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Chymodiactin in patients with herniated lumbar intervertebral disc(s). An open-label, multicenter study
Spine
|April 1, 1985
Summary
Chymodiactin (chymopapain for injection) showed favorable outcomes for herniated lumbar discs in 1,498 patients. However, serious adverse events including anaphylaxis and neurologic complications were reported.
Area of Science:
- Neurosurgery
- Orthopedic Surgery
- Pharmacology
Background:
- Chymodiactin (chymopapain for injection) is used for herniated lumbar intervertebral discs.
- Safety information needed to be extended for this treatment.
Purpose of the Study:
- To extend the safety information for Chymodiactin (chymopapain for injection).
Main Methods:
- An open-label, multicenter, phase 3 clinical study.
- 37 neurologic and orthopedic surgeons enrolled 1,498 patients with herniated lumbar intervertebral discs.
Main Results:
- Therapeutic results were generally favorable, with success rates between 79.6% and 88.9%.
- 13 cases of anaphylaxis occurred, resulting in 2 deaths.
- Two patients experienced serious neurologic problems: transverse myelitis/paraplegia and acute cauda equina syndrome.
- Most frequent adverse experiences included back spasm and stiffness/soreness.
Conclusions:
- Chymodiactin demonstrated favorable therapeutic results for herniated lumbar discs.
- The study identified significant safety concerns, including anaphylaxis and serious neurologic events, necessitating careful patient selection and monitoring.