方法:计算机检索PubMed、EMBase、Web of Science、Cochrane Library、中国期刊全文数据库(CJFD)、中文科技期刊数据库(VIP)和万方数据库,检索时间为建库起至2023年8月30日,收集中医药干预肺结节的疗效及安全性数据.由2名研究人员独立进行文献检索和归纳,对于有争议的部分与第三名高级研究人员协商处理.采用Cochrane偏倚风险评估工具对纳入文献质量进行评估.对符合纳入标准的临床研究进行资料提取后,采用Rev Man 5.3统计软件进行Meta分析,进而运用漏斗图评估研究的发表偏倚,绘制森林图展示结果差异.对于分类变量采用比值比(OR)作为效应量,对于连续型变量采用均数差(MD)作为效应量,并均计算95%置信区间(CI).结果:共纳入12篇文献,总计1 065例患者.组方中提及药物次数最多的为桔梗,其余依次为法半夏、茯苓、黄芪、浙贝母等.Meta分析结果显示:中药治疗组较对照组临床有效率更高[OR=5.76,95%CI(3.83,8.68),P<0.000 01],肺结节直径更小[MD=-1.61,95%CI(-1.90,-1.32),P<0.000 01];中药治疗组较对照组中医证候积分更低[MD=-2.49,95%CI(-2.88,-2.10),P<0.000 01],中医证候疗效有效率更高[OR=32.32,95%CI(14.02,74.52),P<0.000 01];两组梅奥恶性积分相比无明显差异;所有患者治疗期间无明显不良反应.结论:中医药治疗肺结节患者可缩小结节体积,提高临床疗效,且具有较高的安全性.
Systematic evaluation of the efficacy and safety of traditional Chinese medicine intervention in treating pulmonary nodules based on Meta-analysis
Objective:Toematically evaluate the efficiency and safety of traditional Chinese medicine intervention in treating pulmonarynodules,and to provide evidence-based reference for the clinical treatment.Methods:Computer retrieval was conducted in Pub Med,EM-Base,Web of Science,Cochrane Library,Chinese Journal Full Text Database(CJFD),Chinese Journal of Science and Technology Database(VIP)and Wanfang database from the establishment of the database to August 30,2023,to collect the efficacy and safety data of TCM intervention in treating pulmonary nodules.Literature search and generalization were conducted independently by two researchers,and the controversial parts were nego-tiated and resolved by the third senior researcher.The Cochrane bias risk assessment tool was used to evaluate the quality of the included literature.After data extraction for clinical studies that met the inclusion criteria,Meta-analysis was performed using Rev Man 5.3 statistical software.Funnel plots were used to assess publication bias in the studies,and forest plots were drawn to show the differences in results.In the analysis,odds ratio(OR)was used as the effect size for categorical variables,while mean difference(MD)was used as the effect size for continuous variables,and 95%CI was calculated for all of them.Results:A total of 12 articles were included,with a total of 1065 patients.Platycodon platycodon was mentioned most frequently,which was fol-lowed by Pinellia temata,Poria cocos,Astragalus membranaceus,and Fritillaria thunbergii.The results of Meta-analysis showed that:① Compared with the control group,the Chinese medicine treatment group had higher clinical efficacy[OR=5.76,95%CI(3.83,8.68),P<0.000 01],and smaller pulmonary nodules[MD=-1.61,95%CI(-1.90,1.32),P<0.000 01];② The TCM syndrome score in the TCM treatment group was lower than that in the control group[MD=-2.49,95%CI(-2.88,-2.10),P<0.000 01],and the efficacy and efficiency of TCM symptoms were higher[OR=32.32,95%CI(14.02,74.52),P<0.000 01];③ There was no significant difference in Mayo malignancy scores between the two groups;④ All patients had no significant adverse re-actions during the treatment period.Conclusion:Traditional Chinese medicine can reduce the volume of pulmonary nodules,improve the clinical efficacy and efficiency of traditional Chinese medicine,and it has a high safety.
Traditional Chinese medicineChinese medicinePulmonary nodulesMeta-analysis