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氨酚待因2号片(PC-2)每片含磷酸可待因15 mg和扑热息痛300 mg,是国内新开发的复方镇痛药,本文采用多中心、随机双盲双模拟平行对照的试验设计,对中度疼痛患者进行临床验证,以氨酚待因1号片(PC-1,每片含磷酸可待因8.4 mg和扑热息痛500 mg)作为阳性对照药,阴性对照药用安慰剂(PB)。患者总数338例(206例用PC-2,32例用PC-1,100例用PB)。临床验证结果表明:(1)PC-2组对中等程度的手术后疼痛、中晚期癌痛和某些神经痛均有满意的镇痛效果,其疼痛强度差、疼痛缓解度以及2度以上疼痛缓解率等各项检查指标均明显优于PB组(P
Paracetamol Tablets No. 2 (PC-2) contains 15 mg of codeine phosphate and 300 mg of paracetamol each. It is a newly developed compound analgesic in China. In this study, a multicenter randomized, double-blind and double-dummy parallel controlled trial Designed to be clinically validated in patients with moderate pain using as the positive control drug, paracetamol, codeine 1 (PC-1, each containing 8.4 mg of codeine phosphate and 500 mg of acetaminophen), the negative control medicinal placebo PB). The total number of patients was 338 (206 with PC-2, 32 with PC-1 and 100 with PB). Clinical validation results showed that: (1) PC-2 group had satisfactory analgesic effect on moderate postoperative pain, advanced cancer pain and some neuralgia, with poor pain intensity, pain relief and pain more than 2 degrees Mitigation rates and other indicators were significantly better than the PB test group (P