• Title/Summary/Keyword: clinical pharmaceutical sciences

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Pancreaticoduodenectomy with superior mesenteric artery first-approach combined total meso-pancreas excision for periampullary malignancies: A high-volume single-center experience with short-term outcomes

  • Thanh Khiem Nguyen;Ham Hoi Nguyen;Tuan Hiep Luong;Kim Khue Dang;Van Duy Le;Duc Dung Tran;Van Minh Do;Hong Quang Pham;Hoan My Pham;Thi Lan Tran;Cuong Thinh Nguyen;Hong Son Trinh;Yosuke Inoue
    • Annals of Hepato-Biliary-Pancreatic Surgery
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    • v.28 no.1
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    • pp.59-69
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    • 2024
  • Backgrounds/Aims: Pancreaticoduodenectomy (PD) is the only radical treatment for periampullary malignancies. Superior mesenteric artery (SMA) first approach combined with total meso-pancreas (MP) excision was conducted to improve the oncological results. There has not been any previous research of a technique that combines the SMA first approach and total MP excision with a detailed description of the MP macroscopical shape. Methods: We prospectively assessed 77 patients with periampullary malignancies between October 2020 and March 2022 (18 months). All patients had undergone PD with SMA first approach combined total MP excision. The perioperative indications, clinical data, intra-operative index, R0 resection rate of postoperative pathological specimens (especially mesopancreatic margin), postoperative complications, and follow-up results were evaluated. Results: The median operative time was 289.6 min (178-540 min), the median intraoperative blood loss was 209 mL (30-1,600 mL). Microscopically, there were 19 (24.7%) cases with metastatic MP, and five cases (6.5%) with R1-resection of the MP. The number of lymph nodes (LNs) harvested and metastatic LNs were 27.2 (maximum was 74) and 1.8 (maximum was 16), respectively. Some (46.8%) patients had pancreatic fistula, but mostly in grade A, with 7 patients (9.1%) who required re-operations. Some 18.2% of cases developed postoperative refractory diarrhea. The rate of in-hospital mortality was 1.3%. Conclusions: The PD with SMA first approach combined TMpE for periampullary malignancies was effective in achieving superior oncological statistics (rate of MP R0-resection and number of total resected LNs) with non-inferior short-term outcomes. It is necessary to evaluate survival outcomes with long-term follow-up.

Antihypertensive Effects of Novel Isoflavone-Free Black Soy Peptide Mixture as HO-1 Inducer (Heme 산화효소 발현 유도체로서 Isoflavone-Free 검은콩 펩타이드의 항고혈압 활성)

  • Shin, Mi-Kyung;Kwon, Yong-Hyun;Ahn, Chang-Won;Shin, Dong-Seok;Park, Soo-Hyun;Choi, Bo-Hwa;Hong, Soon-Sun;Kang, Ju-Hee;Park, Chang-Shin
    • YAKHAK HOEJI
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    • v.56 no.3
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    • pp.191-197
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    • 2012
  • We previously reported that the novel isoflavone-free peptide mixture (black soybean peptide, BSP) had several beneficial effects like antiobesity and hypotriglyceridemic effect. However, there are no reports for BSP on anti-hypertensive activity. BSP induced heme oxygenase-1 (HO-1) in HUVECs, thus investigated the HO-1-induced activity in HUVECs and the anti-hypertensive effects in SHR animal model. BSP significantly induced HO-1 expression both at transcriptional and protein levels in a time- and dose-dependent manner as measured by RT-PCR and Western blot analysis, respectively. These inductions were abolished by pretreatment of N-acetyl-cystein (NAC, 1~10 mM), but not by employing Tempol, a superoxide dismutase (SOD) mimetic (1~5 mM). As expected, enzymatic activity (~2 fold) determined by bilirubin formation assay and cGMP concentration (~6 fold) were significantly increased in BSP-treated cells. Based on the numerous evidences on the beneficial effects of HO-1 and our results, we investigated in vivo effects of BSP on the antihypertensive activity. The administration of BSP (1% in drinking water) significantly decreased mean blood pressure (BP) (from $218.6{\pm}6.99$ to $190.0{\pm}3.42$ mm Hg, p<0.01). This result indicates that BSP is strong inducer of HO-1 expression, which may be triggered by oxidative stress, and has anti-hypertensive activity.

Toxicity Assessment of Polygalae Radix Aqueous Extract Orally Administered to Rats for 2 Consecutive Weeks (원지 추출물의 랫드에서 2주 반복 경구투여 독성평가)

  • Han, Hyoung-Yun;Kim, Soo Nam;Yang, Young-Su;Han, Su-Cheol;Seok, Ji-Hyeon;Roh, Hang Sik;Lee, Jong-Kwon;Jeong, Jayoung;Jeong, Yeon Woo;Kim, Jeong Ah;Min, Byung Sun
    • Korean Journal of Pharmacognosy
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    • v.46 no.1
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    • pp.44-51
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    • 2015
  • The objective of this study is to characterize a toxicity of Polygalae Radix (PR) in F344 rats and to find a dose levels for the 13 weeks toxicity study. PR is well known as medicinal herb in many Asian countries for treatment of expectorant, tonic, tranquillizer, antipsychotic agent and functional diet for improving memory. However, there is insufficient background information on toxicological evaluation of PR extract to support its safe use. Therefore, we conducted toxicological evaluation of this drug in compliance with OECD and KFDA guideline in this study. The extract of PR was administered orally to F344 rats at dose levels of 0, 500, 1000, 2000, 3500 and 5000 mg/kg/day for 2 weeks. Each group was composed to five male and five female rats. In the result, there were no treatment PR-related adverse changes in food consumption, hematology, clinical chemistry, urinalysis, gross finding at necropsy, organ weight examination. Four males at 5000 mg/kg/day were found dead during the treatment period. These animals showed salivation. The cause of death is still under investigation. The animals treated at 500, 1000, 2000, 3500 and 5000 mg/kg/day showed salivation and all animals at 5000 mg/kg/day exhibited lower body weight and cumulative weight gain in compared to those of control animals. Therefore, we recommend that a dose group of 3500 mg/kg/day is a highest treatment group in 13-week exposure study.

Bioequivalence Evaluation of the Tiropramide Formulation by GC/MS (티로프라미드 주사제의 생물학적 동등성 평가를 위한 GC/MS 방법)

  • Myung, Seung-Woon;Kim, Myungsoo;Kim, Hye-Young;Kwak, Hyun-Tae;Min, Hye-Ki;Sohn, Dong-Ryul;Hong, Young-Hun
    • Analytical Science and Technology
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    • v.14 no.3
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    • pp.221-229
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    • 2001
  • The bioequivalence study of two tiropramide products was evaluated in 16 health male volunteers following intra-muscular injection. Test product was Tiram$^{(R)}$ injection (S Pharm. Co, Ltd.) and reference product was Tiropa$^{(R)}$ injection(D Pharm. Co., Ltd.). The drug concentration in plasma was determined by GC/MS for over a period of 8 hours after injection. Analysis of variance reveal that there are no differences in AUC (area under the plasma concentration-time curve from time zero to infinity), Cmax (maximum plasma concentration) and Tmax (time to reach Cmax). The differences of mean AUC, Cmax and Tmax between two products were 0.73, -1.385 and -12.994%, respectively. Minimum detectable differences (%) at ${\alpha}=0.05$ were all less than 20% given as a guideline (10.05, 17.90 and 19.01% for AUC, Cmax and Tmax, respectively). From these results, the two formulations of tiropramide are bioequivalent and thus, may be prescribed interchangeably.

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Efficacy of Statins on BMB or Fracture Risk in Postmenopausal Women (스타틴이 폐경기 여성의 골밀도 혹은 골절위험에 미치는 효과 -보고된 임상연구결과 분석을 중심으로-)

  • Bang, Joon-Seok
    • Korean Journal of Clinical Pharmacy
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    • v.16 no.2
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    • pp.86-91
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    • 2006
  • There are 3 different hypotheses on how statins may affect bones, through promoting bone formation, inhibiting bone resorption or through anti-inflammatory effect. In the 3 cross-sectional studies above, one showed increase BMD at hip and spine, one showed increase BMD only at mid-forearm and one showed that the risk reduction in fractures is not explained by the changes in BMD however, all 3 studies showed a decrease in risk of fracture associated with statins. In the 2 prospective cohort studies, one showed the use of statins was not associated with BMD at any skeletal site or decreasing the risk of fracture, and the other showed statins except pravastatin decreased in risk of vertebrate fracture but not affecting lumbar spine BMD. All of case-control studies indicated reduction in fracture risk but did not provide any data regarding BMD. 2 of the randomized, controlled studies showed no significant reduction in fracture risk as well as statins' effects on BMD. Finally, one longitudinal study showed statin use reduced fracture risk and increased BMD. Among the conflicting results shown above, even when statin use was shown to increase BMD, it does not seem to account for the reduction in fracture risk. There may be different ways that statins affect bone other than those hypotheses proposed above. Many studies seem to agree that pravastatin does not have any effect on bone. Some studies suggested that the reason statins did not achieve clinically significant increases in BMD in some studies, is due to the low affinity of statins on bone; statins are designed to act in the liver therefore their effective concentration in extrahepatic tissue is low. The limitations to those studies discussed above. Many studies did not account for the change of lifestyle while subjects' were on statins. Increases in weight bearing exercise and changes in diet might affect BMD and thus reduce risk of fractures. Mental alertness and vision acuity might prevent falls from occurring; many statin-users in the studies were young so the risk of fractures from falls would be decreased. Almost all of the studies failed exclude patients with neurological problems. During study periods, many subjects may have been started on drugs for diseases that usually occur with aging which could cause drowsiness and lead to falls. The sample sizes used in some of the trials were small and the duration of treatment and follow up might not have been long enough to see clinically relevant results.

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