口服中成药治疗成人咳嗽变异性哮喘有效性和安全性的系统评价

Systematic Review of Efficacy and Safety of Oral Chinese Patent Medicine in the Treatment of Adult Cough Variant Asthma

目的:系统评价口服中成药联合常规西药治疗成人咳嗽变异性哮喘(CVA)的有效性和安全性。方法:计算机检索中国知网、万方数据库、维普数据库、中国生物医学文献数据库、PubMed、Embase和the Cochrane Library等数据库,检索时间均为建库至2022年1月。检索口服中成药联合常规西药治疗成人CVA的临床随机对照试验,严格按照纳入与排除标准进行文献筛选。采用NoteExpress 3.5、Excel软件进行资料提取,采用RevMan 5.4软件进行文献质量评价及统计学分析。结果:最终纳入35篇文献,合计2947例CVA患者。Meta分析结果显示,相较于常规西药治疗,口服中成药联合常规西药治疗在提高临床总有效率(RR=1.21,95%CI=1.16~1.25,P<0.00001)、第1秒用力呼气容积(SMD=1.59,95%CI=1.17~2.01,P<0.00001)、用力肺活量(SMD=1.58,95%CI=0.99~2.18,P<0.00001)、第1秒用力呼气容积/用力肺活量(SMD=1.29,95%CI=0.65~1.94,P<0.0001)和呼气流量峰值(SMD=1.00,95%CI=0.65~1.36,P<0.00001)等方面疗效显著,在降低白细胞介素4(SMD=-1.56,95%CI=-2.47~-0.64,P=0.0008)、白细胞介素6(SMD=-1.83,95%CI=-2.50~-1.16,P<0.00001)、肿瘤坏死因子α(SMD=-1.72,95%CI=-2.11~-1.34,P<0.00001)和嗜酸性粒细胞(SMD=-1.35,95%CI=-1.78~-0.92,P<0.00001)等指标水平方面具有一定优势,并能有效改善咳嗽症状积分(日间咳嗽症状积分:SMD=-2.07,95%CI=-3.07~-1.07,P<0.0001;夜间咳嗽症状积分:SMD=-2.26,95%CI=-3.39~-1.12,P<0.0001),且不良反应发生率较低(RR=0.55,95%CI=0.33~0.93,P=0.03),上述差异均有统计学意义。结论:在常规西药治疗基础上联合口服中成药治疗成人CVA患者具有良好的临床疗效,且安全性较高,但由于纳入的文献质量、数量有限,未来仍需更大规模的随机对照试验加以验证。

OBJECTIVE: To systematically evaluate the efficacy and safety of oral Chinese patent medicine combined with conventional western medicine in the treatment of adult cough variant asthma(CVA). METHODS: CNKI, Wanfang Data, VIP, CBM, PubMed, Embase, and the Cochrane Library were retrieved to collect the clinical randomized controlled trial of oral Chinese patent medicine combined with conventional western medicine in the treatment of adult CVA, the retrieval time was from the establishment of the database to Jan. 2022. Literature was screened strictly according to the inclusion and exclusion criteria. NoteExpress 3.5 and Excel software were used for data extraction, and RevMan 5.4 software was used for literature quality evaluation and statistical analysis. RESULTS: A total of 35 articles were enrolled, including 2 947 patients with CVA. Meta-analysis showed that compared with conventional western medicine treatment, oral Chinese patent medicine combined with conventional western medicine had significant efficacy in improving the total clinical efficiency(RR=1.21,95%CI=1.16-1.25,P<0.000 01), forced expiratory volume in one second(SMD=1.59,95%CI=1.17-2.01,P<0.000 01), forced vital capacity(SMD=1.58,95%CI=0.99-2.18,P<0.000 01), forced expiratory volume in one second/forced vital capacity(SMD=1.29,95%CI=0.65-1.94,P<0.000 1) and peak expiratory flow(SMD=1.00,95%CI=0.65-1.36,P<0.000 01), had advantages in reducing levels of interleukin-4(SMD=-1.56,95%CI=-2.47--0.64,P=0.000 8), interleukin-6(SMD=-1.83,95%CI=-2.50--1.16,P<0.000 01), tumor necrosis factor-α(SMD=-1.72,95%CI=-2.11--1.34,P<0.000 01) and eosinophils(SMD=-1.35,95%CI=-1.78--0.92,P<0.000 01), and could effectively improve the cough symptom score(daytime cough symptom score: SMD=-2.07,95%CI=-3.07--1.07,P<0.000 1;nocturnal cough symptom score: SMD=-2.26,95%CI=-3.39--1.12,P<0.000 1) with lower incidence of adverse drug reactions(RR=0.55,95%CI=0.33-0.93,P=0.03), the differences were statistically significant. CONCLUSIONS: The clinical efficacy of oral Chinese patent medicine combined with conventional western medicine in the treatment of adult CVA is significant with higher safety. However, due to the limited quality and quantity of the included literature, larger scale randomized controlled trials are still needed to verify it in the future.