Zhou Yangang, Li Ying, Xie Xubiao, Song Lei, Lan Gongbin, Sun Bao, Tang Tiantian, Yan Han, Zhang Bikui, Xu Ping
Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, China.
Institute of Clinical Pharmacy, Central South University, Changsha, China.
Br J Clin Pharmacol. 2022 Nov;88(11):4742-4750. doi: 10.1111/bcp.15384. Epub 2022 May 29.
Toxicity is a major concern related to the clinical use of polymyxin B, and available safety data for renal transplant patients are limited.
We investigated the safety of polymyxin B and toxicity risk factors in renal transplant patients.
A prospective study was performed on a group of renal transplant patients who received intravenous polymyxin B between January 2018 and August 2021. Polymyxin B treatment was monitored to evaluate toxicity and risk factors.
A total of 235 courses of polymyxin B were administered to 213 patients. Of these, 121 (51.5%) developed skin hyperpigmentation (SH), 149 (63.4%) developed neurotoxicity and 10 (5.5%) developed acute kidney injury of which 80% was reversible. Risk factors for developing SH included a high total dose by weight (odds ration [OR] 1.31, 95% confidence interval [CI] 1.08-1.60, P = .008) and the presence of neurotoxicity (OR 2.86, 95% CI 1.56-5.26, P = .001). Neurotoxicity manifested during the first 2 days of treatment. Neurotoxicity occurred most commonly in women (OR 3.84, 95% CI 1.82-8.10, P < .0001), and the presence of SH (OR 1.98, 95% CI 1.13-3.46, P = .016) was also an independent risk factor.
Neurotoxicity and SH are the two major adverse effects of polymyxin B in renal transplant patients, which may limit its clinical use.
毒性是与多黏菌素B临床应用相关的主要问题,肾移植患者可用的安全性数据有限。
我们研究了多黏菌素B在肾移植患者中的安全性及毒性危险因素。
对一组在2018年1月至2021年8月期间接受静脉注射多黏菌素B的肾移植患者进行了一项前瞻性研究。对多黏菌素B治疗进行监测以评估毒性和危险因素。
共对213例患者给予了235个疗程的多黏菌素B。其中,121例(51.5%)出现皮肤色素沉着(SH),149例(63.4%)出现神经毒性,10例(5.5%)出现急性肾损伤,其中80%是可逆的。发生SH的危险因素包括按体重计算的高总剂量(优势比[OR]1.31,95%置信区间[CI]1.08 - 1.60,P = .008)和存在神经毒性(OR 2.86,95% CI 1.56 - 5.26,P = .001)。神经毒性在治疗的前2天出现。神经毒性最常发生在女性中(OR 3.84,95% CI 1.82 - 8.10,P < .0001),并且存在SH(OR 1.98,95% CI 1.13 - 3.46,P = .016)也是一个独立危险因素。
神经毒性和SH是多黏菌素B在肾移植患者中的两个主要不良反应,这可能会限制其临床应用。