Evidence map›Paper›PMID 42039184›Full record

Trial reportFrontiers in immunology2026

A multicenter randomized study: safety of an optimized accelerated house dust mite immunotherapy for patients with allergic rhinitis in China (PERFECT study).

Guangyao He, Qingxiang Meng, Xuan Yuan, Yongzhen Liu, Qinhui Fu, Yongjing Lai, Mao Xie, Zhan Liu, Junyi Zhang, Hua Zhang and 4 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Frontiers in immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

14 authors.

Guangyao HeDepartment of Otolaryngology-Head and Neck Surgery, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.
Qingxiang MengDepartment of Otolaryngology-Head and Neck Surgery, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China.
Xuan YuanDepartment of Otolaryngology-Head and Neck Surgery, Xiangya Hospital of Central South University, Changsha, China.
Yongzhen LiuDepartment of Otolaryngology-Head and Neck Surgery, Xiangya Hospital of Central South University, Changsha, China.
Qinhui FuDepartment of Otolaryngology-Head and Neck Surgery, Xiangya Hospital of Central South University, Changsha, China.
Yongjing LaiDepartment of Otolaryngology-Head and Neck Surgery, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.
Mao XieDepartment of Otolaryngology-Head and Neck Surgery, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.
Zhan LiuDepartment of Otolaryngology-Head and Neck Surgery, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.
Junyi ZhangDepartment of Otolaryngology-Head and Neck Surgery, Xiangya Hospital of Central South University, Changsha, China.
Hua ZhangDepartment of Otolaryngology-Head and Neck Surgery, Xiangya Hospital of Central South University, Changsha, China.
Fengjun WangDepartment of Otolaryngology-Head and Neck Surgery, Xiangya Hospital of Central South University, Changsha, China.
Shumin XieDepartment of Otolaryngology-Head and Neck Surgery, Xiangya Hospital of Central South University, Changsha, China.
Weihong JiangDepartment of Otolaryngology-Head and Neck Surgery, Xiangya Hospital of Central South University, Changsha, China.
Zhihai XieDepartment of Otolaryngology-Head and Neck Surgery, Xiangya Hospital of Central South University, Changsha, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The one-strength injection regimen has increasingly become the mainstream paradigm for subcutaneous immunotherapy (SCIT). This study aimed to assess the safety and tolerability of an optimal accelerated scheme for SCIT using a house dust mite (HDM) product in adolescents and adults with allergic rhinitis (AR) or rhinoconjunctivitis (ARC), with or without asthma in China. Methods: In this multicenter, open-label trial, patients were randomized to either One-strength or Standard group. The One-strength scheme included 6 injections with one-strength (5,000 TU/mL) followed by 4 injections at the maximum tolerated dose, administered without dose reduction when initiating a new vial. In contrast, the Standard regimen involved 14 injections across three strengths (50, 500 and 5,000 TU/mL), followed by 4 maintenance injections administered according to the medication instruction. Safety outcomes were determined by assessing Adverse Drug Reactions (ADRs), while tolerability was evaluated using a 5-point Likert scale. Results: Overall, 211 patients were randomized, with 108 assigned to the One-strength group, and 103 to the Standard group. Among all participants, 57.3% reported ADRs, of which 95.3% were local reactions. Systemic ADRs were observed in 7.4% of patients in the One-strength group and 8.7% in the Standard group, with no significant difference between the two groups (p=0.7233). All ADRs were classified as WAO grade 1 or 2, with no grade ≥3. In both adolescent and adult subgroups, the incidence of systemic ADRs remained comparable between the two arms (p > 0.05). However, in adults, only the incidence of local ADRs in the One-strength group was significantly higher than that in the Standard group (p=0.0004). Tolerability was rated as "good" or "very good" by approximately 84% of patients and investigators in the One-strength group and 70% of the Standard group (p=0.0131 for patient rating; p=0.0142 for investigator rating). Conclusions: The One-strength scheme, consisting of 6 injections and no dose reduction when starting a new pack during the maintenance phase, is as safe and tolerable as standard SCIT regimen in adolescents and adults in China. Clinical Trial Registration: www.chictr.org.cn, identifier ChiCTR2200060194.

Indexed as

AllergensAntigens, DermatophagoidesDesensitization, ImmunologicPyroglyphidaeRhinitis, AllergicAdolescentAdultAnimalsChildChinaFemaleHumansInjections, SubcutaneousMaleMiddle AgedTreatment OutcomeAllergensAntigens, Dermatophagoidesaccelerated dose build-upadolescentsadultshouse dust mitesone-strengthsafetysubcutaneous immunotherapy

Identifiers

PMID42039184
PMCPMC13105971

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.