5 e-Letters

published between 2020 and 2023

  • Chinese Clinical Trial Registry to COVID-19, Where is the Way Out to the Diagnosis and Treatment Therapy

    Chinese Clinical Trial Registry to COVID-19, Where is the Way Out to the Diagnosis and Treatment Therapy
    YaYun Wu1, HuaYe Jiang1, Xun Huang1*
    1Departments of Infection Control, Xiangya Hospital, Central South University, Changsha,HuNan 410008,China
    *Corresponding author:Xun Huang,MD, Department of Infection Control, Xiangya Hospital, Central South University, Changsha , HuNan 410008,China (Email: huangxun@mail.csu.edu.cn)
    To the Editor:
    During the epidemic period of Coronavirus Disease 2019 (COVID-19), many doctors and researchers conducted clinical trial on COVID-19 in China. Until 04:00 am 16 April , 2020, there were 598 clinical trials on COVID-19 registered in Chinese Clinical Trial Register (ChiCTR), including 309 (51.67%) interventional trials and 248 (41.47%) observational trials and 41 (6.86%) diagnostic trials. There were 43 studies have been withdrawn1.We analyze the data for the period, 6 clinical trials were registered in January (1.23-1.31), all of them were interventional studies.There were 291 clinical trials registered in February (2.1-2.29), including 193 (66.32%) interventional studies, 83 (28.52%) observational studies and 15 (5.16%) diagnostic studies.There were 254 clinical trials registered in March (3.1-3.31), including 93 (36.61%) interventional studies,138 (54.33%) observational studies and 23 (9.06%) diagnostic studies. There were 47 clinical trials registered in Apri...

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  • Re: Incidence and prevalence of intravenous medication errors in the United Kingdom: A Systematic Review; Refined Data

    We thank Dr Jones and Professor Franklin’s insightful and constructive response to our systematic review of the incidence and prevalence of intravenous medication errors in the UK. We appreciate and are grateful for their consideration and the opportunity to respond to their observation.

    They are absolutely right to suggest that this is an example of both the limitations of our systematic review methodology, and the importance of grey literature accessing wider datasets as part of these reviews. Our protocol allowed us to contact authors of papers for more detailed data, however did not provide for occasions where authors were not contactable, and did not include grey literature. Two independent data extractors flagged that the data in the original publication [1] was ambiguous. When it was clear that further data was not accessible through direct contact with the author a consensus decision was taken to present only the data that we could reliably associate with IV medication errors from the paper and acknowledge this limitation.

    As the correspondents rightly suggest, by supplanting the thesis data into the analysis, we identify 1773 intravenous doses, and 789 errors, resulting in a weighted prevalence estimate of 451/1000 administrations (95% CI 420–482), however the limitations related to the definition and operationalisation of errors, and how they affect estimates still hold, particularly around the impact of including “wrong time” errors into the...

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  • Re: "Incidence and prevalence of intravenous medication errors in the UK: a systematic review”: refined data

    We read this article with great interest. Given differences among countries in preparation and administration practices for intravenous medicines, it is an important contribution to the literature.

    Sutherland et al. state that their calculation of the incidence of intravenous medication errors may be an underestimate (1), as they were not able to clearly differentiate intravenous from non-intravenous administrations in the study by Ghaleb et al. (2) We are writing to highlight refined data related to the Ghaleb et al. study, which will be useful to readers interested in interpreting the review’s findings.

    Specifically, Table 2 of the review reports that in the Ghaleb et al. study, 85 infusions (5.5%) of a total of 1,554 contained at least one error. However, the Ghaleb et al. study reports data relating to all routes of administration, and not just the intravenous route (2). The total of 1,554 observed doses therefore includes both intravenous and other routes of administration, with the number of intravenous doses not reported in the published paper. Consequently, the incidence of intravenous medication errors reported Table 2 for the Ghaleb et al. study is artificially low. This is likely to considerably influence the systematic review’s pooled estimate of the incidence of intravenous medication errors, (1) as Ghaleb et al. (2) contributes 60% of the observations included in this calculation.

    The PhD thesis on which the paper by Ghaleb et al. is bas...

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  • Response to Van den Eynde and Gillman's letter

    I) We agree with Dr. Van den Eynde that since tedizolid is a more potent inhibitor than linezolid, it is administered at lower doses. Thus, the MAO inhibition would be lower. This is probably the reason why there have been no reports regarding serotoninergic toxicity. However, the possibility of MAO inhibition cannot be ruled out, especially when tedizolid is administered together with serotoninergic drugs. We would like to emphasize that the spontaneous reporting of suspected adverse reactions is useful to identify potential signals that suggest a causal association between a medicinal product and a previously unknown reaction. Whether this suspected adverse reaction is a signal, it should be confirmed by further reports.

    II) In our article we do not affirm that it is a serotonin syndrome or a serotonin toxicity, since, in fact, we do not have enough clinical information to confirm it. We only discuss the possibility that the hypertensive crisis could be related to the co-administration of tedizolid and other serotoninergic drugs. Our position is well defined in the following paragraph of the article: “The causality of hypertension as an adverse drug reaction due to the co-administration of tedizolid and other serotonergic treatments was evaluated using the algorithm of Naranjo et al, obtaining a final score of 3. According to this value, the relationship between tedizolid and the hypertensive crisis should be classified as possible, as we were not able to rule ou...

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  • A critical appraisal

    We note, upon critical appraisal of this case report, two shortcomings:
    (I) the authors provide a one-sided and inaccurate extrapolation to clinical practice from the literature data on tedizolid;
    (II) the authors do not adhere to well-established ‘diagnostic decision rules for serotonin toxicity’: the Hunter criteria.<1>
    I. In gauging the MAO-inhibiting potential of both antibiotics, de Castro Julve et al. rightly note that ‘tedizolid appears to be a more potent inhibitor in vitro of MAO-A than linezolid’ <2>– but neglect to mention (a) that tedizolid is also four to sixteen (or – depending on the source – ‘two to eight’)<3> times more potent than linezolid at treating most gram-positive infections;<4> and (b) that tedizolid is therefore administered at a lower dose than is linezolid (200mg/day vs. 600mg/12 hours).<3> This likely leads, in practice, to less tedizolid-induced (vs. linezolid-induced) MAO-inhibition<3>, as evidenced by the clinically insignificant potentiation of the tyramine pressor response (TYR30)<2>, and to less potential for serotonergic drug interactions<5>, as further evidenced by the fact that no changes in the murine head twitch response occur, even at plasma tedizolid concentrations which exceed – ‘by up to ~25-fold’ – the Cmax observed in humans at the clinical dose of 200mg/day.<3>
    II. The detection in their patient of a hypertensive crisis ‘suspected to be an adverse r...

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