摘要
目的:豆根管食通口服液是郑玉玲教授集二十余年临床经验所研制的纯中药制剂,本课题以此为治疗方剂,通过国际通用的生活质量量表评估其对中晚期食管癌患者生活质量的影响,以及通过对其治疗前后凋亡指数(AI)的测定,评价临床疗效,为该药的临床应用及推广提供依据,也为中医药治疗恶性肿瘤的疗效判定探索出一条科学、客观又切实可行的道路。方法:采用随机、对照的方法,临床观察了60例符合纳入标准的食管癌患者,分为对照组和治疗组,各30例。治疗组口服"豆根管食通口服液"治疗,每天三次,每次一支(10ml,1g/ml),一个月为一个疗程,共两个疗程;对照组口服替加氟,每天四次,每次4片(200mg),一个月为一个疗程,共两个疗程。治疗前、第一及第二疗程后分别测一次生活质量,量表采用欧洲癌症研究与治疗组织生活质量核心量表QLQ-C30(V3.0)中文版进行问卷调查并行记分评定,同时测定血清细胞凋亡指数,比较其变化水平。统计采用SPSS11.0统计软件,计算所有数据以均数±标准差(x±s)表示。结果:在改善生活质量方面,豆根管食通口服液组在1疗程、2疗程后总体健康状况、各功能项目及绝大部分症状单项分别较前有明显改善,差异有显著性(P<0.05);而对照组对生活质量各个领域均无明显改善,差异无显著性(P>0.05),且腹泻(DI)项在治疗1疗程、2疗程后与治疗前相比得分明显提高(症状加重),差异具有显著性(P<0.05);组间比较,除个别症状单项因治疗前基础得分较低,治疗后得分减少不明显外,其余各项在1疗程、2疗程后对比具有显著性差异(P<0.05)。在血清凋亡指数方面,治疗组在1疗程、2疗程后分别较前有明显提高,差异有显著性(P<0.05),组间比较在1疗程后、2疗程后对比有显著性差异(P<0.05)。结论:豆根管食通口服液能有效改善食管癌患者的生活质量,并且能显著提高细胞凋亡指数。
DOL is a pure Chinese traditional medicine preparation,which were developed by professor Zheng Yuling according to her clinical experience over 20 years.In this paper,we used DOL to assess the influence of QOL on patients with Esophageal Cancer by international current questionnaire module;and to evaluate the clinical effect by testing the AI before and after treatment.Through this paper we aim to offer the foundations for clinical using and extending this drug,and to explore a science,impersonality and feasible way for assessing effects of using Chinese traditional medicine to treat malignancy.Methods：60 cases esophageal cancer patient of middle stage and advanced stage were randomly divided into control group and treatment group.Treatment group patients were taked DOL 3 times every day and 10ml every time.One month was as a course of treatment,and the patients were observed for two courses.The control group patients were taked Tegafur 4 times every day and 200mg every time.One month is as a course of treatment,and the patients were observed for two courses.The change of lifequality of patients before and after one or two treatment courses were observed,respectively.EORTC QLQ-C30 （V3.0） was adopted to put up questionnaire investigate and kept the scores.The AI in blood serum was tested at the same time,and the change level was compared.All data expressed with mean±standard deviation,and was analysed by SPSS11.0 statistic software.Results：For QOL,the res ults showed that DOL group could obviously improve the scales in global health,each functional scales and subtotal symptom scales.There were significant differences before and after 1st or 2nd period of treatment（P0.05）;but the control group were not obviously change for the scales in global health,each functional scales and subtotal symptom scales.There were not significant differences before and after 1st、2nd period of treatments（P0.05）.Diarrhoea（DI） scales in control group was changed after 1st、2nd period of treatments compared with that before treatment,and there were significant differences（P0.05）.Between two groups there were significantly difference after 1st、2nd period of treatments （P0.05）,respectively,except few individual symptom scales which had a quite low before treatment.For AI,the DOL group were obviously improved after 1st、2nd period of treatments compared with that before treatment,resparately and there were significant differences（P0.05） between two groups.Conclusion：The study indicate that the Dougenguanshitong oral liquid can obviously improve the QOL and AI of EC patient in middle stage and advanced.
出处
《中医临床研究》
2011年第19期1-5,共5页
Clinical Journal Of Chinese Medicine
