| [Objective] Allergic rhinitis is one of the most common allergic diseases.Clinical treatment reports show that about 50% of patients with allergic rhinitis have inadequate nasal symptoms control,and more rapid and lasting drug treatment is still needed.Objective to evaluate the efficacy and safety of azetidine hydrochloride(AZE)combined with fluticasone propionate(FP)in the treatment of allergic rhinitis,and to provide evidence-based basis for clinical treatment.[Method] The databases CNKI,CBM,Wanfang Data,Pub Med,Clinical trials,EMBASE were searched by computer.The Chinese databases were limited to "Keywords" and "subject",and the key items were "allergic rhinitis","allergic rhinitis","azelastine hydrochloride","fluticasone propionate",etc;The English database mainly adopts the retrieval method of subject words combined with free words.The subject words in the English database are limited to " azetidine hydrochloride","fluticasone propionate","rhinitis,allergic".After the initial search,the selected included literatures were manually searched to collect data as comprehensively as possible.After the retrieval,the effective data were extracted,and the data were analyzed by revman5.4 software for direct meta-analysis,and then by addis16.8 software for network meta-analysis,to evaluate the effectiveness and safety of different medication regimens.[Results] A total of 1861 articles were retrieved and screened according to the established inclusion and exclusion criteria.Finally,16 clinical randomized controlled trials(8020 patients)were included.(1)Results of effectiveness evaluation:(1)Meta analysis showed that AZE combined with FP was better than AZE alone in relieving nasal symptoms [MD =-1.54,95% CI(-1.93,-1.14),P < 0.00001];AZE combined with FP was better than FP alone in relieving nasal symptoms,and the difference was statistically significant [MD =-1.11,95% CI(-1.77,-0.45),P < 0.001].(2)The results of network meta-analysis showed that: in the order of effectiveness of relieving nasal symptoms in patients with allergic rhinitis from low to high,PLA <AZE < FP < AZE(triple dose of conventional recommended dose)< AZE(double dose of conventional recommended dose)< AZE+FP.(3)Meta analysis showed that: AZE combined with FP was better than AZE alone in relieving ocular symptoms,and the difference was statistically significant [MD =-1.12,95% CI(-1.51,-0.73),P < 0.00001];After treatment with AZE and FP,the ocular symptoms were relieved better than those in FP group alone,and the difference was statistically significant [MD =-1.00,95% CI(-1.20,-0.79),P < 0.00001].(4)The results of network meta-analysis showed that PLA < AZE < FP < AZE(triple dose of conventional recommended dose)< AZE+FP was the most effective way to relieve the ocular symptoms of patients with allergic rhinitis.(5)Meta analysis showed that the quality of life of AZE combined with FP was better than that of AZE alone,and the difference was statistically significant [MD = 0.26,95% CI(0.15,0.37),P < 0.00001];The quality of life of AZE combined with FP was better than that of FP alone,and the difference was statistically significant [MD = 0.63,95% CI(0.52,0.74),P < 0.00001].(6)The results of network meta-analysis showed that: in the order of effectiveness of quality of life in patients with allergic rhinitis from low to high,PLA < AZE double dose of conventional recommended dose)< AZE < AZE(triple dose of conventional recommended dose)<FP<AZE+FP。(2)Results of safety evaluation:(1)Meta analysis showed that there was no significant difference in the incidence of serious adverse events between AZE combined with FP and placebo [RR = 1.70,95%CI(0.23,12.78),P = 0.61].(2)The incidence of general adverse events in the treatment of patients with allergic rhinitis by AZE combined with FP: the general adverse events were screened by the frequency of general adverse events,and a total of 4 general adverse events including taste disorders,nasal bleeding,headache and nasal discomfort were included and analyzed.Meta analysis and reticular meta-analysis showed that there was no significant difference in the incidence of epistaxis,headache and nasal discomfort between AZE combined with FP and placebo.(3)Meta analysis showed that there was a significant difference in the incidence of taste disorders between AZE combined with FP and placebo [RR = 3.96,95% CI(2.02,7.75),P < 0.0001];There was no significant difference in the incidence of taste disorders between AZE group and FP Group [RR = 0.80,95% CI(0.37,1.74),P =0.57];After treatment with AZE and FP,the incidence of taste disorders was higher than that in FP group alone [RR = 9.21,95% CI(3.49,24.27),P < 0.00001].(4)The results of network meta-analysis showed that: in the treatment of patients with allergic rhinitis,the incidence of taste disorders ranked from low to high as PLA < FP< AZE(three times of the conventional recommended dose)< AZE(two times of the conventional recommended dose)< AZE+FP < AZE.[Conclusion] In this study,the efficacy of AZE combined with FP in the treatment of allergic rhinitis was analyzed,including nasal symptoms,eye symptoms and quality of life.The results showed that AZE combined with FP in the treatment of allergic rhinitis in nasal symptoms,eye symptoms and quality of life were better than AZE alone or FP alone.In the safety analysis of AZE combined with allergic rhinitis: the analysis results of serious adverse events showed that there was no significant difference in the incidence of serious adverse events between AZE combined with FP and placebo;The analysis of general adverse events showed that the incidence of taste disorders of AZE combined with FP was significantly higher than that of placebo and FP alone,while there was no significant difference between AZE combined with FP and placebo in the comparison of nasal bleeding,headache and nasal discomfort.Large sample and high quality randomized controlled trials are needed for supplementary verification conclusion. |
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