Rosenfeld R M, Doyle W J, Swarts J D, Seroky J, Pinero B P
Pittsburgh Otitis Media Research Center, PA.
Arch Otolaryngol Head Neck Surg. 1992 Jan;118(1):49-52. doi: 10.1001/archotol.1992.01880010053015.
There is concern that third-generation cephalosporins may not be effective in the treatment of acute otitis media due to Streptococcus pneumoniae. Using the chinchilla animal model, we compared two third-generation cephalosporins, cefixime (Suprax) and ceftibuten (investigational), with ampicillin and saline controls in an investigator-blinded, randomized trial. Whereas the saline controls performed worse than all other groups, no significant differences were detected among the three antibiotics regarding the time required to sterilize the middle ear cleft, or the prevalence of positive cultures after 10 days of therapy. The statistical power of the comparisons of cefixime and ceftibuten with ampicillin were 98% and 67%, respectively. The results of this in vivo animal study fail to support the contention that the two third-generation cephalosporins investigated are not effective in the treatment of pneumococcal acute otitis media. Caution is advised when extrapolating these results to the general clinical setting.
有人担心第三代头孢菌素可能对肺炎链球菌引起的急性中耳炎治疗无效。在一项研究者设盲的随机试验中,我们使用龙猫动物模型,将两种第三代头孢菌素,头孢克肟(世福素)和头孢布烯(试验性药物),与氨苄西林及生理盐水对照进行比较。虽然生理盐水对照组的表现比所有其他组都差,但在使中耳腔灭菌所需时间或治疗10天后阳性培养物的发生率方面,三种抗生素之间未检测到显著差异。头孢克肟和头孢布烯与氨苄西林比较的统计功效分别为98%和67%。这项体内动物研究的结果未能支持所研究的两种第三代头孢菌素对肺炎球菌性急性中耳炎治疗无效这一论点。将这些结果外推至一般临床情况时建议谨慎。