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1.
Soon Jun Hong Han Saem Jeong Jeong Cheon Ahn Dong-Hun Cha Kyung Heon Won Weon Kim Sang Kyoon Cho Seok-Yeon Kim Byung-Su Yoo Ki Chul Sung Seung-Woon Rha Joon-Han Shin Kyoo Rok Han Wook Sung Chung Min Su Hyon Han Cheol Lee Jang-Ho Bae Moo-Yong Rhee Hyo-Soo Kim 《Clinical therapeutics》2018,40(2):226-241.e4
Purpose
Combination therapy with ezetimibe and statins is recommended in cases of statin intolerance or insufficiency. The objective of this study was to compare the efficacy and safety of combination therapy with ezetimibe and rosuvastatin versus those of rosuvastatin monotherapy in patients with hypercholesterolemia.Methods
I-ROSETTE (Ildong ROSuvastatin & ezETimibe for hypercholesTElolemia) was an 8-week, double-blind, multicenter, Phase III randomized controlled trial conducted at 20 hospitals in the Republic of Korea. Patients with hypercholesterolemia who required medical treatment according to National Cholesterol Education Program Adult Treatment Panel III guidelines were eligible for participation in the study. Patients were randomly assigned to receive ezetimibe 10 mg/rosuvastatin 20 mg, ezetimibe 10 mg/rosuvastatin 10 mg, ezetimibe 10 mg/rosuvastatin 5 mg, rosuvastatin 20 mg, rosuvastatin 10 mg, or rosuvastatin 5 mg in a 1:1:1:1:1:1 ratio. The primary end point was the difference in the mean percent change from baseline in LDL-C level after 8 weeks of treatment between the ezetimibe/rosuvastatin and rosuvastatin treatment groups. All patients were assessed for adverse events (AEs), clinical laboratory data, and vital signs.Findings
Of 396 patients, 389 with efficacy data were analyzed. Baseline characteristics among 6 groups were similar. After 8 weeks of double-blind treatment, the percent changes in adjusted mean LDL-C levels at week 8 compared with baseline values were –57.0% (2.1%) and –44.4% (2.1%) in the total ezetimibe/rosuvastatin and total rosuvastatin groups, respectively (P < 0.001). The LDL-C–lowering efficacy of each of the ezetimibe/rosuvastatin combinations was superior to that of each of the respective doses of rosuvastatin. The mean percent change in LDL-C level in all ezetimibe/rosuvastatin combination groups was >50%. The number of patients who achieved target LDL-C levels at week 8 was significantly greater in the ezetimibe/rosuvastatin group (180 [92.3%] of 195 patients) than in the rosuvastatin monotherapy group (155 [79.9%] of 194 patients) (P < 0.001). There were no significant differences in the incidence of overall AEs, adverse drug reactions, and serious AEs; laboratory findings, including liver function test results and creatinine kinase levels, were comparable between groups.Implications
Fixed-dose combinations of ezetimibe/rosuvastatin significantly improved lipid profiles in patients with hypercholesterolemia compared with rosuvastatin monotherapy. All groups treated with rosuvastatin and ezetimibe reported a decrease in mean LDL-C level >50%. The safety and tolerability of ezetimibe/rosuvastatin therapy were comparable with those of rosuvastatin monotherapy. ClinicalTrials.gov identifier: NCT02749994. 相似文献2.
Woohyeun Kim Yeonyee E. Yoon Sung-Hee Shin Jang-Whan Bae Bum-Kee Hong Soon Jun Hong Ki Chul Sung Seung Hwan Han Weon Kim Moo-Yong Rhee Sang-Hyun Kim Sang Eun Lee Min Su Hyon Gyo-Seung Hwang Jang Won Son Jang-Young Kim Min Kyu Kim Sang Wook Kim Chang Gyu Park 《Clinical therapeutics》2018,40(6):993-1013
Purpose
The aim of this study was to evaluate the safety and efficacy of combination treatment of rosuvastatin with ezetimibe in patients with primary hypercholesterolemia.Methods
This multicenter, randomized, double-blind study comprised a main study and an extension study. In the main study, the efficacy and safety of a combination of rosuvastatin (5, 10, and 20 mg) with ezetimibe (10 mg) were compared with those of rosuvastatin (5, 10, and 20 mg) alone. The subjects who achieved the National Cholesterol Education Program Adult Treatment Panel III LDL-C goal in the main study and agreed to a further study were enrolled for the extension study. In the extension study, ezetimibe 10 mg was also administered to subjects who had received rosuvastatin (5, 10, and 20 mg) alone in the main study, and the same treatment was continued for subjects who had received a combination of rosuvastatin with ezetimibe in the main study.Findings
At the end of the main study (week 8), LDL-C levels were significantly lower in subjects receiving combination therapy than in those receiving rosuvastatin monotherapy. Other lipid profiles also significantly improved in the combination therapy group. These improvements continued in the extension study. The combination therapy of rosuvastatin and ezetimibe was generally well tolerated. At the end of the main study, more subjects achieved the National Cholesterol Education Program Adult Treatment Panel III LDL-C goal in the combination therapy group than in the monotherapy group. The increased dosage of rosuvastatin was also well tolerated in the combination treatment.Implications
Combination therapy of ezetimibe 10 mg with varying doses of rosuvastatin that are commonly used in the clinical field improved the lipid profile and allowed more subjects to reach the LDL-C goal in primary hypercholesterolemia compared with rosuvastatin monotherapy. In addition, the efficacy of the combination therapy was maintained for the extended period. Additional beneficial changes were also achieved with combination therapy even in patients who responded well to rosuvastatin monotherapy. ClinicalTrials.gov identifier: NCT03288038. 相似文献3.
Maurizio Rondinelli Antonio Rossi Alessandra Gandolfi Fabio Saponaro Loredana Bucciarelli Guido Adda Chiara Molinari Laura Montefusco Claudia Specchia Maria Chiara Rossi Marco Scardapane Maura Arosio Stefano Genovese 《Clinical therapeutics》2017,39(1):159-169
Purpose
An observational retrospective study was conducted by 2 diabetes clinics in Italy to assess patterns of use and long-term effectiveness of liraglutide on established and emerging parameters.Methods
Data from 261 patients with type 2 diabetes who started treatment with liraglutide between 2010 and 2014 were collected. Hierarchical linear regression models were applied to assess trends over time of clinical parameters. Factors associated with higher likelihood of dropout were identified through multivariate logistic analysis.Findings
Liraglutide was initiated as a switch in 42.5% of patients and as an add-on in 49.8%; in 7.7% of the patients initiation of liraglutide was associated with a reduction in the number of pharmacologic agents. A statistically significant reduction after 36 months was found for the following parameters (mean change [95% CIs]): glycosylated hemoglobin (HbA1c; –1.01% [1.34% to –0.68%]), fasting blood glucose (–27.5 [–40.6 to –14.4] mg/dL), weight (–2.9 [–4.5 to –1.3] kg), body mass index (–1.13 [–1.76 to –0.50] kg/m2), waist circumference (–1.74 [–3.85 to –0.37] cm), and LDL-C (–24.7 [–36.67 to –12.8] mg/dL). Improvements in systolic (–3.5 mm Hg) and diastolic (–2.3 mm Hg) blood pressures were observed at 24 months. Albuminuria was reduced by –16.6 mg/L during 36 months, although statistical significance was not reached. Glomerular filtration rate and heart rate were unchanged. Reductions in HbA1c between –0.6% and –1.3% were obtained in specific subgroups. Treatment was effective also in patients with >20 years of diabetes duration, although the likelihood of dropout was 6% higher for each additional year of disease duration (RR = 1.06; 95% CI, 1.01–1.12). The likelihood of dropout was almost four times higher for subjects treated with insulin (RR = 3.82; 95% CI, 1.22–11.96) and more than twice for those treated with sulfonylureas (RR = 2.39; 95% CI, 1.16–4.94) compared with patients not treated with these agents.Implications
Liraglutide used in routine clinical conditions maintains its effectiveness on metabolic control and weight after 3 years. Improvements in terms of metabolic control were found when liraglutide was used as both switch and add-on treatment. In addition, improvements were sustained when liraglutide replaced sulfonylureas or insulin. Diabetes duration had no impact on drug efficacy. Long-term benefits relative to blood pressure and LDL-C were also found, which could not be entirely explained by antihypertensive/lipid-lowering treatment intensification. No major effect on renal parameters was documented. Diabetes duration and some concomitant treatments were associated with a higher likelihood of liraglutide discontinuation. These data can contribute to improve appropriateness and cost-effectiveness profile of liraglutide. 相似文献4.
Diana Gritsenko Marianna Fedorenko Jorg J. Ruhe Jerry Altshuler 《Clinical therapeutics》2017,39(1):212-218
Purpose
Although vancomycin has been the mainstay of therapy for methicillin-resistant Staphylococcus aureus (MRSA) infections, its effectiveness has been challenged. Combination therapy may be used for patients with persistent MRSA bacteremia refractory to initial therapy. Studies have reported in vitro synergy between vancomycin and ceftaroline; however, clinical experience with this therapy is limited. Here, we report our experience with 5 cases of vancomycin-refractory MRSA bacteremia treated with the combination of vancomycin and ceftaroline.Methods
Between January 2014 and August 2016, 5 patients were identified who received vancomycin and ceftaroline combination therapy due to persistent bacteremia or deterioration of their clinical status on vancomycin alone (despite a vancomycin MIC within the susceptible range).Findings
Five patients presented with MRSA bacteremia secondary to endocarditis (n = 2), epidural abscess (n = 2), or left iliopsoas abscess (n = 1). Four of the 5 patients experienced microbiologic cure, and 1 patient transitioned to palliative care.Implications
This case series serves to describe additional clinical experience with vancomycin and ceftaroline combination therapy. This combination may be considered when vancomycin monotherapy does not lead to microbiological and/or clinical improvement in patients with metastatic MRSA bacteremia. Additional studies are warranted to further define its role in salvage therapy for persistent MRSA bacteremia. 相似文献5.
Ryan Jajosky Mark Floyd Thomas Thompson James Shikle 《Transfusion and apheresis science》2017,56(4):591-594
Background
The PLASMIC score was recently described as a convenient tool for predicting ADAMTS13 activity ≤10% in patients with possible thrombotic thrombocytopenic purpura (TTP), while awaiting the results of this send-out test. The purpose of this study was to validate the PLASMIC score at our University Medical Center.Methods
Apheresis records were reviewed from 2008 to 2017 to identify patients who received plasma exchange (PLEX) for suspected TTP. The ADAMTS13 activity and PLASMIC scoring criteria were recorded, and the PLASMIC score was calculated.Results
Of the 41 patients identified, 20 met inclusion criteria, of which 7 patients had ADAMTS13 activity ≤10%. Intermediate and high PLASMIC scores had 100% sensitivity, 46.2% specificity, 50% positive predictive value (PPV), and 100% negative predictive value (NPV).Conclusion
These results are consistent with the original validation study of the PLASMIC score, supporting the efficacy of the PLASMIC score and validating its use at our institution. 相似文献6.
Lishi Wang Yanhong Cao Mingji Ren Amei Chen Jinglin Cui DiaJun Sun Weikuan Gu 《Clinical therapeutics》2017,39(1):34-54
Purpose
Understanding how sex impacts the efficacy of anticancer agents is a crucial step toward personalized and precision medicine. This review and meta-analysis evaluated sex differences in hazard ratios (HRs) of progression-free survival and overall survival in representative Phase III clinical trials of non–small-cell lung cancer (NSCLC).Methods
Data were extracted from 24 large-scale clinical trials that included 12,000 male and 7000 female patients. The data were examined for HR differences between subgroups by sex, smoking status, and age, and for potential sex–smoking status, sex–age, and sex–drug interactions, during cancer treatment.Findings
Summarized information revealed variations in the influences of sex, smoking status, and age on the efficacy of drugs used for the treatment of NSCLC. The male and female subgroups had different HR values. Smoking status, age, and the percentage of female patients in a treatment group had no influence on the sex HR. The sex difference was supported by a set of data collected from all journals.Implications
The findings from this meta-analysis are important for assessing potential toxicity during drug treatment in both sexes. The outcomes measures of a drug in clinical application should be specified by subpopulation, such as males versus females, as a first step in personalized medicine. 相似文献7.
Gyu Chul Oh Jung-Kyu Han Ki Hoon Han Min-Su Hyon Joon Hyung Doh Moo Hyun Kim Jin-Ok Jeong Jang-Ho Bae Sang Hyun Kim Byung-Su Yoo Sang Hong Baek Moo-Yong Rhee Sang-Hyun Ihm Jung Hoon Sung Young Jin Choi Soo-Joong Kim Kyung-Soon Hong Byoung Kwon Lee Hyo-Soo Kim 《Clinical therapeutics》2018,40(5):676-691.e1
Purpose
Hypertension and dyslipidemia are 2 risk factors of cardiovascular disease that often present simultaneously. Traditionally, treatment of these multiple conditions required separate medications for each disease, which may result in poor compliance and thus lead to possible treatment failure. Fixed-dose combination (FDC) therapy with a single pill may be a solution in these situations.Methods
This multicenter, 8-week, randomized, double-blind, Phase III study evaluated the efficacy and safety of FDC treatment with telmisartan (80 mg) and rosuvastatin calcium (20 mg) in Korean patients with mild to moderate hypertension and dyslipidemia. Patients were randomly assigned to 4 groups: (1) FDC drug (80 mg of telmisartan and 20 mg of rosuvastatin); (2) 80 mg of telmisartan; (3) 20 mg of rosuvastatin; or (4) placebo. After 8 weeks of treatment, the change in mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) between the FDC group and the rosuvastatin group, and the percent change in LDL-C between the FDC group and the telmisartan group, were compared.Findings
A total of 210 patients were enrolled in the study (84 in the FDC group, 42 in the rosuvastatin group, 43 in the telmisartan group, and 41 in the placebo group). The reduction in blood pressure was significantly greater in the FDC group than in the rosuvastatin group after 8 weeks of treatment (least squares mean change from baseline, –16.1 [1.6] mm Hg vs –1.7 [2.2] mm Hg [P < 0.001] for MSSBP; –8.8 [1.0] mm Hg vs –1.6 [1.4] mm Hg [P < 0.001] for MSDBP). Least squares mean percent change in LDL-C from baseline was also significantly greater in the FDC group compared with the telmisartan group (–49.3% [2.2%] vs 1.5% [3.0%]; P < 0.001). FDC therapy also had a higher rate of achieving the treatment goal in both blood pressure (60% vs 45%; P = 0.024) and LDL-C (88.8% vs 16.3%; P < 0.001) compared with rosuvastatin or telmisartan alone, respectively. In regression analysis, higher baseline MSSBP, female sex, and lower body mass index were associated with increased reductions in MSSBP, whereas higher baseline LDL-C level and lower body mass index were associated with greater reductions in LDL-C. There were 48 adverse events in 36 patients (17.3% [36 of 208]), and 17 adverse drug reactions in 12 patients (5.8% [12 of 208]), indicating no significant differences in short-term safety among study groups.Implications
Treatment with an FDC drug containing telmisartan and rosuvastatin showed similar efficacy in lowering blood pressure and LDL-C levels compared with that of each single drug. ClinicalTrials.gov identifier: NCT01914432. 相似文献8.
Li-xin Jiao Jiang-hong Yu Xiao-li Yu Lin Chen Yu Han Fan Yang 《Transfusion and apheresis science》2017,56(2):223-225
Objective
To identify the precise ABO blood type subgroups with genotyping.Method
We screened ABO blood type from voluntary blood donors in our blood collection center. Samples were first examined with a routine serological method. Samples with ambiguous results were further examined with genotyping to identify ABO subgroups.Results
Two samples identified as AweakB by serology were considered to be A/B and B/B by PCR-SSP. However, the gene sequencing results revealed the precise subgroup to be CisAB01/B101 and CisAB05/B101, respectively.Conclusion
It may be difficult to identify non-typical AB patients with a routine serological method. Genotyping is a more precise method to identify blood subgroups. 相似文献9.
Sara Alfieri 《Transfusion and apheresis science》2017,56(5):723-731
Background
Scientific literature on blood donation is prevalently concentrated on adults, leaving out adolescents almost completely. While the latter represents “ideal” candidates, they constitute, however, the segment of the population least present among blood donors.Objectives
The present work, composed of two studies, proposes looking into the representations that the adolescents have of blood donation and give voice to the motivations that could persuade them to becoming donors once they reach the legal age for donation. Study I aims to investigate adolescents’ representations about the world of blood donation. Study II aims to investigate a) the underlying motivations for blood donations and b) the relationship between motivations and propensity to donate.Materials/Methods
This paper is based on a mixed methods research design. In Study I, five focus groups were conducted comprising a total of 25 adolescents; for Study II, a self-report questionnaire was administered to 285 adolescents.Results
Study I reveals a lack of information for everything regarding donation, something that produces fear, false beliefs, and an idealized image of the donor.Study II shows that for males, social motivations are fundamental while ego-protective motivations are deterrents, and that females are most impacted by understanding.Conclusion
The study shows how the adolescent population cannot be recruited in the same way as adults, and presents valuable points for those who finalize advertising campaigns for donor recruitment recruitment. 相似文献10.
Akira Iwama Junichi Hirayama Masayuki Nogawa Masayuki Shiba Masahiro Satake Shigeru Takamoto Kenji Tadokoro 《Transfusion and apheresis science》2017,56(2):241-244
Background
Washed platelet concentrate (WPC) is prepared manually in general, but automated preparation is desirable to minimize variation in the WPC quality and enhance WPC production. Recently, the software was improved for an automated cell processor (ACP) to control all processes of WPC preparation. M-sol and BRS-A, which are mixtures of medical solutions, are widely used for WPC preparation with a manual method in Japan. In this study, we prepared WPC suspended in M-sol (WPC-M) or BRS-A (WPC-B) with the ACP, and compared their in vitro properties during 7-day storage.Study design and methods
PC was divided into two equal aliquots for WPC-M and WPC-B. A divided PC, medical solutions and disposable materials were set in the ACP, and it was started to prepare WPC-M or WPC-B on Day 0. Prepared WPC was stored on a flatbed shaker until Day 7.Results
The pH of WPC-M and WPC-B was maintained above 6.8 during the 7-day storage. The differences in aggregation (%), HSR (%), P-selectin expression, GPIbα expression, and phosphatidylserine expression between WPC-M and WPC-B were minimal until Day 3.Conclusion
The in vitro properties of WPC-B are not markedly different from those of WPC-M until Day 3. 相似文献11.
Purpose
Techniques used to identify AmpC β-lactamases in SPICE (Serratia, Pseudomonas, indole-positive Proteus, Citrobacter, and Enterobacter) organisms are not yet optimized for the clinical laboratory and are not routinely used. Clinicians are often left with an uncertainty on the choice of antibiotic when a SPICE organism is isolated. The purpose of this study was to evaluate the outcomes of carbapenem versus noncarbapenem regimens in treating bacteremia or urinary tract infection from a SPICE organism in clinical practice.Methods
This single-center, retrospective, cohort study analyzed data from adult patients who had clinical infection with a SPICE organism isolated from blood or urine cultures. Patients were assigned to a carbapenem- or noncarbapenem-treated group. The primary end point was clinical response, defined as a resolution of signs and symptoms of infection at the end of therapy.Findings
A total of 332 patients were assessed, and 145 patients met the inclusion criteria for the study. There were 20 patients who received a carbapenem, while 125 received a noncarbapenem regimen. The percentage of patients who were bacteremic was 46.2%. Clinical response overall was achieved in 80% of patients on a carbapenem versus 90.3% of patients on a noncarbapenem regimen (P = 0.24). The rate of microbiologic cure was 90% in patients on a carbapenem versus 91.2% in patients on a noncarbapenem regimen (P = 1).Implications
In this study in patients treated for infection with a SPICE organism in clinical practice, the rates of clinical response did not differ significantly between the carbapenem and noncarbapenem groups. Current CLSI breakpoints set for SPICE organisms may still be reliable and may not require additional testing for AmpC β-lactamases. 相似文献12.
Ravi C. Dara Aseem K. Tiwari Dinesh Arora Geet Aggarwal Ganesh Singh Rawat Jyoti Sharma Devi Prasad Acharya Gunjan Bhardwaj 《Transfusion and apheresis science》2017,56(3):367-370
Background
There are several studies on prevalence of individual infectious disease markers (mono-infection) in donors but none on prevalence of coinfection. Co-infection is significant as it leads to accelerated disease progression. We, therefore, evaluated the prevalence of co-infection among blood donors.Materials and methods
The cross-sectional analysis was conducted in blood donors. All donors were tested for anti-HIV I and II, HBsAg, anti-HBC IgM, anti-HCV, Malaria and syphilis by chemiluminescence and ID-NAT assay. All reactive donor samples were confirmed by using confirmatory assays. Donors were grouped as mono-infected and co-infected. The student t-test was used for comparison.Results
During the study period, a total of 106,238 blood donors were tested. Mean age of donors was 34.2 years and 94.2% of blood donors were males. 1776 (1.67%) donor samples were confirmed serologically reactive. 1714 (1.61%) samples were reactive for single marker (mono-infected) while 62 (0.05%) donors’ samples exhibited co-infection. 18 donors were positive for HBV+HCV followed by HIV +syphilis (14).Conclusion
We report for the first time the prevalence of different co-infection patterns in blood donors. Co-infection influence the disease progression; it would be important to investigate the co-infection prevalence in larger sample size. 相似文献13.
J. Caquot A. Perrochon J.-L. Bugeaud X. Dumélié M. Pajon J. Bordes J.-C. Daviet 《Journal de Traumatologie du Sport》2017,34(1):3-14
The jumper's knee is a common pathology particularly debilitating in professional basketball players including youth categories.
Objective
In order to set up an educational process, the objective of this study was to gather epidemiological data concerning TP and draw up an inventory of representations and ideas of the basketball players in the aspiring pro A championship.Materials and methods
We conducted a cross-sectional survey, by questionnaire, one day given, for all the players and coaches of the 18 championship training centres.Results
The rate of analysed questionnaires was 95% (170 of 180 sent) and 100% for coaches. A total of 40.6% of the players admitted suffering from patellar tendon pain during the survey. A total of 59.4% have already experienced at least one episode of TP during their career. Concerning skill level of players in this situation, we could find a lack of awareness concerning TP. Affected populations, injury mechanisms and appropriate actions seem to be confusing elements for players. Furthermore, all coaches seem to be willing to give more time for education and prevention of TP.Conclusion
Our results highlight the extreme frequency of under patellar pain in players who have suffered of TP. They also allowed to bring out misrepresentations about the risk factors and preventive treatments of TP. It is therefore necessary to implement prevention measures in this population. 相似文献14.
Turan Bayhan Şule Ünal Eyüp Çırak Onur Erdem Cemal Akay Orhan Gürsel İbrahim Eker Erdem Karabulut Fatma Gümrük 《Transfusion and apheresis science》2017,56(4):539-543
Objectives
Iron is taken into enterocytes at the duodenum via apical divalent metal-ion transporter 1 protein. Besides iron, divalent metal-ion transporter 1 also transports other divalent metals. We aimed to investigate blood heavy metal levels in patients with ineffective erythropoiesis.Methods
Blood levels of heavy metals including Pb, Al, Cd, Cr, Co, Cu, and Zn were measured in patients with thalassemia major (TM), thalassemia intermedia (TI), congenital dyserythropoietic anemia (CDA), and age- and sex-matched healthy controls.Results
Blood samples were obtained from 68 patients (51 patients with TM, 8 with TI, 9 with CDA), and a control group that included 65 volunteers. Patients with TM were found to have lower Al, Pb, and Zn, and higher Cd levels compared with the control group. The patients treated with deferasirox were further analyzed and Pb and Zn levels were found lower compared with the control group.Discussion
Patients with TM had tendency to have elevated levels of plasma cadmium; however, the median level was not at a toxic level. Increased metal-ion transporter 1 activity may cause heavy metal accumulation, but deferasirox chelation may be protective against heavy metals besides iron. 相似文献15.
Purpose
This post hoc analysis used 11 predictive models of data from a large observational study in Germany to evaluate potential predictors of achieving at least 50% pain reduction by week 6 after treatment initiation (50% pain response) with pregabalin (150–600 mg/d) in patients with neuropathic pain (NeP).Methods
The potential predictors evaluated included baseline demographic and clinical characteristics, such as patient-reported pain severity (0 [no pain] to 10 [worst possible pain]) and pain-related sleep disturbance scores (0 [sleep not impaired] to 10 [severely impaired sleep]) that were collected during clinic visits (baseline and weeks 1, 3, and 6). Baseline characteristics were also evaluated combined with pain change at week 1 or weeks 1 and 3 as potential predictors of end-of-treatment 50% pain response. The 11 predictive models were linear, nonlinear, and tree based, and all predictors in the training dataset were ranked according to their variable importance and normalized to 100%.Findings
The training dataset comprised 9187 patients, and the testing dataset had 6114 patients. To adjust for the high imbalance in the responder distribution (75% of patients were 50% responders), which can skew the parameter tuning process, the training set was balanced into sets of 1000 responders and 1000 nonresponders. The predictive modeling approaches that were used produced consistent results. Baseline characteristics alone had fair predictive value (accuracy range, 0.61–0.72; κ range, 0.17–0.30). Baseline predictors combined with pain change at week 1 had moderate predictive value (accuracy, 0.73–0.81; κ range, 0.37–0.49). Baseline predictors with pain change at weeks 1 and 3 had substantial predictive value (accuracy, 0.83–0.89; κ range, 0.54–0.71). When variable importance across the models was estimated, the best predictor of 50% responder status was pain change at week 3 (average importance 100.0%), followed by pain change at week 1 (48.1%), baseline pain score (14.1%), baseline depression (13.9%), and using pregabalin as a monotherapy (11.7%).Implications
The finding that pain changes by week 1 or weeks 1 and 3 are the best predictors of pregabalin response at 6 weeks suggests that adhering to a pregabalin medication regimen is important for an optimal end-of-treatment outcome. Regarding baseline predictors alone, considerable published evidence supports the importance of high baseline pain score and presence of depression as factors that can affect treatment response. Future research would be required to elucidate why using pregabalin as a monotherapy also had more than a 10% variable importance as a potential predictor. 相似文献16.
Li-xin Jiao Jing-ying Zhang Lin Chen Xiao-li Yu Yu Han Fan Yang Jiang-hong Yu Ling-ling Liu Yue Lang 《Transfusion and apheresis science》2017,56(6):855-857
Objective
To study serologic and gene characteristics of the B(A) blood group of blood donation volunteers in Jilin Province, China.Methods
ABO subgroups were identified by standard serologic techniques in ABO typing discrepancy samples from all donors at the Jilin Blood Center (410,354 non-repeat donors). DNA (deoxyribonucleic acid) was collected from each sample and PCR (polymerase chain reaction) was used to sequence exons 6 and 7 and intron 6, part 5 from the ABO subgroup samples. PCR products were sequenced to identify ABO subgroups and the B(A) allele.Results
Four cases of B(A) blood type were found after sequencing, including two different alleles: B(A)02 and B(A)04. Three of the four alleles were B(A)04.Conclusion
Among blood donation volunteers in Jilin Province, China, B(A)04 is the most common B(A) blood group allele, followed by B(A)02. The B(A) blood group is associated with a complicated serologic phenotype and DNA detection is necessary for this atypical phenotype sample. 相似文献17.
Ayse Esra Karakoc Rukiye Berkem Hasan Irmak Ali Pekcan Demiroz Idil Yenicesu Nigar Ertugrul Önder Arslan Sabri Kemahli Sevinc Yilmaz Osman Ozcebe Abdurrahman Kara Gulsum Ozet Ziya Cibali Acikgoz Tulin Acikgoz 《Transfusion and apheresis science》2017,56(5):732-737
Purpose
In this study we aimed to propose an algorithm for initial anti HCV EIA reactive blood donations in Turkey where nucleic acid amplification tests are not yet obligatory for donor screening.Methods
A total of 416 anti HCV screening test reactive donor samples collected from 13 blood centers from three cities in Turkey were tested in duplicate by Ortho HCV Ab Version 3.0 and Radim HCV Ab. All the repeat reactive samples were tested by INNO-LIA HCV Ab 3.0 or Chiron RIBA HCV 3.0 and Abbott Real Time HCV. Intra-assay correlations were calculated with Pearson r test. ROC analysis was used to study the relationship between EIA tests and the confirmatory tests.Results
The number of repeat reactive results with Ortho EIA were 221 (53.1%) whereas that of microEIA, 62 (14.9%). Confirmed positivity rate was 14.6% (33/226) by RIBA and 10.6% (24/226) by NAT. Reactive PCR results were predicted with 100% sensitivity and 95% specificity with S/CO levels of 8.1 with Ortho EIA and 3.4 with microEIA.Conclusions
Repeat reactivity rates declined with a second HCV antibody assay. Samples repeat reactive with one HCV antibody test and negative with the other were all NAT negative. All the NAT reactive samples were RIBA positive. None of the RIBA indeterminate or negative samples were NAT reactive. Considering the threshold values for EIA kits determined by ROC analysis NAT was decided to be performed for the samples above the threshold value and a validated supplemental HCV antibody test for the samples below. 相似文献18.
Shabnam Asfaram Mahdi Fakhar Mehdi Mohebali Ahmad Mardani Elham Sadat Banimostafavi Hajar Ziaei Hezarjaribi Masoud Soosaraei 《Transfusion and apheresis science》2017,56(3):474-479
Background
Little is known regarding transfusion-transmitted leishmaniasis (TTL) and the real global incidence of visceral leishmaniasis (VL) among blood donors as carriers of Leishmania spp. in endemic VL foci including Iran. Recent epidemiological evidences indicate that blood donor may be harbor of Leishmania infantum (L. infantum) infection in Iran.Methods
The aim of the present study was to determine the prevalence of Leishmania infection among blood donors in a main endemic focus of VL in Iran using DAT and polymerase chain reaction (PCR) based methods Between July–September 2016, blood samples were collected from 600 apparently healthy blood donors from six blood donation centers and blood donation mobile unit in Ardabil Province, where VL cases had been recorded. Each of these samples was tested for anti-Leishmania antibodies, in direct agglutination test (DAT), and for L. infantum kDNA, the PCR-based assay.Results
Of 600 blood donors, which were examined, 23 (3.8%) blood donors were seropositive by DAT and of 23 seropositive subjects, 82.6% (19/23) were positive by PCR. All the seropositive cases were males except one of them was female.Conclusions
Our findings showed that many asymptomatic human carriers of L. infantum live in the endemic regions of northwestern Iran and potentially act as reservoirs of infection; those must be considered carefully by arrangement VL control strategies in the country. 相似文献19.
Olga Ciepiela Anna Jaworska Dominika Łacheta Natalia Falkowska Katarzyna Popko Urszula Demkow 《Transfusion and apheresis science》2017,56(6):858-864
Background
Transfusion of blood-derived products is often used as a life-saving treatment, and being a blood donor should be common, especially among medical professionals. Thus, an awareness of one’s own blood type in medical students should be common. Our aim was to assess if students of the Medical University of Warsaw know their blood type and how many of them are registered blood donors.Material and methods
A survey was conducted in a group of 1121 students. The survey included questions addressing awareness of the students’ blood type, the frequency of blood types in Poland, being a blood donor, and willingness to become a blood donor.Results
Of all students, 86.8% knew their blood type and 13.2% did not. Approximately 30.2% of students in the survey declared that they are blood donors, 57.9% had only considered becoming a blood donor and 11.9% had not even considered becoming a blood donor. Of all non-donors, 48.2% had contraindications to becoming a blood donor, 11.5% were afraid of blood collection and 21.9% did not have time to register as a blood donor. Most students (81%) declared that they could become a blood donor if someone closely-related needed a transfusion, and 5.2% declared that there is nothing that could force them to become a blood donor.Conclusion
Compared to Polish society medical students are significantly more aware of the necessity of blood donation. The majority know their blood type, but they do not know what is the most common blood type in Poland. 相似文献20.
Sheila F. O’Brien Qi-Long Yi Wenli Fan Vito Scalia Mindy Goldman Margaret A. Fearon 《Transfusion and apheresis science》2017,56(3):389-391