Therapeutic advances in gastroenterology · 2022
Linaclotide for treating patients with irritable bowel syndrome with predominant constipation: a multicentre study of real-world data in China.
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Liu Lan, Zhang Weihao, Zhao Wei, Guo Shuang, Wang Yaojun, Lv Xiaojun, Li Bing, Wang Haiping, Xu Enbin, Li Quan, Zhu Qin, Gou Xiao Bo, Zhao Weidong, Guo Jianqiang
Аннотация
INTRODUCTION: Linaclotide, a guanylate cyclase C agonist that improves the symptoms of irritable bowel syndrome with predominant constipation (IBS-C), has been recently approved for IBS-C treatment. This study aimed to report real-world data on linaclotide treatment in China.
METHODS: This was a prospective multicentre study of the effectiveness of linaclotide treatment in patients with IBS-C from 10 primary medical institutions. Changes in defecation, abdominal symptoms, the IBS symptom severity scale (IBS-SSS), IBS quality of life questionnaire (IBS-QOL), Zung Self-Rating Anxiety Scale and Self-Rating Depression Scale in patients were evaluated to determine the drug's clinical efficacy and safety.
RESULTS: We enrolled 97 patients (mean age: 52.39 ± 13.99 years), 55 of whom were women (56.7%). In terms of efficacy, the number of the patients' defecation per week and Bristol stool form scale scores significantly increased at week 4 and week 12 compared with the values at the baseline. The baseline average IBS-SSS score was 211.01 ± 81.23. Of the patients, 24 had severe IBS-C, and their IBS-SSS scores at week 4 (51.81 ± 54.42) and week 12 (9.3 ± 30.39) significantly decreased and showed a pronounced improvement. The IBS-QOL total scores at week 4 and week 12 gradually decreased compared with that at the baseline and the QOL significantly improved. Treatment satisfaction rate was 79.3% in week 4 and 100% in week 12, showing a gradually increased satisfaction and significant differences. However, 11 cases (11.3%) had diarrhoea.
CONCLUSION: Linaclotide has proved to be a safe and effective drug to improve IBS-C symptoms and severity.
METHODS: This was a prospective multicentre study of the effectiveness of linaclotide treatment in patients with IBS-C from 10 primary medical institutions. Changes in defecation, abdominal symptoms, the IBS symptom severity scale (IBS-SSS), IBS quality of life questionnaire (IBS-QOL), Zung Self-Rating Anxiety Scale and Self-Rating Depression Scale in patients were evaluated to determine the drug's clinical efficacy and safety.
RESULTS: We enrolled 97 patients (mean age: 52.39 ± 13.99 years), 55 of whom were women (56.7%). In terms of efficacy, the number of the patients' defecation per week and Bristol stool form scale scores significantly increased at week 4 and week 12 compared with the values at the baseline. The baseline average IBS-SSS score was 211.01 ± 81.23. Of the patients, 24 had severe IBS-C, and their IBS-SSS scores at week 4 (51.81 ± 54.42) and week 12 (9.3 ± 30.39) significantly decreased and showed a pronounced improvement. The IBS-QOL total scores at week 4 and week 12 gradually decreased compared with that at the baseline and the QOL significantly improved. Treatment satisfaction rate was 79.3% in week 4 and 100% in week 12, showing a gradually increased satisfaction and significant differences. However, 11 cases (11.3%) had diarrhoea.
CONCLUSION: Linaclotide has proved to be a safe and effective drug to improve IBS-C symptoms and severity.