Blaha J D, Calhoun J H, Nelson C L, Henry S L, Seligson D, Esterhai J L, Heppenstall R B, Mader J, Evans R P, Wilkins J
Department of Orthopedics, West Virginia University, Morgantown 26506-9196.
Clin Orthop Relat Res. 1993 Oct(295):8-12.
These data do not prove a statistical superiority of conventional antibiotics or Septopal in the treatment of chronic osteomyelitis. This result, however, is complicated by the biased data set represented by the combined treatment. The data do suggest that cost of treatment is considerably less in patients who are treated with local antibiotics (i.e., Septopal) alone. The rate of adverse experiences was directly related to the use of parenteral antibiotics, with higher rates of adverse experiences in the conventional and combined treatment groups. Furthermore, the Cierny-Mader Physiologic Class had the best correlation with outcome, suggesting that host factors are probably of critical importance in inducing remission of chronic osteomyelitis. This protocol was not designed to test the role of debridement in the treatment of osteomyelitis: it was assumed that debridement would be the same in both groups. It is the investigators' strong opinion, however, that adequacy of debridement was an important determinant in quiescence or recurrence in the study patients. Similarly, there was no strict control for adequacy of soft-tissue coverage provided by local or distant tissue transfer. Again, the investigators believe that adequacy, including viability and durability, of soft-tissue covering was an important determinant for the end result in these patients. Other covariants such as smoking, history, nutritional status, and other measures of general health will be added to this model when data are available. This analysis will allow definition of the appropriate clinical situations in which use of Septopal alone or combined with parenteral antibiotic is indicated.
这些数据并未证明传统抗生素或Septopal在治疗慢性骨髓炎方面具有统计学上的优势。然而，联合治疗所代表的偏差数据集使这一结果变得复杂。数据确实表明，仅接受局部抗生素（即Septopal）治疗的患者治疗成本要低得多。不良事件发生率与胃肠外抗生素的使用直接相关，传统治疗组和联合治疗组的不良事件发生率更高。此外，Cierny-Mader生理分级与治疗结果的相关性最佳，这表明宿主因素可能在慢性骨髓炎的缓解中起着至关重要的作用。该方案并非旨在测试清创术在骨髓炎治疗中的作用：假定两组的清创术相同。然而，研究人员坚信，清创术的充分性是研究患者病情静止或复发的重要决定因素。同样，对于局部或远处组织转移所提供的软组织覆盖的充分性也没有严格控制。研究人员再次认为，软组织覆盖的充分性，包括活力和耐久性，是这些患者最终结果的重要决定因素。当有数据可用时，其他协变量，如吸烟、病史、营养状况和其他一般健康指标将被添加到该模型中。该分析将有助于确定单独使用Septopal或与胃肠外抗生素联合使用的合适临床情况。
