中医内治法治疗放射性肠炎疗效的Meta分析及主方用药规律研究

Meta-analysis of the Clinical Efficacy of Traditional Chinese Medicine Internal Treatment on Radiation Enteritis Patients and Research on the Medication Rules

[目的]系统评价中医内治法治疗放射性肠炎的疗效,并总结分析主方用药规律。[方法]通过对中国知网、万方数据库、中文科技期刊数据库(维普资讯)、中国生物医学文献数据库、PubMed、Embase、Cochrane Central数据库进行检索,筛选符合条件的随机对照临床试验文献,并参考Cochrane质量风险评估表进行文献质量和实验偏倚评价。采用RevMan 5.3软件对临床总有效率进行Meta分析及漏斗图绘制,并对肠镜下黏膜损伤缓解率、生活质量评分进行相应分析。使用SPSS Statistics 23.0软件对用药频率最高的20味药物进行聚类分析,得出主方用药规律。[结果]共筛选出1 487篇文献,最终纳入21篇文献,各文献质量评价较高。21篇文献共计纳入1 676例放射性肠炎患者,中医内治组849例、纯西医组827例。中医内治组患者临床总体有效率明显高于纯西医组[相对危险度(relative risk,RR)=1.31,95%置信区间(confidence interval,CI)(1.25,1.38),P<0.01],且漏斗图提示发表偏倚较小;中医内治组的肠镜下黏膜损伤缓解率[RR=1.29,95%CI (1.14,1.46),P<0.001]、行为状态(Karnofsky performance status,KPS)评分[标准化差值(standardized mean difference,SMD)=1.00,95%CI(0.79,1.20),P<0.01]均较纯西医组占有优势。聚类分析发现使用频率最高的20味药物可分为两组,辨证分型可归纳为湿热下注、脾虚湿阻证,理论知识及临床经验提示,对应方剂分别为香连丸、葛根芩连汤、黄芩汤或参苓白术散、补中益气汤。[结论]中医内治法能有效改善放射性肠炎患者的症状及肠道黏膜组织损伤,提高患者生活质量。主方用药可归纳为湿热下注与脾虚湿阻证型,临床随症加减。

[Objective] To assess the clinical efficacy of traditional Chinese medicine(TCM) internal treatment on radiation enteritis patients,and summarize the medication rules. [Methods] Databases like China National Knowledge Infrastructure(CNKI), Wanfang Database,Database of Chinese Scientific and technological journals(VIP Information), China Biomedical Literature Database(CBM), PubMed,Embase and Cochrane Central were independently searched to retrieve qualified randomized controlled clinical trial(RCT), and the Cochrane risk of bias tool was used to evaluate the literature quality and experimental bias. Meta-analysis and funnel plot were performed on the total clinical response rate by RevMan 5.3 software,and corresponding analysis was performed on the remission rate of mucosal injury under colonoscopy and Karnofsky performance status(KPS). SPSS Statistics 23.0 software was used for cluster analysis of the 20herbs with the highest medication frequency to obtain the main prescription rule. [Results] A total of 1 487 literatures were screened out,and 21 literatures were finally included with high quality evaluation. Twenty-one RCTs involving 1 676 radiation enteritis patients were finally included, with 849 patients in TCM internal treatment group and 827 patients in single western medicine group. The total clinical effective rate of TCM internal treatment group was significantly higher than that of single western medicine group [relative risk(RR) =1.31,95% confidence interval(CI)(1.25,1.38), P<0.01] and funnel plot showed small publication bias. The remission rate of mucosal injury under colonoscopy[RR=1.29, 95%CI(1.14,1.46),P<0.001] and KPS[standardized mean difference(SMD)=1.00, 95%CI(0.79, 1.20),P<0.01]in TCM internal treatment group were over single western medicine group. The 20 herbs with the highest frequency could be divided into two groups after cluster analysis, the main syndromes were the syndrome of dampness-heat diffusing downward and spleen deficiency and dampness resistance syndrome. Combined with basic knowledge and clinical experience, the corresponding formulas were Xianglian Pill,Gegen Qinlian Decoction and Huangqin Decoction or Shenling Baizhu Powder, BuzhongYiqi Decoction respectively. [Conclusion] TCM internal treatment can effectively relieve clinical symptoms and injury of intestinal mucosa tissue in patients with radiation enteritis, and improve the quality of life of patients. The main prescription can be classified as syndrome of dampness-heat diffusing downward and spleen deficiency and dampness resistance syndrome, and modified according to symptoms.