• Journal of Acupuncture Research
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• 제29권5호
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• pp.97-108
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• 2012

Objectives : To demonstrate the importance of syndrome differentiation in clinical research of herb medication, through the comparative study on efficacy and safety of herb medication according to cold-heat tendency of OA knee patients. Methods : During December 2010 to July 2011, 138 knee OA patients were randomly assigned to WIN-34B 600mg(300mg, b.i.d.), 1,200mg(600mg, b.i.d.) and placebo b.i.d. for 8 weeks. Patient were re-classified into cold-heat tendency group according to cold-heat questionnaires. To investigate efficacy and safety, we assessed the 100mm pain VAS at baseline and 8 weeks later, and we monitored adverse event of patients during treatment period. Results : 1. Efficacy study : In WIN-34B 1,200mg group, VAS mean changes of heat tendency group showed slightly increase than those of cold tendency, but no significant difference within two groups. In heat tendency group, WIN-34B 1,200mg group showed a significant decrease of VAS compared to placebo group. but there were no significant difference in cold tendency group. 2. Safety study; In WIN-34B 600mg group, incidence of adverse events of cold tendency group was higher than those of heat tendency, but not in WIN-34B 1,200mg group. Conclusions : This study suggests that WIN-34B tend to have more efficacy in heat tendency-knee OA patients and WIN-34B is safe drug relatively, regardless of cold-heat tendency. In further clinical research on efficacy and safety of WIN-34B, stratification using syndrome differentiation is required.

• 한국임상약학회지
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• 제32권2호
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• pp.116-124
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• 2022

Background: High-alert medications (HAMs) are medications that bear a heightened risk of causing significant patient harm if used in error. To facilitate safe use of HAMs, identifying specific HAM lists for clinical setting is necessary. We aimed to develop the national level HAM list for acute care setting. Methods: We used three-step process. First, we compiled the pre-existing lists referring HAMs. Second, we analyzed medication related incidents reported from national patient safety incident report data and adverse events indicating medication errors from the Korea Adverse Event Reporting System (KAERS). We also surveyed the assistant staffs to support patient safety tasks and pharmacist in charge of medication safety in acute care hospital. From findings from analysis and survey results we created additional candidate list of HAMs. Third, we derived the final list for HAMs in acute care settings through expert panel surveys. Results: From pre-existing HAM list, preliminary list consisting of 42 medication class/ingredients was derived. Eight assistant staff to support patient safety tasks and 39 pharmacists in charge of medication safety responded to the survey. Additional 44 medication were listed from national patient safety incident report data, KAERS data and common medications involved in prescribing errors and dispensing errors from survey data. A list of mandatory and optional HAMs consisting of 10 and 6 medication classes, respectively, was developed by consensus of the expert group. Conclusion: We developed national level HAM list for Korean acute care setting from pre-existing lists, analyzing medication error data, survey and expert panel consensus.

• 생물정신의학
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• 제4권2호
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• pp.265-271
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• 1997

2,3-benzodiazepine계 항불안제인 tofisopam의 항불안 효과 및 안전성을 조사하기 위해 단일맹검 비교연구를 시행하였다. 외래로 내원한 불안 장애 환자 40명을 대상으로 무작위로 tofisopam군과 lorazepam군으로 할당하였으며, 최종 연구를 완결한 환자는 tofisopam군 17명(남자 7명, 여자 10명), lorazepam군은 15명(남자 6명, 여자 9명)이었다. 초기용량으로 tofisopam군은 50mg을 하루 3회 복용하고, lorazepam군은 0.75mg을 하루 2회 복용하도록 하였으며, 임상상태와 부작용에 따라 용량을 임의로 증감하도록 하였고, 일일 최대 용량은 tofisopam군 300mg, lorazepam군 3mg으로 하였다. 임상상태에 대한 평가는 Hamilton rating scale for anxiety(HAM-A)와 Clinical global impression(CGI)으로 하였으며, 약물 투여전과 투여 1주후, 2주후, 4주후에 측정되었다. 결과는 다음과 같다. 1) HAM-A 총점수의 경우, 약물 치료군과 시점을 변인으로 한 two-way repeated-measure ANOVA에서 양군간에 시점에 따른 유의한 차이는 없었다. HAM-A 심리적 불안과 신체적 불안아척도 점수에서 양군간 시점에 따른 유의한 차이는 없었다. 각 군에서 HAM-A 총점수의 시점에 따른 유의한 변화를 나타내었으며, 양군 모두 1주후부터 유의한 감소를 나타내었다. 2) CGI의 질병의 전반적인 심각도에서 약물 치료군과 시점을 변인으로 한 two-way repeated-measure ANOVA에서 양군간에 시점에 따른 유의한 차이는 없었다. 각 군에서 CGI 심각도의 시점에 따른 유의한 변화를 나타내었으며, tofisopam군은 1주후부터 lorazepam군은 4주후부터 유의한 감소를 나타내었다. CGI 호전도에선 각 시점에서"minimally improved"이상을 보인 환자군이 tofisopam군이 94.1%로서 lorazepam군 66.7% 보다 높았다. 3) 안전성 분석에서 각 군에서 생명징후, 혈액학, 생화학, 심전도, 체중에서 유의한 변화를 보이지 않았다. 4) 부작용 면에서 tofisopam군이 lorazepam군보다 각 시점에서 부작용을 호소한 환자수가 적었다. 이상에서 tofisopam은 lorazepam과 유사한 항불안효과를 보였으며, 내약성은 lorazepam에 비해 우수하였다.

• Journal of Gastric Cancer
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• 제17권2호
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• pp.120-131
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• 2017

Purpose: Tumor bleeding is a major complication in inoperable gastric cancer. The study aim was to investigate the effects of proton pump inhibitor (PPI) treatment for the prevention of gastric tumor bleeding. Materials and Methods: This study was a prospective double-blind, randomized, placebo-controlled trial. Patients with inoperable gastric cancer were randomly assigned to receive oral lansoprazole (30 mg) or placebo daily. The primary endpoint was the occurrence of tumor bleeding, and the secondary endpoints were transfusion requirement and overall survival (OS). Results: This study initially planned to enroll 394 patients, but prematurely ended due to low recruitment rate. Overall, 127 patients were included in the analyses: 64 in the lansoprazole group and 63 in the placebo group. During the median follow-up of 6.4 months, tumor bleeding rates were 7.8% and 9.5%, in the lansoprazole and placebo groups, respectively, with the cumulative bleeding incidence not statistically different between the groups (P=0.515, Gray's test). However, during the initial 4 months, 4 placebo-treated patients developed tumor bleeding, whereas there were no bleeding events in the lansoprazole-treated patients (P=0.041, Gray's test). There was no difference in the proportion of patients who required transfusion between the groups. The OS between the lansoprazole (11.7 months) and the placebo (11.0 months) groups was not statistically different (P=0.610). Study drug-related serious adverse event or bleeding-related death did not occur. Conclusions: Treating patients with inoperable gastric cancer with lansoprazole did not significantly reduce the incidence of tumor bleeding. However, further studies are needed to evaluate whether lansoprazole can prevent tumor bleeding during earlier phases of chemotherapy (ClinicalTrial.gov, identifier No. NCT02150447).

• 대한소아치과학회지
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• 제34권2호
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• pp.234-246
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• 2007

소아치과에서 진정요법은 chloral hydrate와 hydroxyzine을 함께 경구투여하는 방법이 가장 보편적이고, 진정의 심도가 술자가 원하는 정도에 미치지 못할 때에는 midazolam이나 $N_2O/O_2$를 병용투여하는 경우가 종종 있다. 본 연구는 chloral hydrate와 hydroxyzine을 이용한 진정요법의 효과와 안전성을 평가하고, 경구투여만으로 적절한 진정수준을 얻지 못하여 $N_2O/O_2$를 병용투여한 경우 $N_2O/O_2$의 치료시간과 부작용에 대한 영향 그리고, 진정요법 효과에 영향을 줄 수 있는 변수들(연령, 성별, 체중, patient compliance, waiting time 등)을 확인할 목적으로 시행하였다. 2004년 12월부터 2005년 9월까지 단국대학교 치과병원 소아치과에서 chloral hydrate와 hydroxyzine을 이용하여 진정요법하에 치료받은 평균연령 $30{\pm}8$개월(12-51개월), 체중 $13{\pm}2kg(9.5-18kg)$의 총 94명(남아-46명, 여아-48명)의 환아들을 대상으로 조사하였다. 진정요법의 효과, 체중, 연령, 병용투여 방법에 따라 군을 분류하여 성별, 연령, 체중, patient compliance, waiting time, 치료시간, 치료양(RBVU), 부작용 등을 평가하였다. 진정요법 성공률은 85%였다. 진정요법에 성공한 그룹이 실패한 그룹보다 $N_2O/O_2$로 수면을 유도하여 사용하는 경우가 많았고, 치료시간이 길었다. 36개월, 14kg미만인 환아는 경구투여만으로 수면에 이를 수 있었고, waiting time이 짧았다. 36개월 이상인 환아는 $N_2O/O_2$를 사용하여 수면을 유도하는 경우가 많았다. 연령과 $N_2O/O_2$ 사용시간, $N_2O/O_2$사용과 치료시간사이에는 상관관계가 존재한 반면, 체중과 $N_2O/O_2$사용시간사이에는 상관관계가 없었다. 치료시간 연장, $N_2O/O_2$사용여부와 부작용 발생간에서 는 통계학적으로 유의한 차이는 확인되지 않았다.

• Childhood Kidney Diseases
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• 제13권2호
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• pp.197-206
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• 2009

목적 : 소아에서 정맥용 철분 제제 투여에 대해서는 활용할 수 있는 연구 결과가 제한되어 있다. 이번 연구에서는 만성 투석 환아에게 정맥용 철분 수크로즈 제제를 투여함에 있어서 효과 및 결과 예측 인자, 안정성을 확인해 보고자 한다. 방법 : 혈청 페리틴 농도가 100 ng/mL 이하이거나 트랜스페린 포화도가 20% 이하인 21명의 만성 투석 환자가 선정되었다. 12명의 복막 투석 환자에게 철분 수크로즈를 체표면적당 200 mg의 용량으로 2주 간격으로 4회 투여하였고, 9명의 혈액 투석 환자에게 동일한 제제를 체중당 3 mg의 용량으로 일주일 간격으로 8회 투여하였다. 결과 : 치료 후 혈청 페리틴 농도는 양측 환자에서 유의한 상승을 보였고 복막 투석 환자에서는 트랜스페린 포화도가 유의한 상승을 보였다. 그러나 혈색소 수치는 양측 환자에서 모두 의미 있는 상승을 보이지는 않았다. 기저 혈색소 수치가 10 g/dL 이하이거나 기저 트랜스페린 포화도가 20% 이하인 환자는 정맥용 철분 제제 투여 후 의미있는 혈색소 상승을 보였다. 대조적으로 기저 혈색소 수치와 트랜스페린 포화도가 높았던 환자들은 치료 후 혈청 페리틴 수치의 상승을 보였다. 심각한 부작용은 없었으나 치료하는 과정에서 6명의 복막 투석 환자에서 50% 이상의 트랜스페린 포화도를 보였다. 결론 : 본 연구에서 혈액 투석 환아에서 일주일 간격으로 체중당 3 mg의 철분제제의 정맥 투여는 안전하게 사용될 수 있음을 확인할 수 있었던 반면, 복막 투석 환자에서 격주 간격으로 체표면적당 200 mg의 철분제제의 정맥 투여는 과도한 트랜스페린 포화도를 보일 수 있다.

• 동의신경정신과학회지
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• 제32권2호
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• pp.81-93
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• 2021

Objectives: Mild cognitive impairment (MCI) is condition of cognitive decline shown in transition from normal aging to dementia. Hominis placenta pharmacopuncture (HPP) is a treatment that combines effects of medication and acupuncture by injecting Hominis placenta into acupoints. The objective of this study was to evaluate the efficacy and safety of HPP for MCI. Methods: This was a randomized, double-blind, placebo-controlled, two-center clinical trial. Eligible patients were randomly allocated to either the HPP group or the placebo group. HPP or saline as placebo was administered to participants for eight weeks. Changes in symptoms were observed. The primary outcome was difference in mean change of Korean Version of the Montreal Cognitive Assessment (MoCA-K) score between the HPP group and the placebo group. Cognitive function, overall status of mood and sleep, and quality of life (QoL) were also assessed. Safety assessment and economic analysis were then conducted. Results: Thirty participants were enrolled. One participant in the placebo group dropped out. The score of MoCA-K increased after treatment. Its mean change was smaller in the HPP group than in the control group. HPP ameliorated Global Deterioration Scale and Korean Dementia Rating Scale subtests for attention, organization, and memory compared to the placebo. However, none of them was significantly different between the two groups. Mood, sleep, and QoL all improved more in the HPP group than in the placebo group, although differences between the two groups were not statistically significant. There was no adverse event probably related to the drug. HPP treatment needed KRW 345,000 more than the placebo group in improving Geriatric Quality of Life scale-Dementia score by one point for one year. Conclusions: Although HPP treatment did not significantly improve cognition, it changed behavioral and psychological symptoms in MCI.

• Journal of Digestive Cancer Research
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• 제5권2호
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• pp.113-119
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• 2017

Background: Second line chemotherapy is often considered in advanced gastric cancers. We assessed irinotecan in combination with fluorouracil in patients experienced diseases progression after first line chemotherapy. Methods: Prospective trial was done at 7 centers in republic of Korea. Patients aged 18 years or older with advanced gastric adenocarcinoma and disease progression on or within 4 months after first-line chemotherapy were assigned to receive irinotecan 180 mg/m² and 5-fluorouraicl 400 mg/m² intravenously bolus injection on days 1 and leucovorin 200 mg/m² for 2 hours and 5-fluorouracil 600 mg/m² for 22 hours intravenously infusion on day 2 of a 14-day cycle (FOLFIRI group). The primary endpoint was objective tumor response (OR). Efficacy analysis was by per-protocol, and safety analysis included all patients who received at least one treatment with study drug. Results: Between January 1, 2014 and December 31, 2016, 28 patients were assigned to FOLFIRI treatment. Of those 20 patients were completed the study protocol. Per-protocol analysis, two patients among 20 subjects (10.0%) showed partial response. Overall survivals of FOLFIRI group; median 10.1 months [95% CI 4.9-15.3] Grade 3 and higher adverse event that occurred about 5%, but grade 3 or higher febrile neutropenia or life threatening complication was not reported. Conclusion: Combination chemotherapy with irinotecan, 5-FU, and LV is feasible in gastric cancer patients previously treated with platinum-based chemotherapy