中国新药杂志

利那洛肽治疗便秘型肠易激综合征的前瞻性队列研究

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尹骅 ¹^,² , 占煜 ¹^,² , 温旭东 ¹^,² , 王晓翔 ¹^,² , 闻永 ³

中国新药杂志 | 临床研究 2023,32(15): 1552-1560

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中国新药杂志 | 临床研究 2023, 32(15): 1552-1560

利那洛肽治疗便秘型肠易激综合征的前瞻性队列研究

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尹骅¹^,², 占煜¹^,², 温旭东¹^,², 王晓翔¹^,², 闻永³

作者信息

¹成都中医药大学附属中西医结合医院，成都 610041

²成都市第一人民医院，成都 610041

³西南医科大学附属医院，泸州 646099

尹骅，女，主治医师，主要从事肛肠科临床和新药的研究。联系电话：(028)85328127，E-mail: 644700851@qq.com。

通讯作者:

占煜，男，主治医师，主要从事肛肠疾病的基础及临床研究。E-mail: 277546066@qq.com。

Study on linaclotide in the treatment of IBS with predominant constipation: a prospective cohort

Hua YIN¹^,², Yu ZHAN¹^,², Xu-dong WEN¹^,², Xiao-xiang WANG¹^,², Yong WEN³

Affiliations

¹Affiliated Hospital of Integrative Chinese Medicine and Western Medicine of Chengdu University of TCM, Chengdu 610041, China

²Chengdu First People's Hospital, Chengdu 610041, China

³The Affiliated Hospital of Southwest Medical University, Luzhou 646099, China

出版时间: 2023-08-15

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摘要

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目的：

比较利那洛肽与聚乙二醇4000散、麻仁丸联合奥替溴胺治疗便秘型肠易激综合征（IBS-C）的短期疗效及安全性。

方法：

采用前瞻性、3队列的研究方法，门诊纳入符合标准的IBS-C患者，在一般治疗及健康指导基础上，根据治疗意愿，选择利那洛肽（290 μg·d^-1）分入治疗组；聚乙二醇4000散（10 g·d^-1）+奥替溴胺（120 mg·d^-1）分入西药对照组；麻仁丸（12 g·d^-1）+奥替溴胺（120 mg·d^-1）分入中西医对照组。疗程4周，以疗程一半及以上的时间内（≥2周/4周）达到：腹痛程度改善至少30%且每周至少增加1次完全自发性排便（CSBM）为疗效终点，观察并比较3组患者的一般情况和基线资料，记录腹痛评分（NRS）、自发性排便（SBM）、CSBM、Bristol粪便性状量表（BSFS）、IBS症状严重程度量表（IBS-SSS）等指标变化，评价药物相关不良反应，采用单因素分析和Logistic回归分析疗效相关的影响因素。

结果：

最终完成研究并纳入统计分析的有效病例为129例（治疗组48例，西药对照组41例，中西医对照组40例），3组患者总体具有可比性。在疗程期间，治疗组和中西医对照组患者腹痛、排便频率、症状程度改善均优于西药对照组（P均<0.05）。第4周结束时，治疗组89.58%（43/48）、中西医对照组90%（36/40）达到疗效终点，均高于西药对照组73.17%（30/41）（P均<0.05）。单因素分析显示基线腹痛NRS和IBS-SSS是临床疗效结局的影响因素（P均<0.05）。共线性诊断验证后再行二元Logistic回归分析提示利那洛肽（P=0.023）、基线腹痛NRS（P=0.009）和基线IBS-SSS（P=0.000）是临床疗效的独立影响因素。相关不良反应，治疗组主要是腹泻（16.67%）、肛门坠胀（6.25%）、腹胀（4.17%）等，仅腹泻发生率高于中西医对照组（16.67% vs 2.5%，P<0.05），其他不良反应发生风险无明显差异。

结论：

利那洛肽对IBS-C患者的短期临床疗效及安全性均较好，且具有“一药双效”的特点及优势，值得进一步推广应用。

关键词

肠易激综合征 / 利那洛肽 / 临床疗效

Abstract

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Objective:

To compare the short-term efficacy and safety of linaclotide with macrogol 4000 powder and Maren pills in combination with otilonium bromide in the treatment of irritable bowel syndrome with constipation (IBS-C).

Methods:

In this prospective, three-arm study, patients with IBS-C who met the criteria were enrolled in the outpatient clinic. On the basis of general treatment and health guidance, linaclotide (290 μg·d^-1) was orally administrated according to treatment preference and assigned to the treatment group; or macrogol 4000 powder (10 g·d^-1)+otilonium bromide (120 mg·d^-1), divided into the western medicine control group; or Maren pills (12 g·d^-1)+otilonium bromide (120 mg·d^-1), divided into the western and Chinese medicine control group. The efficacy endpoint was achieved in half or more of the course of treatment (≥2 weeks/4 weeks) with: at least 30% improvement in the degree of abdominal pain and at least 1 increase in complete spontaneous bowel movement (CSBM) per week compared to baseline. The general and baseline data of patients in the 3 groups were observed and compared, and changes in abdominal pain score (NRS), spontaneous bowel movement (SBM), CSBM, Bristol Stool Symptom Scale (BSFS), and IBS Symptom Severity Scale (IBS-SSS) were recorded. To evaluate drug-related adverse effects using univariate analysis and Logistic regression was used to analyze the influencing factors.

Results:

The number of valid cases that finally completed the study and were included in the statistical analysis was 129 (48 cases in the treatment group, 41 cases in the western medicine control group, and 40 cases in the western and Chinese medicine control group), and the three groups of patients were comparable overall. During the course of treatment, the improvement in abdominal pain, frequency of defecation, and degree of symptoms was better in the treatment group and the western and Chinese medicine control group than in the western medicine control group (both P<0.05). At the end of the 4th week, 89.58% (43/48) of the treatment group and 90% (36/40) of the western and Chinese medicine control group reached the efficacy endpoint, both of which were higher than 73.17% (30/41) of the western medicine control group (both P<0.05). Univariate analysis showed that baseline abdominal pain NRS and IBS-SSS were influential factors for clinical efficacy outcome (both P<0.05). Covariate diagnostic validation followed by binary logistic regression analysis suggested linaclotide (P=0.023), baseline abdominal pain NRS (P=0.009) and baseline IBS-SSS (P=0.000) were independent influences on clinical efficacy. Related adverse effects, the main ones in the treatment group were diarrhea (16.67%), tenesmus (6.25%), and abdominal distension (4.17%), etc. Only the incidence of diarrhea was higher than that in the western and Chinese medicine control group (16.67% vs 2.5%, P<0.05), and there was no significant difference in the risk of other adverse effects.

Conclusion:

The short-term clinical efficacy and safety of linaclotide in IBS-C patients are good, and it has the characteristics and advantages of "one drug with two effects". So it's worthy of further promotion and application.

Key words

irritable bowel syndrome / linaclotide / clinical efficacy

引用本文

尹骅, 占煜, 温旭东, 王晓翔, 闻永. 利那洛肽治疗便秘型肠易激综合征的前瞻性队列研究. 中国新药杂志, 2023 , 32 (15) : 1552 -1560 .

Hua YIN, Yu ZHAN, Xu-dong WEN, Xiao-xiang WANG, Yong WEN. Study on linaclotide in the treatment of IBS with predominant constipation: a prospective cohort[J]. Chinese Journal of New Drugs, 2023 , 32 (15) : 1552 -1560 .

基金

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国家自然科学基金青年科学基金项目(82004173)
四川省科技厅-科技创新苗子工程(2021045)
成都市医学科研课题(2022067)

参考文献

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2023年第32卷第15期

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首发时间：2026-03-05
出版时间：2023-08-15

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录用日期：2023-01-03

基金

国家自然科学基金青年科学基金项目(82004173)

四川省科技厅-科技创新苗子工程(2021045)

成都市医学科研课题(2022067)

作者信息

¹成都中医药大学附属中西医结合医院，成都 610041

²成都市第一人民医院，成都 610041

³西南医科大学附属医院，泸州 646099

通讯作者:

占煜，男，主治医师，主要从事肛肠疾病的基础及临床研究。E-mail: 277546066@qq.com。

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https://castjournals.cast.org.cn/joweb/zgxyzz/CN/1236369017124999875

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2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
鹅膏菌科Amanitaceae	2	11	5.26	鹅膏菌属 Amanita	10	4.78
小菇科 Mycenaceae	2	12	5.74	丝盖伞属 Inocybe	5	2.39
多孔菌科 Polyporaceae	8	14	6.70	蜡蘑属 Laccaria	5	2.39
红菇科 Russulaceae	3	23	11.00	小皮伞属 Marasmius	6	2.87
				小菇属 Mycena	11	5.26
				光柄菇属 Pluteus	5	2.39
				红菇属 Russula	17	8.13
				栓菌属 Trametes	5	2.39

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