Therapeutic Evaluation of Irritable Bowel Syndrome with Diarrhea Treated by Warming the Spleen and Stomach and Nourishing the Gut

doi:10.12114/j.issn.1007-9572.2019.00.530

Abstract

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

摘要： 背景　腹泻型肠易激综合征（IBS-D）发病机制不明确，诱发因素较多，发病率增高，尚缺乏特异性临床诊断指标，且治疗后病情极易反复。目的　评价实脾散治疗脾虚湿阻型IBS-D的临床疗效及对胃肠激素水平的影响。方法　2017年9月—2018年10月，将65例IBS-D患者按随机数字表法随机分为中药组33例，采用实脾散煎汤口服，西药组32例口服匹维溴铵片，两组均用药4周。分别于治疗前、治疗2周、治疗4周及停药3个月检测血清P物质（SP）、5-羟色胺（5-HT）、血管活性肠肽（VIP）、白介素10（IL-10）和白介素1β（IL-1β）水平，应用IBS症状尺度表（IBS-BSS）、IBS生活质量问卷（IBS-QOL）、中医证候疗效评分表（TCM-PES）评估两组临床疗效、生活质量、中医证候疗效及复发情况。结果　65例患者治疗过程中共脱落5例，中药组失访2例，西药组3例（失访1例，放弃治疗2例），60例（92.3%）纳入符合方案分析集。治疗2周、治疗4周及停药3个月中药组血清SP、5-HT、VIP、IL-1β水平低于西药组（P<0.05），IL-10水平高于西药组（P<0.01）。治疗后两组IBS-BSS的5个项目积分及总积分比较，差异有统计学意义（P<0.05）；IBS-QOL除躯体意念、人际关系2个维度外，其余6个维度积分比较，差异有统计学意义（P<0.05）。治疗2、4周中药组中医证候疗效优于西药组，差异有统计学意义（P<0.05）。停药3个月，中药组3例复发，西药组6例复发，差异有统计学意义（χ2=9.506，P=0.033）。结论　实脾散能有效缓解IBS-D临床症状，改善患者生活质量，调整胃肠激素水平，且复发率低，中远期疗效确切。

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

ZHAO Hongbo,WU Xiaojing,YANG Yun, et al. Therapeutic Evaluation of Irritable Bowel Syndrome with Diarrhea Treated by Warming the Spleen and Stomach and Nourishing the Gut　[J]. Chinese General Practice, 2019, 22(25): 3137-3143. DOI: 10.12114/j.issn.1007-9572.2019.00.530.
赵红波,吴晓晶,杨云等. “温中厚肠”法治疗腹泻型肠易激综合征临床疗效评价[J]. 中国全科医学, 2019, 22(25): 3137-3143. DOI: 10.12114/j.issn.1007-9572.2019.00.530.

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