扶正祛邪方防治ⅠB~ⅡB期非小细胞肺癌复发转移及对体液免疫功能影响的临床研究  

Clinical research on effects of Fuzheng Quxie Formula on preventing recurrence and metastasis in stageⅠB‑ⅡB non‑small cell lung cancer and on humoral immune function

作　　者：徐力立 李雁[1] 蒋雷[2] 张素芳[3] 骆莹滨 XU Lili;LI Yan;JIANG Lei;ZHANG Sufang;LUO Yingbin(Department of Oncology,Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai Universityof Traditional Chinese Medicine,Shanghai 200071,China;Department of Thoracic Surgery,Shanghai PulmonaryHospital,Shanghai 200433,China;Department of Integrated Traditional Chinese and Western Medicine,ShanghaiPulmonary Hospital,Shanghai 200433,China)

机构地区：[1]上海中医药大学附属市中医医院肿瘤科,上海200071 [2]上海市肺科医院胸外科,上海200433 [3]上海市肺科医院中西医结合科,上海200433

出　　处：《上海中医药杂志》2024年第12期119-124,共6页Shanghai Journal of Traditional Chinese Medicine

基　　金：上海市申康医院发展中心促进市级医院临床技能与临床创新三年行动计划项目(SHDC2020CR4052)。

摘　　要：目的观察扶正祛邪方治疗ⅠB~ⅡB期非小细胞肺癌(NSCLC)术后患者的临床疗效及其对机体体液免疫功能的影响。方法将符合纳入标准的190例ⅠB~ⅡB期肺腺癌术后患者随机分为治疗组和对照组,每组各95例。对照组患者在完成西医标准治疗方案后,仅进行随访观察;治疗组在对照组治疗基础上,加用扶正祛邪方颗粒治疗,疗程为3个月。比较两组术后无病生存期、肿瘤标志物、免疫指标以及生活质量评分的变化。结果①最终完成试验者183例,治疗组91例、对照组92例。②治疗组1年和2年无病生存率显著高于对照组(P<0.05)。③治疗前后组内比较,两组糖类抗原242(CA242)、细胞角蛋白19片段(CY-211)水平差异有统计学意义(P<0.05);组间治疗后比较,治疗组CA242水平较对照组下降(P<0.05)。④治疗前后组内比较,两组外周血补体C3、补体C4、白细胞介素-6(IL-6)、肿瘤坏死因子-α(TNF-α)以及CD4^(+)T细胞水平差异有统计学意义(P<0.05);组间治疗后比较,治疗组外周血补体C3、补体C4、IL-6及CD4^(+)/CD8^(+)T细胞水平较对照组下降,TNF-α及自然杀伤细胞水平较对照组升高(P<0.05)。⑤治疗前后组内比较,治疗组总体健康状况、功能相关领域各评分均上升及一般临床症状各个症状评分均降低(P<0.05),特征性子症状咳嗽、气促、胸痛、手臂或肩膀疼痛以及其他部位疼痛评分降低(P<0.05);对照组仅角色功能评分上升(P<0.05),而总体健康状况评分降低(P<0.05),一般临床症状中疼痛、气促、失眠、食欲丧失评分降低(P<0.05),特征性子症状气促和手臂或肩膀疼痛评分下降(P<0.05)。组间治疗后比较,治疗组总体健康状况、功能相关领域各评分以及一般临床症状中疲倦、恶心呕吐、疼痛、气促、失眠、食欲丧失、便秘评分均优于对照组(P<0.05),特征性子症状咳嗽评分优于对照组(P<0.05)。结论扶正祛邪方能有效延长ⅠB~ⅡB期NSCLC�Objective To observe the clinical efficacy of Fuzheng Quxie Formula(FQF)in treating postoperative patients with StageⅠB-ⅡB nonsmall cell lung cancer(NSCLC)and its effects on humoral immune function.Methods A total of 190 postoperative patients with StageⅠB-ⅡB lung adenocarcinoma meeting inclusion criteria were randomly divided into a treatment group(n=95)and a control group(n=95).The patients in the control group underwent follow-up after receiving the standard treatment regimen of Western medicine.The patients in the treatment group,in addition to the standard treatment of Western medicine,received FQF Granules for 3 months.Postoperative disease-free survival(DFS),tumor markers,immune parameters,and quality of life scores were compared between the two groups.Results①A total of 183 patients completed the trial,with 91 cases in the treatment group and 92 cases in the control group.②The 1-year and 2-year DFS rates in the treatment group were significantly higher than those in the control group(P<0.05).③Intragroup comparisons before and after treatment showed significant differences in carbohydrate antigen 242(CA242)and cytokeratin 19 fragment antigen 211(CY-211)levels in both groups(P<0.05).Post-treatment intergroup comparison revealed that CA242 level in the treatment group were lower than that in the control group(P<0.05).④Intragroup comparisons before and after treatment showed significant differences in peripheral blood complement C3,complement C4,interleukin-6(IL-6),tumor necrosis factor-α(TNF-α),and CD4^(+)T cell levels in both groups(P<0.05).Post-treatment intergroup comparison showed that the treatment group had lower levels of peripheral blood complement C3,complement C4,IL-6,and CD4^(+)/CD8^(+)T cells,but higher levels of TNF-αand natural killer cells than the control group(P<0.05).⑤In the treatment group,intragroup comparisons before and after treatment showed that scores for overall health status and function-related items increased,while scores for general clinical symptoms decreas

关 键 词：非小细胞肺癌 扶正祛邪方 肿瘤预后 免疫功能 中医药疗法 临床试验 

分 类 号：R273[医药卫生—中西医结合]