Randomized And Controlled Trial Of Taishuda In Patients With Parkinson's Disease

Parkinson's disease(PD) is a kind of common and chronic degenerative disease mainly occurring in the elderly,which caused by the reduction of dopamine in the striatum with dopaminergic neurons and its pathways degeneration.The main clinical symptoms are static tremor,muscular rigidity,sluggish and decreasing movement,postures and gait disturbance etc symptoms.At present PD is incurable and aggravating disease.It Seriously affect the quality of life of patients and bring about family and society heavey burden.Therefore it is an important significance for improve quality of life in patients with parkinsion's disease to assess and intervene the psychological and social functions.All the PD patients usally require many kinds of drugs,but it is difficult for patients with PD to adhere to long-term treatment beacause of many side effects.Although some drugs can improve PD syndromes in patients with PD,but it often bring about gastrointestinal symptoms,orthostatic hypotension,erythema limb pain,vasoconstriction,pulmonary and retroperitoneal fibrosis,pericarditis,even with psychiatric symptoms:visual hallucination, auditory hallucination,seriously affecting the quality of life of patients with PD.Currently, in spite of their social,psychological,spiritual and other aspects of the overall evaluation,the assessment of improvement of motion fuction was often considered as an indicator to treat patients with PD.Since the twentieth century,the traditional biomedical model has been changed into modern biological-psychological-social medical model,so the purpose of medication is not only prolongation of life,but also improve the quality of life(Quality of Life,QOL).Many existing internal and external researchs only focus on the design of the PD-specific scale and reliability and the evaluation of validity about the quality of life, However,Few studies on the evaluation of drug efficient based on the quality of life of PD-specific scale are reported.So,Drug efficacy was evaluated by the quality of life of PD-specific scale,then,it may provide a certain basis of rational and effective health care strategies.Few studies on the evaluations of clinical efficiency of dopamine receptor agonists Taishuda combined with madopar in patients with PD were reported.So,this study aimed to observe the clinical efficacy and evaluate safety,adverse events and medication compliance with measure scales,such as unified Parkinson's disease rating scale(UPDRS scale),modified Hoehn & Yahr classification(H-Y classification) and treatment side-effects Scale Treatment Emergent Symptom Scale(TESS Scale) et al.it may provide a certain basis of clinical treatment.Object and MethodsA randomized,controlled clinical trial research methods were performed.Experimental study was used in the period of October 2006-June 2007.Total of 226 cases consists of 135 male and 91 female match diagnosis of Parkinson's as experimental objects from HeNan People's Provincial Hospital,the fifth people's Hospital of Zhengzhou and the First Afiliated Hospital of Zhengzhou University.Objects are divided into two classes by the improved H-Y classification standards:H-Y 1.5-3 as Jia layer,H-Y 4 as Yi layer,then Jia,Yi groups were randomly assigned to intervention and control groups.Objects treated with Madopar in Control group,and the others treated with Madopar and Taishuda in intervention group.The course of treatment is 12 weeks.The study evaluate the reliability of the UPDRS scale based on Cronbach'a coefficient, the construct validity of the UPDRS scale based on factor analysis.The methods of completely random design were performed.To analysis the data of TESS score,UPDRS total score before and after treatment and changes in dimension scores beween the intervention group and control group with two-sample test and the incidence of adverse reactions with Fisher's exact test of probabilities,a=0.05. Results1.UPDRS scale reliability and validity of evaluation1.1 Reliability:The total Cronbach 'αcoefficient is 0.94,the Cronbach'αcoefficients of dimensions of UPDRSⅠ,UPDRSⅡ,UPDRSⅢrespectively is 0.890,0.878,0.976.So the scale has good reliability.1.2 Construct validity:factor analysis turn out three dimensions have larger load on the first common factor.1.3 Content validity:UPDRS scale has good content validity and each entry with its corresponding dimensions have positive correlation,the correlation coefficient range form 0.42 to 0.78.1.4 Standards of validity:the correlation coefficient between H-Y classification and total UPDRS scores is 0.56,UPDRSⅠscores is 0.79,UPDRSⅡscores is 0.69,UPDRSⅢscores is 0.49.So the scale has good validity.2.Effective evaluation2.1 The main effect indicators:After 12 weeks of treatment,decrease level of the total UPDRS score,UPDRSⅠ,UPDRSⅡ,UPDRSⅢscores in the intervention group(9.77±3.46,0.27±0.10,3.73±0.97,7.65±1.97) is respectively higher than the control groups(6.88±2.07,0.23±0.08,3.44±1.14,6.12±1.65),t(p) is 7.148(0.001),3.160 (0.002),2.005(0.046),6.040(0.001).2.2 The secondary effect indicators:the improvement of symptom of "on-off" is better in the intervention group than control groups(χ~2=10.32,P=0.01);the phenomenon of Pharmacy at the end reduse significantly in the intervention group(χ~2= 23.89,P=0.001);to reduce the amount of Madopar(F group=3.98,P=0.046);to improve the classification H-Y patients (χ~2= 0.333,P=0.002).3 Security Analysis and Evaluation:No significient difference was observed in the incidence of abnormal laboratory tests between the intervention group and control group(χ~2=1.390,P =0.238);significient difference was observed in the incidence of adverse reactions(χ~2=4. 609,P=0.032);significient difference was observed in TESS score(t=3.346,P=0.001). 4.Evaluation of medication compliance:the intervention group's compliance is 100%,the control group is 99.3%.Conclusion1.UPDRS scale has good reliability and validity.2.Taishuda combined with madopar in treatment for patients with PD has better effect than single usage of madopar.3.Application of TaiShuda can reduce the amount usage of madopar,side effects and the incidence of adverse reactions.