榄香烯注射液合并放疗对非小细胞肺癌脑转移患者的临床研究
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摘要
我国肺癌的发病率逐年上升,在男性肿瘤中占第一位,女性肿瘤中占第三位。肺癌中约有80%的为非小细胞肺癌(NSCLC), NSCLC脑转移的总发生率为20%,尸检发生率为40%。相关文献报道脑转移的发生率在癌症中占25%—35%,其中来自肺癌的为50%,乳腺癌的为20%,其次为胃肠癌、恶性黑色素瘤。肺癌脑转移患者已属晚期癌症,以现代的医学条件,癌症是不能根治的,但是提高晚期癌症患者的生活质量、延长晚期癌症患者的生存期变成现代医学的发展模式和要求。西医的高强度、大剂量、长周期的治疗使患者苦不堪言。许多患者承受着身体和精神的双重折磨。此时,中医中药在配合西医的辅助治疗和晚期癌症患者的主要治疗发挥着重要的作用。祖国医学历史悠久,经验丰富,它治疗的宗旨是调动全身机体正气以抵御外邪,从而辨证对症治疗疾病所在。中药制剂的现代药物学研究的发展,为中医药在今后发展提供了条件。榄香烯乳是从中药莪术中提取的抗癌药物,祖国医学认为,莪术性温味苦,有行气破血,消积止痛和抗肿瘤的功效。临床实践证明,榄香烯注射液可以减轻西医治疗带来的不良反应及改善和提高癌症患者的生活质量。本研究是采用随机对照前瞻性临床研究方法,将榄香烯注射液合并放疗,证明可以短期内改善患者的临床症状、提高患者的生活质量。
目的：观察榄香烯注射液合并放疗对非小细胞肺癌脑转移患者的临床疗效,研究榄香烯注射液对患者部分症状、卡氏评分、生活质量及减轻放疗引起的不良反应的影响。
方法：研究运用现代循证医学理论指导,采用随机对照方法,具体采用随机表分组,做前瞻性临床研究,按照诊断标准、纳入、排除、脱落标准,对我院及外院住院患者随机分组,分为治疗组和对照组。两组基础治疗均为单纯全脑放疗(40Gy/20f/4W),治疗组即在全脑放疗同时加入榄香烯注射液的静滴(400～600mg/日、两周),对照组不做任何中医药的干预。观察两组患者的脑转移瘤的客观疗效、卡氏评分变化、临床症状改善、生活质量的提高及不良反应。
结果：通过2010年3月至2011年3月这段期间,一共有60例患者顺利完成本研究,其中对照组30例、治疗组30例。榄香烯注射液合并全脑放疗与单纯全脑放疗相比,两组放疗前后转移瘤的客观疗效,治疗组30例中,有效率为30%；对照组30例中,有效率为20%。治疗组优于对照组,但无明显统计学差异。在卡氏评分评价：治疗组30例中,有效率为43.33%,对照组30例中,有效率为13.33%,两组治疗后卡氏评分评价治疗组明显优于对照组,两组比较有统计学差异(P<0.05)。临床总症状改善：治疗组症状改善平均为53.49%±10.98%；对照组症状改善平均为50.37%±12.45%,治疗组明显优于对照组,经统计学分析有差异(P<0.05)。两组各个症状的有效率在气短、咳嗽、咳痰、乏力、胸闷胸痛、头痛头晕经统计学分析有明显差异性(P<0.05)；在失语、半身不遂、神智障碍、癫痫发作、智力障碍、视力改变、感觉障碍、性格行为的改变经统计学分析无明显差异性(P>0.05)。生活质量提高方面：治疗后两组量表总分(TOTAL):治疗组为94.823±5.604、对照组为87.545±8.006,治疗组优于对照组,有统计学差异(P<0.05)。两组在生理状况(PWB)、社会/家庭状况(SFWB)、情感状况(EWB)、功能状况(FWB)、经统计学比较均有差异(P<0.05),根据均值大小可知治疗组优于对照组；两组在肺癌附加的关注(LCS)经统计学分析无差异(P>0.05)。不良反应方面,经统计学分析可知,脱发、血色素、血小板两组经统计学分析无明显差异(P>0.05),WBC下降方面有统计学差异(P<0.05),即治疗组优于对照组(P>0.05)。
结论：
1.榄香烯注射液合并全脑放疗与单纯全脑放疗相比,可以提高患者的卡氏评分。
2.榄香烯注射液合并全脑放疗与单纯全脑放疗相比,可以改善患者某些的临床症状。
3.榄香烯注射液合并全脑放疗与单纯全脑放疗相比,可以较好的提高患者的生活质量。
4.榄香烯注射液合并全脑放疗与单纯全脑放疗相比,可以有效的减少放疗引起的不良反应。
As the incidence rate of lung cancer rising, in the male rate of tumor,which is the first,and in the female of tumor is the third.There is no small cell lung cancer,with its incidence of about 80%, brain metastasis is 20% of NSCLC, which is the 40% in autopsy. Some literatures report the incidence rate of brain metastasis is 25%—35% in the tumor,which comes from lung cancer is 50%, breast cancer is 20%,next to the gastrointestinal Cancer and malignant melanoma. The brain metastasis patients already belong to advanced stage,which can not cure,so we improve the cancer patients quality of life and extend their life span to accommodate the development patterns and requirement of the Modern Medicine.The treatment of modern medicine is high intensity、large dose and long period, which makes the patients painful beyond description.Many patients bear the double pain of spirit and body.At the same time,the assistance therapy of the traditional chinese medicine and the major therapy of the modern medicine all educe significant action.The traditional Chinese medicine have long history, plenty experiences,because it can remove our resistance to resist diseases. With the chinese medicinal pharmaceutics developing in the study of the modern de materia medica,which provides condition for the traditional Chinese medicine in the future. The Elemenum Emulsion is abstracted of blue turmeric rhizome who is a anticancer drug. Chinese medicinal think it is warm and bitter,which resists cancer. The clinic practice demonstrate that The Elemenum Emulsion can lessen adverse reaction and improve the quality of lives for cancer patients.This study adopted randomized control trials and prospective clinical research method,and combined the Elemenum Emulsion with radiotherapy to improve the clinic symptoms for patients and boost the quality of lives.
Objective:To observe the clinical efficacy of the combination of the Elemenum Emulsion with radiotherapy for brain metastasis of NSCLC. We research the Elemenum Emulsion may improve some symptoms、boost KPS、improve the quality of lives and lessen adverse reaction,which is caused by radiotherapy.
Methods:Research is guiding the use of modern evidence-based medicine, randomized controlled method, specific groups by random table, do prospective clinical study, in accordance with the diagnostic criteria, inclusion, exclusion, falling standards of our hospital and the Sino-Japanese Friendship Hospital were randomly assigned divided into treatment and control groups.The two groups both adopte modern therapy which is simple radiotherapy of the whole brain(40gy/20f).The treatment group which added the Elemenum Emulsion by intravenous drip infusion at the same time(400—600mg/day two weeks),and the control group does not any intervention.To observe the clinical efficacy of the two groups for metastatic tumor. the improvement of clinical symptoms、the change of KPS、the elevation of the quality of lives and adverse reaction.
patients. There was no evident difference in the clinical efficacy of metastatic tumor between the Elemenum Emulsion combined radiotherapy and simple radiotherapy,9 cases were efficient(30%) in the treatment group and 6 cases were(20%) in the control group, the treatment group surpassed the control group.In the value of KPS aspect, the effective power of the treatment group is 43.33%,but the control group is 13.33%.There was significant difference between the both groups(P<0.05).The provement of clinical symptoms, the average improvement rate is 53.49%±10.98%in the treatment group,and the control group is 50.37%±12.45%.There were differences in short breath、cough、expectoration、lack of power. chest pain, dyspnea, dizziness. headache,but no significant differences in (P>0.05) Aphasia. hemiplegia. Mental aberration, seizure disorder, dysgnosia. the change of sight. sensation disorders, the change of character and behavior. The aspect of the quality of lives,the total of rating scales, the treatment group is 94.823±5.604 and the control group is 87.545±8.006,there were differences in Physiological Well-Being. Social/Family Well-Being. Emotional Well-Being. Functional Well-Being(P<0.05). The treatment group is better than the control group,whereas no evident difference was found in the Lung Complementation Supervention(P>0.05).The aspect of adverse reaction,there was difference(P<0.05) in white blood cell,and no difference in baldness, hemochrome. blood platelets(P>0.05).
Conclusion:
1.Compared the Elemenum Emulsion combined radiotherapy to simple radiotherapy, may boost the KPS of the patients.
2.Compared the Elemenum Emulsion combined radiotherapy to simple radiotherapy,may improve some symptoms of the patients.
3.Compared the Elemenum Emulsion combined radiotherapy to simple radiotherapy,may elevate the quality of lives of the patients.
4.Compared the Elemenum Emulsion combined radiotherapy to simple radiotherapy,may decrease effectively adverse reaction of radiotherapy.
目的：观察榄香烯注射液合并放疗对非小细胞肺癌脑转移患者的临床疗效,研究榄香烯注射液对患者部分症状、卡氏评分、生活质量及减轻放疗引起的不良反应的影响。
方法：研究运用现代循证医学理论指导,采用随机对照方法,具体采用随机表分组,做前瞻性临床研究,按照诊断标准、纳入、排除、脱落标准,对我院及外院住院患者随机分组,分为治疗组和对照组。两组基础治疗均为单纯全脑放疗(40Gy/20f/4W),治疗组即在全脑放疗同时加入榄香烯注射液的静滴(400～600mg/日、两周),对照组不做任何中医药的干预。观察两组患者的脑转移瘤的客观疗效、卡氏评分变化、临床症状改善、生活质量的提高及不良反应。
结果：通过2010年3月至2011年3月这段期间,一共有60例患者顺利完成本研究,其中对照组30例、治疗组30例。榄香烯注射液合并全脑放疗与单纯全脑放疗相比,两组放疗前后转移瘤的客观疗效,治疗组30例中,有效率为30%；对照组30例中,有效率为20%。治疗组优于对照组,但无明显统计学差异。在卡氏评分评价：治疗组30例中,有效率为43.33%,对照组30例中,有效率为13.33%,两组治疗后卡氏评分评价治疗组明显优于对照组,两组比较有统计学差异(P<0.05)。临床总症状改善：治疗组症状改善平均为53.49%±10.98%；对照组症状改善平均为50.37%±12.45%,治疗组明显优于对照组,经统计学分析有差异(P<0.05)。两组各个症状的有效率在气短、咳嗽、咳痰、乏力、胸闷胸痛、头痛头晕经统计学分析有明显差异性(P<0.05)；在失语、半身不遂、神智障碍、癫痫发作、智力障碍、视力改变、感觉障碍、性格行为的改变经统计学分析无明显差异性(P>0.05)。生活质量提高方面：治疗后两组量表总分(TOTAL):治疗组为94.823±5.604、对照组为87.545±8.006,治疗组优于对照组,有统计学差异(P<0.05)。两组在生理状况(PWB)、社会/家庭状况(SFWB)、情感状况(EWB)、功能状况(FWB)、经统计学比较均有差异(P<0.05),根据均值大小可知治疗组优于对照组；两组在肺癌附加的关注(LCS)经统计学分析无差异(P>0.05)。不良反应方面,经统计学分析可知,脱发、血色素、血小板两组经统计学分析无明显差异(P>0.05),WBC下降方面有统计学差异(P<0.05),即治疗组优于对照组(P>0.05)。
结论：
1.榄香烯注射液合并全脑放疗与单纯全脑放疗相比,可以提高患者的卡氏评分。
2.榄香烯注射液合并全脑放疗与单纯全脑放疗相比,可以改善患者某些的临床症状。
3.榄香烯注射液合并全脑放疗与单纯全脑放疗相比,可以较好的提高患者的生活质量。
4.榄香烯注射液合并全脑放疗与单纯全脑放疗相比,可以有效的减少放疗引起的不良反应。
As the incidence rate of lung cancer rising, in the male rate of tumor,which is the first,and in the female of tumor is the third.There is no small cell lung cancer,with its incidence of about 80%, brain metastasis is 20% of NSCLC, which is the 40% in autopsy. Some literatures report the incidence rate of brain metastasis is 25%—35% in the tumor,which comes from lung cancer is 50%, breast cancer is 20%,next to the gastrointestinal Cancer and malignant melanoma. The brain metastasis patients already belong to advanced stage,which can not cure,so we improve the cancer patients quality of life and extend their life span to accommodate the development patterns and requirement of the Modern Medicine.The treatment of modern medicine is high intensity、large dose and long period, which makes the patients painful beyond description.Many patients bear the double pain of spirit and body.At the same time,the assistance therapy of the traditional chinese medicine and the major therapy of the modern medicine all educe significant action.The traditional Chinese medicine have long history, plenty experiences,because it can remove our resistance to resist diseases. With the chinese medicinal pharmaceutics developing in the study of the modern de materia medica,which provides condition for the traditional Chinese medicine in the future. The Elemenum Emulsion is abstracted of blue turmeric rhizome who is a anticancer drug. Chinese medicinal think it is warm and bitter,which resists cancer. The clinic practice demonstrate that The Elemenum Emulsion can lessen adverse reaction and improve the quality of lives for cancer patients.This study adopted randomized control trials and prospective clinical research method,and combined the Elemenum Emulsion with radiotherapy to improve the clinic symptoms for patients and boost the quality of lives.
Objective:To observe the clinical efficacy of the combination of the Elemenum Emulsion with radiotherapy for brain metastasis of NSCLC. We research the Elemenum Emulsion may improve some symptoms、boost KPS、improve the quality of lives and lessen adverse reaction,which is caused by radiotherapy.
Methods:Research is guiding the use of modern evidence-based medicine, randomized controlled method, specific groups by random table, do prospective clinical study, in accordance with the diagnostic criteria, inclusion, exclusion, falling standards of our hospital and the Sino-Japanese Friendship Hospital were randomly assigned divided into treatment and control groups.The two groups both adopte modern therapy which is simple radiotherapy of the whole brain(40gy/20f).The treatment group which added the Elemenum Emulsion by intravenous drip infusion at the same time(400—600mg/day two weeks),and the control group does not any intervention.To observe the clinical efficacy of the two groups for metastatic tumor. the improvement of clinical symptoms、the change of KPS、the elevation of the quality of lives and adverse reaction.
patients. There was no evident difference in the clinical efficacy of metastatic tumor between the Elemenum Emulsion combined radiotherapy and simple radiotherapy,9 cases were efficient(30%) in the treatment group and 6 cases were(20%) in the control group, the treatment group surpassed the control group.In the value of KPS aspect, the effective power of the treatment group is 43.33%,but the control group is 13.33%.There was significant difference between the both groups(P<0.05).The provement of clinical symptoms, the average improvement rate is 53.49%±10.98%in the treatment group,and the control group is 50.37%±12.45%.There were differences in short breath、cough、expectoration、lack of power. chest pain, dyspnea, dizziness. headache,but no significant differences in (P>0.05) Aphasia. hemiplegia. Mental aberration, seizure disorder, dysgnosia. the change of sight. sensation disorders, the change of character and behavior. The aspect of the quality of lives,the total of rating scales, the treatment group is 94.823±5.604 and the control group is 87.545±8.006,there were differences in Physiological Well-Being. Social/Family Well-Being. Emotional Well-Being. Functional Well-Being(P<0.05). The treatment group is better than the control group,whereas no evident difference was found in the Lung Complementation Supervention(P>0.05).The aspect of adverse reaction,there was difference(P<0.05) in white blood cell,and no difference in baldness, hemochrome. blood platelets(P>0.05).
Conclusion:
1.Compared the Elemenum Emulsion combined radiotherapy to simple radiotherapy, may boost the KPS of the patients.
2.Compared the Elemenum Emulsion combined radiotherapy to simple radiotherapy,may improve some symptoms of the patients.
3.Compared the Elemenum Emulsion combined radiotherapy to simple radiotherapy,may elevate the quality of lives of the patients.
4.Compared the Elemenum Emulsion combined radiotherapy to simple radiotherapy,may decrease effectively adverse reaction of radiotherapy.
引文
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[6]万崇华,罗家洪,张灿珍,徐明清.癌症病人生活质量研究概况[J].国外医学·社会医学分册,2002,19(2)：56—61.
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[8]Schag CAC, Ganz PA, Heinrich RL. Cancer rehabilitation evaluation system-short from(CARES-SF). Cancer,1991,68:1406-1413.
[9]Cella DF, Tulsky DS, Gray G et al. The functional assessment of cancertherapy scale:Development and validation of the general measure. Journal of Clinical Oncology,1993,11 (3):570-579.
[10]孙燕,罗健.中国癌症患者化学生物治疗生活质量量表的编制.中华肿瘤杂志,1997,19(6)：437-441.
[11]Hollen P J, Gralla R J, Kris M G, et al. Quality of life assessment in individuals with lung cancer: lesting the lung cancer symstom scale (LSCC) [J]. Eur J Cancer,1993,29A(suppl 1):S51—58.
[12]张中民,洪介民.黄芪多糖对体外人骨髓造血祖细胞生成的影响[J].中药药理与临床,2000,16(1)：16-17.
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[29]徐娅,程俊,张旗.复方苦参注射液提高癌症患者生活质量的临床观察[J].中国中医急症,2006,15(4)：364—365.
[30]杨钰贤,张述耀等.复方苦参注射液改善KPS≤50分晚期癌症患者生活质量的临床观察[J].中国医院用药评价与分析,2009,9(10)：766—768.
[31]陈云莺,陈乃杰,吴丹红,赖义勤.参芪扶正注射液对42例晚期癌症患者生活质量的影响[J].福建中医药,2008,39(1)：38—39.
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[1]许冠先,郑宝森,罗健.癌症治疗手册[M].郑州：郑州大学出版社,2003：402—405.
[2]Andrews FM, Withey SB, Social indicators well—being. New York:Plenum Press, 1976.
[3]Cribb A.Quality of life:a response to KC. Calman J Med Ethics,1985,11: 142—145.
[4]Cella DF, Cherin EA. Quality of life during and after cancer treatment. Compr Ther,1988,14:69—75.
[5]Schipper H. Guidelines and caveats for quality of life measurement in elinical practice and research. Oncology 1990,4:50—57.
[6]万崇华,罗家洪,张灿珍,徐明清.癌症病人生活质量研究概况[J].国外医学·社会医学分册,2002,19(2)：56—61.
[7]Aaronson NK, Ahmedzai S, Bergman B, et al.The European Organization for Research and Treatment of Cancer QLQ-C30:aquality-of-life instrument for for use in internationnal clinical trails in oncology. J Natl Cancer Inst,1993,85 (5):365—376.
[8]Schag CAC, Ganz PA, Heinrich RL. Cancer rehabilitation evaluation system-short from(CARES-SF). Cancer,1991,68:1406-1413.
[9]Cella DF, Tulsky DS, Gray G et al. The functional assessment of cancertherapy scale:Development and validation of the general measure. Journal of Clinical Oncology,1993,11 (3):570-579.
[10]孙燕,罗健.中国癌症患者化学生物治疗生活质量量表的编制.中华肿瘤杂志,1997,19(6)：437-441.
[11]Hollen P J, Gralla R J, Kris M G, et al. Quality of life assessment in individuals with lung cancer: lesting the lung cancer symstom scale (LSCC) [J]. Eur J Cancer,1993,29A(suppl 1):S51—58.
[12]张中民,洪介民.黄芪多糖对体外人骨髓造血祖细胞生成的影响[J].中药药理与临床,2000,16(1)：16-17.
[13]Cella DF, Tulsky DS, Gray G, et al. The functional assessment of cancer therapy scale:Development and validation of the general measure [J]. Journal of Clinical Oncology,1993,11:(3):570—579.
[14]Aaronson NK, Cull A, Keasa S, et al. The EORTC modular approach to quality of life assessment in oncology[J]. Int J Ment Heslth,1994,23:75—96.
[15]方积乾,万崇华,郝元涛.与健康有关的生活质量的研究概况[J].中国康复医学杂志,2000,15(1)：40—43.
[16]彭鹏等.癌痛患者的生活质量及其影响因素研究[J].中国肿瘤,2009,18(4)：273—277.
[17]沈婵娟,曹培国.肺癌患者癌因性疲乏的影响因素及其与生活质量关系的研究[J]. 中国肿瘤临床与康复,2010,17(1)：87—90.
[18]YUCL, Fielding R, Chan CL, et al. Measuring quality of life of Chinese cancer patients.A validation of the Chinese version of the Funetional Assessment of cancer Therapy-GeneralFACT-G) Scale[J]. Cancer,2000,88(7),1715-1727.
[19]Ganz PA, Lee JJ, Siau J. Quality of life assessment. An independent prognostic variable for survival in lung cancer[J]. Cancer,1991,67 (12):3131.
[20]刘华,王蔚,王平根,等.非躯体因素对癌症患者生存质量的影响[J].中国肿瘤,2001,10(2)：88.
[21]李安乐,陆永良,韩雪.癌症患者生活满意度调查分析[J].中国肿瘤,2010,19(3)：168—170.
[22]乔洁.癌症患者生活质量的研究进展[J].上海护理,2007,7(3)：59—61.
[23]Gunnars B, Nygren P, Glimelius B.Assessment of quality og life during chemotherapy. Acta Oncol,2001,40 (2-3):115—184.
[24]孙启武,郭兰,张宁.癌症患者希望感与生活质量的相关研究[J].医学与社会,2009,22(12)：61—62.
[25]李大鹏.康莱特抗肿瘤研究论文集[M].杭州：浙江大学出版社,1998：10—152.
[26]左芬,林胜友.生存质量与中医治疗肿瘤疗效评价探讨[J].云南中医中药杂志,2008,29(6)：55—56.
[27]金川.中医药在肿瘤姑息治疗中的作用[J].甘肃中医,2010,23(4)：77.
[28]李忠英.艾迪注射液对晚期癌症患者生活质量的影响[J].内蒙古医学杂志,2007,39(5)：523—525.
[29]徐娅,程俊,张旗.复方苦参注射液提高癌症患者生活质量的临床观察[J].中国中医急症,2006,15(4)：364—365.
[30]杨钰贤,张述耀等.复方苦参注射液改善KPS≤50分晚期癌症患者生活质量的临床观察[J].中国医院用药评价与分析,2009,9(10)：766—768.
[31]陈云莺,陈乃杰,吴丹红,赖义勤.参芪扶正注射液对42例晚期癌症患者生活质量的影响[J].福建中医药,2008,39(1)：38—39.
[1]叶任高等.原发性支气管肺癌[M].内科学,北京：人民卫生出版社,2004.1：116.
[2]周斌等.西黄消瘕胶囊联合化疗在Ⅲ期非小细胞肺癌治疗中的应用[J].医学教育与研究,2009,26(3)：26-28.
[3]钱军,秦叔逵.抗癌新药-榄香烯乳药理及临床[J].中国肿瘤临床1996,23(6)：453-454.
[4]高学敏.破血消癥药[M].中药学,北京：中国中医药出版社,2002,397—398.
[5]吴敏,王秦英.榄香烯乳治疗肺癌脑转移的临床研究[J].医学论坛杂志,2006,27(9)：80—81.
[6]冯利,杨宗艳,朴炳奎.中西医结合治疗肺癌脑转移67例疗效分析[J].中西医结合心脑血管病杂志,2004,2(11)：681—682.
[7]王培民等.榄香烯乳、顺铂治疗恶性腹水疗效的对照观察[J].中国医院药学杂志,1999,19(7)：425.
[8]田力等.榄香烯乳剂联合化疗治疗晚期非小细胞肺癌的临床观察[J].中国临床医学,2009,16(5)：725—727.
[9]Aaronson NK, Ahmedzai S,Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30:aquality-of-life instrument for for use in internationnal clinical trails in oncology. J Natl Cancer Inst,1993,85 (5):365—376.
[10]朱熊兆.心理干预对人体免疫调节功能的影响[J].中国临床康复,2002,6(17)：2520—2522.
[11]徐姝丽、金春梅、宋琪.榄香烯乳联合放疗治疗肺癌脑转移40例疗效分析[J].中外医疗,2008,18：99—100.
[12]蔡红兵,闵清芬,宋海珠、罗荣城.中药对放疗后副反应及患者生活质量的影响[J].上海中医药杂志,2003,37(4)：17—18.