乙酰半胱氨酸泡腾片治疗慢性阻塞性肺疾病的药物临床综合评价

Comprehensive Clinical Evaluation of N-Acetylcysteine Effervescent Tablets in the Treatment of Chronic Obstructive Pulmonary Disease

目的:评价乙酰半胱氨酸泡腾片治疗慢性阻塞性肺疾病(COPD)的临床综合价值,为各级决策提供证据并更好地指导临床实践。方法:检索国内外文献/文摘数据库,纳入临床诊疗指南(含专家共识)、系统评价/Meta分析和随机对照试验等循证医学证据;通过药品生产企业和第三方药品市场数据库,获取药品说明书以及药品价格、采购和销售数据。按照《药品临床综合评价管理指南(2021年版试行)》中的方法,对乙酰半胱氨酸泡腾片治疗COPD的安全性、有效性、经济性、创新性、适宜性和可及性6个价值维度进行定性、定量分析。结果:初筛获得1746篇文献,最终纳入系统评价/Meta分析22篇。有效性和安全性方面,乙酰半胱氨酸泡腾片可改善COPD患者的肺功能、血气分析等临床疗效结局指标,且总体不良事件发生率与安慰剂或空白对照相当,未发生严重不良事件。经济性方面,在常规治疗基础上加用乙酰半胱氨酸泡腾片治疗慢性阻塞性肺病急性加重期更具有经济性。乙酰半胱氨酸泡腾片在制剂方面具有创新性,更有利于吞咽不便或对气味敏感的患者人群。乙酰半胱氨酸泡腾片的药价水平、可负担性和可获得性均良好。结论:对于COPD患者,乙酰半胱氨酸泡腾片具有良好的临床应用价值。

OBJECTIVE: To evaluate the clinical comprehensive value of N-acetylcysteine effervescent tablets in the treatment of chronic obstructive pulmonary disease(COPD), so as to provide evidence for decision-making at all levels and to better guide clinical practice. METHODS: Domestic and foreign literature/abstract databases were searched, and evidence-based medical evidence such as clinical diagnosis and treatment guidelines(including expert consensus), systematic reviews/Meta-analysis and randomized controlled trials were included. Drug instructions, prices, procurement and consumption sum were obtained from drug manufacturers and third-party drug market databases. Safety, efficacy, economy, innovation, suitability, and accessibility of N-acetylcysteine effervescent tablets in the treatment of COPD were qualitatively and quantitatively evaluated according to the Guidelines for Comprehensive Clinical Evaluation of Drugs(Trial Version 2021). RESULTS: A total of 1 746 articles were obtained from the primary screening, 22 studies were finally included in the systematic review/Meta-analysis. In terms of efficacy and safety, N-acetylcysteine effervescence tablets could improve the pulmonary function, blood gas analysis and other clinical efficacy outcome indicators of COPD, and the overall incidence of adverse events was similar to that of placebo or blank control, and no severe adverse events were observed. In terms of economy, it was more economical to use N-acetylcysteine effervescent tablets on the basis of conventional treatment in the treatment of acute exacerbation of COPD. N-acetylcysteine effervescent tablets were innovative in terms of preparation, which was more conducive to patients with difficulty in swallowing or sensitive to odor. The price level, affordability and availability of N-acetylcysteine effervescent tablets were good. CONCLUSIONS: For patients with COPD, N-acetylcysteine effervescent tablets have good clinical application value.