贺忠宁 王宝泉 张培彤

摘要 目的：系统评价甘草泻心汤加味治疗放化疗后口腔溃疡的疗效。方法：全面检索国家知识基础设施数据库（CNKI）、PubMed等8个中英文数据库，收集甘草泻心汤加味治疗放化疗后口腔溃疡的随机对照试验学术论文，从建库至2020年9月为各数据库的检索时限，选取2位评价员筛查挑选文献、数据提取、评价偏倚风险后，应用RevMan 5.3对研究数据进行Meta分析。結果：初步检索到476篇文献，剔除重复及不符合纳入标准的文献后，最终纳入8个RCT，包括553例患者，观察组279例，对照组274例。甘草泻心汤加味治疗放化疗后口腔溃疡的总有效率（RR 1.29，95%CI为1.19～1.40，P<0.000 01）、愈合时间（MD-3.16，95%CI为-4.65～-1.67，P<0.000 1）、第5天疼痛缓解率（RR 1.72，95%CI为1.32～2.24，P<0.000 1）、第7天疼痛缓解率（RR 1.41，95%CI为1.20～1.66，P<0.000 1）等结局，与对照组比较，差异有统计学意义;亚组分析结果显示：与生理盐水组比较，在治疗有效率上，甘草泻心汤更高（RR 1.29，95%CI为1.16～1.43，P<0.000 01）。结论：根据现有的文献资料，甘草泻心汤是治疗放、化疗后口腔溃疡的一个有效方剂。但限于纳入的研究的质量、数量，本研究结果的证实要求未来更高质量、更大样本的研究。

关键词 甘草泻心汤;放疗;化疗;癌症;口腔溃疡;观察组;对照组;系统评价

Systematic Review of Modified Gancao Xiexin Decoction in the Treatment of Oral Ulcer after Radiotherapy and Chemotherapy

HE Zhongning1，2，WANG Baoquan1，2，ZHANG Peitong2

（1 Beijing University of Chinese Medicine，Beijing 100029，China; 2 Guang′anmen Hospital，China Academy of Chinese Medical Science，Beijing 100053，China）

Abstract Objective：To systematically evaluate the effects of modifed Gancao Xiexin Decoction on oral ulcer after radiotherapy and chemotherapy.Methods：A comprehensive search of 8 Chinese and English databases such as the National Knowledge Infrastructure Database（CNKI）and PubMed，and the collection of randomized controlled trials academic papers on the treatment of oral ulcers after radiotherapy and chemotherapy with Gancao Xiexin Decoction，from the establishment of the database to September 2020 were retrieved.476 papers were initially retrieved.After excluding duplicates and documents that did not meet the inclusion criteria，8 RCTs were finally included，including 553 patients，279 cases in the test group，and 274 cases in the control group.2 reviewers were selected for screening and selection.After literature selection，data extraction，and evaluation of the risk of bias，RevMan 5.3 was used to conduct a meta-analysis of the research data.Results：The total effective rate of modifed Gancao Xiexin Decoction in the treatment of radiation and chemotherapy in patients with oral ulcers（RR 1.29，95%CI 1.19 to 1.40，P<0.000 01）; Healing time（MD-3.16，95%CI-4.65 to -1.67，P<0.000 1），the pain relief rate on the 5th day（RR 1.72，95%CI 1.32 to 2.24，P<0.000 1）; the pain relief rate on the 7th day（RR 1.41，95%CI 1.20 to 1.66，P<0.000 1），there was significant difference between the 2 groups; Subgroup analysis indicates：Compared with normal saline group，Ganxiexin Decoction was more effective in treating oral ulcers after radiotherapy and chemotherapy（R 1.29，95%CI 1.16 to 1.43，P<0.000 1）.Conclusion：According to the existing literature，Gancao Xiexin Decoction is an effective prescription for the treatment of oral ulcers after radiotherapy and chemotherapy.But limited to the quality and quantity of the included studies，the verification of the results of this study requires higher quality and larger samples in future studies.

Keywords Gancao Xiexin Decoction; Radiotherapy; Chemotherapy; Cancer; Mouth ulcers; Test group; Control group; System evaluation

中图分类号：R289.5文献标识码：Adoi：10.3969/j.issn.1673-7202.2021.09.013

口腔溃疡作为放射疗法或化学疗法治疗癌症的主要不良反应，以口腔黏膜红斑性、糜烂性、疼痛性溃疡样改变为主要表现[1]。口腔溃疡发生在几乎所有接受头颈部放射治疗，80%接受大剂量化学治疗，以及20%～40%常规化疗的癌症患者中[2]。口腔溃疡的特征是黏膜破裂，导致广泛、深层溃疡，出现严重疼痛，甚至继发感染，增加菌血症和败血症的风险[3]。“口疮”“口疡”“口糜”等可作为放化疗后口腔溃疡的中医病名。目前国内外对放化疗后口腔溃疡的治疗多以局部消炎止痛为主，使用的西药包括激素、抗生素、生长因子、维生素等，具体治疗方案尚未达成共识[4-5]。《伤寒论》是甘草泻心汤的出处，甘草、半夏、黄连、黄芩、干姜、大枣、人参是其药物构成，各药合用……