摘要
背景:进行性体质量减轻和体力下降是晚期恶性肿瘤常见的并发症,是影响患者生活质量的一个重要因素。目的:探讨中药复方益气消症冲剂配合应用抗肿瘤药物治疗(化疗)对于晚期恶性肿瘤治疗效果及生活质量的影响。设计:随机对照观察。单位:北京大学临床肿瘤学院。对象:选择1999-06/2002-03在北京肿瘤医院中西医结合病房住院治疗的晚期肺癌、乳腺癌或肠癌患者61例。方法:将61例恶性肿瘤患者随机分为治疗组(中药复方益气消症冲剂加化疗)34例,对照组(单纯化疗)27例,观察两组疗效、带瘤生存时间及生活质量的不同。两组疗效比较按照世界卫生组织制定的实体瘤临床疗效标准:完全缓解,部分缓解,稳定,进展。对治疗前与治疗两个疗程后两组患者进行影像学检查,评价疗效。体力分级根据美国东部肿瘤协作组评定标准,对两组治疗前后进行分级,治疗后分级下降者为改善,分级上升者为加重。主要观察指标:①两组患者的治疗效果比较。②带瘤生存时间比较。③治疗前后的体力状况及气虚症状变化。结果:61例患者均进入结果分析。①两组疗效比较:治疗组有效率高于对照组(两组部分缓解率、稳定率及进展率分别为36%,7%;52%,67%;12%,26%,P<0.05)。②带瘤生存时间比较:截止至2002-03,治疗组平均带瘤生存时间大于对照组[(20.73±19.74),(11.93±5.08)个月,P<0.05]。③体力分级:治疗组治疗后体力分级状况好于对照组[治疗组改善9例(26%),稳定25例(74%),加重0例;对照组改善1例(4%),稳定25例(93%),加重1例(4%),P<0.05]。④中医气虚症状变化比较:治疗前后比较两组气虚症状,治疗组具汗出气短,少气懒言,倦怠乏力等症状明显减少(治疗前后分别为20,9;17,9;20,13例),对照组则稳定或增加(治疗前后分别为13,13;14,17;18,20例)。结论:益气消症冲剂配合化疗治疗晚期恶性肿瘤与对照组相比不仅可提高疗效,还可以改善生活质量,延长带瘤生存时间。
BACKGROUND： Progressive body mass losses and physical strength decrease are common complications of malignant tumors, and they are important factors that affect the quality of life of the patients. OBJECTIVE： To probe into the curative effect of a Chinese herbal compound Yiqi Xiaozheng granules combined with antitumor drugs in the treatment of malignant tumors and its effect on the quality of life. DESIGN： A randomized controlled observation. SETTING：Clinical Tumor College of Peking University. PARTICIPANT： Totally 61 patients with malignant pulmonary carcinoma, breast or intestinal carcinoma hospitalized in the Wards of Integrated Traditional Chinese and Western Medicine of Beijing Cancer Hospital from June 1999 to March 2002 were recruited. METHODS： Altogether 61 cases of malignant tumor were randomized into the treatment group （treated with Chinese herbal compound Yiqi Xioozheng granules supplemented with chemotherapy）（n=34） and the control group （treated with only chemotherapy was used）（n=27）. The difference in curative effect, survival period with tumor and the quality of life of the two groups were observed. The comparison of the curative effects of the two groups was performed according to Clinical Curative Effect Criteria for Solid Tumors stipulated by World Health Organization： completely response, partly response, stable disease, and progressive disease. X-ray examination was performed on the patients before the therapy and two courses of treatment after the therapy to evaluate the curative effect. Physical strength grading was made according to the evaluation criteria of Eastern Oncology Cooperative Group of the United States. The two groups were graded before and after the treatment. The group with decreased grade after the treatment was considered to be improving, but the group with increased grade after the treatment was considered to be worsening. MAIN OUTCOME MEASURES： ①Comparison of the curative effects of the patients between the two groups; ②Comparison of the survival periods with tumors; ③Changes of physical strength and qi-deficiency symptom before and after therapy RESULTS： Sixty-one patients entered the stage of result analysis. ① Comparison of the curative effect of the two groups ： The cure rate of the treatment group was higher than that of the control group （partial response rate, stability rate and progression rate of the two groups was 36% ,7% ;52%, 67%;12%,26% respectively, P 〈 0.05）. ②Comparison of the period of survival with tumors： The mean period of survival with tumors of the treatment group was longer than that of the control group until March 2002 [（20.73±19.74）, （ 11.93±5.08）months,P 〈 0.05].③ Physical strength grading： Physical strength grading status was better after the therapy in the treatment group than that in the control group [In the treatment group, 9 cases （26%）were ameliorated, 25 （74%）appeared stable , none was aggravated; in the control group, 1 case （4%） was ameliorated, 25（93%） appeared stable and 1（4%） was aggravated, P 〈 0.05]. ④Comparison of the changes of qi-deficiency symptoms in traditional Chinese medicine before and after the treatment between the two groups. Symptoms such as sweating and qi deficiency manifested as disclination to talk, listlessness, debility, etc. were significantly reduced in the treatment group （The numbers of cases before and after the treatment were 20, 9; 17,9; 20,13 respectively）. In the control group, the cases either were stable or showed an increase in symptoms（There were 13, 13; 14, 17; 18, 20 respectively before and after treatment）. CONCLUSION： Compared with the control group, in the treatment of malignant tumors, Yiqi Xiaozheng granules supplemented with chemotherapy not only enhanced curative effect, but also improved the quality of life and prolonged the period of survival with tumors.
出处
《中国临床康复》
CSCD
北大核心
2005年第30期209-211,共3页
Chinese Journal of Clinical Rehabilitation
基金
北京市科委重大科技资助项目(95402280)~~
