■尽管随机对照试验(RCT)是过敏原免疫疗法(AIT)的参考证据标准,非随机研究(NRS)需要在更具代表性的人群中证实其结果,特别是治疗持续时间和持久性。然而,当在RCT和NRS之间观察到差异时,NRS可靠性降低,因为这些差异结果通常归因于NRS的方法学缺陷。
■我们比较了舌下AIT(SLIT)在NRS和RCT中对过敏性鼻结膜炎的益处,重点是单一产品/过敏原以减少异质性。
■对于荟萃分析,室内尘螨(HDM)SLIT液体配方研究来自计算机化(Medline,WebofScience,和LILACS数据库,至2023年1月)和手动文献检索。人口,治疗,和结果数据合并(DerSimonian-Laird方法)。将非比较性NRS与治疗前后的RCT\'SLIT臂进行比较。功效被确定为症状评分(SS)和药物评分(MS)的标准化平均差异(SMD)。
■分析了12例NRS(682例患者)和8例RCT(176例患者)的数据。发现反应性指数(IR)-HDMSLIT液体制剂的益处显着,首先,两个NRS中的SS(SMD=-1.27;95%置信区间[CI],-1.64,-0.90)和RCT(SMD=-0.56;95%CI,-0.90,-0.21),第二,SMD等于-1.35(95%CI,-1.77,-0.93)和-0.46(95%CI,-0.67,-0.25)的MS,分别。元回归显示,症状改善与治疗持续时间相关,NRS和RCT结果一致,12个月SS数据:-0.87(四分位距,-1.02,-0.77)和-0.75(四分位数间距,-0.93,-0.41),分别。
■这项荟萃分析显示,随着时间的推移,IR-HDMSLIT液体制剂在NRS和RCT中的临床获益相当,表明NRS可以可靠地整合RCT结果,并可作为指南考虑。
UNASSIGNED: Although randomized controlled trials (RCT) are the reference standard of evidence in allergen immunotherapy (AIT), nonrandomized studies (NRS) are needed to confirm their results in more representative populations, particularly for treatment duration and persistence. However, when discrepancies are observed between RCT and NRS, NRS reliability decreases because these discrepant results are generally attributed to the methodologic flaws of NRS.
UNASSIGNED: We compared the benefit of sublingual AIT (SLIT) for allergic
rhinoconjunctivitis in NRS versus RCT focusing on a single product/allergen to reduce heterogeneity.
UNASSIGNED: For meta-analysis, house dust mite (HDM) SLIT liquid formulation studies were sourced from computerized (Medline, Web of Science, and LILACS databases, to January 2023) and manual literature searches. Populations, treatments, and outcome data were combined (DerSimonian-Laird method). Noncomparative NRS were compared to RCT\' SLIT arm before and after treatment. Efficacy was determined as the standardized mean difference (SMD) in symptom score (SS) and medication score (MS).
UNASSIGNED: Data from 12 NRS (682 patients) and 8 RCT (176 patients) were analyzed. The benefit with index of reactivity (IR)-HDM SLIT liquid formulation was found significant for, first, SS in both NRS (SMD = -1.27; 95% confidence interval [CI], -1.64, -0.90) and RCT (SMD = -0.56; 95% CI, -0.90, -0.21), and second, MS with SMD equal to -1.35 (95% CI, -1.77, -0.93) and -0.46 (95% CI, -0.67, -0.25), respectively. Metaregression showed that symptom improvement was correlated with treatment duration with consistent results in NRS and RCT with 12-month SS data: -0.87 (interquartile range, -1.02, -0.77) and -0.75 (interquartile range, -0.93, -0.41), respectively.
UNASSIGNED: This meta-analysis showed comparable clinical benefit of IR-HDM SLIT liquid formulation increasing over time in both NRS and RCT, suggesting that NRS may reliably integrate RCT results and be considered for guidelines.