Earticle

Heptaplatin is a new platinum derivative with antitumor activity against gastric cancer. Preclinical studies showed that it is less toxic than other platinum analogues. The purpose of this study is to evaluate the efficacy and toxicity of the combination therapy of heptaplatin and 5-fluorouracil in Korean advanced gastric cancer patients. This study was investigated retrospectively. The patients group consisted of 65 advanced gastric cancer patients with no prior radiotherapy. All patients received heptaplatin by 2-3 hour infusion on Day 1 and 5-FU by 12-24 hour continuous infusion for 5 days. After the first cycle, subsequent doses were adjusted according to the toxicity. Courses were repeated every 28 days. As results, objective response occurred in 16 patients . Two were complete and 14 were partial response. Median progression free survival was 32 weeks with of patients progression free at 1 year. The most common hematologic toxicity was anemia. Grade 3 or 4 anemia was seen at of treatment cycles. Grade 3 or higher leucopenia was seen at of cycles. Grade 3 or 4 neutropenia and thrombocytopenia occurred at of cycles, respectively. The most common nonhematologic toxicity was proteinuria. Though no patients experienced grade 3 or 4 proteinuria, proteinuria was a considerable factor for this chemotherapy. Grade 3 or higher gastrointestinal toxicities were nausea and vomiting ( of patients) and diarrhea ( of patients). Grade 2 renal toxicity with elevation of serum creatinine was seen in of cycles, which is less than that of other platinum analogues. This study showed that combination therapy of heptaplatin and 5-FU have modest antitumor activity against advanced gastric cancer without severe renal toxicity.

The author has tested the clinical efficacy and safety of an anti-inflammatory drug in patients with inflammation of the otnrhinolaryngology. Deoxyribonuclease prepared from bovine pancreas destroyed fibers and reduced the viscosity of the exudates. Bromelain is a group of proteolytic enzymes which are known to have an effect on inflammation, swelling, and pain in inflammatory disorders. The mucolytic and anti-inflammatory properties of deoxyribonuclease associated with bromelain in inflammation of otorhinolaryngology were assessed in 67 patients. A standard dose of 3 tablets of deoxyribonuclease bromelain tablet was given for not less than 7 days. In all tile groups of patients considered, the drug showed a considerable therapeutic effectiveness. At the end of 7-28 days treatment, more than of treatment was improved. These findings suggest that it could be permitted to use deoxyribonuclease-bromelain tablet in patients with inflammation of the otorhinolaryngology.

Nifedipine, one of calcium channel antagonists, has been used for the treatment of mild to moderate hypertention, angina pectoris, Raynaud's phenomenon and various other cardiovascular diseases. Because of its short biological half-life, several sustained-release (SR) formulations of nifedipine have been developed. and used clinically. The bioequivalence of the two nifedipine SR preparations was evaluated according to the guidelines of KFDA. The test product was Hanmi Nifedipine SR made by Hanmi Pharm. Co. and the reference was Adalat Oros made by Bayer Korea. Thirty healthy male subjects were divided into two groups and a randomized cross-over study was employed. After one SR tablet containing 33 mg of nifedipine was orally administered, blood sample was taken at predetermined time intervals and the concentrations of nifedipine in plasma were determined using a validated HPLC method with UV detector. Two pharmacokinetic parameters, , were calculated and analyzed statistically for the evaluation of bioequivalence of the two products. Analysis of variance was carried out using logarithmically transformed parameter values. The confidence intewals of the These values were within the acceptable bioequivalence intervals from log 0.8 to log 1.25 in KFDA guidelines. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Hanmi Nifedipine SR tablet is bioequivalent to Adalat Oros tablet.

Bisoprolol, one of the antagonist, has been used for the treatment of mild to moderate essential hypertension anti stable angina pectoris. The oral bloavailability of bisoprolo1 is high and the drug has a long elimination half-life, , which allows once-daily administration. The bioequivalence of two bisoprolol preparations was evaluated according to the guidelines of Korea Food & Drug Administration (KFDA). The test product was Concor made by Newgenpharm and the reference product was Monocor made by Wyeth Korea. Twenty healthy male subjects, 23.8 (21-30) years old and 03.8(52-92) kg, were randomly divided into two groups and a randomized cross-over study was employed. After two tablets containing 10 mg bisoprolol hemifumarate were orally administered, blood was taken at predetermined time intervals and the concentration of bisoprolol in plasma was determined using an HPLC method with fluorescence detector. Two pharmacokinetic parameters, were calculated and analyzed statistical]y for the evaluation of bioequivalence of the two products. Analysis of variance was carried out using logarithmically transformed parameter values. The confidence intervals of were log These values were within the acceptable bioequivalence intervals of log . Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Concor tablet is bioequivalent to Monocor tablet.

당뇨환자가 합병증으로 고혈압이 있을 경우 항고혈압약물인 딜티아젬을 투여시 딜티아젬의 동태학적 측면에서 투여계획을 설계하기 위해서 토끼에 알록산을 당뇨병모델을 만들었다. 알록산으로 유도된 급성 및 만성 당뇨 토끼에서 딜티아젬의 약물동태 변화에 대한 결과는 당므과 같다. 1. Alloxan 45 mg/kg을 토끼의 귀정맥에 투여시 혈당농도는 control군에서 , acute DM군에서는 , chronic DM군에서는 으로 당뇨가 유발되었음이 확인되었다.. 2. Alloxan에 의한 당뇨병 유발토끼에서 딜티아젬의 혈중농도곡선하면적(AUC)값은 대조군 보다 chronic DM군에서 유의성(p<0.05) 있게 증가하였다. 3. 딜티아젬의 요중누적배설량은 대조군에 비해 acute 및 chronic DM군에서 감소되었으나 유의성은 없었다. 4. 당뇨병 유발 토끼에서 딜티아젬의 토탈바디클리어런스 값과 -소실속도정수값이 대조군에 배해서 유의성(p<0.05)있게 감소되었다. 실험적 당뇨 토끼에서 딜티아젬의 생체이용률의 증가는 딜티아젬의 토탈바디클리어런스 값과 베타의 소실속도정수 값이 대조군에 비해서 유의성있게 감소되었기 때문으로 사료된다.

Aminophylline, ceftriaxone 및 ampicillin/sulbactam (Unasyn)을 미숙아용 고영양수액제에 직접 첨가하거나 Y-site로 투여하는 경우의 안정성에 관해 조사하였다. Aminophylline 주사액 (25mg/mL) 와 ceftriaxone sodium (37.5 mg/mL) 2mL를 각각 고영양수액제 직접 첨가하였다. 또한 Y-site에서의 안정성 조사를 위해 ceftriaxone sodium (37.5 mg/mL)을 고영양수액제에 각각 1:1 및 1:2 부피비가 되도록 혼합하였고 Unasyn (25mg/mL)은 고영양수액제와 1:1의 부피비로 혼합하였다. 이상과 같이 조제한 혼합액을 와 에 보관하여 aminophylline은 48시간 동안 그리고 항생제들은 24시간 동안의 경시변화를 HPLC를 이용하여 분석하였다. Aminophylline은 위 보존조건에서 48시간동안 안정하였다(변화율 <). Ceftriaxone sodium을 고영양수액제에 직접 첨가한 경우 ceftriaxone의 잔존률은 에서 4시간째에 이었고 에는 로 측정되었다. Y-site에서의 안정성과 관련하여 ceftriaxone sodium을 고영양수액제와 1:1로 혼합한 경우 양 보존조건에서 ceftriaxone은 24시간 동안 안정하였으나 1:2로 혼합한 경우에는 보관 시에만 안정하였고 에서는 24시간째에 약 정도 분해되는 것으로 나타났다. 한편, Unasyn의 경우 ampicillin은 24시간째에 보관 시에만 안정하였고 에서는 24시간째에 약 정도 분해되는 것으로 나타났다. 한편, Unasyn의 경우 ampicillin은 24시간째에 에서는 안정하였으나 에서는 까지 감소되는 것으로 분석되었고 sulbactam은 24시간째에 온도와 관계없이 안정한 것으로 나타났다. Ceftriaxone sodium을 TPN과 Y-site 혼합 후 1-2시간 이내에 침천이 형성되었고 Unasyn의 경우에는 12시간째에 침천이 형성되었다. 혼합액의 pH나 색상은 연구기간 동안 일정하였다. 이러한 연구결과에 기초할 때, aminophylline은 고영양수액제와 혼합가능하고 ceftriaxone과 Unasyn은 고양양수액제와 혼합시 최소 1시간 동안은 안정한 것으로 평가되었다.