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E J Nordby

Publications and source records attributed to E J Nordby.

At least 19 recordsLinked to original sources
PubMed2001

Chemonucleolysis: the state of the art.

This review presents the history of chemonucleolysis, the techniques, indications, contraindications, and complications. Presenting an historical overview and comparison of success rates with surgical discectomy may provide a fresh understanding of the controversy surrounding chemonucleolysis and establish its efficacy in relation to more invasive treatments. A review of the literature from 1973 through 1998 for chemonucleolysis, open discectomy, and microdiscectomy provided published success rates for these procedures, and a mean rate with standard deviation was determined. In the experience and opinion of the authors, chemonucleolysis remains a viable alternative for patients who have exhausted all conservative means of treatment. Proper patient selection leads to success rates comparable to open discectomy and microdiscectomy.

Chymopapain↗
PubMed2000

Continuing experience with chemonucleolysis.

Chemonucleolysis using chymopapain is the least invasive technique used to treat a herniated lumbar pulposus. After 37 years of clinical experience, multiple clinical trials, a national multicenter, double-blind study mandated by the Food and Drug Administration, and heated controversy in the scientific community, the injection of chymopapain to treat herniated discs has (in appropriately selected patients) proven as successful as laminectomy, with fewer complications and the advantage of considerable cost savings.

Chymopapain↗
PubMed1996

Chemonucleolysis.

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.

Adult↗
PubMed1996

Lumbar chymopapain nucleolysis.

Chemonucleolysis with chymopapain is indicated in the majority of patients who are candidates for surgery for intractable sciatica due to herniated nucleus pulposus. It is safer, as effective, and cheaper than standard surgical discectomy, providing that patients are well selected and the procedure is properly performed. Because the indication for chemonucleolysis is not limited to contained discs, it has proved to be more effective than percutaneous discectomy. At present, of all percutaneous methods, lumbar chymopapain nucleolysis is the only procedure that has withstood the test of time. It is an attractive alternative to surgical discectomy and should be presented for consideration to patients who meet the criteria for the procedure.

Chymopapain↗
PubMed1994

Efficacy of chymopapain in chemonucleolysis. A review.

STUDY DESIGN: This study was designed to determine the current experience in the use of chymopapain injection in the treatment of herniated intervertebral discs by analyzing reports appearing between 1985 and 1993. Forty-five clinical studies included 7,335 patients treated worldwide, some including comparisons to open laminectomy/discectomy and others to percutaneous discectomy. OBJECTIVES: Because controversy persists after 30 years of clinical use of chymopapain, the results of current experience should establish the efficacy for those who want to consider chemonucleolysis as a treatment for a herniated nucleus pulposus. SUMMARY OF BACKGROUND DATA: There is the suggestion that use of other than conservative treatment is made only to achieve a better result in the short term. The selection of type of treatment will depend on contraindications, with failures of chemonucleolysis found largely in those having spinal stenosis or sequestrated discs. Worker compensation patients respond less successfully than those with better motivation. METHODS: The 45 studies were analyzed for determination of successful outcome and divided into 16 with more than 100 patients, 13 with less than 100 patients and 16 with comparison to other treatments. RESULTS: Individual success rates exceeded 60% whereas cohort total averaged 76%. In studies comparing chemonucleolysis with open discectomy, success rate averaged 76.2% as compared with 88% for open surgery. In two other studies, percutaneous discectomy was less successful than chemonucleolysis. Where included, duration of hospitalization showed less time and thus less costs for chemonucleolysis. Return to work complications showed time off slightly less for chemonucleolysis than for laminectomy. CONCLUSIONS: Chemonucleolysis, though somewhat less effective than open discectomy, can be successfully and safely used in about four of five carefully selected patients without the trauma, risks, and subsequent fibrosis associated with lumbar disc surgery.

Chymopapain↗
PubMed1993

Safety of chemonucleolysis. Adverse effects reported in the United States, 1982-1991.

This survey covers 121 "serious" and "unexpected" adverse events after treatment with chymodiactin (chymopapain for injection) among approximately 135,000 patients in the United States. They were reported to the Food and Drug Administration (FDA) within 15 days of notification of the manufacturer between 1982 and the end of 1991. They included fatal anaphylaxis (seven cases), infections (24 cases), hemorrhage (32 cases), and neurologic (32 cases) and miscellaneous (15 cases) events, with a mortality rate of 0.019%. Anaphylactic reactions reported in a postmarketing survey can be attributed to chymopapain itself and infections to lack of asepsis during its administration. The causes of other adverse reactions cannot be as clearly defined, but many are unlikely to have been due to chymopapain or its administration. More careful selection of patients and closer attention to technique during chemonucleolysis have dramatically reduced the incidence of these adverse events, which occur far less frequently than after diskectomy.

Adult↗
PubMed1987

Disability evaluation of the neck and back. The McBride system.

To properly evaluate residual permanent disability arising from impairment of the spine, it is essential to conduct a careful and complete examination in order to arrive at a diagnosis and a determination that present findings are unlikely to change. A formula for computation of permanent disability as developed by McBride includes functional deficiency and physical disorders, taking into account 12 variables. This formula can be simplified to seven components if the physical disorders are mentally computed into the factors of quickness of action, coordination, strength, security, endurance, safety, and adverse employability, which are given weighted values. This method can provide a valid determination of percentage of disability. Some situations only require a delineation of the impairment present and defer disability determination to an agency or board. Currently, there is a trend toward equating the amount of disability with the loss of earnings, which is quite contrary to the longstanding, traditional view.

Activities of Daily Living↗
PubMed1986

Eight- to 13-year follow-up evaluation of chemonucleolysis patients.

739 patients treated eight to 13 years previously with chymopapain injection are evaluated by questionnaire. The results were 76% satisfactory and 24% unsatisfactory. When those with prior surgery, midline discs, and spondylolisthesis were eliminated, there is a satisfactory result in 82% with 60% excellent, reinforcing the importance of patient selection for the procedure. Thirty-one percent of patients had preoperative myelograms, and all had discograms and were done under general anesthesia with the single needle technique. Of the excellent and good results, 50% had a two-level injection, while one-level injections produced only 23% and 20%, respectively. Results in midline discs are comparable to lateral displacement and the 13 patients with spondylolisthesis had 85% satisfactory outcome. In ten patients younger than 19 years of age, only one was a failure. Sixteen percent of patients had prior surgery and they reported a successful outcome of injection in 55%. Of the 179 unsatisfactory results in the series, subsequent treatment reduced the rate of failed end results to 14%. The study verifies the persistence of early satisfactory results and shows no late complications such as symptomatic iatrogenic spinal stenosis.

Adolescent↗
PubMed1986

Four brief reports on long-term results of intradiscal chymopapain.

Five- to 12-year statistics for 842 patients treated with intradiscal chymopapain are presented by four observers. While the results are presented in different formats, long-term satisfactory results can be reported for 81% of the patients, with a range of 71%-83%.

Chymopapain↗
PubMed1985

Decreased incidence and mortality of anaphylaxis to chymopapain.

A recognized side effect of chemonucleolysis is life-threatening anaphylaxis to chymopapain. In the clinical trials of chymopapain, 13 cases of anaphylaxis were reported in 1585 administrations (0.82%). Two patients died. Data from a postmarketing survey (48,239 questionnaires) were reviewed to identify factors influencing the incidence and severity of anaphylaxis. The results indicate the incidence of anaphylaxis decreased to 0.44% in the 1983-1984 period (126/23,736), a level significantly (P less than or equal to 0.001) below the incidence of 0.82% observed in initial clinical trials. Only three deaths from complications related to anaphylaxis occurred in approximately 75,000 administrations (producing 252 anaphylactic episodes) reported since December 1982. The prophylactic use of antihistamines and pretreatment with intravenous fluids coincide with the dramatic reduction in mortality due to anaphylaxis. However, overdiagnosis of anaphylaxis in the clinical trials and avoidance of chemonucleolysis in patients with IgE antibodies to chymopapain may account, in part, for the reduction in incidence.

Adult↗
PubMed1985

A comparison of discectomy and chemonucleolysis.

When comparing two treatment modalities in the care of a herniated nucleus pulposus causing unremitting sciatica, it is difficult to be certain of complete accuracy, despite attentive evaluation. Eight series of patients are presented which compare the effectiveness of discectomy versus chemonucleolysis. Overall evaluation concludes that a similar success rate is obtained as an end result with proper patient selection, technically acceptable treatment, and intelligent follow-up study. Assured potency of the chymopapain is an added consideration in chemonucleolysis. There is evidence of significant decrease in hospitalization time and morbidity in the good result with chymopapain injection. The major advantage of a successful result in the use of chymopapain over discectomy is the absence of postoperative fibrosis, a compelling reason for the consideration of the enzyme in the treatment of a herniated nucleus pulposus where conservative measures have failed.

Chymopapain↗
PubMed1983

Safety and efficacy of chymopapain (Chymodiactin) in herniated nucleus pulposus with sciatica. Results of a randomized, double-blind study.

A double-blind, randomized trial was conducted to compare the efficacy of intradiskal injection of chymopapain (Chymodiactin) with injection of placebo in patients with a herniated lumbar disk. Patients were randomly assigned to either placebo or drug regimens and followed up for six months. The primary measure of performance was agreement by patient and surgeon that further intervention was not necessary. At any time that patient and investigator agreed that treatment had failed, the patient was classified as a failure and the treatment code was broken. Of 53 placebo-treated patients, 31 failed by this criterion. Of 55 drug-treated patients, 15 failed. Placebo-treated patients who failed were allowed to receive drug treatment, and 29 (91%) of 32 were treated successfully. This study demonstrates that chymopapain is more effective than placebo for treatment of patients with a herniated lumbar disk.

Adult↗