Dynamic medication management can help to improve efficacy and save consumption in such trials when an investigational medication is expensive or in short supply or has a fairly short shelf-life in a long-lasting clinical trial, or, if protocol changes during study period. We presented the standard operating procedure of dynamic medication management and drug labeling through an instance of double-blind randomized controlled trial of Chinese Medicine for hepatopathy. Compared to conventional drug labeling, dynamic medication management and drug labeling is more flexibility to deal with problems during the study period, such as protocol update, medication waste, and outdated medication and so on. Appropriate method and reasonable procedure can ensure the precise implementation for drug labeling and medication management of double-blinded randomized controlled trials.
ObjectiveTo investigate the effect ofγ-ray irradiation on echinococcus protoscoleces before abdominal cavity implantation in mice. MethodsEchinococcus protoscoleces were cultured in vitro, and then divided into 5 groups, four groups receivedγ-ray irradiation with 10 Gy, 20 Gy, 40 Gy, and 80 Gy, respectively. The remaining control group was not irradiated. The protoscoleces were then implanted into the abdominal cavity of mice. Four months later, the incidence of echinococcosis was measured by detection of echinococcus antibody in the blood and then abdominal laparotomy was performed to isolate intraabdominal cysts, and the weight and structure of the echinococcus generated from the protoscoleces were measured and observed. ResultsAfter implantation of irradiated echinococcus protoscoleces in mice, the incidence of echinococcosis was 100% in the control group, 80.0% in the 10 Gy group, 33.3% in the 20 Gy group, 33.3% in the 40 Gy group, and 26.7% in the 80 Gy group. The echinococci had lower weight in the irradiated groups with 10 Gy (35.80 mg), with 20 Gy (0.00 mg), with 40 Gy (0.00 mg), and with 80 Gy (0.00 mg) as compared with the control group (157.80 mg). The echinococcus generated from the protoscoleces appeared calcification. Conclusionsγ-ray irradiation could inhibit the formation of echinococcus granulosus generated from protoscoleces, damage the structure of echinococcus generated from the protoscoleces. Irradiation might prevent echinococcosis recurrence after surgical removal of hydatid cysts.