KMID : 0388720120190020038
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Journal of Korean Society of Spine Surgery 2012 Volume.19 No. 2 p.38 ~ p.46
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Comparison The Safety and The Efficacy between the Group of using Pelubiprofen Tab. and the Group of using Aceclofenac Tab. on Back Pain Patients - Multi Institution, Double Blind, Random Sample -
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Shin Byung-Joon
Kim Tae-Kyun Baik Jong-Seok Shim Dae-Moo
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Abstract
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Study Design: Multi institution, double blind, random sample.
Objectives: We conducted a comparative study with Aceclofenac Tab, which is widely used in the clinical field in order to observe the Pelubiprofen Tab¡¯s clinical efficiency in patients with back pain.
Summary of Literature Review: Among the numerous literatures regarding the chronic back pain, there is are few studies with Pelubiprofen Tab¡¯s clinical efficiency.
Materials and Methods: We computed an experimental model through a case control study, practiced from January, 2010 to January, 2011, and thereby, 298 back pain patients were selected. This study was conducted through a multi institution, double blind, and random sample. We compared the experimental and control groups¡¯ clinical efficiency that was estimated by VAS after 28 days of medication. Also, we compared the treatment efficiency of both drugs by using a variation of Oswestry Disability Index (ODI) and Physician¡¯s Global assessment, with a total usage of relief medicine. Also, the side effect and clinical pathologic result were tested. Statistical analysis was done with three different methods, Safety method, ITT (Intent-To-Treat), and PP (Per Protocol). Logistic regression model was used, and this result was compared by a Chi-square or Fisher¡¯s Exact test.
Results: Comparing the VAS of both groups, VAS decreased with statistical significance. Both groups didn¡¯t show a significant difference in VAS (p=0.6764). As the decrement of the total dosage of relief medicine, the decrease in the control group was rather higher, but the difference didn¡¯t show any statistical significance (p=0.9955). The experimental group was not inferior than that of the control group in ODI and PGA variation. Analyzing the side effect, both groups didn¡¯t show any significant difference (p=0.9843).
Conclusions: As a result of the clinical trial, Pelubiprofen Tab. applied to back pain patients was not inferior to that of aceclofenac Tab., in terms of efficiency, and didn¡¯t show any significant difference in safety.
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KEYWORD
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Pelubiprofen tab., Aceclofenac tab., Random sampling, Double blind
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