|
| 养肺消积方治疗驱动基因阴性晚期非小细胞肺癌老年患者的临床疗效观察 |
| Observation of the clinical efficacy of Yangfei Xiaoji Formula in the treatment of elderly patients with driver gene-negative advanced non-small cell lung cancer |
| 投稿时间：2024-05-21 修订日期：2024-06-02 |
| DOI： |
| 中文关键词: 养肺消积方 驱动基因阴性晚期非小细胞肺癌 老年患者 免疫检查点抑制剂 |
| 英文关键词: Yangfei Xiaoji Formula Driver gene negative for advanced non-small cell lung cancer elderly patients Immune checkpoint inhibitors |
| 基金项目:1、浙江省医药卫生科技计划项目-创新人才项目（2021435193）；2、浙江省中医药科技计划重点研究项目（2019ZZ017）；3、浙江省“杏林工程”临床中青年名中医项目；4、浙江省医坛新秀培养项目。 |
| 摘要点击次数: 140 |
| 全文下载次数: 0 |
| 中文摘要: |
| 背景:免疫联合化疗在驱动基因阴性晚期非小细胞肺癌(Non-small cell lung cancer,NSCLC)治疗中有较显著疗效。对于其中的老年患者而言,化疗耐受性差,单药免疫也不失为一个恰当选择。中药是免疫治疗的潜在同盟军,探寻能增强免疫治疗疗效并减轻免疫检查抑制剂治疗的副作用的有效中医治疗方有现实的临床意义。目的:观察养肺消积方(YFXJ)治疗基因阴性晚期NSCLC老年患者的临床疗效；方法:采取前瞻性对列研究,随机分两组,对照组51例采取单纯免疫治疗,治疗周期均为21d,共治疗6个周期后进入随访阶段(6个月)。观察组56例在对照组基础上口服YFXJ汤剂。比较两组无疾病进展时间(Progression-Free-Survival,PFS)、生存期(Overall survival ,OS)、中医症候积分及主要症状疗效、免疫指标及免疫相关毒性评估等方面的差异。结果:观察组中位PFS 为10±0.53个月,较对照组(8±0.45)提高2个月(p＜0.01)；中位OS为16±0.62个月,较对照组(14±0.79)提高2个月(p＜0.01)。临床疗效有效率达到87.5%,高于对照组(70.59%)(P<0.01)；治疗后中医症候评分及疗效均优于对照组(p＜0.05)；治疗后观察组NK细胞、CD3+、CD4+及CD4+/CD8+高于观察组(p值均＜0.01)；观察组不良反应、免疫毒性反应程度主要集中在G2及以下,G3、G4程度低于对照组( 均P ＜ 0. 05) 。结论:YFXJ能够有效提高该类老年患者的中位PFS和OS,改善临床症状,增强免疫功能,并减轻NSCLC疾病或免疫治疗的副作用。为驱动基因阴性的老年晚期NSCLC患者的免疫联合治疗提供了一个新的思路和方向,值得临床进一步推广。 |
| 英文摘要: |
| Background: Immunotherapy combined with chemotherapy has significant efficacy in the treatment of driver-negative advanced non-small cell lung cancer (NSCLC). For these older patients, chemotherapy is poorly tolerated, and single-agent immunization is an appropriate option. TCM is a potential ally of immunotherapy, and it is of practical clinical significance to explore effective TCM treatments that can enhance the efficacy of immunotherapy and alleviate the side effects of immunoassay inhibitor therapy. Objective: To observe the clinical efficacy of YFXJ in the treatment of elderly patients with gene-negative advanced NSCLC. Methods: A prospective study was conducted and randomly divided into two groups, 51 patients in the control group were treated with immunotherapy alone, and the treatment cycle was 21 days, and a total of 6 cycles of treatment entered the follow-up stage (6 months). In the observation group, 56 patients were given YFXJ decoction orally on the basis of the control group. The differences in progression-free-survival (PFS), overall survival (OS), TCM symptom scores, main symptom efficacy, immune indexes and immune-related toxicity assessment were compared between the two groups. Results: The median PFS in the observation group was 10±0.53 months, which was 2 months higher than that in the control group (8±0.45) (p<0.01). The median OS was 16±0.62 months, which was 2 months higher than that of the control group (14±0.79) (p<0.01). The effective rate of clinical efficacy reached 87.5%, which was higher than that of the control group (70.59%) (P<0.01). After treatment, the TCM symptom score and efficacy were better than those of the control group (P<0.05). After treatment, NK cells, CD3+, CD4+ and CD4+/CD8+ in the observation group were higher than those in the observation group (all p<0.01). The degree of adverse reactions and immunotoxicity in the observation group was mainly concentrated in G2 and below, and the degree of G3 and G4 was lower than that in the control group (all P < 0.05). Conclusion: YFXJ can effectively improve the median PFS and OS, improve clinical symptoms, enhance immune function, and alleviate the side effects of NSCLC disease or immunotherapy. It provides a new idea and direction for immunotherapy in elderly patients with advanced NSCLC who are negative for driver genes, and is worthy of further clinical promotion. |
|
View Fulltext
查看/发表评论 下载PDF阅读器 |
| 关闭 |
|
|
|
