| Objective: To study the effects of linaclotide in combination with Bifidobacterium triptans capsules on the clinical symptoms,frequency of bowel movements and stool characteristics of patients with constipated irritable bowel syndrome,and to comprehensively evaluate the efficacy of the combination on constipated irritable bowel syndrome.Methods:1.Basic data: Patients diagnosed with constipation-type irritable bowel syndrome at the outpatient clinic of the Department of Gastroenterology of Yichun People’s Hospital from January 2022 to March 2023 were selected.The 112 patients who met the inclusion criteria and met the exclusion criteria were included,numbered according to the order of consultation,and divided into a control group and an observation group using a random number table,with 56 patients in each group.The control group received 290 μ g of linaclotide alone,30 minutes before meal,once/day;the observation group combined with Bifidobacterium trietnovum capsule 420mg-840 mg,30 minutes after meal,twice/day on the basis of the control group.The treatment period was 2 weeks.The clinical symptoms,number of bowel movements,stool properties and degree of constipation were compared before and after treatment in the control group,before and after treatment in the observation group and after treatment in both groups to comprehensively evaluate the efficacy of the combination on patients with irritable bowel syndrome with constipation.2.Statistical methods: The study data were entered into a constructed EXCEL sheet and the data were statistically analysed using SPSS 25.0 software.The data were first tested for normality.For measures that met the normal distribution,the mean±standard deviation((?)±s)was used,and the t-test for independent samples was used for comparison between groups,and the t-test for paired samples was used for comparison before and after treatment within groups;for measures that did not meet the normal distribution,the median(interquartile spacing)was used,and the non-parametric rank sum test(2 independent samples)was used for comparison between groups,and the t-test for paired samples was used for comparison before and after treatment within groups.Within-group comparisons before and after treatment were made using the paired-samples non-parametric rank-sum test(2 correlated samples).Statistical/qualitative information is expressed as [cases(%)]and comparisons between two groups were made using the χ2 test.P≤0.01 for statistically significant differences and P≤0.05 for statistically significant differences.Results:1.Comparison of baseline information: no statistically significant differences between the control and observation groups in terms of gender,age,duration of disease and e-colonoscopic findings(p > 0.05).2.Comparison of the number of bowel movements before and after treatment between the control and observation groups: the median number of bowel movements before treatment in the control group was 2(2-3),significantly lower than the number of bowel movements after treatment 6.5(4.88-7.63),with a statistically significant difference(P<0.01);the median number of bowel movements before treatment in the observation group was 2(1-3),significantly lower than the number of bowel movements after treatment 7.5(6-10.12)The difference was statistically significant(p<0.01).The number of bowel movements before treatment was 2(1-3)in the observation group,which was significantly better than that in the control group,and the difference was statistically significant(P<0.01);the difference was not statistically significant(P>0.05)when comparing the number of bowel movements before treatment between the two groups,but the number of bowel movements after treatment increased in the observation group,which was significantly better than that in the control group,and the difference was statistically significant(P<0.05).3.Comparison of faecal traits before and after treatment between the control group and the observation group: the median faecal traits before treatment in the control group were 1(1 to 1)significantly lower than those after treatment in faecal traits 4(3 to 5),with a statistically significant difference(P < 0.01);the median faecal traits before treatment in the observation group were 1(1 to 1.25),significantly lower than those after treatment in faecal traits 4(5 to 6),with a statistically significant difference(P < 0.01);there was no statistically significant difference between the two groups in comparing the mean values of faecal traits before and after treatment(P>0.05).4.Comparison of the degree of constipation between the control group and the observation group before and after treatment: the degree of constipation score of the control group before treatment was 14(11-17),which was significantly higher than the degree of constipation score of 9(5.75-11.25)after treatment,with a statistically significant difference(P < 0.01);the degree of constipation score of the observation group before treatment was 13.50(10-16),which was significantly higher than the degree of constipation score of 6(4.75-8)after treatment,with a statistically significant difference(P< 0.01).The difference was statistically significant(P < 0.01);the difference between the two groups was not statistically significant(P > 0.05);the difference between the two groups was statistically significant(P < 0.01);the difference between the two groups was statistically significant(P < 0.01).5.Comparison of clinical efficacy between the control group and the observation group: both groups improved the clinical symptoms of patients,but the total clinical efficiency of the observation group was higher than that of the control group(80% vs.61%),the difference was statistically significant(P < 0.05).6.Comparison of satisfaction between the two groups: Satisfaction ratings were comparable between the two groups(54% vs.58%),with no statistically significant difference(p>0.05).7.Comparison of medication adherence between the two groups: the two groups’ medication adherence was basically the same and the difference was not statistically significant(P>0.05).8.Comparison of the incidence of adverse reactions between the two groups: The main adverse reactions in both groups were diarrhoea,abdominal distension,abdominal pain,dizziness and skin rash,all of which resolved after symptomatic treatment.The difference was not statistically significant(P>0.05).Conclusion:1.Linaclotide in combination with Bifidobacterium trivium capsules was effective in relieving the clinical symptoms associated with IBS-C patients,increasing the frequency of bowel movements,reducing the incidence of adverse effects and improving the quality of life of patients.2.Both treatment regimens were effective in improving stool characteristics in IBS-C patients,but the combination was more superior to linaclotide alone in improving the degree of constipation and bloating symptoms in patients,presumably related to dysbiosis of the intestinal microflora in some IBS-C.3.The efficacy of the combination in patients with IBS-C is clear and worthy of clinical promotion. |
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