A RANDOMIZED, DOUBLE-BLIND-STUDY TO COMPARE LOW-DOSE WITH STANDARD-DOSE CHYMOPAPAIN IN THE TREATMENT OF HERNIATED LUMBAR INTERVERTEBRAL DISKS

被引:26
作者
BENOIST, M
BONNEVILLE, JF
LASSALE, B
RUNGE, M
GILLARD, C
VAZQUEZSUAREZ, J
DEBURGE, A
机构
[1] Department of Orthopaedic Surgery, Hôpital Jean Minjoz, Besancon Cedex
[2] Section of Rheumatology, Hôpital Beaujon, Clichy
[3] Department of Radiology, Hôpital Jean Minjoz, Besancon Cedex
关键词
CHEMONUCLEOLYSIS; CHYMOPAPAIN; INTERVERTEBRAL DISK; SCIATICA;
D O I
10.1097/00007632-199301000-00006
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Postoperative low-back pain and spasm are the main drawbacks of chymopapain chemonucleolysis. To investigate if low-dose chymopapain could reduce this adverse reaction, without modifying the efficacy, 118 patients with persistent low-back and radicular pain due to a lumbar disc herniation underwent chemonucleolysis. 60 patients were randomly selected to receive 2 mL of standard-dose chymopapain (4,000 units) and 58 to receive 2 mL of low dose (2,000 units). The clinical outcome was assessed on study days 1, 30, and 60, and after 1 year by physicians who were unaware of the treatment, and on the basis of the patients' self evaluation. At day 60, Chemonucleolysis was rated as successful in 81% of the cases by the investigator and in 80% by the patient's self assessment. The percentage of good results was remarkably similar in the two treatment groups and this finding was confirmed after 1 year. There was some evidence that the low-dose treatment resulted in less frequent postoperative back pain but the difference was not statistically significant. Moreover, a comparable incidence of acute low-back pain and spasm was observed in the two treatment groups. Low-dose chemonucleolysis appears to be as effective as the standard dose, but the use of 2,000 units does not significantly lower the postoperative back pain.
引用
收藏
页码:28 / 34
页数:7
相关论文
共 27 条
[1]  
Agre K., Wilson R.R., Brim M., McDermott D.J., Chymodiactin postmarketing surveillance: Demographic and adverse experience data in 29, 075 patients, Spine, 9, pp. 479-485, (1984)
[2]  
Benoist M., Bouillet R., Mulholland R., Résultats d’une enquête européenne, Acta Orthop Belg, 49, pp. 34-48, (1983)
[3]  
Bonneville J.F., Low Dose Chymopapain (2, 000) Lumbar Chemonucleolysis: Our Experience with 100 Consecutive Patients, (1989)
[4]  
Boots Pharmaceuticals, Nottingham, England: Chymopapain R (Chymopapain for Injection)
[5]  
Bouillet R., Complications de la nucléolyse discale par la chymopapaine, Acta Orthop Belg, 53, pp. 250-261, (1987)
[6]  
Buttle D.J., Abrahamson M., Barret A.J., The biochemistry of the action of chymopapain in the relief of sciatica, Spine, 11, pp. 688-694, (1986)
[7]  
Carter H., Cormier S., Et al., La Lombalgie post-nucléolyse, Influence Du Lever précoce. La Hernie Discale Lombaire, pp. 216-221, (1990)
[8]  
Dando P.M., Morton D.B., Buttle D.J., Barret A.J., Quantitative assessment of human proteinases as agents for chemonucleolysis, Spine, 13, pp. 188-192, (1988)
[9]  
Darakjan H.E., Low dose chymopapain as a safe alternative to laminectomy, Presented at the Third Annual Meeting of the International Intradiscal Therapy Society, (1990)
[10]  
Diabezies E.F., Langford K., Morris J., Shields C.B., Wilkinson H.A., Safety and efficacy of chymopapain in the treatment of sciatica due to a herniated nucleus pulposus. Results of a randomised double blind study, Spine, 13, pp. 561-565, (1988)