Efficacy and influencing factors of linaclotide in functional defecation disorders
10.3760/cma.j.cn311367-20230805-00033
- VernacularTitle:利那洛肽对功能性排便障碍的疗效及其影响因素
- Author:
Benchang FENG
1
;
Rongrong CHEN
;
Feng ZHU
;
Lin LIN
;
Meifeng WANG
;
Liuqin JIANG
Author Information
1. 南京医科大学第一附属医院消化内科，南京 210029
- Keywords:
Linaclotide;
Polyethylene glycols;
Functional defecation disorder;
Constipation
- From:
Chinese Journal of Digestion
2023;43(12):828-833
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the efficacy and influencing factors of linaclotide in patients with functional defecation disorder (FDD).Methods:From June 1, 2021 to February 28, 2023, at the First Affiliated Hospital of Nanjing Medical University, 160 patients with FDD were enrolled and randomly divided into linaclotide group and polyethylene glycol group by using a random number table method, with 80 cases in each group, and the treatment course both was 4 weeks. The efficacy, weekly complete spontaneous bowel movement (CSBM), patient assessment of constipation symptom (PAC-SYM), numerical rating scale (NRS), Zung′s self-rating anxiety scale (SAS) and Zung′s self-rating depression scale (SDS) before and after treatment of linaclotide group and polyethyetylene glycol group were recorded and compared. Multivariate logistic regression analysis was performed to analyze the factors affected linaclotide in the treatment of FDD (including anorectal manometry). Receiver operating characteristic curve (ROC) was used to analyze the predictive value of risk factors on the efficacy of linaclotide in FDD. Independent sample t-test, paired t-test and chi-square test were used for statistical analysis. Results:After treatment, the weekly CSBM frequencies of linaclotide group and polyethylene glycol group were both higher than those before treatment in the same group (3.20±2.03 vs. 2.44±2.09, 3.10±2.26 vs. 2.58±2.06), and the differences were statistically significant ( t=-4.85 and -5.91, both P<0.001). After treatment, PAC-SYM score of stool shape, rectal symptom, abdominal symptom and total score, NRS score, SAS score and SDS score of linaclotide group and polyethylene glycol group were all lower than those before treatment in the same group (1.41±0.96 vs. 1.89±1.13, 0.95±0.49 vs. 1.14±0.46, 0.69±0.57 vs. 1.00±0.58, 0.96±0.43 vs. 1.23±0.40, 1.54±1.11 vs. 2.48±1.24, 43.54±6.26 vs. 45.13±7.30, 42.10±7.95 vs. 43.78±9.15 and 1.36±1.09 vs. 1.88±1.17, 0.83±0.40 vs. 1.10±0.45, 0.81±0.60 vs. 1.01±0.69, 0.91±0.42 vs. 1.21±0.41, 1.90±1.17 vs. 2.23±1.27, 43.55±7.72 vs. 44.61±8.51, 40.00±6.71 vs. 41.18±7.50), and the differences were statistically significant ( t=7.08, 7.73, 7.15, 9.26, 7.66, 7.96, 8.46, 7.26, 7.16, 5.78, 8.37, 6.17, 4.67 and 7.13, all P< 0.001). After treatment, the NRS score of linaclotide group was lower than that of polyethylene glycol group, and the difference was statistically significant ( t=-2.01, P=0.046). The total effective rate of linaclotide group was higher than that of polyethylene glycol group (77.5%, 62/80 vs. 62.5%, 50/80), and the difference was statistically significant ( χ2=4.29, P=0.038). The results of multivariate logistic regression analysis showed that the threshold of initial sensory volume and maximum tolerable volume were independent risk factors for linaclotide treatment of FDD ( OR=0.965, 95% confidence interval 0.936 to 0.995, P=0.022; OR=0.980, 95% confidence interval 0.962 to 0.999, P=0.041). The results of ROC analysis showed that the efficacy of linaclotide was poor in FDD patients with the threshold of initial sensory volume >67.5 mL or maximum tolerable volume > 117.5 mL. The combined predictive value of initial sensory volume and maximum tolerable volume threshold was higher than that of individual prediction, with an area under the curve of 0.722, sensitivity of 79.0% and specificity of 55.6%. Conclusions:Linaclotide can improve CSBM, constipation symptoms, abdominal pain and psychological status of FDD patients. The initial sensory volume threshold and maximum tolerable volume threshold are independent risk factors of the efficacy of linaclotide in FDD treatment and have certain predictive value in efficacy.
