Observation Of Curative Effect Related To Entacapone’s Addition Treatment In Parkinson’s Disease With Wearing-off Of China

Objective:1.Observe the curative effect and security of entacapone in the treatment of Parkinson’s disease patients with the Wearing-Off phenomenon(WO);2.Collect the interim efficacy data of entacapone in the treatment of patients with Parkinson’s disease in BenQ Hospital;3.Statistical data on the efficacy and safety of entacapone in the treatment of patients with Parkinson’s disease.Methods:The patients who were diagnosed with Parkinson’s disease according to the UK criteria were collected from the Neurology Department of Nanjing BenQ Hospital during January 2015 to February 2017.Finally,32 patients were enrolled.Entacapone(Ent)is a research drug.All patients enrolled received levodopa for over 90 days and had not been treated with entacapone in the past 90 days;patients admitted to the neurology department were enrolled in the group for the end of the Wearing-Of(WO)phenomenon.All patients underwent H-Y staging,and some scales were evaluated before adding entacapone and at 2nd and 8th weeks after the addition.The evaluation scale includes:Unified Parkinson’s Disease Rating Scale(UPDRS)Ⅱ,Ⅲ partial score;patient clinical global impression change(P-CGI-C);investigator clinical global impression change(I-CGI-C);daily oral levodopa oral dose;adverse effects after adding Ent.The data were statistically analyzed by SPSS 17.0.The data of normal distribution measurement data were described by mean±standard deviation(x±s),and the paired t test was used for comparison.The grade data was calculated by quartile spacing(Q)and median(M)description,using the rank sum test,the results were statistically significant at P<0.05.Results:1.General information:A total of 34 patients with Parkinson’s disease were diagnosed in the primary diagnosis,and 1 patient was lost in the follow-up.One patient with Parkinson’s syndrome was diagnosed later and 32 patients were eventually enrolled.H-Y staging was performed before treatment,There were 11 patients with H-Y staging<2 and 21 patients with H-Y staging>2.There were 21 males and 11 females.The age ranged from 51 to 84 years,with an average of 67.8±9.5 years.The course of disease was from 3 years to 16 years,with an average of 7.8±3.5 years.2.UPDRS score result:Compared with entacapone before treatment,UPDRS Ⅱ and UPDRS Ⅲ scores gradually decreased after entacapone treatment,and UPDRS Ⅱ and UPDRS Ⅲ were more obvious as treatment time prolonged.The UPDRSII fraction-daily living ability was P=0.125 compared with baseline in the 2nd week after the addition of Ent treatment,and The UPDRSII fraction-daily living ability was statistically significant at P<0.05 compared with baseline in the 8th weeks after the addition of Ent treatment.The UPDRSIII fraction after the addition of Ent-sports-motor function at 2nd and 8th weeks was statistically significant at P<0.05 compared with that of the baseline.3.Clinical global impression change(CGIC):I-CGI-C and P-CGI-C were improved to some extent in most patients after the addition of Ent.There were the differences significant statistically at P<0.05.compared with I-CGI-C before and after the treatment with Ent in the 2nd week and those of in the 8th week,as well as those of P-CGI-C.4.Levodopa compound daily dosage:The daily oral dose of the compound L-dopa preparation before the Ent treatment and the daily oral dose of the compound L-dopa preparation at the 2nd week and the 8th week after the Ent treatment.The differences between daily oral dose of the compound L-dopa preparation at the 2nd week and that of the 8th week were statistically significant(P<0.05).5.Adverse drug reaction:In this trial,There were 2 patients developed nausea,vomiting and diarrhea,which lasted for about 2 weeks.There were 3 patients developed urine color changes,which were not treated.They disappeared after about 2 weeks.Four patients developed dizziness and were relatively mild.Symptoms were relieved after symptomatic treatment,and no special treatment was performed.1 patient developed dyskinesia,no serious adverse drug events occurred in all patients.ConclusionThe end-of-agent phenomenon is the most common motor complication.The parkinson’s patients with end-of-agent symptoms were sustained increase in traditional levodopa therapy,however entacapone can improve their motor function and reduce their UPDRSII and UPDRSⅢ scores.The overall clinical impression of most researchers and patients has been greatly improved.The patients included in this study were well tolerated after receiving entacapone.A few of them have some adverse reactions which will be improved later.Therefore,a larger sample and longer observation timeline will be required to verify the safety of entacapone treatment.