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1.南阳市第一人民医院中药科,河南 南阳 473000
2.南阳市第一人民医院肛肠科,河南 南阳 473000
3.南阳市中心医院中药药学部,河南 南阳 473000
主管中药师。研究方向:中药临床应用。E-mail:yailishan@163.com
收稿:2025-07-08,
修回:2025-10-10,
录用:2025-10-13,
纸质出版:2025-11-30
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郝满霞,王胜文,姚立山.首荟通便胶囊联合利那洛肽治疗便秘型肠易激综合征的临床 观察 Δ[J].中国药房,2025,36(22):2828-2832.
HAO Manxia,WANG Shengwen,YAO Lishan.Clinical observation of Shouhui tongbian capsule combined with linaclotide in the treatment of constipation-predominant irritable bowel syndrome[J].ZHONGGUO YAOFANG,2025,36(22):2828-2832.
郝满霞,王胜文,姚立山.首荟通便胶囊联合利那洛肽治疗便秘型肠易激综合征的临床 观察 Δ[J].中国药房,2025,36(22):2828-2832. DOI: 10.6039/j.issn.1001-0408.2025.22.13.
HAO Manxia,WANG Shengwen,YAO Lishan.Clinical observation of Shouhui tongbian capsule combined with linaclotide in the treatment of constipation-predominant irritable bowel syndrome[J].ZHONGGUO YAOFANG,2025,36(22):2828-2832. DOI: 10.6039/j.issn.1001-0408.2025.22.13.
目的
2
探讨首荟通便胶囊联合利那洛肽治疗便秘型肠易激综合征(IBS-C)的疗效和安全性。
方法
2
选择2022年3月至2024年2月南阳市第一人民医院收治的97例IBS-C患者,按随机数字表法分为对照组(
n
=46)和观察组(
n
=51)。在常规治疗的基础上,对照组患者口服利那洛肽胶囊,观察组患者口服利那洛肽胶囊和首荟通便胶囊,两组患者疗程均为4周。比较两组患者的临床疗效,治疗前后的IBS症状严重程度量表(IBS-SSS)评分、排便次数、Bristol粪便性状量表(BSFS)评分、IBS生活质量量表(IBS-QOL)评分、胃肠激素水平、肛管直肠动力学指标,以及不良反应发生情况。
结果
2
对照组有2例、观察组有3例患者因不良反应脱落。观察组患者的有效率显著高于对照组(87.50% vs. 68.18%,
P
<0.05)。与治疗前比较,治疗后两组患者的排便次数、BSFS评分、血清P物质和胃动素水平均显著升高,IBS-SSS评分、IBS-QOL评分、血清血管活性肠肽水平、肛管直肠压力差、直肠顺应性、直肠感觉阈值、排便阈值均显著降低(
P
<0.05),且观察组显著优于对照组(直肠感觉阈值、排便阈值除外)(
P
<0.05)。两组患者的不良反应总发生率比较,差异无统计学意义(
P
>0.05)。
结论
2
相比于单用利那洛肽,首荟通便胶囊联合利那洛肽可改善IBS-C患者的胃肠激素功能及肛管直肠动力学,减轻临床症状,提高生活质量,且安全性较好。
OBJECTIVE
2
To investigate the clinical efficacy and safety of Shouhui tongbian capsule combined with linaclotide in the treatment of constipation-predominant irritable bowel syndrome (IBS-C).
METHODS
2
A total of 97 IBS-C patients admitted to Nanyang First People’s Hospital between March 2022 and February 2024 were enrolled. Using a random number table method, patients were divided into control group (
n
=46) and observation group (
n
=51). On the basis of routine treatment, the control group was given Linaclotide capsules orally, while the observation group received Linaclotide capsules combined with Shouhui tongbian capsule orally. The treatment course for both groups was 4 weeks. Clinical efficacy, Irritable Bowel Syndrome Severity Scale (IBS-SSS), stool frequency, Bristol Stool Form Scale (BSFS), Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QOL) score, gastrointestinal hormone levels, anorectal manometry parameters, and the occurrence of adverse reactions were compared between the two groups.
RESULTS
2
Two patients in the control group and three patients in the observation group dropped out due to adverse reactions. The effective rate in the observation group (87.50%) was significantly higher than that in the control group (68.18%)(
P
<0.05). Compared with pre-treatment, both groups showed significant increase in post-treatment stool frequency, BSFS score, serum substance P, and motilin levels. Conversely, IBS-SSS scores, IBS-QOL scores, serum vasoactive intestinal peptide levels, anal-rectal pressure difference, rectal compliance, rectal sensation threshold, and defecation threshold were significantly reduced (
P
<0.05). The observation group demonstrated superior outcomes to the control group (excluding rectal sensation and defecation thresholds,
P
<0.05). No significant difference in the incidence of adverse reactions was observed between the tw
o groups (
P
>0.05).
CONCLUSIONS
2
Compared with linaclotide monotherapy, Shouhui tongbian capsule combined with linaclotide improves gastrointestinal hormone function and anorectal manometry parameters in IBS-C patients, alleviates clinical symptoms, improves quality of life, and exhibits favorable safety.
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