正态分布定量指标统计分析报表的SAS宏程序

为规范临床试验数据管理，简化程序并减少数据统计分析过程中的错误来源，我们编制了一些特定的SAS宏程序，可以直接输出临床试验正态分布的定量指标统计分析报表。     

硬件还原技术在PACS报告工作站管理中的应用

本文阐述了通过硬件还原技术解决PACS报告工作站存在问题的方法。硬件还原技术的引入实现了报告工作站稳定、高效的运行,降低了软件维护时间与成本,提升了放射科医生的工作效率。     

Standalone medical device software: The evolving regulatory framework

Abstract

The paper provides an introduction to the regulatory landscape affecting a particular category of medical technology, namely standalone software—sometimes referred to as ‘software as a medical device’. To aid the reader’s comprehension of an often complex area, six case studies are outlined and discussed before the paper continues to provide detail of how software with a medical purpose in its own right can potentially be classified as a medical device. The reader is provided an appreciation of how to go about classifying such software and references to support the developer new to the field in locating detailed regulatory support documents and contact points for advice.     

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??Abstract??Objective To make doctor perform operation accurately on patients with dentomaxillofacial deformity by preoperative simulation based on digital data which was collected by digital software. Methods Fifteen patients had previously undergone 3-dimensional computed tomography and the data from CT scan were input into digital software. We used the software to simulate operations preoperatively including fixing point??osteotomies and movements of jaw bones. The collected information from software was applied to actual operations. Results All the operations had been completed successfully without serious complication. The patients were satisfied with the effect of operation 6 months after operation??with a satisfaction rate of 93.3%. Conclusion The digital simulation technique is a precise method which provides practical and effective basis for establishing the preoperative planning of individual optimal surgical procedure for patients with dentomaxillofacial deformities in orthognathic surgery.     

A method for determination mass absorption coefficient of gamma rays by Compton scattering

A method was proposed for determination mass absorption coefficient of gamma rays for compounds, alloys and mixtures. It is based on simulating interaction processes of gamma rays with target elements having atomic numbers from Z=1 to Z=92 using the MCSHAPE software. Intensities of Compton scattered gamma rays at saturation thicknesses and at a scattering angle of 90° were calculated for incident gamma rays of different energies. The obtained results showed that the intensity of Compton scattered gamma rays at saturations and mass absorption coefficients can be described by mathematical formulas. These were used to determine mass absorption coefficients for compound, alloys and mixtures with the knowledge of their Compton scattered intensities. The method was tested by calculating mass absorption coefficients for some compounds, alloys and mixtures. There is a good agreement between obtained results and calculated ones using WinXom software. The advantages and limitations of the method were discussed.     

CalcDose: A Software for Drug Dosage Conversion Using Metabolically Active Mass of Animals

Abstract

This Visual Basic computer program has been developed for drug dosage conversions using metabolically active mass (MAM) of the animals. The two body weights (one with known dosage and the other, for which the dosage has to be calculated) and the known dosage are entered in the respective input boxes and the appropriate units are selected using the option buttons. The program displays the report in the form of both the animals’ body weights and the respective dosages in milligram per kilogram body weight as well as the total actual doses in milligrams. The object oriented layout, flexible data entry and comprehensive report format render the CalcDose software a convenient and handy tool for dosage conversions.     

关于医疗器械软件变更监管要求探讨

由于医疗器械软件的特殊性，在产品注册后变更相对频繁，但现在对于医疗器械软件变更的监管要求尚未能充分考虑这种情况，应进一步科学合理设置相应监管要求。本文针对业内人士所关注焦点，分析了医疗器械软件变更类型划分原则，并基于相关变更类型划分，探讨了医疗器械软件变更的监管要求，最后提出了相关工作建议。     

一体化链式急救措施结合Orem自理干预模式在糖尿病伴创伤性骨折患者中的应用价值

目的分析一体化链式急救措施结合Orem自理干预模式对糖尿病(DM)伴创伤性骨折患者救治情况及生活质量综合评定问卷(GQOLI-74)评分、心理健康自评量表(SAS/SDS)评分的影响。方法选取中国医科大学附属第一医院2017年1月-2019年4月收治的120例DM合并创伤性骨折患者,随机分为观察组与对照组,每组60例。对照组采用常规护理方案,观察组在对照组的基础上采用一体化链式急救措施结合Orem自理干预模式护理。记录两组患者的抢救成功率、急救时间,比较两组入组时、治疗2周及治疗1个月时的空腹血糖水平。治疗1个月后,对患者家属满意度及疾病相关知识知晓率进行调查,并记录患者的并发症发生情况。入组后及治疗3个月时采用GQOLI-74评分量表、SAS/SDS评分量表对患者生活质量及心理状态进行评估。结果观察组的抢救成功率为100.00%,明显高于对照组的95.00%,差异有统计学意义(P<0.05)。观察组的病情评估时间、生命体征判断时间及基本生命支持抢救时间均明显短于对照组,差异有统计学意义(P<0.05)。观察组治疗2周及治疗1个月时的血糖水平为(6.74±0.61)、(6.32±0.54)mmol/L,明显低于对照组的(7.58±0.55)、(7.11±0.38)mmol/L,差异有统计学意义(P<0.05)。观察组治疗后的满意率及疾病相关知识知晓率为93.33%、100.00%,明显高于对照组的80.00%、88.33%,差异有统计学意义(P<0.05)。观察组治疗3个月时GQOLI-74评分中的躯体功能、心理功能、社会功能及物质功能分别为(74.59±6.17)、(77.84±6.18)、(70.29±5.02)、(77.34±7.39)分,明显高于对照组的(67.85±5.75)、(69.43±6.05)、(66.12±4.95)、(70.93±6.55)分,差异有统计学意义(P<0.05)。观察组治疗3个月时的SAS评分及SDS评分为(34.28±5.03)、(35.58±5.73)分,明显低于对照组的(45.54±5.65)、(44.73±6.15)分,差异有统计学意义(P<0.05)。观察组治疗后的并发症发生率为5.00%,明显低于对照组的18.33%,差异有统计学意义(P相似文献