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目的 评估按国家药品生物制品检定所修订的国家标准生产的“注射用克痛宁” (电泳纯和免疫纯 )的临床应用效果及毒副作用。方法 各种中、重度急慢性疼痛患者 92例 ,肌肉注射给药 ,70 μg/次 ,70～ 1 40 μg/天。慢性疼痛病例一般按疗程用药 ,每疗程 5天 ,急性疼痛病例及部分慢性疼痛病例疼痛消失即停药。以病人曾用过的镇痛药疗效作为历史对照。结果 总有效率 96 .7% ,总显效率 82 .6 % ,首支总有效率 93.5 %。对癌痛组的首支有效率稍低 ,为 84 .2 %。一般在肌注后 30～ 6 0 min起效 ;对急性疼痛疗效可持续 6～ 1 0 h,对慢性疼痛大多可持续 1 2 h或 2 4 h以上。对阿片类药物成瘾患者也有良好效果。少数病人出现轻度口干、恶心、头晕等不良反应。结论 新标准“注射用克痛宁”对各种急慢性疼痛均有良好的镇痛效果 ,起效快、镇痛作用强而持久、不成瘾、毒副作用小 ,且具有潜在的戒毒作用。优于原地方标准的“克痛宁”。
Objective To evaluate the clinical effect and side effects of “Keteng Injection” (electrophoresis pure and immunopurified) produced according to the national standard as revised by the National Institute for the Control of Pharmaceutical and Biological Products. Methods A total of 92 patients with moderate to severe acute and chronic pain were injected intramuscularly with 70 μg / second and 70-140 μg / day. Chronic pain cases are generally treated by medication, 5 days per course of treatment, acute pain and pain relief in some cases of chronic pain that withdrawal. The patient used to analgesic efficacy as a historical control. The total effective rate was 96.7%, the total effective rate was 82.6%, the first total effective rate 93.5%. The first branch of cancer pain group slightly lower efficiency, 84.2%. Generally in the intramuscular injection of 30 ~ 60 min onset; the efficacy of acute pain sustainable 6 ~ 1 0 h, mostly chronic pain sustainable 12 h or more than 24 h. Good results for opioid addicts. A small number of patients with mild dry mouth, nausea, dizziness and other adverse reactions. Conclusion The new standard “Ke Tong Ning for Injection” has good analgesic effect on various acute and chronic pain. It has fast onset of action, strong and long-lasting analgesic effect, no addiction, little side effects and potential detoxification effect. Better than the original local standard “Ke Tong Ning.”