[Comparative study of Forlax and Transipeg in the treatment of functional constipation in the adult].

D Couturier
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Abstract

The aim of this study was to place Forlax in its therapeutic class comparing its efficacy and its tolerance with Transipeg in the treatment of adult's chronic constipation. A total of 256 outpatients suffering from chronical idiopathic constipation (38 males and 218 females, mean age 51) have been included in a double blind multicentric study run on two parallel groups. Patients have been treated with 1 to 3 intakes daily, adapting themselves the posology to obtain the therapeutic result that would give them satisfaction. The length of the study was of 4 weeks with 3 consultations on D0, D14 and D28. Patients collected every day the frequency and consistency of their stools, the conditions of evacuation, the presence of digestive symptoms; each week the global improvement of the constipation on a visual analogical scale (VAS) and at the end of the period, their opinion on the global digestive state, the quality of life during the study and the taste of the medicine (VAS). The physician also was giving an efficacy score at the end of the study. Frequency and intensity of adverse events were low and identical in both groups. Forlax is significantly more effective than Transipeg: as much on the global improvement of the constipation expressed by the patient (p < 0.001), as on the evolution of the number of stools (p < 0.001). Efficacy has been noticed by the follow-up of the physician who gave a 76.1 score to Forlax against a 56.2 score to Transipeg (p < 0.001) and only with Forlax a stool per day was obtain after the first week of administration. Patients are more satisfied with Forlax which improve significantly their global digestive satisfactory index (p < 0.001) with favourable repercussion on their quality of life (p < 0.001). The taste of Forlax was very much appreciated by the patients (p < 0.001).

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[福拉克斯与特兰佩格治疗成人功能性便秘的比较研究]。
本研究的目的是将福拉克斯纳入其治疗类别,比较其与transpeg治疗成人慢性便秘的疗效和耐受性。共有256名患有慢性特发性便秘的门诊患者(38名男性和218名女性,平均年龄51岁)被纳入一项双盲多中心研究,该研究在两个平行组中进行。患者每天服用1 - 3次,使其适应环境,以获得满意的治疗效果。研究时间为4周,在D0, D14和D28进行3次咨询。患者每天收集大便的频率和稠度、排便情况、有无消化症状;每周用视觉类比量表(VAS)评估便秘的整体改善情况,并在研究结束时,评估他们对整体消化状态、研究期间的生活质量和药物味道的看法(VAS)。在研究结束时,医生也给出了疗效评分。两组不良事件发生的频率和强度均较低且相同。Forlax明显比transpeg更有效:在患者表达的便秘的整体改善(p < 0.001)和大便数量的演变(p < 0.001)方面同样有效。通过对医生的随访发现,福拉克斯的评分为76.1分,而Transipeg的评分为56.2分(p < 0.001),并且在给药第一周后,福拉克斯每天只获得一次大便。患者对福拉克斯更满意,其总体消化满意指数显著提高(p < 0.001),对生活质量有良好的影响(p < 0.001)。患者对福拉克斯的味道非常满意(p < 0.001)。
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