Donati L, Periti P, Andreassi A, Dioguardi D, Gliori A, Landi G, Magliacani G, Marinelli L F, Masellis M, Barachini P, Micali G, Papadia F, Rapisarda V, Savoia A, Bersieri M, D'Arpa N, De Bellis A, Di Lonardo A, Faggiano G, Gianfaldoni R, Magliano E, Marasco L, Novelli A, Ranno R, Zermani R
Div. Chirurgia Plastica e Centro Ustioni, Servizio di Microbiologia, Osp. Niguarda-Cà Granda, Milano, Italy.
J Chemother. 1998 Feb;10(1):47-57. doi: 10.1179/joc.1998.10.1.47.
This is the final report of a large, controlled, multicenter Italian study on immuno- and chemotherapy in adult patients with burns affecting 20 to 95% of total body surface area (mean 35%). The antibiotic treatment of burn patients consisted of topical silver sulfadiazine, short-term antimicrobial chemoprophylaxis with pefloxacin (800 mg i.v. qd) for the first 4 days and polychemotherapy with teicoplanin (800 mg i.v. qd) together with netilmicin (300 mg i.m. qd) in one or more cycles of 5-12 days. At random, half of the patients received thymostimulin, 70 mg i.m. qd for the first month and every other day thereafter. The analysis at completion of 634 valid cases showed that when the results are stratified by means of the Roi risk index, 396 of the 530 patients who contracted wound infection (84%) after chemoprophylaxis were in the first three categories and a mean of 95% survived. Of the remaining 134 patients (Roi index 4-5) only 50% survived. There was no difference in survival of the immunotherapy group in comparison with the parallel group without thymostimulin. The short-term antimicrobial prophylaxis prevented wound infection in only 104 of 634 patients (16%) and they were at low risk (84% Roi index 1). Of the bacterial pathogens involved in septic complications Staphylococcus aureus and Pseudomonas aeruginosa were prevalent (86%): eradication was achieved in 43% of patients and clinical cure or improvement were seen with combination chemotherapy in 64% of all patients, mainly with only one treatment cycle. This value increased to 79% for the 395 protocol-complying patients and went down to 20% in the 135 non-compliers. The total survival of complier and non-complier patients was 447 of the 530 valid patients (84%). The overall mortality of the 634 evaluable patients was 13.1%, ranging from less than 2% to 68%. Burn mortality was directly proportional to the percentage of burned body surface area, to increasing age and other variables of the Roi index, a 50% mortality being associated with a 72.5% total body surface area burned. Normoergic burn patients had a mortality rate of 9.1% versus 35.7% in anergic patients.
这是一项大型、对照、多中心的意大利研究的最终报告,该研究针对成年烧伤患者进行免疫治疗和化疗,烧伤面积占全身表面积的20%至95%(平均35%)。烧伤患者的抗生素治疗包括局部使用磺胺嘧啶银、前4天用培氟沙星(静脉注射800毫克,每日一次)进行短期抗菌化学预防,以及在一个或多个5至12天的疗程中使用替考拉宁(静脉注射800毫克,每日一次)联合奈替米星(肌肉注射300毫克,每日一次)进行联合化疗。随机抽取一半患者接受胸腺刺激素治疗,第一个月每日肌肉注射70毫克,此后隔日注射一次。对634例有效病例完成分析后发现,当根据罗伊风险指数进行分层分析时,在化学预防后发生伤口感染的530例患者中,有396例(84%)属于前三类,平均95%存活。其余134例患者(罗伊指数4至5)中只有50%存活。免疫治疗组与未使用胸腺刺激素的平行组相比,生存率无差异。短期抗菌预防仅使634例患者中的104例(16%)预防了伤口感染,且这些患者风险较低(84%的罗伊指数为1)。在脓毒症并发症所涉及的细菌病原体中,金黄色葡萄球菌和铜绿假单胞菌最为常见(86%):43%的患者实现了根除,64%的所有患者通过联合化疗实现了临床治愈或改善,主要仅需一个治疗周期。对于395例符合方案的患者,这一数值增至79%,而在135例不符合方案的患者中降至20%。符合方案和不符合方案患者的总生存率为530例有效患者中的447例(84%)。634例可评估患者的总体死亡率为13.1%,范围从不到2%至68%。烧伤死亡率与烧伤体表面积百分比、年龄增长以及罗伊指数的其他变量成正比,50%的死亡率与72.5%的全身表面积烧伤相关。正常能量状态的烧伤患者死亡率为9.1%,而无能量状态的患者死亡率为35.7%。