Prospective Randomized Control Trial to Compare the Role of Injection Cerebrolysin for 10 Days Duration Against Placebo in Operated Cases of Degenerative Cervical Myelopathy.
Journal
Spine
ISSN: 1528-1159
Titre abrégé: Spine (Phila Pa 1976)
Pays: United States
ID NLM: 7610646
Informations de publication
Date de publication:
01 Mar 2023
01 Mar 2023
Historique:
received:
13
07
2022
accepted:
08
11
2022
pubmed:
3
2
2023
medline:
10
2
2023
entrez:
2
2
2023
Statut:
ppublish
Résumé
Prospective randomized control trial. To analyze outcomes following the injection of cerebrolysin in surgically treated patients with degenerative cervical myelopathy (DCM). Previous research has concluded that superior functional outcomes are achieved with the use of cerebrolysin in surgically treated patients of DCM for 21 days. Our study has been conducted to analyze the use of this drug for a shorter duration (10 days) and compare its clinical efficacy. Ninety operated cases of mild to severe DCM were randomized into two groups. Sixty patients received the injection Cerebrolysin for 10 days postoperatively. The remaining 30 patients received a placebo. Functional outcomes were measured using modified Japanese Orthopaedic Association (mJOA) scores and visual analogue scale (VAS). The American Spinal Injury Association (ASIA) scale was used to document neurological recovery. Hand function was assessed by measuring the grip strength and the upper limb function score the upper extremity motor mJOA plus upper extremity sensory mJOA score. Assessments were performed and preoperatively and postoperatively and at one-month, three-month, six-month, and one-year following surgery. Preoperative mJOA and VAS scores were comparable in both groups ( P >0.05). Both groups experienced an improvement in mJOA and VAS scores at all time-points during follow-up as compared with preoperative scores. However, the cerebrolysin group demonstrated significantly greater mJOA scores (16.37±1) when compared with the placebo (15.2±1.8) at one-year follow-up ( P <0.0001). Neurological improvement with cerebrolysin therapy was also superior ( P =0.04). No significant adverse reactions were documented. Injection cerebrolysin, when administered for 10 days postoperatively, can result in significantly greater neurological improvement and hand function in patients with DCM who also receive surgery.
Sections du résumé
STUDY DESIGN
METHODS
Prospective randomized control trial.
OBJECTIVE
OBJECTIVE
To analyze outcomes following the injection of cerebrolysin in surgically treated patients with degenerative cervical myelopathy (DCM).
SUMMARY OF BACKGROUND DATA
BACKGROUND
Previous research has concluded that superior functional outcomes are achieved with the use of cerebrolysin in surgically treated patients of DCM for 21 days. Our study has been conducted to analyze the use of this drug for a shorter duration (10 days) and compare its clinical efficacy.
METHODS
METHODS
Ninety operated cases of mild to severe DCM were randomized into two groups. Sixty patients received the injection Cerebrolysin for 10 days postoperatively. The remaining 30 patients received a placebo. Functional outcomes were measured using modified Japanese Orthopaedic Association (mJOA) scores and visual analogue scale (VAS). The American Spinal Injury Association (ASIA) scale was used to document neurological recovery. Hand function was assessed by measuring the grip strength and the upper limb function score the upper extremity motor mJOA plus upper extremity sensory mJOA score. Assessments were performed and preoperatively and postoperatively and at one-month, three-month, six-month, and one-year following surgery.
RESULTS
RESULTS
Preoperative mJOA and VAS scores were comparable in both groups ( P >0.05). Both groups experienced an improvement in mJOA and VAS scores at all time-points during follow-up as compared with preoperative scores. However, the cerebrolysin group demonstrated significantly greater mJOA scores (16.37±1) when compared with the placebo (15.2±1.8) at one-year follow-up ( P <0.0001). Neurological improvement with cerebrolysin therapy was also superior ( P =0.04). No significant adverse reactions were documented.
CONCLUSION
CONCLUSIONS
Injection cerebrolysin, when administered for 10 days postoperatively, can result in significantly greater neurological improvement and hand function in patients with DCM who also receive surgery.
Identifiants
pubmed: 36730671
doi: 10.1097/BRS.0000000000004542
pii: 00007632-202303000-00001
doi:
Substances chimiques
cerebrolysin
37KZM6S21G
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
295-300Informations de copyright
Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
The authors report no conflicts of interest.
Références
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