1.Lu'e Biyan Formula for Treatment of Allergic Rhinitis Patients with Fei (Lung)-Qi Deficiency-Coldness Syndrome: A Randomized, Double Blind, and Placebo-Controlled Trial.
Ming-Yue JIA ; Mei-Yi ZHANG ; Si-Yao XIAO ; Yang YU ; Xiang SHAO ; Chun-Sheng HAN ; Gui-Ling HAN
Chinese journal of integrative medicine 2025;31(11):1029-1036
OBJECTIVE:
To observe the clinical effect and safety of Lu'e Biyan Formula (LBF) combined with loratadine in the treatment of moderate to severe allergic rhinitis (AR) patients with Fei (Lung)-qi deficiency-coldness (FQDC) syndrome.
METHODS:
From September 2023 to December 2024, moderate to severe AR patients with FQDC syndrome were recruited from the Outpatient Department of Integrated Traditional Chinese and Western Medicine for Pulmonary Diseases Part 1, China-Japan Friendship Hospital. Participants were randomly assigned to a test group and a control group by using a random number table at a ratio of 1:1. Both groups received oral loratadine tablets (10 mg, once daily) for 2 weeks. In addition, the test group received oral LBF (30 mL, twice daily), and the control group received a placebo of LBF. Changes in the Total Nasal Symptom Score (TNSS), Total Non-nasal Symptom Score (TNNSS), Visual Analog Scale (VAS), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), and Chinese medicine (CM) syndrome scores before and after treatment were compared between groups. Moreover, the total effective rates and disease recurrence rates were compared. Adverse events (AEs) during the study period were also recorded.
RESULTS:
Totally 109 participants were recruited, and the full analysis set included 105 cases, 54 in the test group and 51 in the control group. Compared with the pre-treatment values, the scores of sneezing, runny nose, nasal obstruction, nasal itching, TNSS, TNNSS, VAS, RQLQ, and CM syndrome were significantly reduced in both groups at 1 and 2 weeks post-treatment and 12 weeks post-drug withdrawal (P<0.01). After treatment, the aforementioned scores in the test group were all markedly lower than those in the control group (P<0.01). Moreover, the total effective rate in the test group was higher than that in the control group (98.15% vs. 70.59%, P<0.01). After 12 weeks of drug withdrawal, there was no significant difference in the recurrence rate between groups (13.21% vs. 22.22%, P>0.05). No obvious AEs were observed in either group following treatment.
CONCLUSIONS
The combination of LBF with loratadine can effectively alleviate the symptoms of moderate to severe AR patients with FQDC syndrome, thereby improving their quality of life. This therapy demonstrated both precise effect and high safety. (Trial registration No. ITMCTR2025000589).
Humans
;
Drugs, Chinese Herbal/therapeutic use*
;
Male
;
Rhinitis, Allergic/drug therapy*
;
Female
;
Adult
;
Double-Blind Method
;
Quality of Life
;
Qi
;
Middle Aged
;
Loratadine/therapeutic use*
;
Medicine, Chinese Traditional
;
Syndrome
;
Lung/drug effects*
;
Young Adult
;
Treatment Outcome
2.Meta-analysis of efficacy and safety of Tripterygium Glycosides Tablets combined with desloratadine in treatment of chronic urticarial.
Yan-Shuo SHI ; Qi-Min WANG ; Xue-Jia QIU ; Guo-Xun PANG
China Journal of Chinese Materia Medica 2019;44(16):3551-3557
To analyze the efficacy and safety of Tripterygium Glycosides Tablets combined with desloratadine as well as desloratadine alone in the treatment of chronic urticaria by Meta-analysis,in order to provide evidence-based reference for clinical treatment.PubMed,CBM,Wan Fang,VIP database and CNKI database were retrieved to collect randomized controlled trials( RCT) about Tripterygium Glycosides Tablets combined with desloratadine( test group) as well as desloratadine alone( control group) in the treatment of chronic urticaria. Meta-analysis was performed by using Rev Man 5. 3 software after data extraction and quality evaluation( a total of 15 RCTs were included,involving 1 411 patients). Meta-analysis showed that the total effective rate( RR = 1. 28,95%CI[1. 22,1. 35],P<0. 000 01) and the quality of life improvement rate( RR = 1. 49,95% CI[1. 33,1. 66],P< 0. 000 01) of the test group were better than those of the control group,and the recurrence rate( RR = 0. 29,95%CI[0. 21,0. 40],P<0. 000 01) was significantly lower than that of the control group,with statistically significant differences; there was no statistically significant difference in the incidence of adverse reactions( RR = 1. 02,95%CI[0. 68,1. 53],P = 0. 92) compared with the control group. Based on the included RCTs,the efficacy of Tripterygium Glycosides Tablets combined with desloratadine in the treatment of chronic urticaria were superior to those of desloratadine alone,with similarity in safety. However,due to the low quality of RCTs and the lack of large-scale multi-center studies,the results shall not be further verified by clinical trials.
Drug Therapy, Combination
;
Drugs, Chinese Herbal
;
therapeutic use
;
Glycosides
;
therapeutic use
;
Humans
;
Loratadine
;
analogs & derivatives
;
therapeutic use
;
Quality of Life
;
Randomized Controlled Trials as Topic
;
Tablets
;
Tripterygium
;
chemistry
;
Urticaria
;
drug therapy
3.Association of CACNA1C gene genetic polymorphism with the susceptibility as well as prognosis for chronic spontaneous urticaria.
Jinjie YAN ; Qinglin LI ; Yuxue LUO ; Siyu YAN ; Yijing HE ; Xiang CHEN
Journal of Central South University(Medical Sciences) 2018;43(9):929-936
To investigate the relationship between single nucleotide polymorphisms (SNPs) of CACNA1C (SNPs rs58619945, rs7316246 and rs216008) and susceptibility of chronic spontaneous urticaria (CSU) as well as the curative effect of non-sedating antihistamine drugs.
Methods: Peripheral blood were extracted from 191 CSU patients to collect DNA. Urticaria Activity Score 7 (UAS7) and Dermatology Life Quality Index (DLQI) changes were collected from these patients with different non-sedating antihistamine drugs. PubMed retrieval system was used to select the 3 SNPs (rs58619945, rs7316246 and rs216008) of CACNA1C. Susceptibility of CSU and curative effect of non-sedating antihistamine drugs (desloratadine, mizolastine, fisofenadine) in 189 CSU patients and 105 controls with different SNPs were compared with Chi-squared test. Data of 105 southern Chinese controls were extracted from the 1 000 genome database.
Results: Frequency of rs58619945 G allele in the CSU patients was significantly higher than that in the controls [OR(95%CI)=0.660(0.470-0.925), P=0.016]. However, there was no significant differences in rs7316246 and rs216008 between the CSU patients and the controls. Meanwhile there was no significant difference in general curative effect of the 3 drugs in the 3 SNPs (rs58619945: OR=0.843, P=0.454; rs7316246: OR=2.103, P=0.102; rs216008: OR=0.237, P=0.363). There was significant difference in different alleles of rs216008 in the patients administered by desloratadine [OR(95%CI)=0.480(0.247-0.933), P=0.029]. No difference was shown in the 3 SNPs in patients administered by mizolastine.
Conclusion: The rs58619945 A/G might be related to susceptibility of CSU, and the rs216008 mutation might affect drug response of desloratadine.
Calcium Channels, L-Type
;
genetics
;
Chronic Disease
;
Genetic Predisposition to Disease
;
Histamine H1 Antagonists, Non-Sedating
;
therapeutic use
;
Humans
;
Loratadine
;
analogs & derivatives
;
therapeutic use
;
Polymorphism, Single Nucleotide
;
Prognosis
;
Retrospective Studies
;
Urticaria
;
drug therapy
;
genetics
4.Clinical evaluation of Montelukast plus Budesonide nasal spray and Desloratadine citrate disodium in treating moderate and severe persistent allergic rhinitis.
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2015;29(23):2041-2043
OBJECTIVE:
To investigate the clinical efficacy of montelukast plus budesonide nasal spray and desloratadine citrate disodium tablets on moderate and severe persistent allergic rhinitis.
METHOD:
Senenty patients with moderate and severe persistent allergic rhinitis were devided randomly study group (n = 35) and control group (n = 35). The study group were treated with montelukast sodium tablets combined with budesonide nasal spray and desloratadine citrate disodium tablets for 4 weeks, the control group received budesonide nasal spray and desloratadine citrate disodium tablets for 4 weeks. Comparing visual analogue scale (VAS) scores of nasal symptoms, rhino conjunctivitis quality of life questionnaire (RQLQ) scores and total effective rate in two groups at baseline and after treatment.
RESULT:
(1) VAS scores of nasal symptoms: the difference of total nasal symptoms VAS scores or single nasal symptom VAS scores from both groups at 2 weeks and 4 weeks after treatment were statistically significant (P < 0.05); (2) RQLQ scores: the difference of RQLQ scores of 2 group's at baseline and 4 weeks after treatment were statistically significant, the difference of RQLQ scores about nasal symptoms in two groups at 4 weeks after treatment were statistically significant (P < 0.05); (3) The total effective rate was 94.29% in study group but 80.00% in control group, the differences were statistically significant (P < 0.05).
CONCLUSION
Montelukast plus budesonide nasal spray and desloratadine citrate disodium tablets can work together better on relieving clinical syptoms quickly and promoting the life quality of patients with moderate and severe persistent allergic rhinitis.
Acetates
;
administration & dosage
;
therapeutic use
;
Budesonide
;
administration & dosage
;
therapeutic use
;
Humans
;
Loratadine
;
administration & dosage
;
analogs & derivatives
;
therapeutic use
;
Nasal Sprays
;
Quinolines
;
administration & dosage
;
therapeutic use
;
Rhinitis, Allergic, Perennial
;
drug therapy
;
Surveys and Questionnaires
5.Evaluation of efficacy and safety of loratadine in the treatment of childhood asthma.
Gulibaha MAIMAITI ; Abulaiti ABDUHAER ; Pei-Ru XU
Chinese Journal of Contemporary Pediatrics 2011;13(11):873-877
OBJECTIVETo evaluate the efficacy and safety of loratadine, a new generation of antihistaminics, in the treatment of childhood asthma.
METHODSThe papers related to loratadine treatment for childhood asthma were searched in the database of PubMed, MEDLINE, EMBASE, Cochrance, CNKI and CBMdisc (January 1990 to December 2010) electronically and manually. According to the Cochrane reviewer's handbook, the quality of the enrolled papers was assessed and a systematic review was performed.
RESULTSA total of 179 papers were obtained. Eleven randomized controlled trials met the criteria and were included in this study. The 11 trials included 317 children with asthma: 159 cases in the loratadine treatment group and 158 cases in the control group. All included studies belonged to the B class according to the quality evaluation criteria. Meta analysis showed that the clinical symptoms were improved more, the forced expiratory volume in 1 second (FEV1) 4 and 8 weeks posttreatment and the peak expiratory flow rate (PEFR) 8 weeks posttreatment were higher in the loratadine treatment group than in the control group. The treatment-related adverse effects, fatigue, tachycardia and palpitation, occurred less in the loratadine treatment group compared with the control group.
CONCLUSIONSLoratadine is safe and effective for the treatment of childhood asthma.
Anti-Allergic Agents ; therapeutic use ; Asthma ; drug therapy ; physiopathology ; Forced Expiratory Volume ; Humans ; Loratadine ; adverse effects ; therapeutic use ; Peak Expiratory Flow Rate
6.Clinical research of Ibudilast on treating the steroid resistant allergic rhinitis.
Hong LUO ; Zezhang TAO ; Nengbing YAN ; Jinjun LIANG ; Pengju WANG ; Jinyun WANG
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2009;23(2):63-66
OBJECTIVE:
To compare the efficacy and safety of histamine H1 receptor antagonist loratadine with Leukotriene receptor antagonist Ibudilast in steroid resistant allergic rhinitis in a randomized controlled clinical trial.
METHOD:
Thirty-five cases were treated by Ibudilast, and 34 cases by loratadine. Score system was used to compare the therapeutic effect of these two drugs on clinical symptoms and signs.
RESULT:
Ibudilast shows a better curative effect than loratadine in the improvement of the total scores on clinical symptom and signs(P<0.05). Scores of symptoms and signs in Ibudilast group after 3, 7, 14 days decreased significantly by means of square analysis of single factor (P<0.01). No complication was observed.
CONCLUSION
Ibudilast can effectively alleviate the clinical symptoms and signs of steroid resistant allergic rhinitis with confirmed efficacy and safety, thus is recommended in steroid resistant allergic rhinitis. Increased doses or prolonged treatment of steroid is inappropriate.
Adolescent
;
Adult
;
Aged
;
Anti-Allergic Agents
;
therapeutic use
;
Female
;
Histamine H1 Antagonists, Non-Sedating
;
therapeutic use
;
Humans
;
Leukotriene Antagonists
;
therapeutic use
;
Loratadine
;
therapeutic use
;
Male
;
Middle Aged
;
Pyridines
;
therapeutic use
;
Rhinitis, Allergic, Perennial
;
drug therapy
;
Rhinitis, Allergic, Seasonal
;
drug therapy
;
Steroids
;
pharmacology
;
Young Adult
7.Clinical study on treatment of atopic dermatitis by integrated traditional Chinese and Western medicine.
Yong-jian SHI ; Chun-min ZHANG ; Dong-mei MA
Chinese Journal of Integrated Traditional and Western Medicine 2008;28(8):686-688
OBJECTIVETo observe the clinical effects and explore the mechanism of the integrated traditional Chinese and Western medicine in treating atopic dermatitis (AD).
METHODSForty-seven patients with AD were randomly assigned to two groups, the control group and the treated group, they were treated with conventional Western medicine (10 mg Loratadine tablet, once daily) and with integrated medicine additionally given modified Jiawei Danggui Decection besides Western medicine respectively for 4 weeks. Double-sandwich ELISA was used to detect the levels of interleukin- 4, -10 and -12 (IL-4, IL-10 and IL-12) before and after treatment.
RESULTSThe total effective rate in the treated group was 56% (14/25 cases), better than that in the control group (22.7%, 5/22 cases), showing significant difference between the two groups (X2 = 5.38, P < 0.05). Before treatment the serum levels of IL-4, IL-10 were significantly higher and level of IL-12 was lower in AD patients as compared with those in healthy persons (P < 0.01); they all restored to normal in the treated group after treatment but unchanged in the control group, showing significant difference between the two groups (P < 0.01).
CONCLUSIONThe clinical effect of integrated traditional Chinese and Western medicine is ascertainable, its mechanism might be associated with the regulation on related cytokines.
Adolescent ; Adult ; Cytokines ; blood ; Dermatitis, Atopic ; blood ; drug therapy ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Integrative Medicine ; Loratadine ; therapeutic use ; Male ; Young Adult
8.Observation on cardiovascular safety of loratadine in treatment of persistent allergic rhinitis.
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2008;22(23):1076-1078
OBJECTIVE:
To evaluate cardiovascular safety of loratadine, a second generation H1-antagonist, in treatment of patients with allergic rhinitis.
METHOD:
A total of 50 patients with persistent allergic rhinitis were enrolled, of which 19 cases (38.0%) had a history of cardiovascular diseases and/or presented abnormal electrocardiogram (ECG) findings without prolonged QT-interval. For all patents, 10 mg loratadine tablet was oral administrated once-daily for 30 days. ECG examinations were carried out both before and after treatment. Cardiovascular effects of loratadine were determined by the comparison of two ECGs.
RESULT:
All patients had no alterations in sinus rhythm after administration of loratadine for 30 days. There were no significant differences of heart rates, P durations, PR or QRS intervals between the baseline and end-point ECGs (P > 0.05), as well as no significant prolongation of the QT or QTc corrected for heart rate using Bazett' formula (P > 0.05).
CONCLUSION
Cardiovascular safety of loratadine, a second generation H1-antagonist, is confirmed in long-term treatment of persistent allergic rhinitis at a recommended dose.
Administration, Oral
;
Adult
;
Aged
;
Aged, 80 and over
;
Female
;
Heart Rate
;
Histamine H1 Antagonists, Non-Sedating
;
administration & dosage
;
adverse effects
;
therapeutic use
;
Humans
;
Loratadine
;
administration & dosage
;
adverse effects
;
therapeutic use
;
Male
;
Middle Aged
;
Rhinitis, Allergic, Seasonal
;
drug therapy
;
physiopathology
;
Young Adult
9.The effect of desloratadine on quality of life of patients with seasonal allergic rhinitis.
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2008;22(10):439-442
OBJECTIVE:
To assess the effect of desloratadine on quality of life (QOL) in patients with seasonal allergic rhinitis.
METHOD:
A randomized, double-blind, placebo-controlled study was designed on fifty patients with seasonal allergic rhinitis. The patients were randomly divided into three groups: A group: taking desloratadine by mouth and taking spraying of normal sodium; B group: placebo group, taking placebo by mouth and taking spraying of normal sodium; C group: taking desloratadine by mouth and taking spraying of Nasonex. Rhinitis quality of life (RQOL) questionnaire was used to evaluate QOL of patients with seasonal allergic rhinitis. The method of taking tabella was one tablet, one time a day; the method of taking spraying was one spray each nostril, once a day. The investigation lasted for two weeks. The RQOL questionnaire was administered at the start of the treatment and after one and two weeks of treatment by the telephone follow-up investigation.
RESULT:
After 1 and 2 weeks of treatment, symptoms scores were significantly decreased in the A group and C group compared with the placebo group (P < 0.05). After 1 and 2 weeks of treatment by the methods of A and C, the QOL of patients with seasonal allergic rhinitis was significantly improved compared with placebo group (P < 0.05). There was no QOL improvement in the placebo group.
CONCLUSION
Desloratadine could decrease symptom scores and improve QOL in patients with seasonal allergic rhinitis. The RQOL questionnaire could help doctor to effectively evaluate QOL in patients with seasonal allergic rhinitis, because of its integrity and convenience.
Adolescent
;
Adult
;
Double-Blind Method
;
Female
;
Histamine H1 Antagonists, Non-Sedating
;
therapeutic use
;
Humans
;
Loratadine
;
analogs & derivatives
;
therapeutic use
;
Male
;
Middle Aged
;
Quality of Life
;
Rhinitis, Allergic, Seasonal
;
drug therapy
;
Treatment Outcome
;
Young Adult
10.The investigation of efficacy and safety of Aerius to seasonal allergic rhinitis.
Xuejun YOU ; Zheng LIU ; Kai XU ; Qixue GAO ; Yonghua CUI
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2008;22(8):382-384
OBJECTIVE:
To evaluate the efficacy and safety of Aerius to seasonal allergic rhinitis.
METHOD:
Using randomized, controlled method, treatment group 40 cases, oral administration Aerius 5 mg/d for 12 days; control group 35 cases, oral administration Aerius 5 mg/d for 12 days, investigating their efficacy and safety.
RESULT:
The total effective rate of treatment group was 92.50%, while control group was 85.71%, there was significant difference between them (P<0.05). Significant improvements of seasonal allergic rhinitis nasal obstruction were seen in treatment group after using Aerius (P<0.05). The incidence of side effect of treatment group was 2.50%.
CONCLUSION
Aerius is safe and can effectively reduction in nasal and nonnasal symptoms in patients with seasonal allergic rhinitis.
Adolescent
;
Adult
;
Anti-Allergic Agents
;
adverse effects
;
therapeutic use
;
Child
;
Female
;
Histamine H1 Antagonists
;
adverse effects
;
therapeutic use
;
Humans
;
Loratadine
;
adverse effects
;
analogs & derivatives
;
therapeutic use
;
Male
;
Middle Aged
;
Rhinitis, Allergic, Seasonal
;
drug therapy
;
Treatment Outcome
;
Young Adult

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