芍黄通便合剂治疗肠道气滞型便秘的随机对照临床试验

发布时间：2018-11-25 12:56

【摘要】：目的观察芍黄通便合剂治疗肠道气滞型便秘的临床疗效和安全性。方法 144例肠道气滞型便秘患者随机分为试验组和对照组,各72例。试验组口服芍黄通便合剂(主要成分:白芍,大黄,火麻仁,决明子等),每次20 m L,每日3次;对照组口服木香槟榔丸,每次6 g,每日3次,通便即停药,随访7 d。观察便意、排便频率、大便形状(根据Bristol粪便分型标准)、排便时间、排便量、排便时伴随症(排便疼痛、腹胀、排便困难、排气等)及主要相关体征、相关理化检查指标变化;观察2组药物不良反应发生情况。结果治疗后,试验组总有效率为91.94%(57/62例),对照组为90.16%(55/61例),差异无统计学意义(P0.05)。治疗后,试验组和对照组便意评分分别为(4.81±0.80),(4.65±0.74)分;排便频率评分分别为(4.19±0.78),(4.26±0.84)分;便质评分分别为(4.91±0.76),(4.81±0.88)分;排便时间评分分别为(5.11±0.92),(5.02±0.99);排便量评分分别为(4.25±0.61),(4.12±0.54)分;排便困难程度评分分别为(4.20±0.77),(4.19±0.81)分;腹胀痛评分分别为(5.11±0.68),(5.02±0.76)分;嗳气评分分别为(5.06±0.79),(5.00±0.75)分;胸胁痞满评分分别为(3.73±0.61),(3.87±0.66)分;肠鸣评分分别为(4.40±0.64),(4.33±0.51)分;2组各单项评分与治疗前相比,差异有统计学意义(P0.05),组间差异无统计学意义(P0.05)。试验组和对照组的药物不良反应均为恶心和腹泻,试验组药物不良反应发生率为3.23%(2/62例),对照组为4.92%(3/61例),差异无统计学意义(P0.05)。结论芍黄通便合剂和木香槟榔丸治疗肠道气滞型便秘的临床疗效相似。芍黄通便合剂治疗肠道气滞型便秘安全、有效。
[Abstract]:Objective to observe the clinical efficacy and safety of Shaihuang Tongbian mixture in the treatment of intestinal qi stagnation constipation. Methods 144 patients with intestinal qi stagnation constipation were randomly divided into experimental group and control group, 72 cases in each group. The experimental group was treated with Shaohuangtongbian mixture (main ingredients: Radix Paeoniae Alba, Radix et Rhizoma Rhei, Huo Ma Ren, Cassia seed, etc.), each time 20 mL, 3 times a day, while the control group took Muxiang Areca Pill, 6 g each time, 3 times a day, the defecation stopped, followed up for 7 days. Observe stool meaning, defecation frequency, defecation shape (according to Bristol stool classification criteria), defecation time, defecation volume, accompanied by defecation (pain, abdominal distension, defecation difficulty, exhaust, etc.) and main related signs. Changes of physical and chemical indexes; Adverse drug reactions were observed in two groups. Results after treatment, the total effective rate was 91.94% (57 / 62 cases) in the experimental group and 90.16% (55 / 61 cases) in the control group (P0.05). After treatment, the scores of stool and defecation frequency were (4.81 卤0.80), (, 4.65 卤0.74), (4.19 卤0.78), (, 4.26 卤0.84), respectively. The scores of fecal quality, defecation time and defecation volume were (4.91 卤0.76), (, 4.81 卤0.88), (5.11 卤0.92), (, 5.02 卤0.99), (4.25 卤0.61), (, 4.12 卤0.54), respectively. The score of difficulty in defecation was (4.20 卤0.77), (, 4.19 卤0.81), the score of abdominal distending pain was (5.11 卤0.68), (, 5.02 卤0.76), the score of belching was (5.06 卤0.79), (), the score of belching was (5.06 卤0.79), (卤0.75), and the score of abdominal distending pain was (5.11 卤0.68), (, 5.02 卤0.76). The scores of thoracic and hypochondriasis were (3.73 卤0.61), (4.40 卤0.64), (3.87 卤0.66), (4.40 卤0.64), (4.33 卤0.51), respectively. The scores of each single item in the two groups were significantly different from those before treatment (P0.05), but there was no significant difference between the two groups (P0.05). The incidence of adverse drug reactions was 3.23% (2 / 62 cases) in the trial group and 4.92% (3 / 61 cases) in the control group (P0.05). Conclusion the clinical efficacy of Shaihuang Tongbian mixture and Muxiang betel nut pill in treating intestinal qi stagnation constipation is similar. Shaihuang Tongbian mixture is safe and effective in the treatment of intestinal qi stagnation constipation.
【作者单位】：重庆医科大学药学院;南充市中心医院药剂科;南充市中心医院中医科;四川省南充卫生学校医学院;
【基金】：四川省科技厅应用基础计划基金资助项目(2015JY0049) 四川省南充市科技局基金资助项目(N2008-SF016)
【分类号】：R256.35

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