of PIT patients versus 82.9% (39147) of T patients (P = NS). Comparably high rates of overall patient satisfaction (72.5% [37151] vs 72.9% [35148], respectively; P = NS) were achieved. Both treatment groups took a comparable number of daily units of study medication, which resulted in significantly (P < 0.001) lower daily doses of tramadol in the P/T group (mean [SD], 172.5 [46.6] mg) than in the T group (227.3 [59.7] mg). More P/T patients (84.3%) than T patients (68.8%) judged treatment tolerability as good or very good (P = NS). Significantly fewer AEs (P < 0.001) were observed in PIT patients, and the overall incidence of AEs (mostly opioid-typical AEs [eg, nausea, dizziness/vertigo, sleepiness/drowsiness, constipation, vomiting]) was much lower after P/T compared with T (P = 0.019). The most common AEs in the P/T and T groups were nausea (8159 vs 21160 patients, respectively; P 0.012) and dizziness (3/59 vs 15/60 patients; P Tramadol, alone and in combination with paracetamol, provided highly effective analgesia for these patients with subacute LSP However, the combination of PIT, which resulted in 25% less tramadol than equianalgesic daily doses of T alone, considerably reduced the incidence of AEs and improved tolerability.
机译：背景：在各种疼痛研究中，发现对乙酰氨基酚/曲马多（PIT）的单剂量组合比单独使用任何一种药物更有效。 PIT可为亚急性下腰痛（LBP）患者提供益处。目的：本研究比较了PIT与单纯曲马多（T）在亚急性LBP患者中的疗效和耐受性，并评估了在可比的镇痛条件下，PIT的耐受性是否更好。方法：这是一项多中心，随机，双盲，平行组研究。如果患者患有持续10到42天的非特异性LBP，并且经历了至少中度疼痛（在100 mm视觉模拟量表上≥40 mm），则入组。患者被随机分配并接受PIT（325 mg / 37.5 mg）或T（50 mg）治疗10天。研究结果为治疗效果（疼痛强度，缓解疼痛，患者满意度，医生对疼痛控制的评估）和耐受性（不良事件[AEs]，患者的耐受性判断）。结果：共有119名患者入组（PIT，n = 59; T，n = 60）。在年龄（平均分别为56.5和54.1岁），性别（男女之间，分别为38121和31129），种族（白人，分别为96.1％和94.2％）和PIT和T组之间，患者的人口统计学特征具有可比性体重指数（24.9 vs 26.1 kg / m2）。疼痛强度（最严重可想象疼痛的平均[SD]百分比）从基线时的几乎相同水平（P / T，67.5 [13.0] vs T，65.3 [14.6]; P = NS）提高到最终访视时的相似低水平（ P / T，27.9 [22.7]与T，24.8 [21.6]; P = NS）。在两个治疗组中，疼痛强度的降低均显着（P <0.001）。在PIT患者中有81.6％（40149）与T患者的82.9％（39147）有足够的疼痛缓解（即“中度”，“重要”或“完全”）（P = NS）。总体患者满意度较高（分别为72.5％[37151]和72.9％[35148]; P = NS）。两个治疗组的每日研究药物用量相当，因此P / T组的曲马多每日剂量（平均[SD]为172.5 [46.6] mg）比T组明显减少（P <0.001）。组（227.3 [59.7]毫克）。 P / T患者（84.3％）比T患者（68.8％）认为治疗耐受性好或很好（P = NS）。在PIT患者中观察到的AEs明显较少（P <0.001），并且AE的总发生率（主要是阿片类AEs（例如，恶心，头晕/眩晕，嗜睡/困倦，便秘，呕吐））较低。 T与T的比较（P = 0.019）。 P / T和T组最常见的AE是恶心（分别为8159和21160例患者; P = 0.012）和头晕（3/59对15/60病人; P曲马多单独或与扑热息痛联用可提供高度有效这些亚急性LSP患者的镇痛效果然而，PIT的使用比曲马多的每日镇痛剂量（单剂量T）少25％，大大降低了AE的发生率并提高了耐受性。

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