Objective : To analyze serious adverse drug reactions (ADRs) in terms of their occurrence, the related factors and the necessary means to avoid such ADRs, and proposal of possible preventive measures against ADRs.
Design : Case series.
Methods : Out of 598 cases collected through an in-patient drug monitoring conducted from April 1990 to March 1996 in Hospital T, 59 cases which were of Grade 3 of the Ministry of Health and Welfare Standards for Severity Classification of ADRs were selected for this study. By classifying the causes of and the possibilities to avoid reactions in 59 cases, we discussed measures to prevent serious reactions to drugs.
Results : Symptoms involved were, in descending order, hypersensitivity, hepatic disorder, blood disorder, renal failure, cadiovascular system disorder, and other symptoms. Causal drugs were, in descending order, antibiotics, central nervous system drugs, circulatory drugs, gastrointestinal drugs, and other drugs.
Regarding the causes for the ADRs, factors involved in “usage”, such as indication and dosage, represented the highest rate, 40.7%. In a detailed survey of the possible avoidance of such reactions, 49.2% of serious ADRs were judged preventable by careful administration of the drugs. Further, 15.3% of the cases were thought to have resulted from a lack of or an inadequate description in the package insert.
Conclusions : The study indicates that the following steps are necessary to prevent ADRs. : (1) To be appropriately cautious to indications and dosages of the drug (including, in particular, indications and dosages for the aged, and renal failure or allergic patients, and the adjustment of dosage on the basis of drug-drug interaction); (2) To adhere strictly to contraindication ; (3) To offer suitable information on the ADRs to the patient who has experienced such a reaction ; and, (4) To be aware of unusual conditions by careful follow-up at an early stage after the administration.
The following action plans were considered important for carrying out the steps mentioned above : 1) to deepen medical workers awareness to prevent ADRs ; 2) to establish a system that can correctly offer fundamental and essential information to physicians ; 3) to standardize drug treatment according to patient condition (age, renal-failure, etc.) and to establish a safety assurance system.

BACKGROUND: Free fat graft has been used for the treatment of congenital hand differences. However, there have been a few reports about the outcome of that treatment. In this study, the outcome of free fat grafts for congenital hand and foot differences was investigated. METHODS: Fourteen bones with longitudinal epiphyseal bracket, 3 wrists with Madelung deformity, and 5 cases of osseous syndactyly were treated with free fat graft with osteotomy, physiolysis, or separation of osseous syndactyly. Of the fourteen bones with longitudinal epiphyseal bracket, 9 were treated with open wedge osteotomy with free fat graft and 5 with physiolysis and free fat graft. The Madelung deformity was treated with physiolysis with free fat graft. For osseous syndactyly, syndactyly release with free fat graft was performed five times on four hands. RESULTS: In the fourteen cases with longitudinal epiphyseal bracket, lateral deviation improved in all except two cases after surgery. The average lateral deviation angle changed from 32.5 degrees before surgery to 15.2 degrees after surgery. The average improvement of the lateral deviation angle was 12.2 degrees in the osteotomy group and 20.6 degrees in the physiolysis group. The mean ratio of improvement of the lateral deviation angle to the lateral deviation angle before surgery was 39.4% in the osteotomy group and 51.2% in the physiolysis group. The Madelung deformity improved after surgery in two cases but there was no improvement in one case. For these conditions, the results were not good enough when surgery was done after age 13 or at age four for severely hypoplastic brachymesophalangy. Of the 5 cases of osseous syndactyly, reunion of the separated bones occurred in one case. The grafted free fat should be deep enough to cover the osteotomy site of the bones to prevent reunion of the separated bones. CONCLUSIONS: Physiolysis and free fat graft performed during the growth period can correct the deviation due to longitudinal epiphyseal bracket and Madelung deformity. Free fat graft is also useful to prevent reunion of the bones after separation of osseous syndcatyly, if the grafted fat is securely filled into the space between the separated bones.
Adipose Tissue/*transplantation ; Adolescent ; Child ; Child, Preschool ; Female ; Fingers/*abnormalities/surgery ; Foot Deformities, Congenital/surgery ; Hallux Varus/surgery ; Hand Deformities, Congenital/*surgery ; Humans ; Male ; Osteotomy ; Statistics, Nonparametric ; Syndactyly/*surgery ; Treatment Outcome

BACKGROUND: Free fat graft has been used for the treatment of congenital hand differences. However, there have been a few reports about the outcome of that treatment. In this study, the outcome of free fat grafts for congenital hand and foot differences was investigated. METHODS: Fourteen bones with longitudinal epiphyseal bracket, 3 wrists with Madelung deformity, and 5 cases of osseous syndactyly were treated with free fat graft with osteotomy, physiolysis, or separation of osseous syndactyly. Of the fourteen bones with longitudinal epiphyseal bracket, 9 were treated with open wedge osteotomy with free fat graft and 5 with physiolysis and free fat graft. The Madelung deformity was treated with physiolysis with free fat graft. For osseous syndactyly, syndactyly release with free fat graft was performed five times on four hands. RESULTS: In the fourteen cases with longitudinal epiphyseal bracket, lateral deviation improved in all except two cases after surgery. The average lateral deviation angle changed from 32.5 degrees before surgery to 15.2 degrees after surgery. The average improvement of the lateral deviation angle was 12.2 degrees in the osteotomy group and 20.6 degrees in the physiolysis group. The mean ratio of improvement of the lateral deviation angle to the lateral deviation angle before surgery was 39.4% in the osteotomy group and 51.2% in the physiolysis group. The Madelung deformity improved after surgery in two cases but there was no improvement in one case. For these conditions, the results were not good enough when surgery was done after age 13 or at age four for severely hypoplastic brachymesophalangy. Of the 5 cases of osseous syndactyly, reunion of the separated bones occurred in one case. The grafted free fat should be deep enough to cover the osteotomy site of the bones to prevent reunion of the separated bones. CONCLUSIONS: Physiolysis and free fat graft performed during the growth period can correct the deviation due to longitudinal epiphyseal bracket and Madelung deformity. Free fat graft is also useful to prevent reunion of the bones after separation of osseous syndcatyly, if the grafted fat is securely filled into the space between the separated bones.
Adipose Tissue/*transplantation ; Adolescent ; Child ; Child, Preschool ; Female ; Fingers/*abnormalities/surgery ; Foot Deformities, Congenital/surgery ; Hallux Varus/surgery ; Hand Deformities, Congenital/*surgery ; Humans ; Male ; Osteotomy ; Statistics, Nonparametric ; Syndactyly/*surgery ; Treatment Outcome