Sodium pentosan polysulfate resulted in cartilage improvement in knee osteoarthritis - An open clinical trial- 英文参考文献.docVIP

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Sodium pentosan polysulfate resulted in cartilage improvement in knee osteoarthritis - An open clinical trial- 英文参考文献.doc

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Sodium pentosan polysulfate resulted in cartilage improvement in knee osteoarthritis - An open clinical trial- 英文参考文献

Kumagaietal.BMCClinicalPharmacology2010,10:7 /1472-6904/10/7 RESEARCH ARTICLE OpenAccess Sodiumpentosanpolysulfateresultedincartilage improvementinkneeosteoarthritis-Anopen clinicaltrial- KenjiKumagai1*?,SusumuShirabe2?,NoriakiMiyata1?,MasakazuMurata1?,AtsushiYamauchi3?, YasuhumiKataoka3?,MasamiNiwa4? Abstract Background:Pentosanpolysulfatesodium(pentosan)isasemi-syntheticdrugmanufacturedfrombeech-wood hemicellulosebysulfateesterificationofthexylopyranosehydroxylgroups.Frominvitroandanimalmodelstudies, pentosanhasbeenproposedasadiseasemodifyingosteoarthritisdrug(DMOAD).Theobjectiveofthisstudywas toassesstheefficacy,safety,andpatientsatisfactioninpatientswithmildradiographickneeosteoarthritis(OA) findingsandOA-associatedsymptomsandsigns. Methods:TwentypatientswereassessedclinicallyatNagasakiUniversityHospital.Theradiographicindicationsof OAweregrade1to3usingtheKellgren-LawrenceGradingSystem(K/Lgrade).Pentosanusedinthisstudywas manufacturedandsuppliedinsterileinjectablevials(100mg/ml)bybeneGmbH,Munich,Germany.Thestudy wasasingle-center,open-labeltrial.Treatmentconsistedof6weeklysubcutaneousinjections(sc)ofpentosan (2mg/kg).Patientswereclinicallyassessedatentryand1to8,11,15,2452weeksposttreatment.Theresults wereanalyzedusingonewayANOVAandDunnett’ smethod. Results:Hydrarthroseswerereducedquicklyinallcases.Theclinicalassessments,i.e.,kneeflexion,painwhile walking,painafterclimbingupanddownstairs,etc,wereimprovedsignificantlyandtheseclinicalimprovements continuedforalmostoneyear.Thedoseusedinthisstudyaffectedthebloodcoagulationtest,butwaswithin safelevels.Slightlyabnormalfindingswerenotedinserumtriglycerides. Conclusions:PentosantreatmentintwentypatientswithmildkneeOAseemedtoprovideimprovementsin clinicalassessmentsandC2Clevelofcartilagemetabolism. TrialRegistration:UMINClinicalTrialsRegistry(UMIN-CTR)UMIN000002790 Background has been explored as an alternative therapeutic treat- Osteoarthritis(OA)isthemostwidespreadjointdisease ment