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Jian Qu,1,2 Ting-Ting Qi,1,2 Qiang Qu,3,4 Wen-Ming Long,5 Ying Chen,6 Yue Luo,7 Ying Wang1,2 1Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, 410011, People’s Republic of China; 2Institute of Clinical Pharmacy, Central South University, Changsha, 410011, People’s Republic of China; 3Department of Pharmacy, Xiangya Hospital, Central South University, Changsha, 410078, People’s Republic of China; 4National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, 410078, People’s Republic of China; 5Department of Pharmacy, Jingzhou District, Second People’s Hospital of Huaihua City, Huaihua, 418400, People’s Republic of China; 6Department of Pharmacy, Wuhan University, Renmin Hospital, Wuhan, 430060, People’s Republic of China; 7Department of Pharmacy, The People’s Hospital of Liuyang, Liuyang, 410300, People’s Republic of ChinaCorrespondence: Ying Wang, Department of Pharmacy, The Second Xiangya Hospital, Central South University, Institute of Clinical Pharmacy, Central South University, No. 139 Middle Renmin Road, Changsha, 410011, People’s Republic of China, Tel +86-15173198700, Fax +86-731-85292072, Email wangying5211@csu.edu.cnBackground: The increasing prevalence of carbapenem-resistant Gram-negative bacteria (CR-GNB) represents a global healthcare crisis. This study explored the efficacy and safety of Polymyxin B (PMB)-based regimens and factors influencing their effectiveness.Methods: Patients with CR-GNB infections treated with PMB for more than three days were enrolled in this retrospective study from 1st June 2018 to 30th April 2020. Data were collected on patient characteristics, bacterial culture, and drug-sensitivity test results; anti-infection treatment regimens, particularly details of PMB use; and adverse drug reactions. Clinical and microbiological efficacy, mortality, and safety of PMB-based regimens in CR-GNB infected patients were evaluated. Univariate analysis and multivariate logistic regression analyses were used to assess factors influencing efficacy and mortality.Results: A total of 373 CR-GNB strains were cultured from 268 patients. About 41.04% of patients used PMB loading dose of 1.01 (0.84– 1.69) mg/kg. Maintenance dose was 0.85 (0.82– 1.00) mg/kg q12h. The clinical efficacy rate was 36.57% (98/268), the total bacterial clearance rate of PMB was 39.42%, and the all-cause mortality rate was 33.96%. The adverse drug reaction rate was 19.58%, among which the incidence of renal toxicity was highest (8.21%). Multivariate logistic regression analysis showed that clinical efficacy, bacterial clearance rate, and all-cause mortality were associated with patient-related facts, including mechanical ventilation use, underlying diseases (such as respiratory disease), the type and site of CR-GNB infection, and PMB administration timing and loading dose.Conclusion: PMB is a relatively safe and effective antibiotic drug for treatment of critically ill patients with CR-GNB infection; however, PMB use should be subject to guidelines recommendations for early administration, loading administration, and adequate administration, which could help to improve the clinical efficacy, microbiological efficacy, and mortality.Keywords: polymyxin B, carbapenem-resistant Gram-negative bacteria, clinical efficacy, bacterial elimination, mortality, adverse effect

Yu-Xin Wen,1,2,* Qiang Qu,3,4,* Wen-Ming Long,5 Yue Luo,6 Hai-Hui Zhuang,1 Xin-Qi Teng,1 Jian Qu1 1Department of Pharmacy, The Second Xiangya Hospital, Central South University; Institute of Clinical Pharmacy, Central South University, Changsha, 410011, People’s Republic of China; 2Department of Pharmacy, Lixian People’s Hospital in Hunan, Lixian, 415500, People’s Republic of China; 3Department of Pharmacy, Xiangya Hospital, Central South University, Changsha, 410078, People’s Republic of China; 4National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, 410078, People’s Republic of China; 5Department of Pharmacy, Jingzhou District, Second People’s Hospital of Huaihua City, Huaihua, 418400, People’s Republic of China; 6Department of Pharmacy, The People’s Hospital of Liuyang, Liuyang, 410300, People’s Republic of China*These authors contributed equally to this workCorrespondence: Jian QuDepartment of Pharmacy, The Second Xiangya Hospital, Central South University; Institute of Clinical Pharmacy, Central South University, No. 139 Middle Renmin Road, Changsha, 410011, People’s Republic of China, Tel +86-15973190614, Fax +86-731-85292072Email qujianstanley@csu.edu.cnPurpose: This study investigates the nephrotoxicity and efficacy assessment of polymyxin B (PMB) use in renal transplant patients.Patients and Methods: This retrospective study included adult (> 18 years of age) renal transplant patients who received PMB intravenous drip for more than 72 hours. Efficacy assessment of PMB included clinical treatment efficacy, microbiological efficacy at the end of PMB treatment, and in-hospital all-cause mortality. Nephrotoxicity of PMB was evaluated for further group comparison.Results: We enrolled 235 renal transplant patients in our study. After PMB treatment, 45 patients occurred PMB-nephrotoxicity, and the nephrotoxicity rate was 19.15%. Among them, 44 patients were RIFLE R stage, and one patient was RIFLE I stage. The dose of PMB used in patients was 40.0 (40.0– 50.0) mg q12h with a loading dose of 41.8± 9.8 mg. Multivariate logistic regression analysis showed that ICU admission, vasoactive agents, aminoglycosides, creatinine clearance rate before PMB use, and mean total hospital stay were independent risk factors of PMB-nephrotoxicity in kidney transplant patients. The clinical effective rate was 97.9%, and the microbiological clean rate was 66.7%.Conclusion: Our study demonstrated that PMB low dose regimens might achieve good efficacy and less nephrotoxicity in renal transplant patients. We should evaluate the severity of the infection and renal function of patients, avoid the combined use of other nephrotoxic drugs, and minimize the course of use to reduce the occurrence of PMB-nephrotoxicity.Keywords: polymyxin B, nephrotoxicity, renal transplant patients, adverse reactions