美国兽药不良反应报告评价标准及案例

收集和整理了美国兽药不良反应报告评价标准和案例,为了解美国兽药不良反应报告评价及我国开展相关工作提供参考。     

Anaesthetic complications in pigs undergoing MRI guided convection enhanced drug delivery to the brain: a case series

ObservationsA total of 13 intracerebral infusions were performed at approximately 1 month intervals in three NIH miniature pigs over the age range of 31–59 weeks. Pigs received azaperone and ketamine premedication to allow venous cannulation and propofol induction of anaesthesia. Anaesthesia was maintained with isoflurane throughout cranial surgery and MRI scanning. Physiological monitoring during surgery consisted of blood pressure, pulse, temperature and oxygen saturation monitoring, ECG and capnography. Analgesia consisted of meloxicam and morphine. However, during MRI scanning blood pressure and ECG monitoring had to be discontinued. Anaesthetized pigs underwent intermittent intraputamenal convection enhanced delivery (CED) of gadolinium with real-time magnetic resonance imaging. Progressive tachycardia was consistently observed in all pigs during CED with a mean ± SD maximum increase of 41 ± 22 beats minute^?1 from a baseline heart rate of 96 ± 9 minute^?1. The heart rate remained elevated until recovery. A mean reduction in body temperature of 2.8 ± 0.6 °C from the start of anaesthesia was also observed during the period of MRI scanning. All pigs recovered from anaesthesia smoothly and heart rates returned to normal during the recovery period.ConclusionsHypothermia is common in pigs undergoing this sedation and anaesthesia protocol. Convection enhanced delivery of drugs in healthy anaesthetized pigs may result in tachycardia.     

A comparison of the effects of propofol and etomidate on the induction of anesthesia and on cardiopulmonary parameters in dogs

ObjectiveTo determine the effects of propofol or etomidate on induction quality, arterial blood pressure, blood gases, and recovery quality in normal dogs.Study designRandomized, blinded trial.AnimalsEighteen purpose-bred adult Beagles.MethodsDogs were randomly assigned to receive propofol at 8 mg kg⁻¹ or etomidate at 4 mg kg⁻¹ intravenously (IV) administered to effect. Midazolam was administered at 0.3 mg kg⁻¹ IV as pre-medication at least 1 minute prior to induction. Direct arterial blood pressure, arterial blood gases, and heart rate were obtained at baseline, before induction, after induction, and for every 5 minutes afterwards until the dog began to swallow and the trachea was extubated. The dogs were allowed to breathe room air with the endotracheal tube in place.ResultsThe systolic arterial pressure (SAP) was higher in the etomidate group compared with the propofol group after induction. The SAP and mean arterial pressure (MAP) were higher in the etomidate group compared with the propofol group at 5 minutes. The recovery quality and ataxia score were worse in the etomidate group compared with the propofol group. Time from extubation to sternal recumbency and sternal recumbency to standing was longer in the etomidate group compared with the propofol group. The heart rate, PaCO₂, and HCO₃ were higher in the propofol group compared with the etomidate group after induction. The PaO₂ and SaO₂ were lower in the propofol group compared with the etomidate group after induction. The SAP and MAP were lower in the propofol group at 5 minutes compared with baseline.Conclusion and clinical relevancePropofol caused a decrease in SAP and MAP which was not observed with etomidate. Etomidate caused longer and poorer recoveries than propofol.     

Evaluation of signal detection algorithms within the Elanco Animal Health Pharmacovigilance database

Statistical algorithms for detecting safety signals are beginning to be applied to Animal Health Pharmacovigilance (PV) databases. How these signal detection algorithms (SDAs) perform in an animal health PV database is the subject of this report. Statistical methods and SDAs were assessed against a set of known signals in order to identify which SDAs were most appropriate for signal detection using the Elanco Animal Health PV database. A reference set of adverse events that should signal was created for 31 products across four species. Nine SDAs based on five disproportionality statistical methods were evaluated against the reference set. The performance metrics were sensitivity, precision, specificity, accuracy, and F score. For bovine and porcine products, the Observed‐to‐Expected (O/E) SDA was the closest in terms of geometric distance to 100% sensitivity and 100% precision. For canine and feline products, the Information Component (IC) SDA was geometrically closest to 100% sensitivity and 100% precision. Principal Component Analysis confirmed that the O/E and IC SDAs were unique performers with respect to one another and other SDAs. The performance of the SDAs was dependent on the choice of the statistical method with differences seen between animal species.     

宠物用贝那普利的研究进展

随着宠物高血压、心脏病等疾病的发病率逐年上升,抗高血压、心脏病药物的研究在不断的探索与实践中得到发展。然而,我国宠物高血压、心脏疾病的控制率、治疗率却有待提高。本文将近些年来国内外血管紧张素转化酶抑制剂(ACEI)中贝那普利的理化性质、合成方法、药理学、药代学研究及临床应用进行了概述,并对用药所产生的不良反应情况作了安全的分析与评价,从而进一步指导兽医临床用药,以期贝那普利在宠物临床中更安全、更有效地使用。     

INADVERTENT INTRATHECAL ADMINISTRATION OF IONIC CONTRAST MEDIUM TO A DOG

A hyperosmolar ionic contrast medium, ioxithalamate (Telebrix), was inadvertently injected intrathecally to a dog during myelography. The resultant severe adverse effects were myoclonus, uncontrollable seizures, and hyperthermia. These symptoms have been described by some authors as "ascending tonic-clonic seizure syndrome". The dog completely recovered within 24 h. The literature on 47 humans receiving intrathecal ionic contrast medium after 1966, one dog and one horse was reviewed, including the drugs involved, the circumstances of their use, and the symptoms, treatment and outcome of patients who received the drugs intrathecally. Recommendations to prevent such a misuse are given. The present report and review are a reminder that ionic contrast media are absolutely contraindicated for myelography. Only nonionic contrast media can be used intrathecally. All of the hyperosmolar contrast media are ionic and therefore contraindicated for myelography.     

枸杞逆流浸提工艺的研究

以浸提效率作为评价指标,就枸杞逆流浸提工艺过程中的浸提温度、浸提时间、浸提级数及固液比进行了研究,得出了优化的逆流浸提工艺条件。     

秸秆纤维素降解真菌QSH3-3的筛选及其特性研究

为了获得高效降解秸秆纤维素的微生物菌株,采用滤纸降解法和刚果红染色法从含纤维素类物质的土壤中筛选到一株产纤维素酶菌株QSH3-3,通过形态观察和ITS序列分析,鉴定为草酸青霉Penicillium oxalicum QSH3-3。摇瓶产酶试验结果表明,该菌株的最佳产酶条件为:碳源为0.5%的碱处理过的玉米秸秆粉,氮源为0.2% 硫酸铵,起始pH为7,接种量为5%,产酶温度为30℃,培养时间为4 d。最佳产酶条件下,滤纸酶（FPase）、内切酶（CMCase）和木聚糖酶（Xylanase）分别为12 U、33 U、605 U（U为酶活性单位）;在15℃,其残余酶活力可达70%～80%;在pH 4～9 范围内,其残余酶活力可达70%以上。酶学稳定性研究表明,FPase、CMCase和Xylanase在pH 4～9范围残余酶活力达85%以上,具有较强的酸碱适应能力;FPase、CMCase和Xylanase在45℃以上酶活力迅速下降,耐热性较差。该菌株具有较高的木聚糖酶活力以及较强的低温、pH的耐受力,因而该菌株在田间温差大、土壤偏碱性等复杂条件下对秸秆纤维素类物质的降解具有较高的应用潜力。     

NON-SELECTIVE ANGIOCARDIOGRAPHY IN THE NORMAL DOG AND CAT

Non-selective angiocardiograms were performed on clinically normal mature dogs and cats to determine the optimal contrast medium dose. A dose of 200 mg of iodine per 0.45 kg of body weight was found to give the most consistent results. A 105 mm spot film camera was used at a speed of 2 frames per second. No study took longer than 11 seconds to complete. The technique provided good visualization of the cranial vena cava, pulmonary outflow tract, the pulmonary arteries, left atrium, left ventricle and aorta. The technique provided fair visualization of the right atrium, right ventricle, valves and papillary muscles     

酸、铝和盐胁迫对夏季豆科绿肥作物种子萌发及根瘤菌抗氧化酶活性的影响

在逆境土壤,种子的成功萌发与根瘤的形成是确保豆科作物正常生长的关键。本试验选择4种夏季豆科绿肥作物,包括竹豆、绿豆、田菁和豇豆,研究了种子萌发及其根瘤菌抗氧化酶活性(SOD,超氧化物歧化酶;POD,过氧化物酶;CAT,过氧化氢酶;GR,谷胱甘肽还原酶)对逆境胁迫的响应机制。种子萌发设置4个pH水平,即4,5,6,7;4个 NaCl胁迫水平,即0、40、120和200 mmol·L^-1;4个活性铝(Al³⁺)水平,即0、50、100和200 mg·L^-1。根瘤菌培养设置4个pH水平,即4,5,6,7;5个NaCl水平,即0、10、20、30和40 g·L^-1;5个活性铝(Al³⁺)水平,即0、25、50、75和100 μmol·L^-1。结果表明,酸、铝、盐胁迫显著影响几种豆科绿肥作物的种子发芽率及其根瘤菌的抗氧化酶活性,其中根瘤菌抗氧化酶活性较发芽率对胁迫敏感。不同夏季豆科绿肥品种中,田菁不耐酸,但对盐胁迫有一定耐受性;竹豆、绿豆和豇豆对低浓度的盐和弱酸性环境有一定耐受性;但是所有品种对活性铝浓度增加较为敏感。在酸性和盐碱化土壤,较高浓度的H⁺、活性铝或NaCl抑制种子萌发,减缓根瘤菌的生长,降低根瘤菌对有害物质的抗氧化能力,最终限制豆科绿肥作物的早期生长。