Pintucci J P
Divisione Otorinolaringoiatrica, Ospedale di Vimercate Milano.
Acta Otorhinolaryngol Ital. 1990;10 Suppl 28:87-100.
In order to evaluate effectiveness and safety of tiaprofenic acid (TA), a multicenter study involving outpatients followed by ENT specialists was carried out. Since October 1988, the trials have prospectively enrolled 4231 patients. The demography of the study's population was: 2165 male and 2066 female, mean age 39.6 +/- 15.8 years. The patients were divided into the following groups by pathology: 1281 (30.4%) otitis, 654 (15.5%) rhinosinusitis, 2178 (51.6%) pharyngo-laryngo-tonsillitis, and 112 (2.6%) flue syndrome, 300 mg b.i.d. of TA was orally administered for seven consecutive days. At T0 and T7 parameters ranged from 75-90% for symptoms related to inflammation of the oral tract, 80% for nasal edema and 100% for otalgia. The physician's judgement about the drug's effectiveness was 90.6% excellent or good. Side effects were reported in 409 cases (9.6%) mainly related to the gastrointestinal tract. There were 72 drop-out (1.7%): 38 (0.9%) for drug intolerance. In conclusion, TA showed excellent safety and effectiveness in improving the recovery of ENT's outpatients.
为了评估噻洛芬酸（TA）的有效性和安全性，开展了一项由耳鼻喉科专家对门诊患者进行随访的多中心研究。自1988年10月起，该试验前瞻性纳入了4231例患者。研究人群的人口统计学特征为：男性2165例，女性2066例，平均年龄39.6±15.8岁。患者按病理情况分为以下几组：中耳炎1281例（30.4%），鼻-鼻窦炎654例（15.5%），咽喉-扁桃体炎2178例（51.6%），流感综合征112例（2.6%）。连续7天口服TA，每日2次，每次300mg。在T0和T7时，与口腔炎症相关症状的参数改善率为75 - 90%，鼻水肿改善率为80%，耳痛改善率为100%。医生对药物有效性的判断为90.6%为优或良。报告有409例（9.6%）出现副作用，主要与胃肠道有关。有72例退出（1.7%）：其中38例（0.9%）是因为药物不耐受。总之，TA在改善耳鼻喉科门诊患者的康复方面显示出优异的安全性和有效性。
