补肺化瘀方改善非小细胞肺癌患者高凝状态的临床研究

Clinical Study on Treatment of Hypercoagulable State of Patients with Non-small Cell Lung Cancer by Bufei Huayu Decoction

目的:评价应用补肺化瘀方汤剂对非小细胞肺癌患者高凝状态的改善作用。方法:选择2015年1月—2016年12月间于本院就诊的60例接受一线化疗的非小细胞肺癌患者,随机分为对照组(30例)和实验组(30例),在吉西他滨联合顺铂方案的基础上,对照组和实验组分别给予安慰剂和补肺化瘀方汤剂治疗。比较两组患者的化疗效果,治疗前后血小板(PLT)、血小板聚集率、纤维蛋白原(FIB)和D-二聚体(D-dimer,DD)水平,死亡率和不良反应发生率;随访6个月并绘制Kaplan-Meier生存曲线,比较两组患者血栓相关事件(如静脉血栓、卒中和多血管区域梗死等)发生风险和生活质量的差异。结果:对照组和实验组的化疗总反应率分别为63.33%和70.00%,P<0.05;对照组疾病进展率明显高于实验组(26.67%vs.6.67%,P<0.05)。治疗后对照组的MAR和DD水平较治疗前明显升高(P<0.05);实验组治疗后的PLT、MAR、FIB和DD水平显著低于治疗前(P<0.05)和对照组(P<0.05)。对照组和实验组共发生血栓相关事件10例和4例,无明显统计学差异(30.00%vs.13.33%,χ~2=3.354,P=0.067);Log rank检验显示,对照组发生血栓相关事件的风险为实验组的3.002倍(HR=3.002,95%CI[1.007,8.261],P=0.049)。对照组和实验组3级以上不良反应(20.00%vs.23.33%,P<0.05)和死亡率(10.00%vs.3.33%,P<0.05)均无统计学差异,实验组的生活质量明显高于对照组。结论:在非小细胞肺癌患者治疗中应用补肺化瘀方汤剂能够显著改善患者的高凝状态,降低患者血栓相关事件的发生风险,并具有较好的安全性。

Objective:To evaluate the effect of Bufei Huayu Decoction on hypercoagulable state in patients with non-small cell lung cancer(NSCLC).Methods:Sixty patients with non-small cell lung cancer who underwent first-line chemotherapy from January 2015 to December 2016 were randomly divided into control group(n=30) and experimental group(n=30).Except for gemcitabine Platinum regimen,the control group and the experimental group were given placebo and Bufei Huayu Decoction treatment.The levels of platelet(PLT),platelet aggregation rate,fibrinogen(FIB) and D-dimer(DD) levels,mortality and adverse events were compared between the two groups before and after treatment.Months and mapped Kaplan-Meier survival curves were used to compare the risk and quality of life differences between the two groups of patients with thrombotic events(such as venous thrombosis,stroke and multiple vascular regional infarction).Results:The total response rates were 63.33% and 70.00% in the control and experimental groups,respectively(P<0.05).The rate of disease in the control group was significantly higher than that in the experimental group(26.67% vs.6.67%,P<0.05).The levels of PLT,MAR,FIB and DD in the experimental group were significantly lower than those before treatment(P<0.05) and those of the control group(P<0.05).There were no significant statistical differences(30.00% vs.13.33%,χ~2=3.354,P=0.067) in the control group and the experimental group.The log rank test showed that thrombosis-related events occurred in the control group was 3.002 times(HR=3.002,95%CI [1.007,8.261],P=0.049) than those of the experimental group.There was no significant difference between the control group and the experimental group(20.00% vs.23.33%,P<0.05) and the mortality rate(10.00% vs.3.33%,P<0.05).The quality of life in the experimental group was significantly higher than that in the control group.Conclusion:The application of Bufei Huayu Decoction in the treatment of non-small cell lung cancer can significantly improve the hypercoagulability of patients and reduce the risk of thrombosis-related events in patients with non-small cell lung cancer.