医学期刊编辑对生物医学研究伦理问题的处理方式调研及建议

【目的】 探讨医学期刊编辑处理生物医学研究伦理问题的方式,为推动确立医学期刊伦理审查规范提供参考。【方法】 通过问卷星向国内医学期刊编辑发放调查问卷,对审稿时和论文出版后处理医学伦理相关问题的方式展开调研。【结果】 共回收问卷230份。调查显示:在审稿阶段,在保护患者隐私方面,英文期刊、中英双语期刊的编辑更注重要求作者提供授权同意相关证明材料;中、英文期刊以及中英双语期刊的编辑对涉及人体试验伦理问题的处理方式都比较规范。但是,对于研究是否获得患者知情同意、动物实验研究是否经过伦理委员会审查、回顾性研究是否需要伦理审查、涉及人的研究是否在临床试验注册中心注册等问题,编辑还需要进一步重视。在论文出版后,编辑发现的医学伦理问题主要是“涉及人的研究未说明是否经过伦理委员会审查”。对论文出版后发现的没有保护患者隐私和没有在临床试验注册中心注册的问题,大部分期刊缺乏相关处理方案。【结论】 编辑应加强对论文知情同意、动物实验伦理、回顾性研究伦理的审查,并审查涉及人的研究是否在临床试验注册中心注册,以推动我国医学期刊的高质量发展。     

多种放射性肺损伤动物模型的建立和效应评价研究

放射性肺损伤是胸部肿瘤放疗后常见并发症,随着对放射性肺炎研究不断深入,如何为基础研究和药物干预寻求最佳的动物模型和效应评价已成为当前亟待解决的难题之一。通过检索近10年文献,对不同放射性肺损伤模型动物及放射部位的选择、照射剂量的确定、照射方法的比较和动物模型效应评价进行了对比研究,以期寻找建立放射性肺损伤动物模型的稳定方法和较为明确的效应机制,为防护和减缓放射性肺损伤的发生发展而进行的基础研究和药物研制提供可靠的方法。     

Inhibiting hydrogen sulfide production in umbilical stem cells reduces their protective effects during experimental necrotizing enterocolitis

IntroductionUmbilical mesenchymal stem cells (USC) have been shown to reduce illness in animal models of necrotizing enterocolitis (NEC), possibly through the paracrine release of hydrogen sulfide (H₂S). We hypothesized that animals treated with USCs with inhibited H₂S synthesis would exhibit more severe disease.MethodsNEC was induced in five-day-old mouse pups by formula feeding and hypoxic and hypothermic stress. Experimental groups received intraperitoneal injection of either saline vehicle or 80,000cells/gram of one of the following cell types: USC, USCs with negative-control siRNA, or USCs with targeted siRNA inhibition of the H₂S-producing enzymes. Pups were monitored by clinical assessment and after euthanasia, intestine and lung histologic injury were scored. Tissue was homogenized, and concentrations of IL-6, IL-10, and VEGF were determined by ELISA. For statistical analysis, p < 0.05 was considered significant.ResultsAnimals treated with negative-control siRNA USCs were significantly improved compared to vehicle. Clinical sickness scores as well as intestinal and lung histologic injury scores in the targeted siRNA groups were significantly worse when compared to the negative-control siRNA group. IL-6, IL-10, and VEGF had varying patterns of expression in the different groups.ConclusionInhibition of H₂S production in USCs reduces the beneficial effects of these cells during therapy in experimental NEC.Level of evidenceAnimal studies are typically described as “foundational evidence” without a true level assigned.Type of studyAnimal Study.     

Variability in non-core vaccination rates of dogs and cats in veterinary clinics across the United States

Vaccination guidelines for dogs and cats indicate that core vaccines (for dogs, rabies, distemper, adenovirus, parvovirus; for cats, feline parvovirus, herpes virus-1, calicivirus) are essential to maintain health, and that non-core vaccines be administered according to a clinician’s assessment of a pet’s risk of exposure and susceptibility to infection. A reliance on individual risk assessment introduces the potential for between-practice inconsistencies in non-core vaccine recommendations. A study was initiated to determine non-core vaccination rates of dogs (Leptospira, Borrelia burgdorferi, Bordetella bronchiseptica, canine influenza virus) and cats (feline leukemia virus) in patients current for core vaccines in veterinary practices across the United States. Transactional data for 5,531,866 dogs (1,670 practices) and 1,914,373 cats (1,661 practices) were retrieved from practice management systems for the period November 1, 2016 through January 1, 2020, deidentified and normalized. Non-core vaccination status was evaluated in 2,798,875 dogs and 788,772 cats that were core-vaccine current. Nationally, median clinic vaccination rates for dogs were highest for leptospirosis (70.5%) and B. bronchiseptica (68.7%), and much lower for canine influenza (4.8%). In Lyme-endemic states, the median clinic borreliosis vaccination rate was 51.8%. Feline leukemia median clinic vaccination rates were low for adult cats (34.6%) and for kittens and 1-year old cats (36.8%). Individual clinic vaccination rates ranged from 0 to 100% for leptospirosis, B. bronchiseptica and feline leukemia, 0–96% for canine influenza, and 0–94% for borreliosis. Wide variation in non-core vaccination rates between clinics in similar geographies indicates that factors other than disease risk are driving the use of non-core vaccines in pet dogs and cats, highlighting a need for veterinary practices to address gaps in patient protection. Failure to implement effective non-core vaccination strategies leaves susceptible dogs and cats unprotected against vaccine-preventable diseases.     

针刺对脑卒中后抑郁动物模型行为学影响的Meta分析

目的:采用系统评价的方法分析针刺对脑卒后抑郁动物模型行为学的影响。方法:检索建库至2020年4月的中国期刊全文数据库(CNKI)、维普期刊数据库(VIP)、万方数据资源系统(WF)、中国生物医学文献数据库(CBM)、Cochrane Library、PubMed等数据库中的针刺对脑卒后抑郁动物模型行为学的影响的相关试验。并且提取文献资料并进行质量评价,并采用Cochrane提供的统计软件Review Manage 5.3对所收集的数据进行统计分析。结果:纳入7篇文献,样本194例,Meta分析结果显示:针刺组大鼠糖水消耗量较模型组更高(WMD=11.49,95%CI[6.16,16.81],Z=4.23,P<0.01),针刺组大鼠较模型组大鼠水平运动次数更多(WMD=19.93,95%CI[11.26,28.60],Z=4.50,P<0.01),差异均具有统计学意义。而两组敞箱实验垂直运动比较(MD=6.79,95%CI[0.75,12.83],Z=2.20,P=0.03),差异无统计学意义。结论:针刺能够改善脑卒中后抑郁动物模型相关行为学指标,但是纳入研究的文献质量及样本数量仍有限,仍需更进一步的研究。     

仿生矿化后的丝素电纺复合支架体内成骨性能的实验研究

目的探讨仿生矿化后的丝素电纺复合支架体内修复颅骨缺损的能力。方法利用静电纺丝技术制备丝素电纺支架(非矿化组),通过模拟体液(SBF)浸泡法对支架仿生矿化(矿化组),扫描电镜观察其微观形貌。18只8周龄的雄性SD大鼠购自南京医科大学动物实验中心,采用随机数字表示法分为3组,分别为矿化组、非矿化组和对照组,每组6只。构建SD大鼠颅骨缺损模型,在直径为5 mm的骨缺损区分别植入矿化组及非矿化组支架,对照组不作处理,分别于术后4、8周取材,通过微计算机断层扫描技术(micro-CT)、苏木精-伊红(HE)及马松染色(Masson染色)比较评估不同支架的体内骨再生情况。应用GraphPad Prism 8统计软件分析,采用单因素方差分析。结果扫描电镜结果显示仿生矿化后的丝素电纺支架表面形成明显的羟基磷灰石矿化层。动物实验结果显示,术后4周和8周,通过对CT三维重建、HE及Masson染色的观察以及对骨体积分数(BV/TV),骨小梁数(Tb.N),骨小梁厚度(TB.Th)和骨小梁间隙(TB.Sp)定量指标的分析结果显示,在矿化组和非矿化组均能观察到新骨的形成,且矿化组的修复效果均优于非矿化组,差异有统计学意义[矿化组、非矿化组及对照组BV/TV在4周时分别为(22.880±2.324)、(12.600±1.965)、(4.967±1.580)%,F=61.838,P<0.05,8周时分别为(45.770±4.433)、(29.400±4.086)、(19.310±2.272)%,F=38.686,P<0.05;Tb.N在4周时分别为(0.029±0.001)、(0.019±0.003)、(0.008±0.003)mm-1,F=52.890,P<0.05,8周时分别为(0.053±0.002)、(0.037±0.003)、(0.023±0.001)mm-1,F=171.433,P<0.05;TB.Sp在4周时分别为(10.810±0.179)、(11.350±0.098)、(11.730±0.163)μm,F=27.655,P<0.05,8周时分别为(8.792±0.175)、(10.060±0.339)、(11.150±0.275)μm,F=56.807,P<0.05]。结论仿生矿化后的丝素电纺复合支架能有效促进骨再生,有望用于骨组织工程。     

药物诱导联合流出道缩窄构建兔腹主动脉瘤模型的实验研究

目的：探讨药物诱导联合腹主动脉流出道缩窄构建兔腹主动脉瘤（AAA）模型的可行性与有效性。 方法：将24只雌性新西兰大白兔随机均分为4组，其中两组分别采用含CaCl2（0.75 mol/L）或胰蛋白酶（0.04 g/mL）溶液的棉条包裹浸润血管30 min诱导AAA，另两组分别在CaCl2或胰蛋白酶浸润的基础上行腹主动脉流出道缩窄术（缩窄50%~60%）造模。术后使用兽用彩超诊断仪监测受累血管管径变化，术后2周，收集损伤段腹主动脉制作组织切片行HE与EVG染色。用计算机模拟评估流出道缩窄对AAA形成的影响。 结果：术后2周，超声检查显示，两个单纯药物浸润组受累血管扩张不明显，均未达到AAA形成标准，两个药物联合缩窄组受累血管明显扩张，其中CaCl2+缩窄组成瘤率66.67%（4/6），血管平均扩张1.61倍；胰蛋白酶+缩窄组成瘤率83.33%（5/6），血管平均扩张1.89倍。与正常腹主动脉比较，CaCl2浸润的血管内膜厚度明显增加（均P<0.05），而胰蛋白酶浸润后的血管内膜厚度变化不明显（均P>0.05）；各组中膜厚度均明显增加，弹力纤维面积百分比均明显降低，其中CaCl2+缩窄组的变化最为明显（均P<0.05）。计算机数值模拟结果显示，流出道缩窄后血管壁应力增大，成瘤率增加。 结论：药物损伤联合腹主动脉流出道缩窄能成功构建兔AAA模型，缩短造模时间，且胰蛋白酶浸润损伤联合腹主动脉流出道缩窄造模方法优于CaCl2联合腹主动脉流出道缩窄造模方法。