| BackgroundChronic spontaneous urticaria(CSU)is a long-term recurrent skin allergic disease without definite cause,which is characterized by wheal and pruritus.CSU affects approximately 1%of the global population.Nearly half of CSU do not respond to standard doses of antihistamines,require higher doses or a combination of two antihistamines or combined with other types of drugs,and even some patients require expensive biologics for symptom control.Rupatadine is a novel second-generation H1-antihistamine and has dual antihistamine and platelet-activating factor(PAF)-antagonist properties,which has been used to treat allergic rhinitis and urticaria around the world.ObjectiveThe purpose of this paper is to evaluate the efficacy and safety of Rupatadine in the treatment of Chronic spontaneous urticaria by Meta-analysis and systematic review.MethodsChinese databases(China National Knowledge Infrastructure(CNKI),Wanfang,China Biomedical Literature Database(CBM),VIP),foreign databases(Web of Science,MEDLINE,EMBASE,Pub Med,Cochrane Library),and other channels were searched by the computer until April 2020.According to the inclusion criteria and exclusion criteria,the final included literature were determined and the data were extracted.The quality of the included studies was evaluated using the bias risk assessment tool in the Cochrane Handbook.Review Manager(version 5.4)was used for data analysis,the odds ratio(OR)was used as the effect measure for dichotomous variable data,while the standardized mean difference(SMD)was used for continuous variable data,and the I~2test and Q statistic test were used to assess heterogeneity.ResultsA total of 19 literature,11 published in Chinese and 8 published in English,were included in this review.The studies included were randomized controlled trials,there were 4 multicenter studies,and the rest were single centers.A total of 2231 subjects were included from multiple countries including Asian,European and African.The subjects consisted of children(2-11 years old),adolescents(12-17 years old),and adults(18-70 years old)with different disease courses.2 studies reported two doses(10 mg/20 mg),1 was an oral solution and dose according to body weight,and the rest were single doses(10 mg).Analysis of the efficacy of Rupatadine in the treatment of CSU showed that the Rupatadine was significantly better than other antihistamines in terms of cure rates(OR:1.88;95%CI:1.44 to 2.54;P=<0.00001);the rate of the invalid was significantly lower in the Rupatadine group than other antihistamines(OR:0.55;95%CI:0.36 to 0.84;P=0.006);the total effective rate of Rupatadine was higher than that of Loratadine(OR:1.77;95%CI:1.05 to 2.98;P=0.003),the recurrence rate was lower than that of Loratadine(OR:0.21;95%CI:0.07 to 0.67;P=0.008).The improvement of pruritus score in Rupatadine group was superior compared with placebo and Cetirizine(SMD:0.45;95%CI:0.27 to 0.63;P<0.00001).In terms of adverse drug reactions,the Rupatadine group was safer than other antihistamines(OR:0.66;95%CI;0.49 to 0.90;P=0.008),and it is lower than Loratadine(OR:0.48;95%CI;0.27 to 0.85;P=0.01),Desloratadine(OR:0.45;95%CI:0.20 to 0.98;P=0.05)and Cetirizine(OR:0.44;95%CI:0.20to 0.98;P=0.04).The incidence rates of 10mg and 20mg dose groups were almost the same(OR:0.90;95%CI:0.51 to 1.62;P=0.73).The most common adverse drug reactions were drowsiness,fatigue,and headache,and no serious adverse reactions were observed.ConclusionOur results show that Rupatadine can relieve wheal,pruritus symptoms and improve quality of life in patients with chronic spontaneous urticaria.From the total effective rate,Rupatadine is better than Loratadine and the recurrence rate is low.In terms of safety,the incidence of adverse drug reactions in the Rupatadine was lower than that in Loratadine,Cetirizine,Desloratadine and Mizolastine;similar to that in Levocetirizine,but higher than that in Olotadine and the difference was not statistically significant.The incidence of adverse reactions was similar between 10mg and 20mg;The most common adverse reactions were drowsiness,fatigue and headache.No serious adverse reactions were observed.More rigorous and high-quality clinical trials are needed to strengthen this evidence in the future. |
