To observe the clinical efficacy and safety of aripiprazole tablets combined with magnesium valproate sustained-release tablets in the treatment of patients with bipolar disorder (BD).

BD patients were divided into control group and treatment group according to treatment regimen. The control group was given oral magnesium valproate sustained-release tablets with an initial dose of 0.25 g per time, bid. After 1-2 weeks, the dose was adjusted to 0.75-1.5 g·d^-1 according to the patient’s condition. On the basis of the treatment for the control group, the treatment group was additionally given oral aripiprazole tablets, 5 mg per time, bid. After 2 weeks of medication, the dose was appropriately adjusted to 10 mg per time, bid, according to the patient’s tolerance. Both groups received treatment for 8 weeks. The efficacy, clinical symptom scores, cognitive function, sleep quality, 5-hydroxytryptamine(5-HT), quality of life and adverse drug reactions were compared between the two groups.

A total of 92 cases were enrolled, including 44 in the control group and 48 in the treatment group. After treatment, the clinical efficacy rates in the control group and treatment group were 72.73% (32 cases/44 cases) and 91.67% (44 cases/48 cases), respectively; the Hamilton depression rating scale (HAMD) scores were (7.07±1.38) and (6.38±1.35) points, respectively; the Bipolar disorder rating scale (BRMS) scores were (8.68±2.01) and (7.65±1.16) points, respectively; the positive and negative syndrome scale (PANSS) scores were (52.07±8.97) and (45.27±8.12) points, respectively; the Wisconsin card sorting test (WCST) scores were (51.57±5.66) and (54.13±5.43) points, respectively; the Hopkins Verbal learning test-revised (HVLT-R) scores were (26.27±3.64) and (28.02±3.50) points, respectively; the continuous performance test (CPT) scores were (1.86±0.63) and (2.13±0.57) points, respectively; sleep efficiency rates were (85.45±2.48)% and (89.17±1.17)%, respectively; wakefulness frequency were (3.39±0.81) and (2.92±0.77) times, respectively; 5-HT levels were (52.29±8.23) and (58.09±8.06) ng·L^-1, respectively. Comparisons between the two groups for all the aforementioned indicators showed statistically significant differences (P<0.05, P<0.01, P<0.001). The overall adverse drug reaction rates in the control group and treatment group were 11.36% (5 cases/44 cases) and 14.58% (7 cases/48 cases), respectively (P>0.05).

The combination therapy regimen of aripiprazole tablets and magnesium valproate sustained-release tablets can effectively alleviate clinical symptoms in patients with BD, improve cognitive function and sleep quality, enhance overall quality of life and demonstrate good safety profiles.