Pružinec Peter, Chirun Natalia, Sveikata Audrius
Faculty of Medicine, Clinical Immunology & Allergology Cathedra, Slovak Medical University, Tabaková 1, 821 07 Bratislava, Slovak Republic.
NPO Petrovax Pharm, Moscow, Russian Federation.
Immunotherapy. 2018 Feb;10(2):131-137. doi: 10.2217/imt-2017-0116.
This study assessed the safety of Polyoxidonium 6 mg lyophilisate for solution for injection in routine practice with a special focus on signs or symptoms of potential adverse renal effects.
MATERIALS & METHODS: A local, multicenter, prospective, open-label, noninterventional, uncontrolled postauthorization safety study was conducted in 15 healthcare centers in Slovakia. Adult patients who received commercially available Polyoxidonium 6 mg lyophilisate for solution for injection as a part of their routine care were observed for one cycle of treatment, consisting of five or ten injections. For safety assessment, adverse events were monitored with a special focus on signs or symptoms of potential adverse renal effects. At the end of the study, investigators and subjects rated the overall tolerance of Polyoxidonium treatment as well as improvement. Data collection was based on the review of medical records and routine examination of subjects.
In total, 502 subjects were enrolled and 498 (99.2%) subjects completed the study. 19 (3.8%) subjects experienced a total of 34 adverse events. Only one (0.1%) subject experienced eight adverse drug reactions (ADRs): restlessness, fatigue, feeling hot (n = 2), pyrexia (n = 3) and asthenia. There were no renal ADRs or serious ADRs. At the end of the study, both investigators and subjects very positively rated global tolerability and global improvement.
Polyoxidonium was well tolerated in the heterogenous population of patients, mostly with chronic recurrent bacterial or viral infections. No renal ADRs were reported in this postauthorization safety study, which was designed with a special focus on identifying potential adverse renal effects.
本研究评估了注射用聚氧化烯冻干物6毫克制剂在常规临床实践中的安全性，特别关注潜在肾脏不良反应的体征或症状。
在斯洛伐克的15个医疗中心开展了一项局部、多中心、前瞻性、开放标签、非干预、非对照的上市后安全性研究。观察接受市售注射用聚氧化烯冻干物6毫克制剂作为常规治疗一部分的成年患者一个治疗周期，该周期由五次或十次注射组成。为进行安全性评估，对不良事件进行监测，特别关注潜在肾脏不良反应的体征或症状。研究结束时，研究者和受试者对聚氧化烯治疗的总体耐受性及改善情况进行评分。数据收集基于病历审查和受试者的常规检查。
总共纳入502名受试者，498名（99.2%）受试者完成研究。19名（3.8%）受试者共经历34次不良事件。仅1名（0.1%）受试者出现8次药物不良反应（ADR）：烦躁不安、疲劳、发热感（2例）、发热（3例）和乏力。未出现肾脏ADR或严重ADR。研究结束时，研究者和受试者对总体耐受性和总体改善情况均给予高度肯定评价。
在主要为慢性复发性细菌或病毒感染的异质性患者群体中，聚氧化烯耐受性良好。在这项专门针对识别潜在肾脏不良反应设计的上市后安全性研究中，未报告肾脏ADR。
