Issues on the selection of non-inferiority margin in clinical trials

Objective The determination of non-inferiority margin is an important and confusing issue which directly influences the acceptability of a new medication. We reviewed the published literature, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use （ICH） Guidelines and Committee for Proprietary Medicinal Products （CPMP） papers on the selection of non-inferiority margin and the corresponding statistical tests in clinical trials, in order to provide practical recommendations and suggestions for establishing reference criteria for the non-inferiority margin in China. Data sources The literature on the selection of a non-inferiority margin and statistical tests was mainly extracted from relevant English articles on non-inferior clinical trials published from 1990 to 2007. The starting point （1990） was chosen due to lack of such papers published prior to 1990. This literature was searched via PubMed, Medline and Chinese Knowledge Information （CNKI）. ICH guidelines and CPMP papers were downloaded from their official websites. The keywords ＂clinical trial＂, ＂non-inferiority＂ and ＂non-inferiority margin＂ were used. Study selection Forty-three original articles and critical reviews, ICH El0 guideline and CPMP papers were selected. Results The non-inferiority testing with treatment difference and ratio are commonly used, where the non-inferiority margin is determined with and without historical data. Traditionally, this margin is treated as a fixed value, while developed methods take the variation into account in the determination of this margin, on which the test depends is more convincing. The mixed margin consisting of a margin based on treatment difference and a margin based on treatment ratio can exactly control the type I error at the desirable level and obtain a better power. In this review, we also provide some recommendations and suggestions for the selection of the non-inferiority margin in the western countries and China. Conclusions Besides the magnitude and variability of the standard control and placebo effects, the determination of the margin depends on other factors, such as, the safety profiles of the two comparative therapies, method of administration and product cost. Hence the margin should be made specifically for a certain case. Reference criteria for different medications should be given to avoid the arbitrary conclusion.

A Non-inferiority Trial Design without Need for a Conventional Margin

The NI （non-inferiority） trial design based on the likelihood ratio test eliminates the dependency on the conventional NI margin, and it explicitly uses the MCID （minimum clinical important difference） that links the statistical analysis to the clinical sense. Different from the conventional trial design, the new methodology is self-adaptive to the change in the sample size and overall cure rate, and it has an asymptotic property. It is shown that MCID is de-composite into constant MCID and statistical MCID. Along with this concept, the concept of the allowed inferiority does not exist, the interpretation of the trial result is more accurate and consistent to the statistical theory as well as the clinical interpretations.

Clinical Non-inferiority Trial on Treatment of Coronary Heart Disease Angina Pectoris of Xin-blood Stasis Syndrome Type with Lyophilized Salvia Salt of Lithospermic Acid Powder for Injection

Objective： To evaluate the effectiveness and safety of lyophilized Salvia salt of lithospermic acid powder for injection （SSLA） in treating coronary heart diseases angina pectoris （CHD-AP） of Xin-blood stasis syndrome type, and to conduct the non-inferiority trial with Danshen injection （丹参注射液, DSI） as positive control. Methods： An non-inferiority clinical layered, segmented, randomized, and blinded trial on three parallel and multiple centered groups was conducted in 480 patients with stable effort angina grade Ⅰ , Ⅱand Ⅲ, who had two or more times of attack every week. The 240 patients in test group A were treated with SSLA 200 mg added in 250 ml of 5% glucose solution for intravenous dripping every day; the 120 patients in test group B were treated with SSLA but the dosage doubled; and the 120 patients in the control group were treated with DSI 20 ml daily in the same method as SSLA was given. The clinical effectiveness and safety were evaluated after the patients were treated for 14 days. Results： The results showed that the markedly effective rate in test groups A, B and control group was 37.45 %, 36.75 % and 30.09 % respectively, while the total effective rate in them was 88.09%, 89.74% and 67.26% respectively. Statistical significance was shown in comparisons of the therapeutic effect between control group with test group A and test group B, with that in the two test groups superior to that in the control group, and non-inferiority trial showed eligibility （P〈0.01）. Adverse reaction appeared in 8 patients in the test groups and 2 in the control group. Conclusion： SSLA has definite therapeutic effect in treating patients with CHD-AP, with its effect not inferior to that of DSI, and no evident toxic-adverse reaction.

Efficacy of tenofovir alafenamide in treatment of hepatitis B virus:A meta-analysis and non-inferiority evaluation

Objective:To evaluate the effect of tenofovir alafenamide versus tenofovir disoproxil fumarate on antiviral efficacy in patients with hepatitis B virus infection.Methods:Randomized controlled trials were searched on CNKI,Wanfang,VIP,China Biomedical Literature Database,PubMed,Cochrane Library,Embase,ClinicalKey,Chinese Clinical Trial Registry and ClinicalTrials.gov from the date of inception to April 2020.The literature was screened according to the inclusion and exclusion criteria,and the efficacy evaluation index of the included RCT was set as the success rate of reaching the endpoint of viral suppression and achieving normalized ALT values at 48 weeks of treatment.Intentionality analysis was adopted and the analysis results were taken as the final conclusion.RevMan 5.3 software was used for this Meta-analysis.Meanwhile,VassarStats was used to evaluate the non-inferiority of TAF and calculate the difference of virus inhibition efficiency rate and 95%confidence interval between experimental group and the control group of each RCT.Results:After the literature search,411 potential articles were found,5 studies were finally included according to the criteria,and 2,120 patients were included.Intentionality analysis showed that TAF regimen and TDF regimen had similar viral suppression success rates(RR=0.97,95%CI:0.94~1.01,P=0.19).The ALT normalization rate in the TAF treatment group was higher than that in the TDF treatment group,and the difference was statistically significant(RR=1.35,95%CI:1.20-1.53,P<0.00001).The non-inferiority margin was set at 10%,and it was found that three RCT studies in the international multi-center all showed that TAF was not inferior to TDF in controlling HBV viral load,while two RCT studies in China's Mainland failed to achieve non-inferiority after calculation.Conclusions:At 48 weeks of treatment,TAF was similar to TDF in controlling HBV viral load.However,the efficacy of TAF in controlling HBV viral load may vary among different populations,which requires further confirmation by more clinical trial evidence.Based on AASLD criteria,the ALT normalization rate of the TAF group was higher than that of the TDF group at 48 weeks of treatment,showing an obvious advantage.

Deep tectonics and seismogenic mechanisms of the seismic source zone of the Jishishan M_(s)6.2 earthquake on December 18,2023,at the northeast margin of the Tibetan Plateau

On December 18,2023,an M_(s)6.2 earthquake occurred in Jishishan,Gansu Province,China.This earthquake happened in the eastern region of the Qilian Orogenic Belt,which is situated at the forefront of the NE margin of the Tibetan Plateau(i.e.,Qinghai-Tibet Plateau),encompassing a rhombic-shaped area that intersects the Qilian-Qaidam Basin,Alxa Block,Ordos Block,and South China Block.In this study,we analyzed the deep tectonic pattern of the Jishishan earthquake by incorporating data on the crustal thickness,velocity structure,global navigation satellite system(GNSS)strain field,and anisotropy.We discovered that the location of the earthquake was related to changes in the crustal structure.The results showed that the Jishishan M_(s)6.2 earthquake occurred in a unique position,with rapid changes in the crustal thickness,Vp/Vs,phase velocity,and S-wave velocity.The epicenter of the earthquake was situated at the transition zone between high and low velocities and was in proximity to a low-velocity region.Additionally,the source area is flanked by two high-velocity anomalies from the east and west.The principal compressive strain orientation near the Lajishan Fault is primarily in the NNE and NE directions,which align with the principal compressive stress direction in this region.In some areas of the Lajishan Fault,the principal compressive strain orientations show the NNW direction,consistent with the direction of the upper crustal fast-wave polarization from local earthquakes and the phase velocity azimuthal anisotropy.These features underscore the relationship between the occurrence of the Jishishan M_(s)6.2 earthquake and the deep inhomogeneous structure and deep tectonic characteristics.The NE margin of the Tibetan Plateau was thickened by crustal extension in the process of northeastward expansion,and the middle and lower crustal materials underwent structural deformation and may have been filled with salt-containing fluids during the extension process.The presence of this weak layer makes it easier for strong earthquakes to occur through the release of overlying rigid crustal stresses.However,it is unlikely that an earthquake of comparable or larger magnitude would occur in the short term(e.g.,in one year)at the Jishishan east margin fault.

Marginal zone lymphoma with severe rashes: A case report

BACKGROUND Marginal zone lymphoma(MZL)is an indolent subtype of non-Hodgkin lymphoma(NHL),which is rare clinically with severe rashes as the initial symptom.CASE SUMMARY This study reports a case of MZL with generalized skin rashes accompanied by pruritus and purulent discharge.First-line treatment with rituximab combined with zanubrutinib had poor effects.However,after switching to obinutuzumab combined with zanubrutinib,the case was alleviated,and the rashes disappeared.CONCLUSION For patients with advanced stage MZL not benefiting from type I anti-CD20 monoclonal antibody(mAb)combination therapy,switching to a type II anti-CD20 mAb combination regimen may be considered.This approach may provide a new perspective in the treatment of MZL.

The largest CPIES array in the marginal sea:abundant dynamics in the northeast South China Sea

The South China Sea(SCS)is a marginal sea connecting the Pacific and Indian oceans and has gained much attention in recent decades.The dynamics in the northeast SCS are considerably influenced by topography,monsoons,tropical cyclones,the Kuroshio intrusion,and water exchange through the Luzon Strait(LS).

Distal margin distance in radical resection of locally advanced rectal cancer after neoadjuvant therapy

Colorectal cancer has a high incidence and mortality rate in China, with the majority of cases being middle and low rectal cancer. Surgical intervention is currently the main treatment modality for locally advanced rectal cancer, with the common goal of improving oncological outcomes while preserving function. The controversy regarding the circumferential resection margin distance in rectal cancer surgery has been resolved. With the promotion of neoadjuvant therapy concepts and advancements in technology, treatment strategies have become more diverse.Following tumor downstaging, there is an increasing trend towards extending the safe distance of distal rectal margin. This provides more opportunities for patients with low rectal cancer to preserve their anal function.However, there is currently no consensus on the specific distance of distal resection margin.

To Uplift the Profitability of Marginal Lands by Cassava Cultivation

Expanding the utilization of marginal land resources in rural areas is regarded as a significant supplement for the sustainable development of modern agriculture for its yield, economic and ecological good. Marginal areas, due to their natural limitations, are only productive for energy crops with strong resistance and tolerance. Cassava, in its longstanding cultivation practices, has marked its adaptability in tropical and subtropical regions. Farmers are allowed to improve reclaimed soils’ fertility, while plants’ canopy coverage could reduce soil erosion. Besides, cassava tubers to be produced as food or fodder can be counted as soil productivity. Breeding advanced cassava varieties on marginal land under proper intensification management and facilitating policies can indeed increase farmers’ income. Some of the projects implemented outside of China speak quite well on that. Additionally, intercropping modes for cassava bring higher incomes than monocropping mode, which simultaneously improves the ecosystem structure and soil conditions. The interspecific cooperation brought by the intercropping pattern has its buffering function and antagonistic effects to counter against plant diseases, pest attacks and weed infestations. It performs as a natural alternative for pesticides and fertilizers with minimal inputs and safe and productive outputs. Although a complete cassava industrial chain has been formed nationwide, there are still challenges like the inadequate use of marginal areas and risks triggered by unfavorable climate, changeable commodity markets, and the composition of the labor force. However, there will still be ample room for further growth of cassava, for recent years have witnessed the acceleration in the circulation of rural land management rights and the stratification of Chinese farmers, which gives an impetus to household management’s dominance as well as the improvements of rural social welfare systems for the overall agricultural efficiency.

Bendamustine and rituximab as frontline therapy in extranodal marginal zone lymphoma:a single-institution experience

Extranodal marginal zone lymphoma(EMZL)encompasses 70%of cases of marginal zone lymphoma.Frontline bendamustine and rituximab(BR)were derived from trials involving other indolent non-Hodgkin’s lymphomas.Only one trial has evaluated frontline BR prospectively in EMZL.This retrospective study reports outcomes among EMZL patients receiving frontline BR.Twenty-five patients were included with a median age of 69 years(40–81).Five(20.0%)patients had stage Ⅰ/Ⅱ disease,and 20(80.0%)had stage Ⅲ/Ⅳ disease.The median number of cycles was 6.0(3.0–6.0).Maintenance rituximab was administered to 10(41.7%)individuals.Overall response rate(ORR)was 100.0%(60.0%complete response,40.0%partial response).Medians of overall survival and progression-free survival were not reached.The estimated 2-year progression-free survival was 85.2%and overall survival was 100.0%.Four(16.6%)patients had infections related to treatment;3(12.0%)transformed to diffuse large B-cell lymphoma;5(20.8%)had a relapse or progression of EMZL;and 3(12.0%)died unrelated to BR.BR is an efficacious and well-tolerated front-line regimen for EMZL with response data consistent with existing literature.

Depositional model of the Member Deng-2 marginal microbial mound-bank complex of the Dengying Formation in the southwestern Sichuan Basin, SW China: Implications for the Ediacaran microbial mound construction and hydrocarbon exploration

Recent advances in hydrocarbon exploration have been made in the Member Deng-2 marginal microbial mound-bank complex reservoirs of the Dengying Formation in the western Sichuan Basin, SW China,where the depositional process is regarded confusing. The microfacies, construction types, and depositional model of the Member Deng-2 marginal microbial mound-bank complex have been investigated using unmanned aerial vehicle photography, outcrop section investigation, thin section identification,and seismic reflections in the southwestern Sichuan Basin. The microbialite lithologic textures in this region include thrombolite, dendrolite, stromatolite, fenestral stromatolite, spongiostromata stone,oncolite, aggregated grainstone, and botryoidal grapestone. Based on the comprehensive analysis of“depositional fabrics-lithology-microfacies”, an association between a fore mound, mound framework,and back mound subfacies has been proposed based on water depth, current direction, energy level and lithologic assemblages. The microfacies of the mound base, mound core, mound flank, mound cap, and mound flat could be recognized among the mound framework subfacies. Two construction types of marginal microbial mound-bank complex have been determined based on deposition location, mound scale, migration direction, and sedimentary facies association. Type Jinkouhe microbial mound constructions(TJMMCs) develop along the windward margin owing to their proximity to the seaward subfacies fore mound, with a northeastwardly migrated microbial mound on top of the mud mound,exhibiting the characteristics of large-sized mounds and small-sized banks in the surrounding area. Type E'bian microbial mound constructions(TEMMCs) primarily occur on the leeward margin, resulting from the presence of onshore back mound subfacies, with the smaller southwestward migrated microbial mounds existing on a thicker microbial flat. The platform margin microbial mound depositional model can be correlated with certain lateral comparison profile and seismic reflection structures in the 2D seismic section, which can provide references for future worldwide exploration. Microbial mounds with larger buildups and thicker vertical reservoirs are typically targeted on the windward margin, while small-sized microbial mounds and flats with better lateral connections are typically focused on the leeward margin.

Three-dimensional constrained gravity inversion of Moho depth and crustal structural characteristics at Mozambique continental margin

Mozambique's continental margin in East Africa was formed during the break-off stage of the east and west Gondwana lands. Studying the geological structure and division of continent-ocean boundary(COB) in Mozambique's continental margin is considered of great significance to rebuild Gondwana land and understand its movement mode. Along these lines, in this work, the initial Moho was fit using the known Moho depth from reflection seismic profiles, and a 3D multi-point constrained gravity inversion was carried out. Thus, highaccuracy Moho depth and crustal thickness in the study area were acquired. According to the crustal structure distribution based on the inversion results, the continental crust at the narrowest position of the Mozambique Channel was detected. According to the analysis of the crustal thickness, the Mozambique ridge is generally oceanic crust and the COB of the whole Mozambique continental margin is divided.

Linkage between precipitation isotopes and water vapor sources in the monsoon margin:Evidence from arid areas of Northwest China

The isotope composition in precipitation has been widely considered as a tracer of monsoon activity.Compared with the coastal region,the monsoon margin usually has limited precipitation with large fluctuation and is usually sensitive to climate change.The water resource management in the monsoon margin should be better planned by understanding the composition of precipitation isotope and its influencing factors.In this study,the precipitation samples were collected at five sampling sites(Baiyin City,Kongtong District,Maqu County,Wudu District,and Yinchuan City)of the monsoon margin in the northwest of China in 2022 to analyze the characteristics of stable hydrogen(δD)and oxygen(δ18O)isotopes.We analyzed the impact of meteorological factors(temperature,precipitation,and relative humidity)on the composition of precipitation isotope at daily level by regression analysis,utilized the Hybrid Single-Particle Lagrangian Integrated Trajectory(HYSPLIT)-based backward trajectory model to simulate the air mass trajectory of precipitation events,and adopted the potential source contribution function(PSCF)and concentration weighted trajectory(CWT)to analyze the water vapor sources.The results showed that compared with the global meteoric water line(GMWL),the slope of the local meteoric water line(LMWL;δD=7.34δ^(18)O-1.16)was lower,indicating the existence of strong regional evaporation in the study area.Temperature significantly contributed toδ18O value,while relative humidity had a significant negative effect onδ18O value.Through the backward trajectory analysis,we found eight primary locations that were responsible for the water vapor sources of precipitation in the study area,of which moisture from the Indian Ocean to South China Sea(ITSC)and the western continental(CW)had the greatest influence on precipitation in the study area.The hydrogen and oxygen isotopes in precipitation are significantly influenced by the sources and transportation paths of air mass.In addition,the results of PSCF and CWT analysis showed that the water vapor source areas were primarily distributed in the south and northwest direction of the study area.

Earthquake detection probabilities and completeness magnitude in the northern margin of the Ordos Block

The assessment of the completeness of earthquake catalogs is a prerequisite for studying the patterns of seismic activity.In traditional approaches,the minimum magnitude of completeness(MC)is employed to evaluate catalog completeness,with events below MC being discarded,leading to the underutilization of the data.Detection probability is a more detailed measure of the catalog's completeness than MC;its use results in better model compatibility with data in seismic activity modeling and allows for more comprehensive utilization of seismic observation data across temporal,spatial,and magnitude dimensions.Using the magnitude-rank method and Maximum Curvature(MAXC)methods,we analyzed temporal variations in earthquake catalog completeness,finding that MC stabilized after 2010,which closely coincides with improvements in monitoring capabilities and the densification of seismic networks.Employing the probability-based magnitude of completeness(PMC)and entire magnitude range(EMR)methods,grounded in distinct foundational assumptions and computational principles,we analyzed the 2010-2023 earthquake catalog for the northern margin of the Ordos Block,aiming to assess the detection probability of earthquakes and the completeness of the earthquake catalog.The PMC method yielded the detection probability distribution for 76 stations in the distance-magnitude space.A scoring metric was designed based on station detection capabilities for small earthquakes in the near field.From the detection probabilities of stations,we inferred detection probabilities of the network for diff erent magnitude ranges and mapped the spatial distribution of the probability-based completeness magnitude.In the EMR method,we employed a segmented model fitted to the observed data to determine the detection probability and completeness magnitude for every grid point in the study region.We discussed the sample dependency and low-magnitude failure phenomena of the PMC method,noting the potential overestimation of detection probabilities for lower magnitudes and the underestimation of MC in areas with weaker monitoring capabilities.The results obtained via the two methods support these hypotheses.The assessment results indicate better monitoring capabilities on the eastern side of the study area but worse on the northwest side.The spatial distribution of network monitoring capabilities is uneven,correlating with the distribution of stations and showing significant diff erences in detection capabilities among diff erent stations.The truncation eff ects of data and station selection aff ected the evaluation results at the edges of the study area.Overall,both methods yielded detailed descriptions of the earthquake catalog,but careful selection of calculation parameters or adjustments based on the strengths of diff erent methods is necessary to correct potential biases.

Influences of burial process on diagenesis and high-quality reservoir development of deep-ultra-deep clastic rocks:A case study of Lower Cretaceous Qingshuihe Formation in southern margin of Junggar Basin,NW China

Taking the Lower Cretaceous Qingshuihe Formation in the southern margin of Junggar Basin as an example,the influences of the burial process in a foreland basin on the diagenesis and the development of high-quality reservoirs of deep and ultra-deep clastic rocks were investigated using thin section,scanning electron microscope,electron probe,stable isotopic composition and fluid inclusion data.The Qingshuihe Formation went through four burial stages of slow shallow burial,tectonic uplift,progressive deep burial and rapid deep burial successively.The stages of slow shallow burial and tectonic uplift not only can alleviate the mechanical compaction of grains,but also can maintain an open diagenetic system in the reservoirs for a long time,which promotes the dissolution of soluble components by meteoric freshwater and inhibits the precipitation of dissolution products in the reservoirs.The late rapid deep burial process contributed to the development of fluid overpressure,which effectively inhibits the destruction of primary pores by compaction and cementation.The fluid overpressure promotes the development of microfractures in the reservoir,which enhances the dissolution effect of organic acids.Based on the quantitative reconstruction of porosity evolution history,it is found that the long-term slow shallow burial and tectonic uplift processes make the greatest contribution to the development of deep-ultra-deep high-quality clastic rock reservoirs,followed by the late rapid deep burial process,and the progressive deep burial process has little contribution.

Transformation of marginal zone lymphoma into high-grade B-cell lymphoma expressing terminal deoxynucleotidyl transferase:A case report

BACKGROUND High-grade B-cell lymphoma(HGBL)is an unusual malignancy that includes myelocytomatosis viral oncogene(MYC),B-cell lymphoma-2(BCL-2),and/or BCL-6 rearrangements,termed double-hit or triple-hit lymphomas,and HGBL-not otherwise specific(HGBL-NOS),which are morphologically characteristic of HGBL but lack MYC,BCL-2,or BCL-6 rearrangements.HGBL is partially transformed by follicular lymphoma and other indolent lymphoma,with few cases of marginal zone lymphoma(MZL)transformation.HGBL often has a poor prognosis and intensive therapy is currently mainly advocated,but there is no good treatment for these patients who cannot tolerate chemotherapy.CASE SUMMARY We reported a case of MZL transformed into HGBL-NOS with TP53 mutation and terminal deoxynucleotidyl transferase expression.Gene analysis revealed the gene expression profile was identical in the pre-and post-transformed tissues,suggesting that the two diseases are homologous,not secondary tumors.The chemotherapy was ineffective and the side effect was severe,so we tried combination therapy including venetoclax and obinutuzumab.The patient tolerated treatment well,and reached partial response.The patient had recurrence of hepatocellular carcinoma and died of multifunctional organ failure.He survived for 12 months after diagnosis.CONCLUSION Venetoclax combined with obinutuzumab might improve the survival in some HGBL patients,who are unsuitable for chemotherapy.

Moho反射波噪声干涉方法及其在青藏高原东北缘地壳结构成像的应用初探

基于南北地震带北段布设的密集流动地震台阵的连续波形记录,采用台阵噪声干涉技术获得了青藏高原东北缘Moho面PmP反射波,利用已有的区域三维地壳速度模型,采用沉积层校正方法建立研究区域的三维地壳初始模型,进而对噪声互相关函数进行基准面校正,然后采用共中心点叠加方法获得了研究区的地壳厚度分布.结果显示,青藏高原东北缘及周边不同块体地壳厚度差异显著,沿青藏高原北东向的扩展方向,地壳厚度逐渐变薄.祁连造山带中、西段地壳厚度约55~65 km,西秦岭造山带地壳厚度从西至东从53 km左右减小至42 km上下,阿拉善块体地壳厚度约50 km,鄂尔多斯块体西缘地壳厚度约40~45 km.六盘山断裂、海原断裂与天景山断裂附近呈现局部的地壳增厚,并且出现脉冲状Moho面反射震相,表明断裂带附近可能存在速度跃变较大的Moho面结构.祁连山北缘断裂出现叠置的反射震相,推测下地壳的逆冲形成了此类Moho结构.

新质生产力对企业对外直接投资的影响研究——基于二元边际的视角

运用A股上市公司2011—2022年的数据,实证分析新质生产力对企业对外直接投资二元边际的影响,结果发现:新质生产力能够显著提升企业的对外直接投资二元边际,且这一结论在经过一系列稳健性检验及对内生性问题处理后仍然成立;机制检验表明,新质生产力通过放松融资约束、提升ESG表现、增加创新产出提升了企业对外直接投资二元边际;异质性分析表明,新质生产力对企业对外直接投资二元边际的影响在非国有企业、非重污染企业、非高科技企业中更加明显,而新质生产力对企业对外直接投资集约边际的影响在技术密集型和劳动密集型企业中更加明显,对扩展边际的影响在资本密集型企业中更加明显;拓展分析表明,具有海外背景的高管在新质生产力提升企业对外直接投资二元边际的过程中起到了正向调节的作用,同时,新质生产力还增加了企业对外直接投资的概率和在海外市场的收益能力。以上研究率先证实了新质生产力对企业对外直接投资的积极影响,不仅丰富了现有的国际投资与生产力理论,还为中国企业的国际化发展以及中国经济的高质量发展提供理论指导和有益借鉴。

窄带成像技术与白光成像技术在支撑喉镜下声带白斑切除术中的应用效果比较

目的比较窄带成像(NBI)技术与传统的白光成像(WLE)技术在支撑喉镜下行声带白斑切除时确定手术安全边界的效果。方法选取2021年10月—2023年9月于东莞市莞城医院接受治疗的32例中重度声带白斑患者,采用随机数字表法分为试验组和对照组各16例。试验组采用NBI辅助的支撑喉镜声带白斑切除术,对照组采用传统的WLE技术辅助的支撑喉镜声带白斑切除术。比较两组患者在不同技术下行手术并进行首次切除后所切除组织边缘的病理学分析结果。结果两组手术均安全无事故完成,对照组术中组织切缘的冷冻病理样本阳性切缘发生率为18.75%(3/16),试验组术中组织切缘的冷冻病理样本阳性切缘发生率为6.25%(1/16),试验组阳性切缘发生率低于对照组,但差异无统计学意义(P>0.05);试验组术中冷冻病理与术后病理诊断符合率为93.75%,术中冷冻病理诊断敏感度为50.00%、阳性预测值为100%;对照组术中冷冻病理与术后病理诊断符合率为75.00%,术中冷冻病理诊断敏感度为42.86%、阳性预测值为100%。试验组术中冷冻病理与术后病理诊断符合率、术中冷冻病理诊断敏感度高于对照组,但差异无统计学意义(P>0.05)。结论与传统WLE技术相比,采用NBI辅助支撑喉镜声带白斑切除手术能更准确地确定术中安全边界。

基于不同Margin的人脸特征选择及识别方法

Margin在机器学习中具有很重要的意义,基于margin的特征选择方法就是从分类的角度对特征集各特征的权重进行分析。该文对不同的margin进行了分析,提出将sample-margin和hypothesis-margin分别作为特征选择标准对SBS特征选择方法进行改进,然后设计具有最佳超参数的SVM多项式分类器进行人脸识别。实验在FRERT人脸图像库上进行并与Relief特征选择方法进行了比较,对SVM和NN分类器的实验结果也进行了分析。实验结果显示:该文提出的人脸识别特征选择及识别方法是有效、适用的。