• 한국임상약학회지
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• 제22권1호
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• pp.9-12
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• 2012

Background: Cefcapene pivoxil hydrochloride, is an ester-type oral cephem antibiotic. This study was performed to compare the pharmacokinetics and evaluate the bioequivalence of two cefcapene pivoxil hydrochloride 75 mg formulations. Method: In a randomized $2{\times}2$ crossover study, sixty healthy male volunteers were randomly assigned into two groups. After a single dose of 75 mg cefcapene pivoxil hydrochloride oral administration, blood samples were collected at specific time intervals from 0-12 hours. The plasma concentrations of cefcapene pivoxil hydrochloride were determined by LC-MS/MS. The pharmacokinetic parameters were determined from the plasma concentration-time profiles of both formulations. The pharmacokinetic parameters such as $AUC_{last}$, $AUC_{inf}$ and $C_{max}$, were calculated and the 90% confidence intervals for test/reference ratio for pharmacokinetic parameters were obtained by analysis of variance on logarithmically transformed data. Results: The mean value for $AUC_{last}$ in test and reference drug was $4053.1{\pm}876.5\;ng{\cdot}hr/mL$ and $3595.7{\pm}1029.1\;ng{\cdot}h/mL$, respectively. The mean value for $C_{max}$ in test and reference drug was $1324.9{\pm}321.4$ ng/mL and $1159.1{\pm}335.9$ ng/mL, respectively. The 90% confidence intervals of the $AUC_{last}$ and $C_{max}$ ratio for test drug and reference drug were log 1.09-log1.22 and log 1.09-log1.24, respectively. No adverse events were reported by subjects or found on analysis of vital signs or laboratory tests. Conclusion: This single dose study found that the test and reference products met the regulatory criteria for bioequivalence in these health volunteers. Both formulations were safe and well tolerated in 75 mg of cefcapene pivoxil hydrochloride.

• 한국보건간호학회지
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• 제15권2호
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• pp.398-411
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• 2001

The separation system of pharmacy and clinic has begun on the purpose of preventing drug misuse and abuse since July 1st of 2000. The system revealed some conflicts between doctors. pharmacists and consumers. Consequently pharmaceutical law and related policies undergone some change. Now in an early period of the implementation of the system, the necessity to examine relevance of those policies and law enforcement to medical doctors' prescriptions pattern evolves. This study tries to verify the pattern through a field study. For the purpose, 930 prescriptions collected in May of 2001, from a pharmacy located in Gangnam-gu in Seoul, were analysed. The prescriptions were issued from several clinics: 459 prescriptions from otorhinolaryngological clinic(ENT), 177 from internal medicine clinic(IM), 130 from ophthalmic clinic(Opt), 52 from obstetric and gynecologic clinic(OB & GY), and 112 from miscellaneous clinics. ENT, IM, Opt. OB & GY are situated in a clinic building of 40m distance. The general findings are following: 1) $88.8\%$ of the total patients came from 5clinics in nearby single clinic building. 2) Average prescribing days were 6.2 days and the average number of used drugs were 4.0 drugs, i.e. 2-4 times of WHO criteria 1-2 drugs. 3) Use of antibiotics in the oral administration drugs rated $71.8\%(WHO: \;22.7\%)$ 4) Use of injection rated $31.3\%(WHO:\;17.2\%)$ 5) $96.2\%$ of the patients use multiple antibiotics in the injection and oral administration together. 6) The patients had multiple disease : ENT patients 1.7 disease and 1M patients has 2.7 disease in average and several regular prescribing types evolved particularly in the ENT prescription. With this result we found that drugs. especially antibiotics are still abused a lot, and there were significant differences in the number of used drugs and prescrbing days between the clinics. It implies somes differences of the preparation work and time for pharmacists. And preparation can be done in advance by pharmacists' own efforts through noticing regular prescribing types. The study suggests the followings: 1) Patient counseling should be done to minimize the incidence of adverse events. 2) The enforcement of the standardized differential preparation price system should be reconsidered. 3) Preparation of typical regularly appeared prescription in advance. which is regarded as 'a prearranged work between doctors and pharmacists' and has been prohibited should be reconsidered. 4) Drug utilization review program should be established to prevent drugs abuse. especially antibiotics abuse.

• 대한소아치과학회지
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• 제47권2호
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• pp.228-234
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• 2020

Chloral hydrate(CH)는 100년이상 동안 진정용 약물로 이용되어 왔다. CH는 1832년 처음 합성되었고, 1861년에는 진정제의 특성이 소개되었으며, 1869년 이후부터는 합성기술의 발달로 이용 빈도가 증가되었다. 1894년 소아에게 CH를 사용하기 시작한 기록이 있다. CH는 최근까지도 안정성에 관한 많은 논란들이 있었음에도 저렴한 가격과 비교적 안전하다는 경험적 이유로 어린이의 치과 진정법에 여전히 사용되고 있다. 그러나, 2006년 미국 FDA의 권고 이후, 2012년부터 미국내 제약회사는 CH를 더 이상 생산하지 않고 있다. 그럼에도 여전히 미국 내 여러 지역에서는 CH 원재료를 이용하여 조제한 현탁액 형태로 진정법에 사용하고 있으며, 2012년 이후에도 사망과 관련한 부작용의 보고는 계속되고 있다. CH는 현재까지 한국에서 소아 진정법에 가장 많이 이용되고 있는 약제이며, 최근 한국에서도 다수의 부작용에 관련한 보고들이 있었다. 최근 진정법을 이용한 소아의 치과치료에, CH를 대신하여 dexmedetomidine, propofol 등 여러 약물들이 소개되었다. 다만 이들을 소아치과 영역에서 사용하는데 있어서는 여러 가지 제한점이 있으며 고려해 볼 사항들도 많다. 이에 CH와 관련된 합병증들과 한국에서의 사용 실태, 그리고 CH를 대체할 수 있는 약물에 대해 알아보고자 한다.

• 수면정신생리
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• 제23권2호
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• pp.84-92
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• 2016

목 적 : 본 연구의 목적은 폐쇄성 수면무호흡증의 치료에 사용되는 하악전방이동장치의 한 제품인 '바이오가드'의 유효성과 안정성을 확인하는 것이다. 방 법 : 코골이 및 수면무호흡으로 내원한 총 62명의 환자를 대상으로 하여 하악전방이동장치를 치료법으로 선택하여 전향적, 다기관, 비열등성 연구를 하였다. 일차적으로 설문지 및 야간수면다원검사를 통해 수면무호흡지수의 변화를 수술적 치료의 선행 연구 결과와 비교한 비열등성 연구를 하였고 이차적으로 수면의 질, 주간졸리움, 산소포화도, 코골이 비율의 변화를 '바이오가드' 사용전후와 비교하였다. 또한 이상반응발생을 조사하여 안정성을 평가하였다. 결 과 : 62명의 환자 중 중도 탈락한 3명을 제외한 59명에게서 MAD 치료 5주 뒤에 평가한 수면무호흡지수의 변화는(54%) 수술적 치료의 선행 연구 결과(45%)와 비교하여 통계적으로 유의한 차이를 보이지 않았다(95% CI). 코골이 비율의 변화를 제외하고 수면무호흡지수, 수면의 질, 주간졸림증, 산소포화도는 통계적으로 유의한 개선을 보였다(p < 0.001). 총 62명 중 39명(62.9%)의 대상자에게서 총 85건의 이상반응이 보고되었으며 대부분(78건, 91.8%)의 경우 경증으로 보고되었고 중증으로 보고된 2건의 경우는 바이오가드와의 연관성은 없는 것으로 밝혀졌다. 결 론 : 하악전방이동장치의 한 제품인 '바이오가드'는 코골이와 수면무호흡 환자에게 안전하고 효과적인 치료방법이다. 따라서 기존의 비가역적인 수술 치료법을 시도하기 전에 적용하는 대체치료법으로써 우선적으로 고려하여 사용할 수 있을 것이다.

• Neonatal Medicine
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• 제18권2호
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• pp.234-239
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• 2011

목적: 최근 indomethacin의 대체약으로 ibuprofen이 미숙아 동맥관 개존증의 예방과 치료에 사용되고 있다. 본 연구는 1,250g 미만의 미숙아를 대상으로 ibuprofen의 예방적 치료 효과 및 임상 경과를 분석하고자 하였다. 방법: 2009년 11월부터 2010년 7월까지 본원 신생아 중환자실에 입원한 1,250 g 미만의 동맥관 개존증 환아 39명을 대상으로 후향적으로 의무기록을 조사하였다. Ibuprofen의 예방적 투여군(출생 후 24시간 이내에 ibuprofen 투여) 13명에 대해 재태연령과 출생체중을 과거 대응(historical match)하여 대조군 26명으로 분류하였고, 두 군의 동맥관 개존증 빈도, 임상 경과 및 합병증을 분석하였다. 결과: Ibuprofen을 투여한 예방적 투여군과 대조군 간의 동맥관 폐쇄율(69.2% vs 77.7%, P=0.825)은 유의한 차이가 없었고, ibuprofen 치료에 실패하여 동맥관 결찰술을 시행 받은 경우도 두 군간에 유의한 차이가 없었다(23.1% vs 30.8%, P=0.719). 약물과 관련된 부작용으로 위장관 천공이 발생한 경우는 예방적 투여군에서 더 많은 경향을 보였으나 대상수의 부족 등으로 통계적 유의성은 없었다(30.8% vs 11.5%, P=0.194). 뇌실 내 출혈(grade${\geq}$3) 및 다른 미숙아 합병증의 발생률도 두 군간 차이는 없었다. 결론: 미숙아에서 ibuprofen의 예방적인 투여가 동맥관 폐쇄율, 동맥관 결찰술 그리고 고도의 뇌실 내 출혈의 빈도를 감소시키지 못하였다. 향후 예방적 ibuprofen 사용과 관련하여 효과 및 부작용에 대한 더 많은 연구가 되어야 할 것이다.

• 대한한방내과학회지
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• 제39권1호
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• pp.22-43
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• 2018

Objective: The purpose of this study is to investigate the effect of Cheonmagudeung-eum (CGE) for essential hypertension by systematic review and meta-analysis. Methods: The period of literature search was until October 30, 2016, and 14 electronic databases were utilized as search engines. The evaluation for the risk of bias (RoB) was conducted by using the Cochrane Risk of Bias Tool. The meta-analysis was performed by synthesizing outcome data, including total effective rate (TER), systolic blood pressure (SBP), diastolic blood pressure (DBP), and the incidence of adverse events. Result: There were a total of 64 RCTs using CGE on adult essential hypertension. In the RoB evaluation, most of the items were unclear, and the qualities of studies were rated low. The concurrent treatment of CGE and antihypertensive drug (AHD) showed a significant hypotensive effect since the risk ratio (RR) of TER was 1.17 times (95% CI 1.14, 1.20, p<0.01) higher than that of AHD alone. In addition, the mean difference (MD) appeared low as 8.73 mm/Hg in SBP (95% CI -11.36, -6.09, p<0.01) and 5.81 mm/Hg in DBP (95% CI -7.50, -4.12, p<0.01). Conclusion: Through this study, it was identified that the combined treatment of CGE and AHD on hypertension would be more effective than that of AHD treatment alone. However, due to the low quality of the selected original articles, the significance of this conclusion is somewhat limited, and we hope that this would be complemented through more rigorous RCTs in the future.

• 대한한방내과학회지
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• 제41권5호
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• pp.705-716
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• 2020

Objective: Tension Type Headache is the most common primary headache, and the prevalence is highest among people in their thirties. The 2009 domestic headache epidemiological survey indicated a prevalence rate of 30.8% per year. The patients often complain of feeling "as if they are tightening their head or wearing a band." No other symptoms, such as nausea and vomiting, accompany the headache, and the physical and neurological findings are normal. Korean medicine treatment of tension type headache is mainly with acupuncture, not herbal medicine. In the present study, a patient with tension type headache was admitted to the Korean medicine hospital for treatment. We report on the patient's progress and the effects of the herbal treatment. Methods: The patient was treated with Gaegyeolseogyeong-tang, acupuncture, herbal acupuncture therapy, and physical therapy. We used the Korean Headache Impact Test-6 and Numeric Rating Scale to assess changes in tension type headache symptoms. Results: The patient was diagnosed with Qi-stagnation syndrome (氣滯證) and Ganyangsanghang-headache (肝陽上亢頭痛). The patient was hospitalized for 42 days and showed recovery from the tension type headache without any adverse events. Conclusion: Patients with tension type headache could be treated with Korean medicine.

• Radiation Oncology Journal
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• 제36권1호
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• pp.25-34
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• 2018

Purpose: This study aimed to evaluate the initial outcomes of proton beam therapy (PBT) for hepatocellular carcinoma (HCC) in terms of tumor response and safety. Materials and Methods: HCC patients who were not indicated for standard curative local modalities and who were treated with PBT at Samsung Medical Center from January 2016 to February 2017 were enrolled. Toxicity was scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Tumor response was evaluated using modified Response Evaluation Criteria in Solid Tumors (mRECIST). Results: A total of 101 HCC patients treated with PBT were included. Patients were treated with an equivalent dose of $62-92GyE_{10}$. Liver function status was not significantly affected after PBT. Greater than 80% of patients had Child-Pugh class A and albumin-bilirubin (ALBI) grade 1 up to 3-months after PBT. Of 78 patients followed for three months after PBT, infield complete and partial responses were achieved in 54 (69.2%) and 14 (17.9%) patients, respectively. Conclusion: PBT treatment of HCC patients showed a favorable infield complete response rate of 69.2% with acceptable acute toxicity. An additional follow-up study of these patients will be conducted.

• 한국한의학연구원논문집
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• 제16권3호
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• pp.85-93
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• 2010

The aim of this review is to investigate clinical studies on oriental medicine treatment for obesity in Korean literature and to propose for the better method of clinical studies in order to seek more effective treatment. Electric searches were performed with NDSL, National assembly library, RISS4U, DBPIA, KISS, KMBASE, KoreaMed, Korean traditional knowledge portal and Oasis. Also, 21 major journals associated with oriental medicine in Korea were searched manually. Eighty three studies were included and analyzed in terms of study design, subjects, interventions, results and evaluation of safety. The numbers of controlled, non-controlled and case studies are respectively 26(31%), 43(52%) and 14(17%). Studies using sample size less than 30 accounts for 49% and studies using subjects diagnosed as obese or overweight by specific criteria were 35(42%). Studies which used more than 2 interventions or co-interventions were 76%. Clinical studies which used single herbal medicine were few and clinically studied single herbal medicine were limited to ephedra. More than half of 83 studies were studied for 8 weeks and less. 12% of 69 studies(except case studies) were not statistically analyzed and studies which evaluated safety of intervention were 22(27%) and reported adverse events were 9(11%). To improve the quality of clinical studies on oriental medicine treatment for obesity, studies need to use restricted number of interventions and subjects need to specifically diagnosed as overweight or obese. In addition, various kinds of single herbs need to be clinically studied based on experimental studies and herbalogy.

• 한국임상약학회지
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• 제21권2호
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• pp.90-99
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• 2011

Health Insurance Review & Assessment Service (HIRA) claims database has a high potential to detect signals of new drug interactions. The aim of this study was to evaluate the usefulness of information component (IC) and relative risk (RR) as a tool for signal detection, and to analyze the possible drug interactions caused by clopidogrel using HIRA claims database. This study was performed in elderly patients over 65 years of age who administered clopidogrel from January 2005 to June 2006 in South Korea. Serious Adverse Events (SAEs) as drug interactions of clopidogrel were defined as any ambulatory hospitalization for ischemic diseases within comcomitant medication period of clopidogrel. Information Component (IC) and Relative Risk (RR) were calculated to compare the proportion of drug-SAE pairs in order to select drug specific SAEs. IC and RR signals of clopidogrel drug interaction were screened when IC's 95% confidence interval was greater than 0 and RR's 95% confidence interval was greater than 1 respectively. All detected signals were compared to references such as $Micromedex^{(R)}$ and 2010 Drug Interaction $Facts^{TM}$. Sensitivity, specificity, positive predicted value and negative predicted value were used to evaluate usefulness of this method. Among 13,252,930 cases of elderly patients who co-administered clopidogrel and other drugs, 47,485 cases were detected as SAE. Of these, one-hundred nine cases were detected by the IC-based data-mining approach and ninety one cases were detected by the RR-based data-mining approach. Total One-hundred sixty three unrecognized signals were detected by IC or RR. Twelve signals from IC-based data-mining (57.1%) were corresponded with drug interactions from references and eight signals from RR-based data-mining (38.1%) were corresponded with drug interactions from references. These signals include proton pump inhibitors, calcium channel blockers and HMG CoA reductase Inhibitors, which were known to affect CYP450 metabolism. Further studies using HIRA claims database are necessary to develop appropriate data-mining measure.