痰热清注射液治疗老年重症肺炎的Meta分析与试验序贯分析

Meta-analysis and trial sequential analysis of Tanreqing Injection in treatment of severe pneumonia in elderly

该研究旨在系统评价痰热清注射液治疗老年重症肺炎的有效性及安全性,检索中、英文数据库以及临床试验注册平台,纳入18篇随机对照试验(RCTs),涉及1457例老年重症肺炎患者。采用Cochrane偏倚风险评估工具评价纳入文献的质量,采用RevMan 5.4及Stata 17软件进行Meta分析,采用TSA 0.9.5.10 beta软件进行试验序贯分析(TSA)。Meta分析结果显示,与常规西医治疗相比,痰热清注射液+常规西医能显著提高老年重症肺炎患者的临床有效率(RR=1.26,95%CI[1.20,1.32],P<0.00001)、动脉血氧分压(SMD=6.23,95%CI[3.29,9.18],P<0.0001)、氧合指数(SMD=11.72,95%CI[4.41,19.04],P=0.002),降低降钙素原(SMD=-6.16,95%CI[-8.10,-4.21],P<0.00001)、C-反应蛋白(SMD=-8.50,95%CI[-11.05,-5.96],P<0.00001)、白细胞计数(SMD=-4.56,95%CI[-5.73,-3.39],P<0.00001),缩短发热时间(SMD=-3.12,95%CI[-4.61,-1.63],P<0.0001)、咳嗽时间(SMD=-4.84,95%CI[-6.90,-2.79],P<0.00001)、肺部啰音时间(SMD=-0.99,95%CI[-1.54,-0.44],P=0.0004)、机械通气时间(SMD=-3.26,95%CI[-5.03,-1.50],P=0.0003),提高CD4^(+)T细胞水平(SMD=6.73,95%CI[5.23,8.23],P<0.00001)、CD8^(+)T细胞水平(SMD=7.47,95%CI[5.32,9.61],P<0.00001),且没有明显的不良反应。TSA证实临床有效率的结果具有稳定性和可靠性。结果表明,痰热清注射液作为一种中药制剂,对老年重症肺炎具有显著的治疗效果和良好的安全性。考虑纳入文献质量偏低,研究结论仍需更多高质量的RCT提供证据支持。

This study aimed to systematically evaluate the effectiveness and safety of Tanreqing Injection in the treatment of severe pneumonia in the elderly.Eighteen randomized controlled trials(RCTs)involving 1457 elderly patients with severe pneumonia were included in the study after conducting searches in both Chinese and English databases as well as clinical trial registration platforms.The quality of the included studies was assessed using the Cochrane risk of bias assessment tool.Meta-analysis were conducted using RevMan 5.4 and Stata 17 software,and trial sequential analysis(TSA)was performed using TSA 0.9.5.10 beta software.Meta-analysis results showed that compared with conventional western medicine treatment,Tanreqing Injection+conventional western medical significantly improved the clinical effectiveness in elderly patients with severe pneumonia(RR=1.26,95%CI[1.20,1.32],P<0.00001),arterial oxygen partial pressure(SMD=6.23,95%CI[3.29,9.18],P<0.0001),oxygenation index(SMD=11.72,95%CI[4.41,19.04],P=0.002),reduce procalcitonin(SMD=-6.16,95%CI[-8.10,-4.21],P<0.00001),C-reactive protein(SMD=-8.50,95%CI[-11.05,-5.96],P<0.00001),white blood cell count(SMD=-4.56,95%CI[-5.73,-3.39],P<0.00001),and shortened the duration of fever(SMD=-3.12,95%CI[-4.61,-1.63],P<0.0001),cough(SMD=-4.84,95%CI[-6.90,-2.79],P<0.00001),lung rales(SMD=-0.99,95%CI[-1.54,-0.44],P=0.0004),and mechanical ventilation time(SMD=-3.26,95%CI[-5.03,-1.50],P=0.0003),increase CD4~+T-cell levels(SMD=6.73,95%CI[5.23,8.23],P<0.00001)and CD8~+T-cell levels(SMD=7.47,95%CI[5.32,9.61],P<0.00001)with no significant adverse reactions.TSA confirmed the stability and reliability of the results related to clinical effectiveness.This study suggests that Tanreqing Injection,as a Chinese medicinal preparation,has a significant therapeutic effect and good safety profile in the treatment of severe pneumonia in elderly patients.Due to the limited quality of the included studies,high-quality RCT is still needed to provide evidence support for the above conclusions.