中药治疗儿童便秘的随机、双盲、安慰剂对照试验。
A Randomized, Double-Blind, and Placebo-Controlled Trial of Chinese Herbal Medicine in the Treatment of Childhood Constipation.
机构信息
Departments of Surgery, Shengjing Hospital of China Medical University, Shenyang, P.R. China.
Department of Pediatrics, Shanghai General Hospital of Shanghai Jiao Tong University, Shanghai, P.R. China.
出版信息
Clin Transl Gastroenterol. 2021 May 3;12(5):e00345. doi: 10.14309/ctg.0000000000000345.
OBJECTIVES
Management of constipation is still challenging in childhood. The pharmacological effect of XiaojiDaozhi Decoction, a prescription of Chinese Herbal Medicine (CHM), has been well described for the treatment of food and Qi stagnation which account for childhood constipation. However, the efficacy and safety of XiaojiDaozhi Decoction in childhood constipation remains unclear.
METHODS
A randomized, double-blind, and placebo-controlled trial was conducted to evaluate the efficacy and safety of XiaojiDaozhi Decoction in childhood constipation. Two hundred children were recruited and randomly allocated to the CHM or placebo group to receive their respective interventions. The duration of treatment was 8 weeks, with a 12-week follow-up. Main outcome measures were complete spontaneous bowel movements and satisfaction with bowel function. Safety and adverse effects were evaluated by blood laboratory measurements.
RESULTS
At the end of follow-up, the response rates of CHM and placebo were 62% and 31%, respectively (χ2 = 19.315, P < 0.01). At the end of treatment, recurrence was found in 7 cases (10.14%) in CHM and 11 cases (26.19%) in placebo (χ2 = 4.947, P < 0.05). In the main outcome measures, 56 patients (56%) in the CHM group and 25 patients (25%) in the placebo group were satisfied with their bowel movements (χ2 = 19.940, P < 0.05). Increased complete spontaneous bowel movements ≥3 per week from baseline were found in 40 patients (40%) who received CHM and 19 patients (19%) who received placebo (χ2 = 10.602, P < 0.05). No serious adverse effects were found in any of the recruited cases.
DISCUSSION
CHM XiaojiDaozhi Decoction is a safe and effective method for the treatment of childhood constipation.
目的
儿童便秘的管理仍然具有挑战性。中药（CHM）小积导滞汤的药理学作用已被很好地描述，用于治疗导致儿童便秘的食积气滞。然而，小积导滞汤治疗儿童便秘的疗效和安全性仍不清楚。
方法
进行了一项随机、双盲、安慰剂对照试验，以评估小积导滞汤治疗儿童便秘的疗效和安全性。招募了 200 名儿童，并将他们随机分配到 CHM 或安慰剂组接受各自的干预措施。治疗持续 8 周，随访 12 周。主要观察指标为完全自发的排便和对排便功能的满意度。通过血液实验室测量评估安全性和不良反应。
结果
随访结束时，CHM 和安慰剂组的有效率分别为 62%和 31%（χ2=19.315，P<0.01）。治疗结束时，CHM 组有 7 例（10.14%）复发，安慰剂组有 11 例（26.19%）复发（χ2=4.947，P<0.05）。在主要观察指标中，CHM 组有 56 例（56%）患者对排便满意，安慰剂组有 25 例（25%）患者对排便满意（χ2=19.940，P<0.05）。CHM 组有 40 例（40%）患者每周完全自发排便增加≥3 次，安慰剂组有 19 例（19%）患者每周完全自发排便增加≥3 次（χ2=10.602，P<0.05）。在任何入组病例中均未发现严重不良反应。
讨论
CHM 小积导滞汤是治疗儿童便秘的一种安全有效的方法。
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