Varese C, Palazzini A
Orthopedic Department C. Forlanini Hospital, Rome, Italy.
Eur Rev Med Pharmacol Sci. 1997 Jan-Jun;1(1-3):57-62.
Fourty adult patients with coxarthrosis were treated for 30 days with oral diclofenac sodium at the daily dose of 150 mg: 20 of these were administered one 150 mg prolonged-release capsule per day, the other 20 received one 50 mg enteric-coated tablet every 8 hours. The presence and severity of several symptoms and signs (various pain types, cramps, morning stiffness, impaired function capacity), the intensity of pain through the Visual Analogical Scale and some laboratory tests (Erythrocyte Sedimentation Rate, C-reactive protein, Rheuma test) were controlled to monitor drug efficacy. The routine laboratory tests of blood, liver and kidney function, the gastrointestinal tolerance of the two administered formulations and the appearance of any adverse event were controlled to monitor drug tolerability. Both administration schemes yielded very positive results as to treatment efficacy, although the prolonged-release capsule often induced a somewhat quicker response. At the end of the one-month treatment more than half of patients in both groups registered disappearance of several symptoms and a noticeable reduction of the remainder ones. Systemic tolerability was also good, with superimposable results in the two groups; gastrointestinal tolerance on the contrary was better in the recipients of the prolonged-release capsules (2 cases of dyspepsia) with respect to those treated with the enteric-coated tablets (2 cases of gastric pyrosis and 2 cases of gastralgia). No adverse events were registered.
40例髋关节炎成年患者接受了为期30天的口服双氯芬酸钠治疗，日剂量为150mg：其中20例患者每日服用1粒150mg缓释胶囊，另外20例患者每8小时服用1片50mg肠溶片。通过控制几种症状和体征（各种疼痛类型、痉挛、晨僵、功能能力受损）的存在及严重程度、视觉模拟评分法评估的疼痛强度以及一些实验室检查（红细胞沉降率、C反应蛋白、风湿检查）来监测药物疗效。通过控制血常规、肝肾功能的常规实验室检查、两种给药制剂的胃肠道耐受性以及任何不良事件的出现情况来监测药物耐受性。两种给药方案在治疗效果方面均产生了非常积极的结果，尽管缓释胶囊往往起效稍快。在为期一个月的治疗结束时，两组中超过半数的患者出现几种症状消失，其余症状明显减轻。全身耐受性也良好，两组结果相近；相反，缓释胶囊服用者的胃肠道耐受性（2例消化不良）优于肠溶片服用者（2例胃灼热和2例胃痛）。未记录到不良事件。
