Chymodiactin in patients with herniated lumbar intervertebral disc(s). An open-label, multicenter study.
To extent the safety information for Chymodiactin (chymopapain for injection), 37 neurologic and orthopedic surgeons conducted an open-label, multicenter, phase 3 clinical study. A total of 1,498 patients with one or two herniated lumbar intervertebral discs were enrolled. Therapeutic results were generally favorable, with the percentages of patients achieving either excellent or good (or successful) results ranging from 79.6% to 88.9%, depending on criteria employed in the tabulation. There were 13 cases of anaphylaxis, and 2 of these patients died of complications of anaphylaxis. Two additional patients experienced serious neurologic problems. The first of these two patients developed transverse myelitis and paraplegia approximately 3 weeks following chemonucleolysis. Transdural discograms at three levels had been done approximately 2 days prior to chemonucleolysis, in violation of the protocol. The second patient developed acute cauda equina syndrome, and, despite emergency laminectomy, had permanent neurologic sequelae. Back spasm and stiffness/soreness were the most frequently encountered adverse experiences.
D000293:Adolescent; D000328:Adult; D000707:Anaphylaxis / Q000139:chemically induced / Q000401:mortality; D002917:Chymopapain / Q000008:administration & dosage / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D010450:Endopeptidases / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007405:Intervertebral Disc Displacement / Q000000981:diagnostic imaging / Q000628:therapy*; D007482:Iothalamate Meglumine; D008297:Male; D008875:Middle Aged; D011859:Radiography; D011897:Random Allocation; D013035:Spasm / Q000139:chemically induced
D010450:Endopeptidases; D002917:Chymopapain; D007482:Iothalamate Meglumine