识别和披露的年表琥珀酰胆碱的不利影响。

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黄L,唱CN,德赛女士

识别和披露的年表琥珀酰胆碱的不利影响。

J Anesth嘘。2019年7月,5 (3):65 - 84。doi: 10.1016 / j.janh.2018.07.003。Epub 2018年7月29日。

PubMed ID

31570201 (在PubMed

]

文摘

背景:创建新疗法解决具体问题,享受流行当他们进入广泛的临床使用。更广泛的使用可以揭示未知的不利影响和影响明显的生命周期。琥珀酰胆碱,去极化的神经肌肉阻滞剂,周围数十年的研究古代的产物化合物,箭毒。它在1950年代被引入实践布罗威康公司(BW公司)和欢迎由于其快速行动肌肉放松的效果。全球临床使用了不利影响,轻度和重度,尤其是血钾过高和恶性高热。我们研究当从业者和制造商意识到这些副作用,这些副作用的信息是如何传播,以及制造商是否符合监管要求的时候,特别是关于及时报告不良反应。beplayapp来源:主要文献检索使用在线和归档文件是由木头Library-Museum麻醉学,摩托罗拉IL。我们咨询了联邦当局BW公司提交的文件,通过《信息自由法》(《信息自由法》),食品和药物管理局(FDA)报道,宣传广告,包插入,发表文章和教科书。结果:1952年在人类最初的临床测试没有发现不良对心血管和呼吸系统的影响。自发性收缩和肌痛是在1952年早期副作用病例报告中描述。1953年的大规模临床试验发现异常长一些患者恢复时间; the discovery of abnormal pseudocholinesterase enzyme activity was not fully demonstrated until the early 1960s. Bradycardia was first reported in 1957 in children, and in 1959 in adults. In 1960, animal studies reported a transient increase in plasma potassium; further experiments in 1969 clearly demonstrated succinylcholine-induced hyperkalemia in burn patients. Malignant hyperthermia was first described in 1966. Similar cases of elevated temperatures and muscle rigidity were described globally but the underlying mechanism was not elucidated until the 1990s. Standard anesthesia textbooks did not report major side effects of succinylcholine until 1960 and included newly documented side effects with each edition. BW Co's packaging contained warnings as early as the 1950s but were later updated in 1962 and beyond to reflect the newly discovered hyperkalemia and malignant hyperthermia. CONCLUSION: Particularly given the regulatory environment of the time, BW Co appropriately reported the adverse effects of succinylcholine after market entry; it updated promotional and packaging material in a timely manner to reflect newly discovered adverse effects. The toxicity, though alarming and put clinicians on alert, did not seem to heavily impact succinylcholine's use, given its various desirable properties. It is still a choice muscle relaxant used today, although there are efforts to develop superior agents to replace succinylcholine.

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