益气除痰法提高老年肺癌生存期的前瞻性研究及预后分析
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摘要
研究背景:肺癌是目前世界上发病率和病死率最高的癌症之一,每年世界范围内诊断的新病例超过了50万例,其中非小细胞肺癌(NSCLC)约占所有肺癌的80%～85%,而约有70%的NSCLC病人在确诊时已为晚期,失去了手术的机会,虽经积极治疗,其中位生存期仍为6～10个月。肺癌也是一种老年病,诊断时,患者年龄在65岁以上的比例超过60%,70岁以上者占30%。然而老年患者由于身体机能、社会、家庭及经济条件等多方面的原因,常得不到及时而有效的治疗,许多的临床研究也将老年肺癌患者排除在外,为晚期老年NSCLC患者寻找出合适有效的治疗方案成为摆在肿瘤学家面前的当务之急。
中医药治疗肺癌注重整体与局部的关系,通过扶正与祛邪相结合,辨病与辨证相统一的方法,达到稳定瘤体,延长生存期,提高生存质量的目的。一些临床研究表明,中医药治疗在提高中晚期NSCLC中位生存期方面与化疗相比有一定的优势。而老年肺癌患者体力状况差,合并症多,肝肾储备功能下降,难以耐受常规剂量的放化疗,故中医药在老年性肺癌的临床治疗中有广泛的应用前景。但是,通过对文献进行复习表明,即使中医药对老年肺癌的治疗研究,也仍处于被忽略的地位,临床报道较少。
中医认为,肺癌的发病,多因正气先虚,邪毒乘虚而入,致肺气闭郁,肃降无权,痰浊内生而成。肺癌的种种病状,皆因痰起,如咳嗽气促为痰湿壅肺,咳血胸痛为痰瘀搏结,淋巴结转移为痰核流窜皮下肌肤,脑转移为痰浊蒙蔽清窍,肺内结块,为痰瘀互结而成,故肺癌的治疗离不了治痰;治痰离不开健脾益气。根据中医对肺癌病因病机认识,结合老年肺癌的发病特点,拟用益气除痰法,按照中医肿瘤学的治疗特点,以中药辨证加辨病的方法,通过前瞻性多中心随机对照的研究方法,探索晚期老年NSCLC患者的有效治疗方法。
研究目的:以老年Ⅲ、Ⅳ期NSCLC作为研究对象,以提高中位生存期作为研究的主要目标,观察益气化痰法的治疗效果以及与化疗结合中的增效减毒作用,为中晚期老年NSCLC提供有效的治疗方案。
对象与方法:采用前瞻性多中心的随机对照试验设计,研究同时在六家医院进行,共纳.2002.01～2006.03期间以住院为主的Ⅲ-Ⅳ期老年NSCLC病人124例,其中中医组46例,中西医组40例,西医组38例。中医组采用辨病与辨证相结合的治疗方法。辨病治疗采用鹤蟾片加参一胶囊;辨证治疗按照肺郁痰瘀、脾虚痰湿、阴虚痰热、气阴两虚四种中医证型予相应汤剂治疗,治疗一个月为一个疗程,共3个疗程。中西医组中医治疗同中医组方案,西医治疗化疗同西医组。西医组,化疗方案为含铂方案,选用NP、GP、TP或DP方案治疗,每21天为一个周期,共4个周期。首要终点指标是生存期和生存质量,其它指标包括疾病进展时间、肿瘤缓解、症状改善、体重变化等。
结果:三组中位生存期比较,以中医组最长(310天),其次为中西医组(292天),
Background:Lung cancer is the most familiar malignant carcinoma, it ranks first in the incidence and mortality. Every year, there are over 500,000 new cases of lung cancer all over the world, about 80% ~ 85% of them is non-small-cell lung cancer (NSCLC), and about 70% of these cases are advanced NSCLC when diagnose, most of them lose the opportunities for resection, the prognosis of these cases are poor, the median suvival is 6—10 months even accept the most active treatment. NSCLC also may be considered typical of advanced age. More than 60% of NSCLC patients are diagnosed at > 65 years of age and approximately one-third of all patients are > 70 years of age. However, elderly always cannot receive the best treatment in time due to the physical hypofunction, society, family and economic condition. Actually, many studies exclude elderly patients, so find a feasible and effective treatment for elderly NSCLC is the most important for oncologist.Treatment of TCM pay attention to the correlation of whole and local, it' s theory combine supporting "Zheng" and lustrating "Xie ";unify "differentiation of disease" and "differentiation of symptoms" . Treatment of TCM can steady the tumour, prolong the survival and improve the quality of life(QOL). Some clinical studies show that Treatment of TCM has advantage in prolonging the survival compared with chemotherapy in patients of NSCLC. Elderly patients tolerate standard chemotherapy and radiotherapy poorly compared with their younger counterpart because of the progressive reduction of organ function and comorbidities related to age. For this reason, there is much hope for TCM used in elderly NSCLC. However, there is few report about elderly NSCLC treated with TCM, it should be arouse the attention.It is considered in TCM that the cause of the lung cancer due to the
deficiency of the Healthy Energy, so that the body is exposed to the evils, lead inaction and sluggishness of lung-energy, accumulation of phlegm-wetness in the lung. Many symptoms of lung cancer is caused by phlegm. For example, cough and dyspnea is caused by stagnation of phlegm-wetness in lung;emptysis and pain is caused by the retention of phlegm and blood, metastasis of lymphanode is caused by the phlegm-retention in the subcutaneous;metastasis of brain is caused by phlegm which beclouds orifices;accour of tumour in lung is caused by the retention of phlegm and blood. So dealing with the phlegm is the most important in the treatment of NSCLC by TCM, and invigorating the spleen and Benefiting Vital Energy is a primary way in dealing with the phlegm. According to the cognition of lung cancer' s cause and pathogenesis, combine the characteristic of elderly lung cancer, we plan to treat them by "Benefiting Vital Energy and Eliminating Phlegm" of TCM base on "differentiation of disease" and "differentiation of symptoms" . We perform a prospective multicenter randomized trial to search the optimal treatment strategy for elderly patients with advanced NSCLC.Purpose: To evaluate response, survival, quality of life(QOL) and tolerability in patients with advanced-stage (HJ/IV) elderly NSCLC receiving "Benefiting Vital Energy and Eliminating Phlegm" of TCM therapy, and to observe the effect of reducing toxicity and increasing efficacy by combine with chemotherapy. To search the optimal treatment strategy for elderly patients with advanced NSCLC.Patients and Method: The prospective trial is performed in six hospitals at the same time. Between Sept 2003 and Mar 2006, 124 patients with a histologically confirmed diagnosis of stage EH/IV NSCLC were enrolled. Thereinto, 46 patients receive treatment of TCM (group I), 40 patients receive combined treatment of TCM and chemotherapy(group II), 38 patients receive chemotherapy only(group HJ). Project for group I : with combination of syndrome differentiation and disease differentiation, Hechan tablets and Shenyi capsules were used according to disease differentiation, and different decoctions were determined from four patterns: phlegmatic stagnation due to passive congestion of lungs(FYTY), phlegmatic hygrosis dueto spleen asthenia(PXTS), yin-deficiency and phlegmopyrexia(YXTR) and deficiency of both qi and yin(QYLX) according to syndrome diffentiation, and the period of treatment was three courses, 1 month per course. Project for group II: the
treatment of TCM is the same as group TCM, chemotherapy is the same as group western medicine. Project for group Ed: Platinum-based chemotherapy were used, either NP/GP/TP/DP regimen was adopted, and were repeated every 21days, 3 times. The primary end point wais survival and QOL, the other end points included time to disease progression(TTP), tumor response rate, symptoms improvement, weight change etc..Result: The median survival time of three group were group I 310 days, group II 292 days and group HI 177 days, with a 1-year survival rate of 39. 71%> 32.33% and 22.87%(P=0. 0052), respectively. TTP of three group were groupI 183 days, group II182 days, group HI 122 days respectively, there were no statistical significance between three groups.The COX regression analysis involve 12 covariates: treatment, sex, course of diseases, location of tumour, stage, statas of metastasis, TCM syndrome differentiation, treatment used have received, Carcinoembryonic antigen(CEA), performance status(PS), weight, symptoms before treatment.The result showed that independent prognosis factors included performance status (PS), treatment, course of diseases and location of tumour.The result of QOL show that TCM and treatment integrating TCM and Western medicine can improve the QOL of advanced elderly NSCLC in physical> emotionaK functional and additional concerning domain.Tumor response rate(CR+PR) were 4.3% of group I, 22.5% of group II, 13. 2% of group m(P=0. 043);The disease control rate were 76. l%of group I, 77. 5%of group II, 63. 2%of group HI;there were no statistical significance between three groups.Performance status improvement compared shows that both group I and groupII are better than group III, there were statistic significance between three groups. Body weight changes compared, patients of weight loss ^ 5 % increased with disease history grow, the change of the body weight is slight through out the process in group I and group II, but the weight lose significant along with the process, group I and group II can also improve the clinical symptoms related to the carcinoma, especially for fatigue^ appetites thirstiness. This suggested that TCM treatment could keep body weight well.No severe adverse events had been observed in the trial. Much fewer hematologic toxicities were reported in group I than group II and group HI.
Conclusions: The treatment of TCM can extends the over all survival, improve the QOL of elderly patients with advanced NSCLC in a poor condition, and it seems can reduce the toxicities of chemotherapy.The treatment of TCM seems preponderant on improving the clinical symptoms and steadying tumours and weight.The treatment of TCM can be recommended as a feasible treatment strategy for elderly patients with advanced NSCLC, and "Benefiting Vital Energy and Eliminating Phlegm" can be considered as a primary therapeutic principle of TCM.
中医药治疗肺癌注重整体与局部的关系,通过扶正与祛邪相结合,辨病与辨证相统一的方法,达到稳定瘤体,延长生存期,提高生存质量的目的。一些临床研究表明,中医药治疗在提高中晚期NSCLC中位生存期方面与化疗相比有一定的优势。而老年肺癌患者体力状况差,合并症多,肝肾储备功能下降,难以耐受常规剂量的放化疗,故中医药在老年性肺癌的临床治疗中有广泛的应用前景。但是,通过对文献进行复习表明,即使中医药对老年肺癌的治疗研究,也仍处于被忽略的地位,临床报道较少。
中医认为,肺癌的发病,多因正气先虚,邪毒乘虚而入,致肺气闭郁,肃降无权,痰浊内生而成。肺癌的种种病状,皆因痰起,如咳嗽气促为痰湿壅肺,咳血胸痛为痰瘀搏结,淋巴结转移为痰核流窜皮下肌肤,脑转移为痰浊蒙蔽清窍,肺内结块,为痰瘀互结而成,故肺癌的治疗离不了治痰;治痰离不开健脾益气。根据中医对肺癌病因病机认识,结合老年肺癌的发病特点,拟用益气除痰法,按照中医肿瘤学的治疗特点,以中药辨证加辨病的方法,通过前瞻性多中心随机对照的研究方法,探索晚期老年NSCLC患者的有效治疗方法。
研究目的:以老年Ⅲ、Ⅳ期NSCLC作为研究对象,以提高中位生存期作为研究的主要目标,观察益气化痰法的治疗效果以及与化疗结合中的增效减毒作用,为中晚期老年NSCLC提供有效的治疗方案。
对象与方法:采用前瞻性多中心的随机对照试验设计,研究同时在六家医院进行,共纳.2002.01～2006.03期间以住院为主的Ⅲ-Ⅳ期老年NSCLC病人124例,其中中医组46例,中西医组40例,西医组38例。中医组采用辨病与辨证相结合的治疗方法。辨病治疗采用鹤蟾片加参一胶囊;辨证治疗按照肺郁痰瘀、脾虚痰湿、阴虚痰热、气阴两虚四种中医证型予相应汤剂治疗,治疗一个月为一个疗程,共3个疗程。中西医组中医治疗同中医组方案,西医治疗化疗同西医组。西医组,化疗方案为含铂方案,选用NP、GP、TP或DP方案治疗,每21天为一个周期,共4个周期。首要终点指标是生存期和生存质量,其它指标包括疾病进展时间、肿瘤缓解、症状改善、体重变化等。
结果:三组中位生存期比较,以中医组最长(310天),其次为中西医组(292天),
Background:Lung cancer is the most familiar malignant carcinoma, it ranks first in the incidence and mortality. Every year, there are over 500,000 new cases of lung cancer all over the world, about 80% ~ 85% of them is non-small-cell lung cancer (NSCLC), and about 70% of these cases are advanced NSCLC when diagnose, most of them lose the opportunities for resection, the prognosis of these cases are poor, the median suvival is 6—10 months even accept the most active treatment. NSCLC also may be considered typical of advanced age. More than 60% of NSCLC patients are diagnosed at > 65 years of age and approximately one-third of all patients are > 70 years of age. However, elderly always cannot receive the best treatment in time due to the physical hypofunction, society, family and economic condition. Actually, many studies exclude elderly patients, so find a feasible and effective treatment for elderly NSCLC is the most important for oncologist.Treatment of TCM pay attention to the correlation of whole and local, it' s theory combine supporting "Zheng" and lustrating "Xie ";unify "differentiation of disease" and "differentiation of symptoms" . Treatment of TCM can steady the tumour, prolong the survival and improve the quality of life(QOL). Some clinical studies show that Treatment of TCM has advantage in prolonging the survival compared with chemotherapy in patients of NSCLC. Elderly patients tolerate standard chemotherapy and radiotherapy poorly compared with their younger counterpart because of the progressive reduction of organ function and comorbidities related to age. For this reason, there is much hope for TCM used in elderly NSCLC. However, there is few report about elderly NSCLC treated with TCM, it should be arouse the attention.It is considered in TCM that the cause of the lung cancer due to the
deficiency of the Healthy Energy, so that the body is exposed to the evils, lead inaction and sluggishness of lung-energy, accumulation of phlegm-wetness in the lung. Many symptoms of lung cancer is caused by phlegm. For example, cough and dyspnea is caused by stagnation of phlegm-wetness in lung;emptysis and pain is caused by the retention of phlegm and blood, metastasis of lymphanode is caused by the phlegm-retention in the subcutaneous;metastasis of brain is caused by phlegm which beclouds orifices;accour of tumour in lung is caused by the retention of phlegm and blood. So dealing with the phlegm is the most important in the treatment of NSCLC by TCM, and invigorating the spleen and Benefiting Vital Energy is a primary way in dealing with the phlegm. According to the cognition of lung cancer' s cause and pathogenesis, combine the characteristic of elderly lung cancer, we plan to treat them by "Benefiting Vital Energy and Eliminating Phlegm" of TCM base on "differentiation of disease" and "differentiation of symptoms" . We perform a prospective multicenter randomized trial to search the optimal treatment strategy for elderly patients with advanced NSCLC.Purpose: To evaluate response, survival, quality of life(QOL) and tolerability in patients with advanced-stage (HJ/IV) elderly NSCLC receiving "Benefiting Vital Energy and Eliminating Phlegm" of TCM therapy, and to observe the effect of reducing toxicity and increasing efficacy by combine with chemotherapy. To search the optimal treatment strategy for elderly patients with advanced NSCLC.Patients and Method: The prospective trial is performed in six hospitals at the same time. Between Sept 2003 and Mar 2006, 124 patients with a histologically confirmed diagnosis of stage EH/IV NSCLC were enrolled. Thereinto, 46 patients receive treatment of TCM (group I), 40 patients receive combined treatment of TCM and chemotherapy(group II), 38 patients receive chemotherapy only(group HJ). Project for group I : with combination of syndrome differentiation and disease differentiation, Hechan tablets and Shenyi capsules were used according to disease differentiation, and different decoctions were determined from four patterns: phlegmatic stagnation due to passive congestion of lungs(FYTY), phlegmatic hygrosis dueto spleen asthenia(PXTS), yin-deficiency and phlegmopyrexia(YXTR) and deficiency of both qi and yin(QYLX) according to syndrome diffentiation, and the period of treatment was three courses, 1 month per course. Project for group II: the
treatment of TCM is the same as group TCM, chemotherapy is the same as group western medicine. Project for group Ed: Platinum-based chemotherapy were used, either NP/GP/TP/DP regimen was adopted, and were repeated every 21days, 3 times. The primary end point wais survival and QOL, the other end points included time to disease progression(TTP), tumor response rate, symptoms improvement, weight change etc..Result: The median survival time of three group were group I 310 days, group II 292 days and group HI 177 days, with a 1-year survival rate of 39. 71%> 32.33% and 22.87%(P=0. 0052), respectively. TTP of three group were groupI 183 days, group II182 days, group HI 122 days respectively, there were no statistical significance between three groups.The COX regression analysis involve 12 covariates: treatment, sex, course of diseases, location of tumour, stage, statas of metastasis, TCM syndrome differentiation, treatment used have received, Carcinoembryonic antigen(CEA), performance status(PS), weight, symptoms before treatment.The result showed that independent prognosis factors included performance status (PS), treatment, course of diseases and location of tumour.The result of QOL show that TCM and treatment integrating TCM and Western medicine can improve the QOL of advanced elderly NSCLC in physical> emotionaK functional and additional concerning domain.Tumor response rate(CR+PR) were 4.3% of group I, 22.5% of group II, 13. 2% of group m(P=0. 043);The disease control rate were 76. l%of group I, 77. 5%of group II, 63. 2%of group HI;there were no statistical significance between three groups.Performance status improvement compared shows that both group I and groupII are better than group III, there were statistic significance between three groups. Body weight changes compared, patients of weight loss ^ 5 % increased with disease history grow, the change of the body weight is slight through out the process in group I and group II, but the weight lose significant along with the process, group I and group II can also improve the clinical symptoms related to the carcinoma, especially for fatigue^ appetites thirstiness. This suggested that TCM treatment could keep body weight well.No severe adverse events had been observed in the trial. Much fewer hematologic toxicities were reported in group I than group II and group HI.
Conclusions: The treatment of TCM can extends the over all survival, improve the QOL of elderly patients with advanced NSCLC in a poor condition, and it seems can reduce the toxicities of chemotherapy.The treatment of TCM seems preponderant on improving the clinical symptoms and steadying tumours and weight.The treatment of TCM can be recommended as a feasible treatment strategy for elderly patients with advanced NSCLC, and "Benefiting Vital Energy and Eliminating Phlegm" can be considered as a primary therapeutic principle of TCM.
引文
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