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Abstract：
Objective In this study, we aimed to compare the efficacy and safety of the fixed-dose combination (FDC) of nimesulide (100 mg) + paracetamol (325 mg) [NP], ketorolac (10 mg) [Kt] alone, diclofenac (50 mg) + paracetamol (325 mg) [DP], and aceclofenac (100 mg) + paracetamol (325 mg) [AP] in patients with acute painful conditions. Methods This was a randomized, prospective, open-label, multicentre, active-controlled study involving patients aged ≥18 years, with acute painful conditions like low back pain, acute musculoskeletal disorders, and trauma such as tendinitis, tenosynovitis, bursitis, sprains and strains, migraine, dental pain, painful dental procedures, and post-surgical pain. Reduction in pain intensity and liver, renal, gastrointestinal, and cardiovascular safety were assessed on days seven and 14. Results A total of 600 patients were randomized into NP, Kt, DP, and AP groups in a 1:1:1:1 ratio. NP, DP, and AP were administered twice a day while Kt was given three times a day. The reduction of pain as measured by the numerical rating scale (NRS) scores at the end of day seven was 3.75 ± 1.58 in the NP group, 2.96 ± 1.18 in the Kt group, 3.42 ± 1.42 in the DP group, and 3.47 ± 1.30 in the AP group. The pain reduction in the NP group was significantly greater (p<0.001) as compared to the Kt group and non-inferior to the DP and AP groups on days seven and 14. Non-inferiority was concluded between the NP, DP, and AP groups as the lower limit of 95% CI of the difference in the change of pain intensity on both days seven and 14 was above the predefined margin of -1.0. All the drugs were well tolerated, but a significantly greater number of adverse events were reported in the DP group (32) as compared to the NP group (14) (p<0.05). The most common adverse events reported during the study were nausea, gastritis, and abdominal pain in all four groups. There was no significant alteration in liver and renal function tests except a rise in serum creatinine in the DP group. Conclusions The FDC of nimesulide with paracetamol is superior to ketorolac and non-inferior to the FDC of diclofenac with paracetamol and aceclofenac with paracetamol in the management of pain in patients with acute painful conditions. The tolerability profile of the FDC of nimesulide with paracetamol is similar to that of ketorolac but better than diclofenac with paracetamol and aceclofenac with paracetamol combinations.
摘要：
目的在本研究中,我们旨在比较尼美舒利（100mg）+对乙酰氨基酚（325mg）[NP]的固定剂量组合（FDC）的疗效和安全性，酮咯酸（10毫克）[Kt]，双氯芬酸（50毫克）+对乙酰氨基酚（325毫克）[DP]，和醋氯芬酸（100mg）+扑热息痛（325mg）[AP]用于急性疼痛患者。方法这是一个随机的，prospective,开放标签，多中心,涉及年龄≥18岁患者的主动对照研究，急性疼痛，如腰痛，急性肌肉骨骼疾病，和创伤如肌腱炎，腱鞘炎,滑囊炎,扭伤和拉伤，偏头痛,牙痛,痛苦的牙科手术，和术后疼痛.减轻疼痛强度和肝脏，肾,胃肠,在第7天和第14天评估心血管安全性.结果共有600例患者被随机分为NP,Kt,DP,和AP组以1:1:1:1的比例。NP,DP,AP每天给药两次，而Kt每天给药三次。在第7天结束时，通过数字评定量表（NRS）评分测量的疼痛减轻在NP组中为3.75±1.58，Kt组2.96±1.18，DP组3.42±1.42，AP组为3.47±1.30。在第7天和第14天，NP组的疼痛减轻明显大于Kt组（p<0.001），并且不劣于DP和AP组。NP之间得出了非劣效性，DP,和AP组作为第7天和第14天疼痛强度变化差异的95％CI的下限高于-1.0的预定义界限。所有的药物都有很好的耐受性,但与NP组(14)相比,DP组(32)的不良事件发生率明显更高(p<0.05).研究期间报告的最常见的不良事件是恶心，胃炎,四组均有腹痛。除DP组血清肌酐升高外，肝肾功能检查无明显变化。结论在急性疼痛患者的疼痛治疗中，尼美舒利联合扑热息痛的FDC优于酮咯酸，而不劣于双氯芬酸联合扑热息痛和醋氯芬酸联合扑热息痛的FDC。尼美舒利与对乙酰氨基酚的FDC的耐受性与酮咯酸相似，但优于双氯芬酸与对乙酰氨基酚和醋氯芬酸与对乙酰氨基酚的组合。
