Puccetti L, Ciompi M L
1st Institute of Medical Pathology, University of Pisa, Italy.
Int J Clin Pharmacol Res. 1991;11(3):143-58.
Patients affected by osteoarthritis totalling 358 (142 males and 216 females) were recruited in an open study which lasted up to three months. All patients started treatment with etodolac 600 mg/die per os. 74 patients were treated and followed for 15 days, 94 for one month, 54 for two months, and 132 for three months. Clinical evaluations, performed at baseline and after 15, 30, 60, and 90 days of treatment were made on the following parameters: intensity of pain, index of sleep disturbance caused by symptoms related to osteoarthritis, investigator's evaluation of the global patient's condition, patient's self-evaluation about his own condition, presence and duration of morning stiffness, presence and duration of stiffness at rest, and finally the investigator's integrated evaluation about the effectiveness tolerance of etodolac during the study. All the parameters showed a noticeable and significant improvement in all groups of patients, stratified by sex, age, and duration of the disease. The younger patients and those patients with osteoarthritis of a less prolonged duration achieved the best results. Only slight differences were registered by examining the baseline values of the various parameters or the extent of the different improvements achieved, on the basis of sex, and duration of osteoarthritis and the non-steroidal anti-inflammatory drugs previously used. Among the 27 patients who withdrew, eight dropped out for clinical inefficacy and 15 for intolerance. In all these latter cases a prompt and complete resolution of the adverse reaction was achieved and maintained after the interruption of therapy. In the 49 patients who presented side-effects, these were almost always related to the gastrointestinal tract and of slight intensity. A complete resolution was promptly achieved in 25 cases, while in 17 other patients the side-effect persisted during the course of the study, but it was considered not worthy of the patient dropping out. The profile of routine laboratory parameters, measured both at inception and at the end of the study, did not show relevant changes after treatment with etodolac. In conclusion this study demonstrated that etodolac is effective and well tolerated in the prolonged treatment of patients with active osteoarthritis.
在一项为期长达三个月的开放性研究中，招募了总计358名骨关节炎患者（142名男性和216名女性）。所有患者开始口服依托度酸，剂量为600毫克/日。74名患者接受治疗并随访15天，94名随访一个月，54名随访两个月，132名随访三个月。在基线以及治疗15、30、60和90天后，针对以下参数进行临床评估：疼痛强度、骨关节炎相关症状引起的睡眠障碍指数、研究者对患者整体状况的评估、患者对自身状况的自我评估、晨僵的存在及持续时间、静息时僵硬的存在及持续时间，最后是研究者对研究期间依托度酸有效性耐受性的综合评估。所有参数在按性别、年龄和疾病持续时间分层的所有患者组中均显示出显著且明显的改善。较年轻的患者以及骨关节炎病程较短的患者取得了最佳效果。根据性别、骨关节炎病程以及先前使用的非甾体抗炎药，在检查各种参数的基线值或所取得的不同改善程度时，仅发现了细微差异。在退出的27名患者中，8名因临床无效退出，15名因不耐受退出。在所有后一种情况下，停药后不良反应迅速且完全消退并得以维持。在出现副作用的49名患者中，这些副作用几乎总是与胃肠道相关且强度轻微。25例中迅速实现了完全消退，而在另外17名患者中，副作用在研究过程中持续存在，但被认为不值得患者退出。在研究开始时和结束时测量的常规实验室参数概况，在使用依托度酸治疗后未显示出相关变化。总之，本研究表明依托度酸在长期治疗活动性骨关节炎患者中有效且耐受性良好。
