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目的:评价国产硫酸吗啡控释片对晚期癌症伴重度疼痛患者的镇痛效果和药物不良反应。方法:30例国产控释片与进口控释片自身交叉对照试验,47例开放试验。采用疼痛强度差、总疼痛强度差、疼痛缓解度、中度以上疼痛缓解率等镇痛评价指标。结果:国产控释片与进口控释片对照试验的临床镇痛显效率和有效率均分别为 96.7%和 3.3%,部分有效和无效均为0,无显著性差异。开放试验显效率和有效率分别为97.6%和 2.1%。药物不良反应主要有头晕、头痛、恶心、呕吐、胃不适、便秘等,如采用滴定法给药,可降低药物不良反应发生率。结论:国产控释片与进口控释片的临床镇痛效果良好,差异无显著性。
OBJECTIVE: To evaluate the analgesic effect and adverse drug reactions of domestic controlled-release morphine sulfate tablets in patients with advanced cancer with severe pain. Methods: 30 cases of homemade controlled-release tablets and imported controlled-release tablets self-controlled cross-over test, 47 open trials. With pain intensity difference, the total pain intensity difference, pain relief, moderate pain relief rate and other indicators of pain evaluation. Results: The effective rates and effective rates of clinical analgesia of controlled release tablets and imported controlled release tablets in controlled trials were 96.7% and 3.3%, respectively. Some of them were effective and invalid, with no significant difference. Open test was effective and effective rate was 97.6% and 2.1%. Adverse drug reactions are dizziness, headache, nausea, vomiting, stomach upset, constipation, etc., such as the use of titration, can reduce the incidence of adverse drug reactions. Conclusion: The clinical analgesic effect of domestic controlled release tablets and imported controlled release tablets is good, with no significant difference.