de los Santos A R, Di Girolamo G, Martí M L
School of Medicine, Department of Medicine, University of Buenos Aires, Argentina.
Int J Tissue React. 1998;20(2):71-81.
In this study lysine clonixinate, a nonsteroidal antiinflammatory agent with selective inhibition of cyclooxygenase-2 and 5-lipooxygenase in in vitro and in vivo pharmacodynamic studies, was evaluated in a prospective, randomized, double-blind, double-dummy clinical study versus paracetamol/codeine, in 151 patients with pain following inguinal hernioplasty. Patients were treated with one 125 mg tablet of lysine clonixinate or paracetamol/codeine (500 mg + 30 mg) administered at fixed doses every 4 h during 2 days. Controls were carried out 1, 2 and 4 h after the first intake of day 1 and day 2. Each control included assessment of pain at rest, when coughing, sitting and upon moderate pressure. Both treatment groups (lysine clonixinate, 77 patients and paracetamol/codeine, 74 patients) were comparable in terms of demographic and baseline pain intensities. Spontaneous pain was reduced significantly in both treatment groups from the 1st-h control. The following values were recorded in the lysine clonixinate group during day 1: baseline: 6.86 +/- 1.24; 1st h: 4.49 +/- 1.77; 2nd h: 2.96 +/- 1.74; 4th h: 2.23 +/- 1.51. The following values for the same group during day 2 were: predose: 1.70 +/- 1.64; 1st h: 1.16 +/- 1.17; 2nd h: 0.78 +/- 1.06; 4th h: 0.63 +/- 1.05. The paracetamol/codeine group revealed the following values: day 1: baseline: 6.72 +/- 1.22; 1st h: 4.57 +/- 1.72; 2nd h: 2.97 +/- 1.68; 4th h: 2.47 +/- 1.68 and day 2: predose: 2.02 +/- 1.57; 1st h: 1.32 +/- 1.23; 2nd h: 0.82 +/- 0.99; 4th h: 0.66 +/- 0.89. Reduction of pain induced by coughing, sitting and pressure showed similar behavior patterns. No significant differences between both treatment groups were encountered in terms of analgesic efficacy. Incidence of adverse effects was significantly higher in the paracetamol/codeine group (X2: p < 0.05): 11 out of 74 patients; three patients had to discontinue treatment. In the lysine clonixinate group four out of 77 patients showed side effects but these did not require treatment discontinuation.
在本研究中，赖氨酸氯尼辛酯是一种非甾体抗炎药，在体外和体内药效学研究中具有选择性抑制环氧化酶-2和5-脂氧合酶的作用。在一项前瞻性、随机、双盲、双模拟临床研究中，将其与对乙酰氨基酚/可待因进行比较，研究对象为151例腹股沟疝修补术后疼痛的患者。患者服用1片125mg的赖氨酸氯尼辛酯或对乙酰氨基酚/可待因（500mg + 30mg），每4小时固定剂量给药，持续2天。在第1天和第2天首次服药后1、2和4小时进行对照。每次对照包括评估静息时、咳嗽时、坐位时以及适度按压时的疼痛情况。两个治疗组（赖氨酸氯尼辛酯组77例患者，对乙酰氨基酚/可待因组74例患者）在人口统计学和基线疼痛强度方面具有可比性。从第1小时对照开始，两个治疗组的自发痛均显著减轻。赖氨酸氯尼辛酯组在第1天记录的以下数值：基线：6.86±1.24；第1小时：4.49±1.77；第2小时：2.96±1.74；第4小时：2.23±1.51。该组在第2天的以下数值为：给药前：1.70±1.64；第1小时：1.16±1.17；第2小时：0.78±1.06；第4小时：0.63±1.05。对乙酰氨基酚/可待因组的数值如下：第1天：基线：6.72±1.22；第1小时：4.57±1.72；第2小时：2.97±1.68；第4小时：2.47±1.68；第2天：给药前：2.02±1.57；第1小时：1.32±1.23；第2小时：0.82±0.99；第4小时：0.66±0.89。咳嗽、坐位和按压引起的疼痛减轻呈现相似的行为模式。两个治疗组在镇痛效果方面未发现显著差异。对乙酰氨基酚/可待因组的不良反应发生率显著更高（卡方检验：p < 0.05）：74例患者中有11例；3例患者不得不停止治疗。在赖氨酸氯尼辛酯组，77例患者中有4例出现副作用，但这些副作用无需停止治疗。
