【作者】 张敏；

【导师】 叶丽红；

【作者基本信息】 南京中医药大学 ， 中医内科学（专业学位）， 2022， 硕士

【摘要】 目的:本研究旨在对周氏克金岩方联合安罗替尼治疗晚期非小细胞肺癌患者(气阴两虚证)的疗效及安全性进行观察和分析,初步探索中医药联合抗血管生成药物治疗晚期非小细胞肺癌的临床意义。方法:共收集60例符合纳入、排除标准的Ⅳ期非小细胞肺癌患者,随机分为对照组30例(单药安罗替尼)及试验组30例(周氏克金岩方联合安罗替尼),分别进行2周期的治疗。分别在入组前1周内及试验终点后1周内对患者的影像学病灶大小、肿瘤指标、中医证候积分、KPS评分、FACT-L生活质量评分、不良反应等数据进行采集,过程中动态观察,可根据实际情况增加随访频次。将最终收集整理的数据录入SPSS 26.0软件,进行统计学分析。结果:60例患者均完成2周期的治疗,临床资料完整。对两组患者的性别、年龄、吸烟史、原发灶部位、病理类型、基因检测情况等基线资料进行分析,差异均具有可比性(P>0.05)。1.近期疗效比较:经治疗后,试验组ORR为10%,DCR为83.3%,均高于对照组,但组间差异不具有统计学意义(P>0.05)。2.肿瘤指标比较:治疗后两组的CEA均较治疗前下降,且具有统计学意义(P<0.05);治疗后组间CEA的差异不具有统计学意义(P>0.05)。3.中医证候疗效比较:治疗后,试验组的中医证候总有效率高于对照组,组间差异具有统计学意义(P<0.05)。将治疗后的各项症状评分进行组间对比,试验组咳嗽、自汗盗汗、口干饮水积分明显低于对照组,差异有统计学意义(P<0.05)。4.KPS评分比较:治疗后,试验组与对照组的KPS评分皆较治疗前升高,但经过统计学分析,治疗组KPS评分的上升具有高度统计学意义(P<0.01),而对照组KPS的变化无统计学差异(P>0.05)。治疗后组间比较,试验组的KPS均值高于对照组,差异具有统计学意义(P<0.05)。5.FACT-L生活质量评分比较:试验组治疗后的生理、情感评分低于治疗前,具有统计学差异(P<0.05);在功能状况、气促、咳嗽、胸闷、呼吸顺畅方面有明显好转,具有高度统计学意义(P<0.01)。对照组患者治疗后的功能状况、呼吸顺畅方面的评分较治疗前升高,具有统计学意义(P<0.05);胸闷症状分值降低,较治疗前具有高度统计学意义(P<0.01)。治疗后组间相比,试验组的功能状况评分、咳嗽评分较对照组有差异,具有统计学意义(P<0.05)。6.用药安全比较:经治疗后,试验组口腔黏膜炎发生率较对照组低,经检验差异具有统计学意义(P<0.05)。两组在肝功能异常、甲状腺功能减退、骨髓抑制等副反应发生率方面,经检验无明显统计学差异(P>0.05)。结论:本次研究结果显示周氏克金岩方联合安罗替尼较单药安罗替尼治疗晚期非小细胞肺癌,在改善患者体力状况和提高患者生活质量方面具有一定的优势,并能减少部分不良反应的发生率,且具有较好的安全性。更多还原

【Abstract】 Objective:This study is designed to evaluate the efficacy and safety of Zhoushi Kejinyan formula combined with anlotinib in treating patients with advanced non-small cell lung cancer(Qi and yin deficiency syndrome),and to preliminarily evaluate the clinical significance of traditional Chinese medicine combined with antiangiogenic drugs in treating advanced non-small cell lung cancer.Methods:60 patients with stage Ⅳ NSCLC who met the inclusion and exclusion criteria were randomly assigned to receive 2 cycles of treatment with 30 patients in the control group(single agent anlotinib)or 30 patients in the experimental group(combination of anlotinib with Zhoushi Kejinyan formula).The data of radiographic lesion size,tumor marker,TCM syndrome score,KPS score,FACT-L quality-of-life score,and adverse effects were collected from patients within 1 week before enrollment and 1 week after the endpoint of the trial,which was observed dynamically through the process and could increase the frequency of follow-up according to actual conditions.The final data were collected for statistical analysis,by SPSS 26.0 software.Results:All 60 patients completed 2 cycles of treatment with complete clinical data.Baseline data such as gender,age,smoking history,primary lesion location,pathological type,and genetic testing status were analyzed in both cohorts,and comparable due to no statistical difference.(P>0.05).(1)Recent objective effect:After treatment,the ORR of the experimental group was 10%and the DCR was 83.3%,which were higher than those of the control group,but the difference between the groups was not statistically significant(P>0.05).(2)Tumor marker:CEA in both groups decreased after treatment and it was statistically significant(P<0.05),compared with that before treatment.The difference in CEA between the groups after treatment was not statistically significant(P>0.05).(3)Curative effect of TCM syndrome:After treatment,the total effective rate of TCM syndromes was higher in the experimental group than in the control group,and the difference between the groups was statistically significant(P<0.05).When all symptom scores after treatment were compared between groups,the scores of cough,self sweating night sweats,and dry mouth and drinking in the experimental group were significantly lower than those in the control group(P<0.05).(4)KPS scores:After treatment,the KPS scores of the experimental group and the control group both rose before treatment,but after statistical analysis,the rise in KPS scores of the treatment group was obviously statistically significant(P<0.01),whereas the change in KPS of the control group was not statistically significant(P>0.05).After treatment,the mean KPS of the experimental group was higher than that of the control group with statistical significance(P<0.05).(5)FACT-L quality of life score:The physical and emotional scores of the experimental group after treatment were lower than those of the experimental group before treatment,which was statistically significant(P<0.05);They were significantly better in functional status,shortness of breath,cough,chest tightness,and smooth breathing with high statistical significance(P<0.01).In the control group,the scores of functional status,smooth breathing increased after treatment compared with those before treatment,with statistical significance(P<0.05);The chest tightness symptom score was reduced,which was highly statistically significant(P<0.01)than before treatment.The functional status score,cough score of the treatment group was statistically different compared to the control group(P<0.05).(6)Drug safety:After treatment,the incidence of oral mucositis in the experimental group was lower than that in the control group,and the difference was statistically significant(P<0.05).There was no significant difference between the two groups in terms of the incidence of side effects such as abnormal liver function,hypothyroidism,and myelosuppression(P>0.05)by post test.Conclusion:The results of this study show that Zhoushi Kejinyan formula combined with anlotinib can significantly improve the physical condition of patients with advanced non-small cell lung cancer,improve the quality of life of patients and reduce the incidence of some adverse reactions,and has good safety.更多还原