ABSTRACT
This study aims to evaluate the effectiveness and economic efficiency of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in the treatment of chronic rhinosinusitis(CRS). The randomized controlled trial(RCT) of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in the treatment of CRS was searched against EMbase, PubMed, Cochrane Library, CNKI, VIP, SinoMed, and Wanfang. The efficacy, nasal mucociliary transport time, and safety of the therapy above in the treatment of CRS were analyzed with single-group rate and Meta-analysis, and the economy and sensitivity were evaluated from the perspective of payer. A total of 9 RCTs were included, including 1 145 patients. Meta-analysis showed that compared with Triamcinolone Acetonide Nasal Spray alone, Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in the treatment of CRS patients increased the effective rate(RR=1.17, 95%CI[1.11, 1.24], P<0.000 01) and shortened the nasal mucociliary transport time(MD=-3.32, 95%CI[-5.86,-0.78], P=0.01), there was no significant difference in the incidence of adverse reactions between the two groups. The incremental cost-effectiveness analysis showed that the treatment costs of the control group and the observation group were 44.15 yuan and 1 044.96 yuan, respectively. In the Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray treatment group, 75.48 yuan was spent to improve the effective rate of CRS by 1%. The one-way sensitivity analysis indicated the days of treatment, the RR of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray, the price of unit preparation of Biyuan Tongqiao Granules, and the effective rate of Triamcinolone Acetonide Nasal Spray alone had great influence on the incremental cost-effectiveness ratio. In conclusion, Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray improves the therapeutic effect on CRS. The probabilistic sensitivity analysis showed that when the willingness to pay was greater than 7 920 yuan(less than 0.1 of GDP per capita 8 098 yuan), the combined therapy was economically superior to the control. Due to the limited number of articles published, it is necessary to carry out a real-world clinical trial of Biyuan Tongqiao Gra-nules and Triamcinolone Acetonide Nasal Spray in the treatment of CRS, so as to compare the cost-effectiveness of Biyuan Tongqiao Granules and Triamcinolone Acetonide Nasal Spray.
Subject(s)
Humans , Triamcinolone Acetonide/adverse effects , Nasal Sprays , Cost-Effectiveness Analysis , Sinusitis/drug therapy , Chronic DiseaseABSTRACT
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.