Detailed Clinical Features of PTPRQ-Associated Hearing Loss Identified in a Large Japanese Hearing Loss Cohort.

The PTPRQ gene has been identified as one of the genes responsible for non-syndromic sensorineural hearing loss (SNHL), and assigned as DFNA73 and DFNB84. To date, about 30 causative PTPRQ variants have been reported to cause SNHL. However, the detailed clinical features of PTPRQ-associated hearing loss (HL) remain unclear. In this study, 15,684 patients with SNHL were enrolled and genetic analysis was performed using massively parallel DNA sequencing (MPS) for 63 target deafness genes. We identified 17 possibly disease-causing PTPRQ variants in 13 Japanese patients, with 15 of the 17 variants regarded as novel. The majority of variants identified in this study were loss of function. Patients with PTPRQ-associated HL mostly showed congenital or childhood onset. Their hearing levels at high frequency deteriorated earlier than that at low frequency. The severity of HL progressed from moderate to severe or profound HL. Five patients with profound or severe HL received cochlear implantation, and the postoperative sound field threshold levels and discrimination scores were favorable. These findings will contribute to a greater understanding of the clinical features of PTPRQ-associated HL and may be relevant in clinical practice.

A Nationwide survey of safety protocols and chemosensory assessments by Japanese clinicians pre- and post-COVID-19 pandemic.

OBJECTIVE: There has been an increase of attention and awareness of smell and taste loss due to the impact of COVID-19. However, little is known about the influence of COVID-19 on the number of psychophysical tests performed, the timing of these tests, or the protection protocols employed to protect against virus transmission. This study aimed to explore the changes in examination approaches, types of tests employed, and safety measures adopted by clinicians before and after the COVID-19 pandemic. METHODS: A survey was distributed to 404 institutes of the Oto-Rhino Laryngological Society of Japan, consisting of otolaryngologists working in university hospitals, general hospitals, and private clinics. The anonymous online survey contained questions related to safety measures and chemosensory assessments performed before and after the COVID-19 pandemic. Specifically, participants were queried on the number and types of examinations conducted, the type of examiners who performed them, the timing of tests in suspected and non-suspected COVID-19 cases, modifications made due to the pandemic, and the protective measures adopted during chemosensory examinations. RESULTS: Of the 201 respondents, representing a 50 % response rate, 49 % were from general hospitals, 48 % from university hospitals, and 3 % from private clinics. The study found a slight decrease in the overall number of chemosensory tests conducted post-COVID-19. In terms of who performed the test, there were no differences pre- and post- COVID-19. Most examinations (52-68 %) for suspected COVID-19 cases were performed 1-2 months after the onset of symptoms. Modifications in testing rooms and personal protective equipment (PPE) were reported by the majority of institutions post-pandemic. While different examination rooms or PPE were not commonly used based on a patient's previous COVID-19 diagnosis, changes were observed in testing practices. Most examinations were conducted in rooms with windows or fans, and PPE usage was high; surgical masks, eye visors or face shields, and disposable gloves being commonly used. Virus transmission from patient to examiner was reported in only one case during T&T olfactometer examination. CONCLUSION: We investigated the impact of the COVID-19 pandemic on the number of olfactory and gustatory tests performed, the type of examiner, the examination room, and the use of PPE and found no significant difference before and after the COVID-19 pandemic on these factors. Adherence to a protection protocol involving the proper use of PPE in controlled environments enabled the continuation of olfactory and gustatory tests during the pandemic.

Improvements in blood IGF-1 and skeletal age following adenotonsillectomy for growth delay in children with obstructive sleep apnea.

OBJECTIVE: In children with obstructive sleep apnea (OSA) who underwent adenotonsillectomy (AT), we measured body height and weight using standard deviation (SD) scores, insulin-like growth factor 1 (IGF-1), and skeletal age using carpal radiography. We then compared these values before and after surgery with the aim of investigating postoperative improvements in growth hormone (GH) deficiency. METHODS: Subjects comprised 35 children between 2 and 9 years of age (21 boys, 14 girls; mean age, 5.85 ± 1.75 years). Respiratory event index (REI), 3 % oxygen desaturation index (3 % ODI), height SD score, body mass index (BMI) percentile, blood IGF-1 level, and skeletal age from carpal radiographs were measured before surgery and both 3 and 12 months after surgery, and compared. RESULTS: Height SD score improved significantly from preoperatively (-0.44 ± 1.13) to both 3 months postoperatively (-0.22 ± 1.14) and 12 months postoperatively (-0.13 ± 0.94). However, no significant improvement in height SD score was seen from 3 months to 12 months after AT. BMI percentile improved significantly from preoperatively (35.6 ± 26.7) to both 3 months postoperatively (44.7 ± 26.5) and 12 months postoperatively (49.1 ± 22.15), with significant improvement also seen from 3 months to 12 months after AT. SD score for IGF-1 showed significant improvement from before (-0.57 ± 1.00) to 12 months after surgery (-0.12 ± 0.89). No significant improvement in the difference between skeletal and chronological ages was seen from before to after surgery, but the number of patients for whom skeletal age normalized from before to after surgery increased significantly (74.3 % vs. 94.3 %), and the number with advanced or delayed skeletal age decreased significantly (25.7 % vs. 5.7 %) CONCLUSION: Early improvements can be obtained with surgical treatment in children with OSA who have short height and poor weight gain due to GH deficiency.

Evaluation of odor recognition threshold measurement methods in T&T olfactometry: A survey study.

OBJECTIVE: The odor recognition thresholds in T&T olfactometry are measured by either the examiner's judgment of the patients' odor expression for each standard odor or by the patient's choice of the correct response from an olfactory term table. This study aimed to clarify the correct odor expressions and use of the olfactory term table. METHODS: A questionnaire was administered to otolaryngologists or medical staff in charge of testing at facilities where T&T olfactometry is performed. The questionnaire consisted of the facility's background, environment and procedures of T&T olfactometry, choice of the correct answer with five different standard odors, and use of the olfactory term table. For the choices, the expressions used were those considered correct at Nippon Medical School Tama Nagayama Hospital and the Kyoto Nose and Allergy Clinic. RESULTS: A total of 81 valid responses were obtained. Most respondents belonged to medical and educational institutions (59.3%, 48/81). The laboratories in the respondents' institutions were completely ventilated using various methods. Clinical laboratory technicians inspected 51.7% (45/81) of the facilities. The order of standard odors in the odor recognition threshold test differs depending on the facility. When the examiner was unsure about the answer given by the patient in the odor recognition threshold test, 16.1% (9/56) of the respondents chose "present the olfactory term table," 33.9% (19/56) chose "increase the concentration," and 37.5% (21/56) chose "present the olfactory term table" or "increase the concentration," depending on the situation. A total of 96.4% (54/56) of the facilities treated odor expressions other than those in the olfactory term table as correct, and the odor expressions that were considered correct differed from facility to facility. Of the respondents, 80.2% (65/81) answered "I know the olfactory term table," and the mean value of satisfaction with the current olfactory term table was 4.4 ± 3.0. Of the respondents, 81.5% (53/65) answered that "the timing of presenting the olfactory term table should be standardized in all facilities." CONCLUSION: In the odor recognition threshold test by T&T olfactometry, this study revealed that the odor expressions considered as correct answers for the standard odors and the use of the olfactory term table differed among facilities.

Efficacy of Japanese cedar pollen sublingual immunotherapy tablets for Japanese cypress pollinosis.

Background: We previously demonstrated the efficacy of Japanese cedar (JC) pollen sublingual immunotherapy (SLIT) tablets for treating seasonal allergic rhinitis in a clinical trial (trial no. 206-2-1) that covered 5 pollen dispersal seasons from 2015 to 2019. Objective: Our aim was to perform post hoc analysis of the 206-2-1 trial data to evaluate the efficacy of JC pollen SLIT tablets for patients with rhinitis induced by pollen from Japanese cypress (JCY), a related Cupressaceae species that has a pollen dispersal season overlapping with that of JC. Methods: Data were analyzed for 240 patients who received placebo during the first pollen dispersal season in 2015, were then rerandomized to receive JC SLIT tablets (the PA group) or placebo (the PP group) for 18 months (the 2016 and 2017 dispersal seasons), and were observed untreated for 2 years (the 2018 and 2019 dispersal seasons). The PA and PP groups were assigned to "high" and "low" subgroups if their rhinitis symptoms were exacerbated/did not change or decreased, respectively, during the peak JCY pollen dispersal period in 2015. The mean total nasal symptom and medication scores and other outcomes were compared for the high-PP, high-PA, low-PP, and low-PA groups during the 2016 to 2019 peak JCY pollen dispersal periods. Results: The mean total nasal symptom and medication scores were significantly lower for the high-PA and low-PA groups than for the corresponding PP groups over the 4 years of treatment and observation. JCY pollen-specific IgE levels increased in both PA groups. Conclusion: JC pollen SLIT tablets effectively suppressed JCY pollinosis symptoms, supporting the clinical relevance of immunologic cross-reactivity between JC and JCY allergens.

AQUACEL® Ag Advantage reduces the stress of postoperative packing removal after endoscopic sinus surgery

Abstract Objective: After Endoscopic Sinus Surgery (ESS), packing plays an important role in wound healing and hemostasis. However, the effect of the packing removal procedure on physician stress has not been evaluated. The purpose of this study was to evaluate physician stress during packing removal for patients treated with AQUACEL® Ag Advantage versus KALTOSTAT®. Methods: This retrospective study included 15 patients who underwent packing with ESS for chronic rhinosinusitis performed at two centers; 9 were treated with AQUACEL® Ag Advantage and 6 were treated with KALTOSTAT®. Physician stress during packing removal was evaluated with the National Aeronautics and Space Administration-Task Load Index (NASA-TLX). The time required to remove the packing and the number of instruments used in the procedure were recorded. Postoperative bleeding (Boezaart bleeding score) and wound healing were graded. Patient symptoms on the day after surgery and pain during packing removal were assessed using a visual analog scale. Results: Computed tomography scores, asthma complications, and blood eosinophil counts were significantly higher in the AQUACEL® Ag Advantage group. Patient symptoms on the day after surgery were not significantly different between the two groups. Physician stress during the task of packing removal was significantly lower in the AQUACEL® Ag Advantage group than in the KALTOSTAT® group (35.5 vs. 81.0, p = 0.016) according to the NASA-TLX scores. The number of instruments used in the procedure was significantly lower in the AQUACEL® Ag Advantage group than in the KALTOSTAT® group (3.0 vs. 6.0, p = 0.015). There were no significant differences in procedure time for packing removal, postoperative bleeding, wound healing, or patient pain at the time of packing removal between the groups. Conclusion: Physicians feel stressed about packing removal. In addition, AQUACEL® Ag Advantage is useful for packing after ESS, requiring fewer instruments for the procedure than KALTOSTAT® and reducing physician stress about the procedure. Level of evidence: Level 3.

AQUACEL® Ag Advantage reduces the stress of postoperative packing removal after endoscopic sinus surgery.

OBJECTIVE: After Endoscopic Sinus Surgery (ESS), packing plays an important role in wound healing and hemostasis. However, the effect of the packing removal procedure on physician stress has not been evaluated. The purpose of this study was to evaluate physician stress during packing removal for patients treated with AQUACEL® Ag Advantage versus KALTOSTAT®. METHODS: This retrospective study included 15 patients who underwent packing with ESS for chronic rhinosinusitis performed at two centers; 9 were treated with AQUACEL® Ag Advantage and 6 were treated with KALTOSTAT®. Physician stress during packing removal was evaluated with the National Aeronautics and Space Administration-Task Load Index (NASA-TLX). The time required to remove the packing and the number of instruments used in the procedure were recorded. Postoperative bleeding (Boezaart bleeding score) and wound healing were graded. Patient symptoms on the day after surgery and pain during packing removal were assessed using a visual analog scale. RESULTS: Computed tomography scores, asthma complications, and blood eosinophil counts were significantly higher in the AQUACEL® Ag Advantage group. Patient symptoms on the day after surgery were not significantly different between the two groups. Physician stress during the task of packing removal was significantly lower in the AQUACEL® Ag Advantage group than in the KALTOSTAT® group (35.5 vs. 81.0, p=0.016) according to the NASA-TLX scores. The number of instruments used in the procedure was significantly lower in the AQUACEL® Ag Advantage group than in the KALTOSTAT® group (3.0 vs. 6.0, p=0.015). There were no significant differences in procedure time for packing removal, postoperative bleeding, wound healing, or patient pain at the time of packing removal between the groups. CONCLUSION: Physicians feel stressed about packing removal. In addition, AQUACEL® Ag Advantage is useful for packing after ESS, requiring fewer instruments for the procedure than KALTOSTAT® and reducing physician stress about the procedure. LEVEL OF EVIDENCE: Level 3.

Barrier Factors of Adherence to Dupilumab Self-Injection for Severe Allergic Disease: A Non-Interventional Open-Label Study.

Purpose: The status of dupilumab self-injection at home is not well understood. We therefore aimed to identify the barriers to adherence to dupilumab self-injection. Patients and Methods: This non-interventional open-label study was conducted between March 2021 and July 2021. Patients with atopic dermatitis, bronchial asthma, and chronic rhinosinusitis with nasal polyps receiving dupilumab, from 15 sites, were requested to complete a self-administered questionnaire regarding the frequency and effectiveness of dosing as well as their use and satisfaction with dupilumab. Barriers to adherence were assessed using the Adherence Starts with Knowledge-12. Results: We included 331 patients who used dupilumab for atopic dermatitis (n = 164), chronic rhinosinusitis with nasal polyps (n = 102), and bronchial asthma (n = 65). The median efficacy of dupilumab scored 9.3 on the visual analog scale. Overall, 85.5% of the patients self-injected dupilumab, and 70.7% perfectly complied with the established injection dates. The pre-filled pen was significantly superior to the conventional syringe in terms of usability, operability, ease of pushing the plunger, and patient satisfaction. However, the pre-filled pen caused more pain during self-injection than did the syringe. Multivariate logistic regression analysis showed that adherence decreased with longer dupilumab treatment duration (p = 0.017) and was not associated with age, sex, underlying disease, or device type. There was a difference in responses related to "inconvenience/forgetfulness" between the good and poor adherence groups. Conclusion: The pre-filled dupilumab pen was superior to the syringe in terms of usability, operability, ease of pushing the plunger, and satisfaction. Repetitive instructions are recommended for preventing poor adherence to dupilumab self-injection.

House dust mite sublingual immunotherapy tablet safety in adolescents with allergic rhinoconjunctivitis: Worldwide clinical trial results.

BACKGROUND: The house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet is a treatment option for allergic rhinitis with/without conjunctivitis (AR/C) approved in adults worldwide and in adolescents in some countries. OBJECTIVE: To supplement existing adolescent HDM SLIT-tablet safety data by conducting the MT-18 trial in adolescents. METHODS: MT-18 (EudraCT:2020-000446-34) was a phase 3, open-label, single-arm, 28-day safety trial of daily HDM SLIT-tablet (12 SQ-HDM dose) in European adolescents (12-17 years) with HDM AR/C, with or without asthma. The primary end point was at least 1 treatment-emergent adverse event (TEAE). MT-18 results were compared with 12 SQ-HDM adolescent subpopulation data from previously described 1-year phase 3 trials conducted in North America (P001; clinicaltrials.gov:NCT01700192) or Japan (TO-203-3-2; JapicCTI:121848). RESULTS: No treatment-related anaphylaxis, epinephrine administrations, severe local swellings, severe mouth or throat edema, or eosinophilic esophagitis occurred in the trials. For MT-18 (N = 253), P001 (N adolescents = 189), and TO-203-3-2 (N adolescents = 206), the percentage of adolescents treated with 12 SQ-HDM reporting any TEAE was 88%, 95%, and 93%, respectively, and the percentage reporting any treatment-related AE (TRAE) was 86%, 93%, and 66%, respectively. The most common TRAEs were local application site reactions. Most TRAEs were mild in intensity and were typically experienced the first 1 to 2 days of treatment. There were no asthma-related TEAEs with the HDM SLIT-tablet. The safety profile appears similar between adolescents with or without asthma at baseline. CONCLUSION: The HDM SLIT-tablet was well tolerated in European, North American, and Japanese adolescents with HDM AR/C, indicating safety of the HDM SLIT-tablet is insensitive to age or geographic region. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: (P001: NCT01700192); EudraCT: (MT-18; 2020-000446-34); JapicCTI: (TO-203-3-2; 121848).

Bilobed Flap for Reconstruction of Skin Defects after Excision of Parotid Carcinoma: A Case Report.

OBJECTIVES: Local flaps, pedicled flaps, and free flaps are used to reconstruct medium-sized skin defects after excision of parotid carcinoma. The bilobed flap is a local flap primarily used by plastic surgeons for small defects of nasal skin. We report a case of parotid carcinoma with skin infiltration successfully treated by skin reconstruction with a bilobed flap. METHODS: An 84-year-old man presented with a parotid mass he had noticed 2 months earlier. Parotid carcinoma with skin infiltration was diagnosed and he underwent radical surgery. The skin defect was round (diameter, 6 cm) and was resected and reconstructed with a bilobed flap designed to be caudal to the defect. RESULTS: Postoperative facial nerve palsy improved within 6 months. The postoperative course was otherwise uneventful, and the patient was discharged on postoperative day 7. Pathological examination revealed a sarcomatoid salivary duct carcinoma. CONCLUSIONS: Bilobed flaps are useful for reconstructing skin defects with a diameter of 6 cm or less.

Executive summary: Japanese guidelines for allergic rhinitis 2020.

The Practical Guideline for the Management of Allergic Rhinitis, the fist guideline for allergic rhinitis in Japan, was prepared after a symposium held by the Japanese Society of Allergology in 1993. The current 9th edition was published in 2020 and is widely used today. The most recent collection of evidence from the literature was supplemented to the revised guideline to incorporate evidence-based medicine. The revised guideline includes updated epidemiology of allergic rhinitis in Japan, a figure representing the mechanisms of allergic rhinitis in both the onset and sensitization phases with the introduction of regulatory T cells and type 2 innate lymphoid cells, practical assessment for diagnosis, new pharmacotherapy agents such as anti-IgE mAb and a new drug delivery system for antihistamines, sublingual immunotherapy for children, dual sublingual immunotherapy for house dust mites and Japanese cedar pollen extract, new classification for surgery for allergic rhinitis, and treatment and prescriptions for older adults. An evidence-based step-by-step strategy for treatment is also described.

A Case of Metastatic Submandibular Salivary Duct Carcinoma that Completely Responded to Pembrolizumab Monotherapy.

Salivary gland carcinoma is a rare cancer and has more than 20 histopathological types. Although chemotherapy has been the mainstay of treatment for unresectable carcinomas such as multiple recurrence and distant metastasis, no standard regimen is available. In this article, we report a case of poorly differentiated salivary duct carcinoma of the submandibular gland with distant metastases that was successfully treated with pembrolizumab monotherapy. A 66-year-old man became aware of a left submandibular mass 2 months before his first visit to our department. A needle biopsy at a previous hospital revealed carcinoma, not otherwise specified. The combined positive score on a programmed death ligand-1 immunohistochemistry test was 1-10%. The patient was referred to our department for further treatment. Computed tomography revealed left level II and IV neck lymphadenopathy, bilateral lung shadowing, and osteolytic changes in the 12th thoracic vertebra. Needle biopsy showed poorly differentiated carcinoma, positive human epidermal growth factor receptor 2, and positive androgen receptor, which suggested salivary duct carcinoma. These findings indicated a diagnosis of submandibular carcinoma T4aN2bM1 stage IVC. Pembrolizumab monotherapy was started, and tumor shrinkage was observed after three courses of treatment. At 1 year, complete response was achieved without adverse events, and treatment is ongoing. Despite a lack of evidence for the efficacy of immune checkpoint inhibitors in salivary gland carcinoma, the present case suggests that some patients might respond to this treatment. Hence, clinical trials are warranted.

Correlation between sensitization to house dust mite major allergens, age, and symptoms in Japanese house dust mite allergic subjects.

Der p 23 has recently been recognized as a new house dust mite (HDM) major allergen that may be linked to the development of asthma in HDM allergic patients. This study aimed to investigate the frequency of sensitization to HDM major allergen components including Der p 23 and to examine the correlation between HDM-sensitization and AR symptom score in Japanese HDM allergic rhinitis (AR) patients without allergic asthma. Serum samples (n = 120) collected from Japanese HDM AR patients (12 to 64 years) without asthma were assessed for allergen-specific IgE (s-IgE) by ImmunoCAP (Dermatophagoides pteronyssinus (D. pteronyssinus; Der p) extract, Der p 23) or immunosolid-phase allergen chip (Der p 1, Der p 2). Japanese HDM AR patients without asthma showed a high prevalence of allergic sensitization to the HDM major allergens Der p 1 (94.2%), Der p 2 (97.5%) and Der p 23 (71.7%). No difference in the prevalence was detected for Der p 1 and Der p 2 s-IgE among three age groups. However, the prevalence of Der p 23 s-IgE was significantly higher in the younger group compared to the elderly group. No significant correlation was found between AR symptom scores and concentration of s-IgE towards Der p extract and any of the three HDM major allergens. Although the prevalence of sensitization towards D. pteronyssinus major allergens is high in Japanese AR patients without asthma, there was no correlation between allergen specific IgE including IgE towards Der p 23 and AR symptom in this population.

Adaptation and validation of the main concept analysis of spoken discourse by native Japanese adults.

Many people with aphasia demonstrate problems of oral production at the discourse level. The Main Concept Analysis (MCA) for oral discourse production is a published evidence-based battery for quantifying the degree of presence, accuracy, completeness, and efficiency of targeted main concepts in oral discourse. In Japan, such a standardized tool specialized for assessing spoken discourse is currently lacking. The purpose of this study was to adapt the Japanese version of MCA for oral discourse production (the Japanese-MCA) and examine its validity and reliability. Stage 1 of the study involved the establishment of linguistically-specific main concepts (MCs) of the Japanese-MCA. Ten speech-language-hearing therapists and 60 healthy participants who were native monolingual Japanese speakers were recruited to determine MCs. Stage 2 examined the criterion validity and reliability of the Japanese-MCA. Language samples of 20 participants with aphasia, as verified by Standard Language Test of Aphasia (SLTA), and 20 healthy older participants were used. Results of Stage 1 of the study yielded normative data with a set of target MCs that were geographically and linguistically specific for use in Japan. The results also revealed the comparability of the Japanese-MCA and previously reported versions of other languages. Stage 2 findings indicated not only a high correlation of criterion validity, but also good reliability of the test. With established norms and specific scoring criteria of the Japanese-MCA, it is believed that this new tool will become a useful addition to clinical management and research of aphasia in Japan.

Trapezius muscle branch of the spinal accessory nerve without penetrating the sternocleidomastoid muscle as a pitfall in neck dissection: prevalence in a Japanese institution and a protocol for the prevention of iatrogenic injury.

BACKGROUND: The spinal accessory nerve (SAN) has several anatomical variations, which may be a pitfall in neck dissection (ND). These include the trapezius muscle branch (TB), which stems from the common trunk before entering the sternocleidomastoid muscle (SCM). AIMS/OBJECTIVES: To investigate the prevalence of this variation and suggest a protocol for preventing unexpected injury of the TB in ND. MATERIALS AND METHODS: We conducted a retrospective cohort study for 93 patients who had undergone neck dissection (117 sides) without resection of the SCM nor SAN. We recorded the division of the TB after and before penetration of the SCM by the common trunk (penetrating type TB [PTB]) and non-penetrating type TB [NPTB], respectively). RESULTS: Among NDs, PTB and NPTB were observed in 61 (52%) and 56 (48%) sides, respectively. In the subgroup of 24 cases with bilateral ND, PTB/PTB, NPTB/NPTB, and NPTB/PTB were observed in eight (33%), nine (38%), and seven (29%) cases, respectively. The prevalence of PTB/NPTB did not differ according to age, sex, or laterality. CONCLUSIONS AND SIGNIFICANCE: NPTB is a common anatomical variation. The presence or absence of a branch from the common trunk must be initially checked to avoid unexpected damage to the TB.

Disease-Modifying Effect of Japanese Cedar Pollen Sublingual Immunotherapy Tablets.

BACKGROUND: Japanese cedar (JC) pollinosis is a common allergic rhinitis in Japan. JC pollen sublingual immunotherapy (SLIT) tablets are licensed for the treatment of JC pollinosis. OBJECTIVE: To assess the disease-modifying effects of JC pollen SLIT tablets over 5 years (2014-2019), comprising a 3-year treatment period and 2-year follow-up. METHODS: A total of 1042 patients with JC pollinosis (aged 5-64 years) were included in the study. An optimal dose-finding study was performed in the first 15 months, after which 240 patients in the placebo (P) group and 236 patients in the optimal active dose (A) group (5000 Japanese allergy units) were re-randomized to receive P or A for an additional 18 months (designated AA, AP, PA, and PP groups). Clinical efficacy was evaluated by the total nasal symptom and medication score (TNSMS) during the peak symptom period of each JC pollen season over 3 years of treatment and 2 years of observation after treatment cessation. RESULTS: The AA, AP, and PA groups exhibited significantly reduced TNSMS; however, the largest relative reduction was seen in the AA group both during the treatment period (third season, 46.3% vs PP, P < .001) and during the 2-year follow-up period (fourth and fifth seasons, 45.3% and 34.0% vs PP, respectively; P < .001). The most common adverse drug reactions were mild reactions at the administration site. CONCLUSIONS: JC pollen SLIT tablets show sustained clinical efficacy during 3 years of treatment and sustained disease-modifying effects for at least 2 years after treatment cessation.

Tonsillectomy Combined With Steroid Pulse Therapy Prevents the Progression of Chronic Kidney Disease in Patients With Immunoglobulin A (IgA) Nephropathy in a Single Japanese Institution.

Background Despite the abundant experience of tonsillectomy with steroid pulse therapy (TSP) for patients with immunoglobulin A (IgA) nephropathy, the therapeutic efficacy of TSP on renal prognosis remains controversial. The purpose of this study was to evaluate the efficacy of whether TSP effectively prevents chronic kidney disease (CKD) progression. Methods This was a single-center, retrospective observational study. A total of 149 patients were enrolled in the current study who were confirmed with IgA nephropathy by renal biopsy between February 2011 and August 2019. The impact of TSP on CKD progression was compared with conservative treatment during a follow-up period of 3 years. Results In total, 110 patients received TSP and 39 patients received conservative treatment. There were no differences between the two groups in the initial CKD stages: 65.1% of patients had CKD G1-2, 32.2% had CKD G3, and 2.7% had CKD G4-5. The initial urine protein was 0.7 g/gCr, which was not different between the two groups. Kaplan-Meier analysis showed that patients with TSP had a significantly better renal prognosis than those in the conservative treatment group after one and a half years (p = 0.007). Multivariable analysis revealed that TSP had a significant impact on the prevention of CKD progression, with an adjusted odds ratio of 0.07 (95% confidence interval, 0.01-0.87; p=0.039). However, we could not confirm the predictive value of the Oxford Classification on TSP efficacy. Additionally, the initial urinary protein level was a risk factor for CKD progression. Conclusions TSP was associated with a lower risk of CKD progression. In this regard, our study supports that TSP may be a reasonable treatment option for patients with IgA nephropathy. In the featured study, it needs to be elucidated which histopathological classifications benefit from TSP treatment.