| ObjectiveParkinson's disease (PD) is a chronic debilitating neurodegenerative disease that is common in middle-aged and older people. The incidence rate is gradually increasing and it's about 1% in people over the age of 55. The clinical manifestations of PD include motor symptoms and non-motor symptoms, affecting the patient's activity and quality of life seriously. PD can't be cured and whether medication or surgery can only improve symptoms. The compound preparation of levodopa and dopa decarboxylase inhibitor is the most commonly used drug in the treatment of Parkinson's disease, but with the progress of the disease and the pulse like stimulation of dopaminergic drugs, the efficacy of levodopa gradually diminishes, and some motor complications like motor fluctuation and dyskinesia occur, which cause great distress to patients. To optimize the therapeutic effects of levodopa, many new drugs were developed, and entacapone is one of them. As a selective peripheral catechol-O-methyltransferase (COMT) inhibitor, entacapone can prevent metabolism of levodopa in peripheral tissues, extend its half-life and enhance the bioavailability the central nervous system. So entacapone can prolong action time and reduce blood concentration fluctuation of levodopa. This study was aimed to investigate the effect of entacapone on levodopa dosage, reaction time to leodopa, motor symptoms, motor complications and non-motor symptoms via a prospective self-control drug trail.Methods1.A total of 43 PD patients were enrolled in the study from July 2010 to December 2010 when they come to Qilu Hospital. The diagnosis of PD referred to the UK PD Brain Bank criteria.2. Entacapone was added on the basis of taking levodopa compound preparations. There were two visits in the trail. One was just before the patients adding entacapone and the other was 8 weeks later. In the visit, some assessments were done, which include:patient diary; Hoehn & Yahr disease grading; Unified Parkinson Disease Rating Scale (UPDRS) PartⅡand PartⅢ; Activity of Daily Living Scale (ADL); Non-motor Symptoms Scale (NMSS); adverse drug reactions. The assessments were conducted during "on" period.3. Statistical Analysis:The data were analyzed with paired t-tests by SPSS 13.0, and measurement data were shown in the form of x±s.p<0.05 was considered statistically significant.Results1. Effects on levodopa action time:Before adding entacapone, it took (24.4±4.8) minutes for levodopa taking effect after patients taking the drug. After entacapone added, the time was (24.3±5.0) minutes, shortened by (0.1±2.7) minutes, and the difference was not statistically significant.The "on" time was (7.4±1.7) hours per day and the "off" time was (7.1±1.7) hours before entacapone was added. After adding entacapone, the "on" time was (8.2±1.6) hours, prolonged by (0.85±0.44) hours, and the "off" time was (6.3±1.6) hours, shortened by (0.78±0.48) hours. Both differences were statistically significant. 2. Effects on levodopa dose:Before adding entacapone, the does of levodopa compound preparation that patients taking was (504.7±141.1) mg per day. After entacapone added, it changed to (496.8±149.1) mg per day, decreased by (7.8±25.3) mg, and the p-value was 0.0577.3. Effects on UPDRSⅡ,Ⅲ:Before adding entacapone, the score of UPDRSⅡwas (17.1±5.1), and UPDRSⅢwas (35.7±8.6). After entacapone added, UPDRSⅡwas (14.9±4.3), reduced by (2.3±1.1), and UPDRSIII was (33.2±8.1), reduced by (2.4±1.3). Both differences were statistically significant.4. Effects on Activities of Daily Living (ADL) score:Before adding entacapone, ADL score was (32.9±9.6). After entacapone added, it changed to (32.6±9.5), decreased by (0.3±0.6) mg, and the difference was statistically significant.5. Effects on dyskinesia:Before adding entacapone, the time of dyskinesia was (2.6±1.0) hours. After entacapone added, it changed to (2.4±0.6) hours, decreased by (0.11±0.22) hours, and the difference was not statistically significant.6. Effects on non-motor symptoms:Before and after entacapone added, the significant differences existed in 4 aspects, including sleep and fatigue, mood and cognition, urinary symptoms, sexual function. Besides them, the difference of total score was also statistically significant.7. adverse drug reactionDuring the trail, we observed nausea and vomiting in 2 patients, and orthostatic hypotension in one patient. All of them dropped out. Dyskinesia arose in another three patients, and it disappeared after adjusting the dose of levodopa compound preparations. Other patients had no obvious adverse reaction. ConclusionsThe study found that entacapone could significantly prolong "on" time and shorten "off" time, improve the motor function at "on" time, improve their ADL and some non-motor symptoms such as sleep and fatigue, mood and cognition, urinary symptoms, sexual function. At the same time the safety of entacapone in this trail is good, and no severe adverse reaction was observed. However, because the sample size of this study is small, and the observation time is short, large-scale clinical trials are still needed to validate the efficacy and safety of entacapone. |
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