| ObjectivesTo compare the effects of budesonide/formoterol and budesonide alone on the treatment of mild-to-moderate persistant asthma and the safety .To evaluate the cost-effectiveness analysis of budesonide/formoterol and budesonide in asthma treatment.Methods60 mild-to-moderate persistant asthma to outpatients, aged 18 to 65, in accordance with the guidelines of prevention and cure of asthma, Chinese Medical Association respiratory branch, 2005, were included in the study in Changzheng Hospital from December, 2005 to December, 2006. It was a randomized, open-minded, parallel-group study carried 12 weeks. According with the inclusions, the patients were randomized into 12 weeks of twice-daily inhaled treatment with either budesonide/formoterol,160μg/4.5μg(Symbicort Turbuhaler,AstraZeneca,Lund, Sweden), or budesonide, 200μg (Pulmicort Turbuhaler,AstraZeneca,Lund, Sweden)and inhaled salbutamol as needed. The main end point was the morning peak expiratory flow (PEFam), and the second end point were the use of reliever medication, daytime asthma symptoms score, and asthma-related nighttime awakenings. Adverse events(pharyngitis,hoarseness)and combined medicine were recorded. Succeesful- treatment weeks, symptom free days and uninvolved days were also recorded. Using SPSS 13.0 statistics software to analyze and handle data. Description statistics was applied to summarize and analysize the safty. Analysis of variance (ANOVA) was adopted to compare the baseline and therapectic result of the three treatment groups. Nonparametric Bootstrap was used to calculate the 95% confidence interval of increment cost-effectiveness. Applying analysis of extremes to accomplish the sensitivity analysis.Results 1 Clinic therapeutic result1.1 Nighttime awakenings and daytime asthma symptom scoresAsthma-related nighttime awakenings and daytime asthma symptom scores were reduced from 1.53±0.35 to 0.39±0.13 and 4.72±1.27 to 0.56±1.20(p﹤0.05) respectively in budesonide/formoterol treatment group. While in budesonide group, the vaules changed from 1.56±0.32 to 0.67±0.13and 4.53±1.35 to 2.47±1.59 respectively, p﹤0.05, and control group changed from 1.51±0.39 to 1.54±0.17and 3.89±1.25 to 3.84±1.48 respectively p﹥0.05. During the treatment, budesonide/formoterol and budesonide improved daytime asthma symptoms significantly compared to control group(p﹤0.05), furtherly, budesonide/formoterol were better than that of budesonide(p﹤0.05) in the first 4 weeks of treatment, and after 12 weeks treatment p﹤0.001.1.2 Use of rescue medicationThe use of rescue medication everyday in both the treatment groups were significantly reduced(p﹤0.05), but the change was not unavailable in control group. After 12 weeks, use of rescue medication everyday in budesonide/formoterol and budesonide induced from 1.77±0.40 to3.47±0.78 and 1.86±0.41 to 3.35±0.45, the difference was statistic variance(p﹤0.05).1.3 Morning peak expiratory flow (PEFam)The morning peak expiratory flow (PEFam) had not difference between treatment group and control group(p﹥0.05) before random. PEFam in budesonide/formoterol group significantly increased from 272±82 to 342±90(p< 0.05),and in budesonide group from 276±86 to 327±92(p< 0.05),Both of which PEFam were different (p< 0.05)after treatment. However ,the control group did not change obviously.2 Safety analysisIn both budesonide/formoterol and budesonide groups there were no changes in blood pressure, heart rate, electrocardiogram. Incidence rate of adverse accident in both treatment groups were 15.8% and 18.2%, respectively p﹤0.05. The adverse accident related to research drugs were hoarseness and pharyngitis. Two patients got hoarseness and one got pharyngitis in budesonide/formoterol group.While, two patients got hoarseness and two got pharyngitis in budesonide group. Difference of constituent ratio in two groups had not statistically significant(p﹤0.05). There were no fungous infection in these patients. 3 Clinical economic evaluation 3.1 Clinical effectAt the end of 12weeks treatment, the average of succeesful- treatment weeks, symptom free days and uninvolved days in budesonide/formoterol group were better than that of in budesonide group p﹤0.05.3.2 Health care costThe frequence of clinic sevice and inspection were almost the same in the two groups. The cost of direct medication, including drug costs and others'medical costs, every patient everyday in budesonide/formoterol group was 39.05±11.45 yuan and that of budesonide regimen was 21.75±9.56 yuan (p﹤0.05).3.3 Cost-effectiveness analysisBoth treatments provided improvements in daily rescue medication as-needed and daytime and nighttime asthma symptoms. Direct resources in budesonide/formoterol compared to budesonide was increased per paitent per day(39.05±11.45vs21.75±9.56,p﹤0.05). Succeesful- treatment weeks of budesonide/formoterol were lower than budesonide(306.37,95%CI 247.35,365.39 vs 360.11, 95%CI 327.91,392.30).The increment cost-effectiveness for succeesful- treatment weeks of budesonide/formoterol was 102.36 (95%CI -96.81, 169.59) compared to budesonide. The cost-effectiveness of uninvolved days and symptom free days of budesonide/formoterol were lower than that of budesonide (54.88 95%CI 51.22, 58.54 vs 107.50 95%CI 84.88,130.11)and (56.90 95%CI 53.27,60.53 vs 93.25 95%CI 75.87,110.62) ,respectively. The increment cost-effectiveness of uninvolved days and symptom free days in the two groups were 30.67(95%CI -28.72, 46.91)and 24.83(95%CI -20.58,40.65) ,respectively.4 Sensitive analysisIf the cost of budesonide/formoterol and Budesonide were increased or reduced by 20%, increment cost-effectivess of succeesful- treatment weeks , uninvolved days and symptom free days would rise, while cost-effectivess of budesonide/formoterol were better than that of budesonide.ConclusionsBudesonide/formoterol 160 /4.5μg, two inhalations, twice a day, can significantly improved daytime and nighttime asthma symptoms, rescue medication everyday and lung function, which was better than that of budesonide 200μg, two inhalations, twice a day, especially in the usage of daily rescue medication. There were no difference in pharyngitis and hoarseness of the two groups.The average succeesful- treatment weeks ,uninvolved days and symptom free days in budesonide/formoterol 160 /4.5μg two inhalation, twice a day, were lower than that of budesonide. Budesonide/formoterol group was more cost-effective than that of budesonide grouop. |
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