糖皮质激素复合制剂联合低剂量茶碱治疗稳定期慢性阻塞性肺疾病疗效及安全性Meta分析

Efficacy and Safety of Glucocorticoid Compound Preparation Combined with Low-Dose Theophylline in the Treatment of Chronic Obstructive Pulmonary Disease at Stable Stage: a Meta-Analysis

目的系统评价糖皮质激素复合制剂[吸入性糖皮质激素(ICS)/长效β2受体激动剂(LABA)]联合低剂量茶碱治疗稳定期慢性阻塞性肺疾病(COPD)的疗效与安全性。方法运用检索式和关键词检索各中、外文数据库,获得相关文献,由2名研究者分别独立按照纳入与排除标准筛选文献、提取资料并评价纳入研究质量,采用Review Manager 5. 3. 5软件进行数据分析。结果纳入10篇文献,Meta分析显示,观察组(应用茶碱联合ICS复合制剂治疗)与对照组(单用ICS复合制剂治疗)的第1秒用力呼气容积(FEV1)占预计值百分比(FEV1%)预计值[OR=1. 21,95%CI(0. 11,2. 32),P=0. 03]、6 min步行距离(6MWD)[OR=12. 92,95%CI(4. 61,21. 22),P=0. 002]、慢性阻塞性肺疾病评估测试(CAT)评分[OR=-3. 08,95%CI(-3. 57,-2. 58),P <0. 000 01]改善比较,差异均有统计学意义;不良反应发生率[OR=1. 24,95%CI(0. 58,2. 67),P=0. 58]、急性加重发生率[OR=0. 65,95%CI(0. 39,1. 08),P=0. 10]、FEV_1[OR=0. 07,95%CI(-0. 01,0. 15),P=0. 09]比较,差异无统计学意义。结论糖皮质激素复合制剂联合低剂量茶碱能显著改善COPD稳定期患者的肺功能和运动能力,临床可在一定范围内应用。

Objective To systematically evaluate the efficacy and safety of glucocorticoid compound preparation [ inhaled corticosteroid（ ICS） and long-acting β2 receptor agonist（ LABA） ] combined with low-dose theophylline in the treatment of chronic obstructive pulmonary disease（COPD）at stable stage. Methods The Chinese and foreign language databases were searched by searching types and keywords,in order to obtain relevant literatures. Two researchers independently screened the literatures according to inclusion criteria,extracted data and evaluated the quality of the included studies. The data were analyzed by Review Manager 5. 3. 5 software. Results A total of 10 literatures were included,Meta-analysis showed that there were significant differences in FEV1% [ OR = 1. 21,95% CI（ 0. 11,2. 32）,P = 0. 03 ],6 MWD [ OR = 12. 92,95 % CI（ 4. 61,21. 22）,P = 0. 002 ],CAT score [ OR =-3. 08,95 % CI（-3. 57,-2. 58）,P〈0. 000 01 ] in the observation group（ treated with theophylline combined with ICS） and the control group（ treated with ICS alone）,but there was no significant difference in the incidence rate of adverse reaction rate [ OR = 1. 24,95% CI（ 0. 58,2. 67）,P = 0. 58 ],acute exacerbations [ OR = 0. 65,95% CI（ 0. 39,1. 08）,P = 0. 10 ],FEV_1[ OR = 0. 07,95% CI（-0. 01,0. 15）,P = 0. 09 ] between the observation group and the control group. Conclusion ICS combined with low-dose theophylline can significantly improve pulmonary function and exercise capacity of patients with COPD at stable stage,which can be used with caution in clinical application.