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Computational Intelligence and Neuroscience


Volume 2022, Article ID 6935758, 6 pages
https://doi.org/10.1155/2022/6935758

Research Article
Efficacy and Safety of Rupatadine Fumarate Combined with
Acupoint Application in Allergic Rhinitis
Complicated with Diabetes

Yu Liu,1 Pengjun Jiang,2 Xuqing Chen,3 Wen Zhang,3 and Jun Shi 3

1
Department of Otolaryngology,
Nanjing Integrated Traditional Chinese and Western Medicine Hospital Affiliated with Nanjing University of Chinese Medicine,
Nanjing 210014, China
2
Department of Hematology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China
3
Department of Otolaryngology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China

Correspondence should be addressed to Jun Shi; shishichuoshou@126.com

Received 7 March 2022; Revised 22 April 2022; Accepted 7 May 2022; Published 14 June 2022

Academic Editor: Rahim Khan

Copyright © 2022 Yu Liu et al. This is an open access article distributed under the Creative Commons Attribution License, which
permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

The prevalence of allergic rhinitis has exhibited an upward trend, and diabetes is a common endocrine metabolic disorder.
Treatment of allergic rhinitis complicated with diabetes has been marginally explored. This study aimed to observe the effect of
rupatadine fumarate combined with acupoint application in the treatment of allergic rhinitis complicated with diabetes and its
effect on serum IgE levels. Totally 80 patients with allergic rhinitis complicated with diabetes admitted to our hospital from
December 2019 to December 2020 were recruited and assigned to receive either rupatadine fumarate (control group) or
rupatadine fumarate plus acupoint application (research group). The clinical observation indexes of the two groups of patients
before and after treatment were analyzed, and the clinical efficacy of the two groups was evaluated. Rupatadine fumarate plus
acupoint application was associated with a significantly higher efficacy (23 cases of markedly effective, 14 cases of effective, and 3
cases of ineffective) versus rupatadine fumarate alone (14 cases of markedly effective, 16 cases of effective, and 10 cases of
ineffective) (χ2  4.501, p  0.034). The immunoglobulin E (IgE) and nasal mucosal eosinophils (EOS) levels of the two groups of
patients after treatment decreased significantly, and the research group had lower results (p < 0.05). Patients in the research group
showed significantly lower syndrome scores than those in the control group (p < 0.05). Rupatadine fumarate plus acupoint
application resulted in significantly lower physical sign scores and interleukin-4 (IL-4) levels and higher levels of interferon-
gamma (INF-c) versus rupatadine fumarate alone (p < 0.05). The two groups showed a similar incidence of adverse events
(p > 0.05). Rupatadine fumarate plus acupoint application may offer a viable alternative for the treatment of allergic rhinitis as it
alleviates the clinical symptoms, improves the treatment efficiency, and enhances the anti-allergic effect of the drug, with a high
safety profile.

1. Introduction remains controversial in clinical settings since antihista-


mines and corticosteroids are associated with recurrence and
In recent years, the prevalence of allergic rhinitis has adverse drug reactions [6].
exhibited an upward trend due to environmental factors Recently, traditional Chinese medicine (TCM) treatment
such as air pollution. Statistics show that the global incidence has demonstrated great advantages in clinical medicine
of the disease is 10–20% [1–3]. Diabetes may lead to allergic [7, 8]. Acupoint application is a treatment method guided by
rhinitis due to impaired immune function [4]. At present, the basic theory of TCM, applying Chinese herbal prepa-
clinical treatment for allergic rhinitis is mainly based on rations to the acupoints [9, 10]. Acupoint application
antihistamines or corticosteroids [5]. However, the efficacy therapy is used to stimulate the meridians, harmonize qi and
2 Computational Intelligence and Neuroscience

blood, improve blood circulation, enhance immune func- Shenshu (bilateral), Pishu (bilateral), Guanyuan, and Dazhui
tion, and regulate the dynamic balance of the human body using the prepared medicinal cakes. (3) Application method:
through acupoint stimulation [11]. TCM classifies allergic the medicinal cakes were applied to the corresponding
rhinitis into the category of bi-qiu, and acupuncture and acupoints, fixed with a 5 cm × 5 cm desensitizing tape and
acupoint application are frequently used for early treatment removed after 8 hours. The skin of the application site should
[12]. This study intends to combine acupoint application be protected from water for 24 hours. The acupoint appli-
therapy with rupatadine fumarate to enhance the curative cation was performed once per week, with four weeks as a
effect of allergic rhinitis and enrich the clinical data for the course of treatment. (4) Precautions: the patients were ad-
treatment of allergic rhinitis. vised against scratching the skin in the case of redness and
swelling or small red blisters on the skin of the application
2. Materials and Methods site, and 75% alcohol was used for local disinfection.
All patients received nasal irrigation with normal saline
2.1. Inclusion Criteria. Patients who met the western med- thrice, and the duration of treatment was 1 month.
icine diagnostic criteria in Guidelines for the Diagnosis and
Treatment of Allergic Rhinitis [13], TCM diagnostic criteria
2.5. Observation Indicators
in Guidelines for the Diagnosis of Common Diseases in TCM
Otorhinolaryngology [14], and diagnostic criteria for dia- 2.5.1. Baseline Patient Profile. The baseline patient profile of
betes, aged >18 years old, with no recent use of anti-allergic the patients such as age, gender, course of disease, BMI,
rhinitis drugs two weeks prior to enrollment, who volun- smoking, drinking, and education level was recorded.
tarily participated in the study, with good treatment com-
pliance, and with no allergies to the drugs used in this study
were included. 2.5.2. Clinical Efficacy. With reference to Allergic Rhinitis
Diagnosis and Efficacy Evaluation Criteria [15], the clinical
efficacy of patients after treatment was evaluated. Effica-
2.2. Exclusion Criteria. Patients with severe systemic dis- cy � (total scores before treatment − total scores after
eases, with allergic sinusitis, acute rhinitis, autonomic rhi- treatment)/total scores before treatment × 100%. Curative
nitis, and other diseases, with allergic asthma, with effect index ≥66% is considered markedly effective, 26% ≤
communication impairments, cognitive disorders, or curative effect index ≤65% is effective, and curative effect
physical disabilities, during pregnancy or lactation, and with index ≤25% is ineffective. The total treatment
use of peripheral H1 receptor antagonist within 1 week efficacy � (effective + markedly effective)/total × 100%.
before enrollment were excluded.
2.5.3. Serum IgE Level. 5 ml of fasting venous blood was
2.3. Screening and Grouping. Between December 2019 and collected from the patient before and after treatment. After
December 2020, 80 patients with allergic rhinitis admitted to anticoagulation and centrifugation, the serum IgE level of
our hospital were considered eligible and recruited as per the the patient was determined using the enzyme-linked im-
inclusion and exclusion criteria. According to the treatment munosorbent assay.
plan of the patients, they were equally assigned to a control
group or a research group. This study is a retrospective 2.5.4. Nasal Mucosal Eosinophils (EOS). A cotton swab was
analysis, does not interfere with the patient’s treatment plan, used to swab the patient’s turbinate forward and backward
and is supervised by the ethics committee of Affiliated 2–3 times, and the exfoliated cells of the nasal mucosa were
Hospital of Nanjing University of Chinese Medicine, No. smeared on the glass slide. The collected exfoliated cells of
A-NJ1138. nasal mucosa were prepared for observation by paraffin
embedding, dewaxing, hematoxylin-eosin staining, dehy-
dration, xylene transparent, and neutral gum sealing, and the
2.4. Method. Patients in the control group received 10 mg
morphology of eosinophils was observed under light mi-
rupatadine fumarate tablets (Yangzijiang Pharmaceutical
croscope. The EOS counts of 10 or more consecutive visual
Group Nanjing Hailing Pharmaceutical Co., Ltd., approval
fields were carried out under high power field (40 × 10 x),
no. H20130047) daily after meals in the evening. A similar
and the average was taken to score.
treatment protocol of rupatadine fumarate was introduced
to the patients in the research group.
Patients in the research group received additional acu- 2.5.5. Syndrome Scores. ① Sneezing: no more than 3 con-
point application. (1) Drug preparation: Corydalis, white secutive sneezes are recorded as 0 points, 3–9 consecutive
mustard seeds, asarum, and raw kansui were ground into sneezes are recorded as 1 point, 10–14 consecutive sneezes
powder and mixed well at a ratio of 1 : 1 : 0.5 : 0.5, followed by are recorded as 2 points, and 15 consecutive sneezes or more
the addition of ginger juice to make a herbal paste, and are recorded as 3 points. ② Running nose: 0 points indicate
borneol and a small amount of vaseline were added to that the number of times to wipe the nose is less than 2 times
prepare a 1 cm × 1 cm × 0.5 cm medicinal pie. (2) The acu- daily; 1 point indicates that the number of times to wipe the
point application was performed on the following acupoints nose is 2–4 daily; 2 points indicate that the number of times
of Xinshu (bilateral), Feishu (bilateral), Geshu (bilateral), to wipe the nose is 5–9 daily; and 3 points indicate that the
Computational Intelligence and Neuroscience 3

Table 1: Comparison of general information of the two groups of patients (n � 40).


Control Research t/χ2 P value
Age (year) 30.53 ± 6.17 31.09 ± 7.11 0.376 0.708
Course of disease (year) 4.23 ± 1.21 4.16 ± 1.17 0.263 0.793
Gender 0.201 0.654
Male 22 (55) 20 (50)
Female 18 (45) 20 (50)
BMI (kg/m2) 24.16 ± 2.34 24.08 ± 2.27 0.155 0.877
History of smoking 0.457 0.499
Yes 24 (60) 21 (52.5)
No 16 (40) 19 (47.5)
History of drinking 0.800 0.371
Yes 18 (45) 22 (55)
No 22 (55) 18 (45)
Educational background 0.200 0.655
Middle school 11 (27.5) 10 (25)
Middle school to high school 8 (20) 11 (27.5)
High school or above 21 (52.5) 19 (47.5)

number of times to wipe the nose is 10 or more daily. ③ 100


92.5%
Nasal Congestion. 0 points: there is no need to breathe 90
through the mouth; 1 point: the patient occasionally 80 75%
breathes through the mouth; 2 points: the patient frequently 70
breathes through the mouth; and 3 points: the patient cannot 57.5%
60
breathe through the nose completely. ④ Itchy nose: 0 points
50
indicate no itching, 1 point indicates occasional itching, 2 40%
points indicate tolerable persistent itching, and 3 points 40 35% 35%
indicate unbearable nasal itching. 30 25%
20
10 7.5%
2.5.6. Physical Signs Scores. 1 point: there is mild swelling of 0
the lower nose; the middle turbinate and nasal septum are Inefficiency Efficiency Apparent Total effective
still visible; 2 points: the nasal septum is close to the inferior efficiency rate
turbinate, and there are small gaps between the inferior
turbinate and nasal septum; 3 points: the inferior turbinate is Control group
close to the nasal septum and the base of the nose, and no Research group
middle turbinate or middle turbinate mucosal polypoid Figure 1: Comparison of the clinical efficacy of the two groups of
changes can be seen. patients (n � 40,%).

2.5.7. Serum Inflammatory Substances. Enzyme-linked 3. Results


immunosorbent assay was used to determine the serum
interleukin-4 (IL-4) and interferon-c (IFN-c) levels before 3.1. Baseline Patient Profile. The general data of the two
and after treatment. groups of patients were not statistically different (P > 0.05)
(Table 1).

2.5.8. Incidence of Adverse Reactions. The adverse reactions


during the treatment of the two groups of patients were 3.2. Clinical Efficacy. In the control group, 14 cases were
recorded. markedly effective, 16 cases were effective, and 10 cases were
ineffective. In the research group, 23 cases were markedly
effective, 14 cases were effective, and 3 cases were ineffective.
2.6. Statistical Analysis. GraphPad Prism 7 (GraphPad Rupatadine fumarate plus acupoint application was asso-
Software, San Diego, USA) was used to plot the graphics, and ciated with a significantly higher efficacy versus rupatadine
SPSS23.0 software was used for data analyses. The counting fumarate alone (χ 2 � 4.501, p � 0.034). (Figure 1).
data are expressed as [n(%)] and analyzed using the chi-
square test, and measurement data are expressed as
(mean ± SD) and analyzed using students’ t-test. Differences 3.3. Serum IgE Levels. The IgE levels of the two groups of
were considered statistically significant at p < 0.05. patients after treatment significantly decreased, and the
research group had lower results (p < 0.05). (Figure 2).
4 Computational Intelligence and Neuroscience

250 20

200

Number/field of vision
15
150
IU (ml)

*
10
100
*
50 5

0
Before treatment After treatment 0
Before treatment After treatment
Control group
Research group Control group
Research group
Figure 2: Comparison of the IgE levels of the two groups of
patients. Note. The abscissa indicates before and after treatment, Figure 3: Comparison of the EOS content of the two groups of
and the ordinate indicates the level, IU/ml; the IgE levels of the patients.
control group before and after treatment were (204.63 ± 32.15) and
(97.86 ± 14.15), respectively; the IgE levels of the research group
before and after treatment were (205.55 ± 33.21) and curative effect of allergic rhinitis and mitigate the symptoms,
(90.37 ± 13.47), respectively; ∗ indicates that the IgE levels of the two suggesting that rupatadine fumarate plus acupoint appli-
groups of patients after treatment were significantly different cation shows a desirable effect in the treatment of allergic
(t � 2.425, p � 0.018). rhinitis. Accordingly, this study was conducted to explore
the application effect of rupatadine fumarate plus acupoint
3.4. EOS Content. After treatment, the EOS content of the application in allergic rhinitis complicated diabetes patients
two groups of patients decreased, and the EOS content of the admitted to our hospital.
research group was significantly lower than that of the Western medicine recognizes that the onset of allergic
control group (p < 0.05, Figure 3). rhinitis is related to the patient’s physique and allergens [17].
After the allergen enters the nasal cavity for the second time,
it binds to IgE on eosinophils and releases a large number of
3.5. Syndrome Scores. The research group had significantly mediators such as leukotrienes and histamine to induce
lower syndrome scores than the control group (p < 0.05). tissue edema and eosinophil infiltration. In this regard, the
(Table 2). prerequisite for clinical treatment of allergic rhinitis lies in
the identification of the allergen [18]. Relevant experimental
3.6. Vital Sign Scores. The physical sign scores of the two studies have shown that the anti-tissue activity of rupatadine
groups of patients were reduced after treatment, and the fumarate is significantly better than that of commonly used
research group showed significantly lower results (p < 0.05) drugs such as loratadine and cetirizine [19]. The drug can
(Table 3). effectively inhibit the activity of eosinophils, mast cells, and
neutrophils and suppress the release of cytokines, emanating
outstanding effects on the treatment of allergic rhinitis and
3.7. Serum Inflammatory Factor Levels. Rupatadine fumarate urticaria. In the present study, patients in the control group
plus acupoint application resulted in significantly lower IL-4 were treated with rupatadine fumarate alone for one month
levels and higher levels of INF-c versus rupatadine fumarate and its was found that their signs and symptoms were al-
alone (p < 0.05). (Figures 4 and 5). leviated, and EOS, IgE levels, and inflammatory cytokines
were all ameliorated, suggesting the outstanding clinical
3.8. Incidence of Adverse Reactions. The two groups showed a value of rupatadine fumarate in the treatment of allergic
similar incidence of adverse events (p > 0.05). rhinitis, and the results are consistent with the previous
studies.
4. Discussion Chinese medicine believes that the contributory factors
for allergic rhinitis include chill and wind, insufficient qi,
Allergic rhinitis is an IgE-mediated inflammatory disease of and evil invasion, leading to deficiency of the spleen, kid-
the nasal mucosa, which is caused by exposure to allergens neys, and lungs. Acupuncture, acupoint application, and
[16]. Thus, anti-allergy is an essential part of the treatment of Chinese medicine decoctions are key treatment methods to
the disease. It is documented that rupatadine fumarate consolidate the function of viscera and the body’s immunity,
tablets are a potent anti-allergic drug. Clinical research thereby mitigating clinical symptoms [20]. In the present
found that rupatadine fumarate relieved the clinical study, patients in the research group were treated with
symptoms and signs of allergic rhinitis and reduces the rupatadine fumarate plus acupoint application using me-
infiltration of eosinophils in the nasal mucosa. Moreover, its dicinal cakes with corydalis yanhusuo, white mustard seeds,
combination with acupoint application can further improve asarum, and kansui root as ingredients for anti-allergic
Computational Intelligence and Neuroscience 5

Table 2: Comparison of the syndrome scores of the two groups of patients.


Control (n � 40) Research (n � 40)
Before treatment After treatment Before treatment After treatment
Sneeze 2.38 ± 0.61 1.60 ± 0.59 2.41 ± 0.58 1.29 ± 0.44
tcontrol-research/Pcontrol-research 2.664/0.0094
Running nose 2.40 ± 0.54 1.44 ± 0.54 2.39 ± 0.52 1.09 ± 0.33
tcontrol-research/Pcontrol-research 3.498/0.0008
Nasal obstruction 2.09 ± 0.61 1.56 ± 0.35 2.13 ± 0.58 1.26 ± 0.43
tcontrol-research/Pcontrol-research 3.422/0.001
Rhinocnesmus 1.88 ± 0.35 1.55 ± 0.34 1.89 ± 0.37 1.14 ± 0.56
tcontrol-research/Pcontrol-research 3.907/0.0002
Total score 8.73 ± 1.31 6.18 ± 1.42 8.70 ± 1.27 4.87 ± 1.34
tcontrol-research/Pcontrol-research 4.244/0.0001

140 *
Table 3: Comparison of the physical sign scores of the two groups
of patients. 120

Group n Before treatment After treatment 100


Control 40 2.47 ± 0.55 1.53 ± 0.52
80
ng (L)
Research 40 2.46 ± 0.53 0.91 ± 0.42
t-value 5.866 60
P value <0.001
40

20

150 0
Before treatment After treatment

Research group
100 Control group
pg (ml)

Figure 5: Comparison of serum INF-c levels of two groups of


patients. Note. The abscissa indicates before and after treatment,
and the ordinate indicates the detection level, ng/L; the INF-c levels
50 of the control group before and after treatment were (45.15 ± 10.75)
* and (55.63 ± 10.49), respectively; the INF-c levels of the research
group before and after treatment were (47.13 ± 11.02) and
(68.27 ± 16.02), respectively; ∗ indicates that the INF-c levels of the
0 two groups of patients after treatment were significantly different
Before After Before After (t � 4.175, p < 0.001).
treatment treatment treatment treatment

Control group
Research group
kansui root can eliminate phlegm and induce diuresis to
Figure 4: Comparison of the serum IL-4 levels of the two groups of alleviate edema [21]. The combination of the above herbs for
patients. Note. The abscissa indicates before and after treatment, acupoint application can warm yang, promote qi, dispel
and the ordinate indicates the detection level, pg/ml; the IL-4 levels wind and chill, and clarify the nose and orifices. The results
of the control group before and after treatment were (78.93 ± 16.47) of the present study indicated that the acupoint application
and (17.05 ± 4.21), respectively; the IL-4 levels of the research group plus rupatadine fumarate can further enhance the thera-
before and after treatment were (79.06 ± 16.69) and (12.11 ± 3.35),
peutic effect of allergic rhinitis and reduce the level of IgE,
respectively; ∗ indicates that the IL-4 levels of the two groups of
patients after treatment were significantly different (t � 5.807,
IL-4, and EOS activity. In addition, INF-c inhibits the
p < 0.001). synthesis of IgE from B cells, and the patient’s INF-c level
after treatment was significantly increased, indicating that
acupoint application could effectively regulate the immune
balance of patients with allergic rhinitis, reduce inflam-
treatment. Corydalis yanhusuo can promote blood circu- mation responses, and relieve clinical symptoms. The EOS
lation and invigorate lung q, white mustard seeds warm the content of nasal secretions in the research group of the
lungs and eliminate phlegm, asarum can dispel the heat, and patients after treatment was reduced, which is in line with
6 Computational Intelligence and Neuroscience

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