Background and Purpose : Many cases of amnesia caused by thalamic hemorrhage involve anterior nucleus hemorrhage, dorsomedial nucleus hemorrhage, and intraventricular rupture. In the present study, intraventricular rupture was studied with a focus on cases with hematoma compression at the fornix. Methods : Of 116 patients with thalamic hemorrhage admitted to our hospital, 50 patients aged <70 years who had hemorrhage during their first stroke confined to the thalamus, internal capsule, and corona radiata, and who neither developed hydrocephalus nor showed dementia prior to onset were investigated. Thalamic hemorrhages were classified by CT findings and the extent of intraventricular rupture. Memory was studied by the FIM memory scores on admission and discharge. Results and Conclusion : Patients with dorsomedial nucleus hemorrhage showed no tendency toward amnesia and were equivalent to patients with posterolateral nucleus hemorrhage, which does not usually result in amnesia on its own. Of the 30 patients with posterolateral nucleus hemorrhage, a high degree of amnesia was observed in the 18 with intraventricular rupture. A high proportion of patients with dorsomedial nucleus hemorrhage experienced intraventricular rupture (5 of 6 patients). Equivalent degrees of amnesia were observed in patients with intraventricular rupture with dorsomedial nucleus hemorrhage and those with posterolateral nucleus hemorrhage. The present findings in conjunction with the fact that amnesia in thalamic hemorrhage involves episodic memory impairment suggest that amnesia in patients with dorsomedial or posterolateral nucleus hemorrhage or with intraventricular rupture does not stem from damage to the dorsomedial nucleus, which is part of the Yakovlev circuit involved in emotional memory. Instead, the primary cause appears to be the effects of intraventricular rupture on the Papez circuit surrounding the lateral ventricle and foramen of Monro.

Objective: In clinical settings, new drugs are frequently administered to patients who have been excluded in the clinical trials. However, health professionals seldom recognize this. Focusing on monoclonal antibody drugs, we conducted a questionnaire survey of pharmaceutical companies and accumulated cases in which risk management differed between clinical trials and post-marketing.Methods: We obtained information on exclusion criteria for clinical trials of monoclonal antibody preparations from pharmaceutical companies. We compared these exclusion criteria with the contraindicated items in the package insert.Results: The most common exclusion criteria were “reproductive-related events”, “cancer-related events”, “HBV/HCV infection”,and “history of allergy/hypersensitivity”. The most common contraindications in the package insert were “history of allergy/hypersensitivity”, “other infectious diseases”, and “tuberculosis infection”. The average number of exclusion criteria for safety measures at the time of clinical trial was 10.1per drug, while that of contraindications was 2.1per drug; the difference was statistically significant. In addition, there were significant differences in one clinical trial exclusion criterion ( “upper age limit” ) and two contraindications ( “tuberculosis infection” and “other infectious diseases” ) between antineoplastic agents compared to therapeutic agents for autoimmune-related diseases. In half the products, serious adverse drug reactions related to the exclusion criteria that were not contraindicated were reported after marketing.Conclusion: Because the contraindications at the time of marketing are drastically fewer compared to the exclusion criteria at the time of clinical trials, pharmacists should inform doctors of it and carefully monitor the outcomes of new drugs that have not been used with patients with complications.