摘要
目的系统评价痰热清注射液治疗急性肺损伤/急性呼吸窘迫综合征(ALI/ARDS)的有效性及安全性。方法检索中国知网、维普中文科技期刊全文数据库、万方数据库、中国生物医学文献数据库、PubMed、Embase及Cochrane Library数据库,纳入痰热清注射液治疗ALI/ARDS的随机对照临床试验。评价纳入研究的方法学质量,并采用RevMan5.3软件对氧合指数、血氧分压、机械通气时间和死亡率等结局指标进行Meta分析。结果纳入9项符合标准的随机对照试验,合计739例患者。5个研究报道随机序列产生的方式,但所有研究均未描述方法学关于分配隐藏和盲法实施的相关信息。Meta分析结果显示,痰热清注射液联合西医常规治疗措施在改善血氧分压[MD=14.41 mmHg,95%CI(7.47,21.35),P<0.01]、减少机械通气时间[MD=-1.27 d,95%CI(-1.78,-0.76),P<0.01],降低全身炎症反应综合征(SIRS)评分[MD=-0.84分,95%CI(-1.16,-0.52),P<0.01]和急性生理与慢性健康评分(APACHE)Ⅱ评分[MD=-5.70分,95%CI(-10.27,-1.14),P=0.01]方面均优于对照组;而在降低死亡率[RR=0.44,95%CI(0.19,1.04),P=0.06]和急性肺损伤评分(LIS)[MD=-0.12分,95%CI(-0.32,0.09),P=0.27]方面,两组之间的差异无统计学意义。纳入研究均未提及不良事件。结论在西医常规治疗基础上,联合使用痰热清注射液治疗ALI/ARDS显示出潜在的治疗价值,但纳入研究的方法学质量偏低,且缺乏安全性方面的研究数据支持,因此临床实践中需谨慎使用痰热清注射液治疗ALI/ARDS,尚需更多高质量、多中心、大样本、严格的随机对照试验予以证实。
Objective:To systematically review the efficacy and safety of Tanreqing Injection on ALI/ARDS.Methods:The databases of CNKI,CQVIP,Wanfang data,CBM,PubMed,Embase and Cochrane Library were re⁃trieved and randomized controlled clinical trials of Tanreqing Injection on ALI/ARDS were included.The method⁃ological quality of the study was evaluated,and the outcome indicators,such as oxygenation index,partial pressure of oxygen,mechanical ventilation time and mortality,were analyzed with RevMan 5.3 software.Results:9 eligible randomized controlled trials were included,involving 739 patients.5 studies reported the way of generating ran⁃dom sequences,but none of them described the information about assignment concealment and blind method imple⁃mentation.Meta-analysis showed that Tanreqing Injection combined with routine western medicine treatment was superior to the control group in improving partial pressure of oxygen[MD=14.41 mmHg,95%CI(7.47,21.35),P<0.01],reducing mechanical ventilation time[MD=-1.27 d,95%CI(-1.78,-0.76),P<0.01],systemic inflammato⁃ry response syndrome(SIRS)score[MD=-0.84 points,95%Cl(-1.16,-0.52),P<0.01)]and APACHEⅡscore[MD=-5.70 points,95%CI(-10.27,-1.14),P=0.01].There was no significant difference between the two groups in reducing mortality[RR=0.44,95%CI(0.19,1.04),P=0.06]and acute lung injury score(LIS)[MD=0.12 points,95%CI(-0.32,0.09),P=0.27].No adverse events were mentioned in the included studies.Conclusion:Tanreq⁃ing Injection combined with routine treatment of western medicine shows potential therapeutic value on ALI/ARDS,but the methodological quality of the included study is low and lacks the support of safety data.Therefore,it is nec⁃essary to use Tanreqing Injectioncautiously for ALI/ARDS in clinical practice,and more high-quality,multicenter,large sample,rigorous randomized controlled trials are needed.
作者
何冰
卢健烨
林建鹏
陈远彬
吴蕾
林琳
He Bing;Lu Jianye;Lin Jianpeng;Chen Yuanbin;Wu Lei;Lin Lin(Liwan District Hospital of Chinese Medicine of Guangzhou Province,Guangdong,Guangzhou 510405,China)
出处
《中国中医急症》
2020年第9期1552-1557,共6页
Journal of Emergency in Traditional Chinese Medicine
基金
国家自然科学基金项目(81503511)
广东省科技计划项目(2017A020213007)
广东省中医院周仲瑛学术经验传承工作室(中医二院[2014]89号)。
作者简介
通信作者:陈远彬,(电子邮箱:chenyuanbin110@163.com)。