扶正解毒法联合盐酸埃克替尼治疗老年晚期肺腺癌的临床研究

Clinical study on the treatment of elderly lung adenocarcinoma with Chinese medicine combined with icotinib

关键词:  老年晚期肺癌  肺腺癌  扶正治癌  盐酸埃克替尼

Key words:  elderly advanced lung adenocarcinoma  traditional Chinese medicine  icotinib

摘要:

[目的]观察扶正治癌辨证汤药联合埃克替尼对老年晚期肺腺癌患者的疗效和安全性。[方法]采用前瞻性随机对照的方法，纳入74例老年晚期肺腺癌患者，分为治疗组[中医扶正治癌辨证汤药（每日1剂）联合埃克替尼（125 mg，每日3次，口服）]和对照组（[单用埃克替尼（125 mg，每日3次，口服）]，观察两组治疗后的不良反应及生活质量，统计疾病无进展生存期（PFS）。[结果]1）随访至2018年9月30日，两组未出现进展的病例数分别为治疗组4例，对照组4例，两组的中位PFS分别为15.4月vs 11.13月（P>0.05）；亚组分析中，一线埃克替尼治疗者，两组mPFS分别为16.90个月vs 13.13个月（P<0.05）。2）毒副反应：两组治疗后的主要不良反应是皮疹、腹泻、肝损、口腔溃疡，其中治疗组口腔溃疡的发生情况低于对照组，差异有统计学意义（P<0.05）。3）治疗1个月后，治疗组较治疗前的各功能领域得分上升（P<0.05），疲倦、疼痛、气促、失眠等症状领域得分下降（P<0.05），经济困难领域得分无变化，肺癌子量表中气促、咳嗽及其他部位痛得分下降（P<0.05）；对照组治疗后的各功能领域中情绪功能、认知功能、社会功能领域得分上升（P<0.05）；疼痛、气促、食欲丧失、便秘等症状领域治疗后得分均下降（P<0.05）；肺癌子量表中，口腔溃疡领域得分上升（P<0.05），咳嗽得分下降（P<0.05）。组间比较提示：治疗组较对照组躯体功能及总健康状况得分高，差异有统计学意义（P<0.05）；肺癌子量表中，治疗组较对照组在口腔溃疡得分低，差异有统计学意义（P<0.05）。[结论]扶正治癌辨证汤药可在一定程度上提高埃克替尼治疗老年晚期肺腺癌的临床疗效，可以延长埃克替尼一线治疗老年肺腺癌的疾病进展时间，并且不增加肝肾毒副反应，改善埃克替尼治疗后引起的口腔溃疡。

Abstract:

[Objective] To observe the efficacy and safety of traditional Chinese medicine combined with icotinib in elderly patients with advanced lung adenocarcinoma.[Methods] A prospective randomized controlled trial was performed in 74 patients with advanced lung adenocarcinoma of the elderly. The patients were divided into treatment group (TCM decoction decoction combined with icotinib 125 mg tid po) and control group (icotinib 125 mg tid po only),observed the side effects,quality of life,and statistics of disease Progression-free survival (PFS).[Results] 1)The ending of follow-up period was September 30 th,2018. The median PFS in the two groups was 15.4 months vs 13.13 months (P>0.05). In the subgroup analysis,the first-line therapists,the PFS were 16.90 months vs 13.13 months (P<0.05). 2)Adverse reactions:the main adverse reactions in the two groups were skin rash,diarrhea,liver damage, and oral ulcers. There was statistically significant difference in the occurrence of oral ulcers between the two groups (P<0.05). 3) After treatment for 1 month,the intragroup comparison of the quality of life of the two groups showed that the scores in the functional areas of the treatment group increased (P<0.05),and the scores in areas of fatigue, pain,shortness of breath,insomnia and other symptoms decreased (P<0.05). There was no change in scores in difficult economic areas,and scores of shortness of breath,cough,and pain in other parts of the lung cancer subscale decreased (P<0.05);scores in the emotional function,cognitive function,and social function of the functional areas of the control group increased (P<0.05). Pain,shortness of breath,loss of appetite,constipation and other symptoms decreased after treatment (P<0.05);in the subscale of lung cancer,the score of oral ulcers increased (P<0.05),and cough score decreased (P<0.05). Comparison between groups showed that the scores of physical function and total health of the treatment group were higher than those of the control group (P<0.05). In the subscale of lung cancer, the score of the oral ulcer was lower in the treatment group than in the control group (P<0.05).[Conclusion] TCM treatment can improve the clinical efficacy of icotinib in the treatment of advanced lung adenocarcinoma in the elderly to a certain extent. It can prolong the time of disease progression in first-line treatment of icotinib and does not increase the adverse reactions,and improve Oral ulcers after treatment with icotinib.