[Side effects of medicinal products: assessment and registration of causality]. / Bijwerkingen van geneesmiddelen.

The Farmacotherapeutisch Kompas (FK) and the KNMP Kennisbank report on side effects of medicinal products, in order of frequency. However, data regarding causality and its assessment are lacking, while this information is crucial when the discontinuation of a drug due to putative side effects is considered. In this article, we describe the role of pharmaceutical companies, the agencies in charge of the evaluation and supervision of medicinal products and Lareb. We also describe how this information is included in the FK and the Kennisbank. Only side effects with a probable causal relation to the drug are registered. However, to err on the side of caution, side effects with a questionable causal relation to the drug are sometimes also registered. It would be helpful for the physician if the FK and the Kennisbank also reported the degree of assessed causality, next to the frequency.

Reply to Gautret et al: hydroxychloroquine sulfate and azithromycin for COVID-19: what is the evidence and what are the risks?

The severity of COVID-19 has resulted in a global rush to find the right antiviral treatment to conquer the pandemic and to treat patients. This requires reliable studies to support treatment. In a recently published study by Gautret et al. the authors concluded that hydroxychloroquine monotherapy and hydroxychloroquine in combination with azithromycin reduced viral load. However, this trial has several major methodological issues, including the design, outcome measure and the statistical analyses. In this paper we discuss the background, clinical evidence, pharmacology and methodological issues related to this clinical trial. We understand the rush to release results, however in case conclusions are far reaching the evidence needs to be robust.

Impact of the BioFire FilmArray gastrointestinal panel on patient care and infection control.

OBJECTIVES: Conventional routine PCR testing for gastrointestinal infections is generally based on pathogen related panels specifically requested by clinicians and can be erroneous and time consuming. The BioFire FilmArray gastrointestinal (GI) panel combines 22 pathogens into a single cartridge-based test on a random-access system, thereby reducing the turnaround time to less than 2 hours. We described the clinical impact of implementing the BioFire FilmArray on patients with gastroenteritis in our hospital. METHODS: Patients attending a Dutch tertiary care center (Radboud University Medical Center), from whom stool samples were obtained, were eligible for inclusion. The clinicians selected one or a combination of different routinely performed PCR panels (bacterial panel, viral panel, clostridium testing, and three parasitic panels) based on clinical history and symptoms. All samples were in parallel tested with the FilmArray. We retrospectively collected patient data regarding infection control and patient management to assess the potential impact of implementing the FilmArray. RESULTS: In total 182 patients were included. Routine PCR detected one or more pathogens in 52 (28.6%) patients compared to 72 (39.6%) using the FilmArray. Turnaround time (including transport) decreased from median 53 hours for the routine PCR to 16 hours for the FilmArray. Twenty-six patients could have been removed from isolation 29 hours sooner, 3.6 antibiotic days could have been saved and in five patients additional imaging testing (including colonoscopies) could have been prevented. CONCLUSION: The theoretical implementation of the BioFire FilmArray GI panel in patients with clinical suspicion of gastroenteritis resulted in a significant better patient management.

Vaccination with Fendrix of prior nonresponding patients with HIV has a high success rate.

BACKGROUND: Patients with HIV have a poor serological conversion rate with the standard vaccination strategy against hepatitis B virus (HBV) of around 50%. Vaccination with Fendrix confers much better results in these patients. In this study, we tested the effect of revaccination with Fendrix in prior nonresponding patients with HIV and aimed to determine which factors are associated with seroconversion. METHODS: Eight Dutch HIV treatment centers participated in this retrospective study. Patients infected with HIV-1 and nonresponding to prior course of vaccination against HBV (anti-HBs <10 IU/ml) and who had Fendrix as a second, third or fourth effort to achieve seroconversion were eligible for inclusion. Primary outcome was the proportion of patients with seroconversion after revaccination with Fendrix. Univariate binary logistic regression analyses were used to determine which factors could be used as predictors for seroconversions. RESULTS: We included 100 patients with HIV. The mean age was 47.3 (±11.0) years and 86% were men. Revaccination with Fendrix showed a seroconversion rate of 81% (95% confidence interval 72-88%). Median nadir CD4+ cell count was 300 (20-1040) cells/µl and median CD4+ cell count at the time at starting vaccination with Fendrix was 605 (210-1190) cells/µl. Regression analyses showed no significant factor associated with seroconversion. CONCLUSIONS: Revaccination with Fendrix of patients prior nonresponding to other hepatitis B vaccination strategies has a high success rate. Eighty-one percentage responded with seroconversion, irrespective of CD4+ cell count.

[Myelitis transversa caused by neuroschistosomiasis]. / Myelitis transversa door schistosomiasis.

BACKGROUND: Neuroschistosomiasis is a severe complication of an infection with Schistosoma; this infection can lead to myelitis transversa. Acute myelitis transversa is a rare disorder of the spinal cord, which can present with muscular weakness, sensory disturbance and intestinal or bladder dysfunction. CASE DESCRIPTION: A 17-year-old refugee from Eritrea, who had been in the Netherlands for 3 weeks, suffered from back pain and progressive weakness of both legs for one week. Both the clinical presentation and the MRI images were consistent with myelitis transversa. Schistosomamansoni eggs were found in the faeces, and antibodies to Schistosoma eggs and worms were found in both liquor and serum, leading to a diagnosis of neuroschistosomiasis. The patient recovered completely following treatment with praziquantel and prednisone. CONCLUSION: Schistosomiasis is a commonly occurring parasitic disease in sub-Saharan Africa, which can lead to myelitis transversa if it spreads to the spinal cord. Early detection and treatment are necessary to prevent lasting damage. A good geographical case history is essential for this process.