Nguyen Elaine, Weeda Erin R, Sobieraj Diana M, Bookhart Brahim K, Piech Catherine Tak, Coleman Craig I
a University of Connecticut School of Pharmacy , Storrs , CT , U.S.A. ;
b Hartford Hospital Evidence-Based Practice Center , Hartford , CT , U.S.A. ;
Curr Med Res Opin. 2016 Jul;32(7):1281-90. doi: 10.1185/03007995.2016.1170673. Epub 2016 Apr 1.
To evaluate current knowledge of the impact of non-medical switching on clinical and economic outcomes, resource utilization and medication-taking behavior.
The literature was searched (Medline and Web of Science, January 2000-November 2015) to identify United States' studies evaluating ≥25 patients and measuring the impact of non-medical switching of drugs (switching to a chemically distinct but similar medication for reasons other than lack of clinical efficacy/response, side effects or poor adherence) on ≥1 clinical, economic, resource utilization or medication-taking behavior outcome. The direction of association between non-medical switching and outcomes was classified as negative or positive if a statistically significant worsening or improvement was reported, or neutral if no significant difference was observed.
Twenty-nine studies contributed 96 outcomes (60.4% clinical; 21.9% resource utilization; 13.5% economic; 4.2% medication-taking behavior) within six disease categories (cardio-metabolic, immune-mediated, acid suppression, psychiatric, hormone replacement therapy and pain). The direction of association was more frequently negative (33.3%) or neutral (55.2%) than it was positive (11.5%). Stratified by outcome type, non-medical switching was negatively associated with clinical, economic, healthcare utilization and medication-taking behavior outcomes in 20.7%, 69.2%, 38.1% and 75.0% of cases, respectively; and positively in only 4.8%-17.2% of outcomes subgroups. Of 32 outcomes in patients demonstrating stable/well controlled disease, 68.8% and 31.3% had a negative and neutral direction of association. In patients without demonstrated disease stability, outcomes were negatively, neutrally and positively impacted by non-medical switching in 15.6%, 67.2% and 17.2% of 64 outcomes.
Our inability to evaluate specific disease state categories and studies/outcomes received equal weight regardless of sample size or magnitude of effect.
Non-medical switching was more often associated with negative or neutral effects than positive effects on an array of important outcomes. Among patients with stable/well controlled disease, non-medical switching was associated with mostly negative effects.
评估非医疗性换药对临床和经济结局、资源利用及用药行为的影响的现有知识。
检索文献（2000年1月至2015年11月的Medline和科学网），以确定美国的研究，这些研究评估了≥25例患者，并测量了药物非医疗性换药（因缺乏临床疗效/反应、副作用或依从性差以外的原因换用化学结构不同但相似的药物）对≥1项临床、经济、资源利用或用药行为结局的影响。如果报告有统计学上显著的恶化或改善，则将非医疗性换药与结局之间的关联方向分类为负面或正面；如果未观察到显著差异，则分类为中性。
29项研究在6种疾病类别（心血管代谢、免疫介导、抑酸、精神、激素替代疗法和疼痛）中贡献了96项结局（60.4%为临床结局；21.9%为资源利用结局；13.5%为经济结局；4.2%为用药行为结局）。关联方向为负面（33.3%）或中性（55.2%）的情况比正面（11.5%）更为常见。按结局类型分层，非医疗性换药在20.7%、69.2%、38.1%和75.0%的病例中分别与临床、经济、医疗保健利用和用药行为结局呈负相关；在仅4.8%-17.2%的结局亚组中呈正相关。在病情稳定/控制良好的患者的32项结局中，68.8%和31.3%的关联方向为负面和中性。在未证明病情稳定的患者中，64项结局中有15.6%、67.2%和17.2%的结局因非医疗性换药受到负面、中性和正面影响。
我们无法评估特定疾病状态类别，且研究/结局无论样本量或效应大小均被同等加权。
非医疗性换药对一系列重要结局的影响更多与负面或中性效应相关，而非正面效应。在病情稳定/控制良好的患者中，非医疗性换药大多与负面效应相关。
