目的 系统评价N-乙酰半胱氨酸(NAC)治疗特发性肺纤维化(IPF)的疗效和安全性,为临床用药提供依据。方法 计算机检索PubMed、Cochrane library、EM base、中国期刊全文数据库(CNKI)、维普数据库(VIP)、万方数据库(Wang Fang Data)发表的有关NAC治疗IPF的对照试验,检索时间为建库到2017年9月。由两名研究者按纳入与排除标准独立筛选相关文献,提取文献资料并评价文献质量,最后采用RevMan 5.3 软件进行Meta分析。结果 最终共纳入9篇文献,共666名患者。Meta分析结果显示,与对照组相比,NAC组IPF患者治疗前后的用力肺活量变化(ΔFVC)[MD=0.14,95%CI(-0.00,0.28),P=0.05]、肺活量占预计值百分比变化(ΔVC%)[MD=3.84,95%CI(1.02,6.66),P=0.008]以及一氧化碳弥散量占预计值百分比变化(ΔDLco%)[MD=0.10,95%CI(0.03,0.17),P=0.006]均显著小于对照组。但两组患者治疗前后6 min步行试验距离的变化(Δ6MWT)[MD=17.58,95%CI(-4.23,39.38),P=0.008],不良反应发生率[OR=1.28,95%CI(0.83,1.98),P=0.26]以及病死率[OR=0.98,95%CI(0.40,2.43),P=0.06]并无显著性差异。进一步依据给药途径分组的亚组分析结果显示,在ΔFVC方面,吸入NAC组与对照组具有显著性差异(P=0.04),但口服NAC组与对照组未有显著性差异(P=0.48),而在不良反应发生率以及病死率方面,吸入NAC组或口服NAC组与对照组均没有显著性差异(P<0.05)。结论 现有的临床证据表明,N-乙酰半胱氨酸能够延缓患者的肺功能下降速度,且安全性较好,但不能降低患者的短期病死率;NAC的给药途径可能对疗效造成影响,吸入给药可能优于口服给药。
Abstract
OBJECTIVE To investigate the efficacy and safety of N-acetylcysteine(NAC) in treatment of patients with idiopathic pulmonary fibrosis(IPF) and provide evidence for clinical medication. METHODS We electronically searched PubMed, The Cochrane Library, EM base, CNKI, Wan Fang Data and VIP database for all relevant studies about NAC in management of patients with IPF from the date of database establishment to September 2017. Two independent reviewers exact data and assess the quality of included studies. All statistical analyses were performed using RevMan V.5.3. RESULTS A total of nine studies were included for final Meta-analysis, involving 666 patients. Our Meta-analysis indicated that NAC group can significantly decrease the change in the forced vital capacity(FVC) [MD=0.14, 95%CI(-0.00, 0.28), P=0.05], percentage of predicted vital capacity(VC%) [MD=3.84, 95%CI(1.02, 6.66), P=0.008] and carbon monoxide diffusing capacity(DLco%) [MD=0.10, 95%CI(0.03, 0.17), P=0.006] when compared with control group, and there were no significant difference in the change of six minutes walking test distance [MD=17.58,95%CI(-4.23,39.38), P=0.008], rates of adverse events[OR=1.28, 95%CI(0.83,1.98), P=0.26], or death [OR=0.98, 95%CI(0.40,2.43), P=0.06] between NAC group and control group. A further subgroup analysis according to route of administration indicated that inhalation administration NAC group can significant decrease the change in FVC(P=0.04), whereas oral administration NAC group had no statistically difference in the change of FVC when compared with control group(P=0.48). Both inhalation and oral administration NAC group had no statistically difference in rates of adverse events or death rates when compared with control group(P<0.05). CONCLUSION Present evidence shows that NAC is well tolerated and can significantly decrease the decline in lung function but can not decrease rates of death. Besides, different routes of administration may affect the efficacy of NAC, inhalation administration seems better than oral administration.
关键词
N-乙酰半胱氨酸 /
特发性肺纤维化 /
疗效 /
安全性 /
Meta分析
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Key words
N-acetylcysteine /
idiopathic pulmonary fibrosis /
efficacy /
safety /
Meta-analysis
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中图分类号：
R969.3
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