ABSTRACT
OBJECTIVE： To systematically evaluate clinical efficacy and safety of Biyuan tongqiao granules combined with Triamcinolone acetonide nasal spray in the treatment of chronic rhinosinusitis， and to provide evidence-based reference for clinical treatment. METHODS： Retrieved from Embase， PubMed， the Cochrane library， CNKI， CBM， VIP and Wanfang database， RCTs about Biyuan tongqiao granules combined with Triamcinolone acetonide nasal spray （trial group） versus Triamcinolone acetonide nasal spray （control group） in the treatment of chronic rhinosinusitis were collected during database establishment to Dec. 8th， 2018. After data extraction and quality evaluation with Cochrane bias risk evaluation tool 5.1.0， Meta-analysis was performed for total response rate， nasal mucociliary transmission rate （MTR）， the levels of IL-5 and IL-8 in nasal secretion， SNOT-20 score， VAS score， Lund-Mackey nasal sinus CT score， the incidence of ADR （nausea， rash） by using Rev Man 5.3 software. TSA 0.9 software was used for trial sequential analysis（TSA）. RESULTS： A total of 9 RCTs were included， involving 998 patients. Results of Meta-analysis showed that total clinical response rate [RR＝1.20，95％CI（1.14，1.26），P＜0.001] of trial group was significantly higher than that of control group； MTR [MD＝－231.74，95％CI（－291.89，－171.58），P＜0.001]， IL-5 [MD＝－0.86，95％CI（－1.37， －0.35），P＜0.001] and IL-8 [MD＝－0.50，95％CI（－0.76， －0.25），P＜0.001] levels of trial group were significantly lower than those of control group. SNOT-20 score， VAS score and Lund-Mackey nasal sinus CT score of trial group were all lower than those of control group， with statistical significance （P＜0.001）. There was no statistical significance in the incidence of nausea [RR＝0.57，95％CI（0.17，1.92），P＝0.37] or rash [RR＝2.25，95％CI（0.70，7.20），P＝0.17] between 2 groups. TSA analysis showed that the evidence for therapeutic efficacy of Biyuan tongqiao granules combined with Triamcinolone acetonide nasal spray in the treatment of chronic rhinosinusitis was reliable. CONCLUSIONS： Biyuan tongqiao granules combined with Triamcinolone acetonide nasal spray is better than Triamcinolone acetonide nasal spray alone in improving total response rate of Biyuan tongqiao granules combined with Triamcinolone acetonide nasal spray in the treatment of chronic rhinosinusitis， reducing MTR， the levels of IL-5 and IL-8， and improving SNOT-20 score， VAS score and Lund-Mackey nasal sinus CT score， without increasing the incidence of nausea， rash.