使用喜寧保(Cinopal)治療骨科關節疾病之臨床研究

A Clinical Study on a New Agent- Cinopal (Fenbufen) in the Treatment of Degenerative Disorders of Joints

—種新型非類固醇抗炎止痛劑喜寧保（Cinopal Fenbufen之商品名，臺灣氰胺公司所提供），使用於治療關節炎性疾患的療效及安全性，經由臺灣大學醫學院附屬醫院外科部，隨機選取30位骨科門診患者施行臨床試驗及評估。每一患者給予喜寧保口服錠劑每日四粒（每錠含200mg）早晚飯後各服兩粒，每日劑量為800mg連續服用28日。接受本劑治療之患者，均獲得顯著的症狀改善。全般療效之評估顯示：27％為特優，67％為優良，6％為頗佳。本藥所導致之副作用及不良反應極為少見。為安全評估所施行之各種實驗室檢查，如尿液分析、大便匿血反應，包括肝功能、腎功能、及其他有關之血液學檢查，於治療開始前及完畢後分別施行；前後相比較，並無顯著的差異。根據此次之臨床研究，喜寧保業已顯示其優異之治療效果。對於關節炎性疾病，為一種安全而耐受性良好之非類固醇抗炎止痛製劑。

An open and non-comparative clinical study was conducted to evaluate the efficacy and safety of a new agent, Cinopal (trade name of fenbufen, supplied by Taiwan Cyanamid Corporation). 28 patients with osteoarthritis, 1 with tendinitis, and 1 with spondylitis were randomly selected from Out-Patient Clinic, Department of Surgery, National Taiwan University Hospital to enter into study. Two tablets (200 mg per each) of Cinopal were given to each patient twice a day orally in a daily dose of 800 mg for consecutive twenty- eight days. Significant improvements were obtained in all patients on Cinopal therapy. The overall efficacy evaluation showed excellent at 27%, good at 67% and fair at 6%. Side effect and adverse reactions were minimal. The clinical laboratory tests including urinalysis, occult blood in stool, and hematological studies taken before and after Cinopal trial revealed its systemic safety profile. Based on this clinical study, Cinopal (fenbufen) has produced superior therapeutic efficacy and exhibited that it is a safe and well-tolerated non-steroidal anti-inflammatory agent in the treatment of arthritis and other orthopedic inflammatory conditions.