益气养阴方对非小细胞肺癌术后放疗患者放射性肺炎及肺功能影响的临床研究

Clinical study on effects of Yiqi Yangyin Formula on radiation pneumonitis and lung function in patients undergoing postoperative radiotherapy for non- small cell lung cancer

目的观察益气养阴方对非小细胞肺癌(Ⅲa期)术后放疗患者放射性肺炎及肺功能的影响。方法将60例非小细胞肺癌(Ⅲa期)术后放疗患者随机分为治疗组与对照组,每组30例。对照组予术后常规放疗,治疗组在术后常规放疗的同时加服益气养阴方。两组疗程均为28天,观察急性放射性肺炎分级(RTOG分级)和肺功能的变化情况。结果①试验期间,治疗组脱落1例,对照组脱落3例;最终完成试验者56例,治疗组29例,对照组27例。②放疗后2个月与放疗结束时组内比较,治疗组RTOG分级差异有统计学意义(P<0.05),对照组RTOG分级差异无统计学意义(P>0.05)。组间放疗结束时比较,RTOG分级差异尚无统计学意义(P>0.05),治疗组(72.41%)与对照组(85.19%)RP发生率差异无统计学意义(P>0.05)。组间放疗后2个月比较,RTOG分级差异有统计学意义,治疗组(37.93%)RP发生率明显低于对照组(85.19%)、炎症程度明显轻于对照组(P<0.05)。③放疗结束时与放疗前组内比较,两组FVC、FEV_1、MVV差异均无统计学意义(P>0.05);放疗后2个月与放疗前组内比较,对照组FVC、FEV_1、MVV差异有统计学意义,明显降低(P<0.05),治疗组FVC、FEV_1、MVV差异无统计学意义,保持稳定(P>0.05)。组间放疗结束时比较,FVC、FEV_1、MVV差异无统计学意义(P>0.05)。组间放疗后2个月比较,FVC、FEV_1、MVV差异有统计学意义,治疗组明显高于对照组(P<0.05)。④重复测量资料的方差分析显示,FVC、FEV_1、MVV组内变异中的时间因素及时间×组别因素存在显著统计学意义(P<0.05);组间变异中的组别因素不存在显著统计学意义(P>0.05)。结论益气养阴方能在一定程度上稳定Ⅲa期非小细胞肺癌术后放疗患者的肺功能,减少放射性肺炎的发生,并有利于降低其发生后的炎症程度。

Objective To observe the effects of Yiqi Yangyin Formula on radiation pneumonitis( RP) and lung function in patients undergoing postoperative radiotherapy for non-small cell lung cancer( NSCLC)( stage IIIa). Methods 60 patients undergoing postoperative radiotherapy for NSCLC( stage IIIa) were randomly assigned into treatment group and control group,30 patients in each group. The control group received routine radiotherapy after operation,and the treatment group received Yiqi Yangyin Formula in addition. Both groups were treated for 28 days. Changes in classification of acute RP( RTOG classification) and in lung function were observed. Results(1)During the trial,there were 1 and 3 drop-outs in the treatment and the control groups respectively;and 56 patients finally completed the trial,including 29 in the treatment group and 27 in the control group.(2)At 2 months after radiotherapy,there was statistically significant difference in RTOG grade in the treatment group( P<0.05),while there was no statistically significant difference in the control group( P>0.05) compared to that at the end of radiotherapy. At the end of radiotherapy,there was no statistically significant difference in RTOG grade between the groups( P>0.05),and no statistically significant difference in the incidence of RP between the treatment group( 72.41%) and the control group( 85.19%)( P>0.05). At 2 months after radiotherapy,there was statistically significant difference in RTOG grade between the groups;and in the treatment group,the incidence of RP was significantly lower than in the control group( 37.93% vs. 85.19%),and the degree of inflammation was significantly lower than in the control group( P<0.05).(3)There was no significant difference in FVC,FEV1 or MVV in the groups at the end of radiotherapy compared to that before radiotherapy( P>0.05). FVC,FEV1 and MVV decreased significantly in the control group( P<0.05) and they remained stable in the treatment group with no statistically significant differences( P>0.05) at 2 months after radiotherapy compared to those before radiotherapy. At the end of radiotherapy,there was no significant difference in FVC,FEV1 or MVV between the groups( P>0.05). At 2 months after radiotherapy,the differences in FVC,FEV1 and MVV were statistically significant between the groups,significantly higher in the treatment group than in the control group( P<0.05).(4)Variance analysis of repeated measures data showed that there was statistical significance in the time factor and the time x group factor in intra-group variation of FVC,FEV1 and MVV( P<0.05),and there was no statistical significance in the group factor in inter-group variation( P>0.05). Conclusion Yiqi Yangyin Formula can stabilize the lung function of patients undergoing postoperative radiotherapy for NSCLC( stage IIIa) to a certain extent,lower the incidence of radiation pneumonitis,and help to reduce the degree of the inflammation.