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ObjectiveTo investigate the effects of dopamine receptor agonist pramipexole and levodopa on emotion and cognition, and mitochondrial membrane potential of rats after global cerebral ischemia-reperfusion injury. MethodsA total of 80 male Sprague-Dawley rats were divided into sham group (n = 20), model group (n = 20), pramipexole group (n = 20) and combined group (n = 20). The latter three groups were used to prepare the model of global cerebral ischemia-reperfusion injury with Pulsinelli's four-vessel occlusion. The pramipexole group was intraperitoneally injected pramipexole 0.5 mg/kg once a day, while the combined group was injected levodopa 50 mg/kg and pramipexole 0.5 mg/kg, for 14 days. Five rats in each group were tested with open field test three, seven and 14 days after modeling; five were tested with Y-maze test seven and 14 days after modeling; five were detected mitochondrial membrane potential three, seven and 14 days after modeling; and five were observed under Nissl's staining14 days after modeling. ResultsCompared with the model group, the number of entries into the central zone (P < 0.05), total distance travelled (P < 0.05) and average velocity (P < 0.05) in the open field test increased in the pramipexole and combined groups seven and 14 days after modeling, duration spent in the central zone increased in the pramipexole and combined groups seven days after modeling (P < 0.05); the rate of spontaneous alternation of Y-maze test increased in the pramipexole and combined groups 14 days after modeling (P < 0.05); mitochondrial membrane potential in hippocampus increased in the pramipexole and combined groups seven and 14 days after modeling (P < 0.05), and it was less in the pramipexole group than in the combined group 14 days after modeling (P < 0.05); and the number of surviving neurons in the hippocampal CA1 increased in the pramipexole and combined groups 14 days after modeling (P < 0.05). ConclusionPramipexole may improve emotion and cognition of rats after global cerebral ischemia-reperfusion injury, and it may be helpful for restoring mitochondrial membrane potential as combining with levodopa.
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Rotigotina e outros medicamentos antiparkinsonianos, com ênfase em agonistas dopaminérgicos (bromocriptina e pramipexol). Indicação: Tratamento da doença de Parkinson. Pergunta: Há superioridade de eficácia e segurança da rotigotina, comparado aos agonistas dopaminérgicos disponíveis atualmente no SUS para o tratamento da doença de Parkinson? Revisão rápida de evidências (overview) de revisões sistemáticas, com levantamento bibliográfico realizado na base de dados PubMed e utilizando estratégia estruturada de busca. A qualidade metodológica das revisões sistemáticas foi avaliada com AMSTAR-2 (Assessing the Methodological Quality of Systematic Reviews Version 2). Foram selecionadas três revisões sistemáticas que atendiam aos critérios de inclusão. A rotigotina não apresenta eficácia e segurança superiores ao pramipexol; não há quantidade de estudos suficientes para comparação com a bromocriptina
Rotigotine and other antiparkinsonians medicines, with emphasis on dopaminergic agonists (bromocriptine and pramipexole). Indication: Treatment of Parkinson disease. Question: Is rotigotine more effective and safer than other dopamine agonists available in the Brazilian Public Health System for the treatment of Parkinson's Disease? Rapid evidence review (overview) from systematic reviews, with a literature search in the PubMed database by employing a structured strategy. The methodological quality of systematic reviews was evaluated using AMSTAR-2 (Assessing the Methodological Quality of Systematic Reviews Version 2). Three systematic reviews that met the inclusion criteria were selected. Rotigotine has not shown superior efficacy and safety when compared to pramipexole; there are insufficient studies for comparison with bromocriptine
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Parkinson Disease/drug therapy , Bromocriptine/therapeutic use , Dopamine Agonists , Pramipexole/therapeutic use , Antiparkinson Agents/therapeutic useABSTRACT
Objective:To investigate the efficacy of levodopa and benserazide hydrochloride combined with pramipexole in the treatment of Parkinson's disease in 30 patients and their effects on neurotransmitters and oxidative stress response.Methods:A total of 90 patients with Parkinson's disease admitted to Jinhua People's Hospital from January 2020 to February 2022 were included in this study. They were randomly assigned to undergo treatment with levodopa and benserazide hydrochloride (levodopa and benserazide hydrochloride group), pramipexole (pramipexole group), or their combination (combined therapy group), with 30 patients in each group. All patients were treated for 12 consecutive weeks. Clinical efficacy, levels of brain neurotransmitters (dopamine, 5-hydroxytryptamine, norepinephrine, and substance P), and oxidative stress response (superoxide dismutase, malondialdehyde, homocysteine levels) were compared among the three groups.Results:Total response rate in the combined therapy group was 96.67% (29/30), which was significantly higher than 66.67% (20/30) in the levodopa and benserazide hydrochloride group and 76.67% (23/30) in the pramipexole group ( χ2 = 8.65, P < 0.05). After treatment, dopamine, 5-hydroxytryptamine, norepinephrine, substance P, superoxide dismutase, malondialdehyde, and homocysteine levels in the combined therapy group were (9.05 ± 1.24) ng/mg, (89.49 ± 10.69) μg/L, (15.16 ± 1.36) ng/mg, (102.8 ± 15.36) μg/L, (88.40 ± 10.04) kU/L, (5.5 ± 2.31) μmol/L, and (9.20 ± 3.36) μmol/L, respectively, which were superior to (6.61 ± 1.02) ng/mg, (68.52 ± 9.52) μg/L, (12.33 ± 1.24) ng/mg, (151.64 ± 16.03) μg/L, (74.99 ± 7.28) kU/L, (9.27 ± 3.07) μmol/L, and (13.52 ± 3.64) μmol/L in the levodopa and benserazide hydrochloride group and (7.22 ± 1.09) ng/mg, (79.52 ± 10.20) μg/L, (13.92 ± 1.31) ng/mg, (131.30 ± 15.65) μg/L, (80.59 ± 8.24) kU/L, (7.53 ± 2.93) μmol/L, (11.35 ± 3.71) μmol/L in the pramipexole group ( F = 38.53, 32.05, 35.49, -73.42, 18.42, -22.65, -12.13, all P < 0.05). Conclusion:Levodopa and benserazide hydrochloride combined with pramipexole are highly effective on Parkinson's disease. The combined therapy can effectively improve brain neurotransmitters and regulate oxidative stress response.
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AIM: To assess the bioequivalence of pramipexole hydrochloride tablets with reference(Sifrol). METHODS: A randomized, open-label, 2-period crossover study was conducted in 48 healthy Chinese volunteers under fasted or fed conditions (24 volunteers for each condition). In each session, the subjects received a single oral dose of 0.25 mg test (T) or reference (R) formulation. Pramipexole concentrations in plasma were determined by a validated HPLC-MS/MS. Pharmacokinetic parameters were calculated using a non-compartmental model through Phoenix WinNonlin version 6.4. Other statistic analysis were analyzed by using software of SAS 9.3. RESULTS: The pharmacokinetic parameters of test drug and reference drug under fasted condition(n=20) were: C
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Objective Evaluating the effect of Shugan-Jieyu capsule combined with pramipexole on depressive symptoms in parkinson's disease(PD) patients.MethodsAccording to the criteria of including and excluding, we collected 63 PD depression cases who visited doctors at neurological outpatient room between June 2014 and April 2016.35 cases only treated with pramipexole, designed as pramipexole group, and 28 cases treated with pramipexole and Shugan-Jieyu capsule, designed as combined treatment group.The Hamilton depression scale(HAMD), activities of daily living scale(ADL) and unified Parkinson's disease rating scale-part III(UPDRS-III) were assessed at baseling, week 6 and week 9.ResultsAt week 9, HAMD was (17.71±6.78) in pramipexole group versus (14.32±4.81) in combined treatment group, there was significant difference between the two groups(P=0.029), As for HAMDΔ9, analysis did show a significant difference(pramipexole group (-11.06±3.27) vs combined group (-14.93±6.24);P=0.002).Analysis showed a significant difference as for ADLΔ6(pramipexole group (-2.37±1.31) vs combined group (-3.57±2.04);P=0.006) at week 6.There was no significant difference between groups for the reduction in total UPDRS-III scale.No serious adverse event was recorded during treatment of depression.ConclusionShugan-Jieyu capsule combined with pramipexole did have significant effects versus pramipexole on depressive symptoms in PD patients.
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OBJECTIVE ① To estimate the value of the subacute MPTP mouse model in aspects of behavioral performance, biochemical changes and pathological abnormalities. ② To find effective positive drugs. METHODS Male C57BL/6 mice were injected with MPTP (30 mg·kg- 1 ·d- 1, ip) for 5 consecutive days. Three days before MPTP injection, the mice were orally administered selegiline (3 mg·kg-1·d-1), pramipexole (3 mg·kg-1·d-1), or medopar (100 mg·kg-1·d-1) for 18 d. Behavioral perfor?mance was assessed in the open field test, pole test and rotarod test. Neurotransmitters in the striatum were detected using HPLC. Protein levels were measured by Western blot. Pathological characteristics were examined by immunohistochemistry. Ultrastructure changes were observed by electron microscopy. RESULTS The subacute MPTP treatment did not induce evident motor defects despite severe injuries in the dopaminergic system. Additionally, MPTP significantly increased the α-synuclein levels and the number of astrocytes in the striatum, and destroyed the blood-brain barrier (BBB) in the substantianigra pars compacta. Both selegiline and pramipexole were able to protect the mice against MPTP injuries. CONCLUSION The subacute MPTP mouse model does not show visible motor defects; it is not enough to evaluate the validity of a candidate just based on behavioral examination, much attention should also be paid to the alterations in neurotransmitters, astrocytes, α- synuclein and the BBB. In addition, selegiline or pramipexole is a better choice than medopar as an effective positive control for the subacute MPTP model.
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Objective To investigate the effect of pramipexole in the treatment of Parkinson after stroke .Methods 94 cases with Parkinson after stroke in our hospital from June 2013 to November 2015 were randomly selected and divided into two groups,47 cases respectively.Control group received routine etiological and symptomatic treatment, the study group received conventional therapy and symptomatic treatment and pramipexole treatment,two groups were treated for eight weeks.Parkinson’s disease scores,inflammatory cytokines and oxidative stress index,and the clinical effect and complications of contrast were compared after the treatment.Results Compared with before treatment,scores of daily activities of emotion integral integral,the motor function in two groups decreased,levels of serum IL-1β,IL-6,TNF-αand Hs-CRP decreased,levels of CAT,T-SOD,T-GSH in plasma increased (P<0.05),and compared with the control group,scores of daily activities of emotion integral integral,the motor function in the study group were lower,levels of serum IL-1β,IL-6,TNF-αand Hs-CRP were lower,levels of CAT,T-SOD,T-GSH in plasma were higher (P<0.05),and the total effective rate in the study group 91.49% was higher than the control group 74.47% (P<0.05).Conclusion Pramipexole in the treatment of Parkinson after stroke was effective with high safety,and it can reduce Inflammatory factors and increase oxidative stress.
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Objective To investigate the effects of pramipexole on serum cystatin C, antioxidant indexes and brain derived neurotrophic factor ( BDNF) in the treatment of patients with Parkinson’s disease.Methods Retrospective a total of 96 patients with Parkinson’s disease were collected and randomly divided into experimental group and control group with 48 cases in each group.Patients in the control group were treated by levodopa,patients in the experimental group were treated on the basis of the control group with pramipexole, movement and non-movement symptoms were assessed by unified Parkinson’ s disease rating scale ( UPDRS), the serum cystatin C, antioxidant indexes and brain derived neurotrophic factor levels were measured, and the clinical efficacy and adverse reactions were compared.Results The effective rate of the control group (68.75%) was lower than the experimental group (87.50%), with statistical significance (P<0.05); compared with the control group, the movement and non-movement symptoms of the experimental group reduced after treatment, after treatment the serum CRP, serum cystatin C decreased, serum BDNF increased, after treatment the glutathione (GSH), catalase (CAT), superoxide dismutase (SOD) and glutathione peroxidate (GPX) levels increased, with statistical significance (P<0.05).Conclusion Pramipexole in the treatment of patients with Parkinson’s disease could reduce serum cystatin C, improve the levels of BDNF and antioxidant capacity, the effect is remarkable.
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Objective To discuss the clinical effect of behavioral therapy combined with pramipexole in patients’ degree of depression and non-motor symptoms in early-onset Parkinson’s disease and depression.Methods A total of 74 cases of patients with early-onset Parkinson’s disease and depression were equally divided into observation group and control group, 37 cases in each groups.Patients in control group were given pramipexole, while patients in observation group were given pramipexole and behavioral therapy.The hamilton depression ( HAMD) scale, Zung self-rating depression scale and unified Parkinson’s disease rating scale ( UPDRS ) were used to evaluate and measure the change of degree of depression and non-motor symptoms.Results Before treatment, the HAMD score, Zung score, UPDRS II score and UPDRS III score between two groups had no statistical difference; after treatment, the HAMD score, Zung score, UPDRS II score and UPDRS III score in two groups were significantly decreased (P<0.05). The HAMD score, and Zung score between two groups had no statistical difference at the end of 4th weekends, and compared with control group, those scores in observation group were much better at the end of 8th and 12th weekend (P<0.05).The UPDRS II and UPDRS III between two group had no statistical difference at the end of 4-8th week, while those scores in observation group were better than those in control group at the end of 12th week(P<0.05).Conclusion Behavioral therapy combined with pramipexole has a great effect on the improvement of patients’ degree of depression and non-motor symptoms, which has a positive promotion on patients’ life quality.
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Objective To study curative efficacy of Pramipexole in treatment of Parkinson's Disease and its effects on Serum C-reactionprotein (CRP), cystatin C, brain derived neurotrophic factor(BDNF) and oxidative stress.Methods 100 patients of Parkinson's Disease who received therapy from February 2014 to April 2016 in our hospital were selected as research objects were randomLy divided into control group and observation group, 50 patients in each group.The control group was treated with Dobasidate tablets;The observation group was given pramipexole tablets on the basis of the control group.Then the clinical effects and adverse reactions were compared.CRP, Cystatin C, BDNF and oxidative stress were measured. Results After treatment, the total effective rate of the observation group [(90.00% (45/50)] was significantly higher than the control group[74.00%(37/50)] (P<0.05);The symptoms of palpitation, depression, nausea, anorexia, diarrhea and vomiting were lower in observation group than in observation group, and the differences of depression, anorexia and vomiting were statistically significant(P<0.05);The BDNF index of the observation group (13.38 ±1.93)ng/L was higher than that of the control group (12.03 ±1.83) ng/L(P<0.05);CRP (3.53 ±0.97) mg/L and Cystatin C index (0.98 ±0.12) mg/L were lower than the control group(4.62 ±1.15)、(1.06 ±0.14) mg/L (P<0.05).After treatment, the glutathione peroxidate (GPX),superroxide dismutase(SOD),glutathione(GSH)and catalase(CAT) of oxidative stress in observation group were higher than those in control group,the difference was statistically significant (P<0.05).Conclusion Pramipexole in the treatment of Parkinson's disease is obvious, can effectively improve the serum CRP, Cystatin C and BDNF index, high security, it is worth promoting the application.
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OBJECTIVE To analyze impulsive-like behaviors of SD rats induced by pramipexole in Y-maze avoidance tasks. METHODS Behaviors of SD rats in Y-maze avoidance tasks were recorded with a camera and analyzed by Noldus Etho Vision XT8 software after acute subcutaneous injection of pramipexole(0.1,1 and 10 mg · kg-1),including right reaction numbers of 20 consecutive avoidance tasks,shuttle number of times between the three arms of Y-maze, distance covered in Y-maze and time spent in safe arms during 20 consecutive avoidance tasks. Then,the prepulse inhibition(PPI)of the startle reflex test was used to assess the effect of pramipexole on sensorimotor gating (SG). Effects of pramipexole on the dialyzed content of monoamine neurotransmitter and its metabolites in the striatum and amygdala of SD rats were measured by microdialysis in vivo. RESULTS Compared with normal control group,the rats of pramipexole group showed a significant increase in the shuttle number of times and distance covered in Y-maze between Y-maze avoidance tasks(P<0.01),but a statistically significant decrease in the time spent in safe arms(P<0.01),while the number of right reactions in Y-maze avoidance tasks was not changed. Such premature responses were quite similar to certain impulsive-compulsive behaviors in rodent models,such as five-choice serial reaction time tasks. In the PPI test,pramipexole displayed an impairing effect on SG(P<0.01). The microdialysis results showed that there was an increase of dopamine and 5-hydroxytryptamine in the striatum of pramipexole group, but not statistically significant. Monoamine neurotransmitters and their metabolites were not significantly changed in the amygdala. CONCLUSION Pramipexole can induce impulsive-compulsive behaviors in Y-maze avoidance tasks,which might be attributed to impaired SG.
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abstract The antiparkinson agent pramipexole dihydrochloride monohydrate was quantified in pharmaceutical products by high performance liquid chromatography (HPLC) and derivative spectrophotometry. The first method was based on HPLC using tamsulosin HCl as an internal standard. In this method, chromatographic separation was achieved using a LiChrospher 60 RP column at 25°C, with a flow rate of 1.0 mL/min at 263 nm. The eluent comprised 0.01 mol/L ammonium acetate (pH 4.4) and acetonitrile (35:65 by volume). The linearity range was found to be 10.0-30.0 µg/mL with a mean recovery of 100.5 ± 1.10. The limit of detection (8 ng/mL) and limit of quantification (50 ng/mL) were calculated. In the second method, the first derivative spectrophotometric technique for the determination of pramipexole dihydrochloride monohydrate was performed by measuring the amplitude at 249 and 280 nm. In the first derivative technique, the absorbance and concentration plot was rectilinear over the 5.0-35.0 µg/mL range with a lower detection limit of 1.5 ng/mL and quantification limit of 4.5 ng/mL. The typical excipients included in the pharmaceutical product do not interfere with the selectivity of either method. The developed methods were validated for robustness, selectivity, specificity, linearity, precision, and accuracy as per the ICH and FDA guidelines (ICH Q2B, 1996; FDA,2000). In conclusion, the developed methods were successful in determining the quantity of the antiparkinson agent pramipexole dihydrochloride monohydrate in pharmaceutical products. The RSD values for the pharmaceutical product used in this study were found to be 0.97% for the HPLC method and 0.00% for the first derivative spectrophotometric method.
resumo O fármaco antiparkinsoniano, dicloridrato de pramipexol monoidratado, foi quantificado no produto farmacêutico por cromatografia líquida de alta eficiência (CLAE) e espectrofotometria derivada. No primeiro método baseado na CLAE, o cloridrato de tansulosina foi usado como padrão interno. Nesse método, a separação cromatográfica foi realizada usando uma coluna Lichrosper 60 RP a 25 °C e acetato de amônio 0,01 mol/L (pH:4.4): acetonitrila (35:65 em volume) como eluente com fluxo de 1,0 mL /min a 263 nm. A faixa de linearidade foi de 10.0-30.0 µg/mL com média da recuperação 100.5 ± 1.10. O limite de detecção (8 ng/mL) e o limite de quantificação (50 ng/mL) foram calculados. Por outro lado, a primeira técnica de espectrofotometria derivada para a determinação de dicloridrato de pramipexol monoidratado foi realizada através da medida da amplitude a 249 e 280 nm. Na técnia da primeira derivada, a absorvância e a plotagem da concentração foi retilínea na faixa de 5.0-35.0 µg/mL com limite inferior de detecção de 1.5 ng/mL e limite de quantificação de 4.5 ng/mL. Os excipientes típicos incluídos no produto farmacêutico não interferem com a seletividade dos métodos. Os métodos desenvolvidos foram validados quanto à robustez, seletividade, especificidade, linearidade, precisão e exatidão de acordo com as diretrizes do ICH e FDA (ICH Q2B,1996; FDA,2000). Concluindo, os métodos propostos foram aplicados com sucesso para a determinação quantitativa do agente antiparkinsoniano dicloridrato de pramipexol monoidrato em produtos farmacêuticos. Os valores de RSD para o produto farmacêutico utilizado neste estudo foi 0.97% para a CLAE e 0.00% para o método de espectrofotometria de primeira derivada.
Subject(s)
Pharmaceutical Preparations , Chromatography, High Pressure Liquid/methods , Antiparkinson Agents/analysis , SpectrophotometryABSTRACT
Objective To investigate and analysis the clinical effect of pramipexole in Parkinson's disease with depression.Methods The patients with Parkinson disease patients with depression were selected in a total of 100 as the research object,and were randomly divided into two groups,the observation group and the control group with 50 cases in each group.The control group was taken conventional treatment,the observation group was given pramipexole based on the conventional treatment methods,the the effects of treatment were observed and compared. Results The MIHD score of the observation group after treated for 12 month (8.26 ±1.96)was lower than the score before treatment (24.91 ±4.6),and the score of the control group after treated for 12 month (11.15 ±2.10)was also lower than the score before treatment (24.48 ±5.34),the difference were all statistically significant(P<0.05). After treated for 12 month,the score in the observation group was lower than that in the control group,and the total effective rate in the two group were 94% and 80% respectively(P<0.05 ).The UPDRS score of the observation group was lower than in the control group,but the difference was not significant(χ2 =14.756,P<0.05).Conclusion Give pramipexole has notable curative effect on the depression disease in patients with Parkinson disease on the basis of conventional therapy method,and has the value of popularization.
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Restless Legs Syndrome (RLS)/Willi’s-Ekbom disease (WED) or Jimmy Legs is a neurological sensory-motor disorder that causes intense restlessness and unpleasant creepy-crawly feelings inside the lower legs at rest. It can be primary (idiopathic) or secondary (symptomatic) and affects 7-10% of general population with a significant female predominance. RLS is generally associated with conditions like iron deficiency, low serum ferritin levels, pregnancy, menopause, chronic renal disease, diabetes mellitus, cardiovascular disease, Parkinson’s disease and rheumatoid arthritis etc, however, the relationship is not completely understood. In this review, I discussed recent developments on epidemiology, etiology, pathogenesis, diagnosis and clinical management of RLS.
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@#The formulations of pramipexole hydrochloride sustained-release tablets were screened by single factor test and optimized by Box-Behnken design. The effects of the viscosity and content of hydroxypropyl methyl cellulose, as well as the insoluble sustained-release material combined with HPMC K100M on the in vitro release behavior were investigated. After single factor screening, a three-factor, three-level Box-Behnken design was used for optimization using the contents of HPMC K100, Eudragit RSPO and Eudragit L100 as independent variables, and the cumulative release at different time as responses. The optimal range of the three-factor optimized by Box-Behnken design, one of the optimized formulations was achieved with HPMC K100M of 101. 5 mg, Eudragit RSPO of 98 mg, and Eudragit L100 of 13. 7 mg, and the observed responses of the optimized formulation were very close to the predicted values. The in vitro drug release mechanism of the tablet was studied by drug released model fitted with different equations. The results explained that Eudragit RSPO promoted the release of the pramipexole hydrochloride, while Eudragit L100 blocked the release, and there was an antagonism between them. In conclusion, the drug release behavior of optimized formulations prepared by Eudragit RSPO/L100 was stable, less pH-dependent, which improved the drug bioavailability in vivo.
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Objective To study and analyze the clinical efficacy and safety of madopar and pramipexole in treatment of Parkinson's disease.Methods 120 cases with Parkinson's disease admitted in the Sixth Hospital of Ningbo City from Mar 2013 to Mar 2014 were randomly and evenly divided into combination group and single group,each group had 60 cases. The single group were treated with madopar,while combination group were treated with madopar and pramipexole. The treatment efficiency,incidence and score of adverse reactions in two groups were recorded and compared in order to assess their efficiency and safety. Results The treatment efficiency,adverse reactions in combination group (95.00%,20.00%)were better than single group (58.33%,83.33%),the differences were statistically significant (P<0.05).The score of adverse reactions in combination group after treatment was better than before treatment,the difference was significant(P<0.05 ). While in control group,the score of adverse reactions was a little higher than before treatment,but the difference was not significant. Conclusion Madopar and pramipexole has better efficacy and high safety in treatment of Parkinson's disease.
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OBJECTIVE: The restless legs syndrome (RLS) is a common disorder affecting up to 5% to 15% of the general population, in which the incidence increases with age, and includes paresthesia in the legs. The purpose of this study is to investigate the incidence of RLS in spine center and to review clinical manifestations of this syndrome and its current treatments. METHODS: Over a period of a year, retrospective medical record review and lumbar magnetic resonance images were performed on 32 patients with RLS in spine clinic who were diagnosed by National Institutes of Health criteria. Affected limbs were classified as five. Two grading systems were used in the evaluation of neural compromises. RESULTS: The incidence of RLS was 5.00% (32/639). There were 16 males (50%) and 16 females (50%). The median age at diagnosis was 55.4 years (range, 25-93 years). There are no correlation between the affected limbs of RLS and neural compromises on the lumbar spine. CONCLUSION: The RLS is a clearly common neurologic disorder of the limbs, usually the legs. The awareness of this syndrome can help reduce diagnostic error; thereby, avoiding the morbidity and expense associated with unnecessary studies or inappropriate treatments in RLS patients.
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Female , Humans , Male , Diagnosis , Diagnostic Errors , Extremities , Incidence , Leg , Medical Records , Nervous System Diseases , Paresthesia , Restless Legs Syndrome , Retrospective Studies , Sleep Initiation and Maintenance Disorders , Spinal Stenosis , Spine , PregabalinABSTRACT
O estudo foi realizado para comparar a biodisponibilidade/bioequivalência de duas formulações de dicloridrato de pramipexol 0,25 mg comprimidos (Aché Laboratórios Farmacêuticos S/A (formulação teste)) e Sifrolâ (Boehringer Ingelheim do Brasil Química e Farmacêutica Ltda. (formulação referência)) em 24 voluntários de ambos os sexos. O estudo foi realizado através de um desenho aberto, randomizado, cruzado em dois períodos com tempo de washout de 14 dias. As amostras de plasma foram obtidas ao longo de um intervalo de 36 horas. As concentrações de dicloridrato de pramipexol foram determinadas através de um equipamento LC-MS-MS, utilizando pramipexol D5 como padrão interno. A partir dos dados obtidos se calcularam os seguintes parâmetros farmacocinéticos: ASC0-t , ASC0-¥ e Cmax. A média geométrica de pramipexol/Sifrolâ 0,25 mg foi de 98,17% para ASC0-t, 96,99% para ASC0-¥ e 96,62% para Cmax; os intervalos de confiança de 90% foram de 93,73 - 102,82%, 93,51% - 100,60% e 89,99 - 103,74%, respectivamente. Uma vez que os intervalos de confiança de 90% para Cmax, e ASC0-t estiveram dentro da faixa de 80% - 125% proposta pelo FDA e pela ANVISA (Agência Nacional de Vigilância Sanitária do Brasil), conclui-se que o comprimido de dicloridrato de pramipexol 0,25 mg foi bioequivalente ao comprimido de Sifrolâ de 0,25 mg e, desta forma, o produto teste pode ser considerado intercambiável na prática médica.
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ObjectiveTo assess cost-effectiveness of pramipexole and levodopa/benseraside in the hospitalized Parkinson's disease (PD) patient.Methods81 PD patients were divided into group A(levodopa/benserazide group) and group B( pramipexole combined with levodopa/benserazide group) according to different pharmacotherapy.The curative effects and costs of hospitalized PD patients were evaluated.The curative effects were evaluated by unified Parkinson's disease rating scale (UPDRS).ResultsThere were 44 patients in group A and 37 patients in group B.Although B group in drug costs and treatment costs were increased more significantly than A group ( P ＜0.01),but declined markedly UPDRS after treatment ( P ＜ 0.05 ) than A group.Pramipexole can be applied in all kinds of Hoehn and Yahr states in PD.ConclusionAlthough the combination of pramipexole would increase drug costs and treatment costs,but could improve the clinical symptoms of PD,and can be applied to different stages of PD.It should be individualized recommendation in the Parkinson's patients.