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目的 :研究新一代非甾体类镇痛抗炎药双氯芬酸钾凝胶剂的临床疗效和安全性。方法 :采用多中心的随机对照 ,使用双氯芬酸钾凝胶剂治疗各种急性疼痛患者 10 4例 ,其中 6 3例与扶他林乳胶剂治疗同类患者 ,6 3例进行随机对照 ,另设开放组 41例。结果 :双氯芬酸钾凝胶剂对疼痛的总临床控制率为 5 7.6 9% ,总有效率为 82 .6 9% ,与对照组比较无显著性差异。其不良反应发生率为 4.81%。结论 :双氯芬酸钾凝胶剂是安全有效的外用镇痛消炎药。
Objective: To study the clinical efficacy and safety of a new generation of non-steroidal analgesic anti-inflammatory drug diclofenac potassium gel. Methods: A multicenter randomized controlled trial of diclofenac potassium gel in the treatment of 104 acute pain patients was performed. Among them, 63 patients were treated with fadalacetate and 63 patients were randomized. In addition, 41 patients in open group . Results: The total clinical control rate of diclofenac potassium gel for pain was 5 7.69% and the total effective rate was 82.69%, which showed no significant difference compared with the control group. The incidence of adverse reactions was 4.81%. Conclusion: diclofenac potassium gel is a safe and effective topical analgesic anti-inflammatory drug.