| Research purposes:Malignant peritoneal ascites is caused by the tumor invasion of the abdominal cavity and peritoneal extensive planting.Malignant ascites is one of the late complications of cancer,and also one of the common causes of death in cancer patients.Cinobufagin injection is a kind of toad skin preparation.Preliminary studies have shown that it has a certain effect on malignant ascites.This experiment is due to systematically observe the tolerability of cinobufagin injection in the treatment of malignant ascites,evaluate the safety and tolerability and provide it for the later clinical trial Drug program reference.Research method:A single group,non randomized and open drug tolerance test was adopted in this study.A total of 24 patients were enrolled(12 in males and 12 in females).The oldest was 80 years old,the youngest was 35 years old,and the mean age 62.5 years old.All patients were included in the routine treatment based on the accepted abdominal drainage catheter drainage and cinobufacini injection of intraperitoneal perfusion therapy.Perfusion drug configuration:0.9%NS 100ml + cinobufagin injection 5ml × branch + 5mg dexamethasone + 10ml lidocaine.Perfusion after the patient was asked to stand up every 10 minutes 1,a total of 4 times to promote the uniform absorption of drugs.The electrocardiogram,blood routine,liver and kidney ion,ascites routine,ascites biochemistry,ascites tumor marker level,ascites color,the number of drainage and drainage were recorded.Record patient temperature,blood pressure,heart rate,respiration,and monitoring of adverse drug reactions before 0.5h,after 1h,2h,4h,6h,8h,12h,24h of drug administration.Then do the final analysis.Research results1.after medication,83.3%(20/24)patients’ WBC increased and 16.7%(4/24)patients had WBC decline after treatment.(1)there was no significant difference in the changes of WBC in 11 patients who were in the normal range before and after the use of drugs.The effect of intraperitoneal perfusion of Cinobufagin on its WBC was not considered.(2)there was a statistically significant difference in the changes of WBC(P<0.05)in the 4 cases of abnormal elevated WBC after medication(P<0.05).It was considered that the intraperitoneal perfusion of Cinobufagin made the WBC increase.(3)for 9 patients with abnormal WBC before and after treatment,there was a significant difference in their WBC before and after treatment.It was considered that the peritoneal perfusion of Hua Yuan Su had an effect on WBC.(4).After analyzing the above WBC in 2 groups of data,P=0.131>0.05 and no statistical difference were obtained.Therefore,it was considered that the intraperitoneal perfusion of Cinobufagin had no effect on the overall change of WBC in the group.2.79.2%(19/24)patients had increased NEUT after treatment,and 21.8%(5/24)had decreased NEUT after treatment.(1)there was no significant difference in the changes of NEUT before and after NEUT in 9 patients who were in the normal range before and after the use of drugs.The effect of intraperitoneal perfusion of Cinobufagin on its NEUT was not considered.(2)there was no significant difference in the changes of NEUT(P>0.05)before and after the abnormal increase of NEUT in 3 cases.It was considered that the intraperitoneal perfusion of Cinobufagin had no significant effect on the NEUT count.(3)for 11 cases of abnormal increase of NEUT before use,after intraperitoneal perfusion of Cinobufagin,the increase of NEUT may be further induced,and there is a statistical significance.(4).After analyzing the above NEUT in 2 groups of data,P=0.128>0.05 and no statistical difference were obtained.Therefore,it was considered that the intraperitoneal perfusion of Cinobufagin had no effect on the overall change of NEUT in the group.3.after medication,91.7%(22/24)patients increased ALT and 8.3%(2/24)patients had ALT decline after treatment.(1)for 18 cases of ALT with normal range before and after treatment,there was a significant difference in ALT before and after treatment.It was considered that the increase of ALT in peritoneal perfusion of toad.(2)for 2 cases of abnormal ALT before admission,there was no obvious change in ALT before and after treatment.(3)for 1 patients who had normal ALT in the group,they were slightly decreased after medication.(4).After analyzing the above ALT in 2 groups of data,P=0.126>0.05 and no statistical difference were obtained.Therefore,it was considered that the intraperitoneal perfusion of Cinobufagin had no effect on the overall change of ALT in the group.4.the patients with 83.3%(20/24)were increased after treatment,and 12.5%(3/24)had decreased AST after treatment,and 4.2%(1/24)patients were not changed after treatment.(1)there was no significant difference in the changes of AST before and after AST in 4 patients who were in the normal range before and after the use of drugs.It was considered that the intraperitoneal perfusion of Cinobufagin had no significant effect on the changes of AST in the 4 patients.(2)there was a statistically significant difference in the changes of AST before and after the 13 cases of abnormal increase of AST before and after the use of drugs,suggesting that the intraperitoneal perfusion of Cinobufagin increased the AST of the 13 patients.(3)after the above AST was combined into 2 sets of data,P=0.012<0.05 was statistically analyzed.Intraperitoneal perfusion of Chinese toad increased the AST of patients.5.24 patients had no significant changes in ECG before and after perfusion.The results showed that no toxicity was observed in the heart after intraperitoneal injection of Chinese toad.The cardiotoxicity induced by intravenous injection of Chinese toad is different from that previously known.It is proved that no significant cardiotoxicity is observed after the peritoneal perfusion,and it is also suitable for patients with cardiac dysfunction and malignant ascites.This is safer than intravenous injection.6.in this tolerance observation,3 cases had abdominal pain after abdominal medication,and 4 cases had elevated body temperature.No other obvious adverse reactions were found.Therefore,in the process of peritoneal perfusion with Chinese toad,the tolerance level of patients is generally high.It can be used as a routine medication in the abdominal cavity of patients with malignant ascites to reduce the amount of ascites in the patients,and the safety degree is higher when a single infusion of Cinobufagin 100ml and below is used.research conclusion1.When the peritoneal perfusion of Chinese toad is used to treat malignant ascites,it is recommended that the maximum dose of a single start should not exceed 100ml.2.When intrahepatic perfusion of Chinese toad in the treatment of malignant ascites,patients with abnormal liver function need to reduce dosage and monitor their liver function changes.If it is found that its AST is greater than 2.5-5.0 ULN,it is necessary to discontinue the medicine in time and make relevant treatment.3.The local intraperitoneal perfusion of toadin is less adverse and tolerable,especially for patients with poor body tumor. |
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