简介:AbstractPurpose:Impending compartment syndrome is a common event following closed tibia fractures, which can progress to sinister compartment syndrome. Fasciotomy is the only definitive treatment available, though it has its own drawbacks and complications. Medical management at present consists of limb elevation and adequate hydration. This study aims at determining whether intravenous administration of Mannitol reduced the intracompartmental pressure in patients with closed tibial fractures.Methods:This is a double blinded, randomized control trial done in a single tertiary care center in India. Forty-five patients were recruited between February 2012 and October 2012. Forty patients who presented to the emergency department with isolated, closed, high velocity, and proximal 2/3 tibia fractures were included in this study. Patients with contraindication to Mannitol were excluded. They were allocated into 2 groups by the investigator using computer generated randomization. The pressure in the anterior compartment of the leg was measured with a handheld Stryker pressure monitor. Then either 20% Mannitol or 0.9% normal saline as given intravenously in a blinded manner, based on the randomization. The intracompartmental pressure was measured at 0, 1 and 3 h after the infusion. The participant, investigator and statistician were masked to the group assessment.Results:There was no difference in intracompartmental pressures at 1 or 3 h, between the groups. However, in patients with the baseline of compartmental pressures ≥30 mmHg, Mannitol showed a marked reduction in pressure of 8.5 mmHg at 1 h compared to almost no change in pressure in the saline group. There were no adverse events with the use of Mannitol.Conclusions:This preliminary study appears to show that Mannitol is useful in the management of the increased compartment pressure. The limitations of this study were that it only involved a small group of patients and the baseline pressures in both the groups were not comparable. More studies are required before the use of Mannitol as a standard of care in the management of compartment syndrome can be established.
简介:AbstractBackground:Synovectomy has been introduced into total knee arthroplasty (TKA) with the aim of relieving pain and inflammation of the synovium. However, there are no long-term, comparative data to evaluate the effect of synovectomy in TKA. This study was aimed at assessing pain, function, and complications in patients undergoing synovectomy during TKA for osteoarthritis (OA) at long-term follow-up.Methods:This was a prospective randomized controlled trial of 42 consecutive patients who underwent staged bilateral TKA. Patients undergoing the first-side TKA were allocated to receive TKA with or without synovectomy followed by a 3-month washout period and crossover to the other strategy for the opposite-side TKA. The overall efficacy of both strategies was evaluated by determination of blood loss, the Knee Society score (KSS), and knee inflammation conditions during a 3-month postoperative period. The postoperative pain, range of motion (ROM), and complications were sequentially evaluated to compare the two groups until 10 years after surgery.Results:At the 10-year follow-up, both groups had a similarly significantly improved ROM (114.88 ± 9.84° vs. 114.02 ± 9.43°, t = 0.221, P = 0.815) and pain relief with no differences between the two groups (1.0 [1.0] vs. 1.0 [1.5], U = 789.500, P = 0.613). Similar changes in total blood loss, KSS, and knee inflammation were found in both groups during 3 months postoperatively (P > 0.05). Additionally, there was no significant difference regarding complications and satisfaction between the two groups (P > 0.05).Conclusions:Synovectomy in conjunction with TKA for primary OA does not seem to provide any benefit regarding postoperative pain, ROM, and satisfaction during a 10-year follow-up. In addition, it may not result in more blood loss and increased incidence of long-term complications. Based on our long-term findings, it should not be performed routinely.Trial registration:Chinese Clinical Trial Registry, ChiCTR-INR-16008245; https://www.chictr.org.cn/showproj.aspx?proj= 13334.
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简介:AbstractBackground:At the end of 2019, a novel coronavirus outbreak causative organism has been subsequently designated the 2019 novel coronavirus (2019-nCoV). The effectiveness of adjunctive glucocorticoid therapy in the management of 2019-nCoV-infected patients with severe lower respiratory tract infections is not clear, and warrants further investigation.Methods:The present study will be conducted as an open-labeled, randomized, controlled trial. We will enrol 48 subjects from Chongqing Public Health Medical Center. Each eligible subject will be assigned to an intervention group (methylprednisolone via intravenous injection at a dose of 1-2 mg/kg/day for 3 days) or a control group (no glucocorticoid use) randomly, at a 1:1 ratio. Subjects in both groups will be invited for 28 days of follow-up which will be scheduled at four consecutive visit points. We will use the clinical improvement rate as our primary endpoint. Secondary endpoints include the timing of clinical improvement after intervention, duration of mechanical ventilation, duration of hospitalization, overall incidence of adverse events, as well as rate of adverse events at each visit, and mortality at 2 and 4 weeks.Discussion:The present coronavirus outbreak is the third serious global coronavirus outbreak in the past two decades. Oral and parenteral glucocorticoids have been used in the management of severe respiratory symptoms in coronavirus-infected patients in the past. However, there remains no definitive evidence in the literature for or against the utilization of systemic glucocorticoids in seriously ill patients with coronavirus-related severe respiratory disease, or indeed in other types of severe respiratory disease. In this study, we hope to discover evidence either supporting or opposing the systemic therapeutic administration of glucocorticoids in patients with severe coronavirus disease 2019.Trial registration:ClinicalTrials.gov, ChiCTR2000029386, http://www.chictr.org.cn/showproj.aspx?proj=48777.
简介:Objective:Toevaluatetheefficacyandfeasibilityofscreeningprocedureforuppergastrointestinalcancerinbothhigh-riskandnon-high-riskareasinChina.Setting:Sevencities/counties,representingthreeeconomical-geographicalregions(Eastern,CentralandWestern)inChina,wereselectedasscreeningcenters:threeinhigh-riskareasandfourinnon-high-riskareas.Participants:Villages/communitiesinthesesevencentersregardedasclusterswererandomlyassignedtoeitherinterventiongroup(screeningbyendoscopicexamination)orcontrolgroup(withnormalcommunitycare)ina1:1ratiostratifiedbyeachcenter.Eligibleparticipantsarelocalresidentsaged40–69yearsintheselectedvillages/communitieswithnohistoryofcancerorendoscopicexaminationinthelatest3yearswhoarementallyandphysicallycompetent.Thosewhoarenotwillingtotakeendoscopicexaminationorareunwillingtosigntheconsentformareexcludedfromthestudy.Totally140,000participantswillbeenrolled.Interventions:Inhigh-riskareasofuppergastrointestinalcancer,allsubjectsinscreeninggroupwillbescreenedbyendoscopy.Innon-high-riskareas,30%ofthesubjectsinscreeninggroup,identifiedthroughasurvey,willbescreenedbyendoscopy.Primaryandsecondaryoutcomemeasures:Theprimaryoutcomeisthemortalitycausedbyuppergastrointestinalcancer.Thesecondaryoutcomesincludedetectionrate,incidencerate,survivalrate,andclinicalstagedistribution.Additionaldataonqualityoflifeandcost-effectivenesswillalsobecollectedtoanswerimportantquestionsregardingscreeningeffects.Conclusions:ScreeningstrategyevaluatedinthoseareaswithpositivefindingsmaybepromotednationallyandappliedtothemajorityofChinesepeople.Ontheotherhand,negativefindingswillprovidescientificevidenceforabandoningatestandshiftingresourceselsewhere.Trialregistration:ThestudyhasbeenregisteredwiththeProtocolRegistrationSysteminChineseClinicalTrialRegistry.
简介:AbstractBackground:Transcranial alternating current stimulation (tACS) offers a new approach for adult patients with major depressive disorder (MDD). The study is to evaluate the efficacy and safety of tACS treating MDD.Methods:This is an 8-week, double-blind, randomized, placebo-controlled study. Ninety-two drug-naive patients with MDD aged 18 to 65 years will receive 20 daily 40-min, 77.5-Hz, 15-mA sessions of active or sham tACS targeting the forehead and both mastoid areas on weekdays for 4 consecutive weeks (week 4), following a 4-week observation period (week 8). The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8. Secondary outcomes are the rates of response at weeks 4 and 8 and rate of remission at week 4 based on HDRS-17, the proportion of participants having improvement in the clinical global impression-improvement, the change in HDRS-17 score (range, 0–52, with higher scores indicating more depression) over the study, and variations of brain imaging and neurocognition from baseline to week 4. Safety will be assessed by vital signs at weeks 4 and 8, and adverse events will be collected during the entire study.Discussion:The tACS applied in this trial may have treatment effects on MDD with minimal side effects.Trial registration:Chinese Clinical Trial Registry, ChiCTR1800016479; http://www.chictr.org.cn/showproj.aspx?proj=22048.
简介:客观:观察膜dialyzer在临床的维护hemodialysis(MHD)由长期的肾的失败病人使用了的polyethersulfone的安全和功效。方法:从1月到2009年2月,36个病人从加盟上海JiaoTong的新华医院被招募大学医学院。实验被人种的委员会同意,新华医院并且在从病人的权限下面。所有病人被使随机化进polyethersulfone组(足,n=18)并且polysulfone组(PS,n=18)。Hemodialysis被使用Fresenius4008S给控制能力的dialyser和极端净化酸式碳酸盐透析液,超过3.5h每次,三次每星期,由肝磷脂antieoagulation列在后面一个星期,三次完全。在血脲氮(甜面包)的变化,浆液creatinine(Scr),磷酸盐(P2+),血红素和白朊层次为功效和安全评估被决定。结果:显著地与不同dialyzers在hemodialysis以后减少的浆液甜面包,Scr和P2+集中,和二个组的减少振幅是相等的(P>0.05)。浆液甜面包和重量的单位的清理率没在二个组之中有重要差别(P>0.05)。浆液P2+的清理率(ml/min)是144.57
简介:AIM:Tocomparesurgicalpeelingandaspirationandneodymiumyttriumgarnetlasercapsulotomyforpearlformofposteriorcapsuleopacification(PCO).METHODS:Aprospective,randomized,doubleblind,studywasdoneatRotaryEyeHospital,Maranda,Palampur,India,SantoshMedicalCollegeHospital,Ghaziabad,IndiaandLaserEyeClinic,NoidaIndia.ConsecutivepatientswithpearlformofPCOfollowingsurgery,phacoemulsification,manualsmallincisioncataractsurgeryandconventionalextracapsularcataractextraction(ECCE)foragerelatedcataract,wererandomizedtohavepeelingandaspirationorneodymiumyttriumgarnetlasercapsulotomy.Correcteddistancevisualacuity(CDVA),intra-operativeandpostoperativecomplicationswerecompared.RESULTS:Atotalof634patientsparticipatedinthestudy,and314(49.5%)patientswererandomizedtosurgicalpeelingandaspirationgroupand320(50.5%)totheNd:YAGlasergroup.Themeanpre-procedurallogMARCDVAinpeelingandneodymium:yttrium-aluminium-garnet(Nd:YAG)lasergroupwas0.80±0.25and0.86±0.22,respectively.ThemeanfinalCDVAinpeelinggroup(0.22±0.23)wascomparabletoNd:YAGgroup(0.24±0.28;t-test,P=0.240).Therewasasignificantimprovementinvisionafterboththeprocedures(P<0.001).AslightlyhigherpercentageofpatientsinNd:YAGlasergroup(283/88.3%)thaninpeelinggroup(262/83.4%)hadaCDVAof0.5(20/63)orbetterat9mo(P<0.001).Onthecontrary,patientshavingCDVAworsethan1.00(20/200)wasalsosignificantlyhigherinNd:YAGlasergroupascomparedtopeelinggroup(25/7.7%vs15/4.7%,respectively).OnapplicationofANCOVA,therewaslessthan0.001%riskthatPCOthicknessandtotallaserenergyhadnoeffectonrateofcomplicationsinNd:YAGlasergroupandlessthan0.001%riskthatPCOthicknesshadnoeffectoncomplicationsinpeelinggrouprespectively.SumofsquareanalysissuggeststhatintheNd:YAGlasergroup,thickPCOhadastrongerimpactoncomplications(Fischertestprobability,Pr<0.0001)
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简介:因为输精管切除术的不可避免的复杂并发症,这研究被承担与一个微型外科的方法与没有解剖刀输精管切除术(NSV)相比植入进管腔的一台nonobstructiveintravas设备(IVD)估计男消毒的功效和安全。IVD被分成二种类型:而,IVD-B让一条尾巴使用了修理到管deferens(固定翅膀)IVD--A不做。multicenter未来的使随机化的控制临床的审判在中国被进行。学习由寻求输精管切除术的1459个男志愿者组成随机被分到IVD--一(n=487),IVD-B(n=485)或NSV(n=487)组并且经历了操作。包括的后续在3rd-6th和12th手术后的月。对这些题目的评价包含了常规物理考试(包括的将军和andrological考试)和精液分析。subjects’;搭挡们也经历了监视因为由月刊的怀孕关于月经会见,如果必要,尿测试。处于怀孕率没有重要差别(0.65%为IVD--一,0为IVD-B并且0.21%为NSV)在三个组之中(P>;0.05)。在12th手术后的月分别地在三个组是零,0.9%和1.7%。在结论,IVD男消毒展出长期的不利事件的低风险并且被发现作为一个男消毒方法有效,类似于NSV技术。IVD男消毒被期望是一个新奇避孕方法。
简介:BackgroundIntravascularvolumeexpansionrepresentsabeneficialmeasureagainstcontrast-inducedacutekidneyinjury(CI-AKI)inpatientsundergoingelectiveangiographicprocedures.However,theefficacyofthispreventivestrategyhasnotyetbeenestablishedforpatientswithST-elevation-myocardialinfarction(STEMI),whoareathigherriskofthiscomplicationafterprimarypercutaneouscoronaryintervention(PCI).Inthisrandomizedstudyweinvestigatedthepossiblebeneficialroleofperiproceduralintravenousvolumeexpansionandwecomparedtheefficacyof2differenthydrationstrategiesinpatientswithSTEMIundergoingprimaryPCI.MethodsandResultsWerandomlyassigned450STEMIpatientstoreceive(1)preprocedureandpostprocedurehydrationofsodiumbicarbonate(earlyhydrationgroup),(2)postprocedurehydrationofisotonicsaline(latehydrationgroup),or(3)nohydration(controlgroup).TheprimaryendpointwasthedevelopmentofCI-AKI,definedasanincreaseinserumcreatinineof≥25%or0.5mg/dLoverthebaselinevaluewithin3daysafteradministrationofthecontrastmedium.Moreover,weevaluatedapossiblerelationshipbetweentheoccurrenceofCI-AKIandtotalhydrationvolumeadministered.Therewerenosignificantdifferencesinbaselineclinical,biochemical,andproceduralcharacteristicsinthe3groups.Overall,CI-AKIoccurredin93patients(20.6%):theincidencewassignificantlylowerintheearlyhydrationgroup(12%)withrespecttoboththelatehydrationgroup(22.7%)andthecontrolgroup(27.3%)(Pfortrend=0.001).Inhydratedpatients(earlyandlatehydrationgroups),lowerinfusedvolumeswereassociatedwithasignificantincreaseinCI-AKIincidence,andtheoptimalcutoffpointofhydrationvolumethatbestdiscriminatespatientsathigherriskwas≤960mL.ConclusionsAdequateintravenousvolumeexpansionmaypreventCI-AKIinpatientsundergoingprimaryPCI.Aregimenofpreprocedureandpostprocedurehydrationtherapywithsodiumbicarbonatea
简介:AbstractBackground:As one of the most common endocrinal disorders for women at childbearing age, the diagnostic criteria of polycystic ovary syndrome (PCOS) have been defined differently among different international health organizations. Phenotypic heterogeneity of PCOS also brings about difficulties for its diagnosis and management assessment. Therefore, more efficient biomarkers representing the progression of PCOS are expected to be integrated into the monitoring of management process using metabolomic approaches.Methods:In this prospective randomized controlled trial, 117 PCOS patients were enrolled from December 2016 to September 2017. Classical diagnostic parameters, blood glucose, and metabolome were measured in these patients before and at 2 months and 3 months of different medical interventions. The receiver operating characteristic (ROC) curves were built based on multivariate statistical analysis using data at baseline and 3 months’ management, and combinational biomarkers with appreciable sensitivity and specificity were selected, which then validated with data collected at 2 months.Results:A set of metabolites including glutamic acid, aspartic acid, 1-methylnicotinamide, acetylcarnitine, glycerophosphocholine, and oleamide were filtered out with high performance in representing the improvement through 3-month management of PCOS with high sensitivity and specificity in ROC analysis and validation with other two groups showed an appreciable area under the curve over 0.96.Conclusions:The six metabolites were representative of the remission of PCOS through medical intervention, making them a set of potential biomarkers for assessing the outcome of PCOS management.Trial Registration:ClinicalTrials.gov, NCT03264638.
简介:Background:AlthoughTaiJiQuanhasbeenshowntorelievepainandimprovefunctionalmobilityinpeoplewithkneeosteoarthritis(OA),littleisknownaboutitspotentialbenefitsongaitcharacteristicsamongolderChinesewomenwhohaveahighprevalenceofbothradiographicandsymptomatickneeOA.ThisstudyaimstoassesstheefficacyofatailoredTaiJiQuaninterventionongaitkinematicsforolderChinesewomenwithkneeOA.Methods:Arandomizedcontrolledtrialinvolving46olderwomeninShanghai,China,withclinicallydiagnosedkneeOA.Randomized(1:1)participantsreceivedeithera60minTaiJiQuansession(n=23)3timesweeklyora60minbi-weeklyeducationalsession(n=23)for24weeks.Primaryoutcomeswerechangesingaitkinematicmeasuresfrombaselineto24weeks.SecondaryoutcomesincludedchangesinscoresontheWesternOntarioandMcMasterUniversityOsteoarthritisIndex(WOMAC)andShortPhysicalPerformanceBattery(SPPB).Results:After24weekstheTaiJiQuangroupdemonstratedbetterperformanceingaitvelocity(meandifference,8.40cm/s,p=0.01),steplength(meandifference,3.52cm,p=0.004),initialcontactangle(meandifference,2.19°,p=0.01),andmaximalangle(meandifference,2.61°,p=0.003)offlexedkneesduringstancephasecomparedtothecontrolgroup.Inaddition,theTaiJiQuangroupshowedsignificantimprovementinWOMACscores(p<0.01)(meandifference,-4.22pointsinpain,p=0.002;-2.41pointsinstiffness,p<0.001;-11.04pointsinphysicalfunction,p=0.006)andSPPBscores(meandifference,1.22points,p<0.001).Conclusion:AmongolderChinesewomenwithkneeOA,atailoredTaiJiQuaninterventionimprovedgaitoutcomes.TheinterventionalsoimprovedoverallfunctionasindexedbytheWOMACandSPPB.TheseresultssupporttheuseofTaiJiQuanforolderChineseadultswithkneeOAtobothimprovetheirfunctionalmobilityandreducepainsymptomatology.