| BackgroundStroke is a common and frequently-occurring disease in the middle-aged and elderly population.It has the characteristics of high morbidity,high mortality,high disability rate,and high recurrence rate,causing a heavy burden on patients’ families and society.Ischemic stroke is the most common type of stroke,accounting for 69.6%to 70.8%of strokes in China.The WHO 2016 Global Burden of Disease Survey shows that in China,the contribution of ischemic stroke to YLDs ranks first.Therefore,the prevention and treatment of ischemic stroke is particularly important.Traditional Chinese medicine(TCM)has extensive experience in preventing and treating ischemic stroke.TCM injection,as a dosage form of Chinese patent medicine,is easy to use and has a definite curative efect.With the improvement of the preparation process,the adverse reactions are gradually reduced and it is welcomed by clinicians.Xingnaojing injection is a commonly used Chinese medicine injection for the treatment of ischemic stroke and is widely used in medical institutions at all levels and pre-hospital rescue links.However,in many cases,it is not under the guidance of the theory of Chinese medicine.In line with the principles of Chinese patent medicines.And through clinical work observation and related research results,it is found that different patients have different efficacy after using Xingnaojing injection,which may include unreasonable medication.If the adaptation and non-adaptation syndrome of Xingnaojing injection can be clearly defined under the guidance of TCM theory,and expressed in the exact combination of symptoms,it can help clinicians to select the suitable crowd during the diagnosis and treatment process,so as to strengthen the relevance of clinical medication and improve the efficacy of medication.The clinical adaptation symptom cluster of Chinese patent medicine is based on the pathogenesis of TCM,and the symptoms of modern medicine and TCM are manifestations.It is a concept that guides the rational use of Chinese patent medicine.It refers to a group of two or more symptoms,signs,and physical and chemical examinations that appear at a certain stage of a disease.These symptoms,signs,and physical and chemical examinations are related and occur at the same time to affect the efficacy of the drug to guide the Chinese patent medicine.The rational use of Chinese patent medicine in clinical practice includes not only the circumstances under which the medicine is suitable for use,but also the circumstances under which the medicine is not suitable for use.It is of great significance to clarify the clinical adaptation symptom cluster of Chinese patent medicine for clinical rational drug use.ObjectivesTo study the adaptation symptom cluster of Xingnaojing injection in the treatment of ischemic stroke,analyze the adaptation syndrome of Xingnaojing injection for ischemic stroke,including the situation of suitable and unsuitable medication.To explore the research model of the clinically adaptation symptom cluster of Chinese patent medicines to provide references for other Chinese patent medicine research.MethodThe study is divided into two parts.The first part is to conduct expert consultation through the Delphi method,and to screen Xingnaojing injection for the treatment of adaptive symptoms and non-adaptive symptoms of ischemic stroke.Consult the experts whether the entry is an adaptation or non-adaptation symptom of Xingnaojing injection,and use the Likert classification method to evaluate the entry of the adaptation symptom.At the same time,set open questions and ask the experts to supplement the entry.Evaluate the importance of the entry for adaptation symptoms with the mean,full score ratio,and coefficient of variation,and use the "cut-off method" to filter out the final entry.Use "more than half" to filter out the items that are not suitable for symptoms,that is,when the number of experts who believe that Xingnaojing injection is not applicable when the item exists exceeds 50%,the item is retained.The second part is the retrospective medical record analysis,taking the hospital records of Xingnaojing injection for ischemic stroke as the research data,collecting information based on the results of Delphi method,according to the change of the condition before and after treatment,and taking the clinical efficacy as the standard to analyze the adaptation symptoms cluster.According to the efficacy standard,the cases were divided into two groups:"effective" and ineffective".Firstly,chi-square test was used to screen out the indicators that had an effect on the curative effect,and binary logistic regression analysis was used to determine the indicators related to the clinical adaptation symptom group.P<0.05 considered the difference to be statistically significant.At the same time,a decision tree model was used to build a predictive model of medication efficacy,and analysis of relevant indicators of clinical adaptation symptom clusters.Compare the performance of binary logistic regression and decision tree model.ResultsDelphi’s expert consultations were conducted in three rounds,including three rounds of consultations for adaptation symptoms and two rounds of consultations for non-adaptation symptoms.In the end,40 items of adaptation symptoms were selected,and 31 items of non-adaptation symptoms,including symptoms and signs,tongue picture,pulse,comorbid diseases,physical and chemical examination and other aspects.Multi-factor analysis was conducted based on whether the treatment was effective,and the indicators that positively affected the efficacy of Xingnaojing injection were selected:red tongue(OR=1.772;95%CI:1.101-2.853),slippery pulse(OR=1.844;95%CI:1.239-2.743);The indicators that negatively affect the efficacy of Xingnaojing injection are:mental fatigue(OR=0.511;95%CI:0.311-0.840),sallow complexion(OR=0.544;95%)CI:0.318-0.929),less tongue coating(OR=0.410;95%CI:0.176-0.954).According to the regression coefficients,a predictive model of medication efficacy is established,and the model is visualized with a nomogram.The C5.0 decision tree and C&RT decision tree were used to build a curative effect prediction model.The C5.0 decision tree introduced less tongue coating,mental fatigue,elevated C-reactive protein,thread pulse,slippery pulse,dysphasia or speechlessness as predictions.and generated 7 rules.The C&RT decision tree introduced weak pulse,yellow tongue coating,less tongue coating,drowsiness and sleepiness,elevated C-reactive protein,bitter taste,dementia,thread pulse,lags in response,and red tongue as predictors,and generated 8 rules.However,the accuracy of the two model is lower than that of the logistic regression model,and there is a certain degree of overfitting,which was not adopted in the end.Conclusion1 The adaptation symptom cluster of Xingnaojing injection for ischemic stroke has the following characteristics:red tongue and slippery pulse.2 Xingnaojing injection is not suitable for the treatment of ischemic stroke for people with the following characteristics:mental fatigue,sallow complexion,and less tongue coating.3 The adaptation syndromes of Xingnaojing injection for ischemic stroke are:heat syndrome,phlegm dampness syndrome,phlegm heat syndrome.4 The syndromes of Xingnaojing injection in the treatment of ischemic stroke incompatibility are:Qi deficiency syndrome,Yin deficiency syndrome,Qi and Yin deficiency syndrome. |
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