Safety and effectiveness of oral medium to high dose blonanserin in patients with schizophrenia: subgroup analysis from a prospective, multicenter, post-marketing surveillance study in mainland China.

BACKGROUND: Blonanserin (BNS) had been undergoing post-market surveillance (PMS) since September 2018. Using the surveillance data, we did this analysis to assess the safety and effectiveness of different doses of BNS to explore a sufficient dose range of BNS in Chinese patients with schizophrenia (SZ). METHODS: A 12-week, prospective, observational, single-arm, multicenter, open-label PMS was conducted. In this analysis, we divided the patients from PMS into low, medium to high, and high dose groups based on the dose of BNS they received, with medium to high dose group being the focus. The Brief Psychiatric Rating Scale (BPRS) scores at week 2 or 4, 6 or 8, and 12 were calculated to evaluate the effectiveness of BNS in improving psychiatric symptoms. The safety of BNS was reported as the incidence of adverse drug reactions. RESULTS: 364 patients were included in the medium to high dose group, of which 321 completed the surveillance, with a dropout rate of 11.8%. The mean daily dose was 15.1 ± 1.92 mg. The BPRS total score was 50.1 ± 11.95 at baseline and decreased to 26.6 ± 7.43 at 12 weeks (P < 0.001). When compared with other groups, the median to high dose group achieved significantly more reduction in BPRS score at week 12 (P = 0.004 versus low dose and P = 0.033 versus higher dose). Extrapyramidal symptoms [EPS (46.4%)] were the most common adverse reactions in the medium to high group. The average weight gain during the surveillance was 0.5 ± 2.56 kg and prolactin elevation occurred in 2.2% patients. Most adverse reactions were mild. CONCLUSIONS: BNS at medium to high doses (mean 15.1 mg/d) significantly improved symptoms of SZ and was well-tolerated. Most ADRs were mild, and the likelihood of causing metabolic side effects and prolactin elevations was low. Medium to high dose of BNS is a more potent treatment choice for SZ. TRIAL REGISTRATION NUMBER: ChiCTR2100048734. Date of registration: 2021/07/15 (retrospectively registered).

[Study on depressive disorder and related factors in surgical inpatients].

OBJECTIVE: To investigate the prevalence and possible influencing factors of depressive disorder in surgical inpatients. METHODS: Two hundred and sixty-six surgical inpatients meeting the inclusion criteria were first screened with the self rating depression scale (SDS), and then the subjects screened positive and 20% of those screened negative were evaluated with Structured Clinical Interview for DSM-IV Axis I Disorders (SCID) as a gold standard for diagnosis of depressive disorder. Possible influencing factors were also analyzed by experienced psychiatrists. RESULTS: The standard score of SDS in the surgical inpatients were significantly higher than those in the Chinese norm, and the incidence of depressive disorder in the surgical inpatients was 37.2%. Unvaried analysis showed that depressive disorder were associated with gender, education, economic condition, variety of diseases, hospitalization duration, and treatment methods. Logistic regression analysis revealed that gender, economic condition, treatment methods and previous history were the main influencing factors. CONCLUSIONS: The incidence of depressive disorder in the surgical inpatients is high, and it is mainly influenced by gender, economic condition, treatment methods and previous history.