| 1.ObjectiveThis study uses a retrospective cohort study to explore the effects of Chinese patent medicines in adjuvant treatment of advanced NSCLC(Non-Small Cell Lung Cancer)on patients with PFS(Progress Free Survival),OS(Overall Survival,total survival),serum tumor marker levels,KPS(Karnofsky,Cassette score),TCM syndrome score,and clarify the efficacy and advantages of proprietary Chinese medicines in adjuvant treatment of advanced NSCLC.2.MethodsBy consulting the hospitalized medical records of the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine from January 1,2015 to December 31,2018,NSCLC patients with pathological types of adenocarcinoma or squamous cell carcinoma and clinical stages IIIb-IV as the research objects.Regarding Chinese patent medicines as exposure factors,they were divided into exposure group and non-exposure group for retrospective cohort study.The non-exposure group was treated in accordance with the 2018V6 version of NCCN(National Comprehensive Cancer Network)clinical practice guidelines,and chemotherapy,targeted therapy,immunotherapy or the best supportive treatment was adopted according to the patient’s condition;the exposure group was in accordance with 2018 The NCCN clinical practice guidelines V6 of the year were treated with Chinese patent medicines,including: Shenyi Capsules,Huisheng Oral Liquid,Zilongjin Tablets,Huaier Granules,Compound Smilax Granules,Kanglaite Soft Capsules,Weimaining Capsules,Xihuang pills/capsules and Huachansu tablets should be taken for at least 8 weeks according to the prescribed dosage in the instructions.Observation index: main observation index: PFS;secondary observation index: OS,serum tumor marker level,KPS,TCM syndrome score.3.ResultsA total of 140 patients were included in the study,68 in the exposed group and 72 in the non-exposed group.The m PFS(Median Progress Free Survival)of the exposed group was significantly different from that of the non-exposed group(5.4 months vs 4.7 months);the m OS(Median Overall Survival)compared with the non-exposed group,the difference was not statistically significant(17.7 months vs 17.2 months).In terms of reducing the level of serum tumor markers,after treatment,the levels of CEA(Carcinoembryonic Antigen)and CYFRA21-1(Cytokeratin 19 fragments)of the two cohorts of patients decreased,but CEA and CYFRA21-1 between the two cohorts was no significant difference in level(P>0.05).In terms of improving the quality of life,the exposed group can improve the patient’s KPS compared with the non-exposed group(P<0.05).In terms of improving TCM symptoms,the exposed group can improve the TCM syndrome score of patients compared with the non-exposed group(P<0.05).The results of stratified analysis of PFS showed that: 1)Stratified analysis without considering exposure factors,western medicine treatment methods,gender,pathological type,smoking status,and clinical stage have statistically significant effects on patients’ PFS;age has no effect on patients’ PFS Statistical significance.2)Among the population who received chemotherapy,supportive treatment,male,age <64 years,and no smoking history,the m PFS of the exposed group was better than the non-exposed group,and the difference was statistically significant.COX regression analysis showed that the use of proprietary Chinese medicines,chemotherapy,targeted therapy,and immunotherapy are independent protective factors for PFS.A stratified analysis of Chinese patent medicines showed that: 1)Zilongjin Tablets,Shenyi Capsules,Weimaining Capsules,Xihuang Pills/Capsules were statistically significant in prolonging PFS in patients.Each exposure group of Chinese patent medicines was effective in prolonging OS no statistical significance.2)Prolonging the medication cycle is statistically significant in improving the OS of patients,but not statistically significant in improving the PFS of patients.3)Cross medication has no statistical significance in prolonging PFS and OS of patients.4.ConclusionChinese patent medicine adjuvant treatment of advanced NSCLC can not only prolong the PFS of patients,but also reduce the serum CEA and CYFRA21-1 levels,improve the quality of life,and reduce the TCM syndrome score.Western medicine treatment methods,gender,pathological type,smoking status,and clinical staging have statistically significant effects on PFS.The beneficiaries of Chinese patent medicines are patients receiving chemotherapy,receiving supportive treatment,males,age <64 years old,and patients without smoking history.Chinese patent medicines,receiving chemotherapy,targeted therapy,and immunotherapy are independent protective factors for PFS.Zilongjin Tablets,Shenyi Capsules,Weimaining Capsules,Xihuang Pills/Capsules of Chinese patent medicines are statistically significant in prolonging PFS of patients.Prolonging the period of taking Chinese patent medicines can improve OS of patients. |