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Levodopa population pharmacokinetic modeling approach and Duo Basi hydrazine combined dopamine agonists for Parkinson's disease clinical observation

Author: GuoXianZhong
Tutor: WangChangLian；WuGang
School: Fujian Medical
Course: Pharmacology
Keywords: Levodopa Population pharmacokinetics Nonlinear mixed effects models High performance liquid chromatography - electrochemical method Parkinson's disease Dopamine agonists Pramipexole Piribedil
CLC: R969.1
Type: Master's thesis
Year: 2010
Downloads: 93
Quote: 1
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Abstract


Objective: 1. Examine levodopa in Parkinson's disease patients and healthy Chinese people groups pharmacokinetic characteristics. 2 combination study pramipexole or hydrazine Duo Basi Piribedil efficacy and safety. Method: 1. Collect hydrazine Duo Basi taking tablets Parkinson's disease (Parkinson's disease, PD) 117 cases of 124 outpatients steady-state concentration of blood samples and 153 healthy volunteers, 13 cases of intensive blood samples by high performance liquid chromatography - Electric Chemistry (HPLC-ECD) method for the determination of levodopa (Levodopa, LD) plasma concentration, and nonlinear mixed-effects model (NONlinear Mixed Effects Model, NONMEM) fixed effects method investigated the impact of the LD clearance. 2.40 cases of PD patients who underwent open, parallel-group controlled clinical trials. Two groups of patients were routinely taking Duo Basi hydrazine tablets, and in the event of symptoms or motor fluctuations, respectively added with pramipexole and piribedil. Using the Unified Parkinson's Disease Rating Scale (Unifited Parkinson's Disease Rating Scale, UPDRS) on the patient's symptoms were scored. After 12 weeks of combination therapy treatment, to various parts of UPDRS score change relative to baseline for the indicators to assess efficacy. And through monitoring of blood pressure and adverse reactions were compared regimens of security. Results: 1. PD patients with LD population pharmacokinetic (Population Pharmacokinetics, PPK) final fitting model are: the central clearance; central apparent volume of distribution V (L) = θV; absorption constant (1) kah? = Θka. Among them, the age (AGE) is an important factor affecting CL. (2) After 12 weeks of treatment, pramipexole group and Piribedil group of the UPDRS score from baseline were decreased (P lt; 0.05). Pramipexole group and Piribedil group UPDRS-Ⅰ mean score decreased by 1.65 points and 0.95 points, the differences between the two groups was statistically significant (P lt; 0.05); groups UPDRS-Ⅳ mean score decreased 1.35 points and 1.0 points, the difference was statistically significant (P lt; 0.01); rest UPDRS score between the two groups showed no statistically significant decrease (P gt; 0.05). The total clinical efficiency: pramipexole group was 80%, Piribedil group was 75%, the difference between the two groups was not statistically significant (P gt; 0.05). The incidence of adverse drug reactions both groups, the difference was not statistically significant (P gt; 0.05). Conclusion: This paper initially established taking Duo Basi hydrazine tablets LD PPK model of PD patients, combined with the patient's age and drug use can be estimated LD clearance for the development of individualized dosing regimens provide evidence. 2 pramipexole or Piribedil hydrazine Duo Basi combination therapy with PD obtain more significant short-term effect.

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