Study on Dalfampridine in the treatment of Multiple Sclerosis Mobility Disability: A meta-analysis
Autoři:
Jianzhen Shi aff001; Xiaohui Wu aff002; Yanmei Chen aff003
Působiště autorů:
School of Science Nantong University, NanTong, P.R. China
aff001; Affiliated Hospital of Nantong University, NanTong, P.R. China
aff002; School of Environmental and Chemical Engineering Jiangsu University of Science and Technology, Zhenjiang, P.R. China
aff003
Vyšlo v časopise:
PLoS ONE 14(9)
Kategorie:
Research Article
prolekare.web.journal.doi_sk:
https://doi.org/10.1371/journal.pone.0222288
Souhrn
Objective
Systematic Review was used to evaluate the efficacy and safety of Dalfampridine (DAP) in the treatment of Mobility Disability (MS) in patients with Multiple Sclerosis.
Methods
Clinical randomized controlled studies about DAP and placebo in the treatment of Mobility Disability in patients with Multiple Sclerosis until March 2019 were explored by searching Embase, PubMed, Cochrane, Web of Knowledge, and ClinicalTrials.gov. Literature screening, data extraction, quality assessment, and statistical analysis were performed by using Stata 14.0.
Results
10 papers were included in the meta-analysis, and the number of patients was 2100. In conclusion, the application of DAP in clinical can significantly improve the Mobility Disability of patients [OR = 2.73, 95%CI (1.66, 4.50), P<0.001, I2 = 74.1%] and boost the mobility speed of patients in Timing 24 Minute Walk Test (T24FW) [SMD = 3,08, 95%CI(1,58, 4.58), P<0.001, I2 = 98.7%]. There are no significant differences of the incidence of adverse events [RR = 1.06, 95%CI (0.99, 1.14), P = 0.928, I2 = 0.0%] and urinary tract infection [RR = 1.21, 95%CI(0.91, 1.60), P = 0.145, I2 = 37.2%] between the DAP test group (Doses≤10 mg) and the placebo control group, and the incidence of adverse events [RR = 1.14, 95%CI(1.02, 1.28), P = 0.793, I2 = 0.0%] and urinary tract infection[RR = 3.05, 95%CI(1.04, 8.99), P = 0.680, I2 = 0.0%] for the DAP test group (Doses>10 mg) is a litter higher than the placebo control group.
Conclusion
DAP can effectively improve Mobility Disability in patients with Multiple Sclerosis, which is safe and reliable in specific DAP usage doses.
Klíčová slova:
Biology and life sciences – Biochemistry – Physical sciences – Research and analysis methods – Proteins – Neuroscience – Mathematics – Anatomy – Medicine and health sciences – Physiology – Statistics – Mathematical and statistical techniques – Statistical methods – Metaanalysis – Research design – Clinical medicine – Clinical immunology – Autoimmune diseases – Immunology – Public and occupational health – Urology – Urinary tract infections – Disabilities – Neurology – Physics – Clinical research design – Adverse events – Neurodegenerative diseases – Electrophysiology – Neurophysiology – Biophysics – Science policy – Renal system – Research integrity – Publication ethics – Multiple sclerosis – Demyelinating disorders
Zdroje
1. Compston A, Coles A. Multiple Sclerosis. Lancet, 2008, 372 (9648): 1502–1517. doi: 10.1016/S0140-6736(08)61620-7 18970977
2. Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M et al. Diagnostic criteria for Multiple Sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol, 2011, 69 (2): 292–302. doi: 10.1002/ana.22366 21387374
3. National Multiple Sclerosis Society. Multiple Sclerosis Information Sourcebook. New York, NY: Information Resource Center and Library of the National Multiple Sclerosis Society; 2005.
4. Dunn J. Impact of mobility impairment on the burden of caregiving in individuals with Multiple Sclerosis. Expert Rev Pharmacoecon Outcomes Res, 2010, 10 (4): 433–440. doi: 10.1586/erp.10.34 20482233
5. Doring A, Pfueller CF, Paul F, Dorr J. Exercise in Multiple Sclerosis–an integral component of disease management. The EPMA Journal, 2011, 3: 2. doi: 10.1007/s13167-011-0136-4 22738091
6. Yamout B, Alroughani R, Al-Jumah M, Khoury S, Abouzeid N, Dahdaleh M et al. Consensus guidelines for the diagnosis and treatment of Multiple Sclerosis. Curr Med Res Opin, 2013, 29: 611–621. doi: 10.1185/03007995.2013.787979 23514115
7. Freedman MS. Teriflunomide in relapsing Multiple Sclerosis: therapeutic utility. Ther. Adv Chron Dis, 2013, 4: 192–205.
8. 杨 亭亭, 高 旭光. 达方吡啶改善多发性硬化相关的行走障碍. 中华脑科疾病与康复杂志,2012,2(2):129–131.
9. Jensen HB, Ravnborg M, Dalgas U, Stenager E. 4-Aminopyridine for symptomatic treatment of Multiple Sclerosis: a systematic review. Ther Adv Neurol Disord, 2014, 7 (2): 97–113. doi: 10.1177/1756285613512712 24587826
10. Kasatkina LA. 4-Aminopyridine sequesters intracellular Ca2+ which triggers exocytosis in excitable and non-excitable cells. Sci Rep, 2016, 6: 34749. doi: 10.1038/srep34749 27703262
11. Lugaresi A. Pharmacology and clinical efficacy of DAP for treating Multiple Sclerosis. Expert Opin Drug Metab Toxicol, 2015, 11 (2): 295–306. doi: 10.1517/17425255.2015.993315 25510833
12. Shi R, Blight AR. Differential effects of low and high concentrations of 4-aminopyridine on axonal conduction in normal and injured spinal cord. Neuroscience, 1997, 77(2): 553–562. doi: 10.1016/s0306-4522(96)00477-0 9472411
13. Wu ZZ, Chen SR, Pan HL. Aminopyridines potentiate synaptic and neuromuscular transmission by targeting the voltage-activated calcium channel beta subunit. J Biol Chem, 2009, 284(52): 36453–36461. doi: 10.1074/jbc.M109.075523 19850918
14. Hobart J, Ziemssen T, Feys P, Linnebank M, Goodman AD, Farrell R et al. Assessment of Clinically Meaningful Improvements in Self-Reported Walking Ability in Participants with Multiple Sclerosis: Results from the Randomized, Double-Blind, Phase III ENHANCE Trial of Prolonged-Release Fampridine. Cns Drugs, 2019, 33(1): 61–79. doi: 10.1007/s40263-018-0586-5 30535670
15. Satchidanand N, Drake A, Smerbeck A, Hojnacki D, Kolb C, Patrick B, et al. DAP benefits ambulation but not cognition in Multiple Sclerosis. Multiple Sclerosis (Houndmills, Basingstoke, England), 2018: 1352458518815795.
16. Jacques F, Schembri A, Nativ A, Paquette C, Kalinowski P. Prolonged-Release Fampridine as Adjunct Therapy to Active Motor Training in Mobility Disability Patients: A Pilot, Double-Blind, Randomized, Placebo-Controlled Study. Mult Scler J Exp Transl Clin, 2018, 4(1): 1–7.
17. Hupperts R, Lycke J, Short C, Gasperini C, McNeill M, Medori R et al. Prolonged-release fampridine and walking and balance in MS: randomised controlled MOBILE trial. Multiple Sclerosis Journal, 2016, 22(2): 212–221. doi: 10.1177/1352458515581436 25921050
18. Jensen HB, Nielsen JL, Ravnborg M, Dalgas U, Aagaard P, Stenager E. Effect of slow release-Fampridine on muscle strength, rate of force development, functional capacity and cognitive function in an enriched population of Mobility Disability patients. A randomized, double blind, placebo controlled study. Multiple Sclerosis and Related Disorders, 2016, 10: 137–144. doi: 10.1016/j.msard.2016.07.019 27919481
19. Yapundich R, Applebee A, Bethoux F, Goldman MD, Hutton GJ, Mass M et al. Evaluation of DAP Extended Release 5 and 10 mg in Multiple Sclerosis: A Randomized Controlled Trial. International journal of Mobility Disability care, 2015, 17(3): 138–45.
20. DAP for Imbalance in Multiple Sclerosis. URL: https://clinicaltrials.gov/ct2/show/NCT01444300.
21. Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis. URL: https://clinicaltrials.gov/ct2/show/NCT00053417.
22. Goodman AD, Brown TR, Edwards KR, Krupp LB, Schapiro RT, Cohen R et al. A Phase 3 Trial of Extended Release Oral DAP in Multiple Sclerosis. Annals of Neurology, 2010, 68(4): 494–502. doi: 10.1002/ana.22240 20976768
23. Goodman AD, Brown TR, Krupp LB, Schapiro RT, Schwid SR, Cohen R et al. Sustained-release oral fampridine in Multiple Sclerosis: a randomised, double-blind, controlled trial. Lancet, 2009, 373(9665): 732–738. doi: 10.1016/S0140-6736(09)60442-6 19249634
24. Motl R. W., Cohen J. A., Benedict R., Phillips G., LaRocca N., Hudson L. D., et al. (2017). Validity of the timed 25-foot walk as an ambulatory performance outcome measure for Multiple Sclerosis. Multiple Sclerosis Journal, 23(5), 704–710. doi: 10.1177/1352458517690823 28206828
25. Kister I, Chamot E, Salter AR, Cutter GR, Bacon TE, Herbert J et al. Disability in Multiple Sclerosis: a reference for patients and clinicians. Neurology, 2013, 80: 1018–1024. doi: 10.1212/WNL.0b013e3182872855 23427319
26. Ziemssen T, Prosser C, Haas JS, Lee A, Braun S, Landsman-Blumberg P et al. Healthcare resource use and costs of Multiple Sclerosis patients in Germany before and during fampridine treatment. BMC Neurol, 2017, 17: 62. doi: 10.1186/s12883-017-0844-z 28347283
27. Cornblath DR, Bienen EJ, Blight AR. The safety profile of DAP extended release in Multiple Sclerosis clinical trials. Clin Ther, 2012, 34(5): 1056–1069. doi: 10.1016/j.clinthera.2012.03.007 22497693
28. Blight AR, Henney HR. Pharmacokinetics of 14 Cradioactivity after oral intake of a single dose of 14C-labeled fampridine (4-aminopyridine) in healthy volunteers. Clin Ther, 2009, 31(2): 328–335 doi: 10.1016/j.clinthera.2009.02.004 19302905
Článok vyšiel v časopise
PLOS One
2019 Číslo 9
- Metamizol jako analgetikum první volby: kdy, pro koho, jak a proč?
- Nejasný stín na plicích – kazuistika
- Masturbační chování žen v ČR − dotazníková studie
- Je Fuchsova endotelová dystrofie rohovky neurodegenerativní onemocnění?
- Fixní kombinace paracetamol/kodein nabízí synergické analgetické účinky
Najčítanejšie v tomto čísle
- Graviola (Annona muricata) attenuates behavioural alterations and testicular oxidative stress induced by streptozotocin in diabetic rats
- CH(II), a cerebroprotein hydrolysate, exhibits potential neuro-protective effect on Alzheimer’s disease
- Comparison between Aptima Assays (Hologic) and the Allplex STI Essential Assay (Seegene) for the diagnosis of Sexually transmitted infections
- Assessment of glucose-6-phosphate dehydrogenase activity using CareStart G6PD rapid diagnostic test and associated genetic variants in Plasmodium vivax malaria endemic setting in Mauritania