Safety and immunogenicity of NVX-CoV2373 (TAK-019) vaccine in healthy Japanese adults: Interim report of a phase I/II randomized controlled trial

BackgroundWe evaluated the safety and immunogenicity of NVX-CoV2373, a recombinant SARS-CoV-2 nanoparticle vaccine, in healthy Japanese participants.MethodsThis phase 1/2, randomized, observer-blind, placebo-controlled trial conducted in Japan (two sites), enrolled healthy Japanese adults aged ≥ 20 years with no history/risk of SARS-CoV-2 infection and no prior exposure to other approved/investigational SARS-CoV-2 vaccines or treatments. Participants were stratified by age (< 65 or ≥ 65 years) and randomized to receive two doses of either NVX-CoV2373 (5 μg SARS-CoV-2 rS; 50 μg Matrix-M1) or placebo, 21 days apart. Primary outcomes were safety and immunogenicity assessed by serum IgG antibody levels against SARS-CoV-2 rS protein on day 36. Herein, we report the primary data analysis at 4 weeks after the second dose, ahead of 12-month follow-up completion (data cut-off: 8 May 2021).ResultsBetween 12 February 2021 and 17 March 2021, 326 subjects were screened, and 200 participants enrolled and randomized: NVX-CoV2373, n = 150; placebo, n = 50. Solicited adverse events (AEs) through 7 days after each injection occurred in 121/150 (80.7%) and 11/50 (22.0%) participants in the NVX-CoV2373 and placebo arms, respectively. In the NVX-CoV2373 arm, tenderness and injection site pain were the most frequently reported solicited AEs after each vaccination, irrespective of age. Robust immune responses occurred with NVX-CoV2373 (n = 150) by day 36: IgG geometric mean fold rise (95% confidence interval) 259 (219, 306); seroconversion rate 100% (97.6, 100). No such response occurred with placebo (n = 49).ConclusionTwo doses of NVX-CoV2373 given with a 21-day interval demonstrated acceptable safety and induced robust anti-SARS-CoV-2 immune responses in healthy Japanese adults. Funding: Takeda Pharmaceutical Company Limited and Japan Agency for Medical Research and Development (AMED). ClinicalTrials.gov identifier: NCT04712110.     

微创治疗方法在输尿管上段结石中应用进展

输尿管上段结石为临床中常见泌尿系结石类型之一,如不能及时诊治,可引起重度积水、泌尿系感染,甚至脓毒血症,对患者肾功能、健康造成严重影响。随着微创治疗技术在泌尿系结石中应用,微创治疗方法能降低对患者造成治疗性创伤,降低相关并发症发生率,促进患者康复,了解临床中微创治疗输尿管上段结石方法,对临床中合理治疗输尿管上段结石有重要价值。     

经络艾灸防治乳腺癌根治术后患侧上肢水肿的效果评价

目的观察循经艾灸预防乳腺癌患者根治术后上肢水肿的效果。方法采用便利抽样法选取乳腺外科乳腺癌根治术的患者150例,随机分为对照组和观察组,每组75例。对照组行常规护理,观察组在对照组基础上在手术侧上肢循经艾灸。于术前1 d、术后第14天和术后1个月,测量两组患者患侧上肢水肿程度。结果观察组术后患侧上肢水肿发生率低于对照组(P<0.05)。结论术后循经艾灸可有效预防乳腺癌根治术后患侧上肢水肿,提高患者舒适度。     

The prognostic value of lymph node ratio in Medullary thyroid carcinoma: A multi-center study

IntroductionThe lymph node ratio (LNR), which represents the proportion of metastatic lymph nodes resected, has been found to be a prognostic variable in several cancers, but data for Medullary thyroid carcinoma (MTC) are sparse. The aim of this study was to determine the value of the LNR in predicting outcome in patients with MTC.Materials and methodsA retrospective multicenter study design of 107 patients with MTC who underwent total thyroidectomy with neck dissection between 1984 and 2016. The association of LNR with patient and tumor characteristics and prognostic factors was evaluated.ResultsStudy population consisted of 53.3% female, mean age at diagnosis was 50.3 ± 18.4 years; 16.8% had inherited MTC. LNR was positively correlated with tumor size (p = 0.018) and inversely correlated with age at diagnosis (p = 0.024). A higher LNR was associated with extrathyroidal extension (p < 0.001), multifocality (p = 0.001), bilateral tumor (p = 0.002), distant metastases (p < 0.001), and tumor recurrence (OR = 14.7, p < 0.001). LNR was also correlated to postoperative calcitonin levels (p < 0.001) and carcinoembryonic antigen (p = 0.011). LNR >0.1 was associated with shorter disease-specific survival in patients at risk: tumor larger than 20 mm at diagnosis (p = 0.013), sporadic MTC (p = 0.01), and age above 40 years at diagnosis (p = 0.004). Cox multivariate survival analysis revealed LNR as the only significant independent factor for disease free survival (p = 0.005).ConclusionsThis study showed that LNR correlates well with patient and tumor characteristics and prognostic variables. We suggest that LNR should be considered an important parameter for predicting outcome in MTC.     

锥形束CT对儿童上颌前部埋伏多生牙定位的研究

目的评价锥形束CT(cone beam computed tomography,CBCT)及三维重建技术对儿童上颌前部埋伏多生牙定位的价值,为临床提供准确的治疗措施。方法选择2017年6月-2018年9月来本院就诊上颌骨内埋伏牙儿童患者263例行锥形束CT扫描,获取牙体表面三维立体图像及任意平面图像和任意曲面体层图像,从多个角度显示埋伏牙的形态、大小、萌出方向、唇腭侧位置及与邻牙位置的关系。结果263例患儿312颗上颌前部埋伏多生牙252颗位于腭侧,50颗位于唇侧,10颗位于牙槽骨中部;牙冠正向生长77颗,牙冠倒置生长154颗,牙冠横向生长81颗。所有患者顺利完成手术,术前诊断与术中结果完全一致,准确率为100%。结论锥形束CT是精确定位儿童上颌前部埋伏多生牙有效方法,可直接、准确地反映埋伏多生牙的位置,为临床诊断和治疗提供可靠信息。     

中医康复护理对中风肢体功能障碍患者的疗效

目的分析脑卒中肢体功能障碍患者应用中医康复护理干预后,上下肢功能、生活品质以及神经功能损伤症状变化情况。方法选取本院2017年3月-2019年3月收治的160例脑卒中肢体功能障碍患者为研究对象,将其随机均分为采用传统康复护理的常规组,与采用中医康复护理的研究组。对比两组患者护理干预前后上下肢力指标、神经功能损伤评估分值以及生活品质评估分值。结果干预前,两组患者上、下肢肌力差异无统计学意义(P>0.05),干预后,两组患者上、下肢肌力全部明显增加,并且研究组增加幅度优于常规组,差异均具有统计学意义(P<0.05);干预后,研究组与常规组脑卒中患者神经功能缺损评分标准(CSS)评估分值均显著降低,且常规组降低幅度低于研究组;两组生活自理能力评估分值全部显著增加,且研究组提升幅度明显高于常规组,差异均具有统计学意义(P<0.05)。结论脑卒中肢体功能障碍患者应用中医康复护理干预,能够显著提高患者肢体肌肉能力以及生活品质,促进神经功能的修复。     

康复新液联合消化内镜治疗急性上消化道出血

目的分析急性上消化道出血患者采用康复新液联合消化内镜治疗的临床疗效。方法将2017年1月-2019年8月在本院接受治疗的42例急性上消化道出血患者纳入本次研究,根据不同的止血方法进行分组:对照组(n=21)采用消化内镜治疗;观察组(n=21)采用康复新液联合消化内镜治疗,比较治疗效果。结果 (1)临床疗效:观察组中,显效13例、有效7例、无效1例,总有效率95.24%;对照组中,显效9例、有效9例、无效3例,总有效率85.71%,差异不具有统计学意义(P> 0.05)。(2)并发症发生率:观察组出现再出血1例、发热1例,发生率9.52%;对照组中,再出血3例、发热3例、穿孔2例,发生率38.10%。差异具有统计学意义(P <0.05)。差异具有统计学意义(P <0.05)。结论康复新液联合消化内镜治疗在急性上消化道出血的治疗中具有良好的应用效果,适合在临床中应用。     

Bypass Surgery or Stenting for Left Main Coronary Artery Disease in Patients With Diabetes

Background

The randomized EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial reported a similar rate of the 3-year composite primary endpoint of death, myocardial infarction (MI), or stroke in patients with left main coronary artery disease (LMCAD) and site-assessed low or intermediate SYNTAX scores treated with percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). Whether these results are consistent in high-risk patients with diabetes, who have fared relatively better with CABG in most prior trials, is unknown.

Pharyngeal airway space changes after maxillomandibular advancement: a five-year retrospective study

The aim of this study was to compare the alterations in three regions of the airway—nasopharynx, oropharynx, and hypopharynx—in relation to the area of the midsagittal plane, volume, and minimal axial area after maxillomandibular advancement (MMA) surgery. Thirty patients who had undergone MMA surgery were evaluated at four time points: preoperative (T0), immediately postoperative (T1), 1 year postoperative (T2), and ≥5 years postoperative (T3). All measurements were performed using computed tomography, analyzed in Dolphin Imaging 11.0 Premium 3D software. The area in the midsagittal plane presented a mean increase of 22.0% between T0 and T3 (P < 0.001), with the highest increase in the oropharynx (24.1%, P < 0.001). The total volumetric increase at T3 was 16.7% (P < 0.001), with the highest increase in the nasopharynx (15.7%; P < 0.001). The lowest minimal axial area was found for the oropharynx at all time points, and the highest increase in minimal axial area was found for the nasopharynx (114.9%; P < 0.001). MMA surgery showed the highest increase in upper posterior airway between T0 and T1, and this was followed by a progressive reduction until T3, but with a statistically significant increase at T3 compared with T0 in all cases.