[Clinical evaluation of Chymodiactin and post-marketing surveillance].
After a short summary of the development of chemonucleolysis technique and of Chymodiactin, the result of a randomized double-blind placebo controlled trial, conducted in the USA with Chymodiactin in 108 patients with monosegmental lumbar disc hernia and an open multicentre-study in 1498 patients, are shown. Furthermore an interim evaluation is presented of an open controlled multicentre-study with Chymodiactin, started in Germany in 1983. The results of these three clinical studies as well as the post-marketing surveillance pending in the USA demonstrate that chemonucleolysis with Chymodiactin is a secure technique with good results, representing a valuable enrichment in the treatment of lumbar herniated nucleus pulposus.
D002917:Chymopapain / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D007404:Intervertebral Disc Chemolysis; D007405:Intervertebral Disc Displacement / Q000188:drug therapy*; D011358:Product Surveillance, Postmarketing; D011897:Random Allocation
D002917:Chymopapain
Klinische Prüfung von Chymodiactin und Post-Marketing Surveillance.