• Title/Summary/Keyword: Clinical adjustment

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Meta-analysis of the Efficacy and Safety of Grazoprevir and Elbasvir for the Treatment of Hepatitis C Virus Infection (C형 간염 바이러스 감염 치료를 위한 grazoprevir 및 elbasvir의 유효성 및 안전성에 대한 메타 분석)

  • Kang, Min Gu;Kang, Min Jung;Ji, Eunhee;Yoo, Bong Kyu
    • Korean Journal of Clinical Pharmacy
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    • v.27 no.3
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    • pp.150-160
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    • 2017
  • Background: Recently, a fixed combination of grazoprevir and elbasvir (GE) has been introduced to the arsenal of chemotherapeutics to fight against this virus. The study aimed to provide information on the efficacy and safety of GE for the treatment of HCV infection by performing a meta-analysis of literature data. Methods: PubMed and EMBASE database searches were conducted. Among the literature retrieved, pivotal Phase III clinical studies were analyzed. Statistical analysis of the data was performed by RevMan. Results: Four pivotal Phase III clinical studies compared the efficacy and safety of GE. When HCV patients were treated with GE for 12 weeks, the sustained virologic response, defined as the viral RNA level below the lower limit of quantification at 12 weeks after the cessation of therapy (SVR12), was 94.7%. The clinical advantage of GE involves its use by patients with cirrhosis and/or renal failure without dose adjustment. If the genotype (GT) of the causative virus was GT1a with NS5A polymorphism or GT4 with resistance to peginterferon/ribavirin, treatment with GE plus ribavirin for 16 weeks resulted in a better outcome compared to treatment with GE alone for 12 weeks. Adverse events reported during the four clinical studies were 71.09% in the GE arms and it was 76.61% in the non-GE arms, with the most frequent events being mild central nervous system symptoms. Conclusion: GE was generally safe and effective for the treatment of HCV infection. However, since HCV mutates very rapidly and becomes resistant to antiviral agents, long-term monitoring should be mandatory.

Subcutaneous progesterone versus vaginal progesterone for luteal phase support in in vitro fertilization: A retrospective analysis from daily clinical practice

  • Schutt, Marcel;Nguyen, The Duy;Kalff-Suske, Martha;Wagner, Uwe;Macharey, Georg;Ziller, Volker
    • Clinical and Experimental Reproductive Medicine
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    • v.48 no.3
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    • pp.262-267
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    • 2021
  • Objective: Progesterone application for luteal phase support is a well-established concept in in vitro fertilization (IVF) treatment. Water-soluble subcutaneous progesterone injections have shown pregnancy rates equivalent to those observed in patients receiving vaginal administration in randomized controlled trials. Our study aimed to investigate whether the results from those pivotal trials could be reproduced in daily clinical practice in an unselected patient population. Methods: In this retrospective cohort study in non-standardized daily clinical practice, we compared 273 IVF cycles from 195 women undergoing IVF at our center for luteal phase support with vaginal administration of 200 mg of micronized progesterone three times daily or subcutaneous injection of 25 mg of progesterone per day. Results: Various patient characteristics including age, weight, height, number of oocytes, and body mass index were similar between both groups. We observed no significant differences in the clinical pregnancy rate (CPR) per treatment cycle between the subcutaneous (39.9%) and vaginal group (36.5%) (p=0.630). Covariate analysis showed significant correlations of the number of transferred embryos and the total dosage of stimulation medication with the CPR. However, after adjustment of the CPR for these covariates using a regression model, no significant difference was observed between the two groups (odds ratio, 0.956; 95% confidence interval, 0.512-1.786; p=0.888). Conclusion: In agreement with randomized controlled trials in study populations with strict selection criteria, our study determined that subcutaneous progesterone was equally effective as vaginally applied progesterone in daily clinical practice in an unselected patient population.

Causes for Non-therapeutic INRs in Cancer Patients: Single Center Analysis (암환자의 치료범위를 벗어난 INR 원인 분석)

  • Park, Eun;Lee, Hye Suk;Kim, Hyang Sook;Ah, Young Mi;Lee, Byung Koo;Lee, Juyeun
    • Korean Journal of Clinical Pharmacy
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    • v.23 no.3
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    • pp.232-238
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    • 2013
  • Background: Although thromboembolism is common and one of the major causes of mortality in cancer patients, maintaining therapeutic anticoagulation effect with warfarin is challenging. This study aimed to determine the prevalence and the causes of non-therapeutic INR (International Normalized Ratio) in cancer patients. Methods: Medical and pharmacy records for cancer patients managed by the pharmacist-run anticoagulation service (ACS) between May, 2010 and April, 2011 at Seoul National University Hospital were retrospectively reviewed. The causes of non-therapeutic INR were identified and compared with the results from a former study with mechanical heart valve patients. Results: A total of 335 cancer patients and 6,737 patient-visits were analyzed producing 68% (n=4,590) of non-therapeutic INR readings. Eighty-five percent of the non-therapeutic INR readings were categorized as sub-therapeutic. Frequent causes linked to non-therapeutic INR included inadequate dosage adjustment (21.8%), changes in health status (11.8%), dietary changes (8.1%), and drug interactions (4.2%). More than half of the non-therapeutic INR values had no known etiology. As causes for non-therapeutic INR, changes in health status (p<0.0001), adverse reactions (p<0.0001), and dietary changes (p=0.017) were statistically more frequent in cancer patients than in patients with mechanical heart valves. Furthermore, exposure to sub-therapeutic INR were more prevalent in cancer patients than in patients with mechanical heart valve (p<0.0001). Conclusions: This study shows that there is a tendency to keep the level of INR low and that health status change, dietary change, and drug interactions are found to be frequent causes for non-therapeutic INR in cancer patients.

Psychological Systematic Consideration of Breast Cancer Radiotherapy (유방암 방사선 치료 환자의 심리의 체계적 분석)

  • Yang, Eun-Ju;Kim, Young-Jae
    • Journal of the Korean Society of Radiology
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    • v.13 no.4
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    • pp.629-635
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    • 2019
  • In term of the factors affecting psychosocial adjustment of breast cancer patients, their quality of life after surgical operation, radiation, and chemotherapy were systematically meta-analyzed. As a result, their qualities of life of the patients that had radiation therapy was the lowest right after the therapy, and gradually increased after the end of the therapy. However, after six months, their quality of life failed to reach the same level before the therapy. They had depression and side effects the most right after the therapy, and somewhat reduced them after the end of the therapy. In case of surgical operation, the more they were educated, the more they had psychosocial adjustment, and the more they had a medical examination and took out an insurance policy, the more they had psychosocial adjustment. In case of chemotherapy, their cognitive function is influenced so that they have impairments in memory, learning, and thinking stages. Since subjective cognitive impairment has a relationship with depression, it is necessary to monitor depression of chemotherapy patients. Given the results of this systematic meta-analysis, when three types of therapies (surgical operation, radiation therapy, and chemotherapy) are applied to patients with breast cancer, it is necessary to recognize their psychosocial adjustment, depression, anxiety, and quality of life in the nursing and radiation therapy fields and thereby to introduce an intervention program for a holistic approach.

Variation in clinical usefulness of biomarkers of acute kidney injury in young children undergoing cardiac surgery

  • Baek, Hee Sun;Lee, Youngok;Jang, Hea Min;Cho, Joonyong;Hyun, Myung Chul;Kim, Yeo Hyang;Hwang, Su-Kyeong;Cho, Min Hyun
    • Clinical and Experimental Pediatrics
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    • v.63 no.4
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    • pp.151-156
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    • 2020
  • Background: Acute kidney injury (AKI) is one of the most significant postoperative complications of pediatric cardiac surgery. Because serum creatinine has limitations as a diagnostic marker of AKI, new biomarkers including neutrophil gelatinase-associated lipocalin (NGAL), kidney injury molecule-1 (KIM-1), and interleukin-18 (IL-18) are being evaluated to overcome these limitations and detect AKI at an early stage after cardiac surgery. Purpose: This study aimed to investigate the clinical usefulness of these biomarkers in young children. Methods: Thirty patients with congenital heart diseases who underwent cardiac surgery using cardiopulmonary bypass (CPB) were selected, and their urine and blood samples were collected at baseline and 6, 24, and 48 hours after surgery. Serum creatinine and blood urea nitrogen levels as well as NGAL, KIM-1, and IL-18 levels in urine samples were measured, and clinical parameters were evaluated. Results: Of the 30 patients, 12 developed AKI within 48 hours after cardiac surgery. In the AKI group, 8 of 12 (66.6%) met AKI criteria after 24 hours, and urine KIM-1/creatinine (Cr) level (with adjustment of urine creatinine) peaked at 24 hours with significant difference from baseline level. Additionally, urine KIM-1/Cr level in the AKI group was significantly higher than in the non-AKI group at 6 hours. However, urine NGAL/Cr and IL-18/Cr levels showed no specific trend with time for 48 hours after cardiac surgery. Conclusion: It is suggested that urine KIM-1/Cr concentration could be considered a good biomarker for early AKI prediction after open cardiac surgery using CPB in young children with congenital heart diseases.

Evaluation of the Current Regimen of Tacrolimus in Patients with Hematopoietic Stem Cell Transplantation (조혈모세포 이식환자에서의 현행 tacrolimus 치료방법 평가)

  • Yeo, Mi-Jin;Park, Soo-Jin;Bang, Joon-Seok;La, Hyen-Oh
    • Korean Journal of Clinical Pharmacy
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    • v.20 no.3
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    • pp.193-199
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    • 2010
  • Tacrolimus, an immunosuppressant prescribed against graft-versus-host disease (GVHD) in patients with allogeneichematopoietic stem cell transplantation (HSCT), is affected to change its pharmacokinetic properties by various factors. For this reason, it is needed a close monitoring to adjust dosage amount in order to optimize the blood concentration of tacrolimus is located within the effective range. According to our in-house study, 62% of HSCT-patients were needed dosage-adjustment and it is necessary to optimize the current immunosuppressive regimen in clinical settings. A retrospective study was designed to evaluate the dosing regimen (converting ratio of IV:PO=1:4) of tacrolimus in HSCT patients (n=62). After collecting data from patient's profile and medical record, pharmacokinetic parameters were calculate and compared between the estimated and the actual values in the selected subjects (n=58). It was found that the bioavailabilty (BA) of oral tacrolimus was 40.5% very much different from that is known as 25%. It implies that the current protocol has a potent risk causes dose-related toxicities to the patients. Furthermore, analyses among factors demonstrated that there was no statistical significance between BA of tacrolimus and the variable factors. In the clinical perspectives, the current converting ratio of tacrolimus in patients with HSCT to be re-considered and an appropriate and optimal alternative regimen should be adopted to prevent GVHD and to increase the quality of life of patients.

Contributions of CYP2C9/CYP2C19 Genotypes and Drug Interaction to the Phenytoin Treatment in the Korean Epileptic Patients in the Clinical Setting

  • Lee, Soo-Youn;Lee, Seung-Tae;Kim, Jong-Won
    • BMB Reports
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    • v.40 no.3
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    • pp.448-452
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    • 2007
  • We examined the contribution of CYP2C9 and CYP2C19 genotypes and drug interactions to the phenytoin metabolism among 97 Korean epileptic patients to determine if pharmacogenetic testing could be utilized in routine clinical practice. The CYP2C9 polymorphism is a wellknown major genetic factor responsible for phenytoin metabolism. The CYP219 polymorphism, with a high incidence of variant alleles, has a minor influence on phenytoin treated Koran patients. Using a multiple regression model for evaluation of the CYP2C9 and CYP2C19 genotypes, together with other non-genetic variables, we explained 39.6% of the variance in serum phenytoin levels. Incorporation of genotyping for CYP2C9 and CYP2C19 into a clinical practice may be of some help in the determination of phenytoin dosage. However, because concurrent drug treatment is common in patients taking phenytoin and many environmental factors are likely to play a role in drug metabolism, these factors may overwhelm the relevance of CYP polymorphisms in the clinical setting. Further investigations with an approach to dose assessment that includes comprehensive interpretation of both pharmacogenetic and pharmacokinetic data along with understanding of the mechanism of drug interactions in dosage adjustment is warranted.

Comparison of Clinical Manifestations and Treatment-Seeking Behavior in Younger and Older Patients with First-time Acute Coronary Syndrome (성인과 노인 관상동맥증후군 초발 환자의 임상적 특성 및 치료추구행위 비교)

  • Hwang, Seon-Young
    • Journal of Korean Academy of Nursing
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    • v.39 no.6
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    • pp.888-898
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    • 2009
  • Purpose: This study was conducted to examine and compare clinical manifestations and predicting factors for treatment-seeking delay among patients <65 and ${\geq}65\;yr$ with first-time acute coronary syndrome (ACS). Methods: A total of 288 patients who were diagnosed with ACS were individually interviewed at C university hospital in G-city from November 2007 to December 2008. Results: Median pre-hospital delays for younger and older patients were 5 and 12 hr, respectively. Younger patients were more likely to be current smokers, heavy drinkers, obese, stressed, and have an unhealthy diet and family history, and to complain of chest pain, left shoulder and arm pain, perspiration, and nausea. Older patients were more likely to have hypertension and diabetes, and to complain syncope and dyspnea. Logistic regression analyses showed that after adjustment for age, gender and education, progressive onset of symptom and no attribution to cardiac problem significantly predicted pre-hospital delay >3 hr in both younger and older patients. Low perceived health status was a significant independent predictor in older patients only. Conclusion: Health care providers should be concerned with different manifestations between younger and older adults, and educate people at risk for heart attack about symptoms and actions to get immediate help.

Treatment of occlusal changes associated with temporomandibular joint disorder (임상가를 위한 특집 2 - 턱관절장애와 관련된 교합변화의 치료)

  • Jung, Jae-Kwang
    • The Journal of the Korean dental association
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    • v.51 no.2
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    • pp.84-91
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    • 2013
  • Temporomandibular joint disorder(TMJD) was mainly characterized with joint pain, motion limitation, joint sound, resulted from pathologic conditions in temporomandibular joint and around tissue. As temporomandibular joint is one of decisive factors determining the occlusion, disorders in temporomandibular joint may cause the occlusal changes. The causes of occlusal changes related with TMJD can be classified into 2 categories; (1) those related to progression of disorder, 2) those related to treatment of the disorder. The clinical manifestation of occlusal changes depend on their causes and affected site. Therefore, whenever possible, treatment should be directed to the relief of the underlying causes, However, it is not always possible to relieve the underlying conditions. Moreover, some occlusal changes may remain irreversible even after the considerable improvement in clinical symptoms. Regarding the treatment of the permanent occlusal changes, it has been reported that the extensive occlusal treatment including occlusal adjustment, prosthodontic treatment, orthodontic treatment should be applied. Here, we present with a case report of occlusal change caused by the progressive temporomandibular joint disorder, together with introducing the intermaxillary traction appliance as the possible treatment option.

Dosage Adjustment of Zinc (아연의 투여용량설정)

  • Jung, So Young;Shin, Wan Gyoon;Kim, Ho Soon;Cho, Nam Choon
    • Korean Journal of Clinical Pharmacy
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    • v.7 no.2
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    • pp.64-66
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    • 1997
  • Zinc is employed in body cell growth and immune function. Zinc deficiency causes growth retardation, night blindness, delay of wound healing, skin disorders, alopecia, et al. Pharmacokinetic study of zinc in Korean has not yet been proceeded to apply to patient. In this study, we investigated to adjust zinc dosage for maintaining constant zinc optimum serum level. Five NPO inpatients (3 males, 2 females) in Seoul National University of Hospital were evaluated, retrospectively. Zinc was mixed with parenteral nutrition solution and administrated intravenously in 24 hour-continuous infusion, and zinc dosage range was 0.17-0.45 mg/kg/day. AUC to zinc dose (AUC/Dose) was $2.421\pm1.007\;kg{\cdot}min/ml.$ 0.5 mg/kg/day zinc administration may achieve the plasma zinc concentration of $120\;{\mu}g/dl.$(Kor. J. Clin. Pharm. 1997; 7: 64-66)

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