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Short course of grass allergen peptides immunotherapy over 3?weeks reduces seasonal symptoms in allergic rhinoconjunctivitis with/without asthma: A randomized, multicenter, double‐blind, placebo‐controlled trial

机译:草疗法肽肽免疫治疗超过3?周减少了过敏性鼻咽炎的季节性症状与/没有哮喘:随机,多中心,双盲,安慰剂对照试验

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Abstract Background Immunotherapy with peptide hydrolysates from Lolium perenne ( LPP ) is an alternative treatment for seasonal allergic rhinitis with or without asthma. The aim of this study was to assess the clinical efficacy and safety of a cumulative dose of 170?μg LPP administered subcutaneously over 3?weeks. Methods In a randomized, double‐blind, placebo‐controlled trial, 554 adults with grass pollen rhinoconjunctivitis were randomized (1:2 ratio) to receive 8 subcutaneous injections of placebo or 170?μg LPP administered in increasing doses in 4 visits over 3?weeks. The primary outcome was the combined symptom and medication score ( CSMS ) measured over the peak pollen season. Reactivity to conjunctival provocation test ( CPT ) and quality of life ( QOL ) was assessed as secondary endpoints. Results The mean reduction in CSMS in the LPP vs placebo group was ?15.5% ( P ?=?.041) during the peak period and ?17.9% ( P ?=?.029) over the entire pollen season. LPP ‐treated group had a reduced reactivity to CPT ( P ??.001) and, during the pollen season, a lower rhinoconjunctivitis QOL global score ( P ?=?.005) compared with placebo group. Mostly mild and WAO grade 1 early systemic reaction ( ESR ) were observed ≤30?minutes in 10.5% of LPP ‐treated patients, whereas 3 patients with a medical history of asthma (1%) experienced a serious ESR that resolved with rescue medication. Conclusion Lolium perenne pollen peptides administered over 3?weeks before the grass pollen season significantly reduced seasonal symptoms and was generally safe and well‐tolerated.
机译:摘要背景免疫疗法来自Lolium Perenne(LPP)的肽水解酸盐是季节性过敏性鼻炎的替代治疗,有或没有哮喘。本研究的目的是评估累积剂量为170Ω·μgLPP的临床疗效和安全性。方法在随机,双盲,安慰剂对照试验中,554种草坪花粉鼻咽炎的成人随机(1:2比例),以获得8个皮下注射的安慰剂或170μgμg液体LPP,在4次上3次访问中施用4次延长剂量周。主要结果是在峰花粉季节测量的组合症状和药物评分(CSMS)。对结膜挑衅试验(CPT)的反应性和寿命质量(QOL)被评估为次要终点。结果在峰值期间,LPP vs安慰剂组中CSMS的平均降低是15.5%(P?=β.041),在整个花粉季节上有17.9%(p?= 029)。 LPP -Treated基团对CPT的反应性降低(p≤001),并且在花粉季节期间,与安慰剂组相比,鼻咽炎QOL全球评分(P?= 005)。在10.5%的LPP -Treated患者中观察到Mild和WaO级1级早期系统性反应(ESR)≤30?分钟,而3例哮喘病史3例患者(& 1%)经历过救援的严重ESR药物。结论培养麦芽糖花粉肽在草坪花粉季节明显减少季节性症状并普遍安全且耐受良好。

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