摘要
目的:观察加味左金丸颗粒剂治疗反流性食管炎(RE)及功能性消化不良(FD)两种疾病相同证候(肝胃不和证)患者的临床疗效。方法:采取随机、双盲、安慰剂对照临床试验的方法,共纳入144例肝胃不和证患者,其中包括72例反流性食管炎(RE)患者和72例功能性消化不良(FD)患者。随后,这些患者被随机分为观察组和对照组,每组不同疾病的患者数量均为36例。观察组予加味左金丸颗粒剂口服,对照组予安慰剂颗粒口服,两组均每日2次,每次2袋,疗程4周。比较两组患者治疗前后中医证候积分及脑肠肽[降钙素基因相关钛(CGRP)、血管活性肠肽(VIP)、5-羟色胺(5-HT)、P物质(SP)]、炎症因子[肿瘤坏死因子-α(TNF-α)、白细胞介素-6(IL-6)]及常见的胃肠相关激素[胃泌素(GAS)、胃动素(MTL)]等指标的变化,判定中医证候疗效及不良反应发生情况。同时分析同一疾病下两组患者上述指标变化情况及中医证候疗效。结果:与本组治疗前比较,观察组和对照组患者CGRP、VIP、5-HT、SP、TNF-α、IL-6、GAS、MTL及中医证候评分在治疗后均有明显改善(P<0.05)。治疗后观察组患者CGRP、VIP、5-HT、SP、TNF-α、IL-6、GAS、MTL及中医证候评分改善情况均优于对照组(P<0.05)。与本组治疗前比较,两组RE患者及两组FD患者CGRP、VIP、5-HT、SP、TNF-α、IL-6、GAS、MTL及中医证候评分在治疗后均有明显改善(P<0.05)。与对照组治疗后比较,观察组RE患者和观察组FD患者CGRP、VIP、5-HT、SP、TNF-α、IL-6、GAS、MTL及中医证候评分改善情况均优于对照组(P<0.05)。在观察组和对照组中,恶心呕吐、乏力、口干等不良反应的发生率均较低,差异无统计学意义。结论:加味左金丸颗粒剂能有效改善RE和FD 2种不同疾病肝胃不和证的中医证候及脑肠肽、胃肠激素及炎症因子,为中医“异病同治”理论的临床应用提供了佐证。
Objective:To observe the clinical efficacy of modified Zuojinwan granules in treating reflux esophagitis(RE)and functional dyspepsia(FD)with the same syndrome with disharmony between liver and stomach).Method:A randomized double-blind placebo-controlled clinical trial was conducted to enroll 144 patients with disharmony between liver and stomach,including 72 patients with RE and 72 patients with FD.These patients were then randomly divided into observation and control groups,with 36 patients in each group.The observation group was given modified Zuojinwan granules orally,and the control group was given placebo granules orally.They both were treated with two packs each time,twice a day,for four weeks.The traditional Chinese medicine(TCM)syndrome scores,cerebrointestinal peptides[calcitonin geneassociated titanium(CGRP),vasoactive intestinal peptide(VIP),5-hydroxytryptamine(5-HT),and substance P(SP)],inflammatory factors[tumor necrosis factor-α(TNF-α)and interleukin-6(IL-6)],common gastrointestinal related hormones[gastrin(GAS)and motilin(MTL)],and other indicators in the two groups were compared before and after treatment,and the curative effect of TCM syndromes and the occurrence of adverse reactions were determined.At the same time,the changes in the above indicators and the curative effect of TCM syndromes in the two groups of patients with the same disease were analyzed.Result:After treatment,CGRP,VIP,5-HT,SP,TNF-α,IL-6,GAS,MTL,and TCM syndrome scores in the observation group and control group were significantly improved(P<0.05).After treatment,the improvement of CGRP,VIP,5-HT,SP,TNF-α,IL-6,GAS,MTL,and TCM syndrome scores in the observation group was better than that in the control group(P<0.05).After treatment,CGRP,VIP,5-HT,SP,TNF-α,IL-6,GAS,MTL,and TCM syndrome scores in both groups of RE patients and FD patients were significantly improved(P<0.05).After treatment,the improvement of CGRP,VIP,5-HT,SP,TNF-α,IL-6,GAS,MTL,and TCM syndrome scores in RE patients and FD patients in the observation group were better than that in the control group(P<0.05).In the observation group and the control group,the incidence of nausea,vomiting,fatigue,dry mouth,and other adverse reactions was lower,and there was no statistical significance.Conclusion:Modified Zuojinwan granules can effectively improve the TCM syndromes of disharmony between liver and stomach of RE and FD,brain and intestinal peptide,gastrointestinal hormone,and inflammatory factors and provide evidence for the clinical application of TCM theory of"treating different diseases with the same method".
作者
王光铭
刘万里
杨璐
吴昊
黄玉珍
WANG Guangming;LIU Wanli;YANG Lu;WU Hao;HUANG Yuzhen(Nanjing Hospital of combination of Chinese Traditional and Western Medicine,Nanjing 210014,China;Nanjing Hospital(Nanjing First Hospital)Affiliated to Nanjing Medical University,Nanjing 210006,China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2024年第12期112-120,共9页
Chinese Journal of Experimental Traditional Medical Formulae
基金
国家自然科学基金面上项目(82174125)
南京中医药大学自然科学基金项目(XZR2020073)
南京市卫生科技发展专项(YKK22189)
江苏省中医药领军人才培养项目(苏中医科教[2018]4号)。
关键词
反流性食管炎
功能性消化不良
肝胃不和证
加味左金丸颗粒剂
异病同治
reflux esophagitis
functional dyspepsia
disharmony between liver and stomach
modified Zuojinwan granules
treating different diseases with the same method
