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OBJECTIVE To evaluate the efficacy， safety and cost-effectiveness of polyisobutylene （PIB）-type Gutong plaster （called “PIB Gutong plaster” for short） versus non-steroidal anti-inflammatory drugs （NSAIDs） in the treatment of osteoarthritis in Chinese adults. METHODS Based on a real-world study， after propensity score matching， the decrease in pain visual simulation score， utility increase， time to pain resolution， time to return to normal range of motion and total adverse events of PIB Gutong plaster versus three NSAIDs （celecoxib， diclofenac sodium， and ibuprofen） were evaluated. Cost-utility analysis was used to calculate the incremental cost-effectiveness ratio （ICER） of patients using PIB Gutong plaster versus the three NSAIDs from the perspective of the whole society， and sensitivity analysis was carried out. RESULTS In terms of effectiveness， the recovery time of joint activity in PIB Gutong plaster group was significantly longer than that in celecoxib group， the decrease in VAS score of PIB Gutong plaster was significantly higher than that of ibuprofen but significantly lower than that of diclofenac sodium； the time of pain disappearance was longer than that in diclofenac sodium group and ibuprofen group， and the increase in health utility was significantly lower than that in diclofenac sodium group （P＜0.05）. In terms of safety， there were no significant differences in the incidence and severity of adverse events of PIB Gutong plaster， compared with the three NSAIDs， without statistical significance （P＜0.05）. In terms of cost-effectiveness， compared with celecoxib and diclofenac sodium， PIB Gutong plaster was dominant. Compared with ibuprofen， the ICER value of PIB Gutong plaster was 178 611.58 yuan/QALY， indicating that at the current price， PIB Gutong plaster was cost-effective if the threshold was 3 times GDP per capita. The results of sensitivity analysis were consistent with those of basic analysis. CONCLUSIONS The efficacy of PIB Gutong plaster was better than that of ibuprofen， similar to that of celecoxib， but worse than that of diclofenac sodium， the safety was consistent with the three NSAIDs， and the cost-effectiveness of PIB Gutong plaster needs to be improved.
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OBJECTIVE To evaluate the econo mical efficiency of Recombinant human thrombopoietin injection （called “rhTPO”for short ）versus Etrapopa ethanolamine tablets （called“Etrapopa”for short ）in the second-line treatment of primary immune thrombocytopenia （ITP）in the Chinese adult patients. METHODS Based on the decision tree-embedded Markov model with a 4-week cycle ，the cost and utility related to bleeding events and adverse events after the use of the two drugs were measured and compared from the perspective of Chinese health system. The horizon was 12 weeks，and the cost and health outcome were not discounted. RESULTS Compared with Etrapopa ，rhTPO improved the quality adjusted life year by 0.002 5 and reduced the cost by 1 824.36 yuan，which was the absolute advantage scheme. Univariate sensitivity analysis showed that the base results were greatly affected by the dosage of rhTPO and Etrapopa during maintainance period. In most cases ，rhTPO was economical. Probability sensitivity analysis showed that when willingness-to-pay threshold varied between 0 yuan and 250 000 yuan，the probability about that rhTPO was economical ranges from 99.90％ to 100％. CONCLUSIONS Based on the available evidence ，rhTPO is more economical in the short term than Etrapopa in the second-line treatment of ITP.
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OBJECTIVE：To review the method and results of pharmacoeconomic evaluation of aspirin for cardiovascular disease prevention ，and to provide reference for economic evaluation of aspirin and clinical medication decision. METHODS ： Using“cardiovascular disease ”“cost-effectiveness”“cost-utility”“cost-benefit”“cost effectiveness ”“cost utility ”as the Chinese search terms ，using“cost-effectiveness”“cost-utility”“cost-benefit”“economic analysis ”“pharmacoeconomics”as English search terms，relevant literatures about pharmacoeconomic evaluation of aspirin for cardiovascular disease prevention published during January 1，2000 to January 17，2021 were retrieved from CNKI ，Wanfang database ，VIP，PubMed，Web of Science ，the Cochrane Library. After screening literatures according to inclusion and exclusion criteria ，extracting relevant data ，the quality of included literatures was evaluated with CHEERS scale. The method and results of pharmacoeconomic evaluation of aspirin in the prevention of cardiovascular diseases were analyzed statistically in terms of basic information ，literature quality ，model structure and elements ，health status and utility value ，cost items and sources ，health output ，economic evaluation and sensitivity analysis. RESULTS & CONCLUSIONS ：Nine literatures were included ，and the total coincidence rates of the literatures were all above 80.00％. The pharmacoeconomic evaluation of aspirin in the prevention of cardiovascular disease mainly adopted Markov model ， and the model structure was relatively mature. The cost mainly considered the direct cost ，and the data mainly came from the medical insurance database ；utility was calculated according to the utility value of health state ，which mostly came from the existing literatures. The sensitivity analysis adopted deterministic sensitivity analysis and probabilistic sensitivity analysis ，and the main influential factor was cost. It was economical to use aspirin for cardiovascular disease prevention in most cases ，and aspirin was more economical for primary prevention of cardiovascular disease. It is suggested that domestic scholars can refer to China ’s pharmacoeconomic guidelines to carry out relvant pharmacoeconomic evaluation research more standardized.
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OBJECTIVE：To analyze th e general characteristics and application of the models used in the pharmacoeconomic evaluation of type 2 diabetes mellitus （T2DM）therapy during the past 5 years，and to provide reference for the selection and improvement of T 2DM pharmacoeconomic model. METHODS ：Retrieved from PubMed ，Embase，CNKI，Wanfang database and VIP during Jan. 1st，2015 to Dec. 31st，2019，pharmacoeconomic evaluation literatures about T 2DM therapy were collected ；the included model was analyzed in respects of general structure ，therapy plan establishment ， short-term therapeutic efficacy ， complication simulation ，model effectiveness validation ，application frequency. RESULTS ：A total of 81 literatures were included ， involving 14 models，such as CORE model ，Cardiff model ，ECHO model ，etc. Mostly ，Markov or micro Markov simulation method were adopted to measure the patient ’s lifetime health outcome and cost mostly from the point of view of third-party payer. Seven models could simulate 2-4 therapy plans ；short-term efficacy mainly included risk factors of diabetic complications （such as glycosylated hemoglobin level and body mass ）and adverse drug reactions. Most models used intermediate indexes to simulate the occurrence of complications ，and the number of complications ranged from 3 to 15；the validity of model effectiveness included surface validity ，internal validity and external validity ，etc. Among 14 models，the most frequently used models in the past 5 years were long-term models that had been validated ，among which CORE model had the most application times （38/81，46.91％）， followed by Cardiff model （12/81，14.81％）. CONCLUSIONS ：The 14 models have similar structure. The differences of the models are mainly reflected in 3 aspects as therapy plan setting， considered short-term efficacy ， the number of model are ideally choose based on available evidences.
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Objective To explore the in vitro antibacterial effect of tanreqing injection combined with cefuroxime sodium injection against staphylococcus aureus. Methods The MIC of tanreqing injection or cefuroxime sodium injection against staphylococcus aureus was detected by microamount dilution method.The antibacterial activity of tanreqing injection combined with cefuroxime sodium injection was determined by a chess board dilution method and assessed according to FIC index. Results The MIC of tanreqing injection and cefuroxime sodium injection against staphylococcus aureus was 1∶256 and 2 μg . mL-1 , respectively. While combined with each other, the MIC of tanreqing injection and cefuroxime sodium injection against staphylococcus aureus was 1∶4 096 and 0. 125 μg . mL-1 , respectively. The FIC index of tanreqing injection combined with cefuroxime sodium injection against staphylococcus aureus was 0. 125. Conclusion Tanreqing injection has a synergistic antibacterial effect against staphylococcus aureus when it was combined with cefuroxime sodium injection.
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@#An LC-MS method was established for the identification of the related substances in rivaroxaban. HPLC separation was carried out on an Inert Sustain C18 column(250 mm×4. 6 mm, 5 μm)with linear gradient elution using a mobile phase consisting of 0. 2% formic acid acetonitrile and 0. 2% formic acid aqueous solution. Rivaroxaban and its related substances could be completely separated under the established HPLC conditions. The structures of the related substances were identified by electrospray positive ESI high resolution TOF/MS and MS/MS spectra determination and elucidation, and further verified through reference substances. Fifteen related substances were detected and identified to be three related substances of starting materials, four synthetic by-products and ten degradation products. The established method is useful for the identification of the related substances in rivaroxaban. The results obtained are valuable for its manufacturing control and quality assurance.