BACKGROUND: Inhaled hypertonic saline acutely increases mucociliary clearance and, in short-term trials, improves lung function in people with cystic fibrosis. We tested the safety and efficacy of inhaled hypertonic s...BACKGROUND: Inhaled hypertonic saline acutely increases mucociliary clearance and, in short-term trials, improves lung function in people with cystic fibrosis. We tested the safety and efficacy of inhaled hypertonic saline in a long-term trial. METHODS: In this double-blind, parallel-group trial, 164 patients with stable cystic fibrosis who were at least six years old were randomly assigned to inhale 4 ml of either 7 percent hypertonic saline or 0.9 percent (control) saline twice daily for 48 weeks, with quinine sulfate (0.25 mg per milliliter) added to each solution to mask the taste. A bronchodilator was given before each dose, and other standard therapies were continued during the trial. RESULTS: The primary outcome measure, the rate of change (slope) in lung function (reflected by the forced vital capacity FVC , forced expiratory volume in one second FEV1 , and forced expiratory flow at 25 to 75 percent of FVC FEF25-75 ) during the 48 weeks of treatment, did not differ significantly between groups (P = 0.79). However, the absolute difference in lung function between groups was significant (P = 0.03) when averaged across all post-randomization visits in the 48-week treatment period. As compared with the control group, the hypertonic-saline group had significantly higher FVC (by 82 ml; 95 percent confidence interval, 12 to 153) and FEV1 (by 68 ml; 95 percent confidence interval, 3 to 132) values, but similar FEF25-75 values. The hypertonic-saline group also had significantly fewer pulmonary exacerbations (relative reduction, 56 percent; P = 0.02) and a significantly higher percentage of patients without exacerbations (76 percent, as compared with 62 percent in the control group; P = 0.03). Hypertonic saline was not associated with worsening bacterial infection or inflammation. CONCLUSIONS: Hypertonic saline preceded by a bronchodilator is an inexpensive, safe, and effective additional therapy for patients with cystic fibrosis.展开更多
目的观察布地奈德长期规律吸入对治疗轻、中度慢性持续期尘螨过敏性哮喘的疗效,并探讨可能的疗效预测指标。方法 50例轻、中度慢性持续期尘螨过敏性哮喘患者,规律吸入布地奈德1年,治疗前后分别进行哮喘控制评分(asthma control question...目的观察布地奈德长期规律吸入对治疗轻、中度慢性持续期尘螨过敏性哮喘的疗效,并探讨可能的疗效预测指标。方法 50例轻、中度慢性持续期尘螨过敏性哮喘患者,规律吸入布地奈德1年,治疗前后分别进行哮喘控制评分(asthma control questionnaire,ACQ)、肺功能测定、尘螨特异性IgE测定、外周血嗜酸粒细胞百分比(EOS%)测定、IL-4、IL-12水平测定。结果①组间细胞因子比较:哮喘组治疗前血清IL-4、IL-12分别为(47.98±19.94)ng/L、(43.74±14.91)ng/L,健康对照组分别为(25.53±16.60)ng/L、(73.10±16.81)ng/L,哮喘组IL-4高于健康对照组,IL-12低于健康对照组,差异有统计学意义(P<0.05)。②布地奈德长期治疗效果:哮喘组中有46例顺利完成了为期12个月的治疗。治疗前后比较发现治疗后ACQ评分、血EOS%、户尘螨sIgE、粉尘螨sIgE、尘螨总sIgE、血清IL-4明显降低,血清IL-12、FEV1、FEV1/FVC、FEV1%pred、PEF%pred明显升高,差异均有统计学意义(P<0.05)。以FEV1改善率12%为治疗有效判断指标,布地奈德长期吸入总体有效率86.96%。③基线ACQ评分、EOS%、IL-12与布地奈德疗效的关系:以基线ACQ评分<7、EOS%≥5%、IL-12≥32ng/L作为布地奈德长期疗效的预测指标,其灵敏度分别为75%、70%、87.5%,阴性预测值分别为33.33%、25%、50%。结论轻、中度尘螨过敏性哮喘患者吸入布地奈德治疗1年疗效显著,基线血清IL-12不高是长期吸入激素治疗效果差的良好预测指标。展开更多
文摘BACKGROUND: Inhaled hypertonic saline acutely increases mucociliary clearance and, in short-term trials, improves lung function in people with cystic fibrosis. We tested the safety and efficacy of inhaled hypertonic saline in a long-term trial. METHODS: In this double-blind, parallel-group trial, 164 patients with stable cystic fibrosis who were at least six years old were randomly assigned to inhale 4 ml of either 7 percent hypertonic saline or 0.9 percent (control) saline twice daily for 48 weeks, with quinine sulfate (0.25 mg per milliliter) added to each solution to mask the taste. A bronchodilator was given before each dose, and other standard therapies were continued during the trial. RESULTS: The primary outcome measure, the rate of change (slope) in lung function (reflected by the forced vital capacity FVC , forced expiratory volume in one second FEV1 , and forced expiratory flow at 25 to 75 percent of FVC FEF25-75 ) during the 48 weeks of treatment, did not differ significantly between groups (P = 0.79). However, the absolute difference in lung function between groups was significant (P = 0.03) when averaged across all post-randomization visits in the 48-week treatment period. As compared with the control group, the hypertonic-saline group had significantly higher FVC (by 82 ml; 95 percent confidence interval, 12 to 153) and FEV1 (by 68 ml; 95 percent confidence interval, 3 to 132) values, but similar FEF25-75 values. The hypertonic-saline group also had significantly fewer pulmonary exacerbations (relative reduction, 56 percent; P = 0.02) and a significantly higher percentage of patients without exacerbations (76 percent, as compared with 62 percent in the control group; P = 0.03). Hypertonic saline was not associated with worsening bacterial infection or inflammation. CONCLUSIONS: Hypertonic saline preceded by a bronchodilator is an inexpensive, safe, and effective additional therapy for patients with cystic fibrosis.
文摘目的观察布地奈德长期规律吸入对治疗轻、中度慢性持续期尘螨过敏性哮喘的疗效,并探讨可能的疗效预测指标。方法 50例轻、中度慢性持续期尘螨过敏性哮喘患者,规律吸入布地奈德1年,治疗前后分别进行哮喘控制评分(asthma control questionnaire,ACQ)、肺功能测定、尘螨特异性IgE测定、外周血嗜酸粒细胞百分比(EOS%)测定、IL-4、IL-12水平测定。结果①组间细胞因子比较:哮喘组治疗前血清IL-4、IL-12分别为(47.98±19.94)ng/L、(43.74±14.91)ng/L,健康对照组分别为(25.53±16.60)ng/L、(73.10±16.81)ng/L,哮喘组IL-4高于健康对照组,IL-12低于健康对照组,差异有统计学意义(P<0.05)。②布地奈德长期治疗效果:哮喘组中有46例顺利完成了为期12个月的治疗。治疗前后比较发现治疗后ACQ评分、血EOS%、户尘螨sIgE、粉尘螨sIgE、尘螨总sIgE、血清IL-4明显降低,血清IL-12、FEV1、FEV1/FVC、FEV1%pred、PEF%pred明显升高,差异均有统计学意义(P<0.05)。以FEV1改善率12%为治疗有效判断指标,布地奈德长期吸入总体有效率86.96%。③基线ACQ评分、EOS%、IL-12与布地奈德疗效的关系:以基线ACQ评分<7、EOS%≥5%、IL-12≥32ng/L作为布地奈德长期疗效的预测指标,其灵敏度分别为75%、70%、87.5%,阴性预测值分别为33.33%、25%、50%。结论轻、中度尘螨过敏性哮喘患者吸入布地奈德治疗1年疗效显著,基线血清IL-12不高是长期吸入激素治疗效果差的良好预测指标。
