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BACKGROUNDTreatment of severe Corona Virus Disease 2019 (COVID-19) is challenging. We performed a phase 2 trial to assess the efficacy and safety of human umbilical cord-mesenchymal stem cells (UC-MSCs) to treat severe COVID-19 patients with lung damage, based on our phase 1 data. METHODSIn this randomized, double-blind, and placebo-controlled trial, we recruited 101 severe COVID-19 patients with lung damage. They were randomly assigned to receive either UC-MSCs (4 x 107 cells per infusion) or placebo on day 0, 3, and 6. The primary endpoint was an altered proportion of whole lung lesion volumes from baseline to day 28. Other imaging outcomes, 6-minute walk test, maximum vital capacity, diffusing capacity, and adverse events were recorded and analysed. RESULTS100 COVID-19 patients were finally recruited to receive either UC-MSCs (n = 65) or placebo (n = 35). UC-MSCs administration exerted numerical improvement in whole lung lesion volume from baseline to day 28 compared with the placebo (the median difference was -13.31%, 95%CI -29.14%, 2.13%, P=0.080). UC-MSCs significantly reduced the proportions of solid component lesion volume compared with the placebo (median difference: -15.45%; 95% CI -30.82%, -0.39%; P=0.043). The 6-minute walk test showed an increased distance in patients treated with UC-MSCs (difference: 27.00 m; 95% CI 0.00, 57.00; P=0.057). The incidence of adverse events was similar in the two groups. CONCLUSIONSUC-MSCs treatment is a safe and potentially effective therapeutic approach for COVID-19 patients with lung damage. (Funded by The National Key R&D Program of China and others. ClinicalTrials.gov number, NCT04288102.)
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OBJECTIVE:To investigate the situation of pharmacoeconomic researches about lipid-lowering drugs in China, and to seek the regimen with good cost-effectiveness in order to provide reference for rational drug use in the clinic. METHODS:Retrieved from CNKI and Wanfang database,pharmacoeconomic literatures about lipid-lowering drugs,published in domestic jour-nals during 2011-2015,were included to discuss the problems of pharmacoeconomic researches about lipid-lowering drugs and put forward related suggestions. RESULTS:Rosuvastatin and other medicines showed good cost-effectiveness,while there were many problems of domestic published pharmacoeconomic researches about lipid-lowering drugs,such as different research methods,dif-ferent treatment courses,different methods of cost calculation,single effect index and absence of ADR. On the whole,the research-es were low in quality,which led the difficulty of accurately obtaining the drugs with best cost-effectiveness. CONCLUSIONS:In the future,related researches should confirm research duration and health output index,effect index and evaluation method accord-ing to disease types and research objectives;enhance the unity of research and design methods;pay attention to cost discount;in addition,strengthen pharmacoeconomic researches about lipid-lowering TCM and compare it with chemical drugs.
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ObjectiveTo evaluate the one-year follow-up of the therapeutic efficacy of human umbilical cord derived-mesenchymal stem cell (UC-MSC) transplantations in decompensated liver cirrhosis patients with ascites.MethodsFifty-four liver cirrhosis patients with ascites in Research Center for Biological Therapy in 302 Military Hospital were divided into treatment group (n=38) and control group (n=16) in a prospective controlled single-blinded trial.UC-MSC (0.5-1.0) × 106/kg and saline were intravenously transplanted into patients monthly for 3 times in treatment group and control group,respectively.The liver function,hepatitis B virus (HBV) DNA level,ascites and the model for end-stage liver disease(MELD)scores at different time points were compared between two groups.The comparison between groups was done by Mann-Whitney U test,and the data before and after transplantations were compared by Wilcoxon signed rank sum test.ResultsThere were no significant differences of alanine transaminase (ALT),total bilirubin (TBil),cholinesterase (CHE),HBV DNA positive rate and MELD scores at different time points between two groups (P＞0.05).However, the albumin ( A1b)level was significantly increased after 36 weeks of UC-MSC transplantation in treatment group, which were (28.47±4.45)g/L at week 0 and ( 34.82±4.50)g/L at week 48 (P=0.046). Meanwhile, the ascites reduced markedly in treatment group with (46.6 ±30.6) mm at week 0 and (6.6±13.6) mm at week 48,which were significantly different from control group at the end of follow-up (P =0.037). Conclusion UC-MSC transplantations may help to increase A1b level and reduce ascites in patients with decompensated liver cirrhosis.
