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Query: EC:3.4.22.6 (
chymopapain
)
407
document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)
In a follow-up study of a large group of patients who had been treated by chemonucleolysis, of those patients who had definite neurologic change in the form of reflex, sensory, or motor disturbance, 74 per cent had reverted to normalcy by the time of evaluation one year after injection. The most significant complication (
anaphylaxis
) was found in 1 per cent of our first 500 patients, but after we started using preoperative steroids along with other safeguards, we were able to control this complication. It is still something to be constantly on guard against. A mildly extruded nucleus pulposus is not a contraindication in chemonucleolysis. A sequestered one is. (table; see text) Patients who have had previous low back surgery have a lower percentage of satisfactory results than those who have not had previous surgery. Chemonucleolysis does not prejudice the chances of a good clinical result if a subsequent open surgical procedure is necessary. Preoperative psychological testing is a very effective predictor of end results in relation to pain relief from chemonucleolysis. Studies in our laboratory again confirm beyond a doubt that, in the dog, injection of very large amount of
chymopapain
in the epidural space of the lumbar spine has no effect on the subarachnoid contents, the dura, or the spinal nerves as they lie outside the dura and exit through the intervertebral foramina. The rare patient in whom there is a direct communication between the disc space and the subarachnoid space can be detected as the contrast medium is injected. If, by chance,
chymopapain
were inadvertently injected intrathecally, the maximum dose of that would be injected at any one level, 8 mg, would be well within the tolerable range in the human being.
...
PMID:Chemonucleolysis in the treatment of lumbar disc disease. 634 6
During the twelve-year period from January 1, 1970, through December 31, 1981, 4,282 patients with the diagnosis of herniated nucleus pulposus were treated by intradiscal injection of
chymopapain
under local anesthesia. Fifteen (0.35 per cent) of these patients sustained an anaphylactic reaction as defined by us. Twelve patients had subjective early warning signs before their blood pressure decreased, including a total-body burning or tingling sensation (five patients), a general feeling of ill health (four patients), and diffuse pruritus (three patients). Profound hypotension without subjective warning symptoms was the first indication of
anaphylaxis
in three patients. In all patients, hypotension requiring vigorous treatment was the life-threatening clinical manifestation of
anaphylaxis
, but respiratory distress severe enough to require endotracheal intubation did not occur. There were no deaths or known sequelae. Ten of the fifteen patients were women. Review of the medical histories of the fifteen patients and follow-up telephone interviews did not identify any other pre-disposing factor for the
anaphylaxis
. Twelve of the fifteen patients obtained complete relief of the symptoms of disc herniation. The advantage of the use of local rather than general anesthesia for
chymopapain
injection is that the patient remains responsive and can give an early warning of the subjective symptoms of
anaphylaxis
if they appear. This potential for early diagnosis allows early and aggressive treatment with intravenous fluids, epinephrine, steroids, and antihistamines, which can be effective in preventing death or permanent sequelae. In our experience, general anesthesia and routine endotracheal intubation are not necessary for intradiscal injection of
chymopapain
.
...
PMID:Anaphylactic reactions following the intradiscal injection of chymopapain under local anesthesia. 636 Oct 34
Chymopapain has been approved for intradiscal injection in the United States and is expected to be used in approximately 100,000 patients per year. The need to identify the population at risk for
anaphylaxis
is obvious. Both in vivo and in vitro methods are available for measurement of IgE against
chymopapain
. This is a report of two cases of
chymopapain
allergy. One case discusses a 25-year-old woman who had rhinitis, asthma, and urticaria associated with occupational health hazards who was rejected for chemonucleolysis. The other case describes a 59-year-old man who had a predictably severe anaphylactic reaction to
chymopapain
and responded to treatment with epinephrine. Both patients had IgE antibody against
chymopapain
.
...
PMID:Chymopapain allergy: case reports and identification of patients at risk for chymopapain anaphylaxis. 638 Aug 59
We studied clinical and immunologic aspects of the reactions to two newly introduced drugs,
chymopapain
and human recombinant deoxyribonucleic acid insulin (HI), in patients demonstrating allergies to one of these two drugs. We then used this information to improve our ability to diagnose and prevent
chymopapain
allergy and to further our understanding of systemic insulin allergy and its management. Of the patients who were sensitive to
chymopapain
, one had severe
anaphylaxis
to intradisc injection while the other had rhinitis, asthma, and urticaria with occupational exposure. The latter demonstrated cutaneous reactivity to papain; the former refused skin testing. Both demonstrated immunoglobulin (Ig) E and IgG to
chymopapain
as measured by enzyme-linked immunosorbent assay. We have prospectively skin tested 61 patients with
chymopapain
. Sixty-one patients have had negative skin tests and have tolerated the intradisc injection of
chymopapain
without incident. We are continuing our prospective skin test study in order to identify a population at risk for allergy to
chymopapain
. Two patients with systemic allergic reactions to animal insulin have at least as much cutaneous reactivity and IgE and IgG antibodies to HI as to porcine insulin. A large local reaction occurred during an attempt to desensitize one of them to HI; the patient was subsequently desensitized without difficulty to porcine insulin, to which she was less skin reactive. We conclude that HI will not eliminate insulin allergy in patients with systemic allergy to animal insulin and that such patients will continue to require the usual therapeutic measures for insulin allergy.
...
PMID:Proteins: chymopapain and insulin. 638 38
Postmarketing surveillance data on 29,075 patients who received Chymodiactin (Smith Laboratories' formulation of
chymopapain
) intradiscal injections for a herniated lumbar intervertebral disc are summarized and tabulated. The serious adverse reactions reported include death,
anaphylaxis
, paraplegia, and discitis. Similar problems also have been reported for Discase (Baxter-Travenol's formulation of
chymopapain
). Of 11 deaths reported following Chymodiactin administration, only 3 appear to be related to the drug or procedure. Two of these three were due to
anaphylaxis
and the third to bacterial discitis with resultant meningitis. Paraplegia appeared to be primarily due to needle trauma or injection of contrast agent and enzyme into the subarachnoid space. Careful patient selection and needle placement are essential for avoiding serious problems.
...
PMID:Chymodiactin postmarketing surveillance. Demographic and adverse experience data in 29,075 patients. 638 53
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.
...
PMID:Safety of chemonucleolysis. Adverse effects reported in the United States, 1982-1991. 833 72
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.
...
PMID:Chemonucleolysis. 872 99
This study was undertaken to evaluate an assay to assess the risk for drug-induced immediate hypersensitivity reactions. Groups of five to 10 guinea-pigs were given six ip injections of the test compound on days 1, 3, 5, 8, 10 and 12. Aluminium hydroxide was also given in the first injection. At day 33, the animals were given an iv injection of the test compound and the response was recorded by grading the severity of clinical symptoms. Cutaneous passive
anaphylaxis
was also evaluated in six naive guinea pigs using Evans blue and sera collected from treated animals on day 26. A panel of six positive model compounds (ovalbumin, aprotinin,
chymopapain
, tetracosactide, cyanocobalamin and procaine), and the negative compound Ribomunyl were tested. Positive systemic and/or cutaneous anaphylactic responses were observed with ovalbumin, aprotinin,
chymopapain
and tetracosactide whereas no responses were noted with cyanocobalamin, procaine and Ribomunyl. Our results suggest that this protocol can help differentiate positive model compounds (known to induce reactions in man) from negative model compounds, provided that their molecular weight is large enough, but that it is not applicable to substances of low molecular weight.
...
PMID:Prediction of drug-induced immediate hypersensitivity in guinea pigs. 2069 69
Anaphylaxis occurs in approximately 1% of the patients treated with
chymopapain
. The incidence of
anaphylaxis
is ten times higher in women than in men. The severity of the reaction may be attenuated by pretreatment with H1- and H2-histamine receptor antagonist. Once
anaphylaxis
occurs, prompt and correct treatment must be instituted.
...
PMID:Anaphylaxis secondary to chymopapain. 2482 62
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