ABSTRACT
Radiation-induced injury, a body dysfunction caused by irradiation, is associated with the dose, duration, and speed of radiation and is predominantly derived from radiation therapy for patients with malignant tumors. The current clinical treatment mainly includes amelioration of injury, alleviation of symptoms, and improvements in function restoration of the affected sites because of lack of targeted agents specific to radiation-induced injuries. Research and development of preventive and therapeutic agents against radiation-induced injuries are of great significance to reduce the body damages caused by radiotherapy and improve the quality of life of cancer survivors. This review summarizes the radiation-induced injury and its mechanisms, radioprotectants, and therapeutic agents for radiation, and proposes future development directions, so as to provide a reference for alleviation of radiation-induced injury and improvement in prognosis.
ABSTRACT
AIM: To evaluate the safety and tolerance of ibandronate in Chinese healthy volunteers. METHODS: The trial protocol was designed according to the Good Clinical Practice(GCP). After physical examination and laboratory tests were performed, 36 healthy volunteers were divided randomly into 6 dose groups, including 1 mg , 2 mg , 3 mg , 4 mg , 5 mg and 6 mg , with 6 subjects in each group(3 male and 3 female). Clinical symptoms, vital signs, routine blood tests, routine urine tests, hepatic function, renal function, blood electrolytes, electrocardiogram, and electroencephalogram were observed or examined before and after a single intravenous infusion of ibandronate. RESULTS: After single intravenous infusion doses of 1- 6 mg , the vital signs, clinical symptoms and laboratory tests were all in the normal range, but there were some slight ADRs concerned with the drug, such as hypophosphataemia, increased body temperature, perspiring,pain of bone or muscle and hypocalcaemia. But the ADRs were found vanishing in one or two weeks. CONCLUSION: Single intravenous infusion (up to 6 mg ) of domestic ibandronate in 36 chinese healthy volunteers is safe and tolerable.