| Objective:Placebo-controlled evaluation rasagiline mesylate tablets as adjunct to levodopa preparations in patients with symptomatic treatment of idiopathic Parkinson’s volatility efficacy and safety.Methods:Three hundred thirty-three parkinson,s disease patients all used levodopa as based drug, they choose one as daily kind and dose, patients were randomly divided into two groups, test group and placebo group, and used rasagiline or placebo respectively. The initial dose of rasagiline and placebo was 0.5mg/d in first two weeks, then added dose to 1mg/d until the fifteen week, the dose reduced to 0.5mg/d till the test accomplished.After test started, patients needed to follow-up in the second, sixth, tenth, fourteenth,sixteenth week, returned old dairy card and got new dairy card, scored UPDRS form,did safety examination, told doctor adverse reactions and so on. After the test finished,random number would be divided into A group and B group in the first uncovering.After statistics of efficacy indexes and adverse reactions, efficacy and safeness in each patient was evaluated. The last, test group and placebo group was determined by the second uncovering.Results:1. The key efficacy index: after sixteen weeks, therapy, difference of the close time in every day compared with initial time, A group was(1.00±1.50)h, B group was(0.03±1.14)h, it had statistical significance to compare the change of difference of A and B group(t=6.58, P<0.0001).2. The secondary efficacy indexes: after sixteen weeks, therapy, difference of UPDRS all-score compared with initial score, A group was(11.99±14.08), B group was(4.37±9.41), it had statistical significance to compare the change of difference of A and B group(Z=5.80, P<0.0001). Difference of UPDRS-I score compared with initial score, A group was(0.55±1.38), B group was(0.24±1.30), it had statistical significance to compare the change of difference of A and B group(Z=2.33, P<0.05).Difference of UPDRS-II score compared with initial score, A group was(3.51±4.04),B group was(1.25±3.28), it had statistical significance to compare the change of difference of A and B group(Z=5.10, P <0.0001). Difference of UPDRS-III score compared with initial score, A group was(7.21±1.38), B group was(2.52±6.07), it had statistical significance to compare the change of difference of A and B group(Z=5.20, P<0.0001). Difference of UPDRS-IV score compared with initial score, A group was(0.71±1.16), B group was(0.36±1.17), it had statistical significance to compare the change of difference of A and B group(Z=3.00, P<0.05).Dose of Levodopa every day compared with initial dose, A group was(0.27±73.66)mg, B group was(-14.95±59.46)mg, it had statistical significance to compare the change of difference of A and B group(Z=2.98, P<0.05).3. Safety indexes: The incidence of adverse events, A group was 41.21%, B group was 32.53%, it had no statistical significance to compare difference of two groups( ? 2=2.68, P=0.1016); the incidence of serious adverse events, A group was 0.00%, B group was 0.60%, it had no statistical significance to compare difference of two groups(P=1.0000). The incidence of adverse reaction, A group was 28.48%, B group was 15.66%, it had statistical significance to compare difference of two groups( ? 2=7.91, P<0.05), except vomit( ? 2=5.10, P=0.0240), the other adverse reactions had no statistical significance.Conclusion:Levodopa combined with rasagiline mesylate tablets have better efficacy in relieving on-off phenomenon, relieving motor fluctuations, reduce increasing extent of levodopa dosage than used levodopa alone, and have good safety, have important clinical significance. |
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