1.
The effect of TJ-28 (Eppikajutsuto) on the prevention of hand-foot syndrome using Capecitabine for colorectal cancer: The Yokohama Clinical Oncology Group Study (YCOG1102).
Watanabe, K, Ishibe, A, Watanabe, J, Ota, M, Fujii, S, Ichikawa, Y, Oba, MS, Endo, I
Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology. 2020;(2):204-210
Abstract
BACKGROUND Eppikajututo (TJ-28, a Kampo medicine) is effective against rheumatoid arthritis and eczema. We conducted a randomized comparative trial to assess the efficacy of TJ-28 for preventing hand-foot syndrome (HFS) as a complication of adjuvant chemotherapy using capecitabine. METHODS The present study was a multi-institutional randomized-controlled trial (UMIN000005899). Colorectal cancer patients scheduled to receive capecitabine chemotherapy as adjuvant therapy were randomly assigned to receive TJ-28 (7500 mg/day) or oral pyridoxine (60 mg/day). Patients were monitored for the development of grade ≥ 2 HFS according to the National Cancer Institute Common Toxicity Criteria until chemotherapy completion. RESULTS Twenty-two patients were enrolled in this study. The relative dose intensity of capecitabine was 76.2% in the TJ-28 group and 68.2% in the pyridoxine group. Grade ≥ 2 HFS developed in 6 (50.0%) of 12 TJ-28 patients and in 4 (40.0%) of 10 pyridoxine patients. Chemotherapy treatment failure was observed in seven patients, mainly due to HFS, liver dysfunction, diarrhea, and neutropenia. Chemotherapy treatment failure due to HFS occurred in none of the TJ-28 group and 2 patients (20.0%) in the pyridoxine group (p = 0.114). CONCLUSION Capecitabine-associated HFS was not markedly prevented by TJ-28 compared with pyridoxine. However, TJ-28 might support the continuation of chemotherapy with capecitabine. Further studies are warranted to clarify the benefits of TJ-28.
2.
Drug use in pregnancy among Italian women.
Donati, S, Baglio, G, Spinelli, A, Grandolfo, ME
European journal of clinical pharmacology. 2000;(4):323-8
Abstract
OBJECTIVE To describe the use of drugs among Italian women during pregnancy and to compare it with other reports in Italy from the last 10 years. METHODS A random sample of women who delivered in 1995-1996 were interviewed with regard to the care they received during pregnancy, delivery and the post-natal period. Information on antenatal care included maternal reports on the use of drugs during pregnancy. RESULTS Of the 9004 women interviewed, 75% took at least one drug during pregnancy. Users took a median number of two drugs. Iron (51%) and vitamins (25%) dominate prescriptions throughout pregnancy. Fifteen percent of women reported treatment for threatened abortion and 27% for risk of pre-term delivery. The data do not differ from the drug exposure profile during pregnancy reported in other Italian studies. Logistic regression analysis of drug use (excluding haematologicals and nutritionals) shows an increased risk of usage for older women, the better educated, for those who reported health problems and those who had compulsory bed rest and/or hospitalisation during pregnancy. CONCLUSION Seventy-five percent of the women reported use of at least one drug during pregnancy. Haematological and nutritional drugs are over prescribed. Although hormones have been clearly proven to be ineffective in preventing threatened abortion, the study shows an almost unchanged and out of date prescription pattern of progestational drugs. In order to avoid unnecessary exposure to potential risk, maternity care procedures should be reviewed and strictly related to an "evidence-based" approach.