普芦卡必利联合乳果糖在顽固性便秘中的应用研究

doi:10.3877/cma.j.issn.2095-3224.2017.03.007

中华结直肠疾病电子杂志 ›› 2017, Vol. 06 ›› Issue (03) : 207 -211. doi: 10.3877/cma.j.issn.2095-3224.2017.03.007

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论著

普芦卡必利联合乳果糖在顽固性便秘中的应用研究

汤东¹, 王杰¹, 黄玉琴¹, 周怀成¹, 史友权¹, 田滢², 陆永蝶², 邹胜男², 陈宇吉², 孙晓明², 徐梦月², 孙鹏翔², 王道荣¹^,^†(

), 李宁³

^1. 225001　扬州大学临床医学院（江苏省苏北人民医院）普外科、普通外科研究所
^2. 225001　扬州大学医学院临床医学系
^3. 210002　南京大学医学院临床学院（南京军区南京总医院全军普通外科研究所）普通外科研究所

收稿日期:2017-03-19 出版日期:2017-06-25
通信作者: 王道荣

Application of the combination of prucalopride and lactulose in the refractory constipation

Dong Tang¹, Jie Wang¹, Yuqin Huang¹, Huaicheng Zhou¹, Youquan Shi¹, Ying Tian², Yongdie Lu², Shengnan Zou², Yuji Chen², Xiaoming Sun², Mengyue Xu², Pengxiang Sun², Daorong Wang¹^,^†(), Ning Li³

^1. Department of General Surgery, Institute of General Surgery, Clinical Medical College, Yangzhou University (Subei People′s Hospital of Jiangsu Province), Yangzhou 225001, China
^2. Clinical Medicine, Medical College of Yangzhou University, Yangzhou 225001, China
^3. Research Institute of General Surgery, Jinling Hospital, Nanjing University School of Medicine, Nanjing 210002, China

Received:2017-03-19 Published:2017-06-25
Corresponding author: Daorong Wang
About author:
Corresponding author: Wang Daorong, Email: daorong666@sina.com

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引用本文：

汤东, 王杰, 黄玉琴, 周怀成, 史友权, 田滢, 陆永蝶, 邹胜男, 陈宇吉, 孙晓明, 徐梦月, 孙鹏翔, 王道荣, 李宁. 普芦卡必利联合乳果糖在顽固性便秘中的应用研究[J]. 中华结直肠疾病电子杂志, 2017, 06(03): 207-211.

Dong Tang, Jie Wang, Yuqin Huang, Huaicheng Zhou, Youquan Shi, Ying Tian, Yongdie Lu, Shengnan Zou, Yuji Chen, Xiaoming Sun, Mengyue Xu, Pengxiang Sun, Daorong Wang, Ning Li. Application of the combination of prucalopride and lactulose in the refractory constipation[J]. Chinese Journal of Colorectal Diseases(Electronic Edition), 2017, 06(03): 207-211.

目的

评价普芦卡必利联合乳果糖对顽固性便秘患者的疗效。

方法

2013年1月至2015年6月，对35例使用普芦卡必利（2 mg/天）单药连续4周治疗效果欠佳即平均每周完全自发排便（CSBMs）≤2次的顽固性便秘患者采用普芦卡必利（2 mg/天）联合乳果糖（15 ml×2次/天）连续8周方案进行治疗。观察指标为：服药后首次完全自发排便所需时间和每周平均CSBMs次数，并采用Bristol粪便评分量表、胃肠生活质量评分（GIQLI）、Wexner便秘评分和健康状况调查问卷（SF-36）比较联合治疗前后患者便秘症状和生活质量改善情况，并观察不良反应事件。

结果

患者联合治疗前后首次CSBMs所需时间为（6.7±3.2）天和（2.4±2.1）天（t=10.161，P<0.01）；平均每周CSBMs为（0.86±0.77）次/周（单药治疗前4周）和（5.26±6.09）次/周（联合治疗后8周）（t=-4.363，P<0.01）；患者总体便秘症状和生活质量各评分较联合治疗前明显改善（均P<0.01）。联合治疗8周后35例患者中有25例每周平均CSBMs≥3次，有效率达71.4%（25/35）。治疗期间不良反应为轻中度恶心、头痛、腹泻和腹胀，持续数天后即缓解。

结论

普芦卡必利联合乳果糖能进一步改善顽固性便秘患者的便秘症状和生活质量，值得临床推广应用。

关键词: 便秘, 治疗, 普芦卡必利, 乳果糖, 联合用药, 效果

Objective

To evaluation of the efficacy of the combination of prucalopride and lactulose in the patients with refractory constipation.

Methods

From January 2013 to June 2015, thirty-five cases of patients with refractory constipation whom were not benefited from single drug treatment (prucalopride, 2 mg/day, for 4 weeks, and the average weekly complete spontaneous bowel movements<3 times) were treated by the combination of prucalopride (2 mg/day) and lactulose (15 ml×2 times/day) for 8 weeks. The time and number of complete spontaneous bowel movements (CSBMs) was observed. The bristol stool scale, gastrointestinal quality of life score (GIQLI), Wexner constipation score and a 36-item short-form (SF-36) were compared before and after combined treatment of prucalopride and lactulose in patients with refractory constipation to observe the improvement of constipation and quality of life, and the adverse reaction events.

Results

The first time of CSBM is (6.7±3.2) d and (2.4±2.1) d h (t=10.161, P<0.01) in the study group before and after combined medication. The average number of CSBMs is (0.86±0.77) times/week (4 weeks before combined medication) and (5.26±6.09) times/week (8 weeks after combined medication), respectively (t=-4.363, P<0.01). Compared to the single drug medication, the constipation symptoms and quality of life of the patients were significantly improved after combined medication (all P<0.01). 25 cases in 35 patients with refractory constipation has CSBMs more than 3 times a week after 8 weeks of combination of prucalopride and lactulose, with the effective rate 71.4% (25/35). Only little mild and moderate adverse reactions such as nausea, headache and abdominal distension were observed and were natural disappeared several days after medication.

Conclusion

The combination of prucalopride and lactulose can be effectively improved the related symptoms and quality of life of the patients with refractory constipation, which is worthy of clinical application.

Key words: Constipation, Therapy, Prucalopride, Lactulose, Combined combination, Effect

表1 35例顽固性便秘患者联合治疗前后GIQLI、Wexner便秘评分和CSBMs比较结果（±s）

评估时间	胃肠生活质量评分（分）	Wexner便秘评分（分）	完全自发排便CSBM（次/周）
单药治疗前4周	94.66±15.68	22.94±3.36	0.86±0.37
联合治疗后8周	66.71±23.43	14.26±6.8	5.26±2.09
t值	7.166	7.843	-4.363
P值	<0.001	<0.001	<0.001

表1 35例顽固性便秘患者联合治疗前后GIQLI、Wexner便秘评分和CSBMs比较结果（±s）

评估时间	胃肠生活质量评分（分）	Wexner便秘评分（分）	完全自发排便CSBM（次/周）
单药治疗前4周	94.66±15.68	22.94±3.36	0.86±0.37
联合治疗后8周	66.71±23.43	14.26±6.8	5.26±2.09
t值	7.166	7.843	-4.363
P值	<0.001	<0.001	<0.001

表2 35例顽固性便秘患者联合治疗前后Bristol粪便评分结果（例）

评估时间	Bristol粪便评分
评估时间	第1~3型	第4~6型	第7型
单药治疗前4周	23	12	0
联合治疗后8周	7	22	6
Χ²值	17.475
P值	<0.001

表2 35例顽固性便秘患者联合治疗前后Bristol粪便评分结果（例）

评估时间	Bristol粪便评分
评估时间	第1~3型	第4~6型	第7型
单药治疗前4周	23	12	0
联合治疗后8周	7	22	6
Χ²值	17.475
P值	<0.001

表3 35例顽固性便秘患者联合治疗前后SF-36各因子得分比较（分，±s）

评估时间	生理功能	生理职能	躯体疼痛	总体健康	活力	社会功能	情感职能	精神健康
单药治疗前4周	25.11±2.46	5.97±1.27	6.78±2.82	17.56±3.75	17.54±3.68	5.89±1.83	4.83±0.89	19.20±5.26
联合治疗后8周	25.95±2.79	6.63±1.35	7.72±2.87	18.68±3.96	18.34±3.79	6.66±2.04	5.06±0.87	20.26±5.58
t值	-4.833	-5.36	-5.303	-4.721	-2.758	-4.552	-4.179	-4.793
P值	<0.001	<0.001	<0.001	<0.001	0.009	<0.001	<0.001	<0.001

表3 35例顽固性便秘患者联合治疗前后SF-36各因子得分比较（分，±s）

评估时间	生理功能	生理职能	躯体疼痛	总体健康	活力	社会功能	情感职能	精神健康
单药治疗前4周	25.11±2.46	5.97±1.27	6.78±2.82	17.56±3.75	17.54±3.68	5.89±1.83	4.83±0.89	19.20±5.26
联合治疗后8周	25.95±2.79	6.63±1.35	7.72±2.87	18.68±3.96	18.34±3.79	6.66±2.04	5.06±0.87	20.26±5.58
t值	-4.833	-5.36	-5.303	-4.721	-2.758	-4.552	-4.179	-4.793
P值	<0.001	<0.001	<0.001	<0.001	0.009	<0.001	<0.001	<0.001

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