Nordby E J, Wright P H, Schofield S R
Boots Pharmaceuticals, Lincolnshire, Illinois.
Clin Orthop Relat Res. 1993 Aug(293):122-34.
This survey covers 121 "serious" and "unexpected" adverse events after treatment with chymodiactin (chymopapain for injection) among approximately 135,000 patients in the United States. They were reported to the Food and Drug Administration (FDA) within 15 days of notification of the manufacturer between 1982 and the end of 1991. They included fatal anaphylaxis (seven cases), infections (24 cases), hemorrhage (32 cases), and neurologic (32 cases) and miscellaneous (15 cases) events, with a mortality rate of 0.019%. Anaphylactic reactions reported in a postmarketing survey can be attributed to chymopapain itself and infections to lack of asepsis during its administration. The causes of other adverse reactions cannot be as clearly defined, but many are unlikely to have been due to chymopapain or its administration. More careful selection of patients and closer attention to technique during chemonucleolysis have dramatically reduced the incidence of these adverse events, which occur far less frequently than after diskectomy.
这项调查涵盖了美国约135,000名患者在接受木瓜凝乳蛋白酶（注射用糜蛋白酶）治疗后出现的121起“严重”和“意外”不良事件。这些事件在1982年至1991年底期间，于制造商通报后的15天内报告给了美国食品药品监督管理局（FDA）。其中包括致命性过敏反应（7例）、感染（24例）、出血（32例）、神经学方面（32例）以及其他各类（15例）事件，死亡率为0.019%。上市后调查中报告的过敏反应可能归因于木瓜凝乳蛋白酶本身，而感染则归因于给药过程中缺乏无菌操作。其他不良反应的原因则不太明确，但许多不良反应不太可能是由木瓜凝乳蛋白酶或其给药方式导致的。在化学溶核术中更谨慎地选择患者并更密切地关注操作技术，已显著降低了这些不良事件的发生率，其发生频率远低于椎间盘切除术后。
