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  1. Article ; Online: Perceptions and Utility of Course Evaluations in US Pharmacy Schools.

    Chen, Aleda M H / Park, Sharon K / Bechtol, Robert A / Shah, Bupendra K / Anderson, Heather D / Young, M Andrew / Hardinger, Karen L / Odem, Samantha / Augustine, Jill

    American journal of pharmaceutical education

    2024  Volume 88, Issue 2, Page(s) 100646

    Abstract: Objective: This study aimed to describe the purpose, implementation, and perceived utility of course evaluations in pharmacy programs.: Methods: After a literature review, a 34-item survey was developed, pretested, and sent to assessment ... ...

    Abstract Objective: This study aimed to describe the purpose, implementation, and perceived utility of course evaluations in pharmacy programs.
    Methods: After a literature review, a 34-item survey was developed, pretested, and sent to assessment administrators at accredited pharmacy programs (N = 139) with at least 3 follow-ups. Descriptive and inferential statistics were performed in IBM SPSS Statistics software.
    Results: A total of 90 programs responded (64.7% response rate). Most students (94%) were offered the opportunity to complete course evaluations. Some students completed evaluations during the course (47%), while others did so within 1 week of completion of the course (49%). Whether or not class time was given for students to complete the survey was often dependent on faculty choice (52.2%). Results were typically released after final grades were posted (92%), in time to use for the next semester of teaching (77%). Faculty were chosen to be evaluated by the number of teaching hours (50%) followed by all instructors (45.6%). Programs used the results for performance reviews by chairs (91%), course coordinator reviews (84%), and committee continuous quality improvement efforts (72%). Most programs did not provide faculty guidance on using evaluations (78%) nor development/mentoring (57%); only 22% of programs offered student development in completing evaluations.
    Conclusion: While most programs invite feedback from all students via evaluations, most did not provide guidance to faculty on how to use this feedback for faculty or course development purposes. A more robust process to optimize the use of course evaluations should be developed.
    MeSH term(s) Humans ; Schools, Pharmacy ; Education, Pharmacy/methods ; Faculty ; Surveys and Questionnaires ; Students, Pharmacy
    Language English
    Publishing date 2024-01-09
    Publishing country United States
    Document type Review ; Journal Article
    ZDB-ID 603807-4
    ISSN 1553-6467 ; 0002-9459
    ISSN (online) 1553-6467
    ISSN 0002-9459
    DOI 10.1016/j.ajpe.2024.100646
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  2. Article ; Online: Racial, Ethnic, and Sex Diversity Trends in Health Professions Programs From Applicants to Graduates.

    Majerczyk, Daniel / Behnen, Erin M / Weldon, David J / Kanbar, Roy / Hardy, Yolanda M / Matsuda, Stanley K / Hardinger, Karen L / Khalafalla, Farid G

    JAMA network open

    2023  Volume 6, Issue 12, Page(s) e2347817

    Abstract: Importance: Diversity is an essential element of an effective health care system. A key to developing a diverse workforce is establishing a diverse student population in health professions programs.: Objective: To examine the diversity of students in ...

    Abstract Importance: Diversity is an essential element of an effective health care system. A key to developing a diverse workforce is establishing a diverse student population in health professions programs.
    Objective: To examine the diversity of students in Doctor of Medicine (MD), Doctor of Osteopathic Medicine (DO), Doctor of Dental Surgery (DDS), Doctor of Dental Medicine (DMD), and Doctor of Pharmacy (PharmD) programs with emphasis on the trends of underrepresented minoritized groups (American Indian or Alaska Native, Black or African American, Hispanic or Latino, and Native Hawaiian or Other Pacific Islander) and sex relative to the overall age-adjusted US population.
    Design, setting, and participants: This cross-sectional study used deidentified, self-reported data from 2003 to 2019 from the Association of American Medical Colleges, American Association of Colleges of Osteopathic Medicine, American Dental Education Association, American Dental Association, and American Association of Colleges of Pharmacy. Data analysis was performed from 2003 to 2004 and from 2018 to 2019.
    Exposures: Data on the race, ethnicity, and sex of applicants, matriculants, and degrees conferred by health professions programs were collected and compared with the age-adjusted population in the US Census (aged 20-34 years) over time.
    Main outcomes and measures: The main outcomes were trends in the proportions of underrepresented minoritized groups and sex diversity among applicants, matriculants, and degrees conferred relative to the overall age-adjusted US population. Trends were measured using the representation quotient, which is defined as the ratio of the proportion of each subgroup to the total population of applicants, matriculants, or graduates relative to the proportion for that subgroup within the US Census population of similar age. Regression analysis was used to evaluate the trend over time.
    Results: A total of 594 352 applicants were analyzed across the examined programs. From 2003 to 2019, the proportions of individuals from underrepresented groups increased for DDS and DMD (applicants, from 1003 of 8176 to 1962 of 11 298 [5.1%]; matriculants, from 510 of 4528 to 966 of 6163 [4.2%]; degrees awarded, from 484 of 4350 to 878 of 6340 [2.7%]), PharmD (applicants, from 9045 of 71 966 to 11 653 of 50 482 [9.0%]; matriculants, from 5979 of 42 627 to 10 129 to 62 504 [6.3%]; degrees awarded, from 922 of 7770 to 2190 of 14 800 [3.0%]), and DO (applicants, from 740 of 6814 to 3478 of 21 090 [5.4%]; degrees awarded, 199 of 2713 to 582 of 6703 [1.4%]) programs, but decreased for MD programs (applicants, from 6066 of 34 791 to 7889 of 52 777 [-2.3%]; matriculants, 2506 of 16 541 to 2952 of 21 622 [-2.4%]; degrees awarded, from 2167 of 15 829 to 2349 of 19 937 [-0.1%]). Compared with age-adjusted US Census data, all programs had more Asian students and fewer male, American Indian or Alaska Native, Black or African American, Hispanic or Latino, and Native Hawaiian or Other Pacific Islander students (representation quotient <1).
    Conclusions and relevance: In this cross-sectional study, most of the health professions in the study saw increases in underrepresented minority applicants, matriculants, and degrees conferred from 2003 to 2019; however, all programs were below the age-adjusted US Census data. The increased racial, ethnic, and sex diversity in the programs illustrates progress, but additional strategies are needed to achieve a more representative health care workforce.
    MeSH term(s) United States ; Humans ; Male ; Cross-Sectional Studies ; Health Occupations ; Health Personnel ; Pharmacy ; Ethnicity
    Language English
    Publishing date 2023-12-01
    Publishing country United States
    Document type Journal Article
    ISSN 2574-3805
    ISSN (online) 2574-3805
    DOI 10.1001/jamanetworkopen.2023.47817
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  3. Article ; Online: Certified Registered Nurse Anesthetists' occupational exposure to inhalational anesthetic agents: a survey of anesthetic gas safety.

    Masselink, Trent / Hardinger, Jan / Bowman-Dalley, Carrie / O'Guinn, Crystal / Hendrix, Kumudhini / Crowell, Nancy / Eshkevari, Ladan

    BMC anesthesiology

    2022  Volume 22, Issue 1, Page(s) 375

    Abstract: Background: Anesthetic gases have been known to cause damage when inhaled over long periods of time. Modern safety measures have been put in place to reduce the risk to anesthesia providers, however there is continued lack of information on providers ... ...

    Abstract Background: Anesthetic gases have been known to cause damage when inhaled over long periods of time. Modern safety measures have been put in place to reduce the risk to anesthesia providers, however there is continued lack of information on providers experiencing short term effects (lethargy, fatigue, headache, slowed cognitive ability, nausea, and mucosal irritation) thereby leading to long-term sequalae (sister chromatid exchanges, micronuclei, chromosomal aberrations, and comet assays).
    Method: A thirteen item, multiple choice survey was sent to 3,000 anesthesia providers, of which 463 completed the survey. A Chi-square test of independence was used to determine the association between gas exposure and participant self-reported symptoms. A Spearman's Correlation test was also utilized to interpret this data since both frequency of smelling gas and frequency of symptoms were ordinal variables for which Spearman's rho correlation was the appropriate measure of association.
    Results: The major findings were that as the frequency of smelling anesthetic gas increased, so too did the frequency of self-reported headaches and fatigue. Spearman's rho = .148 and .092. P value = .002 and .049, respectively.
    Conclusion: There have been many efforts to decrease the risk of exposure of anesthesia providers to anesthetic gases. While there is a decrease in reported exposures, indications of possible long-term effects remain a concern in anesthesia providers. Potential implications of exposure could lead to chromosomal aberrations, sister chromatid exchanges, comet assays, spontaneous abortions, and genotoxic effects.
    MeSH term(s) Female ; Pregnancy ; Humans ; Anesthetics, Inhalation/adverse effects ; Nurse Anesthetists ; Occupational Exposure/adverse effects ; Chromosome Aberrations ; Fatigue
    Chemical Substances Anesthetics, Inhalation
    Language English
    Publishing date 2022-12-03
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, P.H.S.
    ZDB-ID 2091252-3
    ISSN 1471-2253 ; 1471-2253
    ISSN (online) 1471-2253
    ISSN 1471-2253
    DOI 10.1186/s12871-022-01896-y
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  4. Article ; Online: Pharmacists' guide to the management of organ donors after brain death.

    Korte, Catherine / Garber, Jennifer L / Descourouez, Jillian L / Richards, Katelyn R / Hardinger, Karen

    American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists

    2016  Volume 73, Issue 22, Page(s) 1829–1839

    Abstract: Purpose: This article reviews organ donor pathophysiology as it relates to medication use with the goal of maximizing the successful procurement and transplantation of donor organs.: Summary: The number of patients requiring organ transplantation ... ...

    Abstract Purpose: This article reviews organ donor pathophysiology as it relates to medication use with the goal of maximizing the successful procurement and transplantation of donor organs.
    Summary: The number of patients requiring organ transplantation continues to grow, yet organ donation rates remain flat, making it critical to appropriately manage each organ donor in order to ensure viability of all transplantable organs. The care given to one organ donor is tantamount to the care of several transplant recipients. Aggressive donor management ensures that the largest number of organs can be successfully procured and improves the organs' overall quality. Hospital pharmacists are responsible for processing orders and preparing the medications outlined in donor management algorithms developed by their respective medical systems. It is important that pharmacists understand the details of the medications used in these protocols in order to critically evaluate each medication order and appropriately manage the donor. Typical medications used in organ donors after brain death include medications for blood pressure management and fluid resuscitation, medications necessary for electrolyte management, blood products, vasopressors, hormone replacement therapy, antiinfectives, anticoagulants, paralytics, and organ preservation solutions.
    Conclusion: It is essential to provide optimal pharmacotherapy for each organ donor to ensure organ recovery and donation. Typical medications used in organ donors include agents for blood pressure management and fluid resuscitation, medications necessary for electrolyte management, blood products, vasopressors, hormone replacement therapy, antiinfectives, anticoagulants, paralytics, and organ preservation solutions.
    MeSH term(s) Anticoagulants/administration & dosage ; Antihypertensive Agents/administration & dosage ; Brain Death/blood ; Brain Death/diagnosis ; Humans ; Organ Preservation Solutions/administration & dosage ; Pharmacists/standards ; Professional Role ; Tissue Donors ; Tissue and Organ Procurement/methods ; Tissue and Organ Procurement/standards
    Chemical Substances Anticoagulants ; Antihypertensive Agents ; Organ Preservation Solutions
    Language English
    Publishing date 2016-09-23
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 1224627-x
    ISSN 1535-2900 ; 1079-2082
    ISSN (online) 1535-2900
    ISSN 1079-2082
    DOI 10.2146/ajhp150956
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  5. Article: Bortezomib as rescue therapy for antibody mediated rejection: a single-center experience.

    Hardinger, Karen L / Alford, Kelly / Murillo, Daniel

    Clinical transplants

    2010  , Page(s) 429–436

    Abstract: Case series have reported the use of bortezomib for treatment of primary and refractory treatment of cell-mediated acute rejection. The purpose of this article is to review a single-center experience with bortezomib used to treat humoral rejection in ... ...

    Abstract Case series have reported the use of bortezomib for treatment of primary and refractory treatment of cell-mediated acute rejection. The purpose of this article is to review a single-center experience with bortezomib used to treat humoral rejection in four transplant recipients. All patients received bortezomib after suffering antibody-mediated rejection refractory to intravenous immunoglobulin and plasmapheresis. Each patient had improved renal function after bortezomib treatment, biopsies became c4d negative in three of the four patients and the level of donor specific antibody reduction was mixed. Adverse drug events were not encountered, although two patients suffered infections, H1N1 pneumonia and cytomegalovirus colitis. In conclusion, these four cases demonstrate the promising use of bortezomib as rescue therapy for antibody mediated rejection. Future research is needed to explore the impact of bortezomib on HLA removal, histological reversal of rejection, and long-term graft function after transplantation.
    MeSH term(s) Adult ; Biopsy ; Boronic Acids/adverse effects ; Boronic Acids/therapeutic use ; Bortezomib ; Female ; Graft Rejection/immunology ; Graft Rejection/pathology ; Graft Rejection/prevention & control ; Graft Survival/drug effects ; HLA Antigens/immunology ; Humans ; Immunity, Humoral/drug effects ; Immunosuppressive Agents/adverse effects ; Immunosuppressive Agents/therapeutic use ; Isoantibodies/blood ; Kidney Transplantation/immunology ; Male ; Middle Aged ; Protease Inhibitors/adverse effects ; Protease Inhibitors/therapeutic use ; Proteasome Endopeptidase Complex/metabolism ; Proteasome Inhibitors ; Pyrazines/adverse effects ; Pyrazines/therapeutic use ; Salvage Therapy ; Time Factors ; Treatment Outcome
    Chemical Substances Boronic Acids ; HLA Antigens ; Immunosuppressive Agents ; Isoantibodies ; Protease Inhibitors ; Proteasome Inhibitors ; Pyrazines ; Bortezomib (69G8BD63PP) ; Proteasome Endopeptidase Complex (EC 3.4.25.1)
    Language English
    Publishing date 2010
    Publishing country United States
    Document type Case Reports ; Journal Article
    ZDB-ID 607631-2
    ISSN 0890-9016
    ISSN 0890-9016
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  6. Article: Bortezomib for acute humoral rejection in two repeat transplant recipients.

    Hardinger, Karen L / Alford, Kelly / Murillo, Daniel

    Clinical transplants

    2009  , Page(s) 479–483

    Abstract: Case series have reported the use of bortezomib to remove antibodies in live-donor transplant recipients with HLA alloantibodies and to treat antibody and cell-mediated acute rejection. The purpose of this article is to review a single-center experience ... ...

    Abstract Case series have reported the use of bortezomib to remove antibodies in live-donor transplant recipients with HLA alloantibodies and to treat antibody and cell-mediated acute rejection. The purpose of this article is to review a single-center experience with bortezomib used to treat humoral rejection in two sensitized, repeat transplant recipients. Both patients received bortezomib after suffering antibody-mediated rejection refractory to intravenous immunoglobulin and plasmapheresis. Short-term follow-up of the case reports presented here demonstrated that renal function has improved after bortezomib treatment while the immunological outcomes were mixed. In the first case the donor specific antibodies initially decreased, but then rebounded and in the second case the DR antibodies decreased while the DQ antibodies increased slightly. In conclusion, these two cases demonstrate the promising use of bortezomib in antibody mediated rejection. Future research is needed to explore the impact of bortezomib on HLA removal, histological reversal of rejection, and long-term graft function after transplantation.
    MeSH term(s) Acute Disease ; Adult ; B-Lymphocytes/immunology ; Boronic Acids/therapeutic use ; Bortezomib ; Creatinine/blood ; Female ; Flow Cytometry ; Graft Rejection/drug therapy ; HLA-DQ Antigens/immunology ; Humans ; Immunity, Humoral/drug effects ; Immunosuppressive Agents/therapeutic use ; Isoantibodies/blood ; Kidney Transplantation/immunology ; Kidney Transplantation/pathology ; Male ; Middle Aged ; Pyrazines/therapeutic use ; Reoperation ; T-Lymphocytes/immunology
    Chemical Substances Boronic Acids ; HLA-DQ Antigens ; HLA-DQ6 antigen ; Immunosuppressive Agents ; Isoantibodies ; Pyrazines ; Bortezomib (69G8BD63PP) ; Creatinine (AYI8EX34EU)
    Language English
    Publishing date 2009
    Publishing country United States
    Document type Case Reports ; Journal Article
    ZDB-ID 607631-2
    ISSN 0890-9016
    ISSN 0890-9016
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  7. Article: Improvement of Immunosuppressive Medication Adherence Using a SystemCHANGE Intervention: Case Study of an Older Adult Kidney Transplant Recipient.

    Russell, Cynthia L / Miller, Courtney / Remy, Laura M / Wessol, Jennifer L / Andrews, Angela M / Aholt, Dana / Clark, Debra / Hardinger, Karen / O'Brien, Tara / Hathaway, Donna / Goggin, Kathy

    Nephrology nursing journal : journal of the American Nephrology Nurses' Association

    2018  Volume 45, Issue 2, Page(s) 171–223

    Abstract: This article reports a case study of an older adult kidney transplant recipient with poor medication adherence enrolled in an innovative six-month SystemCHANGE intervention that seeks to systematically improve medication adherence by identifying and ... ...

    Abstract This article reports a case study of an older adult kidney transplant recipient with poor medication adherence enrolled in an innovative six-month SystemCHANGE intervention that seeks to systematically improve medication adherence by identifying and shaping routines, involving others in routines, and using medication-taking feedback through small, patient-led experiments. Medication adherence increased immediately and was sustained throughout the intervention and maintenance phases. This is the first case study to demonstrate effectiveness of the SystemCHANGE intervention for promoting medication adherence in a kidney transplant recipient. The intervention improved the timing of doses by linking them to a regularly occurring behavior and providing feedback. The SystemCHANGE intervention represents a systems-thinking approach for both provider and patients, and gives healthcare providers the tools needed to assist patients in using habits and routines, and feedback to improve medication taking and timing.
    MeSH term(s) Aged ; Humans ; Immunosuppressive Agents/administration & dosage ; Kidney Transplantation ; Medication Adherence
    Chemical Substances Immunosuppressive Agents
    Language English
    Publishing date 2018-10-10
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2008177-7
    ISSN 1526-744X ; 8750-0779
    ISSN 1526-744X ; 8750-0779
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  8. Article ; Online: BK-virus and the impact of pre-emptive immunosuppression reduction: 5-year results.

    Hardinger, K L / Koch, M J / Bohl, D J / Storch, G A / Brennan, D C

    American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons

    2010  Volume 10, Issue 2, Page(s) 407–415

    Abstract: A 1-year, single-center, randomized trial demonstrated that the calcineurin inhibitor or adjuvant immunosuppression, independently, does not affect BK-viruria or viremia and that monitoring and pre-emptive withdrawal of immunosuppression was associated ... ...

    Abstract A 1-year, single-center, randomized trial demonstrated that the calcineurin inhibitor or adjuvant immunosuppression, independently, does not affect BK-viruria or viremia and that monitoring and pre-emptive withdrawal of immunosuppression was associated with resolution of BK-viremia and absence of clinical BK-nephropathy without acute rejection or graft loss. A retrospective 5-year review of this trial was conducted. In cases of BK viremia, the antimetabolite was withdrawn and for sustained viremia, the calcineurin inhibitor was minimized. Five-year follow-up was available on 97% of patients. Overall 5-year patient survival was 91% and graft survival was 84%. There were no differences in patient-survival by immunosuppressive regimen or presence of BK-viremia. Immunosuppression and viremia did not influence graft survival. Acute rejection occurred in 12% by 5-years after transplant, was less common with tacrolimus versus cyclosporine (9% vs. 18%; p = 0.082), and was lowest with the tacrolimus-azathioprine regimen (5%, p = 0.127). Tacrolimus was associated with better renal function at 5-years (eGFR 63 FK vs. 52 CsA mL/min, p = 0.001). Minimization of immunosuppression upon detection of BK-viremia was associated with excellent graft survival at 5-years, low rejection rates and excellent renal function. It is a safe, short and long-term strategy that resulted in freedom from clinically evident BK-virus nephropathy.
    MeSH term(s) Azathioprine/therapeutic use ; BK Virus/drug effects ; Cyclosporine/therapeutic use ; Graft Survival/drug effects ; Humans ; Immunosuppression Therapy/methods ; Immunosuppressive Agents/therapeutic use ; Kidney Diseases ; Kidney Function Tests ; Tacrolimus/therapeutic use ; Viremia
    Chemical Substances Immunosuppressive Agents ; Cyclosporine (83HN0GTJ6D) ; Azathioprine (MRK240IY2L) ; Tacrolimus (WM0HAQ4WNM)
    Language English
    Publishing date 2010-01-05
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 2060594-8
    ISSN 1600-6143 ; 1600-6135
    ISSN (online) 1600-6143
    ISSN 1600-6135
    DOI 10.1111/j.1600-6143.2009.02952.x
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    Zs.A 5542: Show issues Location:
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  9. Article: A randomized, prospective, pharmacoeconomic trial of neoral 2-hour postdose concentration monitoring versus tacrolimus trough concentration monitoring in de novo liver transplant recipients.

    Shenoy, Surendra / Hardinger, Karen L / Crippin, Jeffrey / Korenblat, Kevin / Lisker-Melman, Mauricio / Lowell, Jeffrey A / Chapman, William

    Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society

    2008  Volume 14, Issue 2, Page(s) 173–180

    Abstract: Two-hour postdose cyclosporine (C2) monitoring is becoming an accepted method of therapeutic drug monitoring, although it is not known whether C2 monitoring is superior to tacrolimus (FK)-based immunosuppression. The purpose of this trial was to compare ... ...

    Abstract Two-hour postdose cyclosporine (C2) monitoring is becoming an accepted method of therapeutic drug monitoring, although it is not known whether C2 monitoring is superior to tacrolimus (FK)-based immunosuppression. The purpose of this trial was to compare the safety, efficacy, and pharmacoeconomics of cyclosporine A (CsA) monitored by C2 levels versus FK monitored by trough levels in de novo liver transplant recipients. After informed consent, 60 de novo liver transplant recipients were randomized in a 1:1 fashion to receive either FK (trough, 6-10 ng/mL) or CsA (C2, 600-1200 ng/mL) and corticosteroids. The 2 groups were similar for gender, race, indication for liver disease, and age. At 1 year, patient survival was similar (93% for FK versus 90% for C2). One patient in the FK arm was retransplanted because of recurrent hepatitis C virus (HCV). Early acute rejection occurred in 27% of FK-treated patients and 23% of CsA-treated recipients [P = not significant (NS)]. Recurrent HCV occurred in 21% of FK-treated patients and 61% of CsA-treated patient (P = 0.04). The incidence of other infections, new onset diabetes mellitus, requirement for antihypertensives, and requirement for cholesterol medications were similar between the groups. Annual calcineurin inhibitor costs were lower in the C2 arm ($5432 +/- 2091 for C2 versus $8291 +/- 3948 for FK, P = 0.001). Annual pretransplant drug costs ($2292 +/- 2331 for C2 versus $2831 +/- 2358 for FK, P = NS) and 1-year posttransplant drug costs ($17,214 +/- 16,600 for C2 versus $15,151 +/- 11,699 for FK, P = NS) were similar. In conclusion, immunosuppression with CsA, monitored by C2 levels, is safe, effective, and economical in liver transplant recipients and provides immunosuppression at least equivalent to that of FK.
    MeSH term(s) Adrenal Cortex Hormones/therapeutic use ; Adult ; Cost-Benefit Analysis ; Cyclosporine/adverse effects ; Cyclosporine/blood ; Cyclosporine/economics ; Cyclosporine/pharmacokinetics ; Drug Costs ; Drug Monitoring/economics ; Drug Monitoring/methods ; Female ; Graft Rejection/prevention & control ; Graft Survival/drug effects ; Humans ; Immunosuppressive Agents/adverse effects ; Immunosuppressive Agents/blood ; Immunosuppressive Agents/economics ; Immunosuppressive Agents/pharmacokinetics ; Liver Diseases/blood ; Liver Diseases/drug therapy ; Liver Diseases/mortality ; Liver Diseases/surgery ; Liver Transplantation/economics ; Male ; Middle Aged ; Prospective Studies ; Tacrolimus/adverse effects ; Tacrolimus/blood ; Tacrolimus/economics ; Tacrolimus/pharmacokinetics ; Time Factors
    Chemical Substances Adrenal Cortex Hormones ; Immunosuppressive Agents ; Cyclosporine (83HN0GTJ6D) ; Tacrolimus (WM0HAQ4WNM)
    Language English
    Publishing date 2008-02
    Publishing country United States
    Document type Comparative Study ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2006866-9
    ISSN 1527-6473 ; 1527-6465
    ISSN (online) 1527-6473
    ISSN 1527-6465
    DOI 10.1002/lt.21355
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  10. Article: Sirolimus conversion in liver transplant recipients with renal dysfunction: a prospective, randomized, single-center trial.

    Shenoy, Surendra / Hardinger, Karen L / Crippin, Jeffrey / Desai, Niraj / Korenblat, Kevin / Lisker-Melman, Mauricio / Lowell, Jeffrey A / Chapman, William

    Transplantation

    2007  Volume 83, Issue 10, Page(s) 1389–1392

    Abstract: This pilot trial was designed to assess the safety and efficacy of SRL in liver transplant recipients with renal dysfunction. Forty patients with renal dysfunction (24-hr CrCl 40-80 mL/min) were randomized to be withdrawn from the calcineurin inhibitor ( ... ...

    Abstract This pilot trial was designed to assess the safety and efficacy of SRL in liver transplant recipients with renal dysfunction. Forty patients with renal dysfunction (24-hr CrCl 40-80 mL/min) were randomized to be withdrawn from the calcineurin inhibitor (CNI) and receive sirolimus (SRL) or to continue CNI (control arm). Improvement in 24-hour CrCl was seen in the SRL arm at 3 months (75 mL/min SRL vs. 56 mL/min control, P=0.012), whereas at 12 months there was a trend toward improvement in the SRL arm (72 mL/min SRL vs. 58 mL/min control, P=0.09). Two patients, one in each arm, developed steroid-sensitive rejection. Side effects of SRL were limited and included hyperlipidemia requiring treatment (15%), pruritus (5%), and mouth sores (25%). In this trial, SRL-based immunosuppression was a safe alternative to CNI. Although early improvements were observed, withdrawing CNI and replacing it with SRL did not result in a statistically significant improvement in renal function at 12 months of follow-up.
    MeSH term(s) Aged ; Cholesterol/blood ; Female ; Follow-Up Studies ; Graft Rejection/epidemiology ; Humans ; Immunosuppressive Agents/therapeutic use ; Lipoproteins, LDL/blood ; Liver Function Tests ; Liver Transplantation/immunology ; Liver Transplantation/physiology ; Male ; Middle Aged ; Patient Selection ; Sirolimus/pharmacokinetics ; Sirolimus/therapeutic use ; Triglycerides/blood
    Chemical Substances Immunosuppressive Agents ; Lipoproteins, LDL ; Triglycerides ; Cholesterol (97C5T2UQ7J) ; Sirolimus (W36ZG6FT64)
    Language English
    Publishing date 2007-05-27
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 208424-7
    ISSN 1534-6080 ; 0041-1337
    ISSN (online) 1534-6080
    ISSN 0041-1337
    DOI 10.1097/01.tp.0000261630.63550.41
    Database MEDical Literature Analysis and Retrieval System OnLINE

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