• 대한한의학회지
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• 제30권2호
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• pp.30-45
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• 2009

Background: The safety of herbal products is an important issue in Korea. It is more complicated because of the concomitant use of conventional western drugs and herbal medicine, including prescribed medicine, folk herbs and food supplements. Although both western and traditional Korean medical doctors have studied on the safety of HMP, their results did not show relevant or consistent conclusions because of the poor quality of studies, including bias. Objectives: The aim of this study was to review the studies in Korea related to drug induced liver injury (DILI) systematically. We tried to estimate the proportion of causative materials of DILI and evaluate the clinical difference of DILIs from different materials. Methods: Systematic searches were performed on MedRIC and MEDLIS in Korea. The extraction of data as well as selective screening of the studies was carried out independently by two of the authors. There were no restrictions on the types of publication, including grey literature. Results: Twenty-one articles were included. Of them only 7 adapted prospective design and only 6 were published in peer-reviewed journals. The proportion of conventional drugs associated with hepatotoxic injuries in all DILI ranged from 15.8% to 83.3% and that of herbal medicine was from 28.9% to 44.7%. However, the criteria for herbal medicine were not clearly defined and concomitant medications were not fully investigated in most studies. There were limited objective data in the clinical differences of liver injuries from different materials and their results were conflicting. Conclusions: The causality assessments regarding DILI of herbal medicine were not performed properly and causative materials were misclassified in most of the studies published in Korea. These make the safety issue still ambiguous because of the limitations and lack of objectivity of the studies. More rigorous studies are required for clearly addressing these conflicting issues with cooperative investigation between traditional Korean and western medicine.

• Advances in pediatric surgery
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• 제5권1호
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• pp.15-25
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• 1999

최근 소아의 비장 손상시는 비수술적 처치로 치유되는 경우가 대부분이나 대량출혈이 있거나 혈관 손상이 있을 경우에는 수술적 처치가 불가피한 실정이다. 본 연구에서는 소아에서 심한 비장손상 시 비장동맥색전술을 시행하여 비장 출혈을 어느정도 저지 시킬 수 있는지에 대해 검토하였다. 환아는 두 군으로 나누어 제 1군은 1993년 1월 부터 1994년 12월까지 비장 손상으로 내원 후 기존의 비수술적 처치 원칙에 따라 치료받은 환자 18례를 대상으로 하였고 제 2군은 1996년 1월부터 1997년 12월까지 내원하여 비장 동맥 색전술이 치료원칙에 도입된 후 치료 받은 환자 23례를 대상으로 하였다. 비장동맥 색전술은 grade III 또는 IV의 비장 손상시, 복부전산화 단층 촬영상 조영제의 누출 있는 경우, 동반장기의 손상 없이 활력 징후에 이상 있을 경우 등에서만 시행하였다. 제 1군에서는 18례중 6례(33.3%)에서 개복술이 시행되었고 이중 2례는 복강내 장기의 동반 손상이 있었다. 6례중 5례는 비장 절제술 1례는 비장 부분절제술이 시도 되어 총 비장 보존율은 72.2 % 였다. 제 2군에서는 8례에서 동맥 조영술상 비장 출혈이 확인된 후 색전술이 시행되었고 모두 성공적으로 비장 출혈을 멈출 수 있었다. 제 2군에서 개복술이 시행된 경우는 2례였는데 모두 동반 장기 손상으로 수술이 시행되었으며 이중 1례에서만이 비장절제술이 시행되어 제 2군에서의 비장보존율은 95.6%였으며 색전술후 수혈을 필요로 했던 경우는 없었다. 결론적으로 비장동맥 색전술은 비장 손상에 의한 비장 출혈시 매우 효과적인 방법으로, 이를 통해 보다 많은 비장을 보존할 수 있을 뿐더러 불필요한 개복술을 줄일 수 있을 것으로 사료된다.

• Clinics in Shoulder and Elbow
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• 제2권1호
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• pp.74-83
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• 1999

당뇨병 환자에서 동 견관절은 치료가 어려우며 도수 조작에 잘 반응하지 않는 경향이 있다. 이에 본 저자들은 보존적인 요법에 치유되지 않은 당뇨병 환자의 동 견관절에 대해 관절경 하 선택적 관절낭박리술을 시행하고 결과를 보고하고자 한다. 동 견관절이 발생한 당뇨병 환자 중 6개월 이상의 보존적인 치료에 반응하지 않고 지속적인 통증과 견관절의 운동 장애 및 기능 장애가 남아있는 9명을 대상으로 하였다. 관절경 하 박리술이 관절낭 전방 구조물의 상부에서 하부로 점진적으로 이루어 졌으며, 수술 후 관절 운동 범위 유지를 위해 물리 치료를 시행하였다. 추시 기간은 12개월로부터 37개월로 평균18개월이었으며 결과는 동통, 운동 범위, 근육 강도, 안정성, 일상 생활의 5가지 요소로 견관절의 기능을 평가하는 American Shoulder Society Score를 이용하였다. 추가적으로 동통, 외 회전, 외전,그리고 견관절 기능의 4가지 요소가 수술 전, 후로 평가되었다. 수술 후 평가 기준상 호전을 보였으며3명의 환자는 수술 후 통증이 없었으며 건측과 비교한 운동 범위 및 기능면에서 정상을 보였으며 5명의 환자는 약간의 장애는 남았으나 수술전과 비교시 호전되었으나 나머지 1명은 지속적인 동통 및 운동 범위의 감소가 있었다. 보존적 치료에 반응하지 않는 당뇨병성 동 견관절에 있어 관절경 하 박리술이 효과적인 치료 방법 중 한 방법일 것으로 사료된다.

• Journal of Pharmaceutical Investigation
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• 제31권2호
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• pp.125-130
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• 2001

Bucillamine is a novel cysteine derivative with two free intramolecular sulfhydryl groups, and has a preventive and therapeutic effect on adjuvant arthritis, suggesting its antirheumatic action. With respect to the effect on the immune system, bucillamine-exerted such immunoregulating actions are to nomalize an excessive reduction or acceleration in immune reaction. It is useful not only in patients with early stage of rheumatoid arthritis (RA) but also in those with active RA retained for more than 10 years. The purpose of the present study was to evaluate the bioequivalence of two bucillamine tablets, $Rimatil^{TM}$ (Chong Kun Dang Pharmaceutical Co., Ltd.) and $Bucilin^{TM}$ (Kuhn Il Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, $23.67{\pm}2.09$ years in age and $65.03{\pm}6.73\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After three tablets containing 100 mg of bucillamine per tablet were orally administered, blood was taken at predetermined time intervals and the concentrations of bucillamine in serum were determined using GC/MS with mass selective detector. Pharmacokinetic parameters such as $AUC_t$, $C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in $AUC_t$, $C_{max}\;and\;T_{max}$ between two tablets were -0.29%, -3.20% and 8.22%, respectively, when calculated against the $Rimatil^{TM}$ tablet. The powers $(1-{\beta})$ for $AUC_t\;and\;C_{max}$ were 84.31 % and 91.16%, respectively. Minimum detectable differences $({\Delta})$ at ${\alpha}=0.10$ and $1-{\beta}=0.8$ were less than 20% (e.g., 18.58% and 16.51% for $AUC_t\;and\;C_{max}$, respectively). The 90% confidence intervals were within ${\pm}20%$ (e.g.,$-12.77{\sim}12.20$ for $AUC_t$ and $-14.30{\sim}7.90$ for $C_{max}$). Two parameters met the criteria of KFDA for bioequivalence, indicating that $Bucilin^{TM}$ tablet is bioequivalent to $Rimatil^{TM}$ tablet.

• Journal of Pharmaceutical Investigation
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• 제33권4호
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• pp.311-317
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• 2003

Felodipine is a calcium antagonist that lowers blood pressure by reducing peripheral resistance by meas of a direct, selective action on smooth muscle in arterial resistance vessels. Futhermore, it have been approved for the effective in angina pectoris and cardiac failure. The purpose of the present study was to evaluate the bioequivalence of two felodipine extended release (ER) tablets, Splendil (YuHan Corporation) and Stapin (Hana Pharmaceutial Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The felodipine release from the two felodipine formulations in vitro was tested using KP VIII Apparatus II method at pH 6.5 buffer solution. Twenty six healthy male subjects, $22.73{\pm}1.78$ years in age and $66.66{\pm}7.28\;kg$ in body weight, were divided into two groups and a radomized $2{\times}2$ cross-over study was employed. After two tablets containing 5 mg as felodipine were orally administered, blood sample was taken at predetermined time intervals and the concentrations of felodipine in serum were determined using column-switching HPLC method with UV detector. The dissolution profiles of two formulations were similar at pH 6.5 buffer solution. Besides, the pharmacokinetic parameters such as $AUC_t,\;C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t\;and\;C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the Splendil were 2.53%, 1.32% and 18.32% for $AUC_t,\;C_{max}\;and\;T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance rage of log(0.86) to log(1.25) $(e.g.,\;log(0.86){\sim}log(1.20)\;and\;log(0.89){\sim}log(1.23)\;for\;AUC_t,\;C_{max},\;respectively)$. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Stapin ER tablet and Splendil ER tablet are bioequivalent.

• Journal of Korean Neurosurgical Society
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• 제29권10호
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• pp.1316-1321
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• 2000

Objectives : The authors analyzed the surgical series of Cushing's disease to evaluate the proper treatment policy and to verify the possible prognostic factors. Material and Methods : Of 50 patients diagnosed as Cushing's disease and operated at Department of Neurosurgery of our institute between 1988 and 1999, 48 patients with available medical records were analyzed retrospectively. Mean follow-up period was 48 months(3 to 109 months). Preoperative diagnosis was made after evaluating the patients with multiple-stage endocrinological studies and 31 selective patients were evaluated with inferior petrosal sinus sampling(IPSS). Magnetic resonance imaging(MRI) and/or high resolution computerized tomography(CT) was done in all patients. A total of 51 transsphenoidal adenomectomy(TSA) were performed including 3 revision for initial surgical failure cases. Remission was decided on the basis of both endocrinological criteria and clinical status. Radiation and/or ketoconazole therapy were applied to failed cases. For the verification of prognostic factors, the authors evaluated the statistical significance of multiple variables over remission rate by chi-square test. Result : Sensitivity of IPSS for central localization was 93.5% which was better than that of MRI(87.5%). But for lateralization, it was 72.4% for IPSS versus MRI 90.5%. Success rate of TSA was 82%(42/51) and recurrence rate was 9%(4/48). When including adjuvant treatments for surgically failed cases, overall success rate was 89.6% and all of 3 reoperated cases(TSA) due to recurrence were successful. Significant complication occurred in 7.8%(4/51) after TSA including hypopituitarism, diabetes insipidus, and visual loss. Non-existence of tumor in MRI and prolonged symptom duration(>3 years) were significant prognostic factors. Conclusion : TSA can be considered as initial treatment for Cushing's disease. In surgically failed cases, multiple treatment modality may improve the overall outcome and repeated TSA for recurrent cases seem to provide similar success.

• Asian Pacific Journal of Cancer Prevention
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• 제13권6호
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• pp.2669-2673
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• 2012

Purpose: Pancreatic carcinoma is one of the most malignant tumors of the alimentary system, with relatively high incidence rates. The purpose of this study was to assess the efficacy and safety of two regimens for advanced pancreatic carcinoma: continuous transarterial infusion versus systemic venous chemotherapy with gemcitabine and 5-fluorouracil. Methods: Of the 48 patients with advanced pancreatic carcinoma receiving chemotherapy with gemcitabine and 5-fluorouracil, 24 received the selective transarterial infusion, and 24 the systemic chemotherapy. For the continuous transarterial infusion group (experimental group), all patients received gemcitabine 1000 mg/$m^2$, given by 30-minute transarterial infusion, on day 1 of a 4-week cycle for 2 cycles, and a dose of 600 mg/$m^2$ 5-fluorouracil was infused on days 1~5 of a 4-week cycle for 2 cycles. For the systemic venous group (control group), gemcitabine and 5-fluorouracil were infused through a peripheral vein, a dose of 1000 mg/$m^2$ gemcitabine being administrated over 30 min on days 1 and 8 of a 4-week cycle for 2 cycles, and a dose of 600 mg/$m^2$ 5-fluorouracil was infused on days 1~5 of a 4-week cycle for 2 cycles. The effectiveness and safety were evaluated after 2 cyclesaccording to WHO criteria. Results:The objective effective rate in transarterial group was 33.3% versus 25% in the systemic group, the difference not being significant (P=0.626). Clinical benefit rates(CBR) in the transarterial and systemic groups were 83.3% and 58.3%, respectively (P=0.014). The means and medians for survival time in transarterial group were higher than those of the systemic group (P < 0.005). at the same time, the adverse effects did not significantly differ between the two groups (P > 0.05). Conclusion: Continuous transarterial infusion chemotherapy with gemcitabine and 5-fluorouracil could improve clinical benefit rate and survival time of patients with advanced pancreatic carcinoma, compared with systemic venous chemotherapy. Since adverse effects were limited in the transarterial group, the regimen of continuous transarterial infusion chemotherapy can be used more extensively in clinical practice. A CT and MRI conventional sequence can be used for efficacy evaluation after chemotherapy in pancreatic carcinoma.

• Journal of Pharmaceutical Investigation
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• 제32권2호
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• pp.119-125
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• 2002

A rapid, selective and reproducible high-performance liquid chromatographic method has been developed for the determination of terazocin in human plasma. Terazocin plus the internal standard, prazocin hydrochloride, were extracted from alkalified plasma with tert-butylmethyl ether, back-extracted into 0.05% phosphoric acid. Fifty ${\mu}l-portions$ of extract were injected onto a octadecylsilane column and eluted with a mixture of acetonitrile, water and triethylamine (30 : 70 : 0.1 v/v, adjusted to pH 5.0 with dilute phosphoric acid) at a flow rate of 1.0 ml/min. The fluorescence intensity of column eluents was monitored at excitation wavelength of 250 nm and emission wavelength of 370 nm. No interference peaks were observed. The practical limit of quantitation was 5 ng/ml for terazocin. The average intraday and interday coefficients of variation were 4.15 and 3.54%, respectively. Also intraday and interday precisions over the range $5{\sim}60\;ng/ml$ were $0.49{\sim}2.92\;and\;0.38{\sim}5.12%$, respectively. The bioequivalence of two terazosin tablets, the $Hytrine^{\circledR}$ (Il Yang Pharmaceutical Co., Ltd.) and the $Teratonin^{\circledR}$ (Sam-A Pharmaceutical Co., Ltd.), was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Sixteen healthy male volunteers $(24.6{\pm}2.0\;years\;old)$ were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 2 mg of terazosin was orally administered, blood was taken at predetermined time intervals and the concentration of terazosin in plasma was determined with a HPLC method using spectrofluorometric detector. AUC was calculated by the linear trapezoidal method. $C_{max}\;and\;T_{max}$ were compiled from the plasma drug concentration-time data. Analysis of variance (ANOVA) was utilized for the statistical analysis of the parameters. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between the two preparations were 0.21 %, 5.53% and 8.82%, respectively. The powers $(1-{\beta})\;for\;AUC_t,\;C_{max}\;and\;T_{max}$ were >99%, 97.49%, and 33.26%, respectively. Minimum detectable differences $({\Delta},\;%)\;at\;{\alpha}=0.1\;and\;1-{\beta}=0.8$ and the 90% confidence intervals were all less than ${\pm}20%$ except for $T_{max}.\;AUC_t\;and\;C_{max}$ met the criteria of KDFA for bioequivalence, indicating that $Teratonin^{circledR}$ tablets are bioequivalent to $Hytrine^{circledR}$ tablets.

• Journal of Pharmaceutical Investigation
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• 제41권5호
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• pp.317-322
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• 2011

Sertraline HCl, (1S-cis)-4-(3, 4-dichloro-phenyl)-1, 2, 3, 4-tetrahydro-N-methyl-l-naphthalenamine hydrochloride, is a potent and selective serotonin reuptake inhibitor which is used in the treatment of depression and obsessivecompulsive disorders. The purpose of the present study was to evaluate the bioequivalence of two sertraline HCl tablets, Traline tablet (Myungin Pharm. Co. Ltd.) and Zoloft$^{(R)}$ tablet (Pfizer Inc.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of sertraline from the two sertraline HCl formulations was tested using KP VIII Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, $23.50{\pm}1.74$ years in age and $64.09{\pm}7.10\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 50 mg as sertraline HCl was orally administered, blood samples were taken at predetermined time intervals and the concentrations of sertraline in serum were determined using an online columnswitching HPLC method with UV/Vis detection. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and computer programs (Equiv Test and K-BE Test) were utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and un-transformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Zoloft$^{(R)}$ tablet, were 0.04, 3.26 and -1.29% for $AUC_t$, $C_{max}$, and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25. Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Traline tablet was bioequivalent to Zoloft$^{(R)}$ tablet.

• 자원리싸이클링
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• 제22권2호
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• pp.53-61
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• 2013

2000년대 이후 화력발전소, 열병합발전소 및 소각로, 화학플랜트 등 고정 오염원의 질소산화물의 배출규제가 발효됨에 따라 대규모 배출업체를 시작으로 SCR(선택적 촉매 환원법) 탈질설비를 도입하고 있으며, 배출오염물 총량규제 등 점차적으로 배출규제가 강화되고 적용 범위가 확대됨으로 인하여 SCR 탈질촉매의 사용량이 증가하는 추세이다. 발전소나 소각장 등에 이미 설치된 SCR 탈질촉매는 2010년을 기점으로 비활성화하여 새로운 촉매로 교체됨으로써 폐촉매가 폐기물이 아닌 자원으로서 재활용하기 위한 기술개발이 절실히 필요한 상황이다. 본 연구에서는 폐촉매 재활용 기술에 대한 특허와 논문을 분석하였다. 분석범위는 1975년 ~ 2012년까지의 미국, 유럽연합, 일본, 한국의 등록/공개된 특허와 SCI 논문으로 제한하였다. 특허와 논문은 키워드를 사용하여 수집하였고, 기술의 정의에 의해 필터링 하였다. 특허와 논문의 동향은 연도, 국가, 기업, 기술에 따라 분석하였다.