| Purpose:A major content of the standardization and objectification study of the traditional Chinese medicine (TCM) syndrome is the study of syndrome diagnostic scale. Typical representative is quantitative diagnosis form based on the quantitative diagnosis theory, which is mainly used for the object qualitative or disordered classification to establish the gold standard of TCM diagnosis, so that TCM could be more likely to be accepted by the people of the world. The purpose of this study is to establish syndrome diagnostic scale about the pattern of stasis-phlegm complicated with deficiency of Qi and the pattern of stasis-phlegm complicated with deficiency of Yin in recovery phase of ischemic apoplexia based on the guiding ideology of the combination of disease and pattern, and to determine the best diagnostic critical value, sensitivity and specific degrees through the preliminary appraisal the scale in the preliminary investigation for simplifying, quantifying and operating the scale. Then, an effective diagnostic tool could be provided for investigating the recovery phase of ischemic apoplexia.Materials and Methods:1. To establish the research group which is composed of the core team and issues team.The core team is mainly constituted with the clinical doctors, syndrome diagnostic scale experts and clinical epidemiological experts who are responsible for the specific research work; Issues team members includes evidence-based medical experts, cerebrovascular disease experts, neurology department clinical physicians, statistics experts and the patients of ischemic apoplexia with pattern of stasis-phlegm complicated with deficiency of Qi (or Yin) in the recovery phase who are responsible for proposing entry.2. To establish the syndrome standard which taking the syndrome factor as the coreSymptoms and signs differentiating scale should take the Syndrome factors differentiation as the main goal. We obtained the symptoms description of ischemic apoplexia through the medical books collection, the literature sorting and clinical investigation, standardized the symptom naming following the scientific and technological terms naming principles, determine the term definition and cleared logical relations between symptoms on the basis of TCM symptoms differential diagnostics and logic division and combined with expert advice, established the concept system among symptoms, and defined symptoms terms in ischemic apoplexia in the recovery phase.3. Form entry pool and determine the form and answer options of entryTo establish entry pool through the literature review, teaching material carding, standard collection, clinical flow adjustment and expert discussion; to establish symptom indication of the generality and specificity of ischemic apoplexia diseases with pattern of stasis-phlegm complicated with deficiency of Qi (or Yin) in recovery phase referring to the earlier research results of the coronary artery disease differentiation standard research. Based on the literature research, item pool established preliminarily requires comprehensive entries as far as possible.4. Performance evaluation of syndrome diagnostic scale of ischemic apoplexia diseases with pattern of stasis-phlegm complicated with deficiency of Qi (or Yin) in recovery phase4.1selection criteria of research objectDiagnosis standard:conform to the western medicine disease diagnosis standard: according to atherosclerotic cerebral infarction diagnosis standards in all kinds of cerebrovascular disease diagnosis points formulated by the Chinese medical association in1995; At the same time comform to the TCM disease diagnosis standard:refer to the apoplexia diagnosis and curative effect evaluation standard "(for trial implementation) drafted by the national administration of TCM encephalopathy emergency research group in1995. Meet more than two primary symptoms, or one primary symptom and two secondary symptoms in the apoplexia diagnosis and curative effect evaluation standard, combined with onset, incentive, premonitory symptoms, age, it could be diagnosed; If do not have the above conditions, combined with imaging examination results, it also could be diagnosed.Inclusion criteria:accord with atherosclerotic cerebral infarction or lacunar cerebral infarction diagnosis standards; conform to TCM ischemic apoplexia diseases with pattern of stasis-phlegm complicated with deficiency of Qi (or Yin) in recovery phase; The patients were attacked by the diseases for3-6weeks; NIHSS score≥5;35<age<85years old; the patients themselves and their family members signed informed consent voluntarily. Exclusion criteria:Patients whose consciousness is stupor or coma; Non atherosclerotic cerebral infarction (such as cardiac embolism, hypercoagulable state, arteritis, brain tumor, brain trauma, brain parasites disease, stroke caused by metabolic disorder); Cerebral hemorrhage, subarachnoid hemorrhage, transient ischemic attack (TIA); Patients who do not conform to the inclusion criteria.4.2investigation methodChoose ischemic apoplexia patients with pattern of stasis-phlegm complicated with deficiency of Qi (or Yin) in recovery phase; investigate the patients on the basis of obtaining informed consent.Using cross-sectional survey methods:ischemic apoplexia patients with pattern of stasis-phlegm complicated with deficiency of Qi (or Yin) from15hospitals were investigated by cross-sectional survey. We collected patients’ information including general information, TCM diagnosis, and western medicine diagnosis, and related risk factors, vital signs, physical and chemical inspection, syndrome diagnostic scale of ischemic apoplexia with pattern of stasis-phlegm complicated with deficiency of Qi (or Yin).4.3information acquisition time and content:When in groups:information of patients in experimental group and control group which should be collected are general data, TCM diagnosis, western medicine diagnosis, vital signs, and related risk factors, physical and chemical inspection, syndrome diagnostic scale of ischemic apoplexia with pattern of stasis-phlegm complicated with deficiency of Qi (or Yin).Resurvey:20%patients with every patten in treatment group were carried on collection of syndrome diagnostic scale of ischemic apoplexia with pattern of stasis-phlegm complicated with deficiency of Qi (or Yin)Choosing researchers:the researchers are neurology department doctors and rehabilitation doctors engaging TCM or combine TCM and western medicine from15sub-centers.5. Data management5.1fill in information collection tableInformation collection tables were filled by clinical research researchers. Clinical researchers should ensure that the data is accurate, complete and timely records in information collection table; at the same time, they should keep original cases. Completed information collection tables were reviewed by head of sub-centers, and handed over to the research data administrator.5.2data entry and managementData management personnel from the statistics units are responsible for data entry and management work. Data administrator formatted data entry procedures by applying computer software. In order to ensure the accuracy of the data entry, we adopted two researchers and twice back to back input method, and trace to the source and proofread inconsistent data.5.3data review and lockAt the end of the study, the clinical research personnel, data administrators, statistics analysis personnel reviewed the established database, confirm the research data set and statistical analysis plans, and then lock the database.Results1. Clinical data descriptive statistics1144patients were brought into the group of ischemic apoplexia with pattern of stasis-phlegm complicated with deficiency of Qi in recovery phase, including629male cases and515female cases, aged from35to85years old. The average age is62.56±9.96.472patients were brought into the group of ischemic apoplexia with pattern of stasis-phlegm complicated with deficiency of Yin in recovery phase, including246male cases and226female cases, aged from35to85years old. The average age is62.88±10.62.2. Screening syndrome factors2.1P value of every entry is tested whether less than0.01by stepwise regression method. Results show that p values in each entry are0.00which is less than0.01, so no entry was deleted.2.2If the frequency of occurrence is less than1%, then delete the entry. The results showed that the frequency of occurrence were greater than1%, no entry was deleted.In the syndrome information of1144ischemic apoplexia patients with pattern of stasis-phlegm complicated with deficiency of Qi in recovery phase, the syndrome factors frequency see table1. 2.3Entry screening results of factors diagnosis scale2.3.1Reserved entry number of syndrome factors of ischemic apoplexia with pattern of stasis-phlegm complicated with deficiency of Qi was:11phlegm syndrome entries,9blood stasis syndrome entries,9deficiency of Qi syndrome entries.2.3.2Reserved entry number of syndrome factors of ischemic apoplexia with pattern of stasis-phlegm complicated with deficiency of Qi was:11phlegm syndrome entries,9blood stasis syndrome entries,15deficiency of Yin syndrome entries.3. Formation of Ischemic apoplexia syndrome factors diagnosis scaleA good syndrome diagnostic scale should have good performance, then the results of the survey could have good inner authenticity and external objective reality, could be applied to clinical evaluation. Performance evaluations of Syndrome diagnostic scale include entry analysis, sensitivity evaluation and specificity evaluation.3.1We used ROC curve to analyze the syndrome factors of ischemic apoplexia with pattern of stasis-phlegm complicated with deficiency of Qi. The analysis results are shown in this figure: 3.2We used ROC curve to analyze the syndrome factors of ischemic apoplexia with pattern of stasis-phlegm complicated with deficiency of Yin. The analysis results are shown in this figure:To sum up:1. Ischemic apoplexia syndrome factors diagnosis scale is suitable for the syndrome diagnosis of ischemic apoplexia with pattern of stasis-phlegm complicated with deficiency of Qi. The scale is more reliable in evaluation specificity, sensitivity and accuracy.2. Ischemic apoplexia syndrome factors diagnosis scale is suitable for the syndrome diagnosis of ischemic apoplexia with pattern of stasis-phlegm complicated with deficiency of Yin. The scale is more reliable in evaluation specificity, sensitivity and accuracy.Conclusions:1syndrome diagnostic scale could reflect the syndrome diagnostic standard of ischemic apoplexia with pattern of stasis-phlegm complicated with deficiency of Qi.Syndrome diagnostic scale of ischemic apoplexia with pattern of stasis-phlegm complicated with deficiency of Qi reflected the multicenter, large sample size concept through the large sample size and multicenter clinical information acquisition. After statistics analysis, it is found that Syndrome diagnostic scale of ischemic apoplexia with pattern of stasis-phlegm complicated with deficiency of Qi have ideal sensitivity and specificity, suggesting that syndrome diagnostic scale could reflect the diagnostic standard of ischemic apoplexia with pattern of stasis-phlegm complicated with deficiency of Qi.2syndrome diagnostic scale could reflect the syndrome diagnostic standard of ischemic apoplexia with pattern of stasis-phlegm complicated with deficiency of Yin.Syndrome diagnostic scale of ischemic apoplexia with pattern of stasis-phlegm complicated with deficiency of Yin reflected the multicenter, large sample size concept through the large sample size and multicenter clinical information acquisition. After statistics analysis, it is found that Syndrome diagnostic scale of ischemic apoplexia with pattern of stasis-phlegm complicated with deficiency of Qi have ideal sensitivity and specificity, suggesting that syndrome diagnostic scale could reflect the diagnostic standard of ischemic apoplexia with pattern of stasis-phlegm complicated with deficiency of Yin. |
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