| Bjective:This study aims to estimate the curative effect and safety of entacapone’s addition treatment in the Parkinson’s disease(PD)patients with wearing-off phenomenon who have accepted the levodopa compound preparation through the observation of 12 weeks.Methods:1、We choose 21patients up to the standard who come to the Neurology clinic of Sichuan Provincial People’s Hospital from 2014.05 to 2016.01 to join the study.The investigation drug is entacapone,and at the baseline interview,the researcher add relevant entacapone as the supplementary treatment of levodopa compound preparation,according to the previous levodopa compound preparation.This study has a baseline interiew,two follow-up visit(the sixth week and the twelfth week).2、return visit content and evaluation indicators:(1)"on"and"off"time:from"patient’s home diary";(2)Unified Parkinson Disease Rating Scale(UPDRS)part two and part three;(3)clinical global impression change(CGIC):investigator clinical global impression change(ICGIC)and patient clinical global impression change(PCGIC);(4)levodopa compound daily dosage;(5)adverse drug reaction;3、statistical analysis and interpretation:Use the SPSS 17.0 statistics software to do statistical analysis and interpretation.Measurement data is shown by mean±standard deviation((?)±s),and the comparison between the two means pre-and post-addition investigational product is processed by the"pairing t test".Ranked data is shown by median and interquartile range,and the comparison between the two samples pre-and post-addition investigational product is processed by the"rank sum test".We stipulate that there is a statistics significance if P<0.05.Results:1、Data statistics result and medicinal cure effect:1.1 UPDRS score result:UPDRS part two:baseline interiew:17.53±5.80,the sixth week:16.29±5.65,the twelfth week:15.299±5.76;UPDRS part three:baseline interiew:18.88±4.76,the sixth week:17.18±4.43,the twelfth week:15.88±4.61;The result suggested that both score of UPDRS part two and part three at the sixth week and at the twelfth week reduced than that at baseline interiew after the entacapone’s addition.The score of UPDRS part two at the sixth week and at the twelfth week comparing to the baseline interiew showned no significant differences(P>0.05)after the entacapone’s addition;The score of UPDRS part three at the sixth week and at the twelfth week comparing to the baseline interiew showned significant differences(P<0.05)after the entacapone’s addition.1.2 "on"and"off"time:"on" time at the baseline interiew:7.47±2.40hour,"off"time at the baseline interiew:7.53±2.37hour;"on" time at the sixth week:8.12±2.60hour,"off" time at the sixth week:7.18±2.30hour;"on" time at the twelfth week:8.53±2.74hour,"on" time at the twelfth week:6.76±2.31hour.The result suggested that entacapone’s addition treatment in the PD patients could prolong "on"time and shorten"off"time.The"on"and"off"time at the sixth week and at the twelfth week comparing to the baseline interiew showned no significant differences(P>0.05)after the entacapone’s addition.1.3 levodopa compound daily dosage:levodopa compound daily dosage at the baseline interiew:474.26±134.52mg/d;at the sixth week:437.50±110.49mg/d;at the twelfth week:422.79±78.22mg/d.When it is converted to levodopa daily dosage we obtain that levodopa daily dosage at the baseline interiew:379.42±107.61mg/d;at the sixth week:350.00±88.39mg/d;at the twelfth week:338.24±62.57mg/d.The result suggested that entacapone as the supplementary treatment of levodopa compound preparation could reduce levodopa daily dosage comparing to the baseline interiew.Levodopa daily dosage at the sixth week after entacapone’s addition comparing to the baseline interiew showned no significant differences(P>0.05).Levodopa daily dosage at the twelfth week after entacapone’s addition comparing to the baseline interiew showned significant differences(P<0.05).1.4 clinical global impression change(CGIC):statistics investigator clinical global impression change(ICGIC)and patient clinical global impression change(PCGIC)at the baseline interiew and respectively after entacapone’ s addition,the result suggested that ICGIC at the baseline interiew:very remarkable improvement,remarkable improvement and some improvement are all 0 patients,no improvement:17 patients,deterioration,some deterioration and remarkable deterioration are all 0 patient;PCGIC at the baseline interiew:very remarkable improvement,remarkable improvement and some improvement are all 0 patients,no improvement:17 patients,deterioration,some deterioration and remarkable deterioration are all 0 patient;ICGIC at the sixth week:very remarkable improvement:1 patient,remarkable improvement:3 patients,some improvement:7 patients,no improvement:6 patients,deterioration:0 patient,some deterioration:0 patient,remarkable deterioration:0 patient;PCGIC at the sixth week:very remarkable improvement:2 patient,remarkable improvement:2 patients,some improvement:8 patients,no improvement:5 patients,deterioration:0 patient,some deterioration:0 patient,remarkable deterioration:0 patient;ICGIC at the twelfth week:very remarkable improvement:1 patient,remarkable improvement:4 patients,some improvement:7 patients,no improvement:4 patients,deterioration:1 patient,some deterioration:0 patient,remarkable deterioration:0 patient;PCGICat the twelfth week:very remarkable improvement:2 patient,remarkable improvement:3 patients,some improvement:6 patients,no improvement:5 patients,deterioration:0 patient,some deterioration:1 patient,remarkable deterioration:0 patient;The result suggested that ICGIC and PCGIC are improved to a certain degree by Entacapone’s addition treatment in PD patients.ICGIC at the sixth week comparing to the baseline interiew showned significant differences(P<0.05);ICGIC at the twelfth week comparing to the baseline interiew showned significant differences(P<0.05);PCGIC at the sixth week comparing to the baseline interiew showned significant differences(P<0.05);PCGIC at the twelfth week comparing to the baseline interiew showned significant differences(P<0.05);2、adverse drug reaction:there is one adverse event in this study who quit follow-up visit;Motion complication happened to a patient and the symptom improved at a certain extent through the adjustment of levodopa compound dosage and the addition of Das;The harmless change of urine colour happened to two patients,and the symptom sustained for 2weeks,so we did no special dispose;Nausea,vomiting and disrrhea happened to one patient,and the symptom sustained for 1 weeks;Light swirl and headache happened to two patients,and the symptom sustained for a short time,so we did no special dispose;Neck and shoulder pain,waist,arms and legs aching pain happened to one patient,which improved by the additian of Tizanidine Hydrochloride.Light pharynx dryness happened to one patient who could tolerate so we did no special dispose.conclusion:1、This study shows that entacapone’s addition treatment in the PD patients with wearing-off phenomenon could decrease the score of UPDRS part three,improve the symptoms of PD patients,reduce levodopa compound daily dosage,and that ICGIC、PCGIC are improved to a certain degree.2、As a whole,the tolerance of entacapone’ s addition treatment in this study is well,but there are some adverse events and reactions in some patients after entacapone’ s addition treatment in this study,therefore,the tolerance and safety of entacapone should be tested and verified futher more. |
PDF Full Text Request