关键词: 肠易激综合征, 胃肠激素类, 生活质量, 疗效比较研究, 脾虚湿阻

Abstract: Background　The pathogenesis of irritable bowel syndrome with diarrhea（IBS-D）is not clear.It has many precipitating factors，and high incidence，and is easily to recur，but has no specific clinical diagnostic index.Objective　To evaluate the clinical and gastrointestinal hormone responses to Shipi Decoction in IBS-D patients with spleen deficiency with dampness obstruction syndrome.Methods　From September 2017 to October 2018，sixty-five IBS-D patients were randomly divided into TCM group（33 cases）and western medicine group（32 cases）by use of a random number table，receiving a 4-week oral administration of Shipi Decoction，and Dicetel，respectively.Serum levels of substance P（SP），5-hydroxytryptamine（5-HT），vasoactive intestinal peptide（VIP），interleukin-10（IL-10） and interleukin-1β（IL-1β）were measured before treatment，at the end of the 2nd and 4th weeks of treatment and at 3 months after withdrawal，respectively.IBS Bowel Symptom Severity Scale（IBS-BSS），IBS Quality of Life Questionnaire（IBS-QOL）and Traditional Chinese Medicine Pattern Curative Effect Scoring System（TCM-PES）were used to evaluate the clinical efficacy，quality of life，improvement of TCM syndromes and relapse，respectively.Results　Five cases dropped out during the treatment（2 cases were lost in TCM group，1 was lost and 2 abandoned treatment in western medicine group），the remaining 60 cases（92.3%）were included in the per-protocol analysis.TCM group showed lower post-treatment mean serum levels of SP，5-HT，VIP and IL-1β（P<0.05）and higher post-treatment mean IL-10 level（P<0.01）compared with western medicine group at the end of the 2nd and 4th weeks of treatment and at 3 months after withdrawal.After treatment，there were significant differences in scores of 5 items and total scores of IBS-BSS between the two groups（P<0.05）.Except for the scores of two subscales（body image and relationships），the scores of other 6 subscales of IBS-QOL differed significantly between the groups（P<0.05）.The improvements in TCM syndromes in TCM group were better than those of western medicine group at the end of the 2nd and 4th weeks of treatment（P<0.05）.After 3 months of withdrawal，recurrence occurred in 3 cases in TCM group and in 6 cases in western medicine group，showing significant difference（χ2=9.506，P=0.033）.Conclusion　For patients with IBS-D，Shipi Decoction could effectively relieve the clinical symptoms，improve the quality of life，and regulate gastrointestinal hormone levels with low recurrence rate，indicating it has a definite medium- and long-term efficacy.

Key words: Irritable bowel syndrome, Gastrointestinal hormones, Quality of life, Comparative effectiveness research, Splenic asthenia and obstruction of dampness