Li Shaowei, Huang Mengfen, Wu Guojing, Huang Weihan, Huang Zhanhui, Yang Xiaoqian, Ou Jinming, Wei Qipeng, Liu Chengli, Yu Shaoyuan
Guangzhou University of Chinese Medicine, Guangzhou, China.
Department of Otolaryngology, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China.
Front Pharmacol. 2020 Feb 27;11:76. doi: 10.3389/fphar.2020.00076. eCollection 2020.
Based on 122 cases reported in China, data mining indicated that Sini Powder (SNP) and the Zuojin Pill (ZJP) are both widely used as the basic recipe for treating Gastroesophageal Reflux Disease (GERD).
To evaluate the intervention effects of Sini Zuojin Decoction (SNZJD) in patients with GERD.
A comprehensive collection of randomized controlled trials (RCTs) using SNZJD in patients with GERD that were published in domestic and foreign journals was made by computer retrieval. RevMan 5.3 software was used for meta-analysis and bias risk assessment, Stata 14.0 software was used for sensitivity analysis, GRADE profiler 3.6 was used to evaluate the level of evidence, and trial sequential analysis (TSA), employed to control for random errors, was performed to assess the main outcomes. Network pharmacology analysis was applied to preliminarily study the mechanisms of action of SNZJD on GERD.
Thirteen articles were eventually included, covering a total of 966 patients. Meta-analysis indicated that: ① the SNZJD plus traditional stomach medicines (SPTSM) group was more effective than the traditional stomach medicines (TSM) group (RR = 1.16, 95% CI [1.04, 1.29], P = 0.009); ② the experimental group with SNZJD was significantly better than TSM controls in improving heartburn, substernal chest pain, acid regurgitation, and food regurgitation symptoms (P < 0.0001); ③ SPTSM could significantly decrease total symptom scores with substantial effectiveness (P < 0.00001). The recurrence rate and adverse effects of SNZJD treatment were significantly reduced (P < 0.05). TSA showed that the effective rate of meta-analysis might be reliable, but the recurrence and safety results were still uncertain. According to the evaluation by the GRADE method, the quality of evidence was low. Besides, SNZJD might treat GERD by acting on related targets and pathways such as inflammation, hormone regulation, and so on.
SNZJD might be useful in the treatment of GERD, but its long-term effects and specific clinical mechanisms are unclear. Due to the poor quality of the evidence, more samples and high-quality clinical studies should be tested and verified in the future.
基于中国报告的122例病例，数据挖掘表明四逆散（SNP）和左金丸（ZJP）均被广泛用作治疗胃食管反流病（GERD）的基础方剂。
评价四逆左金汤（SNZJD）对GERD患者的干预效果。
通过计算机检索全面收集国内外期刊发表的使用SNZJD治疗GERD患者的随机对照试验（RCT）。采用RevMan 5.3软件进行Meta分析和偏倚风险评估，Stata 14.0软件进行敏感性分析，GRADE profiler 3.6用于评估证据水平，并采用试验序贯分析（TSA）控制随机误差，以评估主要结局。应用网络药理学分析初步研究SNZJD对GERD的作用机制。
最终纳入13篇文章，共966例患者。Meta分析表明：①四逆左金汤联合传统胃药（SPTSM）组比传统胃药（TSM）组更有效（RR = 1.16，95%CI [1.04, 1.29]，P = 0.009）；②SNZJD实验组在改善烧心、胸骨后胸痛、反酸和食物反流症状方面明显优于TSM对照组（P < 0.0001）；③SPTSM可显著降低总症状评分，疗效显著（P < 0.00001）。SNZJD治疗的复发率和不良反应明显降低（P < 0.05）。TSA显示Meta分析的有效率可能可靠，但复发和安全性结果仍不确定。根据GRADE方法评估，证据质量较低。此外，SNZJD可能通过作用于炎症、激素调节等相关靶点和途径治疗GERD。
SNZJD可能对GERD治疗有用，但其长期效果和具体临床机制尚不清楚。由于证据质量较差，未来应进行更多样本和高质量的临床研究进行验证。
