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- Friedman, R. J., et al.
(författare)
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Dabigatran versus enoxaparin for prevention of venous thromboembolism after hip or knee arthroplasty: a pooled analysis of three trials
- 2010
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Ingår i: Thrombosis Research. - : Elsevier BV. - 1879-2472 .- 0049-3848. ; 126:3, s. 175-182
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Three randomized, double-blind trials compared dabigatran, an oral direct thrombin inhibitor, with enoxaparin for the primary prevention of venous thromboembolism (VTE) in patients undergoing elective total hip and knee arthroplasty. OBJECTIVES AND METHODS: We conducted a pre-specified pooled analysis of these trials. 8,210 patients were randomized, of whom 8,135 were treated (evaluable for safety) with dabigatran 220 mg or 150 mg once-daily, or subcutaneous enoxaparin (40 mg once-daily or 30 mg twice-daily). Efficacy analyses were based on the modified intention-to-treat population of 6,200 patients with an evaluable outcome. The common risk difference (RD) of treatment effect between each dabigatran dose and enoxaparin was estimated using fixed-effects models, and statistical heterogeneity was estimated using the I2 statistic. RESULTS: The composite outcome of major VTE (proximal deep vein thrombosis and/or pulmonary embolism) and VTE-related mortality occurred in 3.3% of the enoxaparin group versus 3.0% of the dabigatran 220 mg group (RD vs. enoxaparin -0.2%, 95% CI -1.3% to 0.9%, I2=37%) and 3.8% of the 150 mg group (RD vs. enoxaparin 0.5%, -0.6% to 1.6%, I2=0%). Major bleeding occurred in 1.4% of the enoxaparin group versus 1.4% of the dabigatran 220 mg group (RD vs. enoxaparin -0.2%, -0.8% to 0.5%, I2=40%) and 1.1% of the 150 mg group (RD vs. enoxaparin -0.4%, -1.0% to 0.2%, I2=0%). CONCLUSIONS: Oral dabigatran was as effective as subcutaneous enoxaparin in reducing the risk of major VTE and VTE-related mortality after hip or knee arthroplasty and has a similar bleeding profile.
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- Grävare Silbernagel, Karin, 1965, et al.
(författare)
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A new measurement of heel-rise endurance with the ability to detect functional deficits in patients with Achilles tendon rupture.
- 2010
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Ingår i: Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA. - : Springer Science and Business Media LLC. - 1433-7347. ; 18:2, s. 258-64
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Tidskriftsartikel (refereegranskat)abstract
- Studies evaluating treatment effects on muscle function after an Achilles tendon rupture often use various tests for evaluating calf muscle strength. However, these tests rarely demonstrate the difference between treatment groups; therefore, new tests with a higher ability to detect possible differences in outcome are needed. The purpose of this study was to evaluate the validity and ability to detect differences in outcome of a heel-rise work test that would measure both the height of each heel-rise and the number of repetitions. Seventy-eight patients (65 men and 13 women) at a mean (standard deviation) age of 42 (9) years with Achilles tendon ruptures were included. The patients were evaluated with the new heel-rise test at 6 and 12 months after injury. The limb symmetry index (LSI = involved/uninvolved x 100) was calculated to determine the size of the difference in function between the injured and the uninjured side. The heel-rise height differed significantly between the injured and uninjured sides at the 6- and 12-month evaluations (P < 0.001). At the 6-month evaluation, the patients had achieved a mean LSI of 84% on the number of repetitions parameter but only a mean LSI of 61% on the work parameter. At the 12-month evaluation the mean, LSI of the heel-rise repetition parameter was 95%, indicating that the patients had fully recovered function, but on the work parameter the mean LSI was only 76%. The heel-rise work test in the present study has good validity and greater ability to detect differences between the injured and the uninjured sides than a test that measures only the number of heel-rise repetitions in patients with Achilles tendon rupture.
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- Hesselmar, Bill, 1955, et al.
(författare)
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Interleukin-4 receptor polymorphisms in asthma and allergy: relation to different disease phenotypes.
- 2010
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Ingår i: Acta paediatrica. - : Wiley. - 1651-2227 .- 0803-5253. ; 99:3, s. 399-403
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Tidskriftsartikel (refereegranskat)abstract
- Aim: Inheritance and genetic factors are supposed to influence susceptibility to asthma and allergy. We tested if single nucleotide polymorphisms (SNPs) in the IL4R gene were associated with susceptibility to such diseases, or if they were related to the phenotypic presentation of asthma and allergic rhinoconjunctivitis (ARC). Methods: Three hundred and nine 12- to 13-year-old children were included. Six SNPs in the IL4R were analysed in response to current allergic disease, and to presentation of specific asthma and ARC phenotypes. Questionnaires were used to determine allergic disease status, and skin prick tests to evaluate sensitization to common airborne allergens. Results: Less eczema was seen in individuals with the AA-genotype of rs2057768, and less ARC among those with the AA-genotype of rs2107356, especially ARC associated with sensitization to pollen. The AA-genotype of rs2057768 and the TT genotype of rs3024632 were associated with a specific asthma phenotype. Conclusion: Variations within the IL4R gene are associated with allergic diseases in children, preferably with eczema and disease phenotypes of ARC and asthma.
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- Nilsson-Helander, Katarina, 1957, et al.
(författare)
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Acute achilles tendon rupture: a randomized, controlled study comparing surgical and nonsurgical treatments using validated outcome measures
- 2010
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Ingår i: The American Journal of Sports Medicine. - : SAGE Publications. - 0363-5465 .- 1552-3365. ; 38:11, s. 2186-2193
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: There is no consensus regarding the optimal treatment for patients with acute Achilles tendon rupture. Few randomized controlled studies have compared outcomes after surgical or nonsurgical treatment with both groups receiving early mobilization. PURPOSE: This study was undertaken to compare outcomes of patients with acute Achilles tendon rupture treated with or without surgery using early mobilization and identical rehabilitation protocols. STUDY DESIGN: Randomized, controlled trial; Level of evidence, 1. METHODS: Ninety-seven patients (79 men, 18 women; mean age, 41 years) with acute Achilles tendon rupture were treated and followed for 1 year. The primary end point was rerupturing. Patients were evaluated using the Achilles tendon Total Rupture Score (ATRS), functional tests, and clinical examination at 6 and 12 months after injury. RESULTS: There were 6 (12%) reruptures in the nonsurgical group and 2 (4%) in the surgical group (P = .377). The mean 6- and 12-month ATRS were 72 and 88 points in the surgical group and 71 and 86 points in the nonsurgical group, respectively. Improvements in ATRS between 6 and 12 months were significant for both groups, with no significant between-group differences. At the 6-month evaluation, the surgical group had better results compared with the nonsurgically treated group in some of the muscle function tests; however, at the 12-month evaluation there were no differences between the 2 groups except for the heel-rise work test in favor of the surgical group. At the 12-month follow-up, the level of function of the injured leg remained significantly lower than that of the uninjured leg in both groups. CONCLUSION: The results of this study did not demonstrate any statistically significant difference between surgical and nonsurgical treatment. Furthermore, the study suggests that early mobilization is beneficial for patients with acute Achilles tendon rupture whether they are treated surgically or nonsurgically. The preferred treatment strategy for patients with acute Achilles tendon rupture remains a subject of debate. Although the study met the sample size dictated by the authors' a priori power calculation, the difference in the rerupture rate might be considered clinically important by some.
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- Raskob, G., et al.
(författare)
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Oral direct factor Xa inhibition with edoxaban for thromboprophylaxis after elective total hip replacement. A randomised double-blind dose-response study
- 2010
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Ingår i: Thrombosis and Haemostasis. - 0340-6245. ; 104:3, s. 642-649
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Tidskriftsartikel (refereegranskat)abstract
- Edoxaban is a new oral direct factor Xa inhibitor. The purpose of this study was to evaluate the efficacy and safety of different doses of edoxaban for the prevention of venous thromboembolism (VTE) in patients undergoing elective total hip replacement. A total of 903 patients were randomised to oral edoxaban 15, 30, 60 or 90 mg once daily or subcutaneous dalteparin once daily (initial dose 2,500 IU, subsequent doses 5,000 IU). Both drugs were begun 6-8 hours postoperatively and continued for 7-10 days, when bilateral venography was performed. The primary efficacy endpoint was the incidence of total VTE, which included proximal and/or distal deep-vein thrombosis (DVT) by venography or symptomatic, objectively confirmed DVT or pulmonary embolism during the treatment period. The primary safety outcome was the incidence of the composite of major and clinically relevant non-major bleeding. All venograms and bleeding events were reviewed by a central independent adjudication committee blinded as to treatment allocation. Of the 903 patients randomised, 776 were evaluable for the primary efficacy analysis. The incidences of VTE were 28.2%, 21.2%, 15.2%, and 10.6% in patients receiving edoxaban 15, 30, 60 and 90 mg, respectively, compared with 43.8% in the dalteparin group (p<0.005 ). There was a statistically significant (p<0.001) dose-response for efficacy across the edoxaban dose groups for total VTE and for major VTE. The incidence of clinically relevant bleeding was low and similar across the groups. Oral edoxaban once daily is effective for preventing VTE after total hip replacement.
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- Schulman, S., et al.
(författare)
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Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients
- 2010
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Ingår i: Journal of Thrombosis and Haemostasis. - : Elsevier BV. - 1538-7933 .- 1538-7836. ; 8:1, s. 202-204
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Tidskriftsartikel (refereegranskat)abstract
- The definition of major bleeding varies between studies on surgical patients, particularly regarding the criteria for surgical wound-related bleeding. This diversity contributes to the difficulties in comparing data between trials. The Scientific and Standardization Committee (SSC), through its subcommittee on Control of Anticoagulation, of the International Society on Thrombosis and Haemostasis has previously published a recommendation for a harmonized definition of major bleeding in non-surgical studies. That definition has been adopted by the European Medicines Agency and is currently used in several non-surgical trials. A preliminary proposal for a parallel definition for surgical studies was presented at the 54(th) Annual Meeting of the SSC in Vienna, July 2008. Based on those discussions and further consultations with European and North American surgeons with experience from clinical trials a definition has been developed that should be applicable to all agents that interfere with hemostasis. The definition and the text that follows have been reviewed and approved by relevant co-chairs of the subcommittee and by the Executive Committee of the SSC. The intention is to seek approval of this definition from the regulatory authorities to enhance its incorporation into future clinical trial protocols.
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| 9. |
- Thomeé, Pia, 1955, et al.
(författare)
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A randomized, controlled study of a rehabilitation model to improve knee-function self-efficacy with ACL injury
- 2010
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Ingår i: Journal of sport rehabilitation. - 1056-6716. ; 19:2, s. 200-213
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Tidskriftsartikel (refereegranskat)abstract
- CONTEXT: The Knee Self-Efficacy Scale (K-SES) has good reliability, validity, and responsiveness for patients' perceived knee-function self-efficacy during rehabilitation after an anterior cruciate ligament (ACL) injury. Preoperative knee-function self-efficacy has also been shown to have a predictive ability in terms of outcome 1 y after ACL reconstruction. OBJECTIVE: To evaluate a new clinical rehabilitation model containing strategies to enhance knee-function self-efficacy. DESIGN: A randomized, controlled study. SETTING: Rehabilitation clinic and laboratory. PATIENTS: 40 patients with ACL injuries. INTERVENTION: All patients followed a standardized rehabilitation protocol. Patients in the experimental group were treated by 1 of 3 physiotherapists who had received specific training in a clinical rehabilitation model. These physiotherapists were also given their patients' self-efficacy scores after the initial and 4-, 6-, and 12-mo follow-ups, whereas the 5 physiotherapists treating the patients in the control group were not given their patients' self-efficacy scores. MAIN OUTCOME MEASURES: The K-SES, the Tegner Activity Scale, the Physical Activity Scale, the Knee Injury and Osteoarthritis Outcome Score, and the Multidimensional Health Locus of Control. RESULTS: Twenty-four patients (12 in each group) completed all follow-ups. Current knee-function self-efficacy, knee symptoms in sports, and knee quality of life improved significantly (P = .05) in both groups during rehabilitation. Both groups had a significantly (P = .05) lower physical activity level at 12 mo than preinjury. No significant differences were found between groups. CONCLUSION: In this study there was no evidence that the clinical rehabilitation model with strategies to enhance self-efficacy resulted in a better outcome than the rehabilitation protocol used for the control group.
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| 10. |
- Weitz, J. I., et al.
(författare)
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A dose-finding study with TAK-442, an oral factor Xa inhibitor, in patients undergoing elective total knee replacement surgery
- 2010
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Ingår i: Thrombosis and Haemostasis. - 0340-6245. ; 104:6, s. 1150-1157
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Tidskriftsartikel (refereegranskat)abstract
- This multicentre dose-finding study compared TAK-442, an oral factor Xa inhibitor, with enoxaparin for thromboprophylaxis after knee arthroplasty. In this parallel group study, patients were randomised to oral TAK-442 (40 or 80 mg once-daily [QD] or 10, 20, 40, or 80 mg twice-daily [BID] started 6-8 hours postoperatively), which was blinded as to dose, or to open-label subcutaneous enoxaparin (30 mg BID starting 12-24 hours postoperatively) for 10 days. Treatments were continued until bilateral venography was performed (maximum of 14 days). The primary efficacy endpoint was the composite of any deep-vein thrombosis, non-fatal pulmonary embolism or all-cause mortality, while the primary safety endpoint was major bleeding. Of 1,038 patients randomised who received at least one dose of study drug, 949 completed the study and 730 (76.9%) were evaluable for the primary efficacy analysis. Recruitment into the 10 and 20 mg BID dose groups was stopped early because the incidences of the primary efficacy endpoint were significantly higher than that with enoxaparin. The primary efficacy endpoint occurred in 22.0% of patients given enoxaparin and in 39.0%, 38.4%, 23.5%, 21.4%, 26.8%, and 14.3% of those receiving TAK-442 10 mg BID, 20 mg BID, 40 mg QD, 40 mg BID, 80 mg QD, and 80 mg BID, respectively. The incidences of major and clinically relevant non-major bleeding with TAK-442 were not dose-dependent or different from that with enoxaparin. All TAK-442 doses except 10 and 20 mg BID displayed similar efficacy and safety profiles to enoxaparin.
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