非ステロイド性抗炎症鎮痛剤レリフェン錠 (ナブメトン) の使用成績調査

Post-marketing surveillance was undertaken with non-steroidal anti-inflammatory analgesic Relifen® tablet (nabumetone) in patients with rheumatoid arthritis, low back pain, cervico-omo-brachial syndrome, scapulohumeral periarthritis and osteoarthritis for 6 years from March, 1990 to March, 1996.Total 5, 347 cases surveyed were collected from 558 medical institutions of all over the country : 5, 266 cases were assessed for safety ; 5, 192 cases were assessed for efficacy.In 5, 266 cases assessed for safety, adverse reactions occurred in 2.54% (134/5, 255 eases) . Representative manifestations were gastro-intestinal system disorders such as abdominal pain and nausea in 1.56% (82/5, 266), skin and appendages disorders such as rash and pruritus in 0.40% (21/5, 256), liver and biliary system disorders such as increased GOT and increased GPT in 0.27% (14/5, 266) and urinary system disorders such as increased BUN in 0.19% (10/5, 266) . No patients were judged by doctors as to have severe or serious adverse reactions. The adverse reactions were slight in 83.1%. In almost all the cases, the adverse reactions were recovered or resolved after Relifen® tablet was discontinued or reduced in dosage or appropriately treated.In 5, 192 cases assessed for efficacy in different categories of disease, efficacy rates were 46.4% (481/1, 037) in rheumatoid arthritis, 70.5% (1, 351/1, 917) in low back pain, 71.1% (413/581) in cervico-omo-brachial syndrome, 67.3% (230/342) in scapulohumeral periarthritis and 61.2% (800/1, 307) in osteoarthritis.We submited the documents for the above-stated post-marketing surveillance to apply re-examination in June, 1900, and were informed of the results from the re-examination on March 3, 1999, to confirm that Relifen® tablet (nabumetone) had the similar safety and efficacy as those initially approved.