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KMID : 0941820050150020094
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Korean Journal of Clinical Pharmacy
2005 Volume.15 No. 2 p.94 ~ p.99
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Post-Marketing Survellance Study of the Safety and Efficacy of Mesoglycan Prescribed in Primary and Secondary Care of Patients with Vascular Disease
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Kim Yoon-Hee
Jung Young-Hye
Lee Hwa-jeong
Gwak Hye-Sun
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Abstract
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The aim of this study was to evaluate the safety and efficacy of treatment of mesoglycan. This study was conducted between September 2003 and May 2004. A total of 292 patients with vascular disorders including cerebral infarction were enrolled. The patients were administered with 50-100mg of mesoglycan by an oral route everyday for eight weeks. Subjective physicians’ assessments of efficacy had ratings of "improvement", "invariability", "exacerbation" and "not being able to assess". An improvement was observed in 241 patients out of 274; 18 patients were rules out. The efficacy rate was influenced statistically significantly by the duration of therapy (p=0.0392) and daily mean drug dose (p<0.0001). The adverse events were reported in 8 patients (9 cases) out of 292 patients: skin/appendages disorders (0.7%), liver/biliary system disorders (0.7%), cardiovascular system disorders (0.7%), neurologic disorders (0.3%), respiratory disorders (0.3%) and gastrointestinal system disorders (0.3%). There showed no serious adverse events. These results indicate that mesoglycan was well tolerated and effective for the prevention of vascular disorders.
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KEYWORD
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Mesoglycan, Post-marketing sarveillance, efficacy rate, adverse events
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