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乌灵胶囊联合针灸治疗肝郁脾虚证腹泻型肠易激综合征的临床疗效及安全性

Clinical Efficacy and Safety of Wuling Capsule(乌灵胶囊) Combined with Acupuncture in Treatment of Diarrhea Predominant Irritable Bowel Syndrome with Liver Depression and Spleen Deficiency Syndrome
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摘要 目的探讨乌灵胶囊联合针灸治疗肝郁脾虚证腹泻型肠易激综合征(irritable bowel syndrome with diarrhea,IBS-D)的临床疗效及安全性。方法选取肝郁脾虚证IBS-D患者140例。按随机数字表法将所有患者分为对照组和观察组,各70例。对照组给予水疗基础治疗+口服马来酸曲美布汀胶囊和乌灵胶囊治疗,观察组在对照组的治疗基础之上联合针灸治疗。评价两组患者的综合疗效和总体证候疗效,采用肠易激综合征生活质量量表(irritable bowel syndrome quality of life scale,IBS-QOL)对肝郁脾虚证IBS-D患者治疗前和疗程结束后生活质量变化情况进行评估,采用汉密顿焦虑量表(hamilton anxiety scale,HAMA)评估患者治疗前与疗程结束后焦虑程度,采用汉密顿抑郁量表(hamilton depression scale,HAMD)评估患者治疗前与疗程结束后的抑郁程度。采用酶联免疫吸附试验(enzyme linked immunosorbent assay,ELISA)检测患者血清二胺氧化酶(diamine oxidase,DAO)、D-乳酸和肠脂肪酸结合蛋白(intestinal fatty acid binding protein,IFBP)、5-羟色胺(5-hydroxyteyptamine,5-HT)、降钙素基因相关肽(calcitonin gene related peptide,CGRP)水平。结果观察组的综合疗效97.14%(68/70)高于对照组85.71%(60/70),差异有统计学意义(χ^(2)=5.833,P<0.05);观察组的总体证候疗效98.57%(69/70)高于对照组82.86%(58/70),差异有统计学意义(χ^(2)=10.260,P<0.05);观察组疗程结束后IBS-QOL评分高于对照组,差异有统计学意义(t=4.272,P<0.05),观察组疗程结束后HAMA、HAMD评分低于对照组,差异有统计学意义(t=8.535,10.534,P<0.05);观察组疗程结束后DAO、D-乳酸、IFABP水平低于对照组,差异有统计学意义(t=7.229,13.046,7.016,P<0.05);观察组疗程结束后HT、CGRP表达水平低于对照组,差异有统计学意义(t=4.620,2.027,P<0.05);观察组患者不良反应发生率8.57%(6/70)高于对照组5.71%(4/70)(χ^(2)=0.431,P>0.05)。结论乌灵胶囊联合针灸可提升临床疗效,可有效改善IBS-D患者的生活质量和焦虑抑郁状态,同时对降低DAO、D-乳酸、IFABP、5-HT、CGRP水平,缓解胃肠道症状效果显著,且安全性较高。 Objective To investigate the clinical efficacy and safety of Wuling Capsule(乌灵胶囊)combined with acupuncture in the treatment of diarrhea predominant irritable bowel syndrome(IBS-D)with liver depression and spleen deficiency syndrome.Methods A total of 140 IBS-Dpatients with liver depression and spleen deficiency syndromewere selected.All patients were randomized into control and observation groups by randomized digital tables,with 70 cases in each.The control group used Tramibutin MaleateCapsule and Wuling Capsule orallyand the observation group combined acupuncture on the basis of the control group.Irritable bowel syndrome quality of life scale(IBS-QOL)was used to evaluate the changes of quality of life of IBS-D patients with liver depression and spleen deficiency syndrome before and after treatment.The Hamilton Anxiety Scale(HAMA)was used to assess the condition of anxiety of the patients before and after treatment,and the Hamilton Depression Scale(HAMD)was used to assess the condition of depression of the patients before and after treatment.Enzyme linked immunosorbent assay(ELISA)was used to detect serum levels of diamine oxidase(DAO),D-lactic acid and intestinal fatty acid binding protein(IFABP),5-hydroxytryptamine(5-HT)and calcitonin gene-related peptide(CGRP).Results The comprehensive efficacy of the observation group was 97.14%(68/70),higher than that of the control group(85.71%,60/70)and the difference was statistically significant(χ^(2)=5.833,P<0.05).The overall syndrome efficacy of the observation group was 98.57%(69/70),higher than 82.86%(58/70)of the control group,and the difference was statistically significant(χ^(2)=10.260,P<0.05).The IBS-QOL score of the observation group was higher than that of the control group after the treatment(t=4.272,P<0.05),and the scores of HAMA and HAMD of the observation group were lower than those of the control group after the treatment(t=8.535,10.534,P<0.05).After treatment,the levels of DAO,D-lactic acid and IFABP in the observation group were lower than those in the control group(t=7.229,13.046,7.016,P<0.05).After treatment,the expression levels of HT and CGRP in the observation group were lower than those in the control group(t=4.620,2.027,P<0.05).The incidence of adverse reactions in the observation group was 8.57%(6/70),higher than 5.71%(4/70)in the control group(χ^(2)=0.431,P>0.05).Conclusion Wuling Capsule combined with acupuncture can improve the clinical efficacy,effectively improve the quality of life and relieve the anxiety and depression of IBS-D patients,and have a significant effect on reducing the levels of DAO,D-lactic acid,IFABP,5-HT and CGRP and alleviating gastrointestinal symptoms,with high safety.
作者 范青 贾峻 卢燚 FAN Qing;JIA Jun;LU Yi(Department of Neck and Waist Injuries,The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300193,China)
出处 《辽宁中医杂志》 CAS 2024年第2期139-143,共5页 Liaoning Journal of Traditional Chinese Medicine
关键词 乌灵胶囊 针灸 肝郁脾虚证IBS-D 临床疗效 不良反应 Wuling Capsule(乌灵胶囊) acupuncture and moxibustion IBS-D of liver stagnation and spleen deficiency syndrome clinical effect adverse reactions
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