舌下含服尘螨制剂治疗变应性鼻炎有效性及安全性Meta分析

Meta-analysis of efficacy and safety of sublingual dust mite preparation in treatment of allergic rhinitis

目的通过Meta分析评价舌下含服尘螨制剂治疗变应性鼻炎(AR)的安全性、有效性。方法检索尘螨变应原制剂舌下免疫治疗(SLIT)AR的随机对照研究(RCT),主要包括SLIT与安慰剂相比及SLIT与传统药物相比较的两类RCT。对纳入文献评价,提取相关文献的纳入数据进行Meta分析。对二分类变量采取风险比(RR)作为结局指标,对于连续性数值变量采取标准化均数差(SMD)或加权均数差(WMD)作为结局指标,并计算相应指标的95%可信区间。结果纳入文献16篇,其中10篇是SLIT与安慰剂组之间的RCT,另6篇是SLIT与常规药物治疗之间的RCT。Meta分析显示:在SLIT与安慰剂对照的RCT中,总有效率、鼻症状评分差异显著(RR=1.45,95%CI:1.29~1.63;WMD=-0.72,95%CI:-0.92^-0.52),而不良反应发生率、药物使用评分、治疗后血清sIgE、血清sIgG4等差异无统计学意义,提示与安慰剂相比SLIT安全有效,而相应的血清学指标无明显变化。在SLIT与常规药物组的RCT研究中,总有效率、不良反应发生率、鼻症状评分及药物使用评分等均呈现出显著差异(RR=1.15,95%CI:1.00~1.33;RR=1.91,95%CI:1.01~3.59;WMD=-2.85,95%CI:-3.94^-1.75;SMD=-2.60,95%CI:-3.82^-1.37),提示与传统药物相比,SLIT可显著降低患者鼻部症状及常规药物的使用量。结论尘螨变应原SLIT治疗AR安全可靠,优于常规药物,但需高质量研究加以验证。

Objective To evaluate the safety and efficacy of sublingual dust mite preparation in the treatment of allergic rhinitis(AR) by meta-analysis. Methods The randomized controlled trials(RCT) of AR treated with the dust mite allergen preparation sublingual immunotherapy(SLIT) were searched, including RCTs of SLIT and placebo and RCTs of SLIT and conventional drugs. The included literature was evaluated and relevant literature was extracted for Meta-analysis.Risk ratio(RR) was used as the outcome indicator for binary variables, and standardized mean difference(SMD) or weighted mean difference(WMD) were used as the outcome indicators for continuous numerical variables. The 95%confidence interval of the corresponding indicators was calculated. Results Sixteen articles were included, of which ten were RCTs of SLIT and placebo and the other six were RCTs of SLIT and conventional medication. Meta-analysis showed that of the RCTs of SLIT and placebo, the total effective rates and nasal symptom scores were significantly different(RR=1.45, 95%CI: 1.29 to 1.63;WMD=-0.72, 95%CI:-0.92 to-0.52), while the incidences of adverse reactions,drug use scores, post-treatment serum s IgE and serum sIgG4 were not statistically different, suggesting that SLIT was safe and effective compared with placebo and no significant changes were found in relevant serological indicators. Of the RCTs of SLIT and conventional drugs, the total effective rates, incidences of adverse reactions, nasal symptom scores and drug use scores were all significantly different(RR=1.15, 95%CI: 1.00 to 1.33;RR=1.91, 95%CI: 1.01 to 3.59;WMD =-2.85, 95% CI:-3.94 to -1.75;SMD =-2.60, 95% CI:-3.82 to -1.37), suggesting that SLIT can remarkably reduce the patients’ nasal symptoms and dosage of conventional drugs compared to conventional drugs. Conclusion The dust mite allergen SLIT is safe and reliable in the treatment of AR, which is superior to conventional drugs, but needs high quality research as verification.