Objective:To establish the criterion of bacterial endotoxins test for hemocoagulase atrox for injection and measure the endotoxin concentration in hemocoagulase atrox for injection by the kinetic turbidimetric technique. Methods:The limit of bacterial en-dotoxins in the product was designed according to ChP 2010. Four endotoxin concentrations were prepared to obtain the standard curve. The interfering test was done by measuring the concentration of endotoxin added into the sample solution. The endotoxin concentration in the sample solution was measured. Results:The absolute value of the correlation coefficient was 0. 988 6 (must be above or equal to 0. 980), suggesting the standard curve was valid. The recovery of the added endotoxin in the sample solution was within 50 to 200%when the concentration of the product sample was 0. 25 KU·ml-1 . The measured endotoxin concentration in the sample met the re-quirements for bacterial endotoxins. Conclusion:The bacterial endotoxins assay method for milrinone injections is established, and the kinetic turbidimetric technique is suitable for the bacterial endotoxin test of the product.

China ; epidemiology ; Humans ; Incidence ; Liver Neoplasms ; epidemiology ; mortality

Objective To estimate the mean annual expenditure of patients with prevalent liver cancer in China on the perspective of the natural progression of the disease and to provide baseline information for liver cancer?related disease burden estimation and evaluation of prevention strategies. Methods A multicenter survey on liver cancer was conducted between 2012 and 2014 in 13 sites where the cancer screening program was conducted in Urban China, by face?to?face interviews with hospitalized patients. Data on basic information, clinical diagnosis and treatment, direct medical expenditure, and direct non?medical expenditure were collected. By?year expenditure and number of visits from the first visit to the end of the survey were analyzed. The trend for the two indicators in each year was analyzed. The subgroup analysis of factors such as sex and age was conducted. All the expenditure data were discounted to the year 2014 and presented in Chinese yuan. The statistical analysis was performed using the SAS 9.4 software. Results A total of 2 222 patients with liver cancer, with a mean age of 55.7±11.2 years, were included. Men accounted for 79.2% (1 759 cases) of the patients, women accounted for 20.8% (463 cases) of the patients, and 75.6% (1 679 cases) of the cases were from cancer hospitals. Stage Ⅰ cases only accounted for 14.1% (299 cases) of all the cases, and most cases were stageⅢorⅣ(62.6%, 1 325 cases). Of the cases, 64.4% (1 430 cases) had pathological information, and 83.6%(1 195 cases) were pathologically hepatocellular carcinoma. The sample sizes for the first 3 years from the first visit were 2 222, 149, and 57, respectively (by?year sample sizes thereafter were<50). The annual total medical expenditures for the first 3 years were 49 091 yuan (95% confidence interval [CI]: 47 376-50 806), 30 506 yuan (95% CI: 26 462-34 549), and 32 100 yuan (95% CI: 25 917-38 283) (P<0.001). The corresponding number of visits were 1.9, 1.6, and 1.5 (P<0.001). The trend for each province was consistent with the overall trend, while the down trend from years 1 to 2 varied among provinces, ranging from 1.4 (Zhejiang province) to 5.6 times (Henan province). For the trend in the first 3 years, differences were found in subgroups such as region (P<0.001) and treatment (P<0.05), instead of sex, age, stage, and other subgroups. Conclusions For liver cancer patients in China, the annual expenditure for the first year in the whole disease course was 1.6 times higher than that for the second year, which varied among provinces. However, information on annual expenditure for the later course of liver cancer is still limited.