Safety pharmacology of the respiratory system: Techniques and study design
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Abstract The known effects of drugs from a variety of pharmacologic/therapeutic classes on the respiratory system and worldwide regulatory requirements support the need for conducting respiratory evaluations in safety pharmacology. The objective of these studies is to evaluate the potential for drugs to cause secondary pharmacologic or toxicologic effects that influence respiratory function. Changes in respiratory function can result either from alterations in the pumping apparatus that controls the pattern of pulmonary ventilation or from changes in the mechanical properties of the lung that determine the transpulmonary pressures (work) required for lung inflation and deflation. Defects in the pumping apparatus are classified as hypo‐ or hyperventilation syndromes and are evaluated by examining ventilatory parameters in a conscious animal model. The ventilatory parameters include respiratory rate, tidal volume, minute volume, peak (or mean) inspiratory flow, peak (or mean) expiratory flow, and fractional inspiratory time. Defects in mechanical properties of the lung are classified as obstructive or restrictive disorders and can be evaluated in animal models by performing flow‐volume and pressure‐volume maneuvers, respectively. The parameters used to detect airway obstruction include peak expiratory flow, forced expiratory flow at 25 and 75% of forced vital capacity, and a timed forced expiratory volume, while the parameters used to detect lung restriction include total lung capacity, inspiratory capacity, functional residual capacity, and compliance. Measurement of dynamic lung resistance and compliance, obtained continuously during tidal breathing, is an alternative method for evaluating obstructive and restrictive disorders, respectively, and is used when the response to drug treatment is expected to be immediate (within minutes post‐dose). The species used in the safety pharmacology studies conducted in our laboratory are the same as those used in toxicology studies since pharmacokinetic and toxicologic/pathologic data are available in these species. These data can be used to help select test measurement intervals and doses and to aid in the interpretation of functional change. The techniques and procedures for measuring respiratory function parameters are well established in guinea pigs, rats, and dogs.Keywords:
Safety pharmacology
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Seperti pada dewasa, teknik regional anestesi pada pediatrik kini makin popular digunakan oleh ahli anestesikarena keuntungannya. Namun demikian selalu ada risiko dan kemungkinan timbulnya komplikasi dari setiap tindakan yang dilakukan, termasuk tindakan anestesi regional pada pediatrik. Insidensi komplikasi anestesi regional pada pediatrik tidak banyak, dan kalaupun terjadi komplikasi adalah minor. Komplikasi bisa diakibatkan dari identifikasi ruang saraf, alat, obat, teknis tindakan anestesi regionalnya dan komplikasi lainnya.Walaupun tidak banyak kejadian komplikasi regional anestesi yang dilaporkan pada pediatrik, dan bukanlah komplikasi yang fatal, teknik regional anestesi pada pediatrik harus dilakukan dengan lebih hatihati, pertimbangan risiko dan keuntungannya untuk menghindari terjadinya komplikasi, terlebih karena kebanyakan komplikasi dapat dihindari dengan mempelajari teknik yang benar, menggunakan peralatan yang sesuai, dan sangat menerapkan prinsip keamanan pada pasien dengan baik.
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Genentech is partnering with the German cancer company Affimed to develop immunotherapies for multiple kinds of solid and blood cancers. Affimed is developing therapies that engage natural killer cells of the innate immune system to help direct them to attack cancer cells. Genentech will pay Affimed $96 million up front and up to $5 billion more in potential payments.
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ABSTRACT Airway management is particularly difficult in children with severe congenital anomalies. Such patients are extre- mely sensitive to the respiratory depressant effects of anaesthetic agents. We describe the successful and safe app- lication of caudal anaesthesia for inguinal hernia repair in three cases with severe congenital anomalies (Joubert syndrome, I-cell syndrome). The three patients concerned had congenital anomalies including serious facial defor- mity, respiratory failure and cardiovascular defects. They were administered a single dose of caudal epidural anaest- hesia for inguinal hernia surgery in order to avoid complications associated with general anaesthesia. Caudal block was performed and 1 mL/kg levobupivacaine 0.25% administered. We conclude that caudal epidural anaesthesia can be an effective, suitable and safe anaesthetic technique for inguinal herniotomy without the need for general anaesthesia or endotracheal intubation in children with severe congenital anomalies. Key Words: Caudal anaesthesia, children, congenital anomaly OZET Havayolu yonetimi, ciddi konjenital anomalileri olan cocuklarda ozellikle zordur. Bu tur hastalar anestezik ilaclarin solunum depresan etkilerine karsi asiri derecede duyarlidir. Kaudal anestezinin inguinal herni onarimindaki basarili ve guvenli uygulamasi konjenital anomalileri (Joubert sendromu, I-cell hastaligi) olan uc olguda gosterilmistir. Ilgili uc cocuk hastada, ciddi yuz deformitesi, solunum yetmezligi ve kardiyovaskuler bozukluk dahil konjenital bozuk- luklar vardi. Genel anesteziyle iliskili komplikasyonlari onlemek icin inguinal herni cerrahisinde tek doz kaudal epi- dural anestezi uygulandi. Kaudal anestezide %0.25 levobupivakain 1 mL/kg kullanildi. Kaudal epidural anestezinin, ciddi konjenital bozukluklari olan cocuklarda inguinal herni onarimi acisindan genel anesteziye veya endotrakeal entubasyona gerek duyulmadan etkili, uygun ve guvenli bir alternatif anestezi teknigi olabilecegi sonucuna varildi. A na h ta r Sozcukler: Kaudal anestezi, cocuk, konjenital bozukluk
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Budd–Chiari syndrome
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