基于DEA方法的华法林抗凝分级管理模式的效率评价

目的:通过小范围的临床实践,使用数据包络分析(data envelopment analysis,DEA)方法对基于全程化抗栓药学服务模式的华法林抗凝管理工作效率进行评价。方法:选取2021年7-12月南京大学医学院附属鼓楼医院心胸外科瓣膜置换术后使用华法林抗凝的患者。将患者分为实验组和对照组,实验组由临床药师利用基于分级管理的全程化抗栓药学服务模式进行抗凝管理和药学监护,对照组由临床药师按照无差别监护模式进行抗凝管理和监护,记录2种模式下药师工作内容和工作成效,通过DEA方法分析比较2种抗凝管理模式的效率。结果:研究最终纳入服用华法林的患者233人(实验组116人,对照组117人),实验组的单位患者管理时间显著减少[(27.8±9.7)min vs.(34.8±11.4)min]。经模型计算后,实验组的总体效率值为1,说明其投入和产出最优,且效率高于对照组。结论:全程化抗栓药学服务模式下药师管理单位抗凝患者需要的时间更少,管理效率更高。     

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.     

Disruptions of brain structural network in end-stage renal disease patients with long-term hemodialysis and normal-appearing brain tissues

ObjectiveEnd-stage renal disease (ESRD) patients on hemodialysis were demonstrated to exhibit silent and invisible white-matter alterations which would likely lead to disruptions of brain structural networks. Therefore, the purpose of this study was to investigate the disruptions of brain structural network in ESRD patients.Materials and methodsThiry-three ESRD patients with normal-appearing brain tissues and 29 age- and gender-matched healthy controls were enrolled in this study and underwent both cognitive ability screening instrument (CASI) assessment and diffusion tensor imaging (DTI) acquisition. Brain structural connectivity network was constructed using probabilistic tractography with automatic anatomical labeling template. Graph-theory analysis was performed to detect the alterations of node-strength, node-degree, node-local efficiency, and node-clustering coefficient in ESRD patients. Correlational analysis was performed to understand the relationship between network measures, CASI score, and dialysis duration.ResultsStructural connectivity, node-strength, node-degree, and node-local efficiency were significantly decreased, whereas node-clustering coefficient was significantly increased in ESRD patients as compared with healthy controls. The disrupted local structural networks were generally associated with common neurological complications of ESRD patients, but the correlational analysis did not reveal significant correlation between network measures, CASI score, and dialysis duration.ConclusionGraph-theory analysis was helpful to investigate disruptions of brain structural network in ESRD patients with normal-appearing brain tissues.     

全腹腔镜、腹腔镜辅助与开腹胃癌根治术治疗Ⅱ、Ⅲ期胃癌的疗效对比

目的探讨全腹腔镜胃癌根治术（TLG）、腹腔镜辅助胃癌根治术（LAG）与传统开腹术（TOS）对Ⅱ、Ⅲ期胃癌的近期及远期疗效。 方法回顾性分析2013年1月至2016年6月陕西中医药大学附属医院行胃癌根治术的患者共136例，根据患者手术方式的不同分为TLG组（45例），LAG组（40例），TOS组（51例）。观察和比较3组患者手术时间、出血量、淋巴结清扫数、术后排气时间、住院时间、术后并发症发生情况，采用Kaplan-Meier法对患者术后5年远期疗效进行生存分析。 结果TLG组患者出血量、排气时间及住院时间低于TOS组及LAG组，LAG组患者手术时间高于TLG组及TOS组，差异均有统计学意义（P<0.05）；3组患者术后并发症发生率比较，差异无统计学意义。共129例获得随访，其中TLG组失访2例，LAG组2例，TOS组3例。TLG、LAG、TOS组平均无瘤生存时间为（53.4±2.1）个月（95%CI=50.45~58.22个月）、（54.3±2.0）个月（95%CI= 47.99~56.18个月）、（52.3±2.1）个月（95%CI=50.98~55.65个月），3组患者无瘤生存时间比较，差异无统计学意义（F=0.519，P=0.772）。 结论TLG术能够在保证患者术后疗效的同时，降低患者术中出血量、排气时间及术后住院时间，TLG术治疗Ⅱ、Ⅲ期胃癌安全可行，疗效显著，值得推广。     

Acoustic correlates of vocal effort: External factors and personality traits

ObjectivesTo develop an experimental protocol to study the vocal effort generated by introducing barriers to communication, and its relationship with certain personality traits.Material and methodsThe experimental protocol consisted of an interactive game in which the subject gave an investigator instructions to adopt various body positions (semi-directed communication situation). The Control situation included no constraints on communication. Then a Distance Constraint (increased distance between subject and investigator) and a Time Constraint (generation of performance stress by putting the subject in competition with others) were introduced. The vocal parameters studied comprised vocal intensity and fundamental frequency in the middle of the vowel of 3 target phonemes. Subjects also took the NEO FFI-R personality test.ResultsThe study included 41 women aged between 18 and 52 years. Vocal intensity and fundamental frequency increased significantly with the introduction of the constraints (P < 0.05), intensity passing from 75.5 dB to 81.8 dB and frequency from 249.4 Hz to 335.8 Hz. No correlations were found between these changes and results for the various personality traits.ConclusionsThis ecological protocol enables the impact of both physical and emotional obstacles to communication to be studied. No correlations between vocal effort and personality traits emerged. A larger-scale study would be necessary to analyze the continuum between vocal effort and vocal forcing, to improve speech therapy for dysfunctional dysphonia.     

代谢手术治疗肥胖型多囊卵巢综合征的 meta 分析

目的: 系统评价代谢手术对肥胖型多囊卵巢综合征的影响。方法: 检索 PubMed、EMBASE、Cochrane Library、CNKI 和万方数据库。检索时间为 2000－01 ～ 2017－05。结局指标包括 PCOS、月经周期异常、多毛症、不 孕症。结果: 纳入的 19 篇报道中，共纳入接受代谢手术病人共 2716 例，其中女性病人 2274 例。经代谢手术后， PCOS 发生率术前12．27%术后降低为4．76%( 95%CI: 2．14 ～ 9．86，Z = 3．92，P＜0．0001) 。月经周期异常发生率术前 34．43%术后降低为10．79%( 95%CI: 5．62～ 26．15，Z= 6．36，P＜0．0001) 。多毛症发生率70．59%降低为21．01%( 95% CI: 3．57～ 31．06，Z= 4．27，P＜0．0001) 。不孕症发生率7．69%术后降低为2．56% ( 95% CI: 1．77 ～ 5．81，Z = 3．85，P = 0．0001) 。结论: 代谢手术可显著改善肥胖型多囊卵巢综合征的临床症状。