健脾益肾颗粒治疗肺癌伴发贫血临床研究

【作者】 刘杰；

【导师】 陈信义；

【作者基本信息】 北京中医药大学 ， 中西医结合临床， 2006， 博士

【摘要】 癌症伴发贫血是指恶性肿瘤患者由于肿瘤本身或化疗、放疗等原因所导致的贫血,在肿瘤进展期发生率较高,如晚期肺癌患者贫血发生率可高达50%～60%。贫血不但降低肿瘤患者的生活质量,而且严重影响放化疗效果和预后。目前,输血和应用重组人红细胞生成素是治疗癌症伴发贫血的有效手段,然而疗效维持时间短,所带来的副作用以及高额费用限制了其临床应用。癌症伴发贫血属于中医“血虚”、“虚劳”等范畴,我们认为病机关键缘于脾肾亏虚,故确立健脾益肾、补气生血的治疗原则,并以健脾益肾颗粒为治疗药物,采用前瞻性、随机、平行对照方法,客观地评估了健脾益肾颗粒治疗肺癌伴发贫血的临床疗效。根据临床研究方案,在北京地区2家三级甲等医院,根据贫血严重程度、TNM分期、既往化疗周期数,按“不平衡指数最小的分配原则”对入选的肺癌伴发贫血患者进行随机化分组。2个疗程结束时,共收集有效病例60例,两组各30例。研究结果表明:①试验组中医症状总评分逐渐降低(P<0.001),显效20例(66.67%),有效8例(26.67%),无效2例(6.67%),有效率93.33%;对照组总评分治疗前后无显著差异(P>0.05),显效6例(20.00%),有效9例(30.00%),无效15例(50.00%),有效率50%。经MANOVA分析,两组中医症状总评分降低均呈曲线趋势,试验组降低较对照组明显(P<0.05);经Wilcoxon非参数检验,试验组中医症状有效率明显优于对照组(P<0.001)。②神疲乏力、食欲减退、食后腹胀、头晕耳鸣、面色无华主要单项症状,试验组治疗后较治疗前明显改善(P<0.05),对照组治疗前后未见明显变化(P>0.05),两组之间有显著差异(P<0.01)。③试验组Hb水平稳定(P>0.05),对照组Hb水平比治疗前明显下降(P<0.05),呈线性降低趋势。经MANOVA分析,Hb变化两组之间无显著性差异(P>0.05)。④两组RDW治疗后均较治疗前明显增高,经MANOVA分析,两组RDW增高均呈曲线趋势,对照组RDW增高较试验组明显(P<0.05)。⑤试验组MCH、MCV逐渐升高(P<0.05,P<0.01),RBC、MCHC、HCT治疗前后无显著差异(P>0.05);对照组MCH治疗后比治疗前明显降低(P<0.05),RBC、MCHC、MCV和HCT治疗前后比较均无显著性差异(P>0.05)。更多还原

【Abstract】 Cancer-related anemia results from malignant tumor,chemotherapy,radiotherapy and so on.It occurs in high probability,especially for the advanced stage.About 50% to 60% of advanced lung cancer may appear anemia.Not only cancer-related anemia can impair quality of life,but also it can badly influence curative effect and clinical prognosis.Both blood transfusion and recombination human erythropoietin are effective treatments.Nevertheless,their applications are restricted by the short duration,side effects and expensive cost.In traditional chinese medicine(TCM),cancer-related anemia belongs to the categories of“xue xu”(deficiency of blood),“xu lao”(consumptive diseases)and others.Deficiency of spleen ahd kindey is the main causation,according to which,strengthening the spleen,reinforcing the kidney,invigorating qi and nourishing blood is established as therapeutic principle.We accurately assessed the clinical effect of Jianpi Yishen granule in lung cancer patients suffering from cancer-related anemia by prospectively randomized control clinical trial.At the basis of project,60 cases were admitted in two first-grade,first-class Beijing hospitals from when two periods of treatment were finished.They were divided into two groups on principle of minimizing imbalance index in anemia degree,TNM grade and previous chemotherapy cycles.There were 30 patients in each group.Both groups subjected to necessary treatments including chemotherapy,radiotherapy and heteropathy.Only the treated group subjected to Jianpi Yishen granule.There are results following.①The grade of clinical symptoms falled gradually in treated group(P<0.001).20 of them showed significant improvement(66.67%),8 of them had response(26.67%)and the rest 2 cases were futile(6.67%).The response rate was 93.33%.At the same time,the control group made no difference after treatment(P>0.05).6 of them improved significantly(20.00%),9 of them had response(30.00%)and 15 cases were futile(50.00%).The response rate was 50%.It was concluded by multivariate analysis of variance(MANOVA)that the downtrend of grade was curve in two groups.Further more,the treated group descended excessively(P<0.05).Analysed by Wilcoxon nonparametric test,the response rate of clinical symptoms in the treated group remarkably excelled the control group(P<0.001).②The main symptoms include lack of vitality,lassitude,loss of appetite,abdominal distention,dizziness,tinnitus and dim complexion.The treated group improved prominently on every single symptom(P<0.05).Whereas,the control group do not have obvious change(P>0.05).There was significant difference between them(P<0.01).③The level of hemoglobin(Hb) keep stable in treated group(P>0.05)when linearly dropping in control group(P<0.05).MANOVA revealed that the change got no statistic significance between them(P>0.05).④Red blood cell volume distribution width(RDW)became larger in two groups.By MANOVA,we knew that更多还原