摘要
乳癌是女性最常见的恶性肿瘤,其盛行率有升高而且年轻化的趋势。乳癌是现代社会的流行病,占女性所有恶性肿瘤的三分之一,是女性最常见的恶性肿瘤,也是全球女性的主要死因。西方国家平均每八位女性在其一生当中便有一位曾经罹患乳癌。相较于西方国家,亚洲地区尤其在中国与台湾,乳癌的盛行率与死亡率有年轻化而且有不断升高的趋势。
乳癌细胞的病理特性导致早期正确地诊断乳癌并不容易,而临床追踪复检的方法、时间、与成效并不准确。现行乳癌的筛检成效往往与病患的自觉症状并不一致。致使先期诊断困难,容易延误病情,失去治疗先机。
根据Mathis等人研究[141],有43%的乳癌病患是因为触及肿块与其它症状而就医确诊,经由现行筛检工具而就医确诊者仅有57%。正因如此,很多乳癌的病人等到病情发展到比较严重的时候,才会被诊断出来。
国内早在1980年代开始,就有运用耳廓辅助诊断恶性肿瘤等疾病的实证性研究文献论述,惟多见于消化系统的癌症,而在乳癌方面仅有零星的医师临床个案报导,亦未成专论。又,以往耳廓诊断恶性肿瘤的方法较为耗时,必须仰赖特殊仪器,而且该仪器并不普遍,也非垂手可得。
本病例对照研究应用中医对耳廓的望诊与按诊,辅以简易的耳穴探测器,探讨耳廓辅助诊断或筛检乳癌的可行性。
研究目的:
本研究针对乳癌患者的耳廓特性做为主要的观察指标,同时设计耳廓筛检或辅助诊断的临床前驱试验,通过耳廓望诊、触诊、电位检测等方法,辅助检查受试者是否罹患乳癌,或曾经为乳癌患者经手术或化疗后,追踪检查是否复发或发生转移。尝试以耳廓辅助观察诊断的模式,建立初步诊断或筛检乳癌的辅助工具。
研究方法:
本研究自2010年6月至2011年3月进行,应用病例对照研究法,进入合作诊所的所有病人,在患者知情并签属知情同意书后,完成本研究所需的数据收集程序后,经纳入、排除标准,即进入本研究。其中病例组(乳癌阳性)有效病例数99人,对照组(乳癌阴性)有效病例数96人。按耳穴国际标准图为取穴标准,制作耳廓诊断量化表,通过耳穴望诊、耳穴触诊、耳穴电测等,收集各穴区相关资料填入量化表。耳廓数据的测试者,数据的输入者,与资料统计者采三分离法。
本研究以皮尔森氏卡方检定(Pearson's Chi-Square)与费歇尔氏检定(Fisher's Exact)交叉分析统计与乳癌相关的属于非连续性变项之病史与致病因子;以独立样本t检定合并Levene相等变异数分析,计算与乳癌相关的属于连续性变项之病史与致病因子。以Logistic回归(Logistic Regression)多变项统计法,选取在单变项分析中具有统计显着意义的致病因子与耳穴变项,将该变项带入Logistic回归分析,以估计本耳廓辅助诊断乳癌模式的检测效率与辅助诊断的准确性。
研究结果:
本研究具有统计显着性差异的乳癌病史为:经常性晕或眩、经常性口渴、胁肋闷或痛、经常性便秘、便如羊屎状、经常性睡眠障碍、容易疲劳、经期经常改变、月经期间或前后经常乳房胀或痛。
具有统计显着性差异的乳癌危险致病因子为:生活作息不规律、常有负面或消极想法、经常感到不安或恐惧、承受极大的工作或家庭压力而经常自觉无法承担、承受极大的家庭压力而经常自觉无法承担、平日好食大豆制品(豆浆,豆腐,豆皮…)、初经年龄、停经年龄。
在大部分的文献显示具有显着性差异,而在本研究却不具显着性差异的病史与危险致病因子计有:曾经有一段时间经常服用贺尔蒙、乳房囊肿等乳癌以外的乳房疾病、母亲或姊妹是否有人罹患乳癌、怀孕次数、生产胎数、是否亲自哺乳。
具有具有统计显着性差异的耳穴为:肝区、脾区、内分泌区、与肿瘤特异1区的痛觉及肿瘤特异1区的隆起增生。而胃区、肺区、三焦区、与神门区的痛觉指数,经Levene相等变异数法修正后,虽亦具有显着性差异。但因为统计结果显示,对整体回归解释力的改善相当有限,因此应非直接与其它具有统计显着意义的病史、危险致病因子等具有密切相关,而无法独立显示其特殊意义。
将上述具有统计显着差异的变项带入Logistic回归,仅承受极大的工作或家庭压力而经常自觉无法承担(0或1)、月经期间或前后经常乳房胀或痛(0或1)、初经年龄、肿瘤I区是否有隆起增生(0或1)等四项具统计显着差异,其回归的解释力(pseudo R-square)为80.1%,p<0.000.而判别是否为乳癌阳性的机率Pr=ef(x)/l+ef(x)
f(Xn)为乳癌罹病函数,而乳癌罹病函数f(是否罹患乳癌之危险性)=11.60398+2.715262×(承受极大的工作或家庭压力而经常自觉无法承担0+否;1=是)+1.988133×(月经期间或前后经常乳房胀或痛0=否;1=是) -1.169609×初经年龄+8.265418×(肿瘤I区是否有隆起增生0=否;1=是)
将本试验病例组及对照组的耳廓观察数据代入乳癌罹病函数,建立耳廓诊断四格表,计算本研究耳廓诊断的特异度(Specificity)达97.92%、灵敏度(Sensitivity)达92.93%、假阳性率(False Positive Rate)为2.08%、假阴性率(False Negative Rate)为7.07%、阳性预测值(Positive Predictive Value)达97.87%、阴性预测值达(Negative Predictive Value)达93.07%、符合率(Agreement Rate)为95.38%、ROe曲线以下面积为98.34%。与现行西医乳癌的相关检查与诊断方式具有可比较性,说明了耳廓辅助诊断乳癌具有相当程度的可行性。
结论:
本病历对照研究发现,乳癌患者耳穴肝区和脾区的疼痛,与耳廓肿瘤特异I区的疼痛和增生隆起,相较于对照组,具有统计显着性的高比例。而耳廓肿瘤特异Ⅰ区的增生隆起、工作或家庭压力、月经期间或前后经常乳房胀或痛、与初经年龄四者,对于辅助判别罹患乳癌与否,扮演关键性因素。
通过临床试验数据的统计分析处理,本研究初步建立是否患有乳癌的耳廓筛检或辅助诊断的判别函数,经验证此辅助模式具有较高的特异度和灵敏度。可以尝试作为是否患有乳癌的耳廓辅助检查的方法。本研究使用的耳廓辅助检查方法,具有无创伤、无辐射暴露、成本低、快速、操作简单、容易普及化的优点。可以适用于可能患有乳癌的筛检或初步辅助诊断,或适用于曾经为乳癌患者,经化疗或手术切除后,追踪是否复发的辅助检查方法。
Breast cancer is the predominant malignancy over female, with trend towards higher prevalence in younger population. Breast cancer is the epidemic of modern society, taking one-third of all malignant tumors in female. Not only the most prevailing malignant tumor, but also breast cancer is the world's leading cause of death for women. On average, every eight women in Western countries ever had or will have breast cancer in their life. Compared to Western countries, Breast cancer in Asia, especially China and Taiwan, exists higher incidence and mortality rate in younger group. This tendency is still rising.
Pathological characteristics of breast cancer hinder its early and accurate diagnosis. The process, time interval, and effectiveness of current clinical follow-up schemes are still unable to promptly mirror its deteriorating pathological status. Results of current screening tools on breast cancer are often inconsistent with patients'symptoms. Difficulty on early diagnosis makes breast cancer easy to be delayed and to lose opportunities of early treatment.
Auricular diagnosis on malignant tumors began its empirical exposition as early as 1980, but only seen in cancers of the digestive system. As for breast cancer, there were only few and sporadic case reports of clinical observations on its corresponding auricular characteristics, leaving spaces to systemically extend and construct an auricular diagnostic model on breast cancer. Besides, current methods of auricular diagnosis of malignant tumor are time consuming and need to rely on special instruments fabricated by researchers. These instruments are also not accessible to general physicians.
This clinical research applies knowledge and techniques of auricular inspection of traditional Chinese medicine, complemented by simple tools of electrical ear probe to explore the feasibility of constructing an auricular aided diagnostic method on primary and secondary breast cancer.
Objectives:This clinical trial employs the auricular characteristics of patients with breast cancer as primary diagnostic indicators. Through aural observation, palpation, and potential detection by electrical ear probe to study auricular model of breast cancer and to develop an ear-aided method for preliminary diagnosis and screening for breast cancer.
Methods:From June 2010 to march 2011, implementing the rules of case-control study, every patient stepped into the collaboration clinics, after signing consent forms and completing data collection procedure, were assigned into case group (breast cancer positive) or control group (breast cancer negative) by criteria of inclusion and exclusion. The study collected 99 valid cases for case group (breast cancer positive with evidence of biopsy), and 96 valid cases for control group (breast cancer negative with evidence of ultrasonography or mammography). According to the international standard figure for auricular points, the study collected data of aural inspection, palpation, and potential detection into visualized quantification tables. Data collecting, data recording, and data mining were independently prepared by three different teams.
This study applied Pearson's Chi Square Test and Fisher's Exact Test for discrete variables, independent Student's t Test with Levene's Equity Statistics for continuous variables. Further exploration of those statistical significances drawn from the above procedures into Logistic regression to filtrate critical past histories, risk factors, and indications reflected from ears, including pain sensation and color as well as morphology changes, in order to establish a diagnostic model for breast cancer. According the model, Logistic regression re-assessed the original case and control groups and re-assigned them into predicted groups so as to calculate efficiency and accuracy of the ear-aided diagnostic model for breast cancer.
Results:The study concluded statistical significant past histories and risk factor for breast cancer as recurrent dizzy, frequent thirst, recurrent constipation with or without bullet-shaped stool, stagnation or pain sensation at hypochondriac areas, regular sleep disorder, keeping irregular biological clock, chronic fatigue, negativism or passivism, work or family stress, favorite for soybean food, frequent menstrual changes, breast distension or pain during menstruation, and age of menarche and menopause.
Certain risk factors showed their significance with breast cancer in major lituratures but lack of significance in our study were intake of contraceptive pills or other hormone regulating substances, past history of breast cysts, family aggregation on mother side or female siblings, number of gravid, parity, and breast feeding.
Auricular points with primary statistical significance were liver (C012), spleen (C013), endocrine (C018), and tumor specific area I (M1). Otopoints with statistical significance after adjustment by Levene's statistics were stomach (C04), lung (C014), triple burner (C017), and ear-shenmen(TF4).
Logistic regression processed those variables with primary statistical significance and included four variables into its final equation, including overloaded work stress (0 for none,1 for yes), breast distension or pain during menstruation (o for none,1 for yes), age of menarche, and uplift hyperplasia (0 for none,1 for yes) at tumor-specific areaⅠ. Power of explanation for overall variation to breast cancer, in term of pseudo R-square, is 80.1% with significant level of p<0.000. According assumption of logistic regression, probability of breast cancer positive is {ef(x)/(l+ef(x))}, where f (xn) is odds ratio of breast cancer. F(xn)= 11.60398+2.715262×overloaded work or family stress+1.988133 x breast distension or pain during menstruation-1.169609×age of menarche+8.265418×uplift hyperplasia at tumor-specific areaⅠ.
Post-estimation calculated from logistic probability equation of breast cancer positive showed diagnostic specificity is 97.92%, sensitivity 92.93%, false positive rate 2.08%, false negative rate 7.07%, positive predictive value 97.87%, negative predictive value 93.07%, agreement rate 95.38%, and area under ROC curve is 98.34%. In comparison with concurrent examination tools for breast cancer, auricular aided examination model is comprehensive and feasible.
Conclusion:The findings of the significant past histories, risk factors, and key otopoints for breast cancer were not only concordance with modern endocrine medicine on physiological changes and pathological aspects of mammary gland, but also concordance with the pathological progress described in TCM meridian bible literatures and breast disorders related ancient books.
Through case control study design and statistical data processing, the study proposed a simple way of palpitation at the auricular tumor-specific area 1 along with a predictive equation targeted on risk factors of stress, breast distention or pain during menstruation, and age of menarche, in order to calculate the probability breast cancer positive. Diagnosis evaluation indicators showed the underlining auricular examination method for breast cancer that the study suggested has high sensitivity, high specificity, and acceptable agreement rate in comparison with those of the modern medicine's tools.
Auricular aided examination for breast cancer is an efficient tool of non-invasive, non-radiation exposure, low cost, fast, simple to operate, and easy to adapt. It is suggested to apply to screening, and to long-term following-up scheme in order to track recurrence of breast cancer patients with chemotherapy, radiotherapy, or surgical treatment.
引文
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