艾灸联合免疫检查点抑制剂与化疗治疗晚期非鳞非小细胞肺癌临床研究
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R246.5;R734.2

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浙江省中医药科技计划项目(2022ZB239);杭州市重点学科(高峰学科)(OO20200385);全国名老中医药传承工作室建设项目(GZS202204)


Clinical Study on Moxibustion Combined with Immune Checkpoint Inhibitors and Chemotherapy for Advanced Non-Squamous Non-Small Cell Lung Cancer
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    摘要:

    目的:观察艾灸联合免疫检查点抑制剂与化疗治疗肺脾气虚型晚期非鳞非小细胞肺癌的临床疗效。 方法:选取62例肺脾气虚型晚期非鳞非小细胞肺癌患者,按照随机数字表法分成对照组与试验组各31例。对 照组予免疫检查点抑制剂与化疗治疗,直至疾病进展或发生不可耐受的毒性反应,化疗期间予常规抑酸护胃、 止吐、护肝等对症支持治疗。试验组在对照组基础上给予艾灸治疗。比较2组中医证候积分,中医证候疗效, 实体瘤疗效,无进展生存时间(PFS),CD3+、CD4+、CD8+ T淋巴细胞百分比,CD4+/CD8+值,以及药物不良反 应。结果:治疗后,对照组中医证候积分与同组治疗前比较,差异无统计学意义(P>0.05);试验组中医证候 分较治疗前降低,且低于对照组(P<0.05)。试验组与对照组中医证候改善率分别为77.42%、41.94%,2组比 较,差异有统计学意义(P<0.05)。试验组与对照组肿瘤总缓解率(ORR) 分别为58.06%、51.61%,疾病控 制率(DCR) 分别为83.87%、77.41%,2组ORR、DCR比较,差异均无统计学意义(P>0.05)。试验组PFS长 于对照组(Log RankP<0.05)。治疗方式为影响晚期非鳞非小细胞肺癌PFS的独立因素,与对照组比较,试验 组疾病进展风险较低[HR=0.57(95% CI 0.33~0.99)]。治疗后,试验组CD3+、CD4+ T淋巴细胞百分比及CD4+/ CD8+值均较治疗前升高,CD8+ T淋巴细胞百分比均较治疗前下降,差异均有统计学意义(P<0.05);对照组 CD3+、CD8+ T淋巴细胞百分比均较治疗前下降,差异均有统计学意义(P<0.05);对照组CD4+ T淋巴细胞百分 比及CD4+/CD8+值治疗前后比较,差异均无统计学意义(P>0.05);试验组CD3+、CD4+ T淋巴细胞百分比及 CD4+/CD8+值均高于对照组(P<0.05)。2组白细胞减少、中性粒细胞减少、贫血、血小板减少、肝功能异常、 肾功能异常、恶心呕吐、反应性毛细血管增生、乏力、食欲下降、免疫性肺炎总发生率及上述不良反应程度≥ 3级发生率比较,差异均无统计学意义(P>0.05)。结论:艾灸联合免疫检查点抑制剂与化疗治疗能改善肺脾 气虚型晚期非鳞非小细胞肺癌的临床症状,提高其免疫功能和延长PFS。

    Abstract:

    Abstract:Objective:To observe the clinical effect of moxibustion combined with immune checkpoint inhibitors and chemotherapy on advanced non-squamous non-small cell lung cancer (NSCLC) of lungspleen qi deficiency type. Methods: A total of 62 cases of advanced non-squamous NSCLC patients of lung-spleen qi deficiency type were selected and divided into the control group and the trial group (31 cases respectively) according to random number table method. The control group was treated with immune checkpoint inhibitors and chemotherapy until the disease progressed or intolerable toxic reactions occurred. During chemotherapy, routine acid-suppressing stomach protection, antiemesis, liver protection and other symptomatic supportive treatments were given. The trial group was additionally given moxibustion based on the treatment of the control group. The traditional Chinese medicine (TCM) syndrome scores, TCM syndrome effects, solid tumor effect, progression-free survival time (PFS), the percentages of CD3+ , CD4+ and CD8+ T lymphocytes, CD4+/CD8+ , and adverse reactions were compared between the two groups. Results:After treatment,there was no significant difference in TCM syndrome scores in the control group before and after treatment (P>0.05). The TCM syndrome scores in the trial group were reduced when compared with those before treatment,and lower than those in the control group (P<0.05). The improvement rates of TCM syndromes were respectively 77.42% and 41.94% in the trial group and the control group, the difference being significant (P<0.05). The objective response rate (ORR) were respectively 58.06% and 51.61%, and the disease control rate (DCR) were respectively 83.87% and 77.41% in the trial group and the control group, there being no significant difference in ORR and DCR between the two groups (P>0.05). The PFS in the trial group was longer than that in the control group (Log RankP<0.05). Treatment mode was an independent factor affecting the progression of advanced nonsquamous NSCLC. Compared with that in the control group, the risk of progression in the trial group was lower [HR=0.57 (95%CI 0.33~0.99)]. After treatment, the percentages of CD3+ and CD4+ T lymphocytes, and CD4+ /CD8+ in the trial group were enhanced when compared with those before treatment,while the percentages of CD8+ T lymphocytes were reduced when compared with those before treatment,differences being significant (P<0.05). The percentages of CD3+ and CD8+ T lymphocytes in the control group were declined when compared with those before treatment,differences being significant (P< 0.05). There was no significant difference in the percentage of CD4+ T lymphocytes and CD4+/CD8+ before and after treatment (P>0.05). The percentages of CD3+ and CD4+ T lymphocytes,and CD4+/CD8+ in the trial group were higher than those in the control group (P<0.05). There was no significant difference in the total incidence of leukopenia, neutropenia, anemia, thrombocytopenia, abnormal liver function, abnormal kidney function, nausea and vomiting, reactive capillary hyperplasia, fatigue, decreased appetite and immune pneumonia,and the incidence of above adverse reactions of or over Grade three between the two groups (P>0.05). Conclusion: The therapy of moxibustion combined with immune checkpoint inhibitors and chemotherapy can improve the clinical symptoms of advanced non-squamous NSCLC of lung-spleen qi deficiency type,and improve the immune function and PFS.

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叶知锋,黄挺,胡科科,郭俊华,黄伶,周河燃.艾灸联合免疫检查点抑制剂与化疗治疗晚期非鳞非小细胞肺癌临床研究[J].新中医,2024,56(16):129-135

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  • 在线发布日期: 2024-08-28
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