柴胡疏肝散合旋覆代赭汤治疗肝胃不和型Barrett食管的临床观察

Clinical Observation on Chaihu Shugansan Combined with Xuanfu Daizhetang in Treating Barrett's Esophagus with Liver-stomach Disharmony

摘要:

目的 观察柴胡疏肝散合旋覆代赭汤治疗肝胃不和型Barrett食管（BE）的临床疗效及安全性。方法 通过随机、平行、对照、双盲试验，以符合纳入标准的BE患者为研究对象，随机分为观察组和对照组，每组各34人，观察组采用柴胡疏肝散合旋覆代赭汤联合奥美拉唑胶囊治疗，对照组采用柴胡疏肝散合旋覆代赭汤模拟剂联合奥美拉唑胶囊，治疗周期为12周，以中医证候积分、临床疗效、BE病变面积、BE病理组织学改变、胆汁酸谱结果为疗效指标，共同评价两组临床疗效及安全性。结果 最终完成试验并纳入统计者62例，观察组32例，对照组30例，两组患者基线人口学资料和疾病特征差异无统计学意义，具有可比性。观察组临床总有效率（93.7%，30/32）优于对照组（60.0%，18/30）（χ²=24.766，P<0.05）；治疗后，观察组病变组织病理学疗效总有效率（62.5%，20/32）优于对照组（23.3%，7/30）（χ²=10.270，P<0.05）；观察组食管病变面积改变疗效总有效率（21.9%，7/32）优于对照组（6.7%，2/30），但差异无统计学意义，即两组方案在缩减BE病灶面积方面优势不明显；治疗后与对照组比较，观察组能有效调节胆汁酸谱代谢水平，为进一步探讨本方治疗BE的作用机制指明了方向；治疗期间两组患者安全指标均未出现具有临床意义的异常改变。结论 柴胡疏肝散合旋覆代赭汤对于肝胃不和型BE患者中医临床证候、病理组织学、胆汁酸谱的改善优于对照组，在改善病灶面积方面存在一定潜力，该方用于肝胃不和型BE患者的临床治疗安全有效，值得临床深入研究及推广应用。

Abstract:

Objective To observe the clinical efficacy and safety of Chaihu Shugansan combined with Xuanfu Daizhetang （CHSG-XFDZ） in the management of Barrett's esophagus （BE） with liver-stomach disharmony.Method A randomized， parallel， controlled， double-blind clinical trial was conducted. BE patients who met the inclusion criteria were randomized into an observation group and a control group， with 34 patients in each group. The observation group was treated with CHSG-XFDZ combined with omeprazole capsules， and the control group was treated with CHSG-XFDZ mimetic combined with omeprazole capsules. Both groups were treated for 12 weeks. The traditional Chinese medicine （TCM） symptom scores， response rate， BE lesion area， BE pathological changes， and bile acid profile were taken as the indicators to jointly evaluate the clinical efficacy and safety of the two groups.Result A total of 62 patients who completed the trial were included for statistical analysis， including 32 in the observation group and 30 in the control group. There were no statistically significant differences in baseline demographics or disease characteristics between two groups， which suggested that the two groups were comparable. The total response rate in the observation group was 93.7% （30/32）， which was higher than that （60.0%， 18/30） in the control group （χ²=24.766， P<0.05）. After treatment， the response rate regarding the pathological changes in the observation group was 62.5% （20/32）， which was higher than that （23.3%， 7/30） in the control group （χ²=10.270， P<0.05）. The response rate regarding the BE lesion area change in the observation group was 21.9% （7/32）， which had no statistically significant difference from that （6.7%， 2/30） in the control group， which indicated that the advantages of the two regimens were not obvious in terms of reducing the area of BE lesions. Compared with the control group after treatment， the observation group regulated the bile acid profile， which pointed out the direction for further exploring the mechanism of CHSG-XFDZ in treating BE. Neither group showcased adverse reactions with clinical significance during the treatment period.Conclusion CHSG-XFDZ outperformed the control group in terms of alleviating TCM symptoms， ameliorating pathological changes， and improving the bile acid profile in the BE patients with liver-stomach disharmony. It demonstrates certain potential in reducing the lesion area. This formula is safe and effective in treating BE patients with liver-stomach disharmony and deserves further clinical research and widespread application.