克洛曲片对手术后疼痛的平行对照研究

Randomized, double-blind, placebo-controlled,parallel multicenter trial of Keluoqu tablet(KLQ) in treatment of post-operative pains

目的 :观察克洛曲片对中度以上手术后疼痛的临床镇痛效果。方法 :采用多中心、双盲、随机平行对照研究方法 ,将 2 0 1例患者分为治疗组 10 1例和对照组 10 0例 ,分别采用克洛曲片和安慰剂模拟克洛曲片治疗 ,治疗组服克洛曲片 2片 ,对照组用安慰剂 2片。结果 :治疗组的有效率为 91.1% ,明显高于对照组的 19.0 % (P <0 .0 1) ;但 2组有效患者的平均起效时间、到达最佳缓解时间相近 ;而克洛曲片的平均缓解时间达 6 .5h ,显著长于安慰剂的 2 .9h(P <0 .0 1)。克洛曲片吞服和舌下含化途径给药的有效率相同 ,平均起效时间和缓解时间相近 ,只是含化途径到达最佳缓解的平均时间缩短 5min(P <0 .0 5 )。克洛曲片的不良反应以恶心、头晕、乏力、心慌和多汗多见 (P <0 .0 1) ,但均可耐受。结论 :克洛曲片对中度以上手术后疼痛的临床镇痛疗效确切。

Objective:To observe the clinical effects of Keluoqu tablet(KLQ) in treatment of post-operative pains.Methods:The study was conducted in 201 patients with post-operative pains.They were randomly divided into active( n =101) and control group( n =100).Each group was treated with KLQ or placebo in a regimen of two tablets.Results:The total effective rate was 91.1% in active group vs 19.0% in control group( P <0.01).The mean pain relief time is 6.5h for KLQ vs 2.9h for placebo ( P < 0.01).The administration route (oral and sublingual)of KLQ has no effect on effective rate and onset of action but with shorter mean best response time(5 minutes)for sublingual administration ( P < 0.05). The side effect of KLQ such as nausea,dizziness,hypodynamic palpitation and sweating was more frequent in comparison with placebo but they were tolerable in most cases.Conclusion:KLQ is an effective agent for treatment of moderate to severe post-operative pains.\;[