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      • 우리나라 일부 의학 학술지에 게재된 의약품 광고의 과학적 근거에 대한 평가

        안성복,최원,김철준,최성준,이강희,하경수,김현창,Ahn, Song Vogue,Choi, Won,Kim, Chul Joon,Choe, Seong Choon,Lee, Kang Hee,Ha, Kyoungsoo,Kim, Hyeon Chang 한국의료질향상학회 2006 한국의료질향상학회지 Vol.12 No.1

        Background : The promotion and advertisement of pharmaceuticals should be based on evidence from clinical trials. We conducted this study to assess whether the pharmaceutical advertisement claims in Korean medical journals had relevant references, and whether the claims were supported by the references. Methods : We reviewed pharmaceutical advertisements in five Korean medical journals issued during the first half of 1999 and during the first half of 2004. Three investigators independently reviewed the advertisements to see whether the studies quoted to endorse the advertising messages supported the corresponding claims. Using multiple logistic regression analyses, we investigated which factors were associated with the quality of the advertisement claims. Results : From the 550 advertisements in the five journals, we identified 157 different advertisements and 475 different promotional claims. Only 149 claims had at least one reference, and 105 claims had references of published article. We could find supporting evidences in the 90 claims. The factors which were associated with the quality of advertisement claims were category of drugs, category of claims, and the manufacturer characteristics. Claims for cardiovascular and endocrine drugs, and claims on efficacy, and claims of multinational company were more evidence-based. Conclusion : Majority of the pharmaceutical advertisement claims in Korea did not have appropriate references. Drug category, claim category, and the manufacturer characteristics were associated with the quality of advertisement claims, and the manufacturer characteristics was the most important determinants.

      • KCI등재

        중앙약사심의위원회의 임상시험계획서/결과보고서 심의에 대한 제약업계의 의견 조사

        임경화,박주현,박경미,김혜진,김미영,이일섭,김철준,장준식,신상구,이형기,Lim, Kyung-Hwa,Park, Joo-Hyun,Park, Kyung-Mi,Kim, Hye-Jin,Kim, Mi-Young,Lee, Yil-Seob,Kim, Chul-Joon,Chang, Joon-Shik,Shin, Sang-Goo,Lee, Hyeong-Ki 대한임상약리학회 1998 臨床藥理學會誌 Vol.6 No.1

        Background : The Central Pharmaceutical Affairs Council (CPAC) in Korea has reviewed protocols and study reports of registration clinical trials since 1992. A survey was conducted in order to collect industry's viewpoint of the CPAC's review, to find problems, and finally to suggest better ways of its review process. Methods : 72 people from 56 member companies of the Korean Society for Clinical Trial (total 82 companies) replied to the questionnaire. The questionnaire covered trial experience of respondents, CPAC's review quality and consistency, compatibility with Institutional Review Board(IBB)'s review, feasibility of industry's participation in CPAC as member, necessity of hearing by industry, standing committee, review frequency, satisfaction in regulatory official's coordination, and private contact with CPAC's member prior to the official review. Contingency table analysis was done according to the respondents' experience of registration trials (2 or less, 3 and more) and the number of submission for review (2 or less, 3 to 5, 6 or more). Results : The most frequently stated problems regarding the CPAC's review are overlapped and/or incompatble review result with IRB (24.0%), less frequent or delayed review (21.6%), and lack of hearing process by industry on the result of review (17.6%). The survey respondents regarded CPAC's review quality as intermediate (72.7% for therapeutic category and 54.5% for clinical trial related matters), and 34.8% of respondents evaluated CPAC's review standard, in terms of trial related matters, as low. In order to improve CPAC's review quality, ensuring quality experts (27.5%), industry's participation in CPAC as committee members (27.5%), and hearing by industry (23.0%) were suggested. To reconcile incompatible review results between CPAC and IRB, CPAC's review followed by the notification to IRB (53.6%), and industry's pre­meeting with CPAC (21.7%) were reported essential. 93.1 % of respondents felt CPAC should be run as a sort of standing committee to facilitate its review. Conclusion : To increase the CPAC's review standard and to make its review more accpetable to industries, it is strongly required to ensure experts having a balanced idea and experience in scientific, ethical, and practical aspects of clinical trial, and, in the long run, to operate the CPAC on a continual basis. In the current regulatory system, however, it is suggested to communicate interactively between CP AC and industries by accepting industry's clinical trial experts into CPAC and by securing industry's hearing possbile when neeeded. 배경 및 연구 목적 : 1992년 이후, 중앙약사심의위원회 신약분과 임상평가소분과위원회(중앙약심)에서 담당해 온, 임상시험 계획서/보고서 심의의 관련된 제약업계 실무 담당자들의 의견을 조사하고, 문제점을 도출하여 개선 방향을 모색하고자 본 조사를 실시하였다. 조사 대상 및 방법 : 임상시험연구회원사(총 82개) 중 55개 사(68.3%)에서 임상시험 업무를 담당하는 72명으로부터 설문조사를 실시하였다. 설문서는 임상시험 업무 경험, 중앙약심 위원들의 전문성, 제약업계의 중앙약심 참여가능성, 심의의 비일관성, IRB 심의와의 불일치, 제약업계의 청문/설명 기회 보장, 심의 첫수의 적절성, 상설 기구의 필요성, 보건복지부 담당 공무원의 협조, 중앙약심 위원과의 사전 접촉 등을 묻는 문항으로 구성돼 있다. 허가용 임상시험의 담당횟수(2건 이하, 3건 이상) 및 중앙약심에 의한 총 피심의 첫수 (2건이하, $3{\sim}5$건, 6건 이상)에 대해, 각 설문서의 문항별로 교차표 분석을 실시하였다. 조사 결과 : 중앙약심 심의의 가장 큰 문제점은 IRB와 중앙약심에 의한 심의의 중복 및 불일치 (24.0%), 부족한 심의 횟수 및 지연 (21.6%), 제약업계의 청문 기회제공 결여 (17.6%) 등의 순이었다. 치료 약물 분야 및 임상시험의 실제에 대한중앙약심 위원들의 전문성은 중간 정도라는 응답이 각각 72.7%, 54.5%로 제일 많았고, 특히 임상시험의 실제에 대한 전문성이 부족하다고 응답한 경우도 34.8%에 달하였다. 중앙약심 위원들의 심의 전문성을 높이기 위한 방법으로, 상시 가용한 심의 전문 인력의 확보 (27.5%), 제약업계의 중앙약심 참여 (27.5%),제약업계의 청문/설명기회 보장 (23.0%) 등이 제시되었다. IRB 심의와의 불일치를 해결하기 위해서는, 중앙약심에 의한 사전심의 후 IRB 통보 (53.6% ), 중앙약심과 제약업계외 사전 회합 및 조율 (21.7%) 등이 필요하다고 응답하였다. 중앙약심의 상설 또는 준상설 심의 기구화가 필요하다는 응답은 93.1%였다. 결론 : 중앙약심의 계획서/보고서 심의의 전문성을 높이고 원활한 심의를 가능하게 하려면, 장기적으로는 과학적, 윤리적, 현실적 논점들에 대해 균형 감각을 갖고 있는 산-학-관 전문 인력의 확보 및 심의 기구 상설화가 필요하다. 또한 현행 제도하에서도, 제약업계의 임상시험 전문가를 중앙약심에 참여시키고 제약업계에 청문 및 설명 기회를 제공함으로써, 양방향 의사소통 기회를 늘이는 것이 요망된다.

      • KCI등재

        한국인 류마티스 관절염 환자에 대한 에토리콕시브 90 mg 안전성 및 유효성

        성윤경 ( Yoon Kyoung Sung ),고은미 ( Eun Mi Koh ),박원 ( Won Park ),이수곤 ( So Kon Lee ),이지수 ( Ji Soo Lee ),김철준 ( Chul Joon Kim ),박영주 ( Young Joo Park ),배상철 ( Sang Cheol Bae ) 대한류마티스학회 2005 대한류마티스학회지 Vol.12 No.4

        Objective: To assess the efficacy and the safety of etoricoxib 90 mg daily administered to Korean patients for the treatment of rheumatoid arthritis over a 12-week period. Methods: Eighty-nine patients diagnosed with rheumatoid arthritis were administered Etoricoxib 90 mg for 12 weeks. Tender Joint Count (total 68 joints), Swollen Joint Count (total 66 joints), Patient Global Assessment of Disease Activity, and Investigator Global Assessment of Disease Activity were assessed as primary endpoints. Patient Global Assessment of Pain, Health Assessment of Questionnaire (HAQ: disability scales), Patient Global Assessment of Response to Therapy, Investigator Global Assessment of Response to Therapy, and Duration of Morning Stiffness were assessed as secondary endpoints. Those endpoints were assessed at week 2, 4, 8, and 12. Safety was evaluated by physical examination, serum chemistry, blood count, urinalysis, and occurrence of adverse events. Results: Etoricoxib 90 mg showed significant effects compared to baseline, thus the result indicated etoricoxib was clinically effective. Etoricoxib 90 mg showed significant improvement in all efficacy endpoints (primary endpoints and secondary endpoints). Treatment effects for etoricoxib 90 mg were approximately a 7.3 (95% CI 5.8 8.9, P<0.0001) joint reduction in the number of tender joints, 4.8 (95% CI 3.6 6.0, P<0.0001) joint reduction in the number of swollen joints, a 15.4 (95% Cl 12.1 18.7, p<0.0001) mm improvement in the patient global assessment (100 mm VAS) and 1.3 (95% Cl 1.1 1.6, p<0.0001) unit improvement in the investigator global assessment (0 to 4 Likert scale). Treatment effects were observed at the earliest time point of measurement and were maintained over time during the 12-week period. Drug-related clinical adverse events were reported by 22 (24.7%) of 89 safety evaluable subjects. Eight patients discontinued the drug due to clinical adverse events. Frequency of drug-related laboratory abnormalities was low with 2 (2.2%). Nobody discontinued due to laboratory abnormalities. Conclusion: (1) Etoricoxib 90 mg once daily was clinically effective for the treatment of rheumatoid arthritis in Korea patients. (2) Etoricoxib 90 mg once daily administered to patients with rheumatoid arthritis was generally safe and well tolerated.

      • KCI등재
      • KCI등재

        프로 야구 투수들의 견관절 회전근력

        김철준,김상규,김명화 대한스포츠의학회 1994 대한스포츠의학회지 Vol.12 No.2

        This study was to investigate the biomechanics and characteristics of shoulder rotator muscles of korean professional baseball pitchers and to suggest the direction of training for them. The shoulder internal rotator and external rotator muscles of twenty-one korean professional baseball pitchers were evaluated with Cybex 6000^R isokinetic dynamometer. The test angular velocity was 120℃/sec as a low speed and 240℃/sec as high speed and the test was done in standing neutral position. The peak torque, peak torque % body weight and external/internal rotator peak torque ratio were analysed and compared with those of american professional baseball pitchers and concluded as followings; 1) The peak torque and peak torque % body weight were much smaller than those of american major league pitchers especially in shoulder internal rotator muscle. 2. The external/internal rotator peak torque ratio was higher than that of american major league pitchers especially in high speed test, 240℃/sec, in which the ratio of american pitchers was lower than that of 120℃/sec. 3. The more aggressive and continuous strength training of internal rotator muscle, combined with rotator cuff strengthening, is needed. 4. Additional studies of isokinetic dynamometer are requested in the field of shoulder rehabilitation and biomechanical reserch of pitching especially in much higher speed, both eccentric and concentric methods and various testing positions.

      • KCI등재

        31P MR Spectroscopy를 이용한 생체내 골격근의 무산소성 및 유산소성 운동에 의한 대사 변화

        김철준,신명진,김성수,김동희,성기홍 대한스포츠의학회 1996 대한스포츠의학회지 Vol.14 No.1

        The phosphocreatine concentration ([PCr]) falls during exercise by forming an equimolar amount of inorganic phosphate ([Pi]) as described by the creatineinase reaction. Metabolic cycles employed during the exercise are governed by the level of oxygen supply. Therefore, depending the level of oxygen during the exercise, the exercise can be described by three major categories, which may be attributed from the intensity, frequency, and duration of the exercise : anaerobic, lactic acid, and aerobic exercises. In the present work, the time course of changes in [Pi/PCr] during the maximal intermittent isokinetic exercise of forearm muscle, which involves the three categories, were measured by in vivo ^31P MR spectroscopy. Compare the time course of changes in [Pi/PCr] between sedentaries and trained oarsman during the maximal intermittent isokinetic exercise. Characterise the aerobic and anaerobic exercises by observing different time course of changes in[Pi/PCr]. Forearm(nondominant side) muscle of each subject was placed in the center of RF coil, which was doubly tuned for the ^1H and ^32P resonance frequencies of 200.21 MH and 81.0 MH respectively (Bruker, Switzerland). Forearm flexion was performed with a fixed 0.5 P by a home made ergometer. In vivo 31P MR Spectroscopy was performed on a Bruker Biospec 4.7T lmaging and Spectroscopy System (Bruker, Fa¨allanden, Switzerland). Shimming was done on the ^1H signal, and the ^31P signal was obtained from M.Flex or Digitorum Superficialis. A series of spectrum was acquired before the initial exercise starts and during the time intervals, 1 minute between exercises. Peak areas were measured by integration. Subjects were ordered to do the forearm flexion exercises. For Group 1 (n=10), trained oarsmen were subjected to series of 30, 90 or 180 seconds of exercises intervaled by 1 minute of resting period until 20 minutes passed the all-out, and for Group 2, sedentaries (n=10) were employed, as a control group, to do the same exercise protocol as for the oarsmen. ^31P MR spectra of the forearm muscle before exercise, during exercise, at the end of the exercise(i.e.all-out). For the maximal intermittent 90 seconds isokinetic exercise, the ratio of[Pi/PCr] of the trained oarsmen has the value of 0.9±0.07 at the plateau during about 25 minutes of the exercise. In contrary, the value of the sedentaries is continuously rising until the all-out, during about 10 minutes of the exercise. For the maximal intermittent 180 seconds isokinetic exercise, the ratio of [Pi/PCr] of the trained oarsmen has the value of 0.65±0.07 at the plateau during about 20 minutes of the exercise. In contrary, the value of the sedentaries is continuously rising until the all-out, during about 8 minutes of the exercise. The plateau achieved in the time course of [Pi/PCr] during the exercise by the trained oarsmen may indicate that the exercise can be categrized as the aerobic exercise. The continuously rising [Pi/PCr] observed during the exercise by the sedentaries may indicate that the exercise can be categorized as the anaerobic exercise. We may deduce a conclusion from the above that the accumulation of the [Pi/PCr] may not be an indication of the fatigue

      • KCI등재

        프로야구 손상의 임상적 분석

        김철준,김명화,김미정,신명진,윤준오,김상규 대한스포츠의학회 1995 대한스포츠의학회지 Vol.13 No.1

        Baseball is rapidly getting popularity in Korea as it has been in U.S.A and Japan. During the last decade, threre were several studies about baseball injuries which oriented mainly to the overuse injuries of growing baseball players. But there was no study the professional baseball players systematically. This study was surposed to see the general characteristics of baseball injuries and to provide the prevention and rehabilitation programs if recommended. The number of 83 injuries of 60 baseball players was analysed according to the position, injury site, diagnosis, injury mechanism and duration of injury. The mean age and height of 60 subjects were 24.6 years old and 180.65㎝, respectively. The baseball position of 82 injured cases were composed of 27 pitchers, 30 infielder, 19 outfielder and 6 catchers. The characteristics of injury were as follows: 1.The number of chronic injury was 56 cases(68.3%) and the percentage of chronic injury of pitchers was up to 81.5% compared 73.3% of infielder and 47.4% of outfielder. 2. The injury rate of both lower and upper extremitis were equal and the rate of lower back problems was the second, which should be concerned. 3. The number of cases injured by direct collison is as low as 15(18.3%). The most common secondary cause of injury was aggressive throwing itself and 26 out of 49 cases injured not by direct collision. 4. More concern should be payed about the low back problems and about the catcher and the field players as much as pitchers from now one.

      • 고콜레스테롤혈증 환자의 식이 섭취 양상

        박혜순,신은수,김철준 울산대학교 의과대학 1993 울산의대학술지 Vol.2 No.2

        Hyperlipidemia is recognized as a major rick factor of atherosclerosis and coronary heart disease. Recently, as dietary pattern in Korea is changed to Westernized dietary pattern, so the concentration of serum cholesterol is being observed higher than the past. The purpose of this study is to investigate the difference of dietary pastern between hypercholesterolemia and control group in Korea. We gathered case group among person who had been verified hypercholesterolemia and control group among persons who had taken medical examination in Asan Medical Center. The results are as follows; 1) The hypercholesterolemia group and control group consist of 78 and 140 cases, respectively. 2) The differences of smoking and alcohol histories between two groups were not significant. The number of cases of participating regular exercise in male hypercholesterolemia group is significantly less than the control group, but not in female case. 3) The body weight, relative body weight, and body mass index in male hypercholesterolemia group were significantly greater than those in control group, but not in female case. 4) The total cholesterol and LDL-C in hypercholesterolemia group were significantly greater than control group. The difference of HDL-C between two groups was not significant. The triglyceride in male hypercholesterolemia group was significantly greater than control group, but not in female case. 5) The cholesterol intake in male and premenopausal female hypercholesterolemia group was significant1y greater than that in control group, but not in postmenopausal female case. The differences of intake in total energy, carbohydrate, fat, protein, fiber. animal fat, vegetable fat, animal protein and soy protein between two groups were not significant.

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