Uterus transplantation (UTx) has become an alternative to gestational surrogacy and adoption for women with uterine factor infertility. Brännström et al. achieved the first human delivery after UTx in 2014 and to date a total of 8 babies have been born after UTx from living donors. This outcome attracted much attention worldwide and many countries have recently prepared for UTx. However, this procedure has many medical, ethical and social issues that require discussion prior to clinical application. Moreover, UTx is still in the experimental stage overseas and the safety and efficacy remain unclear despite several clinical applications. Despite the many issues to be resolved, this new organ transplantation technology will provide new hope for women with uterine factor infertility and further development of the technology is important for future reproductive and transplant medicine.
In accordance with the GPSP ordinance of the Ministry of Health, Labor and Welfare, a special drug use surveillance (2-year observation period) was conducted to evaluate the safety and efficacy of everolimus (Brand name: Certican) in kidney transplant patients in real-world setting. Finalized observational data from 315 patients were analyzed. The mean age was 49.0 years and the median time after the transplantation to the start of the drug treatment was 11.0 months. The incidence of adverse drug reactions (ADRs; disorders, symptoms, and abnormal laboratory findings for which a causal relationship to the drug cannot be ruled out) was 53.02% (167/315 patients). ADRs with an incidence of ≥5% were stomatitis, hyperlipidemia and proteinuria. ADRs such as stomatitis, hyperlipidemia and edema peripheral, mostly occurred within 3 months after the start of the drug treatment (28.89%, 91/315 patients). Patient- and graft-survival rates were 99.05% and 98.1%, respectively. Rejection rate was 7.94%. The safety and efficacy results of this surveillance showed no additional newly identified concern in the treatment of Japanese kidney transplant patients with everolimus in clinical practice.
Children needs the dosage forms suitable for pediatric use. A surface body area and weight change rapidly by the age. Therefore the dosage flexibility for pediatric formulation is needed. Moreover, oral medication has to be good taste. Development of age-appropriate medicine is important, because it usually influences children’s treatment adherence. Recently, improved technology of the orally disintegrating tablet (ODT) in Japan and the active development of mini-tablets formulation in foreign countries is attracting attention. The pediatric medicine manufacturing laboratory started by our center facilitates support the promotion of development of pediatric formulation.
Nature is a very important resource for not only new drug discovery but also application of traditional medicines. Kampo (Japanese traditional) medicines have been used as the traditional formula in which multi-active ingredients may attack multiple target sites to recover complicated symptoms caused by disturbance of the body systems such as immune, neural and endocrine systems. Therefore, their multilateral actions are suitable to treat multifactorial diseases. Kampo medicines are using for the treatment depending on the patient’s clinical situation, either separately or to complement modern western medicine in Japan. Present review describes the concept and characterization of Kampo medicines, and introduces our pharmacological studies of Kampo medicines to clarify their action mechanism and active ingredients. The results may contribute for more evidence-based clinical applications of Kampo medicines.