摘要
目的评价益气健脾化积方对胃癌化疗气虚血瘀证患者生活质量的影响。方法收集7家医院58例胃癌化疗气虚血瘀证患者,采取随机分组、双盲、单模拟、安慰剂平行对照的多中心临床研究方案,在多西他赛联合顺铂化疗方案的基础上治疗组(31例)口服益气健脾化积方免煎颗粒,对照组(27例)口服益气健脾化积方免煎颗粒模拟剂,每日1剂,疗程8周。于治疗前及治疗期间每周随访1次,对生活质量、中医症状体征及体力状态进行观察。结果治疗8周时治疗组生活质量评分、中医症状体征及体力状态与治疗前比较差异具有统计学意义(P<0.05),对照组治疗前后不同时间比较差异均无统计学意义(P>0.05)。治疗8周时治疗组中医症状体征分级量化积分与对照组比较差异具有统计学意义(P<0.05)。结论益气健脾化积方可显著改善胃癌化疗患者中医症状体征,对改善患者的生活质量及体力状态具有潜在疗效。
Objective To evaluate the effect of Yiqi Jianpi Huaji Fang（ 益气健脾化积方,YQJPHJF） on quality of life（ QOL） of gastric cancer patients with chemotherapy of Qi deficiency and blood stasis type. Methods The researchers collected 58 gastric cancer patients with chemotherapy of Qi deficiency and blood stasis type from 7 hospitals to conduct a multi-centered,randomized,double-blind,single-dummy,paralleled,placebo-controlled trial. In addition to the chemotherapy of Docetaxel plus cisplatin,the treatment group（ 31 cases） was administered oral YQJPHJF granules,the control group（ 27 cases） was given YQJPHJF granules placebo,one dose daily for 8 weeks.The patients were followed before and in the treatment once a week to assess their QOL,Chinese medicine symptoms and signs and physical status. Results In the 8th week,the QOL score,classification and quantitation score and physical status score showed a significant statistic difference compared with those before treatment（ P〈0. 05）. In the control group,there was no significant statistic difference before and after treatment（ P〈0. 05）. In the 8th week,the classification and quantitation score of symptom and sign in Chinese medicine in the treatment group showed a significant statistic difference compared with that in the control group（ P〈0. 05）. Conclusion YQJPHJF could apparently improve the Chinese medicine symptoms and signs of gastric cancer with chemotherapy,and seems to have a potential efficacy in improving their QOL and physical status.
出处
《中医杂志》
CSCD
北大核心
2017年第9期759-762,共4页
Journal of Traditional Chinese Medicine
基金
国家中医临床研究基地业务建设科研专项(JDZX2012089)
关键词
胃癌
益气健脾化积方
化疗
生活质量
气虚血瘀证
gastric cancer
Yiqi Jianpi Huaji Fang（益气健脾化积方）
chemotherapy
quality of life（QOL）
Qi deficiency and blood statis syndrome
