健脾补肾祛瘀解毒法联合热疗、化疗治疗晚期结直肠癌的临床研究
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摘要
背景
     晚期结直肠癌最主要的治疗手段为以化疗为主的综合治疗,化疗对于提高患者生存期、减少复发、改善生存质量具有重要意义。但是,化疗药物治疗结直肠癌,在杀伤癌细胞的同时,对于人体的某些正常组织器官细胞也会有一定的损害,由于化疗引起严重的毒副反应,使患者难以承受,甚至被迫中止治疗,在一定程度上影响了化疗疗效的提高。值得欣喜的是,近几十年来,中医药在化疗的增效和减毒方面取得了长足的进展,充分发挥了中医中药在化疗的增效和减毒方面的积极作用。而提高肿瘤患者的生存质量亦成为研究热点。
     热疗属于物理治疗,其治疗肿瘤已广泛应用于临床,成为继外科、放疗和免疫生物疗法之后的重要治癌手段。局部热疗方法简便,副作用较小,患者容易接受。且治疗过程短,医护人员实施也很方便。
     目的
     研究各种综合疗法在晚期结直肠癌患者的作用,临床中合理使用各种综合疗法,选择最佳方案,对于提高肿瘤患者的生存期和生存质量,有重要的临床意义。本研究通过观察患者经治疗前后瘤体变化、症状评分、生活质量等评分的变化,进行统计分析,以此评价中医药联合热疗、化疗综合治疗晚期结直肠癌的疗效以及生活质量等的影响。
     方法
     选择符合纳入标准的60例确诊的晚期结直肠癌患者,以就诊的序号查随机数字表分为两组,分别为常规治疗组(中药+化疗组)以及联合治疗组(中药+化疗+热疗组),每组病例30例。所有患者均采用标准的FOLFOX6、XELOX或FORFIRI、XELIRI等方案化疗6周期,热疗组患者隔日热疗一次,连作2周,为一疗程,与化疗同时执行治疗。治疗前后评估一般情况、瘤体变化、生活质量评分变化、证侯改善情况、K氏评分、治疗后不良反应等。进行统计分析,观察健脾补肾祛瘀解毒中药联合热疗、化疗治疗晚期结直肠癌的疗效及其对生存质量等的改善情况。
     结果
     1.患者一般资料
     收集2009年9月至2010年12月期间在广东省中医院住院治疗的晚期结直肠癌患者共64例,其中脱落4例,完成研究共60例。常规组30例,联合治疗组30例。两组患者治疗前的一般资料、肿瘤情况、生存质量评分均无统计学意义(P>0.05),具有可比性。
     2.治疗后临床疗效以及生存质量比较
     在近期疗效方面,60例病人的目标病灶分别经不同的方案治疗后,联合治疗组疾病控制率(DCR=(CR+PR+SD)/(CR+PR+SD+PD)×100%)为83.3%,客观缓解率(ORR=(CR+PR)/(CR+PR+SD+PD)×100%)为23.3%;对照组分别为53.3%、10.0%,经统计比较差异性具有统计学意义(P<0.05)。15例合并腹腔积液患者经治疗后有3例可完全缓解(CR),6例可达到部分缓解(PR),4例稳定(SD),2例进展(PD),有效率为60%。
     在远期疗效比较方面,治疗组TTP为9.3个月,对照组为6.2个月,两组患者的差异有统计学意义(P<0.05)。
     在功能状态评分方面,治疗后对两组的FACT-C评分、K氏评分、中医证候积分进行分析,两组功能状态评分均有所提高,而联合治疗组相比对照组生活质量改善更明显,其差异有统计学意义(P<0.05)。大肠癌患者生存质量测定量表(FACT-C)反映,在躯体状况、社会/家庭情况、情感状况、功能情况、量表总分情况上,联合治疗组均较常规治疗组明显提高。其中在改善躯体状况和情感状况方面优势更为明显(P<0.05)。
     在不良反应方面,治疗组与对照组不良反应均较轻。两组毒副作用无明显差异。
     结论
     1.热疗联合化疗、中医药治疗,在近期疗效方面,疾病控制率、总有效率等方面较单纯化疗、中医药治疗组治疗效果好,且能控制恶性腹水生成。
     2.热疗联合化疗、中医药治疗对晚期结直肠癌远期疗效方面,在瘤体的稳定上有积极的作用,在疾病进展时间方面效果占优。
     3.热疗联合化疗、中医药治疗能提高患者生存质量,在躯体、社会/家庭情况、情感状况、功能情况、疼痛症状的改善程度比单纯化疗、中医药治疗疗效更明显。
     4.联合治疗对提高肿瘤患者的卡氏评分有协同作用,明显改善了肿瘤患者的中医证侯评分,降低了肿瘤标志物和疼痛评分,稳定体重,治疗前后血常规、血肝肾功能无明显变化。提示热疗+化疗+中药治疗适合晚期转移性结直肠癌患者,可以较好改善患者生活质量,安全性好。健脾补肾祛瘀解毒法联合热疗、化疗是晚期结直肠癌较好的治疗方案,值得在临床上推行运用。
Background
     The most important treatment of advanced colorectal cancer is the chemotherapy-based comprehensive therapy. Chemotherapy plays a vital role in improving survival of patients, reducing recurrence and improving the quality of life. However, it also has some damage to the normal tissues and organs at the same time due to the serious side effects. A part of patients can' t bear or even forced to suspend treatment, that would affect the efficiency of chemotherapy to a certain extent. In recent decades, TCM has played a positive role in improving effect and decreasing toxicity made considerable progress. And now improve the quality of life of cancer patients has become a hot topic.
     Hyperthermia is physical therapy, which has been widely used in clinical treatment of cancer. Local hyperthermia is simple, with fewer side effects, patients would easily accept. And the short course is also very convenient for the doctors and nurses.
     Objective
     Choosing the best option and rational use of a variety of combination therapy to improve survival of patients and quality of life is very necessary and with important clinical significance. In this study, the changes in the tumor before and after treatment, symptom scores, quality of life score changes would be observed.The efficacy and quality of life with combined therapy would be evaluated by statistical analysis in order to explore the effect of the TCM combined with hyperthermia and chemotherapy treatment of advanced colorectal cancer.
     Method
     60 cases of lung cancer patients diagnosed by pathology in line with the standards would be chosen for the research. Then the patients would be randomly divided into two groups by their out-patient serial number for 30 cases of each group. All patients were treated with 6 cycles of the standard FOLFOX, XELOX, FORFIRI, or XELIRI chemotherapy and other programs, Hyperthermia would be given each two days and last for two weeks for a course of treatment with the implementation of the cycle of chemotherapy. Before and after 6 cycles tumor changes would be reviewed, each patient would be evaluated including their symptoms, KPS score, the scale of QOL, the changes in the main disease, and adverse reactions of treatment. Then take a statistical analysis for the indicators above-mentioned.
     Result
     1. General data
     From September 2009 to December 2010,64 cases in Guangdong Province hospital of TCM were enrolled in the study. There were 4 patients fell off,60 patients finished.30 patients were randomly assigned to the treat group, and 30 patients were randomly assigned to the control group. There was no statistically significant in general information, tumor status, quality of life scores(P>0.05). Data of two groups was comparable.
     2. Clinical efficacy and changes of quality of life
     Compared with the short term efficacy, the ORR was 23.3 percent and the DCR was 83.3 percent in treat group while control group were 10.0 percent and 53.3 percent after the patients underwent different treatment the statistical comparisons were statistically significant differences (P<0.05). There were
     3 cases reached complete after treatment, while 6 cases reached partial remission,4 cases stable disease and 2 cases progression disease in 15 cases of patients with ascites.
     Comparison of long-term efficacy in the treatment group TTP was 9.3 months in the while the control group was 6.2 months, two groups were significantly (P<0.05).
     For the functional status score, the FACT-C score, KPS score, analysis of TCM syndrome score were improved after different treatment in both group. The quality of life was improved more obvious in the combined treatment group compared with the control group and the difference was statistically significant (P<0.05). Quality of life for colorectal cancer questionnaire (FACT-C) reflected that the combined treatment group improved significantly in the situation in the physical, social/family situation, emotional condition, functional condition, total scale of the situation compared with the control group, and improved the physical condition and emotional status of advantage is more obvious (P<0.05).
     Adverse response in both group was less and no significant difference between two groups of side effects.
     Conelusion
     1. Compared with chemotherapy& TCM treatment, hyperthermia combined with chemotherapy& TCM treatment showed dominant curative effect on the DCR, ORR and the control of malignant ascites for advanced colorectal cancer.
     2. Hyperthermia combined with chemotherapy& TCM treatment played a positive role on the long term effectiveness,such as the stability of the tumor, showed dominant effect on TTP.
     3. The improvement of hyperthermia combined with chemotherapy &TCM is more evident in the patients'quality of life in the physical, social/family situation, emotional status, function, pain symptom than chemotherapy &TCM therapy alone.
     4. Combined treatment significantly had the synergistic effect on KPS, it improved the TCM symptoms, decreased the tumor markers and stabilized the weights. There was no significant changes in blood test, liver and kidney function before and after treatment. Hyperthermia combined with chemotherapy plus TCM treatment is suit for advanced metastatic colorectal cancer with better effect and safety. Combined treatment is a better solution, it is worth implementing in clinical use.
引文
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