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

XU Lili; LI Yan; JIANG Lei; ZHANG Sufang; LUO Yingbin

doi:10.16305/j.1007-1334.2024.z20240701001

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

更新时间：2024-12-23

- Clinical research on effects of Fuzheng Quxie Formula on preventing recurrence and metastasis in stage ⅠB⁃ⅡB non⁃small cell lung cancer and on humoral immune function
- Shanghai Journal of Traditional Chinese Medicine Vol. 58, Issue 12, Pages: 119-124(2024)
- 作者机构：
  
  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）
- 作者简介：
- 基金信息：
- DOI：10.16305/j.1007-1334.2024.z20240701001
  CLC：
- Published：10 December 2024，
  
  Received：01 July 2024，
- 稿件说明：
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徐力立,李雁,蒋雷,等.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[J].上海中医药杂志,2024,58(12):119-124.

XU Lili,LI Yan,JIANG Lei,et al.Clinical research on effects of Fuzheng Quxie Formula on preventing recurrence and metastasis in stage ⅠB⁃ⅡB non⁃small cell lung cancer and on humoral immune function[J].Shanghai Journal of Traditional Chinese Medicine,2024,58(12):119-124.
徐力立,李雁,蒋雷,等.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[J].上海中医药杂志,2024,58(12):119-124. DOI： 10.16305/j.1007-1334.2024.z20240701001.

XU Lili,LI Yan,JIANG Lei,et al.Clinical research on effects of Fuzheng Quxie Formula on preventing recurrence and metastasis in stage ⅠB⁃ⅡB non⁃small cell lung cancer and on humoral immune function[J].Shanghai Journal of Traditional Chinese Medicine,2024,58(12):119-124. DOI： 10.16305/j.1007-1334.2024.z20240701001.

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（

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（

0.05）；组间治疗后比较，治疗组CA242水平较对照组下降（

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（

0.05）；组间治疗后比较，治疗组外周血补体C3、补体C

4、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（

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（

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（

0.05）；对照组仅角色功能评分上升（

0.05），而总体健康状况评分降低（

0.05），一般临床症状中疼痛、气促、失眠、食欲丧失评分降低（

0.05），特征性子症状气促和手臂或肩膀疼痛评分下降（

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（

0.05），特征性子症状咳嗽评分优于对照组（

0.05）。

结论

扶正祛邪方能有效延长ⅠB～ⅡB期NSCLC患者的无病生存期，显著降低外周血补体C3、补体C4、IL-6和TNF-α的表达水平，纠正机体的免疫紊乱，改善患者的生活质量。

Abstract

Objective

To observe the clinical efficacy of Fuzheng Quxie Formula （FQF） in treating postoperative patients with Stage ⅠB-ⅡB non-small cell lung cancer （NSCLC） and its effects on humoral immune function.

Methods

A total of 190 postoperative patients with Stage ⅠB-ⅡB lung adenocarcinoma meeting inclusion criteria were randomly divided into a treatment group （

=95） and a control group （

=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.

Results

①A 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 （

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 （

0.05）. Post-treatment intergroup comparison revealed that CA242 level in the treatment group were lower than that in the control group （

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 （

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-α and natural killer cells than the control group （

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 decreased （

0.05）. Scores for specific symptoms， including cough， shortness of breath， chest pain， arm or shoulder pain， and pain in other areas， also decreased （

0.05）. In the control group， intragroup comparisons before and after treatment showed that only role function scores increased （

0.05）， while overall health status scores decreased （

0.05）. Scores for pain， shortness of breath， insomnia， and loss of appetite in general clinical symptoms decreased （

0.05）， and scores for specific symptoms such as shortness of breath and arm or shoulder pain also decreased （

0.05）. Post-treatment intergroup comparison showed that the treatment group had better scores for overall health status， function-related items， and general clinical symptoms including fatigue， nausea/vomiting， pain， shortness of breath， insomnia， loss of appetite， and constipation （

0.05）. The score

for the specific symptom of cough was better in the treatment group than that in the control group （

0.05）.

Conclusion

Fuzheng Quxie Formula could effectively prolong the DFS in patients with stage ⅠB‑ⅡB NSCLC， significantly reduce the expression levels of peripheral blood complement C3， complement C4， IL-6， and TNF-α， correct immune dysfunction， and improve patients' quality of life.

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

Keywords

non-small cell lung cancerFuzheng Quxie Formulatumor prognosisimmune functiontraditional Chinese medicine therapyclinical trial

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