个性化截骨工具辅助下人工全膝关节置换与传统人工全膝关节置换手术精确度及临床疗效比较

目的比较3D打印个性化截骨工具辅助(patient-specific instrumentation,PSI)下人工全膝关节置换术(total knee arthroplasty,TKA)与传统TKA的手术精确度和临床疗效。方法自2017年9月至2018年12月,将40例拟接受初次膝关节置换患者随机分为2组,每组均为20人。一组应用个性化截骨工具辅助TKA手术(PSI组),另一组接受传统TKA(对照组)。比较两组患者的冠状面下肢机械轴线、手术时间、术中出血量、术后引流量以及HSS评分。结果对照组和PSI组的手术时间分别为(103.3±18.7) min和(91.3±15.7) min;术中出血量分别为(372.0±53.0)mL和(332.8±47.0)mL;术后引流量分别为(378.8±97.2)mL和(315.0±89.0)mL。两组手术时间、术中出血量、术后引流量比较差异均有统计学意义(P0.05)。对照组和PSI组术后2周HSS评分分别为(89.3±2.8)分和(88.7±2.9)分,两组比较差异无统计学意义(P0.05)。对照组和PSI组术后全下肢力线差值分别为(1.9±1.1)°和(1.2±1.0)°,冠状面股骨假体角度(frontal femoral component angle,FFC)差值分别为(2.1±1.1)°和(1.1±0.9)°,两组比较差异有统计学意义(P0.05)。冠状面胫骨假体角度(frontal tibia component angle,FTC)差值分别为(1.3±0.8)°和(1.4±0.8)°,两组比较差异无统计学意义(P0.05)。结论PSI辅助TKA较传统TKA手术时间更短、术中出血量更少,并且术后冠状面全下肢力线及股骨力线的改善优于传统TKA手术。     

旋转叶轮血泵的发展与展望

主要从结构设计、轴承密封设计、控制系统设计三个方面介绍了旋转叶轮血泵技术的最新发展 ,并对其发展趋势做出了展望。     

我国疾病预防控制体系建设政策效力与政策效果评估

目的 评估我国疾病预防控制体系建设相关政策文件效力和实施效果,为我国疾病预防控制体系政策制定建言献策。方法 通过国家卫生健康委员会官网、“北大法宝”检索系统以“疾病预防控制”、“疾控体系”、“疾控”为主要检索词检索2003—2022年中央、国家及各部委发布的政策文件,经筛选后最终纳入52项疾病预防控制相关政策。将政策效力划分为政策力度、政策措施、政策目标3个维度,用疾病预防控制支出表示政策效果,通过构建多元线性回归模型对环境型、供给型、需求型三种不同政策工具疾病预防控制体系建设政策实施效果进行回归分析。结果 2003—2022年,我国疾控体系建设相关政策数量与总体效力值呈现平稳波动,且具有明显的正相关关系,政策平均效力值呈M型稳定变化趋势,整体水平偏低; 政策措施得分最高,政策目标次之,政策力度得分最低。相较于其他两种政策工具,环境型政策工具使用频率最高,需求型政策工具使用频率最低; 环境型(Coef.=0.732,P=0.015)、供给型(Coef.=0.64,P=0.010)、需求型(Coef.=0.523,P=0.035)三种政策工具对政策实施效果均具有促进作用,滞后期保持在1～2年; 上一年度的疾控支出对下一年度的政策效果具有促进作用(Coef.=0.74,P=0.032)。结论 我国疾病预防控制政策效力不断提高主要源于政策颁布数量的累计效应; 不同政策工具使用过程中存在不平衡、不充分问题; 三类政策工具均对我国疾病预防控制体系政策实施效果起到一定影响,且环境型政策工具最优; 疾病预防控制相关支出会强化政策实施效果,推动疾控体系建设快速发展。     

血细胞计数仪与手工HiCN法测定血红蛋白结果比较

目的 :探讨仪器测定 H b结果与手工法测定 H b结果是否存在差异。方法 :采用血细胞计数仪与手工 Hi CN法分别对随机人群、健康人群、贫血病人同时进行 H b测定。结果 :两法测定 H b结果存在显著性差异 ,贫血病人组差异尤为显著 ,P<0 .0 1。结论 :血细胞计数仪测定 Hb结果稳定 ,但两法结果存在差异 ,不可忽视。     

职业紧张测量工具研究

目的 :研究适合评价我国职业人群职业紧张状态的测量工具。方法 :根据目前国际上通用的标准 ,从国外大量现用的职业紧张测量工具中选择信度、效度较高的、使用较广的测量工具进行研究和修订。研究内容包括职业紧张因素 ,紧张反应 ,个体因素 ,缓解因素等。研究对象为六种不同职业的作业者共 65 6人。研究方法为职业流行病学方法。信度的评估指标为内部一致性信度指标 ,包括平均项目 -总分相关系数和Cronbach’α系数 ,效度的评估指标为所研究的因素与各种相关因素之间的相关系数和所研究因素在紧张结局变量系统多元回归方程中的因素贡献率。结果 :职业紧张测量工具的平均项目 -总分相关系数绝大多数均在 0 60以上。Crohach’α系数绝大多数均在 0 70以上 ,大多数样本和总样本中的职业紧张因素、个体因素和中和缓解因素与紧张结局之间的相关系数绝大多数具有显著性和非常显著性意义。结论 :所研究的职业紧张测量工具均具有可接受的信度和效度水平。可在实际工作中加以推广应用。     

Factor analysis, causal indicators and quality of life

Exploratory factor analysis (EFA) remains one of the standard and most widely used methods for demonstrating construct validity of new instruments. However, the model for EFA makes assumptions which may not be applicable to all quality of life (QOL) instruments, and as a consequence the results from EFA may be misleading. In particular, EFA assumes that the underlying construct of QOL (and any postulated subscales or factors) may be regarded as being reflected by the items in those factors or subscales. QOL instruments, however, frequently contain items such as diseases, symptoms or treatment side effects, which are causal indicators. These items may cause reduction in QOL for those patients experiencing them, but the reverse relationship need not apply: not all patients with a poor QOL need be experiencing the same set of symptoms. Thus a high level of a symptom item may imply that a patient's QOL is likely to be poor, but a poor level of QOL need not imply that the patient probably suffers from that symptom. This is the reverse of the common EFA model, in which it is implicitly assumed that changes in QOL and any subscales cause or are likely to be reflected by corresponding changes in all their constituent items; thus the items in EFA are called effect indicators. Furthermore, disease-related clusters of symptoms, or treatment-induced side-effects, may result in different studies finding different sets of items being highly correlated; for example, a study involving lung cancer patients receiving surgery and chemotherapy might find one set of highly correlated symptoms, whilst prostate cancer patients receiving hormone therapy would have a very different symptom correlation structure. Since EFA is based upon analyzing the correlation matrix and assuming all items to be effect indicators, it will extract factors representing consequences of the disease or treatment. These factors are likely to vary between different patient subgroups, according to the mode of treatment or the disease type and stage. Such factors contain little information about the relationship between the items and any underlying QOL constructs. Factor analysis is largely irrelevant as a method of scale validation for those QOL instruments that contain causal indicators, and should only be used with items which are effect indicators.     

Magnetically suspended rotary blood pump with radial type combined motor-bearing

A magnetically suspended centrifugal blood pump is being developed with a combined motor-bearing for long-term ventricular assist systems. The combined motor-bearing actively suspends a rotor in a radial direction to deal with radial force unbalance in the pump and rotates the rotor by using the electric magnetic field. Therefore, the pump has no mechanical parts such as bearings of the motor and has a long lifetime. The developed pump consists of a thin rotor with a semi open-type 6 vane impeller and a stator to suspend and rotate the rotor. The rotor has 4-pole permanent magnets on the circumferential surface. The outer diameter and the thickness of the rotor are 60 mm and 8 mm, respectively. Axial movement and tilt of the rotor are restricted by passive stability based on the thin rotor structure. Radial movements of the rotor, such as levitation in radial direction and rotation, are controlled actively by using electric magnets of the stator. The electric magnet coils to produce levitation and rotation forces are constructed on the periphery stator. The p +/- 2-pole algorithm and the synchronous motor mechanism are adopted to levitate and rotate the rotor. The radial gap between the rotor and the stator is 1 mm. A closed-loop circuit filled with water was connected to the developed pump to examine the basic performance of the pump and the magnetic suspension system. Maximum rotational speed, flow rate, and head were 2,800 rpm, 11 L/min, and 270 mm Hg, respectively. The rotor with the impeller could be suspended completely during the entire pumping process. We conclude the pump with the combined motor-bearing has sufficient performance for the blood pump.     

Paradoxical effects of viscosity on the VentrAssist rotary blood pump

The ability of the VentrAssist blood pump to perform at its optimum design point is determined by a number of factors such as geometry of the pump, surface roughness, and fluid properties. Once the fluid properties are known, the performance characteristics of the pump can be optimized for that fluid. It is important to understand the effects of dynamic viscosity mu (called simply viscosity hereafter) on the performance characteristics and stability of the pump. The performance envelope of the pump and the needs of the patient must be matched. The VentrAssist pump has no shaft, seals, or fixed bearings and relies on the fluid-dynamic forces to maintain its effective performance. A number of different fluids have been tested to determine the effects of viscosity and density on pump performance. These include aqueous glycerol, red blood cells (RBCs) suspended in phosphate buffered saline solution (PBS), and Haemaccel. The effects of viscosity on the bearing stiffness, stage efficiency, and the pressure-flow rate (HQ) are characterized. The experimental results show a slight increase in the pressure rise across the pump shown as a positive upward shift of the H-Q curves with a decrease in viscosity; however, this is relatively small. A paradox in system efficiency exists: for a given fluid asymptotic viscosity, the system efficiency (product of magnetic and stage efficiency) using Haemaccel or PBS is greater than for the same viscosity of aqueous glycerol.     

Is Avoidance of Air Contact Necessary for the In Vitro Evaluation of Thrombogenicity in Mechanical Circulatory Assist Devices?

An effective in vitro protocol for the investigation of thrombogenicity can provide many advantages in the development of mechanical circulatory assist devices. Strict avoidance of air contact with blood recently was proposed for reliable in vitro evaluation. This study was performed to confirm the necessity of avoidance of air contact for the in vitro test of thrombogenicity in a rotary pump. Two sets of mock circuits with the same rotary blood pumps, reservoirs, and connecting tubes were made. In one system, blood came in contact with air while the other did not. The test blood was heparinized at the dose of 1 IU per 1 ml of blood. The tests were terminated at an activated coagulation time of 1.5 times the control value. The levels of hematocrit, platelet, factors VIII and XII, fibrinogen, thromboxane B2, and plasma-free hemoglobin were measured during the procedures. After the experiments, the thrombi formed were observed, measured, and compared with those formed in in vivo circumstances. The tests were repeated 12 times. There were no statistically significant differences between the 2 groups in hematologic parameters and the amounts of thrombi formed. The thrombi observed in both groups showed the same pathologic findings as those formed in vivo with the exception of intermittent multiple air bubbles found in thrombi of the air-contact group. In conclusion, the effect of air contact in the in vitro investigation of thrombogenicity was negligible while the proposed in vitro test models of thrombogenesis in the mechanical circulatory assist device proved to be reliable.     

医疗器械酶洗应注意的问题

目的探讨酶清洗剂在医疗器械清洗消毒过程中应用的重要性和应注意的问题。方法对酶清洗剂的基本原理、使用方法、注意事项和如何选择酶清洗剂进行分析。结果医疗器械的清洗必须使用液态、清澈透明、无泡或少泡,均匀无杂质、具有漂洁功能、最适水温的要求、对水质无限制的多酶清洗剂。结论医疗器械的清洗采用优质多酶清洗剂,对保证消毒成功和控制交叉感染具有重要意义。