| Objective:Pramipexole extended release is a kind of nonergot dopamine agonists,application of controlled release drug slow release of skeleton implementation,to achieve "sustainable" dopamine stimulation,blood drug concentration is stable within 24 hours.This study by observing pramipexole extended release treatment the clinical curative effect and safety of idiopathic Parkinson's disease in China,to explore the extended release agent can better improve the motor symptoms of Parkinson's patients,decrease the levodopa usage,to extend the time of "open" period,and less adverse reaction,safe and reliable.In addition,it may improve the movement symptoms such as depression,sleep disorders.Methods:Collecting 113 cases of idiopathic Parkinson's disease,were randomly divided into pramipexole ER group(n = 45),IR group(n = 37)and L-dopa group(n = 31).Collection of gender,age,course of the disease,H&Y classification,time period of "open","off" period of time,whether to Parkinson's disease are taking other antibacterial drugs,and the general clinical data,such as the specific dose,then enter the drug for four weeks drop regularly symptoms improve the best or optimal tolerance dose,then doses maintenance period for 12 weeks.Among them 5 weeks can be adjusted according tocondition use dose dobutamine silk hydrazine.In 4,8,10,14 and 16 weeks for Parkinson's disease,comprehensive assessment scale(UPDRS)part II and III score,the Epworth sleepiness scale(ESS),Parkinson's sleep scale(PDSS),Hamilton depression rating scale-17(HAMD-17),the Chinese version of MOS SF-36 scale assessment,at the same time record "on-off" period of time,adverse reactions,etc.Using statistical methods of analysis of variance and rank and inspection analysis and comparison between groups before and after treatment between the rating scale difference,"on-off" period time difference,using the analysis of the correlation between HAMD scores and SF-36.Results:1.The mean change in UPDRS II +III scores from baseline to week 16 in the pramipxole ER and IR groups were higer than L-dopa group,the difference was obvious significant(P<0.05),but no significant sustained ER group and IR group(P>0.05).Moreover,the decreased usage of L-dopamine in the pramipxole ER group was higer than that of the pramipxoleIR group,but the difference was not statistically significant(P>0.05).2.After the treatment,the increased “on”time and decreased “off”time of pramipexole ER and IR groups were more than L-dopa group,the difference was obvious significant(P<0.05),but no significant sustained ER group and IR group(P>0.05).3.After the treatment,a significantly greater proprtion of pramipexole ER and IR subjects experimenced >20% improvement in UPDRS II+III scores compared with baseline than L-dopa group,the difference was significant(P<0.0125);but pramipexole extended release and immediate release of the effective rate was similar,the difference was not statistical significance(P>0.0125).4.Compared with baseline,the mean decreased scores of HAMD-17 and the mean increased scores of PDSS in the pramipxole ER group were higher than the pramipxole IR group and L-dopa group,and the difference was statistically significant(P<0.05).The5.There was no serious adverse reactions found in the three groups.The most common adverse reactions of the pramipexole groups were drowsiness,nausea and dizziness,the difference between the pramipexole ER group and the pramipexole IR group was not statistically significant(P>0.05).Conclusion:1?Pamipexole ER and IR were more significant than L-dopa to the improvement in PD patients with motor symptoms,extend the "on" time,reduce the usage of L-dopa;but the effience between ER and IR was similar.2?Pamipexole ER could improve the depression symptom and sleep disorder better than IR and L-dopa,the sustained release agent will become better in patients with Parkinson's disease(PD).3?Pamipexole ER was generally well-tolerated and reliable,which applies to the vast majority of patients with PD. |
PDF Full Text Request