Madisch Ahmed, Heymer Peter, Voss Claudia, Wigginghaus Bernd, Bästlein Elke, Bayerdörffer Ekkehard, Meier Eberhard, Schimming Wolfgang, Bethke Birgit, Stolte Manfred, Miehlke Stephan
Medical Department I, Technical University Hospital, Fetscherstrasse 74, 01307 Dresden, Germany.
Int J Colorectal Dis. 2005 Jul;20(4):312-6. doi: 10.1007/s00384-004-0660-y. Epub 2004 Nov 11.
Collagenous colitis is an idiopathic microscopic colitis characterised by watery diarrhoea. The impact of collagenous colitis on quality of life has not been assessed. Our aim was to assess quality of life in patients with this condition and compare the effect of treatment with budesonide capsules or placebo on this parameter.
Patients with chronic diarrhoea and histologically-proven collagenous colitis were randomised to receive either budesonide controlled-release capsules (Entocort capsules, AstraZeneca, Lund, Sweden), 9 mg/day, or placebo for 6 weeks. Quality of life was measured using the validated Gastrointestinal Quality of Life Index (GIQLI) at baseline and after 6 weeks. With the GIQLI, scores range from 0 to 144, with higher scores representing better quality of life.
Complete quality of life assessment was available in 29 patients (budesonide: n=17; placebo: n=12). At baseline, quality of life was low in patients with collagenous colitis (mean 76). After 6 weeks of treatment, the mean GIQLI score increased significantly in the budesonide group (from 67 to 92, p<0.001), but remained unchanged in the placebo group (86-88). The mean score of the dimensions symptoms (p=0.001), emotional functioning (p=0.003) and physical functioning (p=0.017) increased significantly in the budesonide group compared with the placebo group. A significantly larger proportion of patients in the budesonide group experienced improved stool consistency (p<0.01) and a significant reduction in the mean stool frequency compared with those in the placebo group (p<0.01).
Quality of life is seriously reduced in patients with collagenous colitis. Six-week treatment with oral budesonide controlled-release capsules significantly improves quality of life and clinical symptoms compared with placebo in these patients.
胶原性结肠炎是一种以水样腹泻为特征的特发性微观结肠炎。胶原性结肠炎对生活质量的影响尚未得到评估。我们的目的是评估患有这种疾病的患者的生活质量，并比较布地奈德胶囊或安慰剂治疗对该参数的影响。
患有慢性腹泻且经组织学证实为胶原性结肠炎的患者被随机分为两组，一组接受布地奈德控释胶囊（Entocort胶囊，阿斯利康公司，瑞典隆德），每日9毫克，另一组接受安慰剂，为期6周。在基线期和6周后使用经过验证的胃肠道生活质量指数（GIQLI）来测量生活质量。GIQLI评分范围为0至144分，分数越高表示生活质量越好。
29名患者完成了生活质量评估（布地奈德组：n = 17；安慰剂组：n = 12）。在基线期，胶原性结肠炎患者的生活质量较低（平均76分）。治疗6周后，布地奈德组的平均GIQLI评分显著增加（从67分提高到92分，p<0.001），而安慰剂组保持不变（86 - 88分）。与安慰剂组相比，布地奈德组在症状维度（p = 0.001）、情绪功能（p = 0.003）和身体功能（p = 0.017）的平均评分显著增加。与安慰剂组相比，布地奈德组中粪便稠度改善的患者比例显著更高（p<0.01），且平均排便频率显著降低（p<0.01）。
胶原性结肠炎患者的生活质量严重下降。与安慰剂相比，口服布地奈德控释胶囊进行六周治疗可显著改善这些患者的生活质量和临床症状。
