西酞普兰与阿米替林治疗肠易激综合症比较：一项随机开放8周治疗的随访研究

发布时间：2018-06-22 02:19

本文选题：肠易激综合症 + 阿米替林　；参考：《浙江大学》2012年硕士论文

【摘要】：目的肠易激综合症(irritable bowel syndrome, IBS)的治疗仍将面临严重的挑战。三环类抗抑郁药阿米替林对IBS有较好的疗效,但其耐受性限制了临床的广泛使用。西酞普兰作为5-羟色胺再摄取抑制剂是一种新型抗抑郁药物,具有较好的耐受性,迄今尚未见到西酞普兰治疗IBS的临床研究报道。本研究的目的是比较西酞普兰与阿米替林治疗中度IBS患者的疗效与安全性。方法 68例符合罗马Ⅲ标准的IBS患者纳入这项为期8周的随机、开放、无偏性的临床研究。其中,34例患者接受西酞普兰治疗(治疗起始2周内逐渐加量为20-30mg/d),另外34例患者接受阿米替林治疗(治疗起始2周内逐渐加量为75mg/d)两组对象在基线的人口学资料与疾病相关信息具有可比性。在治疗4周末及观察终点进行疗效与耐受性评估,初级疗效评估方法采用0-10cm视觉模拟标尺的方法观察IBS总体症状、腹痛、腹胀和排便方式的改变,次级疗效采用SF-36健康评估量表评价生活质量的变化。焦虑抑郁症状评估采用汉密尔顿焦虑和抑郁量表。不良事件评估采用治疗时出现的症状量表。采用t检验、卡方检验及多元回归模型进行统计分析。结果阿米替林组与西酞普兰组比较脱落率显著提高,在治疗4周末分别为26.5%和5.9%,治疗8周末分别为35.3%和11.8%,差异均具有统计学意义(P0.05)。阿米替林的不良反应比如便秘显著高于西酞普兰(P0.05)。在治疗4周末,西酞普兰组在IBS整体症状、腹痛、腹胀方面分别下降了(2.6±1.1)cm、(2.7±1.3)cm、(1.1±0.8)cm,而阿米替林组相应地下降了(1.5±0.5)cm、(1.1±0.4)cm、(0.2±0.1)cm；在治疗终点,西酞普兰治疗组在IBS整体症状、腹痛、腹胀方面分别下降了(4.4±2.1)cm、(4.6±2.6)cm、(2.2±1.4)cm,而阿米替林组相应地下降了(2.3±1.6)cm、(2.5±1.3)cm、(0.4±0.2)cm。同时点两组间比较,差异达到极显著统计学意义(P0.01)。虽然阿米替林显著改善IBS患者躯体疼痛(bodily pain, BP),但西酞普兰治疗后生活质量显著改善的维度更广,除BP外,还包括了社会功能(social functioning, SF)、情感职能(role limitations-emotional, RE)、生理职能(role limitations-physical, RP)、总体健康(general health, GH)和活力(vitality, VT).观察终点两组间比较,西酞普兰在改善BP及RE方面显著高于阿米替林,差异达统计学意义(P0.05)。多元线性回归分析表明IBS症状改善程度与SF-36评分改善程度具极强的相关性,而抑郁症状评分改变仅与BP(β=0.55,P0.05)及VT(户0.87,P0.01)有显著的相关性。结论西酞普兰治疗IBS患者在疗效与耐受性方面均优于阿米替林,其作用机制不依赖于改善焦虑抑郁症状。
[Abstract]:objective
The treatment of irritable bowel syndrome (IBS) will still face serious challenges. Amitriptyline of the tricyclic antidepressant amitriptyline has a good effect on IBS, but its tolerance restricts the widespread use of the clinical. Citalopram as a 5- serotonin reuptake inhibitor is a new antidepressant, with good tolerance, so far. The purpose of this study was to compare the efficacy and safety of citalopram and amitriptyline in the treatment of moderate IBS patients. The clinical study of citalopram for the treatment of IBS has not been reported.
Method
68 cases of IBS patients with the Rome III standard were included in this 8 week randomized, open, unbiased clinical study. Among them, 34 patients received citalopram (20-30mg/d) in the first 2 weeks, and 34 patients received amitriptyline (75mg/d) in 2 weeks. Two groups were in the baseline. Demographic data and disease related information were comparable. Efficacy and tolerance assessment was performed at the 4 weekend of treatment and observation endpoint. The primary efficacy evaluation method used the 0-10cm visual analogue scale to observe the overall symptoms of IBS, abdominal pain, abdominal distention and defecation, and the secondary therapeutic effect was evaluated by the SF-36 health assessment scale. The Hamilton anxiety and depression scale was used for the assessment of anxiety and depression. The assessment of adverse events was based on the symptom scale of the treatment. T test, chi square test and multiple regression model were used for statistical analysis.
Result
The exfoliation rate of amitriptyline group was significantly higher than that in Si Pullan group, 26.5% and 5.9% at the end of the 4 week of treatment, 35.3% and 11.8% at the end of the 8 week treatment. The difference was statistically significant (P0.05). The ADR of amitriptyline, such as constipation was significantly higher than Si Pullan (P0.05). At the end of the 4 week, the overall symptoms of IBS in the Si Pullan group were in the abdomen. Pain and abdominal distention were decreased (2.6 + 1.1) cm, (2.7 + 1.3) cm and (1.1 + 0.8) cm, while amitriptyline group decreased (1.5 + 0.5) cm, (1.1 + 0.4) cm and (0.2 + 0.1) cm. At the end of treatment, the treatment group of citalopram decreased (4.4 + 2.7) cm, and amitriptyline group in the whole IBS symptoms, abdominal pain and abdominal distention. The difference between (2.3 + 1.6) cm, (2.5 + 1.3) cm, (0.4 + 0.2) cm. and points two groups was significant statistically significant (P0.01). Although amitriptyline significantly improved body pain (bodily pain, BP) in IBS patients, the dimension of life quality improved significantly after citalopram treatment, and the social function (SOCIAL Fu) except BP was also included. Nctioning, SF), the role limitations-emotional (RE), the physiological function (role limitations-physical, RP), the overall health (general health, GH) and vitality (vitality,). The comparison between the two groups was significantly higher than that of amitriptyline. The difference was statistically significant. The analysis showed that the improvement of IBS symptoms was strongly correlated with the improvement of SF-36 score, and the change of depressive symptom score was only correlated with BP (beta =0.55, P0.05) and VT (0.87, P0.01).
conclusion
Citalopram is superior to amitriptyline in the efficacy and tolerability of IBS in treatment of patients with anxiety and depression.
【学位授予单位】：浙江大学
【学位级别】：硕士
【学位授予年份】：2012
【分类号】：R749.4;R574

【共引文献】