Abstract
Objectives: To investigate the efficacy and safety of montelukast sodium (MKS) combined with levocabastine (LEVO) nasal spray in treating pediatric allergic rhinitis and its impact on quality of life (AR). Methods: A total of 125 pediatric AR patients, diagnosed between September 2022 and September 2024, were enrolled and divided into two groups. The research group (n = 65) received MKS plus LEVO nasal spray, while the control group (n = 60) received LEVO nasal spray alone. Treatment efficacy, safety (assessing xerostomia, headache, and gastrointestinal disturbances), and clinical symptom scores (rhinorrhea, sneezing, nasal obstruction, and nasal pruritus) were evaluated. Additionally, nasal cavity parameters (nasal resistance (NR), minimum cross-sectional area (mCSA), and nasal cavity volume (NCV)), serum inflammatory markers (IL-4, IL-8, IL-10), serum biochemical indices (total immunoglobulin E [TlgE], eosinophil count [EOS], eosinophil cationic protein [ECP]), and quality of life (Rhinoconjunctivitis Quality of Life Questionnaire [RQLQ]) were analyzed. Univariate and multivariate binary logistic regression analyses were conducted to identify factors influencing treatment outcomes. Results: The research group demonstrated significantly higher overall treatment efficacy than the control group (P<0.05), with a comparable safety profile (P>0.05). Post-treatment, clinical symptom scores, IL-4, IL-8, TlgE, EOS, ECP levels and RQLQ scores were significantly reduced in the research group compared to the control group (all P<0.05). Conversely, IL-10 levels were significantly higher in the research group (both P<0.05). Notably, passive secondhand smoke exposure, IL-10, EOS, and treatment modality were significantly associated with treatment efficacy (all P<0.05). Binary logistic regression identified passive secondhand smoke exposure (P = 0.035) and EOS (P = 0.036) as independent risk factors for treatment outcomes. Conclusions: The combination of MKS and LEVO nasal spray demonstrates superior efficacy and safety in pediatric AR treatment, significantly improving patients’ quality of life. Moreover, treatment failure is closely linked to passive secondhand smoke exposure and elevated EOS levels.
Keywords: Montelukast sodium, levocabastine nasal spray, pediatric allergic rhinitis, efficacy, safety, quality of life
Introduction
Allergic rhinitis (AR) is a common, non-infectious, chronic inflammatory disorder of the nasal mucosa, characterized by symptoms such as rhinorrhea, sneezing, nasal congestion, and nasal pruritus [1,2]. Epidemiological data suggest that AR negatively affects approximately 10.0% to 40.0% of children worldwide, with a lifetime risk of around 20.0%. Notably, its incidence has been rising significantly in recent years [3,4]. The pathogenesis of AR is primarily linked to an immunoglobulin E (IgE)-mediated response triggered by allergen exposure. These allergens include house dust mites, fungi, pet dander, indoor plants, and grass pollens [5]. While allergen avoidance remains the primary preventive strategy, it is often impractical in real-world settings [6].
Pharmacological therapy is the cornerstone of AR management. Available treatments include antihistamines, leukotriene receptor antagonists, mast cell stabilizers, corticosteroids, and decongestants [7]. However, no single medication has been proven to completely cure AR in children [8]. This highlights the need to explore effective therapeutic approaches to improve treatment efficacy and enhance the quality of life in pediatric AR patients.
Levocabastine (LEVO) nasal spray, an intranasal antihistamine, acts by inhibiting key mediators involved in nasal mucosal allergic inflammation [9]. It provides rapid symptom relief, often within 30 minutes of administration, but symptom recurrence remains a concern [10]. Montelukast sodium (MKS), a leukotriene receptor antagonist, suppresses leukotriene-mediated inflammation by blocking receptor binding, thereby exerting anti-inflammatory and anti-asthmatic effects [11]. Previous studies have explored the combination of MKS with various agents for AR management [12,13]. For instance, Shao et al. [14] indicated that montelukast combined with levocetirizine effectively alleviated AR symptoms while maintaining a favorable safety profile in patients with AR and asthma syndrome.
This study aims to evaluate the efficacy and safety of the combined use of LEVO nasal spray and MKS in pediatric AR treatment. Despite the potential benefits of this combination, relevant research remains limited. By addressing this gap, our study provides new insights into optimizing treatment strategies for pediatric AR, underscoring its clinical significance and innovative approach.
Materials and methods
Patient selection
This retrospective study enrolled 125 pediatric patients diagnosed with AR between September 2022 and September 2024. The research group (n = 65) received a combination of MKS and LEVO nasal spray, while the control group (n = 60) was treated with LEVO nasal spray alone. This study was approved by the Institutional Ethics Committee of Yongchuan Hospital of Traditional Chinese Medicine, Chengdu University of Traditional Chinese Medicine.
Inclusion criteria: (1) Patients met the diagnostic criteria for pediatric AR as per established guidelines [15]. (2) Patients had not received any anti-allergic medications recently. (3) Patients were between 2 and 14 years of age. (4) Patients had not been treated with leukotriene receptor antagonists or antihistamines in the past three months. (5) Patients had complete medical records available for review.
Exclusion criteria: Patients were excluded if they had: (1) Severe nasal polyps, nasal septum deviation, or chronic sinusitis. (2) Frequent and severe bronchial asthma exacerbations in the past month or concomitant severe chronic respiratory diseases. (3) A history of nasal surgery. (4) Underlying autoimmune or endocrine disorders. (5) Known allergies to the study medications.
Patient selection was conducted through a systematic search of the hospital’s medical records. The flowchart illustrating patient inclusion and exclusion criteria is presented in Figure 1.
Figure 1.
Research flowchart.
Treatment protocols
The control group was treated with LEVO nasal spray, administered as follows: two sprays per nostril, twice daily. Patients were advised to clear their nasal passages before each administration.
The research group received a combination therapy consisting of LEVO nasal spray (administered identically to the control group) and oral MKS. MKS was administered as one tablet, once daily. Both groups underwent continuous treatment for four weeks.
Data extraction and validation
Relevant data were retrieved from the hospital’s medical record system. A comprehensive comparative analysis was conducted between the two groups based on multiple parameters, including treatment efficacy, safety (incidence of dry mouth, headache, and gastrointestinal reactions), clinical symptom scores (rhinorrhea, sneezing, nasal congestion, and nasal pruritus), nasal cavity condition (nasal resistance [NR], minimum cross-sectional area [mCSA], and nasal cavity volume [NCV]), serum inflammatory markers (interleukin [IL]-4, IL-8, IL-10), serum biochemical indices (total immunoglobulin E [tIgE], eosinophil count [EOS], and eosinophil cationic protein [ECP]), and quality of life (assessed via the Rhinoconjunctivitis Quality of Life Questionnaire [RQLQ]). All extracted data were subsequently validated for accuracy.
(1) Treatment efficacy: Treatment efficacy was assessed based on the following criteria: Cured: Complete resolution of inflammation with disappearance of sneezing, rhinorrhea, nasal congestion, and nasal pruritus. Significantly effective: Substantial improvement in symptoms with controlled inflammation. Effective: Partial improvement in rhinitis symptoms, although inflammation persisted. Ineffective: No improvement or worsening of symptoms. The total effective rate was calculated as the proportion of patients classified as cured, significantly effective, or effective relative to the total number of patients.
(2) Safety: Adverse reactions, including dry mouth, headache, and gastrointestinal symptoms, were closely monitored in both groups. The incidence rates of these adverse events were documented and analyzed.
(3) Clinical symptom scoring: Nasal symptoms were assessed using a rhinitis symptom score scale before treatment and four weeks after treatment. The scale assigned scores as follows: 0: Normal; 1: Mild symptoms; 2: Moderate symptoms; 3: Severe symptoms.
(4) Nasal cavity condition: Nasal cavity parameters were measured using acoustic rhinometry to assess nasal resistance, minimum cross-sectional area, and nasal cavity volume. Prior to measurement, patients were seated in a relaxed position for 15 minutes. The probe was then carefully inserted into the nostril while the patient held their breath, ensuring accurate measurements. Assessments were conducted at baseline and four weeks post-treatment.
(5) Inflammatory markers: Five milliliters of fasting venous blood were collected from each patient before treatment and two weeks after treatment. Following centrifugation, serum samples were analyzed for IL-4, IL-8, and IL-10 levels using enzyme-linked immunosorbent assay (ELISA).
(6) Serum biochemical indices: tIgE levels were measured using ELISA. Serum EOS count was determined using an automated biochemical analyzer. Serum ECP levels were assessed via spectrophotometric colorimetry. All measurements were performed at baseline and two weeks after treatment.
(7) Quality of life: The RQLQ [16] was used to evaluate quality of life before treatment and four weeks post-treatment. The questionnaire comprises 28 items scored on a 0-6 scale: 0: No impact; 1: Almost no impact; 2: Slight impact; 3: Mild impact; 4: Moderate impact; 5: Severe impact; 6: Extremely severe impact; Lower scores indicate a better quality of life.
Among these indicators, the primary outcome measures were treatment efficacy, safety, clinical symptom scores, and quality of life, while secondary outcome measures included nasal cavity condition, inflammatory markers, and serum biochemical indices.
Statistical analysis
Categorical variables were presented as frequencies and percentages (n/%). Continuous variables were expressed as mean ± standard error of the mean (SEM).
Comparisons of categorical data between groups were performed using the chi-square (χ2) test. Comparisons of continuous variables between independent groups were conducted using the independent-sample t-test. Within-group changes before and after treatment were analyzed using the paired t-test. All statistical analyses were performed using SPSS 24.0. A P-value <0.05 was considered statistically significant.
Results
Comparative analysis of general characteristics
No significant differences were observed between the research and control groups in terms of gender, age, disease duration, coexisting bronchial asthma, and passive secondhand smoke exposure (all P>0.05) (Table 1).
Table 1.
Comparative analysis of general characteristics
| Indicators | Research group (n = 65) | Control group (n = 60) | χ2/t | P |
|---|---|---|---|---|
| Sex | 0.017 | 0.897 | ||
| Male | 35 (53.85) | 33 (55.00) | ||
| Female | 30 (46.15) | 27 (45.00) | ||
| Age (years) | 7.63±1.97 | 7.57±1.70 | 0.182 | 0.856 |
| Disease course (years) | 15.17±3.64 | 15.55±4.66 | 0.510 | 0.611 |
| Bronchial asthma | 0.069 | 0.792 | ||
| Without | 53 (81.54) | 50 (83.33) | ||
| With | 12 (18.46) | 10 (16.67) | ||
| Passive secondhand smoke exposure | 1.039 | 0.308 | ||
| No | 32 (49.23) | 35 (58.33) | ||
| Yes | 33 (50.77) | 25 (41.67) |
Comparative analysis of treatment efficacy
The total effective rate in the research group was 92.31%, significantly higher than 80.00% in the control group (P<0.05) (Table 2).
Table 2.
Comparative analysis of efficacy
| Indicators | Research group (n = 65) | Control group (n = 60) | χ2 | P |
|---|---|---|---|---|
| Cured | 33 (50.77) | 18 (30.00) | ||
| Significantly effective | 17 (26.15) | 24 (40.00) | ||
| Effective | 10 (15.38) | 6 (10.00) | ||
| Ineffective | 5 (7.69) | 12 (20.00) | ||
| Total effective rate | 60 (92.31) | 48 (80.00) | 4.022 | 0.045 |
Comparative analysis of safety
The total incidence of adverse reactions, including dry mouth, headache, and gastrointestinal symptoms, was 7.69% in the research group, comparable to 6.67% in the control group (P>0.05) (Table 3).
Table 3.
Comparative analysis of safety
| Indicators | Research group (n = 65) | Control group (n = 60) | χ2 | P |
|---|---|---|---|---|
| Dry mouth | 1 (1.54) | 1 (1.67) | ||
| Headache | 2 (3.08) | 1 (1.67) | ||
| Gastrointestinal reactions | 2 (3.08) | 2 (3.33) | ||
| Total | 5 (7.69) | 4 (6.67) | 0.049 | 0.825 |
Comparative analysis of clinical symptom scores
Before treatment, clinical symptom scores for rhinorrhea, sneezing, nasal congestion, and nasal pruritus showed no significant differences between the two groups (P>0.05). After treatment, both groups exhibited a significant reduction in symptom scores (P<0.05), with the research group showing significantly lower scores than the control group (P<0.05) (Table 4).
Table 4.
Comparative analysis of clinical symptom scores
| Indicators | Research group (n = 65) | Control group (n = 60) | t | P |
|---|---|---|---|---|
| Rhinorrhea | ||||
| Before | 2.51±0.53 | 2.38±0.56 | 1.333 | 0.185 |
| After | 0.97±0.39b | 1.93±0.63a | 10.329 | <0.001 |
| Sneezing | ||||
| Before | 2.37±0.52 | 2.28±0.56 | 0.932 | 0.353 |
| After | 0.75±0.43b | 1.42±0.50a | 8.050 | <0.001 |
| Nasal congestion | ||||
| Before | 2.68±0.47 | 2.60±0.49 | 0.932 | 0.353 |
| After | 0.80±0.40b | 1.28±0.61a | 5.241 | <0.001 |
| Nasal pruritus | ||||
| Before | 2.51±0.50 | 2.52±0.50 | 0.112 | 0.911 |
| After | 0.83±0.38b | 1.40±0.56a | 6.704 | <0.001 |
P<0.05 vs. before treatment.
P<0.01 vs. before treatment.
Comparative analysis of nasal cavity condition
Baseline measurements of nasal cavity condition resistance (NR), minimum cross-sectional area (mCSA), and nasal cavity volume (NCV) showed no significant differences between groups (P>0.05). Following treatment, both groups exhibited a significant reduction in NR and mCSA and a significant increase in NCV (P<0.05). Notably, the research group showed significantly lower NR and mCSA and higher NCV compared to the control group (P<0.05) (Table 5).
Table 5.
Comparative analysis of nasal cavity metrics
| Indicators | Research group (n = 65) | Control group (n = 60) | t | P |
|---|---|---|---|---|
| Nasal resistance (cm3) | ||||
| Before | 3.34±0.51 | 3.20±0.42 | 1.667 | 0.098 |
| After | 2.55±0.38b | 2.95±0.33a | 6.260 | <0.001 |
| Minimum crosssectional area (cm2) | ||||
| Before | 0.69±0.19 | 0.77±0.28 | 1.882 | 0.062 |
| After | 0.39±0.10b | 0.57±0.16a | 7.604 | <0.001 |
| Nasal cavity volume (cmH2O/L/min) | ||||
| Before | 2.03±0.38 | 2.10±0.42 | 0.978 | 0.330 |
| After | 2.80±0.42b | 2.48±0.38a | 4.454 | <0.001 |
P<0.05 vs. before treatment.
P<0.01 vs. before treatment.
Comparative analysis of serum inflammatory markers
Before treatment, no significant differences were found in IL-4, IL-8, and IL-10 levels between the groups (all P>0.05). Post-treatment analysis revealed a significant reduction in IL-4 and IL-8 levels and a significant increase in IL-10 levels in both groups (all P<0.05). Moreover, IL-4 and IL-8 levels in the research group were significantly lower, while IL-10 levels were significantly higher than those in the control group (all P<0.05). See Figure 2.
Figure 2.
Comparative analysis of serum inflammatory markers between the two groups. A. Pre- and post-treatment IL-4 levels in both groups. B. Pre- and post-treatment IL-8 in the two groups. C. Pre- and post-treatment IL-10 in the two groups. Note: aP<0.05 vs. before treatment; bP<0.05 vs. Control. IL, including interleukin.
Comparative analysis of serum biochemical indices
At baseline, tIgE, EOS, and ECP levels were similar between the groups (all P>0.05). After treatment, all three parameters were significantly reduced in both groups (all P<0.05), with tIgE, EOS, and ECP levels in the research group significantly lower than those in the control group (all P<0.05). See Figure 3.
Figure 3.
Comparative analysis of serum biochemical indices between the two groups. A. Pre- and post-treatment TlgE in the two groups. B. Pre- and post-treatment EOS in the two groups. C. Pre- and post-treatment ECP in the two groups. Note: aP<0.05 vs. before treatment; bP<0.05 vs. Control. TlgE, total immunoglobulin E; EOS, eosinophil count; ECP, eosinophil cationic protein.
Comparative analysis of quality of life
Prior to treatment, RQLQ scores were comparable between the two groups (P>0.05). After treatment, a significant decrease in RQLQ scores was observed in both groups (P<0.05), with the research group achieving a significantly lower RQLQ score compared to the control group (P<0.05). See Table 6.
Table 6.
Comparative analysis of quality of life
| Indicators | Research group (n = 65) | Control group (n = 60) | t | P |
|---|---|---|---|---|
| Before | 24.60±3.55 | 24.30±3.93 | 0.448 | 0.655 |
| After | 7.86±2.49b | 12.95±3.47a | 9.476 | <0.001 |
P<0.05 vs. before treatment.
P<0.01 vs. before treatment.
Univariate and multivariate analyses of factors influencing treatment efficacy
Univariate analysis identified passive secondhand smoke exposure, IL-10 levels, EOS count, and treatment modality as significant factors associated with treatment efficacy (P<0.05). These variables were incorporated as independent factors in a binary logistic regression model, with treatment efficacy (effective/ineffective) as the dependent variable.
Multivariate analysis confirmed that passive secondhand smoke exposure (P = 0.035) and elevated EOS (P = 0.036) were independent risk factors negatively affecting treatment efficacy in pediatric AR (Tables 7, 8 and 9).
Table 7.
Univariate analysis of factors influencing treatment efficacy
| Indicators | Ineffective group (n = 17) | Effective group (n = 108) | χ2/t | P |
|---|---|---|---|---|
| Gender | 0.155 | 0.694 | ||
| Male (n = 68) | 10 (58.82) | 58 (53.70) | ||
| Female (n = 57) | 7 (41.18) | 50 (46.30) | ||
| Age (years) | 0.638 | 0.424 | ||
| <8 (n = 55) | 9 (52.94) | 46 (42.59) | ||
| ≥8 (n = 70) | 8 (47.06) | 62 (57.41) | ||
| Disease course (years) | 2.895 | 0.089 | ||
| <15 (n = 57) | 11 (64.71) | 46 (42.59) | ||
| ≥15 (n = 68) | 6 (35.29) | 62 (57.41) | ||
| Bronchial asthma | 1.893 | 0.169 | ||
| Without (n = 103) | 12 (70.59) | 91 (84.26) | ||
| With (n = 22) | 5 (29.41) | 17 (15.74) | ||
| Passive secondhand smoke exposure | 4.629 | 0.031 | ||
| No (n = 67) | 5 (29.41) | 62 (57.41) | ||
| Yes (n = 58) | 12 (70.59) | 46 (42.59) | ||
| IL-4 (kU/L) | 0.408 | 0.523 | ||
| <30 (n = 50) | 8 (47.06) | 42 (38.89) | ||
| ≥30 (n = 75) | 9 (52.94) | 66 (61.11) | ||
| IL-8 (kU/L) | 1.373 | 0.241 | ||
| <60 (n = 50) | 9 (52.94) | 41 (37.96) | ||
| ≥60 (n = 75) | 8 (47.06) | 67 (62.04) | ||
| IL-10 (kU/L) | 4.720 | 0.030 | ||
| <11000 (n = 65) | 13 (76.47) | 52 (48.15) | ||
| ≥11000 (n = 60) | 4 (23.53) | 56 (51.85) | ||
| TlgE (kU/L) | 0.033 | 0.856 | ||
| <400 (n = 71) | 10 (58.82) | 61 (56.48) | ||
| ≥400 (n = 54) | 7 (41.18) | 47 (43.52) | ||
| EOS (%) | 4.324 | 0.038 | ||
| <7.50 (n = 73) | 6 (35.29) | 67 (62.04) | ||
| ≥7.50 (n = 52) | 11 (64.71) | 41 (37.96) | ||
| ECP (μg/L) | 0.506 | 0.477 | ||
| <24 (n = 42) | 7 (41.18) | 35 (32.41) | ||
| ≥24 (n = 83) | 10 (58.82) | 73 (67.59) | ||
| Treatment modality | 4.022 | 0.045 | ||
| Levocabastine nasal spray (n = 60) | 12 (70.59) | 48 (44.44) | ||
| Montelukast sodium plus levocabastine nasal spray (n = 65) | 5 (29.41) | 60 (55.56) |
Note: IL, interleukin; TlgE, total immunoglobulin E; EOS, eosinophil count; ECP, eosinophil cationic protein.
Table 8.
Variable assignment analysis of significant factors identified in univariate analysis
| Indicators | Variable | Assignment |
|---|---|---|
| Passive secondhand smoke exposure | X1 | No = 0, yes = 1 |
| IL-10 (kU/L) | X2 | <11000 = 0, ≥11000 = 1 |
| EOS (%) | X3 | <7.50 = 0, ≥7.50 = 1 |
| Treatment modality | X4 | Montelukast sodium plus levocabastine nasal spray = 0, levocabastine nasal spray = 1 |
| Efficacy | Y | Effective = 0, ineffective = 1 |
Note: IL, interleukin; EOS, eosinophil count.
Table 9.
Multivariate analysis of factors influencing treatment efficacy using binary logistic regression model
| Factors | β | SE | Wald | P | OR | 95% CI |
|---|---|---|---|---|---|---|
| Passive secondhand smoke exposure | 1.281 | 0.608 | 4.449 | 0.035 | 3.602 | 1.095-11.848 |
| IL-10 (kU/L) | -1.129 | 0.631 | 3.197 | 0.074 | 0.324 | 0.094-1.115 |
| EOS (%) | 1.243 | 0.594 | 4.384 | 0.036 | 3.467 | 1.083-11.100 |
| Treatment modality | 1.132 | 0.607 | 3.476 | 0.062 | 3.102 | 0.944-10.198 |
Note: IL, interleukin; EOS, eosinophil count.
Discussion
AR is an inflammatory disorder of the nasal mucosa characterized by various allergic symptoms. It not only increases the risk of comorbid conditions such as asthma, sinusitis, and conjunctivitis but also negatively impacts patients’ social activities, academic performance, and overall quality of life [15,17]. Given these implications, optimizing treatment strategies to enhance symptom control and therapeutic efficacy in pediatric AR remains a clinical priority.
The findings of this study demonstrated that the combination therapy of MKS and LEVO nasal spray achieved a significantly higher overall treatment efficacy rate than LEVO monotherapy (92.31% vs. 80.00%). Consistent with research by Yao et al. [18], the therapeutic efficacy of MKS in pediatric AR may be partially influenced by the G473A polymorphism of the lysyl oxidase (LOX) gene, which could account for the superior outcomes observed with MKS-based treatment.
Furthermore, the combined MKS and LEVO regimen exhibited a favorable safety profile, with an incidence of adverse reactions comparable to that of LEVO monotherapy (7.69% vs. 6.67%). MKS has been well-documented as a safe and well-tolerated treatment in pediatric AR, with no reported cardiotoxic effects, which may contribute to the safety of this combination therapy [19].
In addition to its efficacy and safety, the combination therapy significantly improved clinical symptoms (rhinorrhea, sneezing, nasal congestion, and nasal pruritus) and nasal cavity parameters. Similar findings were reported by Micheletto et al. [20], where MKS administration in aspirin-induced asthma patients led to significant improvements in nasal function, supporting the results of the present study.
The pathophysiology of AR involves chronic inflammatory stimulation of the nasal mucosa, which increases permeability and induces tissue damage, exacerbating symptoms [21]. Key inflammatory cytokines, including IL-4, IL-8, and IL-10, play crucial roles in allergic responses. IL-4 and IL-8, as pro-inflammatory cytokines, stimulate IgE production and promote lymphocyte proliferation, thereby aggravating rhinitis symptoms. In contrast, IL-10 is involved in regulating allergic inflammation and immune responses, influencing the disease’s progression [22-24].
Furthermore, tIgE, EOS, and ECP play crucial roles in the pathophysiological processes of AR. Specifically, tIgE reflects immunoglobulin activity in patients, EOS contributes to mucosal mucus secretion and serves as an indicator of disease severity, while ECP is closely associated with the onset and progression of AR [25-28]. Based on these pathophysiological mechanisms, our study evaluated these biomarkers in pediatric patients.
Our findings demonstrated that the combination therapy of MKS and LEVO nasal spray was significantly more effective in modulating serum inflammatory markers and inhibiting disease progression in pediatric AR patients. Consistent with our results, a study by Wei et al. [28] reported that MKS significantly reduced IL-4 and EOS levels in children with cough-variant asthma.
Additionally, our results suggest that MKS combined with LEVO nasal spray significantly enhances quality of life in pediatric AR patients. This therapeutic advantage is likely attributable to the synergistic effects of the combination therapy, which effectively controls clinical symptoms, improves nasal conditions, and suppresses systemic inflammation and disease progression. Consequently, this comprehensive approach facilitates recovery and leads to substantial improvements in patient quality of life. Supporting these findings, a study by Kim et al. [29] demonstrated that MKS combined with levocetirizine effectively managed daytime nasal congestion, rhinorrhea, and nocturnal nasal obstruction in pediatric AR patients, while also exhibiting lower adverse event rates and higher overall satisfaction. Moreover, Guo et al. [30] reported that combining MKS with budesonide significantly improved pulmonary function in children with concomitant AR and asthma. This regimen not only alleviated symptoms of both conditions but also contributed to IgE reduction and a lower EOS percentage, further validating our findings.
Notably, both univariate and multivariate analyses confirmed that pediatric AR patients exposed to passive secondhand smoke and those with elevated EOS levels faced a significantly higher risk of treatment failure.
Despite these promising findings, this study has several limitations. The study did not extensively investigate potential factors affecting patient safety. Further analyses focusing on safety parameters would provide more specific and clinically relevant insights. As a single-center study, there may be inherent selection and information biases. Future multicenter studies are needed to enhance the generalizability of these findings. What’s more, the precise therapeutic mechanisms underlying the combination therapy of MKS and LEVO nasal spray in pediatric AR were not thoroughly explored. Additional basic research is required to elucidate these mechanisms.
Future research efforts should address these limitations to further advance our understanding of this treatment approach.
In conclusion, the combination of MKS and LEVO nasal spray provides superior clinical efficacy with a favorable safety profile in pediatric AR patients. This regimen effectively alleviates rhinorrhea, sneezing, nasal congestion, and nasal pruritus, improves nasal cavity conditions, modulates serum inflammatory responses, and restores serum biochemical indices, ultimately enhancing the quality of life.
However, it is important to recognize that pediatric AR patients with passive secondhand smoke exposure and elevated EOS levels face a significantly higher risk of treatment failure. These findings highlight the need for personalized treatment strategies and targeted interventions to optimize therapeutic outcomes in high-risk pediatric AR populations.
Disclosure of conflict of interest
None.
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