• Clinical and Experimental Vaccine Research
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• v.12 no.2
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• pp.121-126
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• 2023

Purpose: Sublingual immunotherapy is currently promoted by various companies, with administration schedules variable in the different products even though almost all are standardized immunologically. So, this study was planned to examine the efficacy of simple nondaily dosing of sublingual immunotherapy instead of the widely used daily schedule. Materials and Methods: Fifty-two patients with allergic rhinitis and bronchial asthma were enrolled. Sublingual immunotherapy (manufactured at the allergen immunotherapy preparation unit at Mansoura University) was given in suitable bottles with a dropper mechanism that permits comfortable dosing under the tongue. The physician recommended that the patient put the drops under his/her tongue and leave the drops beneath the tongue for 2 minutes before swallowing. This was repeated every 3 days, with the drop number and concentration gradually rising. Results: After 2 months of follow-up, 65.8% responded partially to the symptom score and 26.3% responded completely to the medication score. There was a significant decline in the symptom and medication scores from the baseline scores (p<0.0001). After 4 months of follow-up, 95.8% responded partially to symptom scores and no one has not responded; 54.2% responded completely to medication scores; and 81% of studied patients had no side effects. However, the most frequent side effect was a sore throat. Conclusion: Our nondaily schedule of sublingual immunotherapy is tolerable, safe, and effective in patients with allergic rhinitis and bronchial asthma.

• Clinical and Experimental Vaccine Research
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• v.12 no.4
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• pp.337-345
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• 2023

Purpose: The global fight against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has led to widespread vaccination efforts, yet the optimal dosing schedule for SARS-CoV-2 vaccines remains a subject of ongoing research. This study aims to investigate the effectiveness of administering two booster doses as the third and fourth doses at different intervals to enhance vaccine protection. Materials and Methods: This study was conducted at a military regional hospital operated by the Ministry of National Defense in Taiwan. A cohort of vaccinated individuals was selected, and their vaccine potency was assessed at various time intervals following their initial vaccine administration. The study participants received booster doses as the third and fourth doses, with differing time intervals between them. The study monitored neutralizing antibody titers and other relevant parameters to assess vaccine efficacy. Results: Our findings revealed that the potency of the SARS-CoV-2 vaccine exhibited a significant decline 80 days after the initial vaccine administration. However, a longer interval of 175 days between booster injections resulted in significantly higher neutralizing antibody titers. The individuals who received the extended interval boosters exhibited a more robust immune response, suggesting that a vaccine schedule with a 175-day interval between injections may provide superior protection against SARS-CoV-2. Conclusion: This study underscores the importance of optimizing vaccine booster dosing schedules to maximize protection against SARS-CoV-2. The results indicate that a longer interval of 175 days between the third and fourth doses of the vaccine can significantly enhance the neutralizing antibody response, potentially offering improved protection against the virus. These findings have important implications for vaccine distribution and administration strategies in the ongoing battle against the SARS-CoV-2 pandemic. Further research and largescale trials are needed to confirm and extend these findings for broader public health implications.

• YAKHAK HOEJI
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• v.44 no.1
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• pp.16-21
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• 2000

Peptic ulcer is involved with Helicobacter pylori infection and antibiotic regimens are primary treatments. An optimal therapeutic regimen for eradication of Helicobacter pylori remains uncertain due to variable efficacy. The objectives of this study were to evaluate the efficacy of omeprazole based antibiotic regimens in bacterial eradication, healing of peptic ulcer and to identify factors affecting efficacy. Seventy-seven patients were enrolled in the prospective, open-trial from November 1997 to Setember 1998. H. pylori infection was identified with endoscopy, H. pylori stain and rapid urease test. The first group (OAC7) received omeprazole 20 mg twice daily for 4 weeks which were the same schedule for all, amoxicillin and clarithromycin 500 mg three times daily for 1 week; the second group (OAC14), for 2 weeks on the same regimen as the first; and the last group (OACD) has taken bismuth in addition to the OAC7 regimen for 1 week. Eradication of H. pylori and healing of peptic ulcer were evaluated with endoscopy and tests for H. pylori before and after treatments. There were no significant differences in eradication rates; 77% in OAC7, 76% in OAC14, 81% in OACD (p=0.935) and healing rates; 82% in OAC7, 71% in OAC14, 95% in OACD (p=0.179), respectively. Compliance had an relationship with eradication rates significantly among regimens (p=0.049). Twenty three cases (29%) complained of the minor side effects. In conclusion, OAC7 was better in convenience of dosing schedule and showed fewer side effects with shorter duration and lower cost while There were no significant differences in efficacy among regimens.

• Korean Journal of Clinical Pharmacy
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• v.1 no.1
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• pp.31-36
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• 1991

Tobramycin is one of the most frequently selected agents for pharmacokinetic drug monitoring because of its narrow therapeutic index and essential role for the management of serious infections, especially gram-negative infections. Its pharmacokinetic parameters are dependent on race, sex, age, ideal body weight. disease states, and etc. Therefore, to schedule the dosing of tobramycin, the individual pharmacokinetic parameters such as half-life and volume of distribution are needed. However, these pharmacokinetic parameters have never been reported in Koreans. The purposes of this study were to evaluate the volume of distribution of tobramycin in cancer patients who had normal renal function, to compare the mean values of Vd reported in the literature, and to compare the measured half-life with the expected half-life based on ABW, LBW, and IBW, respectively. Venous blood samples were collected just before and thirty minutes after dosing during steady state. Serum tobramycin concentrations were determined by $TD_x$ (fluorescence immunoassay). IBW were measured by the method of Devine: and LBW were measured by the method of Hallynck. Creatinine clearances (CLcr) of the patients were estimated using the Cockcroft and Gault equation. Elimination rate constants (kel) were determined using the Welling and Craig equation. Infusion rate (ko), volume of distribution (Vd), and half-life $(t_{1/2})$ were determined using the Saw chuk and Zaske equation. The volume of distribution Was $27\%$ greater than the Schentag's study (0.26 vs 0.33 l/kg), but the half-life was similar to the Levy's study. The predicted half-lives based on IBW were the closest to actual half-lives (1.85 vs 2.01 hr).

• Clinical and Experimental Pediatrics
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• v.63 no.7
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• pp.265-271
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• 2020

Background: Pneumococcal diseases among children aged <5 years worldwide are associated with high annual mortality rates. Purpose: This study aimed to evaluate the immunogenicity and safety of GBP411, a 12-valent pneumococcal conjugant vaccine, with a dosing schedule of 2 primary doses plus 1 booster dose (2p+1) in healthy infants. Methods: This randomized active-controlled (Prevnar 13) double-blind phase 2 trial enrolled healthy subjects aged 6-10 weeks. Three serum concentrations of pneumococcal serotype-specific immunoglobulin G (IgG) were evaluated using the pneumococcal serotype-specific pneumonia polysaccharide enzyme-linked immunosorbent assay at 1 month after the primary doses and before and 1 month after the booster dose. The pneumococcal serotype-specific IgG titer was evaluated using a multiplex opsonophagocytic assay in a subset of 15 subjects per group. Results: After administration of the primary doses, the proportion of subjects who achieved pneumococcal serotype-specific IgG concentrations of >0.35 ㎍/mL was lower for some serotypes in the GBP411 group than in the comparator group (6B: 20.83% vs. 39.22%, P=0.047 and 19A: 58.33% vs. 90.20%, P<0.001). However, after administration of the booster dose, >97% of the subjects in each group achieved IgG concentrations of ≥0.35 ㎍/mL for all 12 serotypes. Increased immunogenicity was observed for some serotypes that showed significant intergroup differences after administration of the primary doses but not after the booster dose. We also found no significant intergroup difference in the overall incidence of solicited local adverse events. Furthermore, the overall incidence of solicited systemic adverse events was significantly lower in the GBP411 group than in the comparator vaccine group (79.59% vs. 98.04%; P=0.003). Conclusion: The GBP411 vaccine with a dosing schedule of 2p+1 may be immunogenic and safe for healthy infants.

• Toxicological Research
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• v.5 no.2
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• pp.71-77
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• 1989

A mouse whole animal bioassay was employed to screen for potential mutagenicity of ethanol/water extracts of 16 Chinese herbal drugs that are commonly prescribed in Korea. Specific cytogenetic toxicity was measrured by recording evidence of clastogenesis toxicity was measured by recording evidence of clastogenesis via the mouse bone marrow micronucleus test. Male ICR mice administered ethanol extract of Pinelliae tuber (Pinellia eternata Breitenbach, ARACEAE, 양복) and ddY female mice administered extract of Angelica Koreanae radix(Angelica Koreana Maximowicz, UMBELLIFERAE, ) (both by oral administration, at a dose of 600 mg/kg), in a short-term dosing schedule, demonstrated significant increase in micronucleated polychromatophilic erythrocytes, indicating the increase of clastogenicity.

• Archives of Pharmacal Research
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• v.25 no.4
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• pp.550-555
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• 2002

The discovery and development of the taxane class of antitumor compounds represent significant advances in the treatment of patients with a variety of malignancies. These drugs are effectively used in the treatment of breast cancer. In this study we evaluated the efficacy of fractionated usage of both paclitaxel and docetaxel as a single agent in the breast cancer cell line MCF-7. It has been shown that the cytotoxic effect of paclitaxel was increased when the divided $IC_{50}$ concentrations were used sequentially and in contrast to paclitaxel, cytotoxic effect of docetaxel was decreased with the same schema and the single dose of $IC_{50}$ concentration was optimal. The cause of the difference between the cytotoxic effects of two agents with this schedule is obscure. Demonstrating mechanisms, which are responsible for these differences, will be important for more rational use of taxoids and to provide basis for the following clinical trials.

• Toxicological Research
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• v.8 no.2
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• pp.235-253
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• 1992

A subacute toxicity study of cis-Malonato[(4R,5R)-4,5-bis(aminomethyl)-2-isopropyl-1,3-dioxolane]platinum(II)(SKI 2053R) was carried out to obtain information on its toxicological profiles, and to determine the maximum tolerated dose in beagle dogs. Four groups of beagle dogs (2M and 2F per group, 0,0.5,1.0,2.0mg/kg/day)were given 15 i.v. injections of SKI 2053R. In order to compare the toxic effects of SKI 2053R with those of cisplatin, one group was treated with cisplatin(0.7mg/kg/day)according to the same treatment schedule. The dosing schedule was divided into 3 courses of 5 consecutive days with 23-day dose-free intervals between each course. After completion of the treatments, remaining dogs were necropsied under established guidelines. Three of four dogs in the high dose group and one of four dogs in the middle dose group treated with SKI 2053R died of hypovolemic shock secondary to hemorrhagic and ulcerative enterocolitis. No toxicity-related mortality occurred in the low dose group of SKI 2053R. No survivor was observed in the group of cisplatin. Clinical signs including vomiting, diarrhea, anorexia and loss body weight were apparent in dogs given either cisplatin or high and middle doses of SKI 2053R. Severe thrombocytopenia and leukocytopenia were observed in the high dose group of SKI 2053R and cisplatin-treatment group, while toxicities as bone marrow suppression were reversible. The significant elevation of serum ALP values in group of SKI 2053R(2.0 mg/kg/day and 1.0mg/kg/day) and cisplatin(0.7mg/kg/day)was observed. Slight proteinuria waa observed in high and middle dose level groups of SKI 2053R. In histopathological examinations, pathological alterations of liver, kidney and spleen were noted dose-dependantly in dogs treated with SKI 2053R, and there was no overt sign of toxicity in low dose group of SKI 2053R. Compared to SKI 2053R, more severe durg-related toxicities occurred in dogs treated with cisplatin. It waw estimated that maximum tolerated dose of SKI 2053R in this treatment schedule was 0.5~0.7mg/kg/day. In conclusion, overall toxic potential of SKI 2053R was approximately 3 times lower than that of cisplatin with respect of lethality.

• Toxicological Research
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• v.8 no.2
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• pp.217-233
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• 1992

This study was performed to determine the toxic effects of graded dose levels of SKI 2053R after repeated administration. Three groups of Sprague-Dawley rats(10M and 10F per group) were given a total of 25 i.v. injections of SKI 2053R (1.50,3.75,9.38mg/kg/day). In order to compare the toxic effects of SKI 2053R with those of cisplatin, one group of Sprague-Dawley rats (10M and 10F per group) were given a total of 25 i.v.injections of cisplatin (1.70mg/kg/day). The dosing schedule was divided into five courses of 5 consecutive days with 16-day dose-free intervals between each course. No drug-related toxicity occurred in low dose level group (1.50mg/kg/day) of SKI2053R. From the results of hematological examination, peripheral WBC counts, RBC counts and hemoglobin of high dose level group(9.38mg/kg/day)of SKI 2053R were significantly lower than those of no-treated group. Other toxicities including reduced final body weight, proteinuria and hematuria were observed in high dose level group of SKI 2053R. But, no change was detected in serum biochemical values of SKI 2053R treated groups. All of the rats in cisplatin treated group were died between 3 and 13 weeks, while rats treated with SKI2053R survived to the end except one rat of middle dose level group(3.75mg/kg/day). In histopathological examinations, rats that received cisplatin manifested severe tubular damage in kidney and hemosiderosis in spleen, but no critical pathological lesion was observed in rats of other groups. Considering the results of this study, it was concluded that non-toxic dose of SKI 2053R in this treatment schedule was estimated to be 3.75 mg/kg/day and the maximum tolerated dose was to be higher than 9.38mg/kg/day. The toxic profiles fo SKI 2053R were different from those of cisplatin, and its toxicity was considerably lower than that of cisplatin.

• Korean Journal of Clinical Pharmacy
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• v.19 no.2
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• pp.146-152
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• 2009

Purpose : 본 연구의 목적은 항암치료로 인한 빈혈환자의 치료에서 epoetin alpha (rHuEPO) 피하주사 시, 주일회 요법과 주삼회요법의 헤모글로빈(hemoglobin, Hb) 상승 효과를 비교하는 것이다. Methods : 본 연구는 1999년 3월부터 2005년 3월까지 국립암센터에서 항암치료로 인한 빈혈로 epoetin alpha를 투여 받은 환자를 대상으로 의무기록의 자료를 후향적으로 수집하여 분석하였다. 연구에 포함된 환자는 rHuEPO 10,000 IU 주삼회투여군(n = 127)과 20,000 IU 주일회투여군(n = 81)으로 구분되었으며, 이들은 필요에 따라 경구용 철분보조제를 섭취하였다. Epoetin alpha 치료 시작 후 최대 8주까지 2주 간격으로 Hb 수치변화를 분석하였다. Results : 치료 시작 시점의 rHuEPO 10,000 IU 주삼회투여군과 20,000 IU 주일회투여군의 평균 Hb수치는 유사하였 다 (9.4 g/dL vs. 9.7 g/dL). Epoetin alpha 치료 후 8주까지 두 그룹간의 헤모글로빈 수치의 상승 정도에는 유의한 차이가 없었다 ($1.57{\pm}1.39$ g/dL vs. $1.68{\pm}1.35$ g/dL, p=0.59). 또한 경구용 철분보조제 투여여부, cisplatin 포함 항암제 투여여부 및 성별에 따른 군의 분류에 있어서도 rHuEPO 10,000 IU 주삼회투여군과 20,000 IU 주일회투여군의 평균 Hb 상승수치는 유의한 차이를 보이지 않았다. Conclusion : 한국인에서 항암치료로 인한 빈혈의 치료 시에 rHuEPO 20,000 IU 주일회투여 용법은 10,000 IU 주 삼회투여 용법과 유사한 Hb 상승효과를 가진다.