角色或碳dioxide-releasing栓剂治疗慢性功能性便秘:一项双盲,随机,安慰剂对照试验。

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Lazzaroni M,极V,比安奇普罗G

角色或碳dioxide-releasing栓剂治疗慢性功能性便秘:一项双盲,随机,安慰剂对照试验。

药物Investig。2005; 25 (8): 499 - 505。

PubMed ID

17532693 (在PubMed

]

文摘

摘要目的:治疗慢性功能性便秘是很困难的。同时使用口服和局部泻药可能无法充分缓解症状,和有风险的不利影响肠功能或结构变化等,与电解质紊乱。本研究的目的是评估的有效性和安全性栓剂结合碳酸氢钠和钾酒石酸氢盐在聚乙二醇基生成大约175毫升的二氧化碳(CO (2))。这个版本使直肠壶腹,从而刺激蠕动和随后的排便。病人和方法:这是一个前瞻性,双盲,随机,安慰剂对照,交叉,顺序研究门诊慢性功能性便秘。每个病人收到两个相同的外观栓剂,含活性药物或安慰剂。活动drug-placebo的序列(序列1)或placebo-active药物(2)序列是随机的八组。第二个栓剂是第一个后7天。以下参数进行评估和得分:疏散时间、疏散、直肠壶腹的放空的感觉,凳子特点,病人肛门投诉、腹痛和整体评估。结果:共有29名患者进入研究。 According to a restricted sequential plan, a statistical significance (p < 0.05) in favour of the active drug was reached after 26 patients. A positive response within 30 minutes of introduction of the suppository occurred in 51.7% and 6.9% of patients treated with the active drug and placebo, respectively (p = 0.0003). Normal evacuation occurred in 65.5% and 24.1% of patients treated with the active drug and placebo, respectively (p = 0.004). Normal stool consistency was found in 44.8% and 7.2% of patients treated with the active drug and placebo, respectively (p = 0.04). Patient assessment of treatment as satisfactory occurred in 51.7% and 20.7% of subjects treated with the active drug and placebo, respectively (p = 0.029). Only a trend in favour of the active drug was observed with regard to feeling of incomplete evacuation, and active drug was comparable to placebo with regard to anal and abdominal tolerability CONCLUSION: The CO(2)-releasing suppository may represent an alternative to rectal laxatives for the relief of chronic functional constipation. The data obtained in this study indicate that CO(2)-releasing suppositories may be usefully and safely employed in the treatment of patients at risk for electrolyte disorders such as the elderly or patients with renal or cardiovascular disorders.

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药物

钾酒石酸氢盐