Serra A, Schito G C, Nicoletti G, Fadda G
Department of Otorhinolaringology, University of Catania, Catania, Italy.
Int J Immunopathol Pharmacol. 2007 Jul-Sep;20(3):607-17. doi: 10.1177/039463200702000319.
Eight hundred and seventeen patients with upper respiratory tract infections were treated with thiamphenicol glycinate acetylcisteinate (TGA) or other standard antibiotics for 6-10 days in a randomised trial. In 419 out of 817 patients, the symptomatology was severe and they were treated with TGA in sequential therapy (TGA 500 mg- as thiamphenicol- b.i.d. intramuscularly on the first day and TGA 500 mg b.i.d by aerosol during the following days) (n=151), or with antibiotics of comparison (n=268) given intramuscularly. In this group the disappearance of the symptomatology with TGA ranged from 90 percent of the patients with otitis media to 94 percent in pharyngotonsillitis and rhinosinusitis; in this latter group TGA was significantly better than cefazolin. In 398 patients with mild symptomatology TGA (250 mg as thiamphenicol- b.i.d.) was given by aerosol (n=149) and the antibiotics of comparison by oral route (n=249). In TGA patients, the disappearance of symptoms was achieved in 87 percent of those with rhinosinusitis, in 88 percent of those with pharyngotonsillitis and in 91 percent of those with otitis media. S. pyogenes, S. pneumoniae and H. influenzae were the most frequently isolated pathogens, and none of the isolated bacteria proved to be resistant to TGA. Microbiological eradication was obtained in TGA groups in a percentage of patients ranging from 90.2 to 96.0 percent in those with severe forms, and from 86.2 to 91.6 percent in those with a mild clinical picture. Investigators rated the TGA efficacy as excellent in 96-100 percent of the patients with severe forms and in 85.5-100 percent of the patients with mild forms, whereas in the group of patients with rhinosinusitis the comparison of TGA versus other treatment was significantly in favour of TGA. The Investigator rating of treatment tolerability significantly favoured TGA in sequential treatments in comparison to the other antibiotics. No patient dropped out from the trial because of adverse events.
在一项随机试验中，817例上呼吸道感染患者接受了甘氨酰谷胱甘肽乙酰半胱氨酸硫霉素（TGA）或其他标准抗生素治疗6至10天。在817例患者中的419例中，症状严重，他们接受了序贯疗法的TGA治疗（第一天TGA 500mg-作为硫霉素-每日两次肌肉注射，随后几天TGA 500mg每日两次雾化吸入）（n = 151），或与对照抗生素（n = 268）肌肉注射。在该组中，TGA治疗症状消失的比例从患有中耳炎的患者中的90%到患有咽扁桃体炎和鼻-鼻窦炎的患者中的94%不等；在后者组中，TGA明显优于头孢唑林。在398例症状较轻的患者中，TGA（250mg作为硫霉素-每日两次）通过雾化吸入给药（n = 149），对照抗生素通过口服给药（n = 249）。在使用TGA的患者中，鼻-鼻窦炎患者症状消失的比例为87%，咽扁桃体炎患者为88%，中耳炎患者为91%。化脓性链球菌、肺炎链球菌和流感嗜血杆菌是最常分离出的病原体，且分离出的细菌均未对TGA耐药。在TGA组中，重症患者微生物清除率为90.2%至96.0%，轻症患者为86.2%至91.6%。研究者将TGA的疗效评为：重症患者中96%至100%为优，轻症患者中85.5%至100%为优，而在鼻-鼻窦炎患者组中，TGA与其他治疗方法的比较明显有利于TGA。与其他抗生素相比，研究者对治疗耐受性的评分在序贯治疗中明显有利于TGA。没有患者因不良事件退出试验。
