摘要
在２０６例手术后疼痛病人及１１４例癌症疼痛病人中（共３３０例），进行了阿司匹林－可待因片（ＡＣ片）的双盲、随机对照临床试验。分别按三种设计方案进行观察，以氨酚待因片（ＡＡＣ）作为阳性对照药，安慰剂作为阴性对照药；１）平行对照试验２７７例（与ＡＡＣ比较）；２）自身交叉对照试验２５例；３）首次剂量给予安慰剂作为阴性对照２８例。临床试验结果表明ＡＣ片对轻、中、重度疼痛病人的缓解率分别为５０％，９５％和９８．９％；ＡＡＣ的相应缓解率分别为５０％，１００％和１００％。自身交叉对照试验结果表明ＡＣ与ＡＡＣ镇痛效果相同。术后病人首剂给予安慰剂时镇痛效果为０％，ＡＣ片为１００％。观察到的ＡＣ片不良反应仅为轻度胃肠不适及头晕，无需特殊处理。
Three hundred and thirty patients including 114 cases of cancer pain and 216 cases of postoperative pain entered the double-blind randomized controled study of Co-codaprin tablet (AC)incomparison with acetaminophen and codeine tablet(AAC)or placebo. The study was carried out in three different designs;i.e.1) paralleled control study,AC 185 cases and AAC 92 cases; 2)cross-over design(25 cases);and 3)first-dose placebo control(28 cases).The total pain relief rate of AC in minor, moderate and severe pain were 50%, 95% and 98.9% respectively.Pain relief rate of AAC in minor,moderate and severe pain were 50%, 100% and 100% respectively.The results of cross-over design showed that the analgesic effect of AC and AAC were the same.In first-dose placebo design in postoperative pain patients the pain relief rate of placebo and AC were 0% and 100%respectively. The adverse effect observed of AC was minor gastrointestinal uncomfortable and slightdizziness.No special treatment was needed.
出处
《中国临床药理学杂志》
CSCD
北大核心
1995年第4期193-199,共7页
The Chinese Journal of Clinical Pharmacology
