【摘要】 目的系统评价阿比特龙用于前列腺癌的安全性,为临床合理用药提供循证依据。方法通过计算机检索Pub Med、Web of Science、Clinical Trials、Cochrane Library和CNKI,收集阿比特龙治疗前列腺癌的临床随机对照研究(RCT),检索截止至2017年7月。按照Cochrane系统评价方法,纳入符合要求的RCT,提取与阿比特龙治疗相关的主要不良反应数据,采用Rev Man 5.3版软件进行Meta分析,以漏斗图分析发表偏倚情况。结果共纳入符合纳入标准的RCT 4项,合计5374例前列腺癌患者。Meta分析结果显示,阿比特龙组所有级别低钾血症和严重低钾血症的发生率均高于对照组(RR=3.00,95%CI:1.52~5.93,P=0.002;RR=3.40,95%CI:1.16~9.95,P=0.03)。阿比特龙组所有级别水钠潴留的发生率高于对照组(RR=1.37,95%CI:1.22~1.53,P<0.001),但两组严重水钠潴留发生率的差异无统计学意义(P=0.39)。阿比特龙组所有级别高血压和严重高血压的发生率高于对照组(RR=1.79,95%CI:1.45~2.21,P<0.001;RR=2.17,95%CI:1.71~2.75,P<0.001)。阿比特龙组所有心血管事件和严重心血管事件的发生率均高于对照组(RR=1.40,95%CI:1.22~1.62,P<0.001;RR=2.04,95%CI:1.54~2.72,P<0.001)。阿比特龙组所有级别肝损伤事件和严重肝损伤事件的发生率均高于对照组(RR=1.68,95%CI:1.24~2.26,P=0.0007;RR=3.31,95%CI:1.55~7.07,P=0.002)。漏斗图显示,纳入的RCT无明显发表偏倚。结论阿比特龙治疗期间需要监护治疗相关的各种不良反应,尤其是低钾血症和肝损伤事件需要临床加以重视。更多还原

【Abstract】 Objective To provide reference for clinical rational drug use based on systematic review of safety of abiraterone in the treatment of prostate cancer. Methods Pub Med,Web of Science,Clinical Trials,Cochrane Library and CNKI databases were searched for randomized controlled trials of abiraterone versus placebo for prostate cancer up to July 2017. The quality of materials was under assessment of Cochrane system evaluation method. The interest adverse events were extracted. Then meta-analysis was accomplished by Rev Man 5. 3 software and funnel analysis was used to evaluate publication bias. Results A total of 4 phase Ⅲ,multinational,double-blind,randomized placebo-controlled trials were included,with 5374 patients. The incidence of hypokalaemia of all grades and severe hypokalaemia in abiraterone group was higher than the control group with statistic significance( RR = 3. 00,95% CI:1. 52-5. 93,P = 0. 002; RR = 3. 40,95% CI:1. 16-9. 95,P = 0. 03). The incidence of water-sodium retention of all grades in abiraterone group was higher than that of the control group with statistic significance( RR = 1. 37,95% CI:1. 22-1. 53,P < 0. 001),but the incidence of severe water-sodium retention between the two groups had no significance( P = 0. 39). The incidence of hypertension of all grades and severe hypertension in abiraterone group was higher than that of the control group with statistic significance( RR = 1. 79,95% CI:1. 45-2. 21,P < 0. 001,RR = 2. 17,95% CI:1. 71-2. 75,P < 0. 001). The incidence of cardiovascular events of all grades and event cardiovascular events in abiraterone group was higher than that of the control group with statistic significance( RR = 1. 40,95%CI:1. 22-1. 62,P < 0. 001;RR = 2. 04,95% CI:1. 54-2. 72,P < 0. 001). The incidence of abnormal liver function of all grades and severe abnormal liver function was higher than the control( RR = 1. 68,95% CI:1. 24-2. 26,P = 0. 0007;RR = 3. 31,95% CI:1. 55-7. 07,P = 0. 002). Funnel analysis did not show any publication bias. Conclusion As the analysis revealed a significant increase in the incidence and RR of hypokalaemia and abnormal liver function in the abiraterone therapy,strict monitoring of these side effects should therefore be considered.更多还原