辨证针刺对恶性肿瘤短期化疗患者生存质量影响研究
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摘要
本文以辨证针刺对恶性肿瘤短期化疗生存质量影响研究为切入点,引入中西医结合生存质量量表,对生存质量进行研究。
     研究背景:肿瘤是目前威胁人类生命的主要疾病之一。近年来,恶性肿瘤发病率呈明显上升趋势。据世界卫生组织统计,全球每年新发现恶性肿瘤患者超过1000万人。随着医学模式由生物医学模式向生物-心理-社会医学模式转变,恶性肿瘤的治疗思路也从单纯地追求消灭或缩小肿瘤实体,转变为灭瘤同时注重机体及精神状态的改善,提高生存质量。自从上世纪70年代,医学界尤其是肿瘤领域提出和引入生存质量这一概念,恶性肿瘤患者生存质量问题越来越多地受到关注。近年来,中医药介入到恶性肿瘤患者生活质量的研究中,针灸对恶性肿瘤治疗生活质量有一定潜力,但相关研究较少。因此,本研究选择辨证针刺方法对改善恶性肿瘤患者生活质量的作用进行研究。
     研究创新点:
     1将生存质量研究引入到针刺治疗恶性肿瘤临床疗效评价之中,适合了现代在恶性肿瘤治疗中开始重视患者生存质量的新理念及其注重生理—心理—社会医学新模式转变的需求。
     2对现有中西医结合生存质量量表应用范围加以扩展,并对相关中医临床症状及其变化用“症状频数”转化进行统计分析。
     研究目的:观察辨证针刺方法对恶性肿瘤患者生存质量的影响,客观评价辨证针刺提高恶性肿瘤患者生存质量的临床疗效,为临床提高恶性肿瘤患者的生存质量提供新的思路和方法。
     研究方法:
     病例来源:病例采集时间为2007年2月~2007年11月。所有恶性肿瘤病例均为山东省烟台市肿瘤医院化疗科的住院病人。
     随机分组情况:本研究共观察了符合病例纳入标准的92例住院治疗的恶性肿瘤患者。按随机数字表法,随机分为辨证针刺组、非辨证针刺对照组(简称非辨证针刺组)、西药基础治疗对照组(简称西药对照组),不同组别比例为1∶1∶1。
     治疗方法:辨证针刺组采用西医基础治疗(包括化疗、对症治疗和支持治疗等)结合辨证针刺治疗。辨证分为实证和虚证,实证针刺选取太冲、合谷、血海、丰隆、膻中,虚证针刺选取气海、关元、足三里、三阴交、太溪。非辨证针刺组采用西医基础治疗结合非辨证针刺治疗,根据文献资料检索结果选取穴位应用频率最高的前5位,针刺选取足三里、三阴交、内关、关元、合谷。西药对照组仅采用西医基础治疗。本研究中生存质量包括生理领域、心理领域、独立性领域、生活条件领域、情感领域及整体健康领域。应用中西医结合生存质量量表,测评治疗前和治疗后生存质量以及六个领域评分,进行治疗前后评分比较。另外,还对治疗前后生存质量量表中出现的症状进行了归纳统计,并对治疗前后血白细胞计数、肝肾功能变化情况进行研究。
     观察疗程:选择恶性肿瘤用药相对集中的化疗周期中的一个短期阶段作为疗效观察期,即化疗周期的第1~7天。7天为一个疗程,全部病例均治疗一个疗程。
     统计方法:计量资料应用方差分析,计数资料应用X~2检验。
     研究结果:
     生存质量总评分,不同组别治疗前后生存质量总评分组内比较:辨证针刺组治疗前后生存质量总评分,差异有非常显著性意义(P<0.01);非辨证针刺组及西药对照组治疗前后生存质量总评分差异均无显著性意义(P>0.05)。不同组别治疗前后差值组间比较:辨证针刺组与西药对照组比较,差异有非常显著性意义(P<0.01);非辨证针刺组与西药对照组比较,差异无显著性意义(P>0.05);辨证针刺组与非辨证针刺组比较,差异有显著性意义(P<0.05)。不同组别治疗后组间比较:辨证针刺组与西药对照组相比,差异有显著性意义(P<0.05);非辨证针刺组与西药对照组相比,辨证针刺组与非辨证针刺组相比,差异均无显著性意义(P>0.05)。说明,辨证针刺治疗能够显著拮抗化疗药物毒副作用,显著提高恶性肿瘤患者观察期间患者的生存质量,非辨证针刺治疗和西药治疗对恶性肿瘤患者观察期间患者的生存质量影响不明显,且辨证针刺治疗明显优于西药治疗和非辨证针刺治疗。具体影响指标包括:
     1、生理领域
     不同组别治疗前后生理领域评分组内比较:辨证针刺组治疗后生理领域评分提高,差异有非常显著性意义(P<0.01);非辨证针刺组治疗后生理领域评分提高,差异有显著性意义(P<0.05);西药对照组治疗后生理领域评分降低,但差异无显著性意义(P>0.05)。不同组别生理领域评分治疗前后差值组间比较,辨证针刺组与西药对照组比较,差异有非常显著性意义(P<0.01);非辨证针刺组与西药对照组比较,辨证针刺组与非辨证针刺组比较,差异均无显著性意义(P>0.05)。不同组别治疗后组间比较:辨证针刺组与西药对照组相比,差异极其显著(P<0.01);非辨证针刺组与西药对照组相比,差异无显著性意义(P>0.05);辨证针刺组与非辨证针刺组相比,差异有显著性意义(P<0.05)。说明,辨证针刺治疗能够显著拮抗化疗药物毒副作用,能够显著改善恶性肿瘤患者在观察期间的生理领域功能状况,非辨证针刺治疗和西药治疗对恶性肿瘤患者观察期间生理领域功能状况影响不明显,且辨证针刺治疗明显优于西药治疗和非辨证针刺治疗。
     2、心理领域、独立性领域、生活条件领域和情感领域
     不同组别心理领域、独立性领域、生活条件领域和情感领域评分治疗前后组内比较、治疗前后差值组间比较及治疗后组间比较,差异均无显著性意义(P>0.05)。说明,不同组别治疗对观察期间恶性肿瘤患者心理领域、独立性领域、生活条件领域及情感领域功能状况影响均不明显。
     3、整体健康领域
     不同组别治疗前后整体健康领域评分组内比较:辨证针刺组治疗后整体健康领域评分提高,差异有非常显著性意义(P<0.01);非辨证针刺组治疗后整体健康领域评分提高,差异有显著性意义(P<0.05);西药对照组治疗后整体健康领域评分降低,但差异不显著(P>0.05)。不同组别治疗前后整体健康领域评分差值组间比较:辨证针刺组与西药对照组比较,差异有非常显著性意义(P<0.01);非辨证针刺组与西药对照组比较,辨证针刺组与非辨证针刺组比较,差异均无显著性意义(P>0.05)。不同组别治疗后组间比较:辨证针刺组与西药对照组比较,非辨证针刺组与西药对照组比较,辨证针刺组与非辨证针刺组比较,差异均无显著性意义(P>0.05)。说明,辨证针刺治疗和非辨证针刺治疗能够显著拮抗化疗药物毒副作用,能够显著改善恶性肿瘤患者在观察期间的整体健康领域功能状况,西药治疗对恶性肿瘤患者观察期间患者的整体健康领域功能状况影响不明显,且辨证针刺治疗明显优于西药治疗和非辨证针刺治疗。
     4、症状
     总体症状改善情况组间比较:辨证针刺组与西药对照组比较,非辨证针刺组与空白对照比较,差异均有非常显著性意义(P<0.01);辨证针刺组与非辨证针刺组比较,差异有显著性意义(P<0.05)。
     消化系统症状改善情况组间比较:辨证针刺组与西药对照组比较,非辨证针刺组与西药对照组比较,差异有显著性意义(P<0.05);辨证针刺组与非辨证针刺组比较,差异无显著性意义(P>0.05)。
     疼痛症状改善情况组间比较:辨证针刺组与西药对照组比较,辨证针刺组与非辨证针刺组比较,差异有显著性意义(P<0.05);非辨证针刺组与西药对照组比较,差异无显著性意义(P>0.05)。
     其他症状改善情况组间比较,辨证针刺组与西药对照组比较,差异有非常显著性意义(P<0.01);非辨证针刺组与西药对照组比较,辨证针刺组与非辨证针刺组比较,差异有显著性意义(P<0.05)。
     说明,辨证针刺治疗能显著改善总体症状、消化系统症状、疼痛症状以及其他症状,且能够预防化疗毒副反应的发生,减少症状的加重和新症状的发生。
     5、生化指标
     不同组别治疗后血白细胞计数、肝肾脏功能变化组间比较:辨证针刺组与西药对照组比较,非辨证针刺组与西药对照组比较,辨证针刺组与非辨证针刺组比较,差异均无显著性意义(P>0.05)。说明,不同组别治疗对观察期间恶性肿瘤患者血白细胞计数、肝肾脏功能影响均不明显。
     研究结论:
     研究结果显示,辨证针刺治疗能够拮抗化疗药物毒副作用,提高观察期间恶性肿瘤患者生存质量,具体改善指标包括:
     1、生理领域
     辨证针刺治疗能够拮抗化疗药物毒副作用,提高恶性肿瘤患者在观察期间的生理领域评分。
     2、整体健康领域
     辨证针刺治疗能够拮抗化疗药物毒副作用,提高观察期间恶性肿瘤患者的整体健康领域评分。
     3、症状
     辨证针刺治疗能显著改善总体症状、消化系统症状、疼痛症状以及其他症状,且能够预防化疗毒副反应的发生,减少症状的加重和新症状的发生。
     由此可见,辨证针刺治疗组能够提高恶性肿瘤患者的生存质量,改善生理领域和整体健康领域功能状况,有效改善症状,减缓症状的加重和新症状的发生。为恶性肿瘤患者化疗期间生存质量的改善提供了有效手段,具有积极的临床意义。
The breakthrough point of this study is the influence on quality of life(QOL) of patients suffering from malign tumors treated by acupuncture according to patterns identification. The QOL is studies using the quality of life scale(DQOL) in integrated traditional medicine and western medicine area.
     BACKGROUND
     Tumor is one of the main diseases endangering human life nowadays.It is increasing obviously now.There are more than 10,000,000 new patients diagnosed to be malign tumors globally every year according to the statistics from WHO.The therapeutic route for malign tumors has changed from extinguishing or reducing the solid of tumors into emphasizing the improvement of body,spirit and QOL at the same time of extinguishing tumors when medical model changed from biomedical model into biopsychosocial medical model.The QOL of patients suffering from malign tumors has been paid more and more attention to since 1970's especially since that the concept of QOL was drawn in tumor field. Traditional medicine starts to be used in studies on the QOL of patients suffering from malign tumors recently.Acupuncture is very potential on improving the QOL of patients suffering from malign tumors.But there are very few researches on this aspect.So this study is about the influence on QOL of patients suffering from malign tumors treated by acupuncture according to patterns identification.
     INNOVATIONS
     1.Drawing study on QOL in evaluation of clinical curative effect of acupuncture on malign tumors corresponds with the new thought of emphasizing the QOL of patients and the need of biopyschosocial medical model.
     2.Expand the applied range of DQOL.Calculate and analyze relative clinical symptoms in TCM and their change in frequence of symptoms.
     OBJECTIVE
     To observe the influence on QOL of patients suffering from malign tumors treated by acupuncture according to patterns identification;to evaluate the clinical therapeutic effectiveness on QOL by acupuncture according to patterns identification objectively.And to provide new thinking and methods for improving QOL of patients suffering from malign tumors in clinic.
     METHOD
     Resource:
     All the patients are from chemical treatment department of Yantai Tumor Hospital of Shandong Province.
     Time:
     The collection of cases is from February to November,2007.
     Random:
     Consistent with inclusive criteria,92 cases of patients suffering from malign tumors was observed in the study.According to the random digits table,they were randomly divided into acupuncture group according to patterns identification,acupuncture control group and western medicine control group,with the ratio 1:1:1.
     Treatment:
     Acupuncture group according to patterns identification was applied for conventional therapy of western medicine(including chemotherapy,symptomatic treatment and supportive treatment,etc.) plus acupuncture treatment with patterns identification; Acupuncture control group was applied for conventional therapy of western medicine combined with the acupuncture treatment without patterns identification;Western medicine control group was only applied for the conventional therapy.
     The QOL of this study included physiology,psychology,independence,living conditions and whole status of health.QOL scale of integrated medicine was used to evaluate patients' life quality with six items and compare the result before and after treatments.
     In addition,the changes of leucocyte count,hepatic function and renal function before and after treatment were studied.
     Course of treatment:
     A short period of time which was 1~(st)-7~(th) day within cycles of chemotherapy was selected for observing effectiveness.7 days was a course of treatment,and each group was treated one course.
     Statistics:
     SPSS13.0 was used in the statistical analysis.Measurement data were compared with analysis of variance.The enumeration data were compared with the X~2 test.
     Results:
     QOL:
     The comparison of scores of QOL within the groups before and after treatment: Acupuncture group according to patterns identification:the difference between them was very significant(P<0.01).Acupuncture control group and Western medicine control group: The differences were not significant(P>0.05).
     The comparison of scores of QOL among different groups before and after treatment: Acupuncture group according to patterns identification compared with Western medicine control group:the difference between them was very significant(P<0.01).Acupuncture control group compared with Western medicine control group:The difference was not significant(P>0.05).Acupuncture group according to patterns identification compared with acupuncture control group:the difference between them was significant(P<0.05).
     1.physiology
     The comparison of scores of physiology within the groups before and after treatment: Acupuncture group according to patterns identification:The score increased after treatment. The difference between them was very significant(P<0.01).Acupuncture control group:The score increased after treatment.The difference between them was significant(P<0.05). Western medicine control group:The score decreased after treatment.The difference between them was not significant(P>0.05).
     The comparison of scores of physiology among different groups before and after treatment:Acupuncture group according to patterns identification compared with Western medicine control group:the difference between them was significant(P<0.05).Acupuncture control group compared with Western medicine control group:The difference was not significant(P>0.05).Acupuncture group according to patterns identification compared with acupuncture control group:the difference between them was not significant(P>0.05).And so was the comparison between Acupuncture group according to patterns identification and acupuncture control group.
     2.psychology,independence,living conditions
     The comparison of scores of these ideas no matter within or among groups before and after treatment:The differences were not significant.(P>0.05)
     3.whole status of health
     The comparison of scores of whole status of health within groups before and after treatment:Acupuncture group according to patterns identification:The score increased after treatment.The difference between them was very significant(P<0.01).Acupuncture control group:The score increased after treatment.The difference between them was significant (P<0.05).Western medicine control group:The score decreased after treatment.The difference between them was not significant(P>0.05).
     The comparison of scores of whole status of health among different groups before and after treatment:Acupuncture group according to patterns identification compared with Western medicine control group:the difference between them was significant(P<0.05).Acupuncture control group compared with Western medicine control group:The difference was very significant(P<0.01).No matter the comparison between acupuncture control group and western medicine control group or that between Acupuncture group according to patterns identification and acupuncture control group,the differences were not significant.(P>0.05)
     4.symptoms
     The comparisons of amelioration of total symptoms,digestive system symptoms,pain symptoms,other symptoms among groups:acupuncture group according to patterns identification showed a distinctive significance compared with western medicine group and acupuncture control group.
     5.biochemical index
     The comparisons of leukocyte count,the functional changes of liver and kidney:the comparisons all among different groups were not significant(P>0.05).
     Conclusions:
     QOL:
     Acupuncture group according to patterns identification could antagonize the toxic and side effects of chemotherapy,raise the total scores of QOL,which showed better life quality.
     1.physiology
     Acupuncture group according to patterns identification could antagonize the toxic and side effects of chemotherapy,raise the total scores of physiology,and the change of score evaluation showed increasing trend.
     2.whole status of health
     Acupuncture group according to patterns identification could antagonize the toxic and side effects of chemotherapy,raise the total scores of whole status of health,and the change of score evaluation showed increasing trend.
     3.symptoms
     Acupuncture group according to patterns identification could ameliorate total symptoms, or those in digestive system,pain symptoms etc.It could prevent the toxic and side effects of chemotherapy.
     All in all,the results showed that acupuncture group according to patterns identification could raise the total scores of QOL,ameliorate symptoms and decrease the aggravation of symptoms as well as prevent the new ones.
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