To explore the clinical efficacy and safety of different doses of buspirone hydrochloride tablets combined with venlafaxine hydrochloride sustained-release tablets in the treatment of elderly patients with generalized anxiety disorder (GAD) accompanied by depression.

Elderly patients with GAD accompanied by depression were taken as the research subjects. The control group was given oral treatment with venlafaxine hydrochloride sustained-release tablets (75 mg·d^-1, once daily) and buspirone hydrochloride tablets (the initial dose was 5 mg each time, and it was increased by 5 to 10 mg every 2 to 3 days according to the patient’s tolerance, and then increased to 10 mg each time, twice daily after 2 weeks). The treatment group was treated with venlafaxine hydrochloride sustained-release tablets on the basis of the control group. Different doses of buspirone hydrochloride tablets were given orally for treatment (the initial dose was 5 mg each time, and it was increased by 5 to 10 mg every 2 to 3 days according to the patient’s tolerance, and then increased to 20 mg each time, twice a day after 2 weeks). Both groups were treated continuously for 8 weeks. The clinical efficacy, Hamilton anxiety scale (HAMA) scores, anxiety and depression scores, sleep conditions, levels of neurotransmitters for mood regulation, neurological function levels and endocrine metabolic levels of the two groups of patients were compared, and the safety was evaluated.

A total of 100 cases were screened, and 95 cases were enrolled, including 49 cases in the control group and 46 cases in the treatment group. In the control group, 3 cases dropped out due to loss to follow-up, and eventually 46 cases were included in the statistical analysis. There were no patients with dropout in the treatment group. Eventually, 46 cases were included in the statistical analysis. After 8 weeks of treatment, the HAMA scores of the treatment group and the control group were (17.93±2.85) and (19.51±2.96) points, respectively; the Hamilton depression scale scores were (18.85±3.11) and (20.37±3.08) points, respectively; the scores of the Beck despair scale were (4.64±1.44) and (5.37±1.53) points, respectively; the scores of the Chinese version of the self-rating scale for constrained neurosis were (25.63±4.17) and (27.73±4.31) points, respectively; the scores of melatonin were (38.83±5.78) and (36.24±5.27) pg·mL^-1, respectively; the cortisol levels were (109.36±11.92) and (115.41±12.17) ng·mL^-1, respectively; and the Pittsburgh sleep quality index scores were (8.28±2.35) and (9.48±2.46) points, respectively; the values of substance P were (112.17±10.66) and (117.61±11.37) ng·L^-1, respectively; and those of γ -aminobutyric acid were (5.65±0.65) and (5.31±0.67) μmol·L^-1, respectively; the glutamic acid were (25.02±3.22) and (26.75±3.28) mg·L^-1, respectively; the brain-derived neurotrophic factor were (14.33±1.56) and (13.54±1.46) ng·mL^-1, respectively; the glial cell-derived neurotrophic factor were (556.41±62.12) and (525.57±64.72) pg·mL^-1, respectively; and the glial fibrillary acidic protein were (2.51±0.28) and (2.67±0.35) ng·mL^-1, respectively; the free thyroxine were (13.33±1.96) and (12.41±1.85) pmol·L^-1, respectively; and the 25-hydroxyvitamin D₃ was (33.46±4.39) and (31.57±3.14) ng·mL^-1, respectively; the prolactin levels were (22.56±3.94) and (24.59±3.78) ng·mL^-1, respectively. The differences in the above indicators of the treatment group were statistically significant with control group (all P<0.05). Two groups of patients experienced adverse drug reactions such as dizziness, headache, nausea and vomiting, constipation and dry mouth. The total effective rates of the treatment group and the control group were 82.61% and 73.91%, respectively, and the total incidences of adverse drug reactions were 15.22% and 13.04%, respectively. There were no statistically significant differences between the two group (all P>0.05).

The application of 20 mg buconspirone tablets combined with venlafaxine tablets in the treatment of elderly patients with GAD and depression can improve sleep conditions and clinical symptoms, regulate neurological function and endocrine metabolism, and has certain safety.