不同消毒方式对硅橡胶类义齿软衬材料消毒效果的实验研究

目的 对比微波、紫外线和环氧乙烷对Silagum硅橡胶义齿软衬材料的消毒效果.方法 将高温消毒后的软衬硅橡胶试件染菌(白色念珠菌),分别进行不同时间的紫外线、微波、环氧乙烷消毒,消毒后的试件用无菌生理盐水冲洗,无菌玻璃平皿收集冲洗液,接种环将冲洗液接种于沙氏琼脂平板培养基,37℃恒温培养24～48 h观察,菌落计数,评价消毒效果.结果 环氧乙烷(EO浓度600 mg/L)肖毒60 min灭菌率为100％;紫外线(功率40 W、波长253.7 nm、距离1 m)照射40 min可杀灭99％的白色念珠菌、50 min可完全杀灭;微波(800 W V 100％)照射1 min灭菌率为93％,照射2 min灭菌率为100％.结论 三种消毒方法都具有消毒效果,且消毒时间越长消毒效果越好;环氧乙烷、紫外线、微波消毒口腔硅橡胶义齿软衬材料可与高温高压灭菌达到同样的效果,而且方便、有效,是良好的软衬材料的消毒方法.     

环氧乙烷混合气体消毒柜

消毒和灭菌是提高疗效的重要手段之一。现今消毒和灭菌方法大体可分四类;热灭菌、辐射灭菌、过滤除菌和化学灭菌,应用比较广泛的主要有高压蒸汽、气体、辐射三种方法。随着医学科学和其他科学技术的发展,医用电子仪器、光学内窥器械和医用高分子材料在医学上得到了广泛的应用,传统的高压蒸汽灭菌已无法解决这些器械、材料的灭菌消毒。从而环氧乙烷气体及其设备在消毒和灭菌方面具有更加广泛的实用价值。杂环类气体消毒剂系指以环氧乙烷为基础的一系列具有杀菌作用的衍生物。它的杀菌机制是由于对蛋白质分子的烷基化作用,干扰了微生物酶的正常代谢而使之死亡。无     

60Coγ射线对高免卵黄抗体(IgY)活性和理化特性的影响

利用60Coγ射线照射卵黄抗体,分析了60Coγ射线对IgY的效价、纯度、热稳定性、耐酸性以及酶水解试验等理化特性的影响和不同温度下的保存时间。结果表明照射达10 kGy时,对IgY的效价和纯度无影响;对照组和照射组热稳定性、耐酸性无差异,但照射组更易被酶水解;照射后的IgY明显延长了保存期。     

HA 纳米载体转hGM-CSF 基因的HepG2 疫苗的抗肿瘤活性研究

目的:评价HA纳米载体转hGM-CSF基因的HepG2疫苗的抗肿瘤活性。方法:SCID小鼠20只腹腔内注射健康志愿者外周血淋巴细胞(1×107/ml)1.0 ml,同时背部皮下接种人肝癌HepG2细胞(1×107ml)0.2 ml。当皮下移植瘤体积长至100 mm3时,随机分四组:Ⅰ组,60Co照射的转染GM-CSF基因的HepG2细胞组,Ⅱ组,60Co照射的HepG2细胞组,Ⅲ组,生理盐水组,Ⅳ组,接种前,每组5只。MTT法检测各组小鼠脾细胞CTL活性,ELISA法检测血清IL-4和IL-12的水平。结果:转染GM-CSF基因的HepG2疫苗组小鼠脾细胞CTL活性明显高于其余组(P<0.05);同时血清Th1类细胞因子IL-12的水平明显升高(P<0.05),而Th2类细胞因子IL-4的水平无统计学意义(P>0.05)。结论:HA纳米载体转hGM-CSF基因的HepG2疫苗可刺激机体产生特异性免疫反应。     

聚合物微流控芯片消毒灭菌技术研究进展

聚合物微流控芯片成本低、易加工,目前在医药、生物检测和化学合成等领域得到了普遍应用。以热塑性聚合物聚甲基丙烯酸甲酯(polymethylmethacrylate,PMMA)和热固型聚合物聚二甲基硅氧烷(polydimethy lsiloxane,PDMS)为基材的高分子聚合物材料因具有较好的生物相容性和光学透明性,已逐渐成为聚合物微流控芯片加工的主导材料,被广泛应用于生物医药类微流控芯片的制备。鉴于该类芯片应用场景的特殊性,需在使用前进行消毒灭菌处理以避免微生物干扰。目前,针对PMMA和PDMS的消毒灭菌方法包括高压蒸汽灭菌、紫外线灭菌、电子束、60Co γ射线辐射灭菌、超临界二氧化碳灭菌、乙醇消毒、环氧乙烷灭菌、过氧化氢低温等离子体灭菌、绿原酸消毒、清洗剂消毒。本文从基本原理、消毒灭菌方法、应用场景等方面,回顾和总结了相关技术在PMMA和PDMS基体微流控芯片中的实现方法,并在芯片材质、适用范围等方面分析了所适用的消毒灭菌方法,为以聚合物为基材的生物医药类微流控芯片的消毒灭菌提供有益参考。     

用于人工韧带的聚对苯二甲酸乙二醇酯支架材料 的编织和力学性能分析

目的:通过对聚对苯二甲酸乙二醇酯(Polyethylene terephthalate,PET)材料的编织和力学性能的分析,初步探讨使用该材料构建组织工程韧带支架的可行性。方法:将不同强度的PET单纤维通过经编法编织成支架材料;然后使用电子拉力机对编织好的支架材料以及消毒处理后的支架材料进行力学性能测试并进行分析。结果:PET编织构建的支架材料结构稳定,其极限抗张强度已达到了前交叉韧带的力学要求。辐照消毒对支架材料的力学性能无短期影响。结论:该支架材料编织结构设计合理,具有优良的力学性能,消毒后对其力学性能无短期影响,有望通过改进生物学性能后成为一种较理想的组织工程前交叉韧带支架材料。     

硬膜外麻醉无痛分娩、剖宫产和自然分娩对盆底组织功能的影响

摘要 目的：比较不同的分娩方法（自然分娩、无痛分娩、剖宫产）对产妇盆底组织功能的影响。方法：选择2019年10月～2020年11月在我院进行分娩的80例产妇,其中,自然分娩组15例,无痛分娩组26例、剖宫产组39例。记录自然分娩组和无痛分娩组第一、第二产程的疼痛程度和第一、第二产程所需时间,巨大儿、新生儿黄疸、低体重儿和新生儿窒息等母婴结局,Apgar评分、产时出血量和胎儿体重;且检查产妇的盆底肌力,记录自然分娩组、无痛分娩组、剖宫产组的尿失禁发生率。结果：无痛分娩组的第一、第二产程的视觉模拟评分法（Visual analog scales,VAS）评分和第一、第二产程所需时间明显低于自然分娩组(P<0.05);自然分娩组和无痛分娩组的巨大儿、新生儿黄疸、低体重儿和新生儿窒息率无明显差异(P>0.05);自然分娩组和无痛分娩组的Apgar评分、产时出血量和胎儿体重无明显差异(P>0.05);无痛分娩组的盆底肌力明显高于自然分娩组(P<0.05),剖宫产组的盆底肌力明显高于无痛分娩组(P<0.05);三组尿失禁的发生率对比差异无统计学意义(P>0.05)。结论：无痛分娩不但能减轻分娩疼痛程度,还能减轻对盆底组织功能的损伤,值得进行推广。     

壳聚糖接枝改性PET 人工韧带的表面结构与特性研究

目的:于聚对苯二甲酸乙二醇酯(PET)人工韧带材料表面接枝壳聚糖长链分子,对改性PET人工韧带的表面结构与特性进行分析,以期为较好生物相容性的PET人工韧带材料的设计和研发奠定一定的理论基础和技术支持。方法:首先采用化学接枝法在聚对苯二甲酸乙二醇酯(PET)织物表面接枝丙烯酸(PET-AAc),再与壳聚糖分子发生酰胺化反应实现PET表面的壳聚糖接枝(PET-CHI)。借助接触角、x射线光电子能谱(XPS)、傅立叶红外光谱(FTIR)、热失重(TG)和扫描电镜(SEM)等对PET改性效果进行分析表征。结果:壳聚糖长链分子成功接枝到PET表面,壳聚糖在PET表面的接枝厚度为2.25μm,接枝量为9.66 wt%。结论:接枝改性后PET表面亲水性有较大提高,浸润性得到改善。     

球囊辅助栓塞技术治疗未破裂颅内动脉瘤的有效性及安全性分析

目的:探究球囊辅助栓塞技术治疗未破裂颅内动脉瘤的有效性和安全性。方法:选择2014年1月~2019年1月在本院介入诊疗科接受介入治疗的540例患者作为研究对象。根据治疗方案分为两组,球囊辅助栓塞组有340例,单纯栓塞组有200例。回顾性分析研究对象的一般资料、临床资料、手术并发症等情况。结果:球囊辅助栓塞组和单纯栓塞组在性别组成、年龄、颅内动脉瘤性质、位置、Hunt-Hess分级等方面,差异不具有统计学意义(P>0.05);在术后即刻及术后6个月血管造影结果显示,前者栓塞程度明显优于后者,两组差异具有统计学意义(P<0.05);前者改良Rankin量表评分明显优于后者,两组差异具有统计学意义(P=0.005);前者预后良好率明显高于后者,两组差异具有统计学意义(P<0.001);手术过程中,球囊辅助栓塞组发生2例破裂出血、2例脑血管痉挛、1例弹簧圈移位,单纯栓塞组发生2例破裂出血、1例栓塞、2例脑血管痉挛、3例弹簧圈移位。前者并发症发生率明显低于后者,两者差异具有统计学意义(P<0.001)。结论:在治疗未破裂颅内动脉瘤方面,球囊辅助栓塞技术的有效性、安全性明显优于单纯栓塞介入治疗,值得临床推广。     

不同移植物对兔前叉韧带重建术后血运变化的影响

目的：比较自体和同种异体半肌腱重建兔前叉韧带对血管生成的影响。方法：选择48 只骨骼发育成熟的新西兰种属兔作为 研究对象,将其随机分为自体组(A 组)和异体组(B 组),每组24 只,分别接受半肌腱重建前叉韧带手术。从手术日期开始,分别记 录手术后第3 周、第6 周、第12 周和第24 周重建韧带的血管生成情况同时对血管生成数量进行定量。结果：手术后两组实验兔 关节均无肿胀,关节囊无炎性反应发生。在手术后第3 周,两组血管生成无明显差异(P>0.05);术后第6 周和第12周,自体移植组 新生血管数量明显高于异体移植组(P<0.05);术后第24 周,异体组新生血管数量明显高于自体组(P<0.05)。结论：在兔前叉韧带的 重建过程中,异体移植物重建的血管生成速度和数量明显慢于自体移植物,提示在临床上选择自体移植物对术后恢复更理想.     

Application of a dense gas technique for sterilizing soft biomaterials

Sterilization of soft biomaterials such as hydrogels is challenging because existing methods such as gamma irradiation, steam sterilization, or ethylene oxide sterilization, while effective at achieving high sterility assurance levels (SAL), may compromise their physicochemical properties and biocompatibility. New methods that effectively sterilize soft biomaterials without compromising their properties are therefore required. In this report, a dense-carbon dioxide (CO(2) )-based technique was used to sterilize soft polyethylene glycol (PEG)-based hydrogels while retaining their structure and physicochemical properties. Conventional sterilization methods such as gamma irradiation and steam sterilization severely compromised the structure of the hydrogels. PEG hydrogels with high water content and low elastic shear modulus (a measure of stiffness) were deliberately inoculated with bacteria and spores and then subjected to dense CO(2) . The dense CO(2) -based methods effectively sterilized the hydrogels achieving a SAL of 10(-7) without compromising the viscoelastic properties, pH, water-content, and structure of the gels. Furthermore, dense CO(2) -treated gels were biocompatible and non-toxic when implanted subcutaneously in ferrets. The application of novel dense CO(2) -based methods to sterilize soft biomaterials has implications in developing safe sterilization methods for soft biomedical implants such as dermal fillers and viscosupplements.     

Geometric and mechanical properties of human cervical spine ligaments

This study characterized the geometry and mechanical properties of the cervical ligaments from C2-T1 levels. The lengths and cross-sectional areas of the anterior longitudinal ligament, posterior longitudinal ligament, joint capsules, ligamentum flavum, and interspinous ligament were determined from eight human cadavers using cryomicrotomy images. The geometry was defined based on spinal anatomy and its potential use in complex mathematical models. The biomechanical force-deflection, stiffness, energy, stress, and strain data were obtained from 25 cadavers using in situ axial tensile tests. Data were grouped into middle (C2-C5) and lower (C5-T1) cervical levels. Both the geometric length and area of cross section, and the biomechanical properties including the stiffness, stress, strain, energy, and Young's modulus, were presented for each of the five ligaments. In both groups, joint capsules and ligamentum flavum exhibited the highest cross-sectional area (p < 0.005), while the longitudinal ligaments had the highest length measurements. Although not reaching statistical significance, for all ligaments, cross-sectional areas were higher in the C5-T1 than in the C2-C5 group; and lengths were higher in the C2-C5 than in the C5-T1 group with the exception of the flavum (Table 1 in the main text). Force-deflection characteristics (plots) are provided for all ligaments in both groups. Failure strains were higher for the ligaments of the posterior (interspinous ligament, joint capsules, and ligamentum flavum) than the anterior complex (anterior and posterior longitudinal ligaments) in both groups. In contrast, the failure stress and Young's modulus were higher for the anterior and posterior longitudinal ligaments compared to the ligaments of the posterior complex in the two groups. However, similar tendencies in the structural responses (stiffness, energy) were not found in both groups. Researchers attempting to incorporate these data into stress-analysis models can choose the specific parameter(s) based on the complexity of the model used to study the biomechanical behavior of the human cervical spine.     

经皮椎体成形术对骨质疏松性胸腰椎骨折患者生物力学的影响研究

目的:探讨经皮椎体成形术对骨质疏松性胸腰椎骨折患者生物力学的影响。方法:选取9具冻存新鲜尸体的胸腰段脊柱开展研究,并应用随机数字表法分为观察组、对照1组和对照2组,每组各3具。观察组、对照1组均制作成骨质疏松性胸腰椎骨折模型,观察组经椎弓根注入含有对比剂的低粘度骨水泥,对照1组置入椎弓根螺钉内固定,分别于术前和术后测量两组椎体的主要生物力学指标(最大抗压强度、刚度、高度),对照2组则作为参照,仅测量一次,对三组生物力学指标检测结果进行统计分析。结果:观察组椎体术前的最大抗压强度、刚度、高度与对照1组比较差异无统计学意义(P0.05),但两组术前最大抗压强度、刚度较对照2组降低,而高度较对照2组升高(P0.05)。观察组和对照2组术后的最大抗压强度、刚度均较对照1组升高,高度较对照1组降低(P0.05),而观察组术后的最大抗压强度、刚度、高度与对照2组比较差异无统计学意义(P0.05)。结论:应用经皮椎体成形术对骨质疏松性腰椎骨折患者实施治疗,能够有效恢复患者椎体生物力学,效果确切。     

腓骨短肌腱外侧韧带重建术治疗慢性踝关节外侧不稳的临床疗效

目的:研究外侧副韧带重建手术结合关节镜检查治疗慢性踝关节外侧不稳的临床疗效。方法:选取2012年7月-2014年7月我院收治的慢性踝关节外侧不稳患者60例,随机分为研究组和对照组,每组30例。对照组患者给予保守治疗,研究组患者采取踝关节镜探查清理联合腓骨短肌腱外侧韧带重建手术进行治疗。应用美国足踝外科裸-后足功能评分系统(AOFAS)评价两组患者治疗前后的踝关节功能评分,并比较两组的优良率、复发率以及并发症的发生率。结果:两组治疗前的AOFAS功能评分比较无统计学差异(P0.05),两组治疗后的AOFAS功能评分均较治疗前显著升高,且研究组显著高于对照组,差异具体统计学意义(P0.05)。研究组的优良率为96.7%(29/30),显著高于对照组的73.3%(22/30);研究组的复发率为0.0%(0/30),显著低于对照组的13.3%(4/30);研究组并发症的发生率为3.3%(1/30),显著低于对照组的20.0%(6/30),两组比较差异均具有统计学意义(P0.05)。结论:外侧副韧带重建手术结合关节镜检查治疗慢性踝关节外侧不稳具有较好的临床疗效,且复发率较低,并发症较少。     

Improved Sterilization of Sensitive Biomaterials with Supercritical Carbon Dioxide at Low Temperature

The development of bio-resorbable implant materials is rapidly going on. Sterilization of those materials is inevitable to assure the hygienic requirements for critical medical devices according to the medical device directive (MDD, 93/42/EG). Biopolymer-containing biomaterials are often highly sensitive towards classical sterilization procedures like steam, ethylene oxide treatment or gamma irradiation. Supercritical CO₂ (scCO₂) treatment is a promising strategy for the terminal sterilization of sensitive biomaterials at low temperature. In combination with low amounts of additives scCO₂ treatment effectively inactivates microorganisms including bacterial spores. We established a scCO₂ sterilization procedure under addition of 0.25% water, 0.15% hydrogen peroxide and 0.5% acetic anhydride. The procedure was successfully tested for the inactivation of a wide panel of microorganisms including endospores of different bacterial species, vegetative cells of gram positive and negative bacteria including mycobacteria, fungi including yeast, and bacteriophages. For robust testing of the sterilization effect with regard to later application of implant materials sterilization all microorganisms were embedded in alginate/agarose cylinders that were used as Process Challenge Devices (PCD). These PCD served as surrogate models for bioresorbable 3D scaffolds. Furthermore, the impact of scCO₂ sterilization on mechanical properties of polysaccharide-based hydrogels and collagen-based scaffolds was analyzed. The procedure was shown to be less compromising on mechanical and rheological properties compared to established low-temperature sterilization methods like gamma irradiation and ethylene oxide exposure as well as conventional steam sterilization. Cytocompatibility of alginate gels and scaffolds from mineralized collagen was compared after sterilization with ethylene oxide, gamma irradiation, steam sterilization and scCO₂ treatment. Human mesenchymal stem cell viability and proliferation were not compromised by scCO₂ treatment of these materials and scaffolds. We conclude that scCO₂ sterilization under addition of water, hydrogen peroxide and acetic anhydride is a very effective, gentle, non-cytotoxic and thus a promising alternative sterilization method especially for biomaterials.     

虚拟现实平衡训练联合神经肌肉电刺激对前交叉韧带重建术后患者膝关节功能、腘绳肌肌力和步行功能的影响

摘要 目的：探讨虚拟现实平衡训练联合神经肌肉电刺激（NMES）对前交叉韧带重建术（ACLR）后患者膝关节功能、腘绳肌肌力和步行功能的影响。方法：选择2019年8月~2021年12月期间我院收治的前交叉韧带（ACL）损伤患者96例,并成功实施ACLR,采用随机数字表法分为对照组（n=48,常规康复训练、虚拟现实平衡训练）和研究组（n=48,常规康复训练、虚拟现实平衡训练联合NMES干预）。对比两组膝关节功能优良率、膝关节功能、腘绳肌肌力和步行功能。结果：研究组的临床膝关节功能优良率93.75%（45/48）高于对照组68.75%（33/48）,差异有统计学意义（P<0.05）。两组干预后膝关节功能评分、膝关节活动度对均升高,且研究组高于对照组（P<0.05）。两组干预后患侧腘绳肌等长肌力升高,且研究组高于对照组（P<0.05）,两组干预后健侧腘绳肌等长肌力对比无明显差异（P>0.05）。两组干预后步长、步速升高,且研究组高于对照组,患侧摆动相降低,且研究组低于对照组（P<0.05）。两组干预后被动活动察觉阀值、进行被动角度再生试验降低,且研究组低于对照组（P<0.05）。结论：虚拟现实平衡训练联合NMES应用于ACLR术后患者的疗效显著,有助于其膝关节功能恢复,提高腘绳肌肌力,改善步行功能。     

本体感觉训练联合肌内效贴对前交叉韧带断裂术后患者肢体肿胀程度、运动平衡功能及生活质量的影响

摘要 目的：观察本体感觉训练联合肌内效贴对前交叉韧带断裂术后患者肢体肿胀程度、运动平衡功能及生活质量的影响。方法：选择2019年1月-2022年1月期间我院接收的120例行前交叉韧带断裂术患者,按照信封抽签法将患者分为对照组（60例,本体感觉训练）和研究组（60例,对照组的基础上接受肌内效贴干预）。对比两组优良率、肢体肿胀程度、运动平衡功能及生活质量。结果：研究组的优良率高于对照组（P<0.05）。两组治疗2周后、治疗4周后肢体肿胀值减小,且研究组低于对照组（P<0.05）。两组治疗4周后Fugl-Meyer运动量表（FMA）、Berg 评分量表（BBS）评分升高,且研究组高于对照组（P<0.05）。两组治疗4周后总体/精神健康、生理/社会功能、活力、躯体疼痛和情感/生理职能评分升高,且研究组高于对照组（P<0.05）。结论：本体感觉训练联合肌内效贴对前交叉韧带断裂术后患者,可有效减轻肢体肿胀程度,改善运动平衡功能及生活质量,效果显著。     

微创改良双纽扣型金属接骨板结合高强度纤维修复喙锁韧带治疗肩锁关节脱位合并喙锁韧带撕裂的临床研究

摘要 目的：探讨微创改良双纽扣型金属接骨板结合高强度纤维修复喙锁韧带治疗肩锁关节脱位合并喙锁韧带撕裂的临床疗效。方法：采用前瞻性随机病例对照的研究方法,选取2017年3月~2019年6月我院收治的肩锁关节脱位合并喙锁韧带撕裂患者64例,采用随机数字表法将患者分为两组：对照组（n=32）和观察组（n=32）。对照组的治疗方案为AO锁骨钩钢板内固定,观察组的治疗方案为微创改良双纽扣型金属接骨板结合高强度纤维修复喙锁韧带。比较两组手术相关指标、术后肩关节Constant评分、疼痛视觉模拟评分（VAS）及并发症发生情况。结果：观察组手术时间较对照组显著延长,疼痛消失时间及住院费用较对照组降低（P＜0.05）,两组术后住院时间比较未见差异（P>0.05）。观察组术后3个月肩关节VAS评分较对照组降低（P＜0.05）,术后3个月及1年观察组肩关节Constant评分均显著高于对照组（P＜0.05）。两组术后3个月、术后1年并发症发生率比较无统计学意义（P>0.05）。结论：微创改良双纽扣型金属接骨板结合高强度纤维修复喙锁韧带治疗肩锁关节脱位合并喙锁韧带撕裂更符合解剖学特点,可减轻肩关节疼痛,促进肩关节功能恢复。     

Effects of <Superscript>60</Superscript>Co gamma radiation dose on initial structural biomechanical properties of ovine bone—patellar tendon—bone allografts

Gamma radiation is established as a procedure for inactivating bacteria, fungal spores and viruses. Sterilization of soft tissue allografts with high dose ⁶⁰Co gamma radiation has been shown to have adverse effects on allograft biomechanical properties. In the current study, bone-patellar tendon-bone (BPTB) allografts from 32 mature sheep were divided into two treatment groups: low-dose radiation at 15 kGy (n = 16) and high-dose radiation at 25 kGy (n = 16) with the contralateral limb serving as a 0 kGy (n = 32) non-irradiated control. Half of the tendons from all treatment groups were biomechanically tested to determine bulk BPTB mechanical properties, cancellous bone compressive properties, and interference screw pull-out strength. The remaining tissues were prepared, implanted, and mechanically tested in an acute in vitro anterior crucial ligament (ACL) reconstruction. Low-dose radiation did not adversely affect mechanical properties of the tendon allograft, bone, or ACL reconstruction compared to internal non-irradiated control. However, high-dose radiation compromised bulk tendon load at failure and ultimate strength by 26.9 and 28.9%, respectively (P < 0.05), but demonstrated no negative effect on the cancellous bone compressive properties or interference screw pull-out strength. Our findings suggest that low dose radiation (15 kGy) does not compromise the mechanical integrity of the allograft tissue, yet high dose radiation (25 kGy) significantly alters the biomechanical integrity of the soft tissue constituent.