To observe the clinical efficacy and safety of duloxetine hydrochloride enteric-coated capsules combined with Bifidobacterium quadruple live bacteria tablets in patients with depression accompanied by gastrointestinal disorders.

According to the treatment method, patients with depression and gastrointestinal dysfunction were divided into control group and treatment group. The control group took 30 mg duloxetine hydrochloride enteric-coated capsules once a day after breakfast, and adjusted to 60 mg once a day after 1 week. The treatment group was combined with 1.5 g Bifidobacterium quadruple viable tablets, 3 times a day. Both groups were treated for 8 weeks. The clinical therapeutic effects, and intestinal microbiota composition of the two groups of patients were compared, and safety evaluation was conducted.

A total of 76 patients were enrolled, 32 patients were included in the control group and 44 patients in the treatment group. After treatment, the total effective rate of the treatment group was 84.09% (37 cases /44 cases), and that of control group was 62.50% (20 cases/32 cases), and the difference was statistically significant (P<0.05). After treatment, the Lactobacillus of treatment group and control group were (7.14±1.14) and (6.54±1.24) lg CFU·g^-1, respectively; Staphylococcus were (3.73±0.73) and (4.12±0.74) lg CFU·g^-1, respectively; Bifidobacterium were (8.39±1.44) and (7.69±1.34) lg CFU·g^-1, respectively; Escherichia coli were (7.08±0.93) and (7.52±0.81) lg CFU·g^-1, respectively; Enterococcus faecalis were (5.95±0.76) and (6.50±0.84) lg CFU·g^-1, respectively. The above indicators of treatment group were compared with those of the control group, and the differences were statistically significant (all P<0.05). The adverse drug reactions in the treatment group mainly included nausea, dry mouth, constipation, insomnia and dizziness. The adverse drug reactions in the control group mainly included palpitations, nausea, dry mouth, constipation, insomnia and dizziness. The total incidence of adverse drug reactions in the treatment group and the control group were 15.91% (7 cases /44 cases) and 40.63% (13 cases /32 cases), respectively, with no statistically significant different (P<0.05).

Duloxetine hydrochloride enteric-coated capsules combined with Bifidobacterium quadruflora live bacteria tablets have a good clinical efficacy in patients with depression accompanied by gastrointestinal disorders. They can improve the intestinal flora of patients and reduce the occurrence of adverse drug reactions.