Clinical Study On The Pharmacokinetics And Safety Of Distribution For Injection In Patients With Superficial Bladder Cancer

Objective To observe the distribution and clearance of the Duteroporphyrin in the tumor tissues of patients with bladder cancer, and to observe the safety of the treatment of bladder cancer by using the Duteroporphyrin.Methods The experiment was divided into 2 stages: pre experiment and formal experiment. Pre experiment with 5mg/kg dose, blood samples and tissue samples were collected for 6 hours after administration. The formal test was divided into: 5mg/kg group and 7.5mg/kg group, each group was divided into 3 subgroups according to the time interval between administration and laser irradiation treatment, each subgroup of 3 patients. The dose escalation method was used to test the 5mg/kg group, and then the 7.5mg/kg group. Each group was carried out in the order of 1 times. To drugs after a certain period of time, the blood samples were collected for detection of drug concentration and for all subjects of bladder tumor were by transurethral resection(TUR) and take part of the tumor tissue and surrounding normal tissue into the drug content determination, after laser irradiation in the treatment of bladder of subjects, and postoperative routine of intravesical chemotherapy.Results Pharmacokinetic results: both 5mg / kg group and 7.5 mg / kg group, drug test results show, LC-MS/MS method, 3.5 hours, 6 hours, 15 hours of tumor tissue can detect Duteroporphyrin concentration; and concentration of 15 hours of normal tissue is low and in some cases failed to detect to. The drug content of different administration time group decreased with time, and there were some differences between tumor tissue and normal tissue.The ratio of 6 hours of tumor tissue and normal tissue concentration is difference.Safety results During the trial had a total of 20 cases occurred and drug related adverse events in four cases, one case with the white blood cell coefficient and the neutrophil coefficient decreased, one case with triglyceride and urea nitrogen increased, one case with low serum albumin, one case with skin itching and heart beats, four cases of subjects had been relieved or returned to normal range after 2 weeks. No serious adverse events occurred during the test, no serious adverse events related to the drug test, and no adverse events related to death or loss occurred.Conclusion Studies have shown that Duteroporphyrin is a safe and effective new photosensitizer, it is expected to become the ideal drug for photodynamic therapy for bladder cancer. At the same time, this experiment provides the basis for the determination of the time interval between the dose and the dose of the drug in the later period of the photodynamic therapy.