中国地区局限性晚期宫颈癌动脉介入新辅助化疗有效性与安全性:基于随机对照试验的Meta分析与GRADE证据评分

Efficacy and safety of arterial interventional neoadjuvant chemotherapy for locally advanced cervical cancer in China:a Meta-analysis of randomized controlled trials and GRADE evidence score

目的评估新辅助动脉介入化疗(NAIC)和新辅助全身静脉化疗(NIVC)治疗局部晚期宫颈癌(LACC)的有效性与安全性。方法通过检索PubMed、Web of Science、Embase、中国知网、万方数据库获取符合主题的随机对照试验(RCT),经文献质量评估和数据提取后使用Stata 17.0进行统计学分析,使用GRADE质量评价系统对结局进行质量评估。结果共纳入14项RCT,合计1063例LACC患者。Meta分析结果表明,NAIC和NIVC在有效性指标方面:完全缓解(CR)[RR=1.23,95%CI(0.91,1.67),P=0.174]、部分缓解(PR)[RR=1.10,95%CI(0.86,1.20),P=0.874]、总缓解(TR)[RR=1.10,95%CI(0.95,1.25),P=0.212]、无变化(NC)[RR=0.62,95%CI(0.33,1.16),P=0.137]和进展(PD)[RR=1.43,95%CI(0.41,4.99),P=0.574]间的差异无统计学意义;在安全性指标方面:胃肠道反应[RR=0.96,95%CI(0.76,1.23),P=0.755]、肝肾功能损害[RR=0.71,95%CI(0.41,1.23),P=0.226]差异无统计学意义,而在骨髓抑制[RR=0.62,95%CI(0.45,0.86),P=0.04]的发生率方面,NAIC较NIVC更优。此外,GRADE评分结果显示CR、PR、TR、NC为高质量证据。结论对于LACC患者,NAIC在治疗后骨髓抑制的发生率较NIVC更低、更安全,在其他有效性与安全性指标上两者并未发现显著差异。临床医师根据患者的实际情况综合评估,选择适宜新辅助化疗方案。

Objective To evaluate the efficacy and safety of neoadjuvant arterial interventional chemotherapy(NAIC)and neoadjuvant intravenous chemotherapy(NIVC)for the treatment of locally advanced cervical cancer(LACC).Methods Randomized controlled trials(RCTs)which fit the theme were included by searching PubMed,Web of Science,Embase,CNKI,and Wanfang databases.After study quality assessment and data extraction,statistical analysis was performed using Stata 17.0,and outcome quality was assessed using the GRADE system.Results A total of 14 RCTs were included,with 1063 LACC patients.The results of the Meta-analysis showed that NAIC and NIVC had a positive effect on the effectiveness indicators:complete response(CR)[RR=1.23,95%CI(0.91,1.67),P=0.174],partial response(PR)[RR=1.10,95%CI(0.86,1.20),P=0.874],total response(TR)[RR=1.10,95%CI(0.95,1.25),P=0.212],no change(NC)[RR=0.62,95%CI(0.33,1.16),P=0.137]and progressive disease(PD)[RR=1.43,95%CI(0.41,4.99),P=0.574]were not statistically significant.Differences in safety indicators:gastrointestinal reactions[RR=0.96,95%CI(0.76,1.23),P=0.755],hepatic and renal impairment[RR=0.71,95%CI(0.41,1.23),P=0.226]were not statistically significant.While in the incidence of myelosuppression[RR=0.62,95%CI(0.45,0.86),P=0.04],NAIC was superior to NIVC.In addition,the GRADE score results showed CR,PR,TR,and NC were high-quality evidence.Conclusion For LACC patients,the incidence of myelosuppression after treatment with NAIV is lower and safer than that with NIVC,and no significant difference was found between the two in terms of other efficacy and safety indicators.Clinicians should choose the appropriate neoadjuvant chemotherapy regimen based on a comprehensive assessment of the patient's actual condition.