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The authors report a 12-year follow-up review of 33 patients treated with chymopapain (Discase) injection for intervertebral disc disease. This carefully controlled series of patients was treated under local anesthesia in the prone position. Only the single offending disc that correlated with the myelographic and clinical pathology (without the use of discography) was injected with Discase. Anaphylaxis is treated instantly at the first sign of disturbance, and no patients suffered shock. The percentage of patients who were completely cured or improved continues at about 70%. Aside from sensitivity, complications attributable to proper use of the enzyme remain at zero. Follow-up review of those patients over 10 years would indicate that there is no risk of delayed organ toxicity, no risk of carcinogenesis, and no apparent risk of first-generation teratogenesis.

The authors report 66 patients with signs, symptoms, and a myelographic abnormality of herniated lumbar disc, who were not responsive to conservative treatment. The discs were injected at random with either chymopapain or a placebo. Neither patient nor surgeon knew which agent was used until after the results had been tabulated. Unless early laminectomy was necessary for intractable pain, all patients were followed for 2 months or more. There was no statistically significant difference in incidence or quality of improvement between the two groups: chymopapain was successful in 58% while placebo was successful in 49% (p = 0.15). Early results from this study indicate that most, if not all, of the putative effectiveness of chemonucleolysis probably derives from a placebo effect.

In the first of a two-part study, the authors review the known biochemical, pharmacological, toxicological, and experimental data concerning chymopapain and the intervertebral disc. They describe the action of this proteolytic enzyme, which apparently disrupts the protein mucopolysaccharide component of disc material, most marked in the nucleus pulposus. A rapid conversion to collagen causes a loss of disc space height; toxicity appears to result from alteration of bonding between capillary endothelial cells that in turn produces hemorrhage. Part 2 reviews significant reported results and complications of clinical chemonucleolysis.

Lumbar disc tissue from 10 patients who had previously undergone chemonucleolysis without success was studied by light and scanning electron microscopy. Seven patients had a sequestrated disc; three had large protrusions. As a control, material from 10 patients subjected to disc surgery without previous chemonucleolysis was studied in the same way. The control discs revealed the characteristic signs of degeneration: alteration of the collagen, microcystic areas, and giant chondromas. Changes following chemonucleolysis were restricted exclusively to the ground substance and characterized by a marked loss of basophilia in the cartilage matrix. There was no involvement of the anulus fibrosus, cartilage plate, or bone. Following chymopapain administration, scanning electron microscopy showed a naked collagen network devoid of ground substance.

A 9- to 12-year follow-up review was conducted in 105 of 124 patients who were treated with chymopapain chemonucleolysis for herniated lumbar disc. The data were obtained from responses to a questionnaire. Seventy-nine patients (75.2%) reported marked improvement, six (5.7%) had slight improvement, and 20 (19.0%) had no improvement. Of the 87 patients not receiving workman's compensation, 70 patients (80.5%) had marked improvement; four (4.6%) had slight improvement; and 13 (14.9%) had no improvement. Of the 18 compensation cases, nine patients (50.0%) had marked improvement; two patients (11.1%) had slight improvement; and seven patients (38.9%) had no improvement. These results are comparable to those reported for surgical discectomy, and confirm that chymopapain chemonucleolysis is an alternative to surgery.

Chymopapain chemonucleolysis was performed on 100 patients with primary lumbar intervertebral disc disease. The results were compared with those of 174 patients who underwent laminotomy, foraminotomy, and discectomy. Primary lumbar intervertebral disc disease was arbitrarily divided into degenerative, complex, previous surgical, and simple disc syndromes. No difference was seen between chemonucleolysis and surgery in the first three divisions; between 55 percent and 60 per cent of patients responded successfully to treatment. In the simple disc division 89 per cent of the surgical and 60 per cent of the chemonucleolysis patients had successful results.

The author presents an evaluation of 72 patients given intradiscal chymopapain as the treatment for symptoms related to ruptured intervertebral disc. The rationale, criteria for patient selection, risks, and results are described. The author believes thatt this early follow-up suggests tha chymopapain may have a place in the treatment of symptomatic disc protrusions and extrusions.