Zawisza Edward
Poradnia Chorób Zapalnych Górnych Dróg Oddechowych Szpitala Bielańskiego im. Ks. J. Popiełuszki w Warszawie.
Otolaryngol Pol. 2005;59(1):141-5.
During this randomized, double blind study versus placebo efficacy of 3 month treatment of patients with chronic sinusitis was assessed. Main efficacy criterion was defined as the change in computed tomography of paranasal sinuses, measured in V. Lund scale. In fenspiride group, overall score changed from 8.54 to 7.57 points (0.97 points i.e. 11.4% decrease, p=0.008), while in placebo group no statistically significant change was observed (change from 9.25 to 9.27 points--0.02 points i.e. 0.2% increase). Percentage of patients who experienced worsening (defined as at least 1 point increase between the beginning and the end of the study) in the placebo group was twice as big as in the fenspiride group (35.4% and 15.2% respectively; p=0.025). Clinical symptoms of chronic sinusitis--sneezing, itchy nose and purulent character of sputum--were decreasing in the fenspiride group significantly more than in the placebo group. Data from previous studies demonstrated beneficial effect of fenspiride treatment of patients with chronic sinusitis. During this study fenspiride treatment was proved to be relatively effective in terms of computed tomography results, and well tolerated during three month therapy.
在这项针对慢性鼻窦炎患者进行的为期3个月的随机双盲对照安慰剂研究中,评估了疗效。主要疗效标准定义为鼻旁窦计算机断层扫描的变化,采用V. Lund量表进行测量。在芬司匹利组,总分从8.54分降至7.57分(下降0.97分,即11.4%,p = 0.008),而在安慰剂组未观察到统计学上的显著变化(从9.25分变为9.27分,上升0.02分,即0.2%)。安慰剂组中病情恶化(定义为研究开始和结束之间至少增加1分)的患者百分比是芬司匹利组的两倍(分别为35.4%和15.2%;p = 0.025)。慢性鼻窦炎的临床症状——打喷嚏、鼻痒和痰液脓性——在芬司匹利组中的减轻程度明显大于安慰剂组。先前研究的数据表明芬司匹利治疗慢性鼻窦炎患者有有益效果。在本研究中,就计算机断层扫描结果而言,芬司匹利治疗被证明相对有效,且在三个月的治疗期间耐受性良好。