感染幽门螺旋杆菌患者耳廓辅助诊断的研究
摘要
幽门螺旋杆菌(Helicobacter Pylori, Hp)目前已被世界卫生组织(WHO)的附属单位--国际癌症研究机构(International Agency for Research into Cancer, IARC)列为Ⅰ类的生物性致癌因子。目前全球自然人群及许多发展中国家,感染率已超过50%,成为严重危害健康的潜在危险因子。Hp感染已经发展成一个世界性问题。许多研究证实Hp感染是上消化道胃肠疾病及许多严重的胃肠外及并发症的重要因素及致病的危险因子。
我国属于发展中国家,Hp感染率相对较高。经全国性Hp流行病学调查研究结果显示了我国Hp感染率为40%-90%,平均为59%,其中Hp感染率最低的地区是广东省,为42%,Hp感染率最高地区是西藏喇嘛为90%。
许多患者在不自觉具有肠胃不适,或尚未发生各型消化道溃疡或炎症前后,就已经遭Hp感染。已置身于各型胃十二指肠溃疡或未来有移转为消化道癌症的危险当中而身不自觉。目前西医以各种检测法测定患者是否感染Hp,虽然准确率很高,但大多具有侵入性、费用高、耗时长、不易普及的局限性。如果透过中医耳廓辅助诊断,可以及早发现是否感染Hp。以达到早期发现,早期治疗的预防医学效果。
研究目的：
本研究针对是否感染幽门螺旋杆菌为主要的诊断指标,设计耳廓诊断的临床试验,通过耳廓望诊、触诊、电位检测等方式,探讨并建立是否感染Hp的耳廓辅助诊断方法,达到初步诊断及筛选可能感染Hp的患者的目的。
研究方法：
本研究自2009年6月至2010年3月进行,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,经纳入、排除标准,即进入本研究。其中病例组(Hp阳性)有效病例数101人,对照组(Hp阴性)有效病例数91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。
研究结果：
本研究以Logistic回归(Logistic Regression)筛选有意义的耳穴变项,再将该变项带入判别分析法(Discriminat Analysis),以全模型法(Enter independent together)估计本辅助诊断模式的判别效率。采K-邻近判别分析法(Kth-Nearest-Neighbor Discrininant Analysis)建立了幽门螺旋杆菌的判别函数。
将本试验病例组及对照组耳廓诊断数据代入判别函数,建立耳廓诊断四格表,计算本研究耳廓诊断的特异度达97.03%、灵敏度(Sensitivity)达98.9 0%。证实了耳廓辅助诊断是否感染Hp的可行性,因此未来诊断受试者是否感染Hp,只需诊断有意义的变项：年龄数字、胃区是否痛(0或1)、心区是否痛(0或1)、皮质下区是否痛(0或1)、尿道区是否痛(0或1)。将这些数据代入判别函数,即可判别受试者是否感染Hp。
加上针对问诊了解受试者是否有与本研究成“负相关”的胃肠外疾病,做为另一种辅助诊断。如果受试者为Hp阳性,根据中医证型及耳廓型态,再深入判断受试者是否已经发展成慢性胃炎或胃、十二指肠溃疡、甚至胃癌。
结论：
通过对本临床试验数据的统计学处理得出的耳廓辅助诊断幽门螺旋杆菌的判别函数具有较高的特异度和灵敏度,从而建立了耳廓辅助诊断HP感染的方法。并且本方法具有无创伤,费用低,操作简便,易于普及的优点,可作为初步诊断及筛选可能感染Hp的患者的辅助诊断方法。
Helicobactor (Helicobacter pylori, Hp) is currently classified as class I of biological carcinogenic factor by the International Agency for Research into Cancer (IARC), a subsidiary unit in the World Health Organization (WHO). Helicobactor infection rates have reached more than 50% in the current global population and in many developing countries, becoming a potential risk factor which seriously endangers the health. HP infection has grown into a worldwide problem. A number of studies have confirmed that HP is an important risk factor of upper gastrointestinal diseases and serious complications of disorders other than gastrointestinal track.
China is a developing country, Hp infection rates are relatively high. National epidemiological investigation shows our HP infection rate is 40%-90%, an average of 59%, which among the lowest is in the region of Guangdong Province, as 42%, and among the highest group is in Tibetan Lama of 90%.
About 80% of patients with Hp are unconscious of the disease even in suffering or in dangerous of possible transformation into gastrointestinal cancer in the future, as it has no obvious symptoms. Western exam method is accurate, but expensive, time consuming and less easy to carry out. This study designs the clinical trial on auricular diagnosis, by inspecting, palpating and electric examining the auricular to achieve the purpose of auxiliary diagnosis, which can assist in screening Hp patients with low cost, and provide further suggestions on diagnosis and treatment in its early stage.
Objectives:this study designs Helicobacter pylori infection as the major diagnostic criteria. By ways of aural inspection, palpation, and potential detection, this study establishes a model to assist in preliminary diagnosis and screening of HP infection.
Methods:From June 2009 to March 2010, every patient entered the cooperation clinics, after signing the consent forms will be assigned into case group (HP positive) or control group (HP negative) by criteria of inclusion and exclusion. The study collected 101 valid cases for case group (Hp positive), and 91 valid cases for control group (Hp negative). According to the international standard figure for auricular points, the study collected data of aural inspection, palpation, and potential detection.
Results:this study employed the logistic regression to filtrate significant variables, then brought those variables into the K-th nearest neighbor discriminant analysis, using method of enter independent together, to establish a discriminant model of detecting HP infection. The model utilized information of patient's age, and pain sensation (yes or no) of auricular points of stomach, heart, subcortical, and urethral. The results show feasibility of auricular diagnosis on HP infection with diagnostic specificity of 97.03%, and sensitivity of 98.90%.
Conclusion:This study demonstrates high efficiency of detecting HP infection through auricular diagnosis. Auricular diagnosis is able to apply to screening or preliminary diagnosis of HP infection with characteristics of non-invasive, low-cost, easy to operate, and easy to promote.
我国属于发展中国家,Hp感染率相对较高。经全国性Hp流行病学调查研究结果显示了我国Hp感染率为40%-90%,平均为59%,其中Hp感染率最低的地区是广东省,为42%,Hp感染率最高地区是西藏喇嘛为90%。
许多患者在不自觉具有肠胃不适,或尚未发生各型消化道溃疡或炎症前后,就已经遭Hp感染。已置身于各型胃十二指肠溃疡或未来有移转为消化道癌症的危险当中而身不自觉。目前西医以各种检测法测定患者是否感染Hp,虽然准确率很高,但大多具有侵入性、费用高、耗时长、不易普及的局限性。如果透过中医耳廓辅助诊断,可以及早发现是否感染Hp。以达到早期发现,早期治疗的预防医学效果。
研究目的：
本研究针对是否感染幽门螺旋杆菌为主要的诊断指标,设计耳廓诊断的临床试验,通过耳廓望诊、触诊、电位检测等方式,探讨并建立是否感染Hp的耳廓辅助诊断方法,达到初步诊断及筛选可能感染Hp的患者的目的。
研究方法：
本研究自2009年6月至2010年3月进行,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,经纳入、排除标准,即进入本研究。其中病例组(Hp阳性)有效病例数101人,对照组(Hp阴性)有效病例数91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。
研究结果：
本研究以Logistic回归(Logistic Regression)筛选有意义的耳穴变项,再将该变项带入判别分析法(Discriminat Analysis),以全模型法(Enter independent together)估计本辅助诊断模式的判别效率。采K-邻近判别分析法(Kth-Nearest-Neighbor Discrininant Analysis)建立了幽门螺旋杆菌的判别函数。
将本试验病例组及对照组耳廓诊断数据代入判别函数,建立耳廓诊断四格表,计算本研究耳廓诊断的特异度达97.03%、灵敏度(Sensitivity)达98.9 0%。证实了耳廓辅助诊断是否感染Hp的可行性,因此未来诊断受试者是否感染Hp,只需诊断有意义的变项：年龄数字、胃区是否痛(0或1)、心区是否痛(0或1)、皮质下区是否痛(0或1)、尿道区是否痛(0或1)。将这些数据代入判别函数,即可判别受试者是否感染Hp。
加上针对问诊了解受试者是否有与本研究成“负相关”的胃肠外疾病,做为另一种辅助诊断。如果受试者为Hp阳性,根据中医证型及耳廓型态,再深入判断受试者是否已经发展成慢性胃炎或胃、十二指肠溃疡、甚至胃癌。
结论：
通过对本临床试验数据的统计学处理得出的耳廓辅助诊断幽门螺旋杆菌的判别函数具有较高的特异度和灵敏度,从而建立了耳廓辅助诊断HP感染的方法。并且本方法具有无创伤,费用低,操作简便,易于普及的优点,可作为初步诊断及筛选可能感染Hp的患者的辅助诊断方法。
Helicobactor (Helicobacter pylori, Hp) is currently classified as class I of biological carcinogenic factor by the International Agency for Research into Cancer (IARC), a subsidiary unit in the World Health Organization (WHO). Helicobactor infection rates have reached more than 50% in the current global population and in many developing countries, becoming a potential risk factor which seriously endangers the health. HP infection has grown into a worldwide problem. A number of studies have confirmed that HP is an important risk factor of upper gastrointestinal diseases and serious complications of disorders other than gastrointestinal track.
China is a developing country, Hp infection rates are relatively high. National epidemiological investigation shows our HP infection rate is 40%-90%, an average of 59%, which among the lowest is in the region of Guangdong Province, as 42%, and among the highest group is in Tibetan Lama of 90%.
About 80% of patients with Hp are unconscious of the disease even in suffering or in dangerous of possible transformation into gastrointestinal cancer in the future, as it has no obvious symptoms. Western exam method is accurate, but expensive, time consuming and less easy to carry out. This study designs the clinical trial on auricular diagnosis, by inspecting, palpating and electric examining the auricular to achieve the purpose of auxiliary diagnosis, which can assist in screening Hp patients with low cost, and provide further suggestions on diagnosis and treatment in its early stage.
Objectives:this study designs Helicobacter pylori infection as the major diagnostic criteria. By ways of aural inspection, palpation, and potential detection, this study establishes a model to assist in preliminary diagnosis and screening of HP infection.
Methods:From June 2009 to March 2010, every patient entered the cooperation clinics, after signing the consent forms will be assigned into case group (HP positive) or control group (HP negative) by criteria of inclusion and exclusion. The study collected 101 valid cases for case group (Hp positive), and 91 valid cases for control group (Hp negative). According to the international standard figure for auricular points, the study collected data of aural inspection, palpation, and potential detection.
Results:this study employed the logistic regression to filtrate significant variables, then brought those variables into the K-th nearest neighbor discriminant analysis, using method of enter independent together, to establish a discriminant model of detecting HP infection. The model utilized information of patient's age, and pain sensation (yes or no) of auricular points of stomach, heart, subcortical, and urethral. The results show feasibility of auricular diagnosis on HP infection with diagnostic specificity of 97.03%, and sensitivity of 98.90%.
Conclusion:This study demonstrates high efficiency of detecting HP infection through auricular diagnosis. Auricular diagnosis is able to apply to screening or preliminary diagnosis of HP infection with characteristics of non-invasive, low-cost, easy to operate, and easy to promote.
引文
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