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신약개발을 위한 바이오이미징 기술의 동향 파악 및 발전 방안
이종구(Jong Gu Lee),김승희(Seung Hee Kim),김정곤(Jeong Kon Kim),김경원(Kyung Won Kim),조우리(Woo Ri Jo),유선애(Sun Ae Ryu),박지원(Zewon Park),이정연(Jung-Yeon Yi),김보라(Bora Kim),오우용(Woo Yong Oh) 대한약학회 2018 약학회지 Vol.62 No.4
With change of medical paradigm toward patient-focused and personalized medication, the focus has changed from treatment of diseases to prevention of diseases. Owing to the increase in chronic diseases and population aging, the Korean pharmaceutical market size has rapidly increased, making the pharmaceutical industry the next-generation strategic sector. However, when considering the scale of investments, has indicated very low success rate. In addition, it took very long time to develop a new drug, leading to such undesirable outcomes (approval of small number of new drugs and decreased productivity, compared to R&D investment). Therefore, the need for development of new drug development strategies and introduction of new concept to increase the efficiency of the new drug development and to reduce the devel-opment cost has been highlighted. Accordingly, it is necessary to assure paradigm shift and coherent linking of pre-clinical and clinical studies, in order to correctly select candidate drugs for clinical studies. In order to overcome limitations of clin-ical studies, developed countries have expanded supports and investments in development of techniques for clinical eval-uation and improvement of clinical program. Techniques obtained from such activities will be primarily used in establishing regulatory requirements as well as international standards. One of such alternative techniques for clinical evaluations is “bioimaging technique”. The bioimaging technique is a non-invasive technique to show living organism s structural and functional images. It can visualize normal biological processes, pathological processes and pharmacological responses to treatments and enable objective measurement and evaluation. It includes X-ray, CT, MRI, PET and others widely used in medical examinations. In this study, the bioimaging technique and its utilization are carefully investigated and regulatory trends in foreign countries are analyzed to identify current status in Korea. In addition, suggestions have provided to activate research of bioimaging technique in Korea and improve the system for review and evaluation of medicinal products.
관동맥연축에서 서방형 칼슘길항제인 Diltiazem 과 Verapamil 의 치료효과 : Ergonovine Echocardiography 를 이용한 무작위 비교 연구
송재관(Jae Kwan Song),박성욱(Seong Wook Park),제수정(Soo Jung Je),김재중(Jae Joong Kim),두영철(Young Cheoul Doo),김원호(Won Ho Kim),진재용(Jae Yong Chin),김형호(Hyeong Ho Kim),정상식(Sang Sig Cheong),박승정(Seung Jung Park),이종구(Jo 대한내과학회 1994 대한내과학회지 Vol.46 No.3
N/A Background: Detection of left ventricular regional wall motion abnormality with two dimensional echocardiography during ergonovine injection (Ergonovine Echocardiography: Erg Echo) is a useful noninvasive diagnostic method of coronary vasospasm, and as it can be used repeatedly, comparison of the therapeutic efficacy of the prescribed drugs for the patients with variant angina may be possible with this method. The purpose of this study were to compare the antispasmotic action of short-term medication of two currently available sustained-releasing (SR) calcium antagonists (Diltiazem vs Verapamil) with Erg Echo, to investigate the factors determining the drug efficacy and to determine if the results of repeated tests of Erg Echo after shortterm medication correlate with the clinical response. Methods: Forty patients with angiographicallyproven coronary vasospam and positive Erg Echo without medication were randomly assigned into group I and II. Diltiazem SR 90mg b.i,d. was prescribed in the patients of group l and Verapamil SR 120 mg b.i.d. in group II. Isosorbide-5-mononitrate (ISMN, Elantan 20 mg b.i.d.) was commonly given in both groups. After medication of 4 days Erg Echo was repeated, and if follow up results were positive doubling of the dosage of prescribed calcium channel antagonists (i.e. Diltiazem SR 180 mg or Verapamil SR 240 mg b.i.d.) was done and the second follow up test of Erg Echo was performed after another 4 days. Clinical follow-up was done with the dosage of negative Erg Echo, and during 9 (±3) month follow-up period one patient of group I and two of group II were lost and final analysis was done with total 37 patients (19 in group I and 18 in group II). Results: Among 37 patients with variant angina, 32 were male and the mean age was 53 (±8). Sex ratio, mean age, body weight, clinical activity of variant angina assessed by the frquency of chest pain attack, number of spasm-documented coronary vessels, dosage of ergonovine for positive response in baseline Erg Echo and number of the patients with concomitant fixed coronary stenosis were not significantly different between both groups. After 4 day medication coronary vasospasm was not provoked with ergonovine injection in 13 patients of group I, and the positive rate of Erg Echo after medication was 32% (6/19) in group I, which was not significantly different from that (50%, 9/18) of group II (p=0.66). In 15 patients coronary vasospasm was provoked with ergonovine injection despite the medication, and ergonovine dose for positive response rose from 146±84 microgram (mcg) to 218±75 mcg with medication. Patients with 'mixed disease' (coronary vasospasm and concomitant fixed disease) showed higher positive result of Erg Echo after medication than the patients with pure spasm (p=0.001). During open label follow-up of 9±3 months, there was neither case of acute myocardial infarction nor that of sudden cardiac death. Recurrent chest pain with medication was observed in 6 patients of group I and 7 of group II (p=0.90), and recurrent chest pain during follow-up was more frequently observed in patients with positive Erg Echo after 4 day medication than those with negative test (p=0.01). In group II medication was modified to control the high activity of variant angina (chest pain attacks more than 5 per week) in 3 patients and verapamil SR was withdrawned in 4 patients due to side effects (2 cases of impotence, each case of constipation and peripheral edema), while there was no case of drug modification or withdrawl of diltiazem SR (p<0.05) in group I. Conclusion: Although there was no significant difference of short term medication on prevention of coronary vasospasm provoked by ergonovine injection, during long term follow-up of variant angina, diltizem SR with ISMN was superior to verapamil SR with ISMN in control of chest pain and absence of side effects. Erg Echo after short term medication was useful in comparison of drug efficacy, investication of the fact