• 제목/요약/키워드: clinical benefit

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Efficacy of Exemestane After Nonsteroidal Aromatase inhibitor Use in Metastatic Breast Cancer Patients

  • Kim, Sun-Hye;Park, In-Hae;Lee, Hye-Won;Lee, Keun-Seok;Nam, Byung-Ho;Ro, Jung-Sil
    • Asian Pacific Journal of Cancer Prevention
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    • 제13권3호
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    • pp.979-983
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    • 2012
  • Background : Previous studies have suggested a lack of complete cross-resistance between steroidal (exemestane) and non-steroidal aromatase inhibitors (nSAI). Methods : Eighty-eight metastatic breast cancer (MBC) patients who received 25 mg of exemestane orally once a day at the National Cancer Center, Korea, between 2003 and 2009, were reviewed retrospectively. All patients had received nSAI for metastatic disease prior to exemestane therapy. Results : The median age was 52 years (range, 33-79), and 13 (14.8%) patients were premenopausal who concomitantly received GnRH agonist. Exemestane was given as a second- (80.7%) or third-line (19.3%) hormone therapy. The clinical benefit (CB) rate (complete response + partial response + stable disease ${\geq}$ 24 weeks) was 30.7%, with a median CB duration of 10.0 months (range, 6.3-78.7). The median progression-free survival (PFS) was 3.0 months (95% confidence interval [CI], 1.99-4.01) and the overall survival (OS) 21.5 months (95% CI, 17.96-25.04), with a median followup of 50.3 months. Patients who achieved CB had longer OS than those patients who did not (29.6 vs 17.9 months; P=0.002). On univariate analysis of predictive factors, patients who had achieved CB from previous nSAI tended to show lower CB rate (24.6% vs 44.4%, respectively; P=0.063) and shorter PFS (2.8 vs 4.8 months, respectively; p=0.233) than patients who had not. Achieving CB from previous nSAI became independent predictive factor for CBR to exemestane on multivariable analysis (Odds ratio = 2.852, P = 0.040). Conclusions : Exemestane after nSAI failure was effective in prolonging CB duration. The drug's efficacy seemed to be inferior in patients who had benefit from previous nSAI use.

노인환자에게 제공하는 개국약국 약료서비스의 경제적 가치 (Economic Value of Pharmaceutical Care for the Elderly Patients in Community Pharmacies)

  • 손현순;신현택
    • 약학회지
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    • 제51권5호
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    • pp.327-335
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    • 2007
  • This study was to evaluate economic impact of a comprehensive pharmaceutical care intervention provided by community pharmacists on drug-related morbidity and mortality in the elderly population, in a societal perspective. Clinical outcomes of pharmaceutical care included compliance increase, inappropriate medication discontinuation, and subsequent drug-related morbidity and mortality reduction. Economic outcomes included cost savings from direct medical costs reduction such as medication and healthcare resource utilization. Input costs for pharmaceutical care included pharmacist time and computerized prescription review supporting program costs. Model parameters of outcomes were derived from published literatures, and costs were from literatures and health insurance statistical data in Korea. Annual costs and benefits were estimated in the year 2005. Current usual care and standardized pharmaceutical care required 0.3 and 2.0 hours per year respectively, for elderly outpatient using average 4.4 prescription drugs per visit and average annual frequency of 17.8 pharmacy visits. Comprehensive pharmaceutical care provided to overall elderly outpatients at community pharmacies would have cost of \74,994 mil. and benefit of \357,002 mil. per year. Benefit:cost ratio was 4.8:1 and net benefit was \282,008 mil/year. It was corresponded to net benefit of \73,816/year for individual elderly patient. In addition, pharmaceutical care was estimated to reduce 1,531 drug-related deaths/year. Conclusively this study, a first attempt in Korea to evaluate an economic value of pharmaceutical care at community pharmacies, proved that it was a cost-effective intervention having significant economic benefit.

Pharmacokinetic and Pharmacodynamic Modeling of Levodopa in Parkinson Disease

  • Holford, Nick H.
    • 대한약학회:학술대회논문집
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    • 대한약학회 2002년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2
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    • pp.220-222
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    • 2002
  • The concentration effect relationship (pharmacokinetic pharmacodynamic model, PKPD) of drugs used for Parkinson's disease is complex. The benefits and adverse effects of drug treatment have to be considered in terms of short term and long term effects. Acute effects, observed over hours and days, reflect symptomatic benefit while chronic effects, observed over months and years, also reveal influences on the progress of the disease. (omitted)

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Clinical Study on Safety and Efficacy of Qinin® (Cantharidin Sodium) Injection Combined with Chemotherapy in Treating Patients with Gastric Cancer

  • Zhan, Yi-Ping;Huang, Xin-En;Cao, Jie;Lu, Yan-Yan;Wu, Xue-Yan;Liu, Jin;Xu, Xia;Xu, Lin;Xiang, Jin;Ye, Li-Hong
    • Asian Pacific Journal of Cancer Prevention
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    • 제13권9호
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    • pp.4773-4776
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    • 2012
  • Objectives: To assess the efficacy, side effects, and the impact on quality of life with $Qinin^{(R)}$ (Cantharidin sodium) injection combined with chemotherapy for gastric cancer patients. Method: A consecutive cohort of 70 patients were divided into two groups: experimental group with cantharidin sodium injection combined with chemotherapy, while the control group received chemotherapy alone. After more than two courses of treatment, efficacy, quality of life and side effects were evaluated. Results: The response rate of experimental group was not significantly different from that of the control group (P>0.05), but differences were significant in clinical benefit response and KPS score. In addition, gastrointestinal reactions and the incidence of leukopenia were lower than in the control group (P<0.05). Conclusions: $Qinin^{(R)}$ (Cantharidin sodium) injection combined with chemotherapy enhances clinical benefit response, improving quality of life of gastric cancer patients and reducing side effects of chemotherapy. Thus $Qinin^{(R)}$ (Cantharidin sodium) injection deserves to be further investigated in randomized control clinical trails.

급성 진정제 중독 추정 환자에서 플루마제닐의 투여: 위험도/이익 재평가 (Flumazenil administration in suspected patients with acute hypnotics and sedatives poisoning: risk-benefit re-evaluation)

  • 허재홍;최상천;임용균;샘슨램포탕;박은정
    • 대한임상독성학회지
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    • 제14권2호
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    • pp.92-99
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    • 2016
  • Purpose: The use of flumazenil administration in the emergency department is still controversial because of concerns about adverse effects. The present study was conducted to re-evaluate the risk-benefit ratio associated with flumazenil administration to patients suspected of having acute hypnotics and sedatives poisoning in the emergency department. Methods: A retrospective chart review study was conducted for patients whose final diagnoses were "poisoning" and "benzodiazepine" or "sedatives-hypnotics" from Mar. 2006 to Feb. 2015. The basal characteristics of the patients, including past medical history, ingredients and dose of ingested drug and co-ingested drugs were investigated. For patients administered flumazenil, responsiveness and time from admission to flumazenil administration were investigated with supplement. All collected data were analyzed in aspect terms of risk/benefit. Results: A total of 678 patients were included in our study. Benzodiazepine was the most common sedative/hypnotic drug prescribed, and the frequency of prescription continuously increased. The proportion of TCA as co-ingestion decreased from 13.1% to 3.9% in patients with acute sedative/hypnotic poisoning. Flumazenil was administered to 55 patients (8.1%), of which 29 patients (52.7%) were applied to contraindications. Fifty-three patients (96.4%) showed positive responsiveness, including partial responsiveness after flumazenil administration. No severe adverse events were identified. Conclusion: Based on the current trends in prescription patterns for sedative/hypnotic drugs, increased use of non-TCA antidepressants, and responsiveness to administration of flumazenil, benefit seemed weighted more in this study, although the observed benefits were based on limited results. Further prospective multicenter studies will be needed to optimize benefit-risk ratio.

Retrospective evaluation of toceranib phosphate (Palladia) for treatment of different tumor types in 31 dogs

  • Choi, Seo-In;Nam, Ye-Lim;Kim, Jin-Kyoung;Park, Hyung-Jin;Song, Kun-Ho;Seo, Kyoung Won
    • 대한수의학회지
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    • 제61권1호
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    • pp.10.1-10.11
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    • 2021
  • The purpose of this retrospective study was to provide additional data on the use of toceranib in a wide variety of tumor types in small breed dogs, especially < 8 kg (except 5 dogs). This was a retrospective study of 31 dogs with malignant tumors treated with a 2.5 mg/kg median dose of toceranib (Palladia; Zoetis, USA) on a Monday-Wednesday-Friday schedule. Clinical benefit was observed in 13 of 15 dogs (86.7%, 3 with complete response, 4 with partial response, 6 with stable disease) with gross disease. Distant metastasis, response to treatment, and treatment setting were significantly associated with survival time. Negative prognostic factors were multiple chemotherapy and distant metastasis (affecting progression-free survival [PFS]), surgery, regional enlarged lymph nodes, underlying disease, and toxicity (affecting median survival time [MST]). Positive prognostic factors were epithelial and round cell tumor (affecting PFS), epithelial tumor, microscopic disease, no evidence of disease response, and stable disease (MST). In conclusion, a clinical benefit from toceranib treatment was noted in most of the dogs with gross disease in our study. This study suggested that the toceranib is probably selective treatment to various tumor types in small breed dogs.

Peripheral Blood Immune Cell-based Biomarkers in Anti-PD-1/PD-L1 Therapy

  • Kyung Hwan Kim;Chang Gon Kim;Eui-Cheol Shin
    • IMMUNE NETWORK
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    • 제20권1호
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    • pp.8.1-8.15
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    • 2020
  • Immune checkpoint blockade targeting PD-1 and PD-L1 has resulted in unprecedented clinical benefit for cancer patients. Anti-PD-1/PD-L1 therapy has become the standard treatment for diverse cancer types as monotherapy or in combination with other anticancer therapies, and its indications are expanding. However, many patients do not benefit from anti-PD-1/PD-L1 therapy due to primary and/or acquired resistance, which is a major obstacle to broadening the clinical applicability of anti-PD-1/PD-L1 therapy. In addition, hyperprogressive disease, an acceleration of tumor growth following anti-PD-1/PD-L1 therapy, has been proposed as a new response pattern associated with deleterious prognosis. Anti-PD-1/PD-L1 therapy can also cause a unique pattern of adverse events termed immune-related adverse events, sometimes leading to treatment discontinuation and fatal outcomes. Investigations have been carried out to predict and monitor treatment outcomes using peripheral blood as an alternative to tissue biopsy. This review summarizes recent studies utilizing peripheral blood immune cells to predict various outcomes in cancer patients treated with anti-PD-1/PD-L1 therapy.

Evidence-Based Medicine에 대한 소개 (Introduction to Evidence-based Medicine (EBM))

  • 최재걸
    • 대한핵의학회지
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    • 제35권4호
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    • pp.224-230
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    • 2001
  • EBM is "the conscientious, explicit and judicious use of current best evidence in mating decisions about the care of the individual patient. It means integrating individual clinical expertise with the best available external clinical evidence from systematic research." EBM is the integration of clinical expertise, patient values, and the best evidence into the decision making process for patient care. The practice of EBM is usually triggered by patient encounters which generate questions about the effects of therapy, the utility of diagnostic tests, the prognosis of diseases, or the etiology of disorders. The best evidence is usually found in clinically relevant research that has been conducted using sound methodology. Evidence-based medicine requires new skills of the clinician, including efficient literature-searching, and the application of formal rules of evidence in evaluating the clinical literature. Evidence-based medicine converts the abstract exercise of reading and appraising the literature into the pragmatic process of using the literature to benefit individual patients while simultaneously expanding the clinician's knowledge base. This review will briefly discuss about concepts of evidence medicine and method of critical appraisal of literatures.

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Development of the Numerical Guide for Cost-Benefit Analysis of Occupational Radiation Exposure In the Korean Next Generation Reactor

  • Sohn, Ki-Yoon;Kang, Chang-Sun
    • Nuclear Engineering and Technology
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    • 제29권1호
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    • pp.78-84
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    • 1997
  • The specific purpose of this study is to develop the numerical guide for the cost-benefit analysis of ORE ($/person-Sv reduction) to meet the criterion of ALARA in the design stage of the KNGR. In deriving the guide, the risk factor which is defined by the risk to unit collective radiation exposure dose (deaths/person-Sv) and the monetary value of human life ($/death) are required. The risk factor has been estimated from various clinical data accumulated for a number of years and continuously modified. And the monetary value of human life is usually quantified using the human capital approach. In this study, the risk to radiation exposure perceived by a group of people is investigated through an extensive poll survey conducted among university students in order to modify the existing risk factor for radiation exposure. And in evaluating the monetary value of human life, the QOL factor is introduced in order to incorporate the degree of public welfare or quality of life. As a result of study, a value within the range of 151, 000~172, 000 dollars per person-Sv reduction is recommended as the appropriate interim numerical guide for cost-benefit analysis of ORE to meet the criterion of ALARA in the design stage of the KNGR. A poll survey was also conducted in order to see whether the public acceptance cost of nuclear power should be incorporated in developing the guide, and the result of study shooed that such a cost does not need to be considered.

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Continuous Transarterial Infusion Chemotherapy with Gemcitabine and 5-Fluorouracil for Advanced Pancreatic Carcinoma

  • Hong, Guo-Bin;Zhou, Jing-Xing;Sun, Hua-Bin;Li, Chun-Yang;Song, Li-Qing
    • Asian Pacific Journal of Cancer Prevention
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    • 제13권6호
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    • pp.2669-2673
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    • 2012
  • Purpose: Pancreatic carcinoma is one of the most malignant tumors of the alimentary system, with relatively high incidence rates. The purpose of this study was to assess the efficacy and safety of two regimens for advanced pancreatic carcinoma: continuous transarterial infusion versus systemic venous chemotherapy with gemcitabine and 5-fluorouracil. Methods: Of the 48 patients with advanced pancreatic carcinoma receiving chemotherapy with gemcitabine and 5-fluorouracil, 24 received the selective transarterial infusion, and 24 the systemic chemotherapy. For the continuous transarterial infusion group (experimental group), all patients received gemcitabine 1000 mg/$m^2$, given by 30-minute transarterial infusion, on day 1 of a 4-week cycle for 2 cycles, and a dose of 600 mg/$m^2$ 5-fluorouracil was infused on days 1~5 of a 4-week cycle for 2 cycles. For the systemic venous group (control group), gemcitabine and 5-fluorouracil were infused through a peripheral vein, a dose of 1000 mg/$m^2$ gemcitabine being administrated over 30 min on days 1 and 8 of a 4-week cycle for 2 cycles, and a dose of 600 mg/$m^2$ 5-fluorouracil was infused on days 1~5 of a 4-week cycle for 2 cycles. The effectiveness and safety were evaluated after 2 cyclesaccording to WHO criteria. Results:The objective effective rate in transarterial group was 33.3% versus 25% in the systemic group, the difference not being significant (P=0.626). Clinical benefit rates(CBR) in the transarterial and systemic groups were 83.3% and 58.3%, respectively (P=0.014). The means and medians for survival time in transarterial group were higher than those of the systemic group (P < 0.005). at the same time, the adverse effects did not significantly differ between the two groups (P > 0.05). Conclusion: Continuous transarterial infusion chemotherapy with gemcitabine and 5-fluorouracil could improve clinical benefit rate and survival time of patients with advanced pancreatic carcinoma, compared with systemic venous chemotherapy. Since adverse effects were limited in the transarterial group, the regimen of continuous transarterial infusion chemotherapy can be used more extensively in clinical practice. A CT and MRI conventional sequence can be used for efficacy evaluation after chemotherapy in pancreatic carcinoma.