藿苏养胃口服液联合SOX化疗方案干预晚期胃癌的临床研究  

Clinical study of Huosu Yangwei Oral Liquid combined with SOX chemotherapy in intervention of advanced gastric cancer

作　　者：李富龙[1,2] 秦艺文 王宏伟 邓玉海[1] 汤瑾[1] 倪红梅[2] 方盛泉[1] LI Fulong;QIN Yiwen;WANG Hongwei;DENG Yuhai;TANG Jin;Ni Hongmei;FANG Shengquan(Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200437,China;Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)

机构地区：[1]上海中医药大学附属岳阳中西医结合医院,上海200437 [2]上海中医药大学,上海201203

出　　处：《上海中医药大学学报》2023年第1期23-30,共8页Academic Journal of Shanghai University of Traditional Chinese Medicine

基　　金：上海市自然科学基金资助项目(20ZR1459300);上海申康医院发展中心临床科技创新项目(SHDC12018X30);上海中医药大学附属岳阳中西医结合医院科研项目(2019YY201)。

摘　　要：目的:探讨藿苏养胃口服液联合SOX化疗方案治疗晚期胃癌的临床疗效。方法:纳入晚期胃癌脾虚痰湿证患者150例,随机分为治疗组和对照组,每组各75例。两组患者均给予SOX方案化疗,在此基础上治疗组患者给予藿苏养胃口服液服用,21 d为1个疗程,共治疗4个疗程。评价临床疗效,比较两组患者的疾病控制率和客观缓解率;比较两组患者的中位生存期;治疗前后比较两组患者的中医证候总积分,评价中医证候疗效;采用Karnofsky功能状态(KPS)评分评价所有患者的健康状况;采用欧洲癌症研究与治疗组织生命质量测定量表(EORTC QLQ-C30V3.0中文版)评价所有患者的生存质量;比较两组患者的不良反应发生率。结果:研究过程中,对照组剔除或脱落患者4例,治疗组剔除或脱落患者4例,最终纳入统计分析者治疗组71例、对照组71例。①治疗后,对照组和治疗组患者的客观缓解率分别为5.6%、7.0%,组间比较差异无统计学意义(P>0.05);对照组和治疗组患者的疾病控制率分别为40.8%和60.6%,治疗组患者的疾病控制率较对照组明显升高(P<0.05)。②对照组患者的中位生存期为7.4个月,治疗组为8.8个月,治疗组患者的中位生存期较对照组延长(P<0.05)。③治疗后,两组患者的中医证候总积分较治疗前均下降(P<0.05),且治疗组患者的积分低于对照组(P<0.05);治疗组的中医证候疗效总有效率为66.2%,对照组为23.9%,治疗组的中医证候疗效优于对照组(P<0.05)。④治疗后,两组患者的KPS评分较治疗前均升高(P<0.05),且治疗组患者的评分高于对照组(P<0.05)。⑤治疗后,在功能及总体健康状况领域方面,两组患者的EORTC QLQ-C30各项评分较治疗前均升高(P<0.05),且治疗组患者的角色功能、情绪功能及总体健康状况评分均高于对照组(P<0.05);在症状领域方面,治疗组患者的疲劳、疼痛评分较治疗前均降低(P<0.05),且上述症状评分低于对照组(PObjective:To explore the clinical efficacy of Huosu Yangwei Oral Liquid combined with SOX chemotherapy in the treatment of advanced gastric cancer.Methods:A total of 150 patients of advanced gastric cancer with spleen deficiency and phlegmdampness syndrome were enrolled and randomly divided into the treatment group and control group,75 cases in each group.The patients in both groups were treated with SOX chemotherapy.Based on above,the patients in the treatment group were orally treated with Huosu Yangwei Oral Liquid.Twenty-one was a course of treatment,and a total of 4 courses of treatment were performed.The clinical efficacy was evaluated,and the disease control rate(DCR)and objective response rate(ORR)of the two groups were compared.The median survival time of the two groups was compared.Before and after treatment,the total scores of traditional Chinese medical syndrome in the two groups were compared,and the efficacy of traditional Chinese medical syndrome was evaluated.The health status of all patients was evaluated by Karnofsky performance status(KPS)score.The quality of life of all patients was evaluated by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire(EORTC QLQ-C30 V3.0 Chinese version).The incidence of adverse reactions was compared between the two groups.Results:During the study,4 patients in the control group and 4 patients in the treatment group were eliminated or dropped out.Finally,71 cases in the treatment group and 71 cases in the control group were included in statistical analysis.①After treatment,the ORRs of the control group and the treatment group were 5.6%and 7.0%respectively,with no statistically significant difference between the two groups(P>0.05).The DCRs of the control group and the treatment group were 40.8%and 60.6%respectively,and the DCR of the treatment group was significantly higher than that of the control group(P<0.05).②The median survival time of the control group was 7.4 months,and that of the treatment group was 8.8 months.The med

关 键 词：胃癌 晚期 藿苏养胃口服液 化疗 生存质量 生存期 

分 类 号：R735.2[医药卫生—肿瘤]