randomized controlled trials as topic

随机对照试验作为主题
  • 文章类型: Journal Article
    氨甲环酸是一种抗纤维蛋白溶解剂,广泛用于多种外科手术中以减少术中出血。术中出血是耳部外科医生的关键问题,因为它阻止了手术视野的良好可视化。这项工作的目的是分析有关氨甲环酸在耳部手术中使用的相关文献。与2020年系统审查和荟萃分析(PRISMA)声明的首选报告项目一致进行了文献检索,跨3个数据库(Medline,科克伦,和谷歌学者),带有“氨甲环酸”的术语,“和”耳朵,“和”手术。\"三个潜在的,随机化,双盲临床试验符合纳入标准.由于材料的异质性,研究无法汇总,交付和评估方法,和使用的程序。尽管有这些限制,所有3篇论文都发现术中出血显著减少,允许操作领域的更好的可视化。尽管已发表的试验很少,氨甲环酸是安全的,似乎有助于减少耳部手术的术中出血,从而提高手术视野的可视化。
    Tranexamic acid is an antifibrinolytic agent widely used in several surgical procedures to reduce intraoperative bleeding. Intraoperative bleeding is a crucial problem for the ear surgeon, as it prevents good visualization of the surgical field. The aim of this work was to analyze the relevant literature about the use of tranexamic acid in ear surgery. A literature search was conducted in agreement with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 statement, across 3 databases (Medline, Cochrane, and Google Scholar), with the terms \"tranexamic acid,\" and \"ear,\" and \"surgery.\" Three prospective, randomized, and double-blind clinical trials met the inclusion criteria. Studies were not able to be pooled because of heterogeneity in material, methods of delivery and evaluation, and procedures used. Despite these limitations, all 3 papers found a significant reduction in intraoperative bleeding, allowing a better visualization of the operating field. Despite the scarcity of published trials, tranexamic acid is safe and seems to be useful in reducing intraoperative bleeding in ear surgery, thus improving operative field visualization.
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  • 文章类型: Systematic Review
    Bedaquiline(BDQ)用于治疗耐药结核病(DR-TB)的风险和收益尚未确定。我们旨在评估含BDQ方案治疗DR-TB的安全性和有效性,如现有的随机对照试验(RCTs)所证明。在这篇系统综述和荟萃分析中,五个数据库(即,ClinicalTrials.gov,科克伦中部,PubMed,ScienceDirect,和SinoMed)进行了搜索。有控制臂的DR-TB患者的RCT是合格的。安全性终点是全因死亡率和严重不良反应(SAE)。疗效结果为8-12周和24-26周的痰培养转换率,治疗成功,和文化转换的时间。共筛选了476条记录;18条符合资格标准。汇总分析包括2520名参与者(55.8%接受含BDQ的方案,n=1408)。汇总安全性结果显示,BDQ方案组的全因死亡率(相对风险[RR][95%置信区间(CI)]=0.94[0.41-2.20])或SAE(RR[95CI]=0.91[0.67-1.23])没有显著降低。汇总的疗效结果显示,在8-12周(RR[95CI]=1.35[1.10-1.65])和24-26周(RR[95CI]=1.25[1.15-1.36])时,培养物转换率明显较高,更多的治疗成功率(RR[95CI]=1.30[1.17-1.44]),BDQ方案组(参考:非BDQ方案)的培养转化时间减少了17天(标准化平均差[SMD][95CI]=-17.46[-34.82至-0.11])。总的来说,BDQ方案对DR-TB显示出显著的治疗效果,但没有降低死亡率或SAE。
    The risks and benefits of bedaquiline (BDQ) for treatment of drug-resistant tuberculosis (DR-TB) have not been firmly established. We aimed to assess the safety and efficacy of BDQ-containing regimens for the treatment of DR-TB as evidenced in available randomized controlled trials (RCTs). In this systematic review and meta-analysis, five databases (i.e., ClinicalTrials.gov, Cochrane CENTRAL, PubMed, ScienceDirect, and SinoMed) were searched. RCTs among DR-TB patients that had a control arm were eligible. The safety endpoints were all-cause mortality and serious adverse effects (SAEs). Efficacy outcomes were sputum culture conversion rate at 8-12 weeks and 24-26 weeks, treatment success, and time to culture conversion. A total of 476 records were screened; 18 met the eligibility criteria. The pooled analysis included 2520 participants (55.8% received BDQ-containing regimens, n = 1408). Pooled safety outcomes showed no significant reduction in all-cause mortality (relative risk [RR] [95%confidence interval (CI)] = 0.94 [0.41-2.20]) or SAEs (RR [95%CI] = 0.91 [0.67-1.23]) in the BDQ-regimen group. Pooled efficacy outcomes showed significantly superior culture conversion rates at 8-12 weeks (RR [95%CI] = 1.35 [1.10-1.65]) and 24-26 weeks (RR [95%CI] = 1.25 [1.15-1.36]), more treatment success (RR [95%CI] = 1.30 [1.17-1.44]), and a 17-day reduction in the time to culture conversion (standardized mean difference [SMD] [95%CI] = -17.46 [-34.82 to -0.11]) in the BDQ-regimen group (reference: non-BDQ regimen). Overall, BDQ regimens showed significant treatment effect against DR-TB but did not reduce mortality or SAEs.
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  • 文章类型: Journal Article
    背景:有一个新的需要,系统地调查希腊剖宫产率增加的原因,并采取干预措施,以大幅降低剖宫产率。为此,将探讨参与的希腊产科医生在管理劳动时遵循循证指南并应对其他教育和行为干预措施的能力,以及障碍和推动者。本文讨论的是希腊产科的阶梯式楔形设计干预试验的方案,并牢记上述目标,名为ENGAGE(希腊的ENhancinGvaginaldelevery)。
    方法:希腊的22个选定的产妇单位将参加一项涉及20,000至25,000个分娩的多中心阶梯式随机前瞻性试验,其中两个人每月进入研究的干预期(逐步随机化)。进入研究的产妇护理单位将根据他们进入研究干预阶段的时间将建议的干预措施应用8-18个月。研究的初始阶段还将持续8至18个月,包括观察和记录常规实践(剖宫产,阴道分娩,以及参与单位的孕产妇和围产期发病率和死亡率)。第二阶段,干预期,将包括诸如HSOG(希腊妇产科学会)劳动管理指南的应用等干预措施,关于正确解释心电图的培训,处理阴道分娩中的紧急情况,虽然指导委员会成员将可以讨论和实施组织和行为的变化,回答问题,澄清相关问题,并在定期访问或视频会议期间向参与的医疗保健专业人员提供实际指导。此外,在研究过程中,结果将提供给参与单位,以便他们监测自己的表现,同时也收到关于他们费率的反馈。该研究的最后2个月阶段将致力于完成随访问卷,其中包含干预期结束后发生的孕产妇和新生儿发病率数据。研究的总持续时间估计为28个月。评估的主要结果将是剖宫产率的变化,次要结果将是孕产妇和新生儿的发病率和死亡率。
    结论:该研究预计将产生有关影响的新信息,优势,可能性,以及持续的临床参与和行为实施的挑战,教育,和组织干预措施在希腊剖宫产手术方案中详细描述。这些结果可能会对提高孕产妇和新生儿护理质量的方法产生新的见解,特别是因为这代表了降低希腊高剖宫产率的共同努力,此外,为他们在其他国家的减少指明了道路。
    背景:NCT04504500(ClinicalTrials.gov)。该试验进行了前瞻性登记。伦理参考号:320/23.6.2020,生物伦理和行为委员会,医学院,雅典国立和卡波迪斯大学,雅典,希腊。
    BACKGROUND: There is an emerging need to systematically investigate the causes for the increased cesarean section rates in Greece and undertake interventions so as to substantially reduce its rates. To this end, the ability of the participating Greek obstetricians to follow evidence-based guidelines and respond to other educational and behavioral interventions while managing labor will be explored, along with barriers and enablers. Herein discussed is the protocol of a stepped-wedge designed intervention trial in Greek maternity units with the aforementioned goals in mind, named ENGAGE (ENhancinG vAGinal dElivery in Greece).
    METHODS: Twenty-two selected maternity units in Greece will participate in a multicenter stepped-wedge randomized prospective trial involving 20,000 to 25,000 births, with two of them entering the intervention period of the study each month (stepped randomization). The maternity care units entering the study will apply the suggested interventions for a period of 8-18 months depending on the time they enter the intervention stage of the study. There will also be an initial phase of the study lasting from 8 to 18 months including observation and recording of the routine practice (cesarean section, vaginal birth, and maternal and perinatal morbidity and mortality) in the participating units. The second phase, the intervention period, will include such interventions as the application of the HSOG (the Hellenic Society of Obstetrics and Gynecology) Guidelines on labor management, training on the correct interpretation of cardiotocography, and dealing with emergencies in vaginal deliveries, while the steering committee members will be available to discuss and implement organizational and behavioral changes, answer questions, clarify relevant issues, and provide practical instructions to the participating healthcare professionals during regular visits or video conferences. Furthermore, during the study, the results will be available for the participating units in order for them to monitor their own performance while also receiving feedback regarding their rates. Τhe final 2-month phase of the study will be devoted to completing follow-up questionnaires with data concerning maternal and neonatal morbidities that occurred after the completion of the intervention period. The total duration of the study is estimated at 28 months. The primary outcome assessed will be the cesarean section rate change and the secondary outcomes will be maternal and neonatal morbidity and mortality.
    CONCLUSIONS: The study is expected to yield new information on the effects, advantages, possibilities, and challenges of consistent clinical engagement and implementation of behavioral, educational, and organizational interventions described in detail in the protocol on cesarean section practice in Greece. The results may lead to new insights into means of improving the quality of maternal and neonatal care, particularly since this represents a shared effort to reduce the high cesarean section rates in Greece and, moreover, points the way to their reduction in other countries.
    BACKGROUND: NCT04504500 (ClinicalTrials.gov). The trial was prospectively registered. Ethics Reference No: 320/23.6.2020, Bioethics and Conduct Committee, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
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  • 文章类型: Systematic Review
    背景:阿片类药物使用与室性心律失常(VA)风险之间的关联知之甚少。
    目的:本研究的目的是综合与阿片类药物使用相关的VA风险的证据。
    方法:我们系统地搜索了Cochrane库,Embase,MEDLINE,2022年7月和CINAHL数据库。使用Cochrane用于随机对照试验(RCTs)的偏倚风险工具和ROBINS-I用于观察性研究的偏倚风险进行评估。使用等级评估证据的确定性。
    结果:我们纳入了15项研究(12项观察性,对RCT进行2次事后分析,1RCT)。大多数研究集中在阿片类药物用于维持治疗(n=9),比较美沙酮与丁丙诺啡(n=13),并报告QTc延长(n=13)。六项观察性研究存在严重的偏倚风险,1例RCT存在高偏倚风险.两项研究无法纳入荟萃分析,因为它们报告了不同的结果并研究了阿片类药物拮抗剂。对13项研究的荟萃分析表明,与使用丁丙诺啡相比,使用美沙酮与VA风险增加相关。吗啡,安慰剂,或左乙酰美沙多(风险比[RR],2.39;95%CI,1.31-4.35;I2=60%)。观察性研究之间的汇总估计值差异很大(RR,2.12;95%CI,1.15-3.91;I2=62%)和RCT(RR,14.09;95%CI,1.52-130.61;I2=0%),但两者都表明风险增加。
    结论:在本系统综述和荟萃分析中,我们发现,美沙酮的使用与对照组相比,VA的风险是前者的两倍多.然而,鉴于现有证据的质量有限,我们的研究结果应谨慎解释.
    BACKGROUND: The association between opioid use and the risk of ventricular arrhythmias (VA) is poorly understood.
    OBJECTIVE: The objective of this study was to synthesize the evidence on the risk of VA associated with opioid use.
    METHODS: We systematically searched the Cochrane Library, Embase, MEDLINE, and CINAHL databases in July 2022. Risk of bias was assessed using the Cochrane risk for bias tool for randomized controlled trials (RCTs) and ROBINS-I for observational studies. Certainty of evidence was assessed using GRADE.
    RESULTS: We included 15 studies (12 observational, 2 post hoc analyses of RCTs, 1 RCT). Most studies focused on opioid use for maintenance therapy (n = 9), comparing methadone to buprenorphine (n = 13), and reported QTc prolongation (n = 13). Six observational studies had a critical risk of bias, and one RCT was at high risk of bias. Two studies could not be included in the meta-analysis as they reported a different outcome and studied an opioid antagonist. Meta-analysis of 13 studies indicated that the use of methadone was associated with an increased risk of VA compared to the use of buprenorphine, morphine, placebo, or levacetylmethadol (risk ratio [RR], 2.39; 95% CI, 1.31-4.35; I2 = 60%). The pooled estimate varied greatly between observational studies (RR, 2.12; 95% CI, 1.15-3.91; I2 = 62%) and RCTs (RR, 14.09; 95% CI, 1.52-130.61; I2 = 0%), but both indicated an increased risk.
    CONCLUSIONS: In this systematic review and meta-analysis, we found that methadone use is associated with more than twice the risk of VA compared to comparators. However, our findings should be interpreted cautiously given the limited quality of the available evidence.
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  • 文章类型: Journal Article
    尽管最近在牛皮癣治疗方面取得了进展,管理方面的挑战依然存在。最近,患者对补充和替代药物(CAM)的兴趣越来越高,在对更自然的渴望的驱使下,整体方法和对常规治疗的不满。高达41%的银屑病患者报告使用替代疗法,39.5%使用补充疗法(MurphyEC,努斯鲍姆D,PrussickR,弗里德曼·AJ(2019)银屑病患者使用补充和替代药物。JAmAcadDermatol81:280-283)。尽管它们的患病率迅速增长,缺乏CAM治疗牛皮癣的文献,使他们的推荐困难。自2018年发表关于这一主题的最后一次系统综述以来,已经出现了新的替代疗法的证据。促进对其功效的进一步调查(GamretAC,价格A,FertigRM,Lev-TovH,NicholsAJ(2018)银屑病的补充和替代医学治疗:系统评价。JAMADermatol154:1330-1337)。本系统综述旨在收集有关研究最多的牛皮癣替代疗法的最新文献,并进一步讨论其有效性,以建议临床医生指导患者使用这些非标准方法。在PubMed进行了文献检索,EMBASE,Cochrane中央控制试验登记册,和Clinicaltrials.gov数据库,用于2018年3月至2024年4月期间银屑病辅助和替代疗法的随机对照试验(RCT),导致12项研究纳入本综述.许多治疗如姜黄素的初步结果,饮食调整和添加,天然靛蓝,冥想,针灸,和护理疗法显示出积极的临床效果。然而,我们还需要更多精心设计的随机试验来确认潜在的有益效果,并确定使用的安全性.
    Despite recent advancements in psoriasis treatment, challenges in management persist. Recently, there has been a rising interest amongst patients in complementary and alternative medicines (CAM), driven by the desire for more natural, holistic approaches and dissatisfaction with conventional treatments. Up to 41% of patients with psoriasis reported using alternative therapies and 39.5% use complementary therapies (Murphy EC, Nussbaum D, Prussick R, Friedman AJ (2019) Use of complementary and alternative medicine by patients with psoriasis. J Am Acad Dermatol 81:280-283). Despite their rapidly growing prevalence, literature on CAM therapies for psoriasis is lacking, making their recommendation difficult. Since the last systematic review on this topic published in 2018, evidence for new alternative therapies has emerged, promoting a further investigation of their efficacy (Gamret AC, Price A, Fertig RM, Lev-Tov H, Nichols AJ (2018) Complementary and Alternative Medicine Therapies for Psoriasis: A Systematic Review. JAMA Dermatol 154:1330-1337). This systematic review aims to compile recent literature on the most studied alternative therapies for psoriasis and further discuss their effectiveness in order to counsel clinicians in guiding patients on the use of these non-standard approaches. A literature search was conducted in the PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and Clinicaltrials.gov databases for randomized controlled trials (RCT) on complementary and alternative therapies in psoriasis from March 2018 through April 2024, resulting in 12 studies being included in this review. The preliminary results for many treatments such as curcumin, dietary modification and additions, indigo naturalis, meditation, acupuncture, and balneotherapy showed positive clinical effects. However, additional well-designed randomized trials are needed to confirm the potential beneficial effects and to establish safety of use.
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