摘要
目的 系统评价蒲地蓝消炎口服液辅助治疗幽门螺杆菌（Hp）感染的有效性与安全性。方法 计算机检索SinoMed、CNKI、万方、VIP、PubMed、Embase和the Cochrane library数据库，收集蒲地蓝消炎口服液联合常规根除疗法治疗 Hp 感染的随机对照试验（RCT），检索时限均为从建库至 2024年03月。根据纳入与排除标准选择2名研究人员进行文献筛选和资料提取，同时对纳入研究进行偏倚风险评价，采用RevMan 5.3软件进行Meta分析，采用TSA 0.9软件对Hp根除率进行试验序贯分析。结果 共纳入10个RCT，共1110例患者（试验组557例，对照组553例）。Meta分析结果显示：①Hp根除率：与常规根除疗法相比，蒲地蓝消炎口服液联合常规疗法可提高Hp根除率[RR=1.21, 95%CI (1.13,1.29), P <0.00001]；②总不良反应发生率：蒲地蓝消炎口服液联合常规根除疗法总不良反应发生率虽低于对照组，但差异无统计学意义[RR=0.86, 95%CI(0.64, 1.16), P =0.15]。试验序贯分析结果提示证据可靠。结论 与常规根除疗法相比，蒲地蓝消炎口服液联合常规根除疗法有利于提高Hp根除率，且没有增加不良反应发生率。受纳入研究的质量和数量的影响，上述结论有待开展多中心、高质量的RCT予以证实。
关键词： 蒲地蓝消炎口服液；幽门螺杆菌；Meta分析；试验序贯分析
Abstract
Objective To evaluate the efficacy and safety of Pudilan Xiaoyan oral liquid in the adjuvant treatment of Helicobacter pylori (Hp) infection. Methods SinoMed, CNKI, Wanfang, VIP, PubMed, Embase and the Cochrane library were searched by computer to collect the randomized controlled trial (RCT) of Pudilan Xiaoyan oral liquid combined with conventional eradication therapy for Hp infection. The search period was from the establishment of the database to March 2024. Two researchers were selected according to inclusion and exclusion criteria for literature screening and data extraction, and the risk of bias was evaluated for included studies. RevMan 5.3 software was used for meta-analysis, and TSA 0.9 software was used for sequential analysis of Hp eradication rate. Results A total of 10 RCTS were included, with a total of 1110 patients (557 patients in test group and 553 patients in control group). The results of meta-analysis showed as follows: ①Hp eradication rate: Compared with conventional eradication therapy, Pudi LAN Xiaoyan oral liquid combined with conventional therapy could improve Hp eradication rate [RR=1.21, 95%CI (1.13,1.29), P <0.00001]; ② Incidence of total adverse reactions: Although the incidence of total adverse reactions of Pudilan Xiaoyan oral liquid combined with conventional eradication therapy was lower than that of control group, the difference was not statistically significant [RR=0.86, 95%CI(0.64, 1.16), P =0.15]. The results of sequential analysis suggest that the evidence is reliable. Conclusion Compared with conventional eradication therapy, Pudilan Xiaoyan oral liquid combined with conventional eradication therapy can improve the eradication rate of Hp, and does not increase the incidence of adverse reactions. Subject to the quality and quantity of included studies, these conclusions need to be confirmed by multicenter, high-quality RCTS.
Key words： Pudilan anti-inflammatory oral liquid; Helicobacter pylori; Meta-analysis; Sequential analysis of experiments
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