| ObjectiveTo study the dynamic evaluation of the curative effect of TCM from the perspective of differentiation of syndrome elements,and toestablish an evaluation system with the characteristics of TCM diagnosis and treatment.1 Analysis the related implication of clinical efficacy evaluation,and analyze the current situation of TCM curative effect evaluation.2 Literature research:sorting out the literature of TCM clinical research over the past decade,constructing a database for TCM clinical research literature,as well as selecting and confirming the candidate parameters for the evaluation of clinical curative efficacy.3 Setting up a therapeutic evaluation system based on differentiation of syndrome elements:syndrome element screening,expert consultation,TCM medicine clinical efficacy scaledeveloping based on differentiation of syndrome elements.4 The clinical trial of the patients with perimenopause syndrome in Chinese medicine was taken as an example to verify the feasibility of the dynamic evaluation method of the clinical efficacy of TCM based on the principle of differentiation of syndrome elements.Results1 The theoretical framework of the therapeutic evaluation method(2X-4Y),the screening of the evaluation parameters of the curative effect,the determination of the scope of the evaluation of the efficacy evaluation and the classification of the parameters of the therapeutic evaluation parameters were set up.The screening of syndrome elements based on syndrome differentiation and syndrome differentiation was studied.9 common self-rating scale for syndrome elements and 31 self-rating questionnaires by experts were identified.2 Evaluation for the curative effectof the disease:cured3.22%,markedly effective 16.13%,improvement 78.23%and failure 2.42%.Before and after treatment,there was a significant difference in the KI scores between the 4 diagnoses(P<0.01),and the KI scores during the course of treatments decreased significantly,indicating that the curative effect of traditional Chinese medicine is significant.There were significant differences in the treatment of abnormal sensation,insomnia and impatient treatment(P<0.05),whichshowed that the treatment effect was good.Othersymptoms like tidal heat sweating,depression,vertigo,fatigue,muscle,joint,headache,palpitation,skin ant walking,vulva and vaginal discomfort(dry,pain,itching),and urological stimulationshow no significant differences between the diagnosis(P>0.05).During the third course ofdiagnosis,there were significant differences in sensory abnormalities,insomnia,and anxiety(P<0.05),comparing with the first diagnosis,there weresignificant differences on tidal heat sweating and palpitation(P<0.05).In the fourth diagnosis,there were significant differences in hot perspiration,palpitation comparing withthefirst diagnosis(P<0.05).3 The curative effect evaluation:the liver,kidney,heart God have significant difference during the course of four diagnosis(P<0.05).There are significant differences in the liver,kidney,heart,gallbladder,meridians and collaterals,as well as the spleen in the four diagnosis treatment(P<0.05);there is significant differencein the liver and kidney in the course of the 3rd diagnosis(P<0.05);for the heart,lung,bone,table and half table,there were significant differencesin the 4th diagnosis of(P<0.05);liver,kidney and table have been improved in the treatment,and there were significant differences(P<0.05).The improvement of liver disease was more obvious in the common medium(P<0.05);There were significant differenceson Qi stagnation,yin deficiency,heat,Qi deficiency,Yang deficiency and blood deficiency(P<0.05).There were significant differences in the degree of disease between the four diagnoses of qi stagnation,yin deficiency,heat,Qi deficiency,Yang deficiency and blood deficiency(P<0.05);it showed significant differences on Qi stagnation,yin deficiency,heat,Qi deficiency,blood deficiency,blood stasis both in the 1st diagnosis and the 2nd diagnosis(P<0.05);it showedsignificant differences on Yin deficiency,heat,Qi deficiency and yang deficiency,Blood deficiency both in the lstdiagnosis andthe 3rd diagnosis have(P<0.05);it showed significant differences on Qi stagnation,yin deficiency,heat,damp,Qi deficiency,Yang deficiency,blood deficiency,and phlegm both in the 1st diagnosis and the 4th diagnosis(P<0.05);also it showed significant difference in Yin deficiency both in the 2nd diagnosis and the 3rd diagnosis have(P<0.05).ConclusionThe research on the dynamic evaluation method of clinical curative effect of TCM based on the principle of differentiation of syndrome elements is in line with the academic characteristics of TCM.The dynamic evaluation is reasonable and practicable,and it is worth popularizing in clinical practice. |