头孢唑肟联合氨苄西林-舒巴坦与庆大霉素联合氨苄西林-舒巴坦预防肝移植受者移植后早期细菌感染的比较：一项随机对照试验
Comparison of Ceftizoxime Plus Ampicillin-Sulbactam versus Gentamicin Plus Ampicillin-Sulbactam in the Prevention of Post-Transplant Early Bacterial Infections in Liver Transplant Recipients: A Randomized Controlled Trial.
作者信息
Shafiekhani Mojtaba, Karimzadeh Iman, Nikeghbalian Saman, Firoozifar Mohammad, Pouladfar Gholamreza, Vazin Afsaneh
机构信息
Department of Clinical Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.
Shiraz Organ Transplant Center, Abu-Ali Sina Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.
出版信息
Infect Drug Resist. 2020 Jan 8;13:89-98. doi: 10.2147/IDR.S222934. eCollection 2020.
PURPOSE
In this study, we aimed to compare the efficacy of combined ceftizoxime with ampicillin-sulbactam versus combined gentamicin with ampicillin-sulbactam as prophylactic antibiotic regimen in preventing early bacterial PTIs in liver TX recipients at a referral center.
PATIENTS AND METHODS
All patients older than 18 years who had undergone liver TX at Abu-Ali Sina transplantation center in Shiraz, Iran from July 2018 to April 2019 were included in this study. In a single-blinded manner, the participants randomly received either combined intravenous ceftizoxime plus ampicillin-sulbactam (ceftizoxime group) or gentamicin plus ampicillin-sulbactam (gentamicin group) as prophylactic antibiotic regimen before the incision of the surgery, which was continued for 48 hrs after liver Tx. The rate and type of bacterial infections, length of hospital and intensive care unit (ICU) stay, mortality rate, and kidney function were assessed during 1 month following liver TX in the two groups.
RESULTS
Two hundred and thirty patients were divided into two groups. One patient in the gentamicin group and five in the ceftizoxime group were excluded due to emergency exploratory laparotomy within the first 3 days after transplantation. The rate of bacterial infections during the first month after transplantation was 25.4%. This rate was significantly lower in the gentamicin group (13.16%) in comparison to the ceftizoxime group (38.18%) (<0.01), based on the univariate logistic regression analysis. Length of ICU and hospital stay and also mortality rate were significantly lower in the gentamicin group ( <0.01). There was no significant difference regarding kidney function between the two groups ( = 0.16).
CONCLUSION
Our results suggested that gentamicin can be considered as a promising agent in prophylactic antibiotic regimen for patients undergoing liver TX.
TRIAL REGISTRATION
The study was registered at the Iranian Registry of Clinical Trials (IRCT20120731010453N2; http://www.irct.ir/).
目的
在本研究中，我们旨在比较头孢唑肟与氨苄西林 - 舒巴坦联用和庆大霉素与氨苄西林 - 舒巴坦联用作为预防性抗生素方案，在一家转诊中心预防肝移植受者早期细菌性移植后感染（PTIs）的疗效。
患者与方法
纳入2018年7月至2019年4月在伊朗设拉子的阿布 - 阿里·西纳移植中心接受肝移植的所有18岁以上患者。采用单盲方式，参与者在手术切口前随机接受静脉注射头孢唑肟加氨苄西林 - 舒巴坦联用（头孢唑肟组）或庆大霉素加氨苄西林 - 舒巴坦联用（庆大霉素组）作为预防性抗生素方案，肝移植后持续48小时。在肝移植后的1个月内评估两组患者的细菌感染率和类型、住院时间和重症监护病房（ICU）住院时间、死亡率以及肾功能。
结果
230例患者被分为两组。庆大霉素组有1例患者和头孢唑肟组有5例患者因移植后前3天内进行急诊剖腹探查而被排除。移植后第一个月的细菌感染率为25.4%。基于单因素逻辑回归分析，庆大霉素组（13.16%）的这一感染率显著低于头孢唑肟组（38.18%）（<0.01）。庆大霉素组的ICU住院时间、住院时间以及死亡率均显著更低（<0.01）。两组之间的肾功能无显著差异（P = 0.16）。
结论
我们的结果表明，庆大霉素可被视为肝移植患者预防性抗生素方案中有前景的药物。
试验注册
该研究在伊朗临床试验注册中心注册（IRCT20120731010453N2；http://www.irct.ir/）。
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