A benefit-risk review of systemic haemostatic agents: Part 2: In excessive or heavy menstrual bleeding
Department of Obstetrics and Gynaecology, University of Sydney, Sydney, NSW, Australia.Drug Safety (Impact Factor: 2.82). 02/2008; 31(4):275-82.
The first part of this benefit-risk review examined the efficacy and adverse effect profiles of systemic haemostatic agents commonly used in major surgery. The second part of this review examines the efficacy and adverse effect profiles of systemic haemostatic agents commonly used in the treatment of excessive or heavy menstrual bleeding, and provides individual benefit-risk profiles that may assist clinicians in selecting appropriate pharmacological therapy in this setting. Historically, surgery has played a dominant role in treatment; however, pharmacological therapy is increasingly popular, especially in women who wish to retain their fertility. When selecting the appropriate treatment, patient preference should be considered, as well as the benefits and risks associated with each agent. Recommended pharmacological therapies that are effective and generally well tolerated include the levonorgestrel-releasing intrauterine system and the oral agents tranexamic acid, NSAIDs (e.g. mefenamic acid) and combined estrogen/progestogen oral contraceptives. In patients with an underlying bleeding disorder (e.g. von Willebrand disease), an additional option is intranasal desmopressin.
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- "Kalkwarf reported that the response may be caused by an altered microvasculature, increased gingival permeability, and increased synthesis of prostaglandin. Newer hemostatic agents include antifibrinolytics such as epsilon-aminocaproic acid and tranexamic acid. "
ABSTRACT: von Willebrand disease (vWD) is an inherited bleeding disorder affecting both the sexes with a prevalence of approximately 1% in general population. The cause for bleeding in this disorder can be attributed to the primary deficiency or defect in von Willebrand factor (vWF) that results in the platelet adhesion abnormalities. It is characterized by bleeding episodes that may be severe and life threatening, menorrhagia in females, epistaxis, and gingival bleeding and enlargement. A case of 29-year-old female having all the characteristic features of vWD is presented. The family history revealed consanguineous marriage of the parents. The patient was initially on oral contraceptives, but later she underwent diagnostic hysteroscopy with endometrial ablation with roller ball to treat menorrhagia.
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ABSTRACT: An upgrade program for increasing the stored beam current in the LANSCE Proton Storage facility is presently under way. Part of the upgrade effort has been to design, specify and add four bump-magnet/modulator systems to the ring. This paper describes the initial test results of the first bump-magnet/modulator system. The paper begins with an overview of the pulsed power system including important specifications of the modulator, magnet, cabling and control system. In the main portion of the paper, waveforms and test data are included showing the accuracy, repeatability and stability of the magnet-current pulses. These magnet pulses are programmable both in rise and fall time as well as in amplitude. The amplitude can be set between 50 and 300 A, the rise-time is fixed at 1 ms and the linear fall-time can be varied between 500 μs and 1500 μs. Other issues such as loading effects and power dissipation in the magnet-bore beam tube are examined and reported
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ABSTRACT: Systemic haemostatic agents play an important role in the management of blood loss during major surgery where significant blood loss is likely and their use has increased in recent times as a consequence of demand for blood products outstripping supply and the risks associated with transfusions. Their main application is as prophylaxis to reduce bleeding in major surgery, including cardiac and orthopaedic surgery and orthotopic liver transplantation. Aprotinin has been the predominant agent used in this setting; of the other antifibrinolytic agents that have been studied, tranexamic acid is the most effective and epsilon-aminocaproic acid may also have a role. Eptacog alfa (recombinant factor VIIa) has also shown promise. Tranexamic acid, epsilon-aminocaproic acid and eptacog alfa are generally well tolerated; however, when considering the methods to reduce or prevent blood loss intra- and postoperatively, the benefits of these agents need to be weighed against the risk of adverse events. Recently, concerns have been raised about the safety of aprotinin after an association between increased renal dysfunction and mortality was shown in retrospective observational studies and an increase in all-cause mortality with aprotinin relative to tranexamic acid or epsilon-aminocaproic acid was seen after a pre-planned periodic analysis of the large BART (Blood conservation using Antifibrinolytics in a Randomized Trial) study. The latter finding resulted in the trial being halted, and aprotinin has subsequently been withdrawn from the market pending detailed analysis of efficacy and safety results from the study. Part 1 of this benefit-risk review examines the efficacy and adverse effect profiles of systemic haemostatic agents commonly used in surgery, and provides individual benefit-risk profiles that may assist clinicians in selecting appropriate pharmacological therapy in this setting.
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