To observe the clinical efficacy and safety of quilu tablets combined with lithium carbonate tablets and modified electroconvulsive therapy (MECT) in the treatment of bipolar disorder.

Patients with bipolar disorder were divided into control group and treatment group, both receiving routine treatment. The control group received MECT in addition to conventional treatment, with 3 sessions per week, administered every other day, totaling 12 treatments. During the treatment period, the patient was prescribed sustained-release lithium carbonate tablets with an initial dose of 0.25 g·d^-1, administered in 1-2 divided doses. Serum lithium levels were monitored weekly, maintained within the therapeutic range of 0.8-1.2 mmol·L^-1, and the medication was continued for a total of 6 weeks. The treatment group took quetiapine fumarate tablets orally after meals based on control group. The total doses for the first 4 days were 50, 100, 20 and 300 mg, respectively, taken in 2 doses. After the 4th day, the dose gradually increased to 300-450 mg·d^-1, and the dose was adjusted according to the patient’s clinical response and tolerance. The intake was controlled at 150-750 mg·d^-1, and the medication was shared for 6 weeks. Clinical efficacy, serological testing, depression and mania severity, cognitive ability, social function and occurrence of adverse drug reactions were compared between the two groups.

A total of 136 cases were screened in this study. Among them, 22 did not meet the inclusion and exclusion criteria, leaving 114 eligible for the study. They were divided into treatment group and control group, each comprising 57 cases. Six cases in control group were excluded due to personal reasons and loss to follow-up, while two cases in treatment group were excluded due to adverse drug reactions and loss to follow-up. Ultimately, 51 and 55 cases were included in control and treatment groups, respectively. After 6 weeks of treatment, the overall response rates were 72.55% (37 cases/51 cases) and 89.09% (49 cases /55 cases) in control and treatment groups; thyroid-stimulating hormone (TSH) levels were (2.72±0.42) and (2.90±0.44) μIU·mL^-1, respectively; prolactin (PR) levels were (13.58±2.40) and (15.27±2.56) ng·mL^-1, respectively; Hamilton depression scale -17 (HAMD-17) scores were (9.53±1.79) and (8.76±1.67) score, respectively; Bech - Rafaelsen mania rating scale (BRMS) scores were (7.04±1.39) and (6.47±1.35) score, respectively; Hopkins verbal learning test-revised (HVLT-R) scores were (26.94±4.85) and (29.76±3.81) score, respectively; continuous performance test (CPT) scores were (0.79±0.12) and (0.84±0.10) score, respectively; and social dysfunction screening scale (SDSS) scores were (6.92±1.18) and (6.38±0.99) score, respectively. All these indicators in treatment group showed statistically significant differences compared to control group (all P<0.05). During treatment, the main adverse drug reactions in treatment group were drowsiness, dry mouth, dizziness and orthostatic hypotension; while those in control group were nausea, drowsiness, dry mouth and constipation. The overall incidence of adverse drug reactions were 11.76% (6 cases/51 cases) and 7.27% (4 cases /55 cases) in control and treatment groups, respectively, with no statistically significant difference (P>0.05).

Quetiapine tablets combined with lithium carbonate tablets and MECT are more effective than using only lithium carbonate tablets and MECT in treating bipolar disorder, and the safety is good.