Journal of Korean medical science
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J. Korean Med. Sci. · Jan 2014
Multicenter Study Clinical Trial Observational StudySuccess rate and risk factors for failure of empirical antifungal therapy with itraconazole in patients with hematological malignancies: a multicenter, prospective, open-label, observational study in Korea.
We assessed the success rate of empirical antifungal therapy with itraconazole and evaluated risk factors for predicting the failure of empirical antifungal therapy. A multicenter, prospective, observational study was performed in patients with hematological malignancies who had neutropenic fever and received empirical antifungal therapy with itraconazole at 22 centers. ⋯ Eight patients (2.0%) had premature discontinuation of itraconazole therapy due to toxicity. It is suggested that positive galactomannan tests and abnormal findings on the chest imaging tests at the time of initiation of the empirical antifungal therapy are risk factors for predicting the failure of the empirical antifungal therapy with itraconazole. (Clinical Trial Registration on National Cancer Institute website, NCT01060462).
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J. Korean Med. Sci. · Jan 2014
Randomized Controlled Trial Multicenter StudyA randomized, open-label, multicenter trial for the safety and efficacy of adult mesenchymal stem cells after acute myocardial infarction.
Recent studies suggest that the intracoronary administration of bone marrow (BM)-derived mesenchymal stem cells (MSCs) may improve left ventricular function in patients with acute myocardial infarction (AMI). However, there is still argumentative for the safety and efficacy of MSCs in the AMI setting. We thus performed a randomized pilot study to investigate the safety and efficacy of MSCs in patients with AMI. ⋯ There was no treatment-related toxicity during intracoronary administration of MSCs. No significant adverse cardiovascular events occurred during follow-up. In conclusion, the intracoronary infusion of human BM-derived MSCs at 1 month is tolerable and safe with modest improvement in LVEF at 6-month follow-up by SPECT. (ClinicalTrials.gov registration number: NCT01392105).
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J. Korean Med. Sci. · Jan 2014
Randomized Controlled Trial Comparative Study Clinical TrialComparison of acarbose and voglibose in diabetes patients who are inadequately controlled with basal insulin treatment: randomized, parallel, open-label, active-controlled study.
We studied the efficacy and safety of acarbose in comparison with voglibose in type 2 diabetes patients whose blood glucose levels were inadequately controlled with basal insulin alone or in combination with metformin (or a sulfonylurea). This study was a 24-week prospective, open-label, randomized, active-controlled multi-center study. Participants were randomized to receive either acarbose (n=59, 300 mg/day) or voglibose (n=62, 0.9 mg/day). ⋯ The mean fasting plasma glucose level and self-monitoring of blood glucose data from 1 hr before and after each meal were significantly decreased at week 24 in comparison to baseline in both groups. The levels 1 hr after dinner at week 24 were significantly decreased in the acarbose group (from 233.54 ± 69.38 to 176.80 ± 46.63 mg/dL) compared with the voglibose group (from 224.18 ± 70.07 to 193.01 ± 55.39 mg/dL). In conclusion, both acarbose and voglibose are efficacious and safe in patients with type 2 diabetes who are inadequately controlled with basal insulin. (ClinicalTrials.gov number, NCT00970528).
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J. Korean Med. Sci. · Jan 2014
Randomized Controlled Trial Comparative StudyA randomized controlled trial of comparison on time and rate of cecal and termianl Ileal intubation according to adult-colonoscope length: intermediate versus long.
For a complete colonoscopic examination, a high intubation rate and a short intubation time have been demanded to colonoscopists, if possible. The aim of the present study was to compare these examination parameters, intubation time and rate, according to the length of colonoscope. A total of 507 healthy Korean subjects were randomly assigned into two groups: intermediate length adult-colonoscope (n=254) and long length adult-colonoscope (n=253). ⋯ There were no significant differences in other colonoscopic parameters between the two groups. The intermediate length adult-colonoscope decreased the time to reach the cecum, whereas the long-scope showed a success rate of terminal ileal intubation. These findings suggest that it is reasonable to prepare and use these two types of colonoscope appropriate to the needs of the patient and examination, instead of employing only one type of colonoscope.
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J. Korean Med. Sci. · Jan 2014
Multicenter StudyCorrection of anemia with continuous erythropoietin receptor activator in Korean patients on long-term hemodialysis.
Continuous erythropoietin receptor activator (CERA) is an erythropoietin with a long-half life. This study investigated the efficacy of CERA for correcting anemia in Korean patients on dialysis. Patients (≥ 18 yr) who were not receiving any ESAs for more than 8 weeks were randomly assigned to either intravenous CERA once every 2 weeks (n=39) or epoetin beta thrice-weekly (n=41) during a 24-week correction phase. ⋯ Median time to response was 12 weeks in CERA and 10.3 weeks in epoetin beta (P=0.03). It is suggested that once every 2 weeks administration of CERA is effective for correcting anemia in Korean patients on long-term hemodialysis with longer time-to-response than thrice weekly epoetin beta. (ClinicalTrials.gov registry No. NCT00546481).