罗沙司他致不良反应的文献分析 点击下载
论文标题: 罗沙司他致不良反应的文献分析
英文标题:
中文摘要: 目的 研究罗沙司他致不良反应(ADR)的临床表现和特点,为其临床合理应用提供参考。方法计算机检索PubMed、WebofScience、万方医学网、维普网及中国知网,收集罗沙司他致ADR的临床试验研究、病例报道(含病例系列研究和个案报道),采用描述性方法分析患者的基本信息、累及系统/器官及主要临床表现,并比较临床试验研究中罗沙司他组和促红细胞生成素(EPO)组患者的ADR发生率。结果与结论共纳入文献17篇,包括14篇临床试验研究和3篇病例报道。临床试验研究中,使用罗沙司他的患者共计4033例,其中男性1972例(48.9%)、女性2061例(51.1%),年龄36~80岁;1项临床试验研究的患者类型为低风险骨髓增生异常综合征,其余均为肾性贫血;用药剂量为40~120mg,大多为每周3次给药;罗沙司他所致ADR(1~2级)累及系统/器官以心脑血管系统、呼吸和胸部系统、消化系统、感染和侵染为主,所致严重不良反应(sADR)累及系统/器官以心脑血管系统、感染和侵染为主;罗沙司他组患者的ADR总发生率与EPO组比较,差异无统计学意义(P>0.05),但罗沙司他组患者sADR的发生率显著高于EPO组(P<0.05)。病例报道中,罗沙司他致ADR的临床表现为肺动脉高压、横纹肌溶解、疲劳。临床用药时需注意患者相关系统/器官的变化,如发现相关ADR,应及时干预。
英文摘要: 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 .
期刊: 2022年第33卷第20期
作者: 郑丽,刘明,孙雪林
英文作者: ZHENG Li,LIU Ming ,SUN Xuelin
关键字: 罗沙司他;不良反应;安全性;肾性贫血;文献分析
KEYWORDS: roxadustat; adverse drug reactions ; safety;
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