宫颈癌化疗心血管毒性预防的间断时间序列试验

Interrupted time series trial for prevention of cardiovascular toxicity induced by chemotherapy in cervical cancer

目的在已知有效措施的基础上构建一套实用可行的宫颈癌化疗CVT综合防治方案,为临床治疗提供科学指导与依据。方法 2016年11月—2018年1月对164例研究对象进行化疗前CVT发生风险及化疗后CVT评估,构建干预前后CVT发生率改变情况的ITS模型;同时比较ITS模型中干预后患者化疗前后CVT生物标志物和临床检查结果,评价干预措施的效果。结果干预前后CVT发生率改变情况的ITS模型无统计学意义(P>0.05);超声心动图检查结果中二尖瓣E峰流速和E/A比值增大,差异均有统计学意义(P<0.05),LVEF、FS、SV、二尖瓣A峰流速均无统计学差异(P>0.05);心电图和双下肢动静脉超声检查结果均无统计学差异(P>0.05);生物标志物检测结果中sICAM-1、sTM、vWF、h-FABP水平出现下降,NO、eNOS水平出现上升,差异均有统计学意义(P<0.05);hs-CRP、E-selectin水平变化均无统计学差异(P>0.05)。结论本研究构建的综合防治方案可在微观上改善宫颈癌化疗CVT,应扩大样本量开展进一步研究。

Objective The aim of this study was to establish a practical and feasible prevention,and a treatment scheme of cardiovascular toxicity(CVT)induced by chemotherapy in cervical cancer based on known effective measures and to provide scientific guidance and basis for clinical treatment.Methods The risk of pre-chemotherapy CVT and post-chemotherapy CVT were evaluated in 164 subjects from November 2016 to January 2018.The Interrupted time series(ITS)model of CVT incidence before and after intervention was established.The CVT biomarkers and results of clinical examination before and after chemotherapy were compared in selected patieds.The effects of measures were evaluated.Results There was no difference in the ITS model of CVT incidence before and after intervention(P>0.05).Among echocardiography examination results,the E peak velocity of mitral valve and E/A ratio increased,and the difference was statistically significant(P<0.05),LVEF、FS、SV and A peak velocity of mitral valve had no differences(P>0.05).There were no differences in ECG and double lower extremities arteriovenous ultrasonography results(P>0.05).The level of sICAM-1,sTM,vWF and h-FABP decreased(P<0.05),the levels of NO and eNOS increased(P<0.05);there was no significant difference in the levels of hs-CRP and E-selectin(P>0.05).Conclusion The comprehensive prevention and treatment program established in this study can improve the cervical cancer chemotherapy CVT microscopically,and further research should be carried out by expanding the sample size.