布地奈德福莫特罗粉吸入剂治疗哮喘的疗效评价

目的观察布地奈德福莫特罗粉吸入剂(信必可)治疗哮喘的疗效。方法选择哮喘患者40例随机分为观察组20例及对照组20例。观察组在常规吸入布地奈德气雾剂20μg/次,2次/d的基础上,加用福莫特罗,80~160μg/d(12岁以上),分2次口服,每日2次,连续应用3个月。对照组除不用福莫特罗治疗外,其余治疗均与观察组相同。观察两组临床疗效。结果观察组总有效19例,总有效率95%;对照组总有效15例,总有效率75%,两组疗效比较有显著性差异(P<0.05)。结论吸入信必可治疗哮喘疗效更佳。     

布地奈德福莫特罗粉吸入剂治疗儿童哮喘疗效观察

目的探讨吸入布地奈德福莫特罗粉吸入剂（信必可都保）治疗儿童哮喘的疗效及不良反应。方法子26例6—14岁确诊为儿童哮喘患儿吸入信必可都保（80／4．5μg／吸）1吸，2～3次／d，连续应用3个月，分别于治疗后第1、4、8及12周，观察其日、夜间哮喘症状评分、咳嗽评分、最大呼气峰流速值（PEF）、吸入β2受体激动剂喷数及无症状天数。结果经吸入信必可都保治疗后12周，患儿日、夜间哮喘症状评分、咳嗽评分显著减少（P〈0．01）；PEF增加35．5％；应用β2激动剂的喷数均显著减少（P〈0．01），无症状天数显著增加（P〈0．01），且未见明显不良反应。结论信必可都保能够控制绝大多数儿童哮喘患儿的症状，改善其肺功能，具有良好的依从性和安全性。     

布地奈德混悬液雾化治疗与布地奈德福莫特罗粉吸入剂吸入治疗对中重度支气管哮喘患者的疗效比较

目的 比较布地奈德混悬液雾化治疗与布地奈德福莫特罗粉吸入剂吸入治疗对中重度支气管哮喘患者的临床疗效.方法 按照随机数字表法将中山市人民医院2019年1月至2019年12月收治的78例中、重度支气管哮喘患者分为观察组与对照组,每组39例.观察组采用布地奈德福莫特罗粉吸入剂吸入治疗,对照组采用布地奈德混悬液雾化治疗,评价治...     

布地奈德福莫特罗粉吸入剂治疗儿童中重度持续性哮喘疗效观察

支气管哮喘是以气道慢性变态反应性炎症和气道高反应性为特征的慢性呼吸道疾病.全球哮喘防治会议(GINA)和中国哮喘防治指南推荐对中重度持续性哮喘联合吸入糖皮质激素(ICS)和长效β2受体激动剂(LABA).布地奈德福莫特罗粉吸入剂是新型ICS和LABA的复方制剂,它针对哮喘的发病机制具有抗炎和解痉的双重功效,能快速有效缓解哮喘症状.     

吸入布地奈德福莫特罗治疗支气管哮喘临床效果和依从性、安全性分析

目的探讨吸入布地奈德福莫特罗治疗支气管哮喘的临床效果和依从性、安全性。方法选取支气管哮喘84例作为研究对象,根据治疗方法不同将其分为观察组(44例)和对照组(40例)两组。观察组在对症治疗基础上予以布地奈德福莫特罗复方干粉剂吸入治疗,对照组在对症治疗基础上予以丙酸倍氯米松气雾剂吸入治疗。观察比较两组治疗前后肺功能指标[第1秒用力呼气量(FEV_1)、FEV_1占预计值百分数(FEV_1/FVC)、晨间测定最大呼气峰值流速(PEFam)及晚间测定最大呼气峰值流速(PEFpm)]情况,治疗前后临床症状和自我评价评分,治疗后临床效果,治疗依从性,以及治疗过程中不良反应发生情况。结果治疗前,两组各肺功能指标和临床症状、自我评价评分比较差异均无统计学意义(P0.05)。治疗后,两组各肺功能指标均较治疗前明显升高,临床症状和自我评价评分均较治疗前降低,差异有统计学意义(P0.05)。治疗后,观察组各肺功能指标均高于对照组,临床症状评分低于对照组,差异有统计学意义(P0.05)。治疗后,观察组总有效率93.18%显著高于对照组总有效率75.00%,差异有统计学意义(P0.05)。观察组治疗依从率为93.18%较对照组治疗依从率95.00%稍低,但两组比较差异无统计学意义(P0.05)。治疗过程中,观察组总不良反应发生率11.36%,对照组总不良反应发生率10.00%,两组比较差异无统计学意义(P0.05)。结论布地奈德福莫特罗复方干粉剂吸入治疗支气管哮喘,有利于改善患者肺功能及临床症状,且具有较好的治疗依从性和安全性。     

布地奈德福莫特罗粉吸入剂治疗支气管哮喘的疗效观察

目的探讨布地奈德福莫特罗粉吸入剂治疗支气管哮喘的效果及对肺功能和生活质量的影响。方法选取收治的支气管哮喘患者68例作为研究对象,按照随机数字表法分为对照组和试验组各34例。对照组给予常规治疗,试验组在常规治疗基础上给予布地奈德福莫特罗粉吸入剂治疗,连续治疗3个月,比较两组临床疗效、肺功能、生活质量及不良反应发生率。结果试验组临床疗效优于对照组(P0.05);治疗前两组肺功能无明显差异(P0.05);治疗3个月后,两组肺功能指标均增高(P0.05),且试验组增高程度高于对照组(P0.05);试验组生活质量高于对照组(P0.05);两组不良反应发生率无明显差异(P0.05)。结论布地奈德福莫特罗粉吸入剂治疗支气管哮喘疗效明显,可有效改善肺功能,提高患者生活质量且安全性高。     

孟鲁司特钠联合布地奈德福莫特罗治疗成人的哮喘疗效观察

目的探究孟鲁司特钠联合布地奈德福莫特罗治疗成人哮喘的疗效。方法将2017年6月～2018年6月我院治疗的48例成年哮喘病患者作为研究对象,按随机对照表法分为试验组和对照组各24例。对照组采用布地奈德福莫特罗粉吸入剂进行治疗,试验组在对照组治疗的基础上加入孟鲁斯特纳片进行治疗,两组的治疗时间均为2个月。观察两组患者治疗效果及治疗期间不良反应发生情况,记录其治疗前及治疗2个月后肺功能[一秒用力呼气容积(FEV1)、FEV1/用力肺活量(FVC)、最大呼气流量(PEF)]水平的变化、哮喘症状严重程度[哮喘控制测试表(ACT)]评估情况。结果患者治疗2个月后,试验组87.50%的总有效率高于对照组的62.50%(P0.05)。两组患者在治疗期间不良反应发生情况差异无统计学意义(P0.05)。治疗2个月后,两组ACT评分、FVV1、FEV1/FVC和PEF水平比起治疗前有明显升高,且试验组高于对照组,差异有统计学意义(P均0.05)。结论孟鲁司特钠联合布地奈德福莫特罗治疗成人的哮喘可有效减轻患者症状,具有较好的治疗效果。     

布地奈德福莫特罗粉吸入联合孟鲁司特钠治疗支气管哮喘急性发作的效果及对免疫功能的影响

目的 探讨布地奈德福莫特罗粉吸入联合孟鲁司特钠治疗支气管哮喘急性发作的效果及对免疫功能的影响。方法 选取2020年1月至2023年1月收治的80例支气管哮喘急性发作患者为研究对象,随机将其分为对照组(布地奈德福莫特罗粉吸入治疗)和观察组(布地奈德福莫特罗粉吸入联合孟鲁司特钠治疗),各40例。比较两组的治疗效果。结果 观察组的治疗总有效率高于对照组(P<0.05)。治疗后,观察组的第1秒用力呼气容积(FEV₁)、呼气峰值流速(PEF)、第1秒用力呼气容积占用力肺活量的百分比(FEV₁/FVC)均高于对照组(P<0.05)。治疗后,观察组的调节性T细胞(Treg)高于对照组,辅助性T细胞17(Th17)、Th17/Treg低于对照组(P<0.05)。治疗后,观察组的嗜酸性粒细胞趋化因子-2(eotaxin-2)、白细胞介素-33(IL-33)水平低于对照组(P<0.05)。结论 布地奈德福莫特罗粉吸入联合孟鲁司特钠可提高支气管哮喘急性发作患者的治疗效果,促进肺功能及免疫功能改善,也能下调eotaxin-2、IL-33表达。     

Extrafine beclomethasone dipropionate breath-actuated inhaler (400 micrograms/day) versus budesonide dry powder inhaler (800 micrograms/day) in asthma

Hydrofluoroalkane-134a beclomethasone dipropionate extrafine aerosol breath-actuated inhaler (Qvar Autohaler; BDP-AH) provides an alternative to chlorofluorocarbon metered dose inhalers or dry powder inhalers (DPIs). The aim of this six-week, open-label study was to determine whether BDP-AH demonstrates equivalent asthma control to twice the dose of budesonide (BUD)-DPI (Pulmicort Turbuhaler). Adults with symptomatic asthma inadequately controlled on BUD-DPI 400 micrograms/day and beta-agonist were enrolled. Patients (n = 193) were randomised to receive 400 micrograms/day BDP-AH (n = 98) (two puffs of 100 micrograms/actuation inhaler twice daily) or 800 micrograms/day BUD-DPI (n = 95) (two puffs of 200 micrograms/actuation inhaler twice daily). Both groups showed a statistically significant change from baseline in morning (a.m.) peak expiratory flow (PEF) at weeks 5-6 (p < 0.01), indicating study treatment improved a.m. PEF over prestudy 400 micrograms/day BUD. Changes from baseline in a.m. PEF at weeks 5-6 were 15.9 l/min for BDP-AH and 14.2 l/min for BUD-DPI; the groups were statistically equivalent (90% CI -7.02-10.44; p < -0.001 [equivalence = within +/- 25 l/min]). Other efficacy assessments (evening PEF, FEV1, asthma symptoms, beta-agonist use) confirmed the treatments were clinically equivalent. Thirty-nine (40%) patients on BDP-AH and 35 (37%) on BUD-DPI experienced at least one adverse event (p = 0.767). Four (4%) patients on BDP-AH and 3 (3%) on BUD-DPI reported increased asthma symptoms. BDP-AH at half the daily dose provided equivalent asthma control to BUD-DPI; both treatments were well tolerated.     

Therapeutic comparison of a new budesonide/formoterol pMDI with budesonide pMDI and budesonide/formoterol DPI in asthma

BACKGROUND: Budesonide/formoterol is an effective treatment for both asthma and chronic obstructive pulmonary disease. This study compared the efficacy and safety of a novel hydrofluoroalkane (HFA) pressurised metered-dose inhaler (pMDI) formulation of budesonide/formoterol with that of budesonide pMDI and budesonide/formoterol dry-powder inhaler (DPI; Turbuhaler). METHODS: This was a 12-week, multinational, randomised, double-blind, double-dummy study involving patients aged > or = 12 years with asthma. All patients had a forced expiratory volume in 1 s of 50-90% predicted normal and were inadequately controlled on inhaled corticosteroids (500-1600 microg/day) alone. Following a 2-week run-in, during which they received their usual medication, patients were randomised (two inhalations twice daily) to budesonide pMDI 200 microg, budesonide/formoterol DPI 160/4.5 microg or budesonide/formoterol pMDI 160/4.5 microg. The primary efficacy end-point was change from baseline in morning peak expiratory flow (PEF). RESULTS: In total, 680 patients were randomised, of whom 668 were included in the primary analysis. Therapeutically equivalent increases in morning PEF were observed with budesonide/formoterol pMDI (29.3 l/min) and budesonide/formoterol DPI (32.0 l/min) (95% confidence interval: -10.4 to 4.9; p = 0.48). The increase in morning PEF with budesonide/formoterol pMDI was significantly higher than with budesonide pMDI (+28.7 l/min; p < 0.001). Similar improvements with budesonide/formoterol pMDI vs. budesonide pMDI were seen for all secondary efficacy end-points. Both combination treatments were similarly well tolerated. CONCLUSIONS: Budesonide/formoterol, administered via the HFA pMDI or DPI, is an effective and well-tolerated treatment for adult and adolescent patients with asthma, with both devices being therapeutically equivalent.     

Combined budesonide/formoterol turbuhaler treatment of asthma

OBJECTIVE: To provide product information; review and analyze the clinical literature studying combination therapy, budesonide, and formoterol in asthmatics; and to define the role for this therapy in asthma treatment. DATA SOURCES: A MEDLINE search (1990-September 2001) was conducted to identify the primary literature. Bibliographies were reviewed for further relevant citations. STUDY SELECTION/DATA EXTRACTION: All randomized, blinded, controlled studies at least 3 months in duration exploring the efficacy of the combination of budesonide and formoterol (in 1 or separate formulations) compared with other treatments were selected to be included in the review of clinical studies. DATA SYNTHESIS: The combination of budesonide and formoterol was more effective than increasing the dose of budesonide in patients with moderate or severe persistent asthma and in patients with mild asthma not previously controlled with inhaled corticosteroids. Milder corticosteroid-na?ve asthmatics did not derive benefit compared with inhaled corticosteroids alone. CONCLUSIONS: Combination therapy in 1 device is a preferred treatment option in patients with moderate to severe persistent asthma and in those with milder asthma not controlled with inhaled corticosteroids. Advantages of this product include rapid onset of action, long duration of action, and a wide dosing range to assist with titration. Further research is required to evaluate this therapy in asthmatic children <5 years old and in patients with oral corticosteroid-dependent asthma. Investigations into the effect of this combination product on other disease outcomes, such as quality of life and productivity, will further define the role for this drug therapy.     

Asthma and COPD: differences and similarities. With special reference to the usefulness of budesonide/formoterol in a single inhaler (Symbicort) in both diseases

Asthma and chronic obstructive pulmonary disease (COPD) both have a high prevalence worldwide and yet each condition remains underdiagnosed. Despite a number of common features, these inflammatory respiratory syndromes have distinct clinical outcomes. COPD represents a greater economic burden than asthma because it has a less favourable prognosis and is associated with greater morbidity and mortality. Therefore, it is important to distinguish between these two diseases at an early stage, so that appropriate therapy can be prescribed to prevent deterioration. However, effective treatments that may be used in both conditions can minimise the effects of misdiagnosis and maximise the impact of treatment without the associated complexity when both conditions occur together. The current review summarises the differences and similarities of asthma and COPD, in terms of risk factors, pathophysiology, symptoms and diagnosis, to provide greater understanding of the role of budesonide/formoterol in a single inhaler in both diseases.     

支气管哮喘患者吸入糖皮质激素治疗依从性的研究

目的 调查门诊成人支气管哮喘患者吸入糖皮质激素治疗的依从状况,并探讨其影响因素.方法 采用便利抽样方法,选取北京市某三级甲等医院呼吸科门诊就诊的167例成人哮喘患者.用一般资料调查表、哮喘用药依从性量表和哮喘知识问卷分别测评患者的一般资料、吸入糖皮质激素治疗的依从性和哮喘知识水平;让患者采用吸入装置模型演示糖皮质激素的吸入方法,依据吸入技术的6个步骤判断患者的吸入方法是否正确.采用二元logistic回归对吸入糖皮质激素治疗依从性的影响因素进行统计分析.结果 哮喘患者吸入糖皮质激素治疗依从性好的比例为37.7％.logistic回归结果显示,疾病严重程度[OR =0.61,95％CI(0.44,0.86),P=0.01]、哮喘知识[OR=1.12,95％CI(1.01,1.25),P=0.03]及吸入技术[OR=2.94,95％CI(1.36,6.36),P＜0.01]对哮喘患者吸入糖皮质激素治疗依从性的影响有显著性差异.结论 门诊成人哮喘患者吸入糖皮质激素治疗的依从性不佳.疾病严重程度、哮喘知识及吸入技术影响患者吸入糖皮质激素治疗的依从性.     

A comparison of budesonide/formoterol maintenance and reliever therapy vs. conventional best practice in asthma management

Objective: To study the effectiveness and safety of budesonide/formoterol (Symbicort^®) Maintenance And Reliever Therapy (Symbicort SMART^®, AstraZeneca, Södertalje, Sweden), a simplified management approach with one inhaler compared with conventional best practice (CBP) with multiple inhalers in patients with persistent asthma. Design: Open‐label randomised controlled parallel group trial, 6‐month treatment. Participants: A total of 908 patients ≥ 12 years of age, with persistent asthma receiving treatment with inhaled corticosteroids (ICS), either alone or in conjunction with long‐acting β₂‐agonist. Main outcome measures: Time to first severe asthma exacerbation and number of severe asthma exacerbations. Results: No difference between groups was seen in time to first severe exacerbation (p = 0.75). Exacerbation rates were low in both groups. A total of 12 patients in the Symbicort SMART^® group experienced a total of 14 severe asthma exacerbations, and 19 patients in the CBP group experienced a total of 25 severe asthma exacerbations (annual rate 0.07 vs. 0.13 p = 0.09). The mean daily dose of ICS expressed in BDP equivalent was significantly lower in the Symbicort SMART^® group (including as‐needed use) vs. in the CBP group (749 μg vs. 1059 μg; p < 0.0001). Mean scores in Asthma Control Questionnaire, 5 question version improved significantly in the SMART group compared with the CBP group (p = 0.0026). Symbicort SMART and CBP were equally well tolerated. The mean drug cost/patient/month was significantly lower for the patients in the Symbicort SMART group compared with patients receiving CBP (51.3 € vs. 66.5 €; p < 0.0001). Conclusions: In Belgian patients, a simplified regimen using budesonide/formoterol maintenance and reliever therapy was at least as effective at improving clinical control compared with CBP with a significantly lower ICS dose and significantly lower drug costs.     

Twelve-week, randomized, placebo-controlled, multicenter study of the efficacy and tolerability of budesonide and formoterol in one metered-dose inhaler compared with budesonide alone and formoterol alone in adolescents and adults with asthma

BACKGROUND: The addition of the long-acting beta(2)-adrenergic agonist formoterol to low- to moderate-dose budesonide has shown clinical efficacy in patients with persistent asthma. Combination therapy with budesonide/formoterol in 1 pressurized metered-dose inhaler (pMDI) has been found to have greater efficacy than its monocomponents in patients with moderate to severe persistent asthma, but it has not been assessed in patients with mild to moderate persistent asthma. OBJECTIVE: The aim of this study was to compare the efficacy and tolerability of budesonide and formoterol delivered via 1 pMDI (budesonide/formoterol pMDI), budesonide pMDI, formoterol dry powder inhaler (DPI), and placebo. METHODS: This 12-week, multicenter, double-blind, randomized, placebo-controlled, double-dummy study was conducted at 56 centers across the United States. Patients aged > or =12 years with mild to moderate persistent asthma treated with inhaled corticosteroids (ICSs) for > or =4 weeks before screening and who had a forced expiratory volume in 1 second (FEV(1)) of > or =60% to < or =90% of predicted normal at screening were eligible. After 2 weeks (current asthma therapy discontinued), patients received twice-daily budesonide/formoterol pMDI 80/4.5 microg x 2 inhalations (160/9 microg), budesonide pMDI 80 microg x 2 inhalations (160 microg), formoterol DPI 4.5 microg x 2 inhalations (9 microg), or placebo. The coprimary efficacy variables were changes from baseline in morning predose FEV(1) and 12-hour mean FEV(1) (from serial spirometry) after administration of the morning dose of study medication. Tolerability was assessed based on adverse events (AEs); routine laboratory assessments; electrocardiography; 24-hour Holter monitor assessments; and physical examinations, including vital signs (eg, systolic and diastolic blood pressure and heart rate). AEs were recorded manually by the patient in paper notebooks and reviewed at each clinic visit by the investigator and during a final follow-up phone call. RESULTS: A total of 480 patients were randomized (299 females, 181 males; mean age, 36 years; mean FEV(1), 2.4 L; budesonide/formoterol pMDI, 123 patients; budesonide pMDI, 121; formoterol DPI, 114; placebo, 122). At end of treatment, the mean increases from baseline in predose FEV(1) were greater with budesonide/formoterol pMDI versus budesonide pMDI, formoterol DPI, and placebo (0.37 vs 0.23, 0.17, and 0.03 L, respectively; all, P<0.005). 0.005). After administration of the first dose and at weeks 2 and 12, mean increases in 12-hour mean FEV(1) were significantly greater with budesonide/formoterol pMDI (0.41, 0.47, and 0.50 L, respectively) versus budesonide pMDI (0.17, 0.30, and 0.32 L) and placebo (0.15, 0.12, and 0.12 L) (all, P < 0.001). Fewer patients receiving budesonide/formoterol pMDI met criteria for (18.7%; P < 0.001) or withdrew because of (7.3%; P < or = 0.010) worsening asthma versus formoterol DPI (42.1% and 18.4%, respectively) and placebo (56.6% and 32.8%); results were similar between budesonide pMDI (21.5% and 6.6%, respectively) and budesonide/formoterol pMDI. Three patients experienced serious AEs; none was considered related to study medication. The proportions of withdrawals due to worsening asthma were not significantly different between the budesonide/formoterol pMDI and budesonide pMDI groups. CONCLUSIONS: In this population of adults and adolescents with mild to moderate persistent asthma previously treated with ICSs, twice-daily budesonide/formoterol pMDI was associated with significantly increased pulmonary function versus its monocomponents. All study drugs were generally well tolerated.     

An economic assessment of inhaled formoterol dry powder versus ipratropium bromide pressurized metered dose inhaler in the treatment of chronic obstructive pulmonary disease

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is debilitating and costly to manage. A recent clinical trial concluded that formoterol, a long-acting beta(2)-adrenoceptor agonist, was more clinically effective than inpratropium bromide in the management of COPD. OBJECTIVE: The aim of this study was to perform an economic assessment of the management of COPD with formeterol versus ipratropium bromide. METHODS: Assessment were based on the results of a previously published 12-week, multicenter, double-masked, randomized, parallel-group, placebo-controlled clinical trial comparing inhaled formoterol dry powder 12 and 24 microg BID with ipratropium bromide 40 microg QID pressurized metered dose inhaler and with placebo in 780 COPD patients. Treatment costs for study drugs and rescue medications were estimated from resource utilization and average wholesale prices. Costs were assessed with respect to forced expiratory lung volume in 1 second (FEV(1)) and patient-reported quality of life (QOL) as assessed via the St. George's Respiratory Questionnaire. Cost-effectiveness ratios were calculated for each treatment arm and incremental cost-effectiveness ratios (ICERs) were calculated for each treatment relative to the next best alternative. Economic efficiency frontiers were identified. Sensitivity analysis was conducted. RESULTS: Cost analysis with respect to FEV(1) revealed an economic efficiency frontier formed by placebo, ipratropium bromide 40 microg, and formoterol 12 microg at their respective FEV(1) levels, with cost-effectiveness ratios of $30.18, $53.50, and $142.04, respectively, per FEV(1). The ICER for ipratropium over placebo was $273.03; for formoterol 12 microg over ipratropium, $1611.32. Cost analysis with respect to QOL showed an economic efficiency frontier formed by placebo and formoterol 12 microg at their respective QOL outcomes, with cost-effectiveness ratios of $25.96 and $32.56, respectively, per QOL score change. The cost-effectiveness ratio for ipratropium was $69.40,which was not on the QOL economic efficiency frontier. The ICER for formoterol 12 microg over placebo was $34.51 per QOL score point. CONCLUSIONS: Formoterol 12 microg provided greater QOL outcome than ipratropium bromide at an additional cost of $554.28 per year. Further research would be necessary to assess whether the differences in outcomes, particularly QOL, observed in the short term with formoterol would lead to favorable long-term health and economic outcomes.     

布地奈德福莫特罗粉吸入剂联合脾氨肽治疗支气管哮喘急性发作的效果研究

目的 观察布地奈德福莫特罗粉吸入剂联合脾氨肽治疗支气管哮喘急性发作的效果.方法 将98例支气管哮喘急性发作患者随机分为对照组和研究组,每组49例.对照组给予布地奈德福莫特罗治疗,研究组给予布地奈德福莫特罗联合脾氨肽治疗.比较2组症状改善情况、肺功能指标[第1秒用力呼气量(FEV1)、第1秒用力呼气量与肺活量的比值(FEV1/FVC)、晨间测定最大呼气峰值流速(PEFam)、晚间测定最大呼气峰值流速(PEFpm)]、辅助性T细胞1/辅助性T细胞2(Th1/Th2)漂移状况及微小RNA-146a(miR-146a)表达水平.结果 研究组憋喘、咳嗽、哮鸣音、湿啰音症状改善时间均短于对照组,差异有统计学意义(P＜0.05).治疗后,2组FEV1、FEV1/FVC、PEFam、PEFpm均高于治疗前,且研究组FEV1、FEV1/FVC、PEFam、PEFpm均高于对照组,差异有统计学意义(P＜0.05).治疗后,2组白细胞介素-2(IL-2)、γ-干扰素(IFN-γ)、Th1、Th1/Th2均高于治疗前,白细胞介素-5(IL-5)、白细胞介素-13(IL-13)、Th2均低于治疗前,且研究组IL-2、IFN-γ、Th1、Th1/Th2均高于对照组,IL-5、IL-13、Th2均低于对照组,差异有统计学意义(P＜0.05).治疗后,2组miR-146a表达水平均低于治疗前,且研究组miR-146a表达水平低于对照组,差异有统计学意义(P＜0.05).结论 布地奈德福莫特罗联合脾氨肽治疗支气管哮喘急性发作效果显著,能加快症状缓解,改善肺功能,其机制可能与逆转Th1/Th2漂移方向、下调miR-146a表达水平有关.     

An economic evaluation of budesonide/formoterol for maintenance and reliever treatment in asthma in general practice

Introduction

In budesonide/formoterol (Symbicort® Turbuhaler®, AstraZeneca, Lund, Sweden) maintenance and reliever therapy (SMART), patients with asthma take a daily maintenance dose of budesonide/formoterol, with the option of taking additional doses for symptom relief instead of a short-acting β₂-agonist (SABA). This study assesses the cost-effectiveness of SMART compared with usual care in patients with mild-to-moderate persistent asthma treated by general practitioners in the Netherlands from a societal perspective.

Methods

The study was linked to a randomized, active-controlled, open-label, multicenter, 12-month clinical trial, with a prospective collection of resource use. One hundred and two patients ≥18 years with mild-to-moderate persistent asthma and daily inhaled corticosteroids (ICS) prior to the trial were included. SMART was given as two inhalations of budesonide/formoterol (100/6 μg) once daily, plus additional doses as needed. The control group was treated according to guidelines, which prescribe medium daily doses of ICS plus an SABA if needed. A long-acting β₂-agonist (LABA) is added if necessary. Effectiveness was measured as the proportion of asthma-control days, Asthma Control Questionnaire (ACQ) scores, the net proportion of patients with relevant ACQ improvement, and the proportion of well-controlled patients. Costs included asthma medication, physician contacts, and absence from work.

Results

Mean total costs for SMART were €134.81 lower (95% CI: ?€439.48; €44.85). Production losses were €94.10 (95% CI: ?€300.60; €0.29) lower for SMART (€10.77 vs. €104.87). No significant differences in health outcomes were seen, with 3.81 fewer asthma-control days per patient-year for SMART (95% CI: ?36.8; 30.8), a 0.049 better ACQ score (95% CI: ?0.21; 0.29), a 5.8% larger net proportion of improved patients (95% CI: t15.6%; 27.3%), and a 2.1% (95% CI: ?25.5; 20.8%) smaller increase in the proportion of well-controlled patients.

Conclusions

Treating primary care patients with mild-to-moderate persistent asthma with SMART instead of ICS plus bronchodilators does not affect health outcomes and does not increase costs; therefore, is likely to be an alternative for guideline-directed treatment, from a health and economic perspective.