正鑫一消贴对癌症小鼠疼痛的缓解作用及临床疗效观察

Experimental and clinical observation of Xin rehabilitation patch in relieving cancer pain

目的观察正鑫一消贴对癌症疼痛的镇痛作用并初步评价其抗肿瘤效果。方法建立小鼠肿瘤模型,温水浴测尾和痛针刺激足跖,从热和机械力刺激两方面检测正鑫一消贴对小鼠痛阈的影响。临床观察中随机选择临床影像学和病理检查确诊的中、晚期肿瘤伴轻、中、重度疼痛患者60例。患者按NRS疼痛程度评分分为两组,NRS疼痛评分1-6分者(轻度、中度疼痛)为A组,共38例,以正鑫一消贴治疗或贴剂联合非甾体类抗炎止痛药或弱阿片类止痛药。NRS疼痛评分为7～10分者(重度疼痛)为B组,共22例,采用正鑫一消贴剂联合口服吗啡止痛治疗。所有患者均自测疼痛强度、一般状况及药物不良反应。结果动物试验温水浴测尾法显示,正鑫一消贴使用30min后受试动物痛阈有提高趋势,2h镇痛效果确切,24h仍有镇痛效果;痛针试验显示,正鑫一消贴能有效提高小鼠耐痛克数(本实验以耐受痛针克数反映耐痛程度),有一定的镇痛作用,效果略弱于芬太尼。临床观察结果,A组与B组止痛有效率分别为94.7%(36例/38例)、59.1%(13例/22例);两组均未见与贴剂相关的毒副反应。结论正鑫一消贴有一定的抑制肿瘤疼痛的作用。临床应用有望改善中晚期肿瘤患者的一般状况。

Objective To observe the effect of relieving cancer pain with Xin rehabilitation patch. Methods The effect of Xin rehabilitation patch on pain threshold of mice were tested by the tail test with thermal water and mechanical pain stimulation test. Sixty patients with mid-advanced tumors accompanying mild to severe cancer pain were divided into group A （n=38,NRS pain score 1～6） and group B （n=22,NRS pain score 7～10）. Patients in group A accepted Xin rehabilitation patch,or patch combined with non-steroidal anti-inflammatory drugs or opioids,while patients in group B used Xin rehabilitation patch combined with oral morphine. Pain intensity,general condition and adverse drug reactions were observed in both groups. Results The tail test with thermal water showed that Xin rehabilitation patch could improve the pain threshold after 30 mins,and analgesic effect was observed after 2 h and then sustaining to 24 h. Mechanical pain stimulation test showed that Xin rehabilitation patch could improve the pain threshold and showed analgesic effect which was a little weaker than fentanyl. The clinical study showed that the rate of analgesic effect of group A was 94.7% （36/38） and which of group B was 59.1% （13/22）. Conclusion Xin rehabilitation patch may have certain analgesic effect on cancer pain,and maybe helpful to improve general condition in patients with mid-advanced tumors.