JBJS Reviews | Year: 2017
BACKGROUND:: Most total elbow arthroplasty (TEA) designs aim to replicate anatomy and provide stability in the treatment of the degenerative elbow joint. Given the promising results that have been reported following the use of TEA for the treatment of complex fractures, the indications for this procedure are growing. The objective of the present study was to review the most recent literature on the results of the most commonly performed TEAs. METHODS:: A comprehensive literature search was conducted. All relevant studies were reviewed according to a set of predefined inclusion and exclusion criteria. After the initial assessment, 2 authors extracted data from the included articles. Groups were created on the basis of the design of TEA implant, the type of implant (linked or unlinked), and the indication for treatment. Outcome parameters were survival rate, pain, range of motion, complications, and specific elbow outcome scores. RESULTS:: Seventy-three articles involving a total of 9,379 TEAs were included. The level of evidence was primarily Level IV. Nineteen specific designs of TEA implants were described, including the Souter-Strathclyde (n = 2,387), Coonrad-Morrey (n = 1,586), Kudo (n = 560), and GSB III (n = 498). The most common indication for TEA was rheumatoid arthritis (70%). The weighted mean survival rate for the linked and unlinked prostheses was 85.5% at 7.8 years and 74% at 12.3 years, respectively. For the Coonrad-Morrey, Souter-Strathclyde, and GSB III, the weighted mean survival rate was 87.2% at 7.2 years, 70.6% at 14.2 years, and 81.7% at 9.5 years, respectively. The range of motion after TEA was good overall, with a mean flexion angle of 129° and a mean extension lag angle of 30°. The complication rates ranged from 11% to 38%, with clinical loosening being the most frequently reported complication (7%). CONCLUSIONS:: The results of TEA are respectable overall. It appears that there are small differences between designs. However, despite the fairly good functional results and elbow scores, the survival and complication rates are still not as favorable as those following arthroplasties in other joints. LEVEL OF EVIDENCE:: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence. © 2017 All Rights Reserved.The Journal of Bone and Joint Surgery, Inc.
van den Bekerom M.P.J.,OLVG
Strategies in Trauma and Limb Reconstruction | Year: 2013
The objective of this article is to systematically review the currently available literature to formulate evidence-based guidelines for the treatment of femoral shaft nonunions for clinical practice and to establish recommendations for future research. Articles from PubMed/MEDLINE, Cochrane Clinical Trial Register, and EMBASE, that presented data concerning treatment of nonunions of femoral shaft fractures in adult humans, were included for data extraction and analysis. The search was restricted to articles from January 1970 to March 2011 written in the English, German, or Dutch languages. Articles containing data that were thought to have been presented previously were used once. Reports on nonunion after periprosthetic fractures, review articles, expert opinions, abstracts from scientific meetings, and case reports on 5 or fewer patients were excluded. The data that were extracted from the relevant articles included: type of nonunion, type of initial and secondary treatments, follow-up, union rate, and general complications. Most studies had different inclusion criteria and outcome measures, thus prohibiting a proper meta-analysis. Therefore, only the union rate and number of complications were compared between the different treatments. Methodological quality was assessed by assigning levels of evidence as previously defined by the Centre for Evidence-Based Medicine. This systematic review provides evidence in favour of plating if a nail is the first treatment; after failed plate fixation, nailing has a 96 % union rate. After failed nailing, augmentative plating results in a 96 % union rate compared to 73 % in the exchange nailing group. © 2013 The Author(s).
Serruys P.W.,Imperial College London |
Chevalier B.,Institute Jacques Cartier |
Dudek D.,Jagiellonian University |
Cequier A.,University of Barcelona |
And 14 more authors.
The Lancet | Year: 2015
Background Despite rapid dissemination of an everolimus-eluting bioresorbable scaffold for treatment for coronary artery disease, no data from comparisons with its metallic stent counterpart are available. In a randomised controlled trial we aimed to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent. Here we report secondary clinical and procedural outcomes after 1 year of follow-up. Methods In a single-blind, multicentre, randomised trial, we enrolled eligible patients aged 18-85 years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels. We randomly assigned patients in a 2:1 ratio to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (Xience, Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetes status and number of planned target lesions. The co-primary endpoints of this study are vasomotion (change in mean lumen diameter before and after nitrate administration at 3 years) and difference between minimum lumen diameter (after nitrate administration) after the index procedure and at 3 years. Secondary endpoints were procedural performance assessed by quantitative angiography and intravascular ultrasound; composite clinical endpoints based on death, myocardial infarction, and coronary revascularisation; device and procedural success; and angina status assessed by the Seattle Angina Questionnaire and exercise testing at 6 and 12 months. Cumulative angina rate based on adverse event reporting was analysed post hoc. This trial is registered at ClinicalTrials.gov, number NCT01425281. Findings Between Nov 28, 2011, and June 4, 2013, we enrolled 501 patients and randomly assigned them to the bioresorbable scaffold group (335 patients, 364 lesions) or the metallic stent group (166 patients, 182 lesions). Dilatation pressure and balloon diameter at the highest pressure during implantation or postdilatation were higher and larger in the metallic stent group, whereas the acute recoil post implantation was similar (0·19 mm for both, p=0·85). Acute lumen gain was lower for the bioresorbable scaffold by quantitative coronary angiography (1·15 mm vs 1·46 mm, p<0·0001) and quantitative intravascular ultrasound (2·85 mm2 vs 3·60 mm2, p<0·0001), resulting in a smaller lumen diameter or area post procedure. At 1 year, however, cumulative rates of first new or worsening angina from adverse event reporting were lower (72 patients [22%] in the bioresorbable scaffold group vs 50 [30%] in the metallic stent group, p=0·04), whereas performance during maximum exercise and angina status by SAQ were similar. The 1-year composite device orientated endpoint was similar between the bioresorbable scaffold and metallic stent groups (16 patients [5%] vs five patients [3%], p=0·35). Three patients in the bioresorbable scaffold group had definite or probable scaffold thromboses (one definite acute, one definite sub-acute, and one probable late), compared with no patients in the metallic stent group. There were 17 (5%) major cardiac adverse events in the bioresorbable scaffold group compared with five (3%) events in the metallic stent group, with the most common adverse events being myocardial infarction (15 cases [4%] vs two cases [1%], respectively) and clinically indicated target-lesion revascularisation (four cases [1%] vs three cases [2%], respectively). Interpretation The everolimus-eluting bioresorbable scaffold showed similar 1-year composite secondary clinical outcomes to the everolimus-eluting metallic stent. Funding Abbott Vascular. © 2015 Elsevier Ltd.
Oddens J.R.,Robert Bosch GmbH |
Sylvester R.J.,European Organization for Research and Treatment of Cancer |
Brausi M.A.,New Estense S Agostino Hospital Ausl |
Kirkels W.J.,Erasmus Medical Center |
And 5 more authors.
European Urology | Year: 2014
Background Although maintenance bacillus Calmette-Guérin (BCG) is the recommended treatment in high-risk non-muscle-invasive bladder cancer (NMIBC), its efficacy in older patients is controversial. Objective To determine the effect of age on prognosis and treatment outcome in patients with stage Ta T1 NMIBC treated with maintenance BCG. Design, setting, and participants A total of 957 patients with intermediate- or high-risk Ta T1 (without carcinoma in situ) NMIBC were randomized in European Organization for Research and Treatment of Cancer (EORTC) trial 30911 comparing six weekly instillations of epirubicin, BCG, and BCG plus isoniazid followed by three weekly maintenance instillations over 3 yr. Outcome measurements and statistical analysis Cox multivariate proportional hazards regression models were used to assess the relative importance of age for recurrence, progression, overall survival, and NMIBC-specific survival with adjustment for EORTC risk scores. Results and limitations Overall, 822 eligible patients were included: 546 patients in the BCG with or without INH arms and 276 in the epirubicin arm. In patients treated with BCG with or without INH, 34.1% were >70 yr of age and 3.7% were >80 yr. With a median follow-up of 9.2 yr, patients >70 yr had a shorter time to progression (p = 0.028), overall survival (p < 0.001), and NMIBC-specific survival (p = 0.049) after adjustment for EORTC risk scores in the multivariate analysis. The time to recurrence was similar compared with the younger patients. BCG was more effective than epirubicin for all four end points considered, and there was no evidence that BCG was any less effective compared with epirubicin in patients >70 yr. Conclusions In intermediate- and high-risk Ta T1 urothelial bladder cancer patients treated with BCG, patients >70 yr of age have a worse long-term prognosis; however, BCG is more effective than epirubicin independent of patient age. Patient summary Intravesical bacillus Calmette-Guérin for non-muscle-invasive bladder cancer is less effective in patients >70 yr of age, but it is still more effective than epirubicin. © 2014 European Association of Urology.
News Article | November 14, 2016
BOSTON - A new study led by clinician-researchers at Beth Israel Deaconess Medical Center (BIDMC) testing the safety and effectiveness of anticoagulant strategies for patients with atrial fibrillation who undergo stenting procedures has shown that therapies combining the anticoagulant drug rivaroxaban with either single or dual anti-platelet therapy (DAPT) were more effective in preventing bleeding complications than the current standard of care. Principal Investigator C. Michael Gibson, MD, Chief of Clinical Research in the Division of Cardiovascular Medicine at BIDMC, reported the new research findings today online in The New England Journal of Medicine and simultaneously presented the findings at the American Heart Association's Scientific Sessions 2016 in New Orleans. The PIONEER AF-PCI randomized clinical trial involved more than 2,100 patients at 430 sites in 26 countries. Each year, nearly 1 million patients in the United States undergo percutaneous coronary intervention (PCI) and are implanted with stents positioned to treat narrowed coronary arteries. Following PCI, patients receive dual anti-platelet therapy - a combination of aspirin and a second blood-thinning medication - to prevent the formation of blood clots in the stent. Approximately 5 to 8 percent of patients undergoing PCI have atrial fibrillation, the most common type of cardiac arrhythmia and an important risk factor for stroke. These patients typically take a blood thinner, such as warfarin (Coumadin), to prevent stroke. "In managing the stented patient with atrial fibrillation, a pharmacologic strategy must carefully balance the risk of stent thrombosis, or blood clot, with the risk of bleeding complications," said Gibson, who is also Professor of Medicine at Harvard Medical School and chairman of the PERFUSE (Percutaneous/Pharmacologic Endoluminal Revascularization for Unstable Syndromes Evaluation) Study Group. "This trial, which tested two entirely new strategies, now provides us with randomized clinical trial data demonstrating that a combination of rivaroxaban with anti-platelet therapy is successful in minimizing bleeding while preventing clotting." Current guidelines call for combining three drugs - DAPT plus a vitamin K antagonist (VKA) anticoagulant - in a strategy known as "triple therapy." But as the authors note, this approach may result in excess major bleeding rates of 4 to 12 percent within the first year of treatment. The PIONEER AF-PCI trial studied men and women over age 18 with atrial fibrillation who had undergone a PCI procedure with stent placement. The study subjects were randomly assigned to one of three groups: Group 1 received reduced dose rivaroxaban plus a P2Y-12 inhibitor monotherapy; Group 2 received very low dose rivaroxaban plus DAPT; and Group 3 received VKA plus DAPT. The findings showed that among patients with atrial fibrillation who underwent intracoronary stent placement, the administration of rivaroxaban in one of two dose strategies reduced the risk of clinically significant bleeding in about one out of every 10 to 11 patients as compared with triple therapy including a vitamin K antagonist. The risks of rehospitalization and death from all causes were also reduced in about one out of every 10 to 15 cases. "This new treatment strategy benefits patient health as well as hospital finances," added Gibson. The PIONEER AF-PCI study is supported by Janssen Scientific Affairs LLC, and Bayer Health Care Pharmaceuticals. Study coauthors include BIDMC investigators Serge Korjian, MD and, Yazan Daaboul, MD,; Roxana Mehran, MD, and Jonathan Halperin, MD, of Mount Sinai Medical Center, New York; Christoph Bode, MD, of the University of Freiburg, Germany; Freek W.A. Verheugt, MD, of Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam; Peter Wildgoose, PhD, Mary Birmingham, PharmD, Juliana Ianus, PhD, and Paul Burton, MD, PhD, of Jansen Pharmaceuticals, Inc.; Martin van Eickels, MD, of Bayer Pharmaceuticals; Gregory Y.H. Lip, MD of The University of Birmingham Centre for Cardiovascular Services, Birmingham, UK; Marc Cohen, MD, of Newark Beth Israel Medical Center, Newark, NJ; Steen Husted, MD, of Aarhus University Hospital, Herning, Denmark; Eric D. Peterson, MD, MPH of Duke Clinical Research Institute, Durham, NC; and Keith AA Fox, MB, ChB, of the Royal Infirmary of Edinburgh, UK. Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School and consistently ranks as a national leader among independent hospitals in National Institutes of Health funding. BIDMC is in the community with Beth Israel Deaconess Hospital-Milton, Beth Israel Deaconess Hospital-Needham, Beth Israel Deaconess Hospital-Plymouth, Anna Jaques Hospital, Cambridge Health Alliance, Lawrence General Hospital, MetroWest Medical Center, Signature Healthcare, Beth Israel Deaconess HealthCare, Community Care Alliance and Atrius Health. BIDMC is also clinically affiliated with the Joslin Diabetes Center and Hebrew Rehabilitation Center and is a research partner of Dana-Farber/Harvard Cancer Center and the Jackson Laboratory. BIDMC is the official hospital of the Boston Red Sox. For more information, visit http://www. .
News Article | December 1, 2016
AIDSmonument in Amsterdam Counts Down Till the end of AIDS Elsevier/ RELX Group on behalf of the NAMES Project Netherlands From December 1st 2016, World Aids Day, onwards the Netherlands have their own HIV/AIDSmonument, officially unveiled by the mayor of Amsterdam, Eberhard van der Laan, together with the artist Jean-Michel Othoniel and Louise van Deth, managing director of AIDS Fonds (AIDS Foundation) the Netherlands. It is located on the south bank of the river IJ on a permanent location between Central Station and the concert hall Muziekgebouw aan 't IJ. The monument "Living by Numbers" was created by the French artist Jean-Michel Othoniel. The striking features of the landmark are the great scarlet beads made of hand-blown glass; the monument has the shape of a giant abacus, which counts down till the end of AIDS. Development of the monument is an initiative of the NAMES Project Netherlands Foundation, and could be realized thanks to the support of main sponsors: Aids Fonds (Aids Foundation), OLVG hospital of Amsterdam, RELX Group and ViiV Healthcare. Other contributing sponsors include among others, Amsterdams Fonds voor de Kunst, The Art of Impact, Zabawas, and the Centrum district of Amsterdam; funding was also raised through a crowdfunding campaign. The monument is a beacon of hope and support to anyone living with HIV. At the same time it is a tribute to all buddies, supporters, medical employees, activists and scientists. Moreover it is also a memorial, dedicated to all loved ones who have died of AIDS. The initiators of developing the monument chose Amsterdam because this city has been and is a sanctuary for many people with HIV who were not welcome in their own countries. "Othoniel demonstrates with his design that an AIDSmonument does not necessarily have to be somber. He combines very delicately a heavy subject with elegance and beauty. The wonderful light at the bank of the river IJ will be freely reflected in the shining beads, made of hand-blown glass. The monument will match its surroundings perfectly. The AIDSmonument will enrich Amsterdam with a significant work of art," the appointed art committee had said upon selecting the design of the monument. See for more information: http://www.hiv-aidsmonument.nl - and further details provided in appendix below. Twitter hashtags: #Aidsmonument #WorldAIDSDay What is the significance of the HIV/AIDSmonument? The aim of this monument is to keep the attention for AIDS and HIV alive and kicking. At this moment there are approximately 22,100 people in the Netherlands with AIDS and HIV. Every week there are still 19 people in this country who are getting the diagnosis that they have HIV. Moreover a quarter of people with HIV don't even know that he or she is carrying the HIV virus. Therefore HIV and AIDS deserve all our attention, and was the AIDSmonument unveiled December 1st 2016 - Worlds Aids Day - in the footsteps of other cities such as New York, San Francisco and Vancouver. The AIDSmonument was designed in the form of an abacus; an instrument to teach people to count. The abacus is significant, because it symbolizes the countdown to the moment that AIDS will have disappeared from this world for good. The beads in the abacus are made of hand blown glass and therefore all slightly different. They catch the light of the river IJ, reflecting the light in bright colors. It puts a spell on the eyes of anyone passing by. Every year the number of beads will be adjusted and this will be clarified during an event. The beads will, for example, show how many people have been cured of HIV. In that way the AIDSmonument will reflect not only loss, but will also emphasize that there is hope for the future. The monument is an initiative of the foundation NAMENproject Nederland, an organization that works with volunteers who want to keep the attention for HIV and AIDS alive and kicking. In search of a suitable design the foundation was advised by an independent commission of arts. Moreover there was a web-election among the public. This resulted in a longlist of forty artists. Eventually the foundation chose a work of art by the internationally well-known French artist Jean-Michel Othoniel. The river IJ seems a perfect site for the AIDSmonument due to its history. This river symbolizes trade overseas. Sailors did not only exchange goods; they also exchanged diseases. Such as syphilis in the fifteenth century and plague in the seventeenth century. In that way the river IJ reflects almost tangibly the international dimension of AIDS. But there is more: only a few decades ago the De Ruyterkade was the place for hookers and junkies, with just around the corner social workers and the bus that was providing methadone. For gay men the eastern side of the quay was a popular car-cruising-area and Café West-Indië - no longer existing - at De Ruyterkade 110 was the meeting point of Motor Sportclub Amsterdam, a motorclub for gay people. Nowadays the 'back of Amsterdam' shows the dynamics of the capital of the Netherlands. The site, where the AIDSmonument is located, is now a beautiful spot at the river IJ, among exceptional architecture and international splendor. Nowadays the south bank of the river IJ offers a 'coming and going' of many people due to the Central Station, the river-ferries, rivercruise-ships and the Passenger Terminal Amsterdam (PTA), which is the harbor for international cruise-ships. Every year hundreds of thousands residents and visitors will see the AIDSmonument: from the street, from passing busses, trams and trains, from bigger and smaller ships and boats. The AIDSmonument will also be seen by pedestrians and by people driving their cars and riding their bikes. Amongst them there will be many, many tourists. The AIDSmonument will not only be a place for official ceremonies, but also for intimate memorials by individuals. Therefore Othoniel has designed a bench right underneath the abacus with a beautiful view of the river. Underneath the huge abacus people will be able to daydream and reflect, while they look at the horizon, pondering on the future. In this way the AIDSmonument is to give people the courage to go on. How is the artist involved? Jean-Michel Othoniel (Saint-Étienne, 1964) was eighteen, when a mysterious disease got a name: AIDS. Since the eighties AIDS plays an important part in Othoniel's work. The absence of bodies is a significant recurrent theme. For this Living by Numbers Othoniel was inspired by figures: the number of people with HIV and AIDS. Counting is a recurrent theme in this design: the number of victims, the number of people who live with HIV, the number of CD4-cells. All this led to the idea of the abacus; a calculation tool from the past. The hand blown beads symbolize hope, especially our hope that one day people will be able to stop counting. Colored balls have been the principal material that Jean-Michel Othoniel has been using in his work since the late 1990's. Therefore his work looks like monumental jewels. Othoniel says: "Beauty in art seems kind of taboo in the Western world, whereas beauty, compassion and hope are absolutely necessary in our world." The foundation NAMENproject Nederland could only realize the HIV/AIDSmonument thanks to many companies and organisations that supported this monument ever since 2014. The main sponsors are the Aids Fonds (Aids Foundation), the Amsterdam hospital OLVG, RELX Group (formerly Reed Elsevier) and ViiV Healthcare. Founding sponsors are DoubleTree by Hilton and Gilead. Many individuals donated money due to crowdfundation through http://www.voordekunst.nl And there was support by major (art)foundations: the Amsterdams Fonds voor de Kunst (Amsterdam Foundation for the Arts), Art of Impact and Zabawas. Other sponsors are the hospital Academisch Medisch Centrum (AMC), het Amsterdamsche Fonds, Amsterdam Lowlanders Rugby Club, Michael Bakish & Peter M. Hirsch, Canal Company, COC Nederland, Cordaan, dance4life, Drugspastoraat Amsterdam, Eelco & Frank, Elsevier Women's Network & Elsevier Pride, Les Enfants Terribles, Firma Netjes, Stichting GALA, Gebr. Silvestri, GGD Amsterdam, hello gorgeous, Stichting HIV Monitoring, Hiv Vereniging Nederland, i.m. Kees Rümke, Stichting Homomonument, IHLIA LGBT Heritage, Joep Lange Institute, Lloyd Hotel & Culturele Ambassade, Mr. B, De Nederlandsche Bank, Nederlandse Vereniging van Hemofilie Patiënten (NVHP), Nederlandse Vereniging van HIV Behandelaren (NVHB), Nieuwezijds Gay Sauna, Pascal van den Noort, Mark Noyons & Partners, PlanetRomeo Foundation, De Regenboog Groep, RutgersWPF, Sanquin Bloedvoorziening, Thalys, Thermos Sauna, Tijgertje, TrutFonds, VU Medisch Centrum and Zorggroep Amsterdam Oost (Flevohuis | De Open Hof). Other supporters were the Municipality of Amsterdam and the central district of Amsterdam. The Netherlands have always been a runner-up in the international battle against AIDS. Scientists and experts from our country have been important in the development of the combination therapy. Due to this therapy of HIV-inhibitors dying of AIDS became living with HIV. This meant a huge breakthrough, but meanwhile the danger remains that HIV has become invisible. People tend to forget that even this year and even in The Netherlands there are still people dying of AIDS. See for more information: http://www.hiv-aidsmonument.nl
Oddens J.,Robert Bosch GmbH |
Brausi M.,B Ramazzini Hospital |
Sylvester R.,European Organization for Research and Treatment of Cancer EORTC |
Bono A.,Ospedale di Circolo |
And 8 more authors.
European Urology | Year: 2013
Background: The optimal dose and duration of intravesical bacillus Calmette-Guérin (BCG) in the treatment of non-muscle-invasive bladder cancer (NMIBC) are controversial. Objective: To determine if a one-third dose (1/3D) is not inferior to the full dose (FD), if 1 yr of maintenance is not inferior to 3 yr of maintenance, and if 1/3D and 1 yr of maintenance are associated with less toxicity. Design, setting, and participants: After transurethral resection, intermediate- and high-risk NMIBC patients were randomized to one of four BCG groups: 1/3D-1 yr, 1/3D-3 yr, FD-1 yr, and FD-3 yr. Outcome measurements and statistical analysis: The trial was designed as a noninferiority study with the null hypothesis of a 10% decrease in the disease-free rate at 5 yr. Times to events were estimated using cumulative incidence functions and compared using the Cox proportional hazards regression model. Results and limitations: In an intention-to-treat analysis of 1355 patients with a median follow-up of 7.1 yr, there were no significant differences in toxicity between 1/3D and FD. The null hypotheses of inferiority of the disease-free interval for both 1/3D and 1 yr could not be rejected. We found that 1/3D-1 yr is suboptimal compared with FD-3 yr (hazard ratio [HR]: 0.75; 95% confidence interval [CI], 0.59-0.94; p = 0.01). Intermediate-risk patients treated with FD do not benefit from an additional 2 yr of BCG. In high-risk patients, 3 yr is associated with a reduction in recurrence (HR: 1.61; 95% CI, 1.13-2.30; p = 0.009) but only when given at FD. There were no differences in progression or survival. Conclusions: There were no differences in toxicity between 1/3D and FD. Intermediate-risk patients should be treated with FD-1 yr. In high-risk patients, FD-3 yr reduces recurrences as compared with FD-1 yr but not progressions or deaths. The benefit of the two additional years of maintenance should be weighed against its added costs and inconvenience. Trial registration: This study was registered at ClinicalTrials.gov, number NCT00002990; http://clinicaltrials.gov/ct2/show/ record/NCT00002990. © 2012 European Association of Urology.
Brausi M.,New Estense S Agostino Hospital Ausl Modena |
Oddens J.,Robert Bosch GmbH |
Sylvester R.,European Organisation for Research and Treatment of Cancer |
Bono A.,Ospedale di Circolo |
And 7 more authors.
European Urology | Year: 2014
Background Although bacillus Calmette-Guérin (BCG) has proven highly effective in non-muscle-invasive bladder cancer (NMIBC), but it can cause severe local and systemic side effects. Objectives The objective was to determine whether reducing the dose or duration of BCG was associated with fewer side effects. Efficacy comparisons of one-third dose versus full dose BCG given for 1 yr versus 3 yr have previously been published. Design, setting, and participants After transurethral resection, patients with intermediate- and high-risk NMIBC without carcinoma in situ were randomised to one-third dose or full dose BCG and 1 yr or 3 yr of maintenance. Outcome measurements and statistical analysis Local and systemic side effects were recorded at every instillation and divided into three time periods: during induction, during the first year after induction, and during the second and third years of maintenance. Results and limitations Of the 1316 patients who started BCG, 826 (62.8%) reported local side effects, 403 (30.6%) reported systemic side effects, and 914 (69.5%) reported local or systemic side effects. The percentage of patients with at least one side effect was similar in the four treatment arms (p = 0.41), both overall and in the different time periods. The most frequent local and systemic side effects were chemical cystitis in 460 (35.0%) patients and general malaise in 204 patients (15.5%); 103 patients (7.8%) stopped treatment because of side effects. No significant difference was seen between treatment groups (p = 0.74). In the 653 patients randomised to 3 yr of BCG, 35 (5.4%) stopped during the first year, and 21 (3.2%) stopped in the second or third year. Conclusions No significant differences in side effects were detected according to dose or duration of BCG treatment in the four arms. Side effects requiring stoppage of treatment were seen more frequently in the first year, so not all patients are able to receive the 1-3 yr of treatment recommended in current guidelines. This study was registered at ClinicalTrials.gov with identifier NCT00002990 (http://clinicaltrials.gov/ct2/show/record/NCT00002990). © 2013 European Association of Urology. Published by Elsevier B.V. All rights reserved.
BMJ case reports | Year: 2013
This case report describes a 38-year-old woman in whom a primary caesarean section for placenta previa was complicated by postpartum haemorrhage due to a placenta accreta. Despite tamponade with a Bakri balloon and placement of a B-Lynch suture, the amount of blood loss could not be effectively reduced. The blood loss was eventually minimised by the placement of a Penrose drain around the cervix as a cervical tourniquet. We think that a cervical tourniquet is an effective method of stopping haemorrhage during caesarean section, as shown in this case report, and we consider this technique to be a valuable addition to several existing methods through which fertility is preserved by preventing emergency hysterectomy.
van den Bekerom M.P.J.,OLVG |
Sjer A.,MCA |
Somford M.P.,Amphia hospital |
Bulstra G.H.,OLVG |
And 2 more authors.
Knee Surgery, Sports Traumatology, Arthroscopy | Year: 2015
Purpose: In the recent clinical guideline for acute lateral ankle sprain, the current best evidence for diagnosis, treatment and prevention strategies was evaluated. Key findings for treatment included the use of ice and compression in the initial phase of treatment, in combination with rest and elevation. A short period of taking non-steroidal anti-inflammatory drugs (NSAIDs) may facilitate a rapid decrease in pain and swelling can also be helpful in the acute phase. The objective was to assess the effectiveness and safety of oral and topical NSAID in the treatment for acute ankle sprains. Methods: Randomised controlled trials comparing oral or topic NSAID treatment with placebo or each other were included. Primary outcome measures were pain at rest or at mobilisation and adverse events. Trials were assessed using the Cochrane risk of bias tool. Results: Twenty-eight studies were included, and 22 were available for meta-analysis. Superior results were reported for oral NSAIDs when compared with placebo, concerning pain on weight bearing on short term, pain at rest on the short term, and less swelling on short- and intermediate term. For topical NSAIDs, superior results compared with placebo were found for pain at rest (short term), persistent pain (intermediate term), pain on weight bearing (short- and intermediate term) and for swelling (short and intermediate term). No trials were included comparing oral with topic NSAIDs, so conclusions regarding this comparison are not realistic. Conclusions: The current evidence is limited due to the low number of studies, lack of methodological quality of the included studies as well as the small sample size of the included studies. Nevertheless, the findings from this review support the use of NSAIDs for the initial treatment for acute ankle sprains. Level of evidence: Meta-analysis of RCTs, Level I. © 2014, Springer-Verlag Berlin Heidelberg.