Study On The Method Of Evaluating Clinical Efficacy Of Traditional Chinese Medicine Combined With Coronary Heart Disease And Angina Pectoris

Purpose：To establish the framework of Chinese clinician reported outcomes(CRO) andpatient reported outcomes(PRO) among patients with coronary heart disease angina pectoris,and finally form the combination of clinician-patient reported outcomes to evaluate theeffectiveness of Chinese medicine.Material and method：Data analysis, Delphi expert panels, in-depth interview ofpatients and a cross-sectional investigation were used to establish the framework of CRO,PRO and the combination of clinician-patient reported outcomes evaluation method. An RCTwas conducted to test the applicability of this method.Results：1. There are three components of the CRO framework that disease, syndrome, and the changethe above two components. Disease is evaluate by chest pain and oppression. Syndrome isevaluated by six special symptoms that palpitation, short breath, heavy limb, dark lips andtongue and pulse.2. There are three main components of the PRO framework that clinical manifestation, healthrelated quality of life and treatment satisfaction. Clinical manifestation contains diseaserelated symptoms and syndrome features phlegm and blood stasis. Heath related quality oflife contains physical limitation, energy status, dietary, sleepiness, mental status. Treatmentsatisfaction contains intervention and effectiveness.3. There are240patients included which120patients in experimental and control groupsrespectively. There is no significant difference between the two groups as to the global scoreand each dimensions in Traditional Chinese Medicinal Symptom Score Scale. As to the PROindex, there are no significant difference between two groups among global scores, anginadimension, sleepiness,worry, treatment satisfaction, but show significant difference inphysical limitation dimension44.26±4.01vs42.92±5.69(P=0.036) and syndrome dimension 32.18±4.45vs30.82±5.42(P=0.035) in TCMSAQ.Conclusion：1.Chinese CRO is based on professional background of traditional Chinese medicine and thereport is different from the patients due to the requirement of professional background whichcan give the subjective evaluations.2.Patient reported outcomes characterized with TCM is the judgement of the body status afterthe acceptance of Chinese medicinal intervention by patients. PRO can acquire informationfrom patients which gives more emphasis on the patients self-feeling and is good for theself-management of disease.3.The combination of PRO and CRO evaluation method is in some degree suitable of patientsfor the effectiveness evaluation of angina patients, which can be the supplement andcombination for clinical effectiveness evaluation.