克洛曲片对癌痛的开放研究

PROSPECTIVE CLINICAL TRIAL OF THE ANALGESIC EFFECT OF KELUOQU TABLETS IN TREATMENT OF CANCER PAIN

目的 :评价克洛曲片对癌性疼痛的镇痛效果。方法 :采用多中心开放研究的方式 ,观察克洛曲片对 111例癌痛患者用药 63 1次的临床效果 ,分析用药次数、近期用镇痛药史及其他因素对克洛曲片镇痛效果的影响。结果 :克洛曲片的首剂总有效率为 92 .8%。平均 3 5min起效 ,1h达到最佳缓解状态 ,疼痛缓解时间可持续 6h以上。克洛曲片对中度和重度疼痛的有效率无显著差异 ,但重度疼痛患者起效较快 ,缓解时间较短 (P <0 .0 5 )。连续 10次用药后 ,完全缓解 (CR)率的降低和部分缓解 (PR)率的增加均有显著意义 (P <0 .0 1) ,缓解时间也显著缩短 (P <0 .0 1) ;近期应用二、三阶梯镇痛药史 ,也明显降低克洛曲片的CR率 (P <0 .0 1)。克洛曲片的不良反应以恶心、头晕、乏力较多 ,但均可耐受。结论 :克洛曲片对中度和重度癌性疼痛的镇痛效果确切 。

OBJECTIVE:To evaluate the analgesic effect and ADRs of Keluoqu tablets in treatment of moderate to severe cancer pain.METHODS:The prospective,multicenter,open trial was conducted in 111 patients with cancer pain.The total number of treatment was 631 by doses.The analgesic effect and influence factors such as number of treatment with this agent and histories of analgesic use were analyzed.RESULTS:The total effective rate of first dose efficacy was 92.8% with a mean onset of action of 35 minutes,a mean maximum pain relief of 1 hour,and duration of pain relief of more than 6 hours.No significant difference in effective rate was observed in moderate and severe pain but onset of action was quicker and duration of pain relief was shorter in severe pain patients.Reduce in CR,increase in PR and significant reduce in duration of pain relief were observed after continuous treatment with 10 doses of the agent.The CR rate was also significantly decreased in patients with recent analgesic experience.Nausea,dizziness,and fatigue were the main ADRs.CONCLUSION:Keluoqu tablet is an effective agent for treatment of moderate to severe cancer pain.