【目的】观察肠安菌泰颗粒（由太子参、白术、茯苓、炙甘草、白芍、防风、陈皮、黄连、木香等中药组成）治疗肝郁脾虚型腹泻型肠易激综合征（IBS-D）的临床疗效，并评价其安全性。【方法】采用单中心、随机、双盲、安慰剂对照临床试验设计，共纳入130例肝郁脾虚型IBS-D患者，采用随机数字表法将患者随机分为治疗组和对照组，每组各65例。治疗组给予肠安菌泰颗粒治疗，对照组给予肠安菌泰安慰剂颗粒治疗，疗程为12周。观察2组患者治疗前后IBS症状严重程度量表（IBS-SSS）、Bristol粪便性状分型量表（BSFS）、IBS生活质量量表（IBS-QOL）、医院焦虑与抑郁量表（HADS）评分的变化情况，并评估2组患者的临床疗效和用药安全性。【结果】（1）脱落情况方面，研究过程中，治疗组脱落6例，对照组脱落8例，最终共有116例患者完成临床研究，其中治疗组59例，对照组57例。（2）临床疗效方面，治疗12周后，治疗组的总有效率为88.14%（52/59），对照组为45.61%（26/57），组间比较（χ2检验），治疗组的临床疗效明显优于对照组，差异有统计学意义（P＜0.01）。（3）量表评分方面，治疗后，2组患者的IBS-SSS评分及治疗组的BSFS和IBS-QOL评分均较治疗前明显降低（P＜0.01），而2组患者的医院焦虑量表（HADA）和医院抑郁量表（HADD）评分及对照组的BSFS和IBS-QOL评分均较治疗前无明显降低（P＞0.05）；组间比较，治疗组对IBS-SSS、BSFS和IBS-QOL评分的降低幅度均明显优于对照组（P＜0.05或P＜0.01）。（4）安全性方面，在整个试验过程中，2组患者均未发生严重不良反应和不良事件，也未发现与药物有关的肝肾功能异常、血液和心功能异常等情况。【结论】肠安菌泰颗粒可有效改善肝郁脾虚型IBS-D患者的临床症状和大便性状，提高患者的生活质量，疗效确切且安全性高，具有一定的临床推广应用价值。

Objective To observe the clinical efficacy of Chang’an Juntai Granules（mainly composed of Pseudostellariae Radix，Atractylodis Macrocephalae Rhizoma，Poria，Glycyrrhizae Radix et Rhizoma Praeparata cum Melle，Paeoniae Radix Alba，Saposhnikoviae Radix，Citri Reticulatae Pericarpium，Coptidis Rhizoma，and Aucklandiae Radix）in the treatment of diarrhea-predominant irritable bowel syndrome（IBS-D）with liver depression and spleen deficiency syndrome，and to evaluate its safety. Methods A single-center，randomized，double-blind，placebo-controlled clinical trial was designed. A total of 130 patients with IBS-D of liver depression and spleen deficiency were included. The patients were randomly divided into a treatment group and a control group by random number table method，with 65 cases in each group. The treatment group was treated with Chang’an Juntai Granules，and the control group was treated with Chang’an Juntai Placebo Granules. The course of treatment covered 12 weeks. The changes in the scores of IBS Symptom Severity Scale（IBS-SSS），Bristol Stool Form Scale（BSFS），IBS Quality of Life Questionnaire（IBS-QOL）and Hospital Anxiety and Depression Scale（HADS）in the two groups were observed before and after treatment. After treatment，the clinical efficacy and medication safety in the two groups were evaluated. Results （1）During the trial，six cases in the treatment group and eight cases in the control group fell off. Eventually，a total of 116 patients completed the clinical trial，including 59 cases in the treatment group and 57 cases in the control group.（2）After 12 weeks of treatment，the total effective rate of the treatment group was 88.14%（52/59），and that of the control group was 45.61%（26/57）. The intergroup comparison（tested by chi-square test）showed that the clinical efficacy of the treatment group was significantly superior to that of the control group，and the difference was statistically significant（P＜0.01）.（3）After treatment，the IBS-SSS scores of the two groups and the BSFS and IBS-QOL scores of the treatment group were significantly lower than those before treatment（P＜0.01），while the scores of Hospital Anxiety and Depression Scale-Anxiety subscale（HADA）and Hospital Anxiety and Depression Scale-Depression subscale（HADD）in the two groups and the BSFS and IBS-QOL scores in the control group showed no obvious changes（P＞0.05）. Compared with the control group，the decrease of IBS-SSS，BSFS and IBS-QOL scores in the treatment group was significantly superior to that in the control group（P＜0.05 or P＜0.01）.（4）During the trial，no serious adverse reactions or adverse events occurred in the two groups，no drug-related abnormalities of liver and kidney function，blood，and heart function were found，either. Conclusion Chang’an Juntai Granules are effective on improving the clinical symptoms and fecal characteristics of IBS-D patients with liver depression and spleen deficiency syndrome，and on enhancing the quality of life of patients. The granules excert definite curative effect and high safety，and has certain value of clinical application.

R259.744

国家自然科学基金项目 （编号：81804047，82174303）；刘凤斌广东省名中医传承工作室项目[粤中医办函 （2020） 1号]