Rajakulasingam K
Department of Respiratory Medicine/Allergy, Homerton University Hospital NHS Foundation Trust, Homerton Row, London, United Kingdom.
Eur Ann Allergy Clin Immunol. 2012 Jun;44(3):128-34.
A double-blind, placebo-controlled study was performed with 37 patients to assess the efficacy as well as the safety of short-term pre-seasonal subcutaneous immunotherapy (SCIT) with a six-grass pollen allergoid for one year.
After one pre-seasonal treatment cycle there are significant differences between the groups in favour of active treatment. On a "1-10" visual rating scale patients' condition is improved in the active group by a median of 2.5 points, whereas no change is found in the placebo treated group (p = 0.024). Thirteen of 20 (65%) actively treated patients in comparison to 6 of 17 (35%) placebo treated patients improved for at least two points which was defined as clinically relevant. The efficacy of SCIT is further demonstrated by significantly reduced skin test reactivity and significant increases in immunological parameters like allergen-specific IgG1 and IgG4 in actively treated patients. Injections are well tolerated and only mild to moderate systemic reactions occurred.
The high-dose hypoallergenic grass pollen preparation was shown to be safe and clinically efficacious. One pre-seasonal course of 7 SCIT injections was sufficient to reach significant and clinically relevant efficacy with good safety.
对37例患者进行了一项双盲、安慰剂对照研究,以评估为期一年的短期季节性前皮下免疫疗法(SCIT)使用六草花粉变应原疫苗的疗效和安全性。
在一个季节性前治疗周期后,各治疗组间存在显著差异,支持活性治疗。在“1-10”视觉评分量表上,活性组患者的病情中位数改善了2.5分,而安慰剂治疗组未发现变化(p = 0.024)。20例接受活性治疗的患者中有13例(65%)改善至少2分,而17例接受安慰剂治疗的患者中有6例(35%)改善至少2分,这被定义为具有临床意义。活性治疗患者皮肤试验反应性显著降低以及变应原特异性IgG1和IgG4等免疫参数显著增加,进一步证明了SCIT的疗效。注射耐受性良好,仅出现轻度至中度全身反应。
高剂量低变应原性草花粉制剂被证明是安全且临床有效的。7次SCIT注射的一个季节性前疗程足以实现显著且具有临床意义的疗效,且安全性良好。