Objective To evaluate the risk factors,treatment and follow-up of capsule retentions after capsule endoscopy examination.Methods A total of 1 100 capsule enteroscopic examinations,performed at our hospital from October 2006 to March 2013,were retrospectively studied.The positive findings of lesions, clinical indications of capsule endoscopy,treatment and follow-ups were recorded.Results The incidence of capsule retentions was 1.18%(n =13).The rates of capsule retentions in OGIB,suspected Crohn′s disease (CD),known CD,suspected tumors and chronic abdominal pain were 0.95%,4.0%,10.5%,7.1% and 0.3%,respectively.In 11 patients,the capsule was removed by means of double-balloon enteroscopy,the cap-sule was removed surgically in one patient,and spontaneous expulsion occurred in another patient after 1 year of treatment.Risk factors for capsule retention were known or suspected CD and suspected tumor(OR =11.44, P =0.02;OR =5.59,P =0.02),and suspected tumor was also a risk factor(OR =7.42,P =0.04).Conclu-sion Capsule endoscopy is a safe procedure with low risk of capsule retentions.Advantages and disadvantages of capsule endoscopy examinations should be considered carefully when high-risk patients are involved.

The aim of this study was to apply the reference-scaled average bioequivalence (RSABE) approach to evaluate the bioequivalence of 2 formulations of agomelatine, and to investigate the pharmacokinetic properties of agomelatine in Chinese healthy male subjects. This was performed in a single-dose, randomized-sequence, open-label, four-way crossover study with a one-day washout period between doses. Healthy Chinese males were randomly assigned to receive 25 mg of either the test or reference formulation. The formulations were considered bioequivalent if 90% confidence intervals (CIs) for the log-transformed ratios and ratio of geometric means (GMR) of AUC and C max of agomelatine were within the predetermined bioequivalence range based on RSABE method. Results showed that both of the 90% CIs for the log-transformed ratios of AUC and C max of 7-desmethyl-agomelatine and 3-hydroxy-agomelatine were within the predetermined bioequivalence range. The 90% CIs for natural log-transformed ratios of C max, AUC0-t and AUC0-∞ of agomelatine (104.42-139.86, 101.33-123.83 and 97.90-117.94) were within the RSABE acceptance limits, and 3-hydroxy-agomelatine (105.55-123.03, 101.95-109.10 and 101.72-108.70) and 7-desmethyl-agomelatine (104.50-125.23, 102.36-111.50 and 101.62-110.64) were within the FDA bioequivalence definition intervals (0.80-1.25 for AUC and 0.75-1.33 for C max). The RSABE approach was successful in evaluating the bioequivalence of these two formulations.