Clinical observation of Xiangchai Shuyu Decoction combined with probiotics in treating constipation irritable bowel syndrome with liver depression and Qi stagnation syndrome
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摘要: 目的 观察香柴舒郁汤联合益生菌治疗肝郁气滞证便秘型肠易激综合征(constipation-predominant irritable bowel syndrome,IBS-C)的临床疗效。方法 将诊断为肝郁气滞证IBS-C的90例患者随机分为对照组和治疗组,每组各45例。对照组予双歧杆菌三联活菌肠溶胶囊治疗,治疗组在对照组基础上加用香柴舒郁汤治疗。连续治疗4周,观察两组患者治疗前、治疗4周后中医证候积分改善情况,采用汉密尔顿焦虑量表(Hamilton anxiety scale,HAMA)、汉密尔顿抑郁量表(Hamilton depression scale,HAMD)评估患者精神心理状况;检测肠道菌群变化,并比较两组患者的临床有效率和不良反应发生率。结果 治疗后两组患者的中医证候均改善,且治疗组腹痛腹胀、排便频率、大便性状、嗳气频作、胸闷不舒、两胁胀痛改善效果优于对照组(P < 0.05),而在排便状况方面两组改善效果差异无统计学意义(P>0.05);两组患者的HAMA、HAMD评分均有不同程度降低,且治疗组评分降低更显著(P < 0.05);两组患者的肠道双歧杆菌、乳杆菌水平均升高而肠杆菌水平下降,且治疗组双歧杆菌及乳杆菌水平高于对照组,肠杆菌水平低于对照组(P < 0.05);两组不良反应发生率比较差异无统计学意义(P>0.05);治疗组总有效率为92.86%,高于对照组的73.81%(P < 0.05)。结论 香柴舒郁汤联合益生菌治疗肝郁气滞证IBS-C临床疗效显著,同时可有效舒缓患者的不良情绪,优化肠道菌群,且安全性较高。Abstract: Objective To observe the clinical effect of Xiangchai Shuyu Decoction combined with constipation-predominant irritable bowel syndrome(IBS-C) with liver depression and Qi stagnation.Methods Ninety patients with IBS-C with liver depression and Qi stagnation syndrome were randomly divided into the control group and the treatment group, 45 patients in each group. The control group was treated with Bifidobacterium triple live bacteria enteric-coated capsules, while the treatment group was treated with Xiangchai Shuyu Decoction on the basis of the control group. After 4 weeks' continuous treatment, the improvement of Traditional Chinese Medicine(TCM) syndrome score in the two groups was observed before and after 4 weeks' treatment. The mental and psychological status of patients was evaluated by Hamilton anxiety scale(HAMA) and Hamilton depression scale(HAMD), and the changes of intestinal flora were detected. The clinical effective rate and incidence of untoward effects were compared between the two groups.Results The TCM syndromes of all patients in both groups had improved after treatment, and the improvement effects of abdominal pain, abdominal distension, defecation frequency, stool characteristics, frequent belching, chest tightness and hypochondriac pain in the treatment group was superior to that of the control group(P < 0.05), while there was no difference in defecation status between the two groups(P>0.05). The scores of HAMA and HAMD in both groups were decreased in different degrees, and the score in the treatment group was more significantly decreased(P < 0.05). The levels of intestinal bifidobacteria and lactobacilli in both groups increased, while the levels of enterobacteriaceae decreased. The levels of bifidobacteria and lactobacilli in the treatment group were higher than those in the control group, while the levels of enterobacteriaceae were lower than those in the control group(P < 0.05). Comparing the occurrence rate of untoward effects of two groups, there was no obvious difference(P>0.05). The aggregate effective rate of the treatment group was 92.86%, up from 73.81% in the control group(P < 0.05).Conclusion Xiangchai Shuyu Decoction combined with probiotics has a significant clinical effect on IBS-C with liver-Qi stagnation syndrome, and can effectively relieve bad mood, optimize intestinal flora, and safe.
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表 1 两组患者治疗前后中医证候各项积分的比较
分,M(Q1,Q3) 症状 对照组(n=42) 治疗组(n=42) Z P 治疗前 治疗后 治疗前 治疗后 腹痛腹胀 6.0(4.0,6.0) 2.0(0.0,2.0)1) 6.0(4.0,6.0) 0.0(0.0,2.0)1)2) -3.066 0.002 排便频率 4.0(4.0,6.0) 2.0(0.0,4.0)1) 4.0(4.0,6.0) 0.0(0.0,2.0)1)2) -2.972 0.003 大便性状 4.0(4.0,6.0) 2.0(1.5,4.0)1) 4.0(4.0,6.0) 0.0(0.0,2.0)1)2) -4.342 < 0.001 排便状况 4.0(4.0,6.0) 2.0(2.0,4.0)1) 4.0(4.0,6.0) 2.0(0.0,2.0)1) -0.504 0.614 嗳气频作 2.0(2.0,3.0) 1.0(1.0,2.0)1) 2.0(2.0,3.0) 1.0(0.0,1.0)1)2) -2.766 0.006 胸闷不舒 2.0(2.0,3.0) 1.0(1.0,2.0)1) 3.0(2.0,3.0) 1.0(0.0,2.0)1)2) -2.061 0.039 两胁胀痛 2.0(2.0,3.0) 1.0(1.0,2.0)1) 2.0(2.0,3.0) 0.0(0.0,1.0)1)2) -3.574 < 0.001 与本组治疗前比较,1)P < 0.05;与对照组治疗后比较,2)P < 0.05。 表 2 两组患者治疗前后的HAMA、HAMD评分比较
分,X±S 组别 例数 HAMA HAMD 治疗前 治疗后 治疗前 治疗后 对照组 42 13.57±2.96 8.05±1.611) 11.36±2.27 7.10±1.641) 治疗组 42 12.79±2.59 6.88±1.921)2) 11.83±2.54 5.12±1.531)2) t 1.296 3.024 -0.906 5.713 P 0.199 0.003 0.367 < 0.001 与本组治疗前比较,1)P < 0.05;与对照组治疗后比较,2)P < 0.05。 表 3 两组患者治疗前后的肠道菌群比较
logCFU/g,X±S 组别 例数 双歧杆菌 乳杆菌 肠杆菌 治疗前 治疗后 治疗前 治疗后 治疗前 治疗后 对照组 42 7.50±1.53 8.53±1.581) 7.43±1.49 8.26±1.711) 8.85±1.78 8.36±1.871) 治疗组 42 7.61±1.58 9.30±1.631)2) 7.37±1.51 9.13±1.801)2) 9.04±1.66 7.47±1.801)2) t -0.310 -2.192 0.184 -2.279 -0.515 2.221 P 0.757 0.031 0.855 0.025 0.608 0.029 与本组治疗前比较,1)P < 0.05;与对照组治疗后比较,2)P < 0.05。 表 4 两组患者的不良反应发生情况比较
例(%) 组别 例数 恶心 腹泻 口干 皮疹 总不良反应 对照组 42 1(2.38) 1(2.38) 1(2.38) 0 3(7.14) 治疗组 42 1(2.38) 0 0 1(2.38) 2(4.76) χ2 0.213 P 0.645 表 5 两组患者的中医证候疗效比较
例(%) 组别 例数 临床痊愈 显效 有效 无效 总有效 对照组 42 3(7.14) 9(21.43) 19(45.24) 11(26.19) 31(73.81) 治疗组 42 7(16.67) 21(50.00) 11(26.19) 3(7.14) 39(92.86) χ2 5.486 P 0.019 -
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