中晚期原发性肺癌血瘀证量化标准的研究

Study on the Quantizing Diagnostic Criteria of the Blood Stasis Syndrome of the Advanced Primary Lung Cancer Patients

目的探索建立中晚期原发性肺癌血瘀证量化诊断标准和程度分级标准的方法。方法收集中晚期原发性肺癌患者共253例,随机分为实验组129例、对照组124例,实验组用于建立中晚期原发性肺癌血瘀证量化诊断标准及对量化诊断标准进行回顾性检验,对照组用于量化诊断标准的前瞻性检验。以血瘀证辨证参考标准对观察病例进行辨证分组,填写病例报告表(CRF表),用统计比较方法筛选相关因素,对相关因素进行赋分,建立量化诊断标准,并对量化诊断标准进行检验,建立程度分级标准。结果对建立的量化诊断标准进行回顾性检验敏感度91.8%,特异度90.0%,准确度90.7%,阳性似然比9.18,阴性似然比9.1%。对建立的量化诊断标准进行前瞻性检验敏感度88.0%,特异度93.2%,准确度91.1%,阳性似然比13.0,阴性似然比12.9%。确定中晚期原发性肺癌血瘀证量化诊断标准阈值为21分。程度分级标准:轻度21～28分,中度29～35分,重度>35分。结论以病证结合模式,采用统计学方法建立的中晚期原发性肺癌血瘀证量化诊断标准和程度分级标准,符合临床实际,具有创新性和实用性。

Objective To establish the quantizing diagnostic criteria and degree classifying criteria of blood stasis syndrome of the advanced primary lung cancer patients. Methods Totally 253 observed eases were randomized into a experimental group （129 eases） and a control group （124 cases）. The experimental group was to establish a quantizing diagnostic criteria and to make retrospective test. The control group was to make prospective test. The patients were divided into groups according to the differentiation criteria of blood stasis syndrome. The ease report form （CRF） was filled in and the statistical comparing method was applied to seleet the related factors, which were scored to establish the quantizing diagnostic criteria. A test for the quantizing diagnostic criteria was conducted to build up the degree classifying criteria of the blood stasis syndrome. Results The sensitivity in the retrospective test for the quantizing diagnostic criteria was 91.8%, the specificity was 90. 0%, the accuracy was 90.7%, the positive likelihood ratio was 9. 18%, and negative likelihood ratio was 9.1%. The sensitivity in the prospective test for the quantizing diagnostic criteria was 88. 0 %, the specificity was 93.2%, the accuracy was 91.1%, the positive likelihood ratio was 13.0%, and negative likelihood ratio was 12.9%. The threshold score of the quantizing diagnostic criteria for the blood stasis syndrome of the advanced primary lung cancer was 21. The degree classifying criteria： score between 21 and 28 as the mild ease, between 29 and 35 as the moderate ease, and score larger than 35 as serious case. Conclusion In the form of disease-and-syndrome, based on the statistical method, the quantizing diagnostic criteria and the degree classifying criteria of the blood stasis syndrome of the advanced primary lung cancer patients is practical with innovation and applicability.