Serni U
Istituto Ortopedico Toscano, Florence, Italy.
Eur J Rheumatol Inflamm. 1993;12(4):47-54.
The clinical relevance of piroxicam-beta-cyclodextrin (PBC) in the long-term treatment of osteoarthritis and rheumatoid arthritis is reviewed. Two hundred and twenty-five patients--one hundred with rheumatoid arthritis and one hundred and twenty five with osteoarthritis--were enrolled in a double-blind, randomised, controlled study versus piroxicam. Drugs were administered once-daily, for twelve weeks. The indices of efficacy (pain intensity, severity of inflammation, functional impairment evaluated at 0,2,4,8 and 12 weeks showed the good analgesic effect of piroxicam without significant differences between its two formulations. Tolerance appeared to be better in the group of patients treated with PBC than in the one treated with piroxicam. Both the incidence and severity of side effects were lower for patients treated with PBC. The majority of side effects were related to the gastrointestinal tract. The study suggests that PBC, used in the long term treatment of rheumatic diseases, improves the safety of piroxicam without affecting its efficacy. In another study, thirty patients with chronic osteoarthritis were randomly assigned to receive PBC or tenoxicam daily for eight weeks. Both drugs effectively reduced pain, inflammation, and functional limitation of the affected joints. Endoscopy revealed minor post-treatment mucosal lesions; these tended to be less severe with PBC than with tenoxicam. The clinical experience in the long-term treatment of rheumatic conditions indicates that the microencapsulation of piroxicam as piroxicam-beta-cyclodextrin has provided a new drug with a superior tolerability compared to the parent compound without affecting its high efficacy on the symptoms of the primary disease.
本文综述了吡罗昔康-β-环糊精（PBC）在骨关节炎和类风湿关节炎长期治疗中的临床相关性。225例患者——100例类风湿关节炎患者和125例骨关节炎患者——参与了一项与吡罗昔康对照的双盲、随机、对照研究。药物每日给药一次，持续12周。疗效指标（疼痛强度、炎症严重程度、功能障碍）在0、2、4、8和12周时进行评估，结果显示吡罗昔康具有良好的镇痛效果，其两种剂型之间无显著差异。PBC治疗组患者的耐受性似乎优于吡罗昔康治疗组。PBC治疗患者的副作用发生率和严重程度均较低。大多数副作用与胃肠道有关。该研究表明，PBC用于风湿性疾病的长期治疗可提高吡罗昔康的安全性，且不影响其疗效。在另一项研究中，30例慢性骨关节炎患者被随机分配，分别接受PBC或替诺昔康每日治疗，为期8周。两种药物均有效减轻了受累关节的疼痛、炎症和功能受限。内镜检查显示治疗后有轻微的黏膜病变；PBC组的病变往往比替诺昔康组的病变轻。风湿性疾病长期治疗的临床经验表明，将吡罗昔康微囊化为吡罗昔康-β-环糊精后，与母体化合物相比，提供了一种耐受性更好的新药，且不影响其对原发性疾病症状的高效治疗作用。
