Reversible HER2 antibody-drug conjugate-induced ocular toxicity.

Purpose: To report 3 cases of reversible epitheliopathy induced by A166-a human epidermal growth factor receptor (HER2)-targeted antibody-drug conjugate (ADC) therapy for resistant HER2 tumours.

Methods: Advanced HER2 tumour patients were enrolled in A166 phase I/II clinical trial using Bayesian logistic regression model dose escalation. Key exclusion criteria were ≥grade 2 (G2) corneal pathology, severe organ disease, and other cancer therapy within 4 weeks.

Validation of the Chinese Western Ontario and McMaster Universities Osteoarthritis Index in Patients From Mainland China With Osteoarthritis of the Knee.

Objective: To establish the reliability, validity, and sensitivity to change of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) among Chinese subjects with osteoarthritis (OA) of the knee, living in mainland China.

Methods: A multicenter, randomized, double-blind, placebo-controlled, parallel-group study was conducted for validation of the electronic personal digital assistant version of the WOMAC Numerical Rating Scale (NRS) 3.1 Index in China.

Duloxetine versus placebo in the treatment of patients with generalized anxiety disorder in China.

Background: Duloxetine is approved for the treatment of generalized anxiety disorder (GAD) in the United States and elsewhere. This study aimed to assess the efficacy, tolerability, and safety of duloxetine in Chinese patients with GAD.

Methods: This 9-site study consisted of double-blind treatment for 15 weeks either with duloxetine 60 - 120 mg or with placebo.

Association between painful physical symptoms and clinical outcomes in Chinese patients with major depressive disorder: a three-month observational study.

Background: Painful physical symptoms (PPS) may present as a component of major depressive disorder (MDD). Their effect in Chinese patients has not been investigated. This analysis reports the changes in disease severity, treatment patterns, quality of life and outcomes in a Chinese cohort according to the presence (PPS+) or absence (PPS-) of painful physical symptoms.

Olanzapine versus lithium in the acute treatment of bipolar mania: a double-blind, randomized, controlled trial.

Background: This multicenter, double-blind, randomized, controlled study conducted in China examined the efficacy and safety of olanzapine versus lithium in the treatment of patients with bipolar manic/mixed episodes.

Methods: Patients with bipolar manic or mixed episode (DSM-IV criteria) and Young Mania Rating Scale (YMRS) score> or =20 at screening received olanzapine (5-20 mg/day, n=69) or lithium carbonate (600-1800 mg/day, n=71) for 4 weeks. The primary outcome was mean change from baseline in Clinical Global Impressions-Bipolar Version Overall Severity of Illness (CGI-BP) score.

Effectiveness and safety of olanzapine in the treatment of schizophrenia among Asian patients switching from conventional antipsychotics.

Objectives: The objectives of this study were: (1) to investigate, in a clinical practice setting, the effectiveness of olanzapine in the treatment of schizophrenia among partially-responding, symptomatic Asian patients who switch from conventional antipsychotic treatment, (2) to assess the safety of olanzapine and (3) to assess the change in quality of life in Asian patients with schizophrenia who switch to olanzapine.

Methods: Effectiveness, safety and quality of life were assessed in outpatients with schizophrenia (n=1267) who lacked symptomatic control with conventional antipsychotics and were switched to olanzapine therapy. Data for this prospective, observational study were collected for 12 months from Asian patients in China, Hong Kong, the Philippines, South Korea and Taiwan.