Nordby E J, Fraser R D, Javid M J
Department of Orthopaedics, University of Wisconsin Medical School, Madison, USA.
Spine (Phila Pa 1976). 1996 May 1;21(9):1102-5. doi: 10.1097/00007632-199605010-00023.
Even with a history of controversy and troubling complications, chymopapain has endured the test of time to show 30 years of clinical success in the treatment of herniated nucleus pulposus. Strict attention to indications, contraindications, and technique ensures safety and efficacy of treatment. A trend to decreased dosage may result in less postinjection spasm. Between 1982-1991, 121 adverse events in 135,000 patients were reported to the Food and Drug Administration and investigated. Seven cases of fatal anaphylaxis, 24 infections, 32 bleeding problems, 32 neurologic events, and 15 miscellaneous occurrences were found. Overall mortality rate was 0.019%. All categories were of lesser incidence than complications with laminectomy. Long-term results show that improvement after chemonucleolysis is maintained, whereas the outcome after laminectomy is reported to deteriorate with time. Cost savings with chemonucleolysis over laminectomy are largely a matter of shorter hospitalization. A protocol for cervical chemonucleolysis is being developed in the United States after good results have been shown in Spain and France. Other enzymes continue under investigation, but chymopapain remains the standard to which they are compared.
尽管存在争议和令人困扰的并发症史，但木瓜凝乳蛋白酶经受住了时间的考验，在治疗腰椎间盘突出症方面已取得了30年的临床成功。严格注意适应证、禁忌证和技术可确保治疗的安全性和有效性。剂量减少的趋势可能会减少注射后痉挛。1982年至1991年间，向美国食品药品监督管理局报告并调查了135,000名患者中的121起不良事件。发现7例致命过敏反应、24例感染、32例出血问题、32例神经事件和15例其他事件。总死亡率为0.019%。所有类别事件的发生率均低于椎板切除术的并发症。长期结果表明，化学髓核溶解术后的改善得以维持，而据报道椎板切除术后的结果会随时间恶化。与椎板切除术相比，化学髓核溶解术节省成本主要在于住院时间较短。在美国，在西班牙和法国取得良好效果后，正在制定颈椎化学髓核溶解术的方案。其他酶仍在研究中，但木瓜凝乳蛋白酶仍是与之比较的标准。
