多黏菌素 B 与黏菌素：在多重耐药革兰氏阴性菌感染中评估肾毒性和神经毒性及有效性的实用方法。
Colistin versus polymyxin B: A pragmatic assessment of renal and neurological adverse effects and effectiveness in multidrug-resistant Gram-negative bacterial infections.
机构信息
Department of Pharmacy Practice, Amrita School of Pharmacy, Amrita Vishwa Vidyapeetham, Health Science Campus, Kochi, Kerala, India.
Department of GI Surgery, Amrita Institute of Medical Sciences and Research Centre, Amrita Vishwa Vidyapeetham, Health Science Campus, Kochi, Kerala, India.
出版信息
Indian J Pharmacol. 2023 Jul-Aug;55(4):229-236. doi: 10.4103/ijp.ijp_762_20.
OBJECTIVES
Our study aimed to evaluate the real-world data on renal and neurological adverse effects and effectiveness of colistimethate sodium (CMS) and polymyxin B (PMB).
MATERIALS AND METHODS
An observational prospective study was performed on inpatients receiving CMS and PMB for multidrug-resistant Gram-negative bacterial infections. CMS dose was titrated to renal function, and serum creatinine was assessed daily. The incidence of nephrotoxicity, the primary outcome, was evaluated based on an increase in serum creatinine from baseline as well as by the Risk, Injury, Failure, Loss of kidney function, and End-stage renal disease criteria. Neurological adverse effects were assessed based on clinical signs and symptoms, and the causality and severity were assessed by the Naranjo scale and modified Hartwig-Siegel scale, respectively. The effectiveness of polymyxin therapy was ascertained by a composite of microbiological eradication of causative bacteria and achievement of clinical cure. Thirty-day all-cause mortality was also determined.
RESULTS
Between CMS and PMB, the incidence of nephrotoxicity (59.3% vs. 55.6%, P = 0.653) or neurotoxicity (8.3% vs. 5.6%, P = 0.525) did not significantly differ. However, reversal of nephrotoxicity was significantly more with patients receiving CMS than PMB (48.4% vs. 23.3%, P = 0.021). Favorable clinical outcomes (67.6% vs. 37%, P < 0.001) and microbiological eradication of causative bacteria (73.1% vs. 46.3%, P = 0.001) were significantly more with CMS than PMB. Patients treated with CMS had lower all-cause mortality than those with PMB treatment (19.4% vs. 42.6%, P = 0.002).
CONCLUSION
There is no significant difference in the incidence of renal and neurotoxic adverse effects between CMS and PMB when CMS is administered following renal dose modification. CMS shows better effectiveness and lower mortality compared to PMB.
目的
本研究旨在评估黏菌素硫酸盐（CMS）和多黏菌素 B（PMB）用于治疗多重耐药革兰氏阴性菌感染的真实世界数据中的肾脏和神经不良事件及疗效。
材料和方法
对接受 CMS 和 PMB 治疗多重耐药革兰氏阴性菌感染的住院患者进行了一项观察性前瞻性研究。根据肾功能调整 CMS 剂量，并每天评估血清肌酐。根据基线时血清肌酐的升高以及根据风险、损伤、衰竭、丧失肾功能和终末期肾病标准评估肾脏毒性的主要结局的发生率。根据临床症状和体征评估神经毒性，分别使用 Naranjo 量表和改良 Hartwig-Siegel 量表评估因果关系和严重程度。通过确定引起细菌的微生物清除和临床治愈的复合指标来确定多黏菌素治疗的疗效。还确定了 30 天全因死亡率。
结果
CMS 和 PMB 之间，肾脏毒性（59.3%比 55.6%，P=0.653）或神经毒性（8.3%比 5.6%，P=0.525）的发生率无显著差异。然而，接受 CMS 治疗的患者的肾脏毒性逆转率明显高于接受 PMB 治疗的患者（48.4%比 23.3%，P=0.021）。CMS 的临床疗效（67.6%比 37%，P<0.001）和引起细菌的微生物清除率（73.1%比 46.3%，P=0.001）明显高于 PMB。与接受 PMB 治疗的患者相比，接受 CMS 治疗的患者的全因死亡率较低（19.4%比 42.6%，P=0.002）。
结论
在根据肾功能调整 CMS 剂量后，CMS 和 PMB 之间肾脏和神经不良事件的发生率无显著差异。与 PMB 相比，CMS 显示出更好的疗效和更低的死亡率。
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