逍遥散合四磨汤加减对便秘型肠易激综合征肝郁气滞证脑-肠轴的影响

Effect of Addition and Subtraction Therapy of Xiaoyaosan Combined with Simotang to Gut-brain Axis of Patients with Irritable Bowel Syndrome with Predominant Constipation and Syndrome of Stagnation of Liver Qi

目的:观察逍遥散合四磨汤加减治疗便秘型肠易激综合征(IBS-C)肝郁气滞证的临床疗效及对脑-肠轴的影响作用。方法:将144例患者采用随机按数字表法,按1∶1分为观察组和对照组各72例。对照组脱落、失访2例,剔除4例,完成66例;观察组脱落、失访2例,剔除5例,完成65例。对照组口服四磨汤口服液,20 mL/次,3次/d。观察组给予逍遥散合四磨汤加减内服,1剂/d。两组疗程均为连续治疗4周。进行治疗前后腹痛程度,肠易激综合征(IBS)症状严重程度量表(IBS-SSS),肠易激综合征生活质量(IBS-QOL),肝郁气滞证、汉密顿焦虑量表-14(HAMA-14)和汉密顿抑郁量表-17(HAMD-17)评分,记录每周的完全自主排便次数(CSBM),记录治疗后腹痛应答率、排便应答率和IBS-SSS缓解率;检测治疗前后血管活性肠肽(VIP),P物质(SP),神经肽Y(NPY),5-羟色胺(5-HT),生长抑素(SS)和降钙素相关基因肽(CGRP)水平;并进行安全性评价。结果:观察组腹痛程度,IBS-SSS和肝郁气滞证评分均低于对照组(P<0.01),CSBM次数多于对照组(P<0.01);观察组IBS-QOL评分高于对照组(P<0.01),HAMA-14和HAMD-17评分均低于对照组(P<0.01);观察组VIP,NPY,5-HT,SS和CGRP水平均低于对照组(P<0.01),SP水平高于对照组(P<0.01);观察组腹痛应答率、排便应答率和IBS-SSS缓解率分别为95.38%(62/65),93.85%(61/65)和90.77%(59/65),分别于高于对照组的83.33%(55/66),78.79%(52/66)和75.76%(50/66),比较差异均有统计学意义(P<0.05);观察组中医证候疗效优于对照组(Z=2.1034,P<0.05);研究过程患者均没有发生严重不良事件,未发现与中药相关不良反应。结论:逍遥散合四磨汤加减内服治疗IBS-C肝郁气滞证可显著改善IBS-C症状,并能减轻不良情绪,提高患者生活质量,还能调节多种脑肠肽因子,改善脑-肠轴紊乱情况,有着较好的临床疗效与安全性。

Objective: To observe clinical effect of addition and subtraction therapy of Xiaoyaosan combined with Simotang to irritable bowel syndrome with predominant constipation(IBS-C)and syndrome of stagnation of liver Qi and to study influence to gut-brain axis. Method: One hundred and forty-four patients were randomly divided into control group(72 cases)and observation group(72 cases)by random number table.The 66 patients in control group completed the therapy(2 patients were falling off or missing visit,5 patients were eliminate),65 patients in observation group completed the therapy(4 patients were falling off or missing visit,2 patients were eliminate). Patients in control group got Simotang,20 mL/time,3 times/day. In control group,patients in observation group added addition and subtraction therapy of Xiaoyaosan combined with Simotang,1 dose/day. And courses of treatment in two groups were 4 weeks. Before and after treatment,degree of abdominal pain,irritable bowel syndrome(IBS)symptom severity scale(IBS-SSS),quality of life in irritable bowel syndrome(IBS-QOL),syndrome of stagnation of liver Qi,scores of Hamilton anxiety scale-14(HAMA-14),Hamilton depression scale-17(HAMD-17),complete spontaneous bowel movement(CSBM),response rate of abdominal pain and defecation,remission rate of IBS-SSS were all recorded. And levels of vasoactive intestinal peptide(VIP),substance P(SP),neuropeptide Y(NPY),5-hydroxytryptamine(5-HT),somatostatin(SS)and calcitonin related gene peptide were detected,and safety was evaluated. Result: Degree of abdominal pain,scores of IBS-SSS,syndrome of stagnation of liver Qi,HAMA-14,HAMD-17 and levels of VIP,NPY,5-HT,SS and CGRP in observation group were all lower than those in control group(P<0.01). And times of CSBM,score of IBS-QOL and level of SP were all higher than those in control group(P<0.01). Besides,response rate of abdominal pain and defecation and remission rate of IBS-SSS in observation group 95.38%(62/65),93.85%(61/65)and 90.77%(59/65)were higher than 83.33%(55/66),78.79%(52/66)and 75.76%(50/66)in control group(P<0.05). And curative effect of traditional Chinese medicine(TCM)syndromes in was better than that in control group(Z=2.1034, P<0.05). No serious adverse events happened and no adverse reaction caused by TCM.Conclusion: Addition and subtraction therapy of Xiaoyaosan combined with Simotang can significantly ameliorate IBS-C symptoms,reduce bad mood,improve patients’ quality of life,regulate a variety of brain gut peptide factors,and improve brain gut axis disorder. It has good clinical efficacy and safety.