Six versus 12 Months of Anti Tubercular Therapy in Patients With Biopsy Proven Spinal Tuberculosis: A Single Center, Open Labeled, Prospective Randomized Clinical Trial-A Pilot study.
Journal
Spine
ISSN: 1528-1159
Titre abrégé: Spine (Phila Pa 1976)
Pays: United States
ID NLM: 7610646
Informations de publication
Date de publication:
01 Jan 2019
01 Jan 2019
Historique:
pubmed:
26
7
2018
medline:
14
6
2019
entrez:
26
7
2018
Statut:
ppublish
Résumé
A single center pilot study, open labeled, prospective randomized clinical trial. To compare six versus 12 months of anti TB therapy in patients with biopsy proven spinal TB. There is no clear consensus or evidence based guidelines for the duration of treatment of spinal tuberculosis. We studied if 6 and 12 months of anti tubercular therapy (ATT) had equivalent outcomes at 24 months from completion of therapy. A prospective randomized open labeled clinical trial of 6 versus 12 months ATT in patients with biopsy proven spinal-vertebral tuberculosis. The primary end point was absence of recurrence 24 months after completing therapy. Secondary end points were clinical cure at the end of therapy, significant adverse effect of ATT, need for delayed surgery, and residual neurological dysfunction. Hundred patients, randomized to 6 or 12 months ATT, were followed up for a minimum of 24 months from completion of therapy. All patients completed scheduled duration of ATT, with one crossover from 6 months ATT group to 12 months. There were no recurrences of disease on the 24 months follow up following completion of ATT. All 100 patients met criteria for cure at time of stopping medicines. One patient (12 months group) had residual neurological dysfunction at the time of stopping treatment, which completely resolved over the next 12 months.There were no patients with major drug induced hepatitis. One patient (12 months group) needed percutaneous drainage of an abscess. None needed surgical re-exploration for persistent infection of implant removal. This pilot study concludes that, in patients with biopsy proven spinal-vertebral, TB, 6 and 12 months of ATT give similar clinical outcomes at 24 months of completion of therapy. 2.
Sections du résumé
STUDY DESIGN
METHODS
A single center pilot study, open labeled, prospective randomized clinical trial.
OBJECTIVE
OBJECTIVE
To compare six versus 12 months of anti TB therapy in patients with biopsy proven spinal TB.
SUMMARY OF BACKGROUND DATA
BACKGROUND
There is no clear consensus or evidence based guidelines for the duration of treatment of spinal tuberculosis. We studied if 6 and 12 months of anti tubercular therapy (ATT) had equivalent outcomes at 24 months from completion of therapy.
METHODS
METHODS
A prospective randomized open labeled clinical trial of 6 versus 12 months ATT in patients with biopsy proven spinal-vertebral tuberculosis. The primary end point was absence of recurrence 24 months after completing therapy. Secondary end points were clinical cure at the end of therapy, significant adverse effect of ATT, need for delayed surgery, and residual neurological dysfunction.
RESULTS
RESULTS
Hundred patients, randomized to 6 or 12 months ATT, were followed up for a minimum of 24 months from completion of therapy. All patients completed scheduled duration of ATT, with one crossover from 6 months ATT group to 12 months. There were no recurrences of disease on the 24 months follow up following completion of ATT. All 100 patients met criteria for cure at time of stopping medicines. One patient (12 months group) had residual neurological dysfunction at the time of stopping treatment, which completely resolved over the next 12 months.There were no patients with major drug induced hepatitis. One patient (12 months group) needed percutaneous drainage of an abscess. None needed surgical re-exploration for persistent infection of implant removal.
CONCLUSION
CONCLUSIONS
This pilot study concludes that, in patients with biopsy proven spinal-vertebral, TB, 6 and 12 months of ATT give similar clinical outcomes at 24 months of completion of therapy.
LEVEL OF EVIDENCE
METHODS
2.
Identifiants
pubmed: 30045346
doi: 10.1097/BRS.0000000000002811
pii: 00007632-201901010-00004
doi:
Substances chimiques
Antitubercular Agents
0
Types de publication
Comparative Study
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
E1-E6Références
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