柯萨奇病毒A组16型疫苗免疫后中和抗体检测方法的比较

目的 采用3种方法检测灭活的柯萨奇病毒A组16型(CA16)疫苗的免疫保护性抗体水平,旨在构建评价疫苗免疫保护的检测平台.方法 CA16候选株疫苗(3726,4430和4432)按0、4、6、8周,经腹腔接种小鼠、大鼠和豚鼠,采集0、4、6、8周和10周血样.通过竞争抑制ELISA、细胞微孔病变实验和乳鼠攻毒保护实验评估免疫血清中和抗体水平,利用SPSS16.0软件分析3种检测方法相关性.结果 血清中和抗体在首次加强免疫2周后达到峰值;竞争抑制ELISA和细胞微孔病变实验测得中和效价的相关系数为0.861;竞争抑制ELISA和乳鼠攻毒保护的相关系数为0.8;细胞微孔病变实验和乳鼠攻毒保护的相关系数为0.89.结论 竞争抑制ELISA检测中和抗体与“金标准”相比具有灵敏、快速、大量、低廉等特点,具有广阔的应用前景.     

1H和19F核磁共振定量法测定塞来昔布含量

目的 分别采用_¹H核磁共振定量法和_¹⁹F核磁共振定量法测定塞来昔布绝对含量,并将两种方法测定结果与质量平衡法测定结果进行比较。方法 氢核磁共振定量法以塞来昔布δ 6.92处质子峰作为定量峰,马来酸δ 6.33处为内标峰。在弛豫延迟时间10 s,采样时间4.01 s,扫描次数为32条件下采集混合物的氢谱。氟核磁共振定量法以4-溴-2-氟-乙酰苯胺为内标,在谱宽240 ppm,中心频率-94.26 ppm,样品扫描次数为16次条件下采集氟谱,计算两种核磁共振定量法的测试结果。结果 氢核磁共振定量法和氟核磁共振定量法测定结果相近,且与质量平衡法测定结果基本一致。结论 核磁共振定量法可以用来测定塞来昔布含量,具有准确、高效优势。     

基于指纹图谱、多指标含量测定的头痛宁胶囊质量评价

目的：建立指纹图谱、多指标定量相结合的头痛宁胶囊质量评价方法。方法：采用高效液相色谱法,选用Kromasil C₁₈色谱柱（250 mm×4.6 mm,5 μm）;以甲醇-0.1%磷酸水溶液为流动相,梯度洗脱;流速：1.0 mL·min^-1;柱温：30℃;检测波长：220 nm（0~40 min）、290 nm（40~100 min）;进样量：10 μL。运用"中药色谱指纹图谱相似度评价系统（2012版）"对15批样品色谱图进行分析,以落新妇苷为参照,确定22个共有峰为特征峰,相似度均>0.977;天麻素、阿魏酸、落新妇苷、5-O-甲基维斯阿米醇苷、二苯乙烯苷线性关系良好,r均>0.999 9,加样回收率在95.5%~98.9%,RSD<5%（n=6）。结论：该方法简便、准确及专属性强,可用于头痛宁胶囊质量控制和综合评价。     

硝呋莫司与大鼠犬猴和人血浆蛋白结合率的测定

目的建立硝呋莫司与SD大鼠、比格犬、食蟹猴和人血浆蛋白结合率的测定方法,计算硝呋莫司与4个不同种属的血浆蛋白结合率。方法采用体外快速平衡透析法,将透析后的血浆和缓冲液分别加入对应的空白基质,用乙酸乙酯萃取后采用HPLC法测定。结果硝呋莫司在样品中的线性范围为0.1⁵μg·ml^-1,在不同血浆中的色谱方法专属性良好,提取回收率为（73.64±1.00）%^81.20±0.66%。硝呋莫司在人、犬、大鼠、猴中的血浆蛋白结合率范围为46.0%⁵8.2%、40.7%⁴2.6%、38.7%⁴3.8%、30.8%⁴2.8%。结论硝呋莫司与4种血浆蛋白的结合率中等,且在不同种属的血浆蛋白结合率随药物浓度不同存在一定种属差异。     

Resultados de la ablación con catéter con mínimo o nulo empleo de fluoroscopia en pacientes pediátricos con taquiarritmias supraventriculares

Introduction and objectivesIonizing radiation exposure in catheter ablation procedures carries health risks, especially in pediatric patients. Our aim was to compare the safety and efficacy of catheter ablation guided by a nonfluoroscopic intracardiac navigation system (NFINS) with those of an exclusively fluoroscopy-guided approach in pediatric patients.MethodsWe analyzed catheter ablation results in pediatric patients with high-risk accessory pathways or supraventricular tachycardia referred to our center during a 6-year period. We compared fluoroscopy-guided procedures (group A) with NFINS guided procedures (group B).ResultsWe analyzed 120 catheter ablation procedures in 110 pediatric patients (11 ± 3.2 years, 70% male); there were 62 procedures in group A and 58 in group B. We found no significant differences between the 2 groups in procedure success (95% group A vs 93.5% group B; P = .53), complications (1.7% vs 1.6%; P = .23), or recurrences (7.3% vs 6.9%; P = .61). However, fluoroscopy time (median 1.1 minutes vs 12 minutes; P < .0005) and ablation time (median 96.5 seconds vs 133.5 seconds; P = .03) were lower in group B. The presence of structural heart disease was independently associated with recurrence (P = .03).ConclusionsThe use of NFINS to guide catheter ablation procedures in pediatric patients reduces radiation exposure time. Its widespread use in pediatric ablations could decrease the risk of ionizing radiation.     

Characteristics and Transformation Mechanism of Nonmetallic Inclusions in 304 Stainless Steel during Heat Treatment at 1250 °C

Evolutions of two typical types of nonmetallic inclusions, i.e., inclusions based on CaO-SiO₂-Al₂O₃ and MnO-SiO₂-Al₂O₃ of 304 stainless steel were investigated in laboratory-scale experiments under isothermal heat treatment at 1250 °C for 0, 30, 60 and 120 min. Results show inclusion population density increases at the first stage and then decreases while their average size decreases and then increases. Moreover, almost no Cr₂O₃ content within the inclusion before the heat treatment, but Cr₂O₃ content increases gradually along with increasing heat treatment time. Furthermore, the increasing of Cr₂O₃ content in the inclusions would increase their melting points and reduce their plasticities. The experimental results and thermodynamic analysis indicate that there are three steps for inclusion evolution during the heat treatment process, in which Ostwald ripening plays an important role in inclusion evolution, i.e., inclusions grow by absorbing the newly formed small-size MnO-Cr₂O₃ inclusions.     

Antinociceptive effects of novel melatonin receptor agonists in mouse models of abdominal pain

AIM: To characterize the antinociceptive action of the novel melatonin receptor(MT) agonists, Neu-P11 and Neu-P12 in animal models of visceral pain. METHODS: Visceral pain was induced by intracolonic(ic) application of mustard oil or capsaicin solution or by intraperitoneal(ip) administration of acetic acid. Neu-P11, Neu-P12, or melatonin were given ip or orally and their effects on pain-induced behavioral responses were evaluated. To identify the receptors involved, thenon-selective MT1/MT2 receptor antagonist luzindole, the MT2 receptor antagonist 4-P-PDOT, or the μ-opioid receptor antagonist naloxone were injected ip or intracerebroventricularly(icv) prior to the induction of pain. RESULTS: Orally and ip administered melatonin, Neu-P11, and Neu-P12 reduced pain responses in a dose-dependent manner. Neu-P12 was more effective and displayed longer duration of action compared to melatonin. The antinociceptive effects of Neu-P11 or Neu-P12 were antagonized by ip or icv. administered naloxone. Intracerebroventricularly, but not ip administration of luzindole or 4-P-PDOT blocked the antinociceptive actions of Neu-P11 or Neu-P12. CONCLUSION: Neu-P12 produced the most potent and long-lasting antinociceptive effect. Further development of Neu-P12 for future treatment of abdominal pain seems promising.     

84例肾细胞癌患者MSCT检查的图像分析及相关生物学行为评价

目的分析肾细胞癌患者多层螺旋CT(MSCT)检查的图像及相关生物学行为。方法选取2015年6月~2018年11月我院肾细胞癌患者84例,患者均采取MSCT检查,并行手术治疗,在术中取肾细胞癌组织和相应癌旁正常肾组织标本,以免疫组织化学SP法检测患者肾细胞癌组织和癌旁正常肾组织中Ki-67、缺氧诱导因子-1α(HIF-1α)表达情况,并观察患者MSCT征象(瘤体大小、强化程度、有无坏死、液化、囊变,肿瘤边界清楚与否、有无血管受侵、有无邻近脏器侵犯或远处转移),分析肾细胞癌MSCT征象和Ki-67、HIF-1α表达情况相关性。结果本组术前应用MSCT扫描对肾细胞癌检出率及定性诊断率均为100%;Ki-67、HIF-1α在肾细胞癌组织中表达均高于癌旁正常肾组织(P<0.05);MSCT征象表现为瘤体大小>5cm、强化程度≥20HU、存在坏死、液化、囊变、肿瘤边界不清楚、有血管受侵、产生邻近脏器侵犯或远处转移者Ki-67、HIF-1α表达均高于瘤体大小≤5cm、强化程度<20HU、无坏死、液化、囊变、肿瘤边界清楚、无血管受侵、未产生邻近脏器侵犯或远处转移者(P均<0.05)。结论应用MSCT扫描可对肾细胞癌施行准确术前诊断,且肾细胞癌患者MSCT征象和Ki-67、HIF-1α表达有着密切相关性,能间接反映肿瘤生物学行为,为肾细胞癌诊断、治疗提供有力参考。     

各国生物类似药参照药管理比对研究及完善我国生物类似药参照药管理的建议

参照药是生物类似药研发的标杆,对参照药进行规范管理,有利于保证生物类似药的研发质量。通过对美欧日韩等国家以及WHO对于生物类似药参照药的相关要求进行对比研究,提炼管理要素;结合我国参照药的现状、设计问卷、开展调研和专家研讨;综合对比研究、调研和研讨,提出完善我国生物类似药参照药管理的建议及建议的考量。