Clinical trials with multiple endpoints can establish a correlation,but not (yet) causality,between dietary supplementation with omega-3 fatty acids and keratoconjunctivitis sicca

Aim: We review clinical evidence of therapeutic efficacy and effectiveness of omega-3 fatty acids (omega-3s) in keratoconjunctivitis sicca, colloquially known as dry eye disease. In doing so, we identify relevant literature to address the following questions: (1) What definitive guidance can clinical evidence offer eye physicians and their patients? (2) What aspects of omega-3 supplementation lack definitive evidence, and how might economic assessments help?

Methods: A targeted and systematic search strategy based on PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) was designed in this study for refereed clinical trials of omega-3s in dry eye treatment. Four key databases were accessed. Records were filtered through a three-step process using predetermined inclusion criteria. Data was extracted for experimental design, sample population characteristics, content of test and control groups, symptoms and associated opthalmologic conditions, diagnostic measures, patient health outcomes, adverse events, and model time horizon.

Results: A total of 219 records were initially identified, of which 21 prospective clinical trials, with a total of 2,973 participants, were admitted for review. Clinical evidence indicates that daily oral supplementation with omega-3s statistically correlates with dry eye treatment in the general symptomatic population as well as induced sub-populations. Reported adverse events are minimal. These trials nonetheless exhibit considerable heterogeneity in clinical endpoints, particularly as a result of the multi-factorial character of dry eye as well as continuous advances in scientific knowledge and technology. Their findings and recommendations appear to be of limited external validity. And causal inferences are needed, but difficult to establish. These have encouraged and sustained wide variations in ophthalmologic practice and normative decision-making.

Conclusions: Comparability of omega-3 therapeutic efficacy and effectiveness remains a major challenge in dry eye disease management. Notwithstanding its multi-factorial character, addressing prevailing methodological and empirical issues in clinical trials will help reduce knowledge gaps and normative choices among eye physicians and patients alike. In this regard, pharmacoeconomics offers a useful and robust toolset through which analysis of cost-minimization, cost-effectiveness, and cost-utility as well as meta-analysis can be comparatively pursued. Blending measures of costs and outcomes puts in perspective the heterogeneity of clinical endpoints in keratoconjunctivitis sicca.     

Factors associated with increased hospital costs in patients treated with lipid-based amphotericin B for empirical therapy

Summary

Lipid-based amphotericin B agents have been studied in a number of clinical settings and patient populations, most notably as empirical therapy for patients at-risk for systemic fungal infection and for patients with documented invasive disease. In clinical practice, lipid-based therapies have been considered second- or even third-line therapy due to concerns about costs. However, few analyses have been conducted to determine those factors associated with empirical antifungal therapy and lipid-based agents that are most likely to influence hospital costs and length of stay.

The purpose of this analysis is to determine which demographic, treatment, and clinical outcome factors contribute to increased hospital costs and length of stay in patients treated empirically with a lipid-based amphotericin B agent.

A retrospective analysis of 89 patients enrolled in the clinical study was performed to assess hospital costs and length of stay following the start of empirical antifungal therapy. Bivariate and multivariate regressions were performed to identify variables most likely to affect hospital costs and length of stay.

Allogeneic bone marrow transplant (BMT) status, days of treatment, doubling of baseline creatinine, and dialysis were found to be predictive both of increased hospital costs and length of stay. Length of stay and number of concomitant nephrotoxic agents also were found to affect hospital costs.

Overall, risk factors and clinical outcomes associated with nephrotoxicity increased hospital costs and length of stay in patients treated empirically with lipid-based antifungal agents. Renal dialysis also increased hospital cost significantly. For empirical antifungal therapy, providers should consider both patient-specific risk factors and product-specific outcomes in selecting an appropriate agent.     

剖宫产产妇抗菌药物使用疗程的成本-效果分析

目的:寻找广州市妇婴医院剖宫产产妇术后预防性使用抗菌药物的最佳疗程。方法:采用回顾性研究,收集和整理该院2006年6月至2007年5月493例剖宫产产妇相关资料,利用成本-效果分析方法对剖宫产产妇术后预防性使用抗菌药的不同疗程进行分析。结果:剖宫产产妇预防性使用抗菌药的疗程A组((d<3)天)、B组((3≤d<4)天)、C组((4≤d<5)天)、D组((d≥5)天)的有效率分别为:66.67%、85.12%、89.5%、85.19%;以抗菌药费用作为成本计算的成本-效果比分别为:9.21、7.22、8.62、14.32;以西药费作为成本计算的成本-效果比分别为:13.92、15.29、16.89、21.89;以住院费作为成本计算的成本-效果比分别为:61.15、67.09、66.78、79.96。结论:剖宫产产妇术后预防性使用抗菌药物,最经济、有效、合理的使用时间为术后3天(B组),增加用药天数并不能增加治疗效果,而费用却明显增加。