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制酶菌素上市后监测。29075例患者的人口统计学和不良事件数据。

Chymodiactin postmarketing surveillance. Demographic and adverse experience data in 29,075 patients.

作者信息

Agre K, Wilson R R, Brim M, McDermott D J

出版信息

Spine (Phila Pa 1976). 1984 Jul-Aug;9(5):479-85.

PMID:6387953
Abstract

Postmarketing surveillance data on 29,075 patients who received Chymodiactin (Smith Laboratories' formulation of chymopapain) intradiscal injections for a herniated lumbar intervertebral disc are summarized and tabulated. The serious adverse reactions reported include death, anaphylaxis, paraplegia, and discitis. Similar problems also have been reported for Discase (Baxter-Travenol's formulation of chymopapain). Of 11 deaths reported following Chymodiactin administration, only 3 appear to be related to the drug or procedure. Two of these three were due to anaphylaxis and the third to bacterial discitis with resultant meningitis. Paraplegia appeared to be primarily due to needle trauma or injection of contrast agent and enzyme into the subarachnoid space. Careful patient selection and needle placement are essential for avoiding serious problems.

摘要

对29075名接受了椎间盘内注射Chymodiactin(史密斯实验室生产的木瓜凝乳蛋白酶制剂)治疗腰椎间盘突出症的患者的上市后监测数据进行了总结和列表。报告的严重不良反应包括死亡、过敏反应、截瘫和椎间盘炎。对于Discase(百特-特拉文诺尔生产的木瓜凝乳蛋白酶制剂)也报告了类似问题。在报告的Chymodiactin给药后发生的11例死亡中,只有3例似乎与药物或操作有关。这3例中的2例是由于过敏反应,第3例是由于细菌性椎间盘炎并发脑膜炎。截瘫似乎主要是由于针头创伤或向蛛网膜下腔注射造影剂和酶所致。仔细选择患者和正确放置针头对于避免严重问题至关重要。

相似文献

1
Chymodiactin postmarketing surveillance. Demographic and adverse experience data in 29,075 patients.制酶菌素上市后监测。29075例患者的人口统计学和不良事件数据。
Spine (Phila Pa 1976). 1984 Jul-Aug;9(5):479-85.
2
Two anaphylactic deaths after chemonucleolysis.
J Forensic Sci. 1976 Jan;21(1):187-90.
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Safety of chemonucleolysis. Adverse effects reported in the United States, 1982-1991.化学髓核溶解术的安全性。1982 - 1991年美国报告的不良反应。
Clin Orthop Relat Res. 1993 Aug(293):122-34.
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[Clinical evaluation of Chymodiactin and post-marketing surveillance].
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Update on chymopapain.木瓜凝乳蛋白酶的最新情况。
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[Chymopapain allergy. Diagnostic value of a skin test before and after chemonucleolysis].[木瓜凝乳蛋白酶过敏。化学溶核术前及术后皮肤试验的诊断价值]
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Chemonucleolysis. The treatment of lumbar intervertebral disc disease by the intradiscal injection of chymopapain.化学髓核溶解术。通过椎间盘内注射木瓜凝乳蛋白酶治疗腰椎间盘疾病。
Mo Med. 1983 Dec;80(12):735-7, 742.
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Chemonucleolysis of herniated lumbar discs.腰椎间盘突出症的化学髓核溶解术
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