Randomized study

随机研究
  • 文章类型: Editorial
    植物动物园是一种罕见的疾病,在西方国家不太常见。胃是这些形成的主要部位,传统上,涉及破碎和提取的内窥镜治疗是最有效的方法。然而,使用酶和化学试剂的医学治疗,比如纤维素酶和可口可乐,旨在溶解牛黄,也被利用了,显示出不同程度的决议成功。值得注意的是,可口可乐的口服溶解治疗已经成为一种有希望的,更简单,和更具成本效益的方法。Liu等人的研究代表了该主题临床研究的重要一步,尽管需要解决一些局限性,以便更全面地了解其发现。未来研究的关键考虑因素包括样本量计算,内窥镜手术细节,门诊vs.住院治疗,和详细的成本计算。这项研究的排除,比如胃上部手术的病人,植物动物年龄超过14d,和胃轻瘫的病例,限制其对更广泛人群的适用性,尤其是在西方国家。鉴于可口可乐治疗的有希望的结果,它被提倡作为植物动物的一线疗法。尽管如此,进一步的研究对于克服这些局限性至关重要。然而,穿孔或小肠梗阻等特殊情况需要手术治疗。
    Phytobezoars is a rare disease and less common in Western countries. The stomach is the primary site for these formations, and endoscopic treatment involving fragmentation and extraction has traditionally been the most effective approach. However, medical treatments using enzymatic and chemical agents, such as cellulase and Coca-Cola, aimed at dissolving the bezoars, have also been utilized, showing varying degrees of resolution success. Notably, the oral dissolution treatment with Coca-Cola has emerged as a promising, simpler, and more cost-effective method. The study by Liu et al represents an important step in clinical research on this topic, despite some limitations that need addressing for a more comprehensive understanding of its findings. Key considerations for future research include sample size calculation, endoscopic procedure details, outpatient vs. inpatient treatment, and detailed cost calculations. The study\'s exclusions, such as patients with upper gastric surgery, phytobezoars older than 14 d, and cases of gastroparesis, limit its applicability to broader populations, especially in Western countries. Given the promising outcomes of the Coca-Cola treatment, it\'s advocated as a first-line therapy for phytobezoars. Nonetheless, further research is essential to overcome these limitations. However special situations such as perforation or small bowel obstruction will require surgical treatment.
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  • 文章类型: Journal Article
    背景:新诊断的胶质母细胞瘤患者的标准治疗包括手术,放疗(RT)和替莫唑胺(TMZ)化疗(TMZ/RT→TMZ)。长期以来,蛋白酶体一直被认为是有希望的治疗靶标,因为它是肿瘤细胞中的中心生物枢纽。Marizomib是一种穿过血脑屏障的新型全蛋白酶体抑制剂。
    方法:EORTC1709/CCTGCE.8是多中心,随机化,控制,开放标签第三阶段优势试验。关键资格标准包括新诊断的胶质母细胞瘤,年龄>18岁,Karnofsky表现状态>70。患者以1:1的比例随机分组。主要目的是比较除TMZ/RT→TMZ外接受marizomib治疗的患者与仅接受标准治疗的患者的整体生存率(OS)。以及MGMT启动子未甲基化肿瘤患者的亚组。
    结果:该试验在欧洲82个机构开始,加拿大和美国。共有749例患者(计划750例的99.9%)被随机分组。标准和marizomib组之间的OS没有差异(中位数17vs16.5个月;HR=1.04;p=0.64)。PFS也没有统计学差异(中位数6.0vs.6.3个月;HR=0.97;p=0.67)。在MGMT启动子未甲基化肿瘤患者中,标准疗法和marizomib之间的OS也没有差异(中位数14.5vs15.1个月,HR=1.13;p=0.27)。与标准臂相比,在marizomib臂中观察到更多的CTCAE3/4级治疗引起的不良事件。
    结论:在标准的替莫唑胺放化疗中加入marizomib会导致更多的毒性,但未改善新诊断的胶质母细胞瘤患者的OS或PFS。
    BACKGROUND: Standard treatment for patients with newly diagnosed glioblastoma includes surgery, radiotherapy (RT) and temozolomide (TMZ) chemotherapy (TMZ/RT→TMZ). The proteasome has long been considered a promising therapeutic target because of its role as a central biological hub in tumor cells. Marizomib is a novel pan-proteasome inhibitor that crosses the blood brain barrier.
    METHODS: EORTC 1709/CCTG CE.8 was a multicenter, randomized, controlled, open label phase 3 superiority trial. Key eligibility criteria included newly diagnosed glioblastoma, age > 18 years and Karnofsky performance status > 70. Patients were randomized in a 1:1 ratio. The primary objective was to compare overall survival (OS) in patients receiving marizomib in addition to TMZ/RT→TMZ with patients receiving only standard treatment in the whole population, and in the subgroup of patients with MGMT promoter-unmethylated tumors.
    RESULTS: The trial was opened at 82 institutions in Europe, Canada and the US. A total of 749 patients (99.9% of planned 750) were randomized. OS was not different between the standard and the marizomib arm (median 17 vs 16.5 months; HR=1.04; p=0.64). PFS was not statistically different either (median 6.0 vs. 6.3 months; HR=0.97; p=0.67). In patients with MGMT promoter-unmethylated tumors, OS was also not different between standard therapy and marizomib (median 14.5 vs 15.1 months, HR=1.13; p=0.27). More CTCAE grade 3/4 treatment-emergent adverse events were observed in the marizomib arm than in the standard arm.
    CONCLUSIONS: Adding marizomib to standard temozolomide-based radiochemotherapy resulted in more toxicity, but did not improve OS or PFS in patients with newly diagnosed glioblastoma.
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  • 文章类型: Randomized Controlled Trial
    背景:本研究旨在比较放射疗法(RT)和经动脉化疗栓塞(TACE)作为肝细胞癌(HCC)患者窄切缘肝切除术后术后辅助治疗的疗效和安全性。
    方法:这项单中心前瞻性随机研究在肿瘤医院进行,广西医科大学,南宁。纳入2017年8月至2019年7月在该医院接受治疗的72例患者,随机分为TACE组(n=48)和RT组(n=24)。接下来,总生存率(OS)和无进展生存率(PFS),复发模式,财政负担,并对安全性进行了评估。
    结果:RT和TACE组之间的差异在一个-,三-,和五年操作系统(87.5%,79.0%,和62.5%vs.93.8%,75.9%,和63.4%,分别,P=0.071)和PFS率(79.0%,54.2%,和22.6%vs.75.0%,47.9%,和32.6%,分别,P=0.071)。与TACE组相比,RT组肝内复发率明显降低(20.8%vs.52.1%,P=0.011),肝外复发率较高(37.5%vs.14.6%,P=0.034),并且没有边缘和弥漫性复发(0%与16.7%,P<0.05)。平均总治疗费用较高(¥62,550.59±4397.27vs.¥40,732.56±9210.54,P<0.01),住院时间(15.1±3.7vs.11.8±4.1天,P<0.01)较长,和总体治疗停留时间(13.3±5.3vs.41.29±12.4天,TACE组P<0.01)短于RT组。此外,两组在不良事件发生频率和严重程度方面均无显著差异.
    结论:TACE和RT均可改善HCC患者的OS和PFS。然而,RT在改善肝内复发率方面明显优于TACE,治疗费用和住院时间。
    BACKGROUND: This study was recruited to compare the efficacy and safety of radiotherapy (RT) and transarterial chemoembolization (TACE) as postoperative adjuvant therapy after narrow-margin hepatectomy in hepatocellular carcinoma (HCC) patients.
    METHODS: This single-center prospective randomized study was conducted in the Cancer Hospital, Guang Xi Medical University, Nanning. A total of 72 patients who received treatment in this hospital between August 2017 and July 2019 were included and randomly allocated to TACE group (n = 48) and RT group (n = 24). Next, overall survival (OS) and progression-free survival (PFS) rates, recurrence patterns, financial burden, and safety were evaluated.
    RESULTS: The difference between the RT and TACE groups was not significant in one-, three-, and five-year OS (87.5%, 79.0%, and 62.5% vs. 93.8%, 75.9%, and 63.4%, respectively, P = 0.071) and PFS rates (79.0%, 54.2%, and 22.6% vs. 75.0%, 47.9%, and 32.6%, respectively, P = 0.071). Compared to the TACE group, the RT group had significantly lower intrahepatic recurrence rate (20.8% vs. 52.1%, P = 0.011), higher extrahepatic recurrence rate (37.5% vs. 14.6%, P = 0.034), and no marginal and diffuse recurrences (0% vs. 16.7%, P < 0.05). The mean overall treatment cost was higher (¥62,550.59 ± 4397.27 vs. ¥40,732.56 ± 9210.54, P < 0.01), the hospital stay (15.1 ± 3.7 vs. 11.8 ± 4.1 days, P < 0.01) was longer, and the overall treatment stay (13.3 ± 5.3 vs. 41.29 ± 12.4 days, P < 0.01) was shorter in the TACE group than in the RT group. Besides, both groups did not exhibit significant differences in the frequency and severity of adverse events.
    CONCLUSIONS: Both adjuvant TACE and RT can better the OS and PFS of patients with HCC. However, RT has a significantly better performance than TACE in terms of improving intrahepatic recurrence rate, treatment cost and hospital stay.
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  • 文章类型: Randomized Controlled Trial
    目的:比较米拉贝隆和vibegron在女性OAB患者中的疗效和安全性。
    方法:我们进行了多中心,prospective,女性OAB患者的随机交叉研究。患者被分配到MV组(mirabegron,为期8周,随后是vibegron,持续8周)或VM组(vibegron,持续8周,随后是米拉贝隆8周)。主要终点是OABSS相对于基线的变化,次要终点是FVC参数的变化。研究完成后,每位患者都被问及哪种药物更可取.
    结果:共纳入83例患者(MV组和VM组分别为40例和43例,分别)。在第8周和第16周,MV组中的33和29以及VM组中的34和27继续接受治疗。在使用mirabegron和vibegron的治疗之间,PVR的变化没有显着差异。OABSS的变化,夜间频率,意思是,mirabegron和vibegron的最大排气量相似。白天频率的平均变化在vibegron中比在mirabegron中更大。在56名患者中,15人(27%)和30人(53%)更喜欢米拉贝格龙和vibegron,分别。其余11名患者(20%)没有表现出偏好。对于喜欢vibegron而不是mirabegron的患者,vibegron期间的尿失禁评分变化更好。
    结论:mirabegron和vibegron在女性患者中的疗效相似。患者对vibegron的偏好可能取决于vibegron对急迫性尿失禁的疗效。
    OBJECTIVE: To compare the efficacy and safety of mirabegron and vibegron in female OAB patients.
    METHODS: We conducted a multicenter, prospective, randomized crossover study of female patients with OAB. The patients were assigned to Group MV (mirabegron for 8 weeks, followed by vibegron for 8 weeks) or group VM (vibegron for 8 weeks, followed by mirabegron for 8 weeks). The primary endpoint was the change in OABSS from baseline, and the secondary endpoint was the change in FVC parameters. After completion of the study, each patient was asked which drug was preferable.
    RESULTS: A total of 83 patients were enrolled (40 and 43 in groups MV and VM, respectively). At 8th and 16th week, 33 and 29 in Group MV and 34 and 27 in Group VM continued to receive the treatment. The change in PVR was not significantly different between treatment with mirabegron and vibegron. The changes in OABSS, nighttime frequency, mean, and maximum voided volume were similar between mirabegron and vibegron. The mean change in the daytime frequency was greater in the vibegron than in the mirabegron. Of the 56 patients, 15 (27%) and 30 (53%) preferred mirabegron and vibegron, respectively. The remaining 11 patients (20%) showed no preference. The change in the urgency incontinence score during vibegron was better in patients who preferred vibegron to mirabegron.
    CONCLUSIONS: The efficacies of mirabegron and vibegron in female patients was similar. The patients\' preference for vibegron could depend on the efficacy of vibegron for urgency incontinence.
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  • 文章类型: Journal Article
    社交媒体(SoMe)正在成为研究传播的重要工具。Twitter/X推广已被证明可以提高成熟期刊的引用率。我们旨在测试SoMe促销策略对Mendeley读者数量的影响,Altmetric注意力得分和即将到来的开放获取期刊中的引用次数。
    #TweetTheJournal研究是一项随机研究,对照研究。在随后的七期《国际心脏病学心脏与脉管系统杂志》(2021年4月至2022年4月)上发表的文章被随机分配到Twitter/X推广臂(文章发布四次)和控制臂(未主动发布)。附有社论的文章被排除在外。研究的主要终点是门捷利读者计数,次要终点是Altmetric注意力评分和引用次数.后续是一年。
    SoMe推广的文章显示,在一年的随访中,门捷利读者计数或引用次数没有统计学上的显着差异。与对照组相比,SoMe的推广导致干预组的Altmetric注意力评分在统计学上显着提高(RR1.604,95%CI1.024-2.511,p=0.039)。在整个群体中,Altmetric注意力评分显示与Mendeley读者计数相关(Spearman的ρ=0.202,p=0.010),而Mendeley读者计数与引用次数显着相关(Spearman的ρ=0.372,p<0.001)。
    专门的SoMe促销策略并未导致早期影响指标的统计学显着差异,因为Mendeley读者在即将出版的期刊中计数,但提高了Altmetric注意力得分.
    UNASSIGNED: Social media (SoMe) are emerging as important tools for research dissemination. Twitter/X promotion has been shown to increase citation rates in well-established journals. We aimed to test the effect of a SoMe promotion strategy on the Mendeley reader counts, the Altmetric Attention Score and the number of citations in an upcoming open-access journal.
    UNASSIGNED: The #TweetTheJournal study is a randomized, controlled study. Articles published in seven subsequent issues of the International Journal of Cardiology Heart & Vasculature (April 2021-April 2022) were randomized to a Twitter/X promotion arm (articles were posted four times) and to a control arm (without active posting). Articles with accompanied editorials were excluded. Primary endpoint of the study was Mendeley reader count, secondary endpoints were Altmetric Attention Score and number of citations. Follow-up was one year.
    UNASSIGNED: SoMe promotion of articles showed no statistically significant difference in Mendeley reader counts or number of citations at one year follow up. SoMe promotion resulted in a statistically significant higher Altmetric Attention Score in the intervention compared to the control group (RR 1.604, 95 % CI 1.024-2.511, p = 0.039). In the overall group, Altmetric Attention Score showed a correlation with Mendeley reader counts (Spearman\'s ρ = 0.202, p = 0.010) and Mendeley reader counts correlated significantly with number of citations (Spearman\'s ρ = 0.372, p < 0.001).
    UNASSIGNED: A dedicated SoMe promotion strategy did not result in statistically significant differences in early impact indicators as the Mendeley reader count in a upcoming journal, but increased the Altmetric Attention Score.
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  • 文章类型: Journal Article
    子宫腺肌病的医学管理是现代妇科的一个新兴观点。虽然左炔诺孕酮宫内系统(LNG-IUS)和地鼠(DNG)有效缓解子宫腺肌病的症状,两者都没有被批准用于相同的适应症。我们的研究旨在比较这些孕激素治疗子宫腺肌病的疗效和安全性。
    研究LNG-IUS与DNG在有症状的子宫腺肌病患者中的疗效和安全性。
    开放标签,平行,单中心,随机临床试验。
    子宫腺肌病相关疼痛伴或不伴异常子宫出血的患者随机分为LNG-IUS组和DNG组。主要结果是通过视觉模拟量表(VAS)评分测量的治疗12周后疼痛症状的减少。月经失血(MBL)的变化,生活质量(QoL)的改善,并对药物不良反应进行分析。
    两组的VAS评分均较基线显著降低。LNG-IUS组的基线和治疗后VAS评分分别为6.41±1.07和3.41±1.04(p=<0.001),DNG组,分别为6.41±0.95和3.12±1.40(p=<0.001),分别。与DNG组相比,LNG-IUS组中明显更大比例的患者经历了较轻的MBL[LNG-IUS组中的27/30(90%)对DNG组中的17/22(77.2%)(p=0.006)]。根据世界卫生组织QOL量表(WHOQOLBREF)问卷计算,两组的QOL得分均有改善;然而,在DNG组中更为明显[(LNG-IUS组28.76±30.47vsDNG组48.26±44.91(p=0.04)].两种药物都是安全的,因为没有报告重大的药物不良反应。
    DNG可以是LNG-IUS的有效且安全的替代品,用于子宫腺肌病的医疗管理。
    该试验在临床试验注册处进行了前瞻性注册-印度(CTRI),CTRI编号为CTRI/2020/05/025186。
    比较曼月乐(LNG-IUS)与地鼠治疗子宫腺肌病的有效性和安全性子宫腺肌病是一种影响女性的疾病,通常年龄在40-50岁,但其发病率在年轻女性中上升,影响生育能力。它会引起痛经等痛苦症状,性交困难,慢性盆腔疼痛,大量月经出血。管理症状至关重要,和医疗方法包括左炔诺孕酮宫内节育器系统(LNG-IUS)和地鼠(DNG)。LNG-IUS是可逆避孕,批准了八年,有效治疗症状。DNG,一种新的孕激素,对子宫内膜异位症有效,但子宫腺肌病的证据有限.这个单一中心,开放标签随机临床试验比较了LNG-IUS和DNG治疗子宫腺肌病的疗效.使用超声诊断20岁以上患有盆腔疼痛的女性,并符合特定标准。知情同意后,参与者被随机分配到LNG-IUS或DNG组.治疗结果,包括骨盆疼痛,生活质量(QoL),和不利影响,评估超过12周。在84个评估中,招募了74名妇女,每组34人进行分析。12周后,两组均显示骨盆疼痛(VAS评分)显着降低,但两组间无显著差异。LNG-IUS导致月经大出血(HMB)的显著减少,而DNG在整体生活质量方面表现出更好的改善。两组的不良反应相似,DNG组中报告的潮热。本研究是为数不多的比较LNG-IUS和DNG治疗子宫腺肌病的研究之一,发现两者都有效缓解症状。尽管LNG-IUS在降低HMB方面具有优势,DNG在QoL方面表现出更好的整体改善。安全性相似。先前的研究支持DNG在减轻子宫腺肌病症状方面的功效。最后,LNG-IUS和DNG均能有效缓解子宫腺肌病症状,LNG-IUS在减少大量月经出血方面优于DNG,在生活质量方面表现出更好的整体改善。DNG是LNG-IUS的可行且有效的替代方案。
    UNASSIGNED: Medical management of adenomyosis is an emerging perspective in modern gynecology. Though levonorgestrel intrauterine system (LNG-IUS) and dienogest (DNG) effectively relieve symptoms in adenomyosis, neither has been approved for the same indication. Our study aims to compare the efficacy and safety of these progestins in treating adenomyosis.
    UNASSIGNED: To study the efficacy and safety of LNG-IUS versus DNG in patients with symptomatic adenomyosis.
    UNASSIGNED: Open-labeled, parallel, single-centered, randomized clinical trial.
    UNASSIGNED: Patients with adenomyosis-associated pain with or without abnormal uterine bleeding were randomly allocated to either LNG-IUS group or DNG group. The primary outcome was a reduction in painful symptoms after 12 weeks of treatment measured by visual analog scale (VAS) score. Changes in menstrual blood loss (MBL), improvement in quality of life (QoL), and adverse drug reactions were also analyzed.
    UNASSIGNED: The VAS score significantly decreased from baseline in both groups. The baseline and post-treatment VAS scores in the LNG-IUS group were 6.41 ± 1.07 and 3.41 ± 1.04 (p = <0.001) and in the DNG group, were 6.41 ± 0.95 and 3.12 ± 1.40 (p = <0.001), respectively. A significantly greater proportion of patients in the LNG-IUS group experienced lighter MBL as compared to the DNG group [27/30 (90%) in the LNG-IUS group versus 17/22 (77.2%) in the DNG group (p = 0.006)]. Both the groups had improvement in QOL scores calculated by the World Heath Organisation QOL scale (WHOQOL BREF) questionnaire; however, it was more pronounced in the DNG group [(28.76 ± 30.47 in the LNG-IUS group versus 48.26 ± 44.91 in the DNG group (p = 0.04)]. Both the agents were safe as there were no reported major adverse drug reactions.
    UNASSIGNED: DNG can be an effective and safe alternative to LNG-IUS for the medical management of adenomyosis.
    UNASSIGNED: The trial was prospectively registered at the clinical trial registry - India (CTRI) vide CTRI number CTRI/2020/05/025186.
    Comparison of effectiveness and safety of Mirena (LNG-IUS) with dienogest for treatment of adenomyosis Adenomyosis is a condition affecting women, typically aged 40–50, but its incidence is rising in younger women, impacting fertility. It causes painful symptoms like dysmenorrhea, dyspareunia, chronic pelvic pain, and heavy menstrual bleeding. Managing symptoms is crucial, and medical approaches include levonorgestrel intrauterine system (LNG-IUS) and dienogest (DNG). LNG-IUS is reversible contraception, approved for eight years, effectively treating symptoms. DNG, a newer progestin, is effective for endometriosis, but evidence for adenomyosis is limited. This single-center, open-label randomized clinical trial compared LNG-IUS and DNG in treating adenomyosis. Women over 20 with pelvic pain were diagnosed using ultrasound and met specific criteria. After informed consent, participants were assigned randomly to LNG-IUS or DNG groups. Treatment outcomes, including pelvic pain, quality of life (QoL), and adverse effects, were assessed over 12 weeks. Out of 84 assessed, 74 women were recruited, with 34 in each group analyzed. After 12 weeks, both groups showed significantly reduced pelvic pain (VAS scores), but no significant difference was found between the groups. LNG-IUS resulted in a significantly greater reduction in heavy menstrual bleeding (HMB), whereas DNG showed better improvement in overall QOL. Adverse effects were similar in both groups, with hot flushes reported in the DNG group. This study is one of the few comparing LNG-IUS and DNG for adenomyosis, finding both effective for symptom relief. Although LNG-IUS was superior in reducing HMB, DNG showed better overall improvement in QoL. Safety profiles were similar. Previous studies support the efficacy of DNG in reducing adenomyosis symptoms. To conclude, both LNG-IUS and DNG effectively alleviate adenomyosis symptoms, with LNG-IUS superior in reducing heavy menstrual bleeding and DNG showing better overall improvement in QOL. DNG is a viable and effective alternative to LNG-IUS.
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  • 文章类型: Journal Article
    背景:2019年冠状病毒病(COVID-19)大流行已经持续了3年多,在此期间进行了许多临床和实验研究。本系统评价和荟萃分析的目的是评估接受体外膜氧合(ECMO)的COVID-19患者的生存概率和并发症。
    方法:我们通过使用人口干预-比较-结果-研究设计(PICOS)搜索数据库。我们搜索了PubMed,WebofScience,和EMBASE数据库检索到2022年12月10日之前发表的研究。随机效应荟萃分析,亚组分析,并使用纽卡斯尔-渥太华量表评分对研究进行评估。结果表示为具有95%置信区间的合并发病率。
    结果:这项研究是对19项研究进行的,共纳入1494名患者,结果显示合并生存概率为66.0%.合并颅内出血的发病率为8.7%,颅内血栓形成7.0%,气胸9.0%,肺栓塞11.0%,肺出血9.0%,心力衰竭14.0%,肝功能衰竭13.0%,肾损伤44.0%,消化道出血6.0%,胃肠道缺血6.0%,静脉血栓31.0%。
    结论:这项对观察性研究的系统评价和荟萃分析侧重于接受ECMO的COVID-19患者的生存概率和并发症,这对评估ECMO在COVID-19患者中的使用具有重要意义,并为进一步的研究提供了基础。
    背景:我们的研究在PROSPERO上注册,注册号为CRD42022382555。
    BACKGROUND: The Coronavirus Disease 2019 (COVID-19) pandemic has been ongoing for over 3 years, during which numerous clinical and experimental studies have been conducted. The objective of this systematic review and meta-analysis was to assess the survival probability and complications of COVID-19 patients receiving extracorporeal membrane oxygenation (ECMO).
    METHODS: We searched the databases by using Population-Intervention-Comparison-Outcome-Study Design (PICOS). We conducted a search of the PubMed, Web of Science, and EMBASE databases to retrieve studies published until December 10, 2022. A random-effects meta-analysis, subgroup analysis, and assessed the studies using the Newcastle-Ottawa Scale score. The results were presented as pooled morbidity with 95% confidence intervals.
    RESULTS: The study was conducted on 19 studies that enrolled a total of 1494 patients, and the results showed a pooled survival probability of 66.0%. The pooled morbidity for intracranial hemorrhage was 8.7%, intracranial thrombosis 7.0%, pneumothorax 9.0%, pulmonary embolism 11.0%, pulmonary hemorrhage 9.0%, heart failure 14.0%, liver failure 13.0%, renal injury 44.0%, gastrointestinal hemorrhage 6.0%, gastrointestinal ischemia 6.0% and venous thrombosis 31.0%.
    CONCLUSIONS: This systematic review and meta-analysis of observational studies focused on the survival probability and complications of COVID-19 patients undergoing ECMO, which are significant in evaluating the use of ECMO in COVID-19 patients and provide a basis for further research.
    BACKGROUND: Our study was registered on PROSPERO with registration number CRD42022382555.
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  • 文章类型: Randomized Controlled Trial
    目的:只有一项III期前瞻性随机研究,发表于2006年,评估了5-氨基乙酰丙酸(5-ALA)荧光引导手术(FGS)切除胶质母细胞瘤的性能。RESECT研究的目的是比较根据当前护理标准治疗的胶质母细胞瘤患者与5-ALA荧光和白光常规显微手术相关的肿瘤功能结果。
    方法:这是一项III期前瞻性随机单盲研究,涉及21个法国神经外科中心,比较5-ALAFGS与白光常规显微手术治疗的胶质母细胞瘤患者,根据当前的护理标准,包括神经导航使用和术后放化疗。按机构分层,以1:1的比例进行随机化。在切口前3-5小时口服施用5-ALA(20mg/kg)或安慰剂(抗坏血酸)。主要终点是由独立委员会盲目评估的总切除率(GTR)。未确诊胶质母细胞瘤病理诊断或术后MRI研究不可用的患者被排除在符合方案分析之外。
    结果:在2013年3月至2016年8月之间,共有171名患者被分配到5-ALA荧光组(n=88)或安慰剂组(n=83)。由于不符合WHO4级神经胶质瘤的组织学标准,因此排除了24例。5-ALA荧光组(53/67,79.1%)的GTR比例显著高于安慰剂组(33/69,47.8%;p=0.0002)。调整后的年龄,术前Karnofsky表现量表评分,和肿瘤的位置,GTR仍与5-ALA荧光相关(OR4.13[95%CI1.94-8.79])。术后7天平均Karnofsky性能量表评分(49/71≥80%,69.0%[5-ALA组];50/71,70.4%[安慰剂组],p=0.86)和术后3个月神经系统状况恶化的患者比例(9/68,13.2%[5-ALA组];9/70,12.9%[安慰剂组],p=0.95)组间相似。与5-ALA摄入相关的不良事件很少见,包括4/87(4.6%)患者的光敏化和1/87(1.1%)患者的肝细胞溶解。6个月PFS(70.2%[95%CI57.7%-79.6%]和68.4%[95%CI55.7%-78.1%];p=0.39)和24个月OS(30.1%[95%CI18.9%-42.0%]和37.7%[95%CI25.8%-49.5%];p=0.89)无显著差异。在多变量分析中,GTR是PFS的独立预测因子(风险比0.56[95%CI0.36-0.86],p=0.008)和OS(危险比0.65[95%CI0.42-1.01],p=0.05)。使用5-ALAFGS会产生2732.36欧元(95%CI1658.40欧元-3794.11欧元)的显着额外成本。
    结论:作者发现5-ALAFGS易于使用,成本效益高,和最耗时的技术,可以安全地优化患有胶质母细胞瘤的患者的切除范围。
    OBJECTIVE: Only one phase III prospective randomized study, published in 2006, has assessed the performance of 5-aminolevulinic acid (5-ALA) fluorescence-guided surgery (FGS) for glioblastoma resection. The aim of the RESECT study was to compare the onco-functional results associated with 5-ALA fluorescence and with white-light conventional microsurgery in patients with glioblastoma managed according to the current standards of care.
    METHODS: This was a phase III prospective randomized single-blinded study, involving 21 French neurosurgical centers, comparing 5-ALA FGS with white-light conventional microsurgery in patients with glioblastoma managed according to the current standards of care, including neuronavigation use and postoperative radiochemotherapy. Randomization was performed in a 1:1 ratio stratified by institution. 5-ALA (20 mg/kg) or placebo (ascorbic acid) was administered orally 3-5 hours before the incision. The primary endpoint was the rate of gross-total resection (GTR) blindly assessed by an independent committee. Patients without a confirmed pathological diagnosis of glioblastoma or with unavailable postoperative MRI studies were excluded from the per-protocol analysis.
    RESULTS: Between March 2013 and August 2016, a total of 171 patients were assigned to the 5-ALA fluorescence group (n = 88) or to the placebo group (n = 83). Twenty-four cases were excluded because the WHO histological criteria of grade 4 glioma were not met. The proportion of GTR was significantly higher in the 5-ALA fluorescence group (53/67, 79.1%) than in the placebo group (33/69, 47.8%; p = 0.0002). After adjustment for age, preoperative Karnofsky Performance Scale score, and tumor location, GTR was still associated with 5-ALA fluorescence (OR 4.13 [95% CI 1.94-8.79]). The mean 7-day postoperative Karnofsky Performance Scale score (≥ 80% in 49/71, 69.0% [5-ALA group]; 50/71, 70.4% [placebo group], p = 0.86) and the proportion of patients with a worsened neurological status 3 months postoperatively (9/68, 13.2% [5-ALA group]; 9/70, 12.9% [placebo group], p = 0.95) were similar between groups. Adverse events related to 5-ALA intake were rare and consisted of photosensitization in 4/87 (4.6%) patients and hepatic cytolysis in 1/87 (1.1%) patients. The 6-month PFS (70.2% [95% CI 57.7%-79.6%] and 68.4% [95% CI 55.7%-78.1%]; p = 0.39) and 24-month OS (30.1% [95% CI 18.9%-42.0%] and 37.7% [95% CI 25.8%-49.5%]; p = 0.89) did not significantly differ. In multivariate analysis, GTR was an independent predictor of PFS (hazard ratio 0.56 [95% CI 0.36-0.86], p = 0.008) and OS (hazard ratio 0.65 [95% CI 0.42-1.01], p = 0.05). The use of 5-ALA FGS generates a significant extra cost of 2732.36€ (95% CI 1658.40€-3794.11€).
    CONCLUSIONS: The authors found that 5-ALA FGS is an easy-to-use, cost-effective, and minimally time-consuming technique that safely optimizes the extent of resection in patients harboring glioblastoma amenable to a large resection.
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  • 文章类型: Journal Article
    目的:探讨静脉注射可能的急性毒性及病理改变,腹膜内,在皮下携带人胰腺癌(PaC)的小鼠中或肿瘤内注射自然杀伤(NK)细胞。
    方法:在给药前9天用人PaCBXPC-3细胞皮下移植100只NPG荷瘤小鼠(50/性别)。随机分为10组,每组男性5例,女性5例。第1组小鼠静脉注射氯化钠作为载体对照,和第2-4组小鼠以2×107、1×108和5×108个细胞/kg的剂量静脉注射人外周血来源的NK细胞,分别;第5-7组小鼠腹膜内注射NK细胞,剂量为2×107、1×108和5×108细胞/kg,分别,和第8-10组小鼠肿瘤内NK细胞的剂量分别为4×103、2×104和1×105细胞/mm3。每组给予单剂量;对小鼠进行临床观察,和体重,食物摄入量,血液生物化学,并测量肿瘤体积。在第15天,将小鼠安乐死用于大体解剖和组织病理学。
    结果:关于计划中的安乐死,在第2-4组中,未发现与细胞注射相关的总体或微观病理变化;在第5-7组中,两性小鼠的脾脏髓外造血功能降低,在5×108细胞/kg的剂量下,两种性别的小鼠都显示脾脏白髓细胞的组成增加。在第8-10组中,剂量为4×103和1×105细胞/mm3的两性小鼠和剂量为2×104细胞/mm3的雌性小鼠显示脾的髓外造血减少,4×103细胞/mm3剂量的雌性小鼠和≥2×104细胞/mm3剂量的两性小鼠显示脾白髓细胞组成增加;在≥2×104细胞/mm3剂量的两性小鼠中观察到肺和支气管的血管周围/细支气管周围炎症细胞浸润,在1×105细胞/mm3剂量的两性小鼠中观察到肝脏的炎症细胞浸润。临床观察未见其他有毒理学意义的异常改变,体重,食物摄入量,或血液生化观察各组。
    结论:在我们的研究中,静脉注射似乎是给人携带PaC的小鼠提供NK细胞的最安全方法。使用腹膜内或肿瘤内给药,脾,脾肝脏,肺是最常受累的器官,尽管大多有轻微的病理变化。
    OBJECTIVE: To investigate the possible acute toxicities and pathological changes associated with intravenous, intraperitoneal, or intratumoral injection of natural killer (NK) cells in mice subcutaneously bearing human pancreatic adenocarcinoma (PaC).
    METHODS: 100 NPG tumor-bearing mice (50/sex) were engrafted subcutaneously with human PaC BXPC-3 cells 9 days before administration. They were randomly divided into 10 groups with 5 males and 5 females in each group. Mice in Group 1 were given sodium chloride intravenously as vehicle control, and mice in Groups 2-4 human peripheral blood-derived NK cells intravenously at doses of 2 × 107, 1 × 108, and 5 × 108 cells/kg, respectively; mice in Groups 5-7 were injected with NK cells intraperitoneally at doses of 2 × 107, 1 × 108, and 5 × 108 cells/kg, respectively, and mice in Groups 8-10 with NK cells intratumorally at doses of 4 × 103, 2 × 104, and 1 × 105 cells/mm3, respectively. Each group was given a single dose; the mice were observed clinically, and body weight, food intake, blood biochemistry, and tumor volume were measured. On Day 15, the mice were euthanized for gross anatomy and histopathology.
    RESULTS: On planned euthanasia, in Groups 2-4 no gross or microscopic pathological changes related to cells injection were found; in Groups 5-7 mice of both sexes showed a decrease in extramedullary hematopoiesis of spleen, and at the dose of 5 × 108 cells/kg, mice of both sexes showed an increase in the composition of spleen white pulp cells. In Groups 8-10, mice of both sexes at doses of 4 × 103 and 1 × 105 cells/mm3 and female mice at the dose of 2 × 104 cells/mm3 showed a decrease in extramedullary hematopoiesis of spleen, and female mice at a dose of 4 × 103 cells/mm3 and mice of both sexes at doses of ≥ 2 × 104 cells/mm3 showed an increase in the composition of spleen white pulp cells; perivascular/peribronchiolar inflammatory cell infiltration in lung and bronchus was observed in mice of both sexes at doses of ≥ 2 × 104 cells/mm3, and inflammatory cell infiltration in liver was observed in mice of both sexes at a dose of 1 × 105 cells/mm3. No other abnormal changes with toxicological significance in clinical observation, body weight, food intake, or blood biochemistry were observed in each group.
    CONCLUSIONS: In our study intravenous injection appears the safest way to give NK cells to human PaC-bearing mice. Using intraperitoneal or intratumoral administration, spleen, liver, and lung were the most often affected organs, albeit with mostly mild pathological changes.
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  • 文章类型: Journal Article
    冠状病毒病-2019(COVID-19)是由SARS-CoV-2病毒引起的极具传染性的疾病,已被世界卫生组织(WHO)宣布为大流行。目前没有特殊的治疗方法,然而,雾化肝素已被提供作为一种可行的治疗方法。这项系统评价的目的是评估雾化肝素在有呼吸道症状的COVID-19患者中的疗效。
    通过对PubMed的系统搜索确定了相关研究,Medline,Embase,Cochrane图书馆和WebofScience,和Scopus数据库。搜索词包括“雾化肝素,\“\”COVID-19,\“和\”SARS-CoV-2。“包括评估雾化肝素在有呼吸道症状的COVID-19患者中使用的研究。其余的研究以及未以英文发表的研究都被排除在外。系统评价在PROSPERO-CRD42023413927注册。
    本系统综述中包括了五项研究。病例报告,案例系列,观察性研究,随机对照试验(RCT)包括这些研究。患者样本量范围从2到98。这些研究评估了雾化肝素对疾病严重程度不同的COVID-19患者的疗效。评估的结果包括死亡率,住院时间,氧气需求,和实验室参数。
    根据本系统综述中的临床研究,雾化肝素可能有助于COVID-19的治疗。氧饱和度更高,炎症指标较低,这些患者的住院时间较短。然而,这些研究有局限性,包括不一致的样本量,不同剂量的雾化肝素,没有对照组。雾化肝素在COVID-19患者中的应用需要进一步研究,以确定其安全性和有效性。
    GuptaB,AhluwaliaP,GuptaN,GuptaA.雾化肝素在有呼吸道症状的COVID-19患者临床结局中的作用:系统评价。印度J暴击护理中心2023年;27(8):572-579。
    Coronavirus disease-2019 (COVID-19) is an extremely contagious illness caused by the SARS-CoV-2 virus and has been declared a pandemic by the World Health Organization (WHO). There are currently no particular treatments, however, nebulized heparin has been offered as a viable therapy. The purpose of this systematic review is to assess the efficacy of nebulized heparin in COVID-19 patients with respiratory symptoms.
    UNASSIGNED: Relevant studies were identified through a systematic search of the PubMed, Medline, Embase, Cochrane Library and Web of Science, and Scopus databases. The search terms included \"nebulized heparin,\" \"COVID-19,\" and \"SARS-CoV-2.\" Studies that evaluated the use of nebulized heparin in COVID-19 patients with respiratory symptoms were included. The rest of the studies along with those that were not published in English were excluded. The systematic review was registered under PROSPERO-CRD42023413927.
    UNASSIGNED: Five studies have been included in this systematic review. Case reports, case series, observational studies, and randomized controlled trial (RCT) comprised the studies. The patient sample sizes ranged from 2 to 98. The studies assessed the efficacy of nebulized heparin in COVID-19 patients with variable disease severity. The evaluated outcomes included mortality, hospital stay duration, oxygen requirements, and laboratory parameters.
    UNASSIGNED: Based on the clinical studies included in this systematic review, nebulized heparin may be useful in the management of COVID-19. Oxygen saturation was greater, inflammatory indicators were lower, and hospital stays were shorter in these patients. However, the studies had limitations, including inconsistent sample sizes, varying dosages of nebulized heparin, and no control groups. Nebulized heparin in patients with COVID-19 needs to be studied further to determine its safety and effectiveness.
    UNASSIGNED: Gupta B, Ahluwalia P, Gupta N, Gupta A. Role of Nebulized Heparin in Clinical Outcome of COVID-19 Patients with Respiratory Symptoms: A Systematic Review. Indian J Crit Care Med 2023;27(8):572-579.
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