目的 分析两项阿帕替尼治疗进展期肉瘤患者的临床试验(NCT0271100 和 NCT03491371)中患者的生活质量(quality of life,QoL)和不良事件(adverse effects,AEs).方法 利用 t 检验对患者的动态QoL 进行评估,采用线性回归模型分析 AEs 对总体健康状况(general health score,GHS)的影响,并找出影响 QoL 最重要的因素.结果 虽然 GHS 在患者接受阿帕替尼治疗后有轻微下降的趋势,但差异无统计学意义(P=0.154).最常见的 3 或 4 级 AEs 为:气胸(14.6%)、伤口开裂(11.0%)、食欲不振(6.1%)和高血压(6.1%).气胸的发生与 GHS 的降低具有高度相关性(P=0.002).结论 进展期肉瘤患者的 QoL 在接受阿帕替尼治疗后没有显著的下降.气胸是最常见的 3 或 4 级 AEs,也是总 QoL 下降的最主要影响因素,造成了患者功能评分的下降和症状评分的增加.
Effect on quality of life of advanced sarcoma patients after anti-angiogenesis therapies of apatinib
Objective We analyzed files about quality of life(QoL)and adverse effects(AEs)from two clinical trials of apatinib for advanced sarcoma(NCT02711007 and NCT03491371).Methods Dynamic QoL scores in three major domains were analyzed by t-test.The effect of these ese AEs on general health score(GHS)was then analyzed using linear regression models to find out which was the most important factor affecting QoL.Results QoL has a slight end of decline after anti-angiogenic therapy,however,with no statistical significance(P=0.154).Pneumothorax(14.6%),wound dehiscence(11.0%),appetite loss(6.1%)and hypertension(6.1%)were the most common grade 3/4 AEs.The appearance of pneumothorax was closely related to a lower GHS(P=0.002).Conclusions QoL for advanced sarcoma patients has a non-significant trend of decline after anti-angiogenic therapy.Pneumothorax,as the most common grade 3/4 AEs,is the major concern related to poor general quality of life,resulting in poor function and aggravated symptoms.
Angiogenesis inhibitorsSarcomaDrug-related side effects and adverse reactionsQuality of lifeApatinib
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