Current medical research and opinion
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Objective: Clinical guidelines for the treatment of septic shock are based on the studies with the best scientific evidence, which are meta-analyses of clinical trials. However, these meta-analyses may have methodological limitations that prevent their conclusions from being extrapolated to routine clinical practice. Therefore, the objective of this study is to determine the quality of these meta-analyses through a systematic review. ⋯ Most elements of the OQAQ were conducted satisfactorily, although 35.3% of meta-analyses did not use a quality assessment of the studies included in other analyses. In 52.9% of meta-analyses, the quality of the studies was high or very high. Conclusions: The methods used to obtain the results should be taken into account when recommending an intervention to treat septic shock if the evidence comes from a meta-analysis of the analyzed characteristics.
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Objective: This economic evaluation aims to provide a preliminary assessment of the cost-effectiveness of radiofrequency ablation (RFA) compared with argon plasma coagulation (APC) when used to treat APC-refractory gastric antral vascular ectasia (GAVE) in symptomatic patients. Methods: A Markov model was constructed to undertake a cost-utility analysis for adults with persistent symptoms secondary to GAVE refractory to first line endoscopic therapy. The economic evaluation was conducted from a UK NHS and personal social services (PSS) perspective, with a 20-year time horizon, comparing RFA with APC. ⋯ The model estimated that implementing RFA would result in reductions in the need for intravenous iron, endoscopic intervention and requirement for blood transfusions by 27.1%, 32.3% and 36.5% respectively. Compared to APC, RFA was associated with an estimated 36.7% fewer procedures. Conclusions: RFA treatment is likely to be cost-effective for patients with ongoing symptoms following failure of first line therapy with APC and could lead to substantive reductions in health care resource.
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Multicenter Study Observational Study
Long-term safety and effectiveness of biosimilar insulin glargine in Japanese patients with diabetes mellitus in routine clinical practice: results of a post-marketing safety study.
Objective: To evaluate the long-term safety and effectiveness of biosimilar insulin glargine (GLY) in real-world clinical practice. Methods: This prospective, non-interventional, multicenter, observational, post-marketing safety study (PMSS) enrolled Japanese patients with type 1 or 2 diabetes mellitus (T1DM or T2DM) starting GLY therapy, and was required by Japanese Pharmaceutical Affairs Law mandating post-marketing safety surveillance to acquire safety and effectiveness data of biosimilar products. Data collected from the 12-month observation included patient characteristics, adverse events, and blood glucose control. ⋯ Baseline mean hypoglycemic events/month were 1.8 and 0.1 in T1DM and T2DM, respectively: the mean change from baseline (CFB) was -1.2 (p = .066) and 0.0 (p = .915), respectively. Baseline mean HbA1c was 8.4% and 8.7% in T1DM and T2DM, respectively; the mean CFB was -0.5% (p < .001) and -0.9% (p < .001), respectively, and -1.5% (p < .001) in insulin-naive T2DM. Conclusions: This first long-term Japanese PMSS of GLY demonstrated adverse events, hypoglycemia, and glycemic control consistent with the known GLY profile for T1DM and T2DM patients, in routine clinical practice.
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Objectives: Childhood asthma is a common chronic illness that has been associated with mode of delivery. However, the effect of cesarean delivery alone does not fully account for the increased prevalence of childhood asthma. We tested the hypothesis that neuraxial anesthesia used for labor analgesia and cesarean delivery alters the risk of developing childhood asthma. ⋯ Additionally, a unit increase in the composite dose of local anesthetics and opioid analgesics administered via the spinal route was associated with a lower risk of asthma in both male (OR = 0.59, 95% CI = 0.36-0.96) and female children (OR 0.26, 95% CI 0.09-0.82). Conclusion: Our data suggest that peripartum exposure to neuraxial anesthesia may reduce the risk of childhood asthma primarily in males. Larger human studies and model systems with longer follow-up are required to elucidate these findings.
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Objective: To explore whether newly diagnosed iron deficiency anemia (IDA) is associated with subsequent systemic autoimmune disease onset. Methods: The study identified 22,440 patients who received a diagnosis of IDA between 2000 and 2012 from a random sample of 1 million people from Taiwan's National Health Insurance Research Database. The patients with IDA were randomly matched with 89,528 patients with no IDA by age, gender, and index year. ⋯ The autoimmune disease was significantly more likely to occur within 2 years after a new diagnosis of IDA. Conclusions: IDA significantly increases autoimmune disease risk, particularly in female patients and patients with certain comorbidities. Clinicians should conduct further clinical evaluations and laboratory tests of autoimmune disease in patients with IDA.