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 analyze the disease burden of liver cancer in China.Methods:Based on eight data sources, including the series of Chinese Cancer Registry Annual Report, three national death cause surveys in China, China Health Statistical Yearbook, China Death Cause Surveillance Datasets, GLOBOCAN, Cancer Incidence in Five Continents (CI5), WHO Mortality Database and the Global Burden of Disease (GBD), the information on incidence, mortality and disability-adjusted life year (DALY) of liver cancer, were extracted for the analysis on the past, current and future disease burden caused by liver cancer in China.Results:1) Past situation: The long-term data from 1973 to 2012 reported by the CI5 showed that in urban populations in China (taking Shanghai as an example), the incidence rate of liver cancer in males and females decreased by 41.3 % and 36.3 %, respectively, and that in rural areas (taking Qidong as an example) decreased by 32.3 % and 12.2 %, respectively. The Chinese Cancer Registry Annual Reports showed that the national incidence and mortality rates of liver cancer decreased by 8.1 % and 12.8 % respectively from 2005 to 2015. The Joinpoint analysis based on the data from the China Health Statistics Yearbook also showed a declining trend: the average annual percentage change of liver cancer mortality in China from 2002 to 2017 was -3.0 % ( P<0.05), and that in rural areas was -3.1 % ( P<0.05). 2) Current status: GLOBOCAN estimates that the rates of incidence, mortality and prevalence of liver cancer in China in 2018 were 18.3 per 100 000, 17.1 per 100 000 and 10.8 per 100 000, respectively. According to the latest annual report, the incidence and mortality rates of liver cancer in cancer registration areas in 2015 were 17.6 per 100 000 and 15.3 per 100 000, respectively, and both increased with age. The mortality rate was similar to that reported in 2017 (16.7 per 100 000) by the China Death Cause Surveillance Datasets, and the male to female ratio of live cancer deaths was estimated as 3.1. The GBD 2017 reports that the DALYs caused by liver cancer in China reached 11 153.0 thousand in 2017 (accounting for 53.7 % of the global DALYs) and hepatitis B virus infection was always the leading cause. 3) Prediction: The GLOBOCAN 2018 predicts that, by 2040, the number of liver cancer cases and deaths in China would reach 591 000 and 572 000 (with an increase of 50.5 % and 54.9 %, respectively, compared with those in 2018), with a more significant increase in people over 70 years old. 4) Economic burden: According to the literature review of economic burden data on liver cancer, the direct medical expenditure per patient with liver cancer generally showed a rising trend. Conclusions:Multiple data sources indicate that the incidence and mortality rates of liver cancer in populations in China decreased in the past decades, indicating the effect of population interventions. However, the population-level disease burden are still substantial, and comprehensive intervention strategies need to be continually strengthened and optimized, especially the primary and secondary prevention.

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.