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萘普生速溶混悬液制剂的疗效与耐受性:一项上市后调查

Efficacy and tolerance of naproxen instant suspension formulation: a post-marketing survey.

作者信息

Cordaro C I, Sartini A, Celotti F

机构信息

Medical Department, Recordati SpA, Milan, Italy.

出版信息

J Int Med Res. 1988 Mar-Apr;16(2):157-65. doi: 10.1177/030006058801600211.

Abstract

A multi-centre uncontrolled clinical trial was performed in 42 Italian hospitals to evaluate the efficacy and tolerance of an instant suspension of naproxen, a well known anti-inflammatory drug. A total of 390 adults of all ages with musculoskeletal rheumatic diseases or minor traumatic injuries entered the trial. Patients received 500 mg naproxen instant suspension twice daily after meals, for 1-4 weeks. Assessment of signs and symptoms was made before starting the therapy, after 3 days and at the end of the treatment period. The drug produced a rapid and progressive relief of pain and articular symptoms in most patients and was equally effective in all the diagnostic sub-groups. The efficacy of treatment was 'excellent' or 'good' in about 85% of patients, 'moderate' in 10% and 'minimal' or 'absent' in about 5%. Almost 90% of patients had no side-effects; 5% were withdrawn because of unwanted effects. No correlation between incidence or intensity of side-effects and age of the patients or duration of therapy was observed. The complaints reported are common to other anti-rheumatic drugs, e.g. epigastric pain, pyrosis, nausea, vomiting and headache. In conclusion, naproxen instant suspension is highly effective and well tolerated.

摘要

在42家意大利医院进行了一项多中心非对照临床试验,以评估知名抗炎药萘普生速溶混悬液的疗效和耐受性。共有390名患有肌肉骨骼风湿性疾病或轻度创伤性损伤的各年龄段成年人参与了该试验。患者在饭后每天服用两次500毫克萘普生速溶混悬液,持续1至4周。在开始治疗前、3天后以及治疗期结束时对体征和症状进行评估。该药物在大多数患者中迅速且逐步缓解了疼痛和关节症状,并且在所有诊断亚组中效果相同。约85%的患者治疗效果为“优”或“良”,10%为“中”,约5%为“差”或“无”。近90%的患者无副作用;5%因不良反应退出。未观察到副作用的发生率或严重程度与患者年龄或治疗持续时间之间存在相关性。所报告的不适症状与其他抗风湿药物常见的症状相同,例如上腹部疼痛、胃灼热、恶心、呕吐和头痛。总之,萘普生速溶混悬液高效且耐受性良好。

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