We examined the effects of two African herbal medicines recommended for HIV/AIDS patients on antiretroviral metabolism. Extracts from Hypoxis and Sutherlandia showed significant effects on cytochrome P450 3A4 metabolism and activated the pregnane X receptor approximately twofold. P-glycoprotein expression was inhibited, with Hypoxis showing 42-51% and Sutherlandia showing 19-31% of activity compared with verapamil. Initiating policies to provide herbal medicines with antiretroviral agents may put patients at risk of treatment failure, viral resistance or drug toxicity.
Though use of the controversial precautionary principle in risk management has increasingly been recommended as a guide for the construction of public policy in Canada and elsewhere, there are few data available characterizing its use in risk management by senior public policymakers. Using established survey methodology we sought to investigate the perceptions and terms of application of the precautionary principle in this important subset of individuals. A total of 240 surveys were sent out to seven departments or agencies in the Canadian government. The overall survey response rate was 26.6%, and our findings need to be interpreted in the context of possible responder bias. Of respondents, the overwhelming majority perceived the precautionary principle and the management of risk as complementary, and endorsed a role for the precautionary principle as a general guideline for all risk management decisions. However, 25% of respondents responded that the lack of clarity of the definition of the principle was a limitation to its effective use. The majority of respondents viewed their own level of understanding of the precautionary principle as moderate. Risk managers appeared to favor an interpretation of the precautionary principle that was based on the seriousness and irreversibility of the threat of damage, and did not endorse as strongly the need for cost effectiveness in the measures taken as a precaution against such threats. In contrast with its perceived role as a general guideline, the application of the precautionary principle by respondents was highly variable, with >60% of respondents reporting using the precautionary principle in one-quarter or less of all risk management decisions. Several factors influenced whether the precautionary principle was applied with the perceived seriousness of the threat being considered the most influential factor. The overwhelming majority of risk managers felt that "preponderance of evidence" was the level of evidence required for precautionary action to be instituted against a serious negative event. Overall, the majority of respondents viewed the precautionary principle as having a significant and positive impact on risk management decisions. Importantly, respondents endorsed a net result of more good than harm to society when the precautionary principle was applied to the management of risk.
A n 18-year-old man with a three-year history of well-controlled systemic lupus erythematosus experienced new-onset fatigue, malaise and diffuse myalgia before leaving on a camping trip to the midwestern United States. These symptoms began about one week before leaving on the trip and coincided with changes to his maintenance dose of mycophenolate. When the diagnosis was originally made at the age of 14 years, the pa tient had arthralgia, rash, nephritis, nasal ulcers and multiple biochemical markers consistent with systemic lupus erythematosus. He was initially given immunosuppressants, and his disease had been in remission for about three years with treatment with mycophenolate.Over a period of about 48 hours, the patient experienced ascending numbness and flaccid paralysis in both legs, accompanied by thoracolumbar pain, malar rash, fever and rigor. Rectal incontinence and urinary retention followed, prompting emergent transportation to a large tertiary care centre.On admission, the patient had no fever and was alert, with normal vital signs. He had a malar rash, but no actively inflamed joints, identifiable insect bites or visual symptoms. He had flaccid leg paralysis and areflexia, with paresthesia below the level of T11, and an upgoing left plantar response. The results of initial blood work, including a complete blood count, liver enzymes levels, total bilirubin level, coagulation profile, renal function and urinalysis, were all within normal ranges. The erythrocyte sedimentation rate and C-reactive protein level were within the reference ranges, whereas the serum levels of C3 (0.41 [normal 0.73-1.73] g/L) and C4 (0.113 [normal 0.13-0.52] g/L) were low. Results of tests for antiphospholipid antibodies, including anticardiolipin and anti-β 2 -glycoprotein, were negative.The results of a lumbar puncture showed an opening pressure of 10 (normal 5-20) cm H 2 O, a leukocyte count of 160 (normal 0-5) × 10 6 /L, with 90% neutrophils, 8% lymphocytes and 2% monocytes (normal 70% lymphocytes and 30% monocytes), a glucose level of 2.01 (normal 1.5-4.0) mmol/L and a total protein level of 1.27 (normal 0.18-0.58) g/L. The patient's cerebrospinal fluid sample was negative for bacterium and syphilis antibody testing. The results of viral serology of the cerebrospinal fluid for enterovirus, HIV, herpes simplex virus, cyto megalovirus and West Nile virus were also negative. Tests for antineuromyelitis optica antibodies were negative, and there was no evidence of oligoclonal banding.Magnetic resonance imaging (MRI) of the patient's spine indicated heterogeneous abnormal T 2 -weighted hyperintensive cord signal beginning at the level of T3 and extending caudally to the conus medullaris (Figure 1). These findings were consistent with a diagnosis of longitudinally extensive transverse myelitis.The patient was originally given antibiotics and antiviral agents, which were stopped when no infectious agents could be identified. Given the patient's history, physical findings, and biochemical and radiographic test results, longitud...
Background Oral anticoagulants (OACs) are commonly prescribed, have well-documented benefits for important clinical outcomes but have serious harms as well. Rates of OAC-related adverse events including thromboembolic and hemorrhagic events are especially high shortly after hospital discharge. Expert OAC management involving virtual care is a research priority given its potential to reach remote communities in a more feasible, timely, and less costly way than in-person care. Our objective is to test whether a focused, expert medication management intervention using a mix of in-person consultation and virtual care follow-up, is feasible and effective in preventing anticoagulation-related adverse events, for patients transitioning from hospital to home. Methods and analysis A randomized, parallel, multicenter design enrolling consenting adult patients or the caregivers of cognitively impaired patients about to be discharged from medical wards with a discharge prescription for an OAC. The interdisciplinary multimodal intervention is led by a clinical pharmacologist and includes a detailed discharge medication reconciliation and management plan focused on oral anticoagulants at hospital discharge; a circle of care handover and coordination with patient, hospital team and community providers; and early post-discharge follow-up virtual medication check-up visits at 24 h, 1 week, and 1 month. The control group will receive usual care plus encouragement to use the Thrombosis Canada website. The primary feasibility outcomes include recruitment rate, participant retention rates, trial resources management, and the secondary clinical outcomes include adverse anticoagulant safety events composite (AASE), coordination and continuity of care, medication-related problems, quality of life, and healthcare resource utilization. Follow-up is 3 months. Discussion This pilot RCT tests whether there is sufficient feasibility and merit in coordinating oral anticoagulant care early post-hospital discharge to warrant a full sized RCT. Trial registration NCT02777047.
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