中国循证医学杂志

中国循证医学杂志

环丙沙星治疗非囊性纤维化支气管扩张症有效性及安全性的 Meta 分析

查看全文

目的 系统评价环丙沙星治疗非囊性纤维化支气管扩张症的疗效和安全性。 方法 计算机检索 PubMed、EMbase、The Cochrane Library、CBM、VIP、CNKI 和 WanFang Data 数据库,搜集关于环丙沙星治疗非囊性纤维化支气管扩张症的随机对照试验(RCT),检索时限均从建库至 2018 年 8 月。由 2 位研究员独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用 RevMan 5.3 软件进行 Meta 分析。 结果 最终纳入 9 个 RCT,共 1 666 例患者。Meta 分析结果显示,稳定期治疗时,环丙沙星组的呼吸道细菌根除率[RR=4.34,95%CI(2.04,9.23),P=0.0001]、急性加重再发生率[RR=0.81,95%CI(0.71,0.93),P=0.002]和痰液细菌负荷量[MD=–4.08,95%CI(–6.29,–1.87),P=0.000 3]均优于对照组。无论稳定期还是急性期治疗时两组在治疗有效率、肺功能变化、总不良反应发生率方面差异均无统计学意义。 结论 环丙沙星治疗可有效降低稳定期非囊性纤维化支气管扩张症患者的急性加重再发生率和痰液细菌负荷量以及更好的根除呼吸道细菌。但受纳入研究的数量和质量限制,上述结论尚需要开展更多研究予以验证。

Objective To systematically review the efficacy and safety of ciprofloxacin for non-cystic fibrosis bronchiectasis. Methods Databases including PubMed, EMbase, The Cochrane Library, CBM, VIP, CNKI and WanFang Data were electronically searched from inception to August 2018 to collect randomized controlled trials (RCT) about ciprofloxacin in the treatment of bronchiectasis. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. Then, meta-analysis was performed by using RevMan 5.3 software. Results A total of 9 RCTs involving 1666 patients were included. The results of meta-analysis showed that: compared with control group, the ciprofloxacin could better eradicate bacteria from sputum (RR=4.34, 95%CI 2.04 to 9.23, P=0.0001), decrease the mean bacterial load (MD=–4.08, 95%CI –6.29 to –1.87, P=0.001) and risk of the exacerbations (RR=0.81, 95%CI 0.71 to 0.93, P=0.002). However, there were no significant differences between two groups in clinical efficiency and adverse events. Conclusion The current evidence shows that, ciprofloxacin can decrease the mean bacterial load and risk of the exacerbations. Due to limited quality and quantity of the included studies, more studies are needed to verify conclusion.

关键词: 非囊性纤维化支气管扩张症; 环丙沙星; Meta 分析; 随机对照试验

Key words: Non-cystic fibrosis bronchiectasis; Ciprofloxacin; Meta-analysis; Randomized controlled trial

登录后 ,请手动点击刷新查看图表内容。 没有账号,
1. Cole PJ. A new look at the pathogenesis and management of persistent bronchial sepsis: a "vicious circle" hypothesis and its logical therapeutic connotations. Oxford: Medicine Publishing Foundation, 1984.
2. Brodt AM, Stovold E, Zhang L. Inhaled antibiotics for stable non-cystic fibrosis bronchiectasis: a systematic review. Eur Respir J, 2014, 44(2): 382-393.
3. Fjaellegaard K, Sin MD, Browatzki A, et al. Antibiotic therapy for stable non-CF bronchiectasis in adults-a systematic review. Chron Respir Dis, 2017, 14(2): 174-186.
4. Justo JA, Danziger LH, Gotfried MH. Efficacy of inhaled ciprofloxacin in the management of non-cystic fibrosis bronchiectasis. Ther Adv Respir Dis, 2013, 7(5): 272-287.
5. Cartlidge MK, Hill AT. Inhaled or nebulised ciprofloxacin for the maintenance treatment of bronchiectasis. Expert Opin Investig Drugs, 2017, 26(9): 1091-1097.
6. Higgins J, Green S. Cochrane Handbook for Systematic Reviews of Interventions. Avariable at: http://www.handbook.cochrane.org/.
7. 陈素芹, 陈晨, 高海燕. 头孢哌酮/舒巴坦与环丙沙星治疗老年支气管扩张急性加重患者临床比较. 老年医学与保健, 2014, 20(6): 396-399.
8. 康建军, 高仑, 孙秀娥. 头孢哌酮舒巴坦钠与环丙沙星治疗老年支气管扩张急性加重患者临床效果比较. 临床医学研究与实践, 2017, 2(13): 31-32.
9. Aksamit T, De Soyza A, Bandel TJ, et al. RESPIRE 2: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis. Eur Respir J, 2018, 51(1): 1702053.
10. Bilton D, Henig N, Morrissey B, et al. Addition of inhaled tobramycin to ciprofloxacin for acute exacerbations of Pseudomonas aeruginosa infection in adult bronchiectasis. Chest, 2006, 130(5): 1503-1510.
11. Chan TH, Ho SS, Lai CK, et al. Comparison of oral ciprofloxacin and amoxycillin in treating infective exacerbations of bronchiectasis in Hong Kong. Chemotherapy, 1996, 42(2): 150-156.
12. Wilson R, Welte T, Polverino E, et al. Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis: a phase II randomised study. Eur Respir J, 2013, 41(5): 1107-1115.
13. Serisier DJ, Bilton D, De Soyza A, et al. Inhaled, dual release liposomal ciprofloxacin in non-cystic fibrosis bronchiectasis (ORBIT-2): a randomised, double-blind, placebo-controlled trial. Thorax, 2013, 68(9): 812-817.
14. De Soyza A, Aksamit T, Bandel TJ, et al. Efficacy and tolerability of ciprofloxacin dry powder for inhalation (ciprofloxacin DPI) in bronchiectasis (non-CF etiology): results from the phase iii respire 1 study. Chest, 2016, 150(4): 1315A-1315A.
15. De Soyza A, Aksamit T, Bandel TJ, et al. RESPIRE 1: Two phase III, randomized, multicentre, placebo-controlled trials of Ciprofloxacin dry powder for inhalation (Ciprofloxacin DPI) in non-cystic fibrosis bronchiectasis. Contemp Clin Trials, 2017, 58: 78-85.
16. Rademacher J, Welte T. Bronchiectasis-diagnosis and treatment. Deutsches Ärzteblatt International, 2011, 108(48): 809.
17. McDonnell, Melissa J, Hester, et al. Bronchiectasis: clinical features and management with a focus on inhaled antibiotics. Clin Pulm Med, 2014, 21(6): 251-261.
18. Shi ZL, Peng H, Hu XW, et al. Effectiveness and safety of macrolides in bronchiectasis patients: a meta-analysis and systematic review. Pulm Pharmacol Ther, 2014, 28(2): 171-178.
19. Wu Q, Shen W, Cheng H, et al. Long-term macrolides for non-cystic fibrosis bronchiectasis: a systematic review and meta-analysis. Respirology, 2014, 19(3): 321-329.
20. Rayner CF, Tillotson G, Cole PJ, et al. Efficacy and safety of long-term ciprofloxacin in the management of severe bronchiectasis. J Antimicrob Chemother, 1994, 34(1): 149-156.
21. Cipolla D, Blanchard J, Gonda I. Development of liposomal ciprofloxacin to treat lung infections. Pharmaceutics, 2016, 8(1): e6.