Literature analysis of adverse drug reactions induced by roxadustat
- VernacularTitle:罗沙司他致不良反应的文献分析
- Author:
Li ZHENG
1
;
Ming LIU
2
;
Xuelin SUN
3
Author Information
1. Dept. of Pharmacy，No. 731 Hospital of China Aerospace Science & Industry Corporation，Beijing 100074，China
2. Evidence-based Medicine Center，Lanzhou University，Lanzhou 730013，China
3. Dept. of Pharmacy，Beijing Hospital，Beijing 100010，China
- Publication Type:Journal Article
- Keywords:
roxadustat;
adverse drug reactions;
safety
- From:
China Pharmacy
2022;33(20):2519-2523
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To study clinical manifestations and characteristics of adverse drug reactions （ADRs）induced by roxadustat，and to provide reference for rational use of it in clinic . METHODS Retrieved from PubMed ，Web of Science ，Wanfang Med，VIP and CNKI ，clinical trials and case reports （including series studies and case reports ）of ADRs induced by roxadustat were collected ；descriptive method was used to analyze patients ’basic information ，involved systems/organs and main clinical manifestations. The incidence of ADR was compared between roxadustat group and erythropoietin （EPO）group. RESULTS & CONCLUSIONS A total of 17 articles were included ，including 14 clinical trials and 3 case reports . In the clinical trial studies ， there were 4 033 patients using roxadustat ，including 1 972 males（48.9%）and 2 061 females（51.1%），aged from 36 to 80 years. The type of patients in one clinical trial was low -risk myelodysplastic syndrome ，and the others were renal anemia ；they received relevant drugs with dosage of 40-120 mg，mostly three times a week . Roxadustat-induced ADR （1-2 grade）involved systems/ organs mainly included cardiovascular system ，respiratory and thoracic system ，digestive system ，infection and infestation . The major systems/organs involved in serious adverse drug reaction （sADR）were cardiovascular system ，infection and infestation ； there was no statistically significant difference in the incidence of ADR between roxadustat group and EPO group （P＞0.05），but the incidence of sADR in roxadustat group was significantly higher than that in EPO group （P＜0.05）. In the case reports ， pulmonary hypertension ，rhabdomyolysis and fatigue were the clinical manifestations of ADRs induced by roxadustat . During clinical medication ，attention should be paid to the changes in relevant systems/organs of patients . If ADR is found ，timely intervention should be carried out .
