ObjectiveTo learn the development and implementation of orphan drug policies, in order to provide decision-making references for the establishment of orphan drug policy according with China's national conditions. MethodsWe electronically searched databases including CBM, CNKI, VIP, EMbase, PubMed, Web of Knowledge, National Library of Medicine, CRD database, The Campbell Library, The Cochrane Library and the drug administration websites of USA, Canada, UK, Ireland, the Netherlands, Germany, Spain, France, Australia, New Zealand, China, India, South Korea, Japan, and South Africa to collect studies about orphan drug policy. The search date was up to February 2014. Two reviewers independently screened literature, and extracted data. Then, all included orphan drug policies were summarized and a comparative analysis was performed. ResultsA total of 110 studies were included. USA, Singapore, Japan, Australia, European Union, Chinese Taiwan and South Korea had introduced orphan drugs incentive policies. South Africa, India, Canada, New Zealand and Chinese Hongkong were producing orphan drugs policy frameworks. The main items of orphan drug policy included marketing exclusivity, tax incentives, technical assistance, grant funding, expedite approval process and prolong re-evaluated time. ConclusionIn mainland China, there is no orphan disease management policy. China should establish specific organization and working procedures, promote orphan drug policy related legislative work, clarify the definition and prevalence of orphan diseases, provide incentive mechanism to promote the research and development of orphan drugs, provide enterprises to develop compensation mechanism to safeguard the rights and interests of patients, as well as establish patients register network platform to track the processes of the diseases.
Objective To study the predictive value of inspiratory capacity (IC) and total lung capacity (TLC) on acute exacerbation of patients with chronic obstructive pulmonary disease (COPD). Methods The in-patients due to acute exacerbation of COPD (AECOPD) from February 2017 to March 2019 were recruited in the study. Research data were collected during the recovery period and one year follow-up , and the patients were divided into two groups according to whether there was another acute exacerbation. Results A total of 372 patients were included in the study. In the patients with acute exacerbation, the age and TLC as a percentage of the expected value (TLC%pred) were higher, while IC as a percentage of the expected value (IC%pred) and the ratio of IC and TLC (IC/TLC) were lower. Univariate analysis revealed that IC/TLC≤25% was a significant predictor of acute exacerbation (P<0.001) after the AECOPD patients were discharged. Multivariable analysis revealed age (OR=1.25, 95%CI 1.17 to 1.44, P<0.001) and IC/TLC≤25% (OR=1.68, 95%CI 1.36 to 2.07, P<0.001) were independent risk factors of AECOPD.Conclusions Decreased IC/TLC significantly correlates with poor prognosis of COPD. IC/TLC≤25% is an independent risk factor for acute exacerbation.
ObjectiveTo systematically evaluate the risk prediction models for postoperative delirium in adults with cardiac surgery. MethodsThe SinoMed, CNKI, Wanfang, VIP, PubMed, EMbase, Web of Science, and Cochrane Library databases were searched to collect studies on risk prediction models for postoperative delirium in cardiac surgery published up to January 29, 2025. Two researchers screened the literature according to inclusion and exclusion criteria, used the PROBAST bias tool to assess the quality of the literature, and conducted a meta-analysis of common predictors in the model using Stata 17.0 software. ResultsA total of 21 articles were included, establishing 45 models with 28733 patients. Age, cardiopulmonary bypass time, history of diabetes, history of cerebrovascular disease, and gender were the top five common predictors. The area under the curve (AUC) of the 45 models ranged from 0.6 to 0.926. Fourteen out of the 21 studies had good applicability, while the applicability of the remaining seven was unclear; 20 studies had a high risk of bias. Meta-analysis showed that the incidence of postoperative delirium in adults with cardiac surgery was 18.6% [95%CI (15.7%, 21.6%)], and age [OR=1.04 (1.04, 1.05), P<0.001], history of cerebrovascular disease [OR=1.76 (1.46, 2.06), P<0.001], gender [OR=1.73 (1.43, 2.03), P<0.001], minimum mental state examination score [OR=1.00 (0.82, 1.17), P<0.001], and length of ICU stay [OR=5.59 (4.29, 6.88), P<0.001] weer independent influencing factors of postoperative delirium after cardiac surgery. ConclusionThe risk prediction models for postoperative delirium after cardiac surgery have good predictive performance, but there is a high overall risk of bias. In the future, large-sample, multicenter, high-quality prospective clinical studies should be conducted to construct the optimal risk prediction model for postoperative delirium in adults with cardiac surgery, aiming to identify and prevent the occurrence of postoperative delirium as early as possible.
ObjectiveTo compare the disinfection effect of peracetic acid versus glutaraldehyde in disinfection of flexible endoscope, and provide suggestions for choosing endoscopic disinfectant.MethodsWe searched literatures in PubMed, Embase, Cochrane Central Library, China National Knowledge Infrastructure, Wanfang database and VIP database, with the retrieval time from the establishment of each database to July 2017, screening and comparing the disinfection qualification rate of peroxyacetic acid versus glutaraldehyde in immersion disinfection of flexible endoscope. The number of flexible endoscopies after disinfection was the main effect index, and a fixed effect model analysis was performed.ResultsSix comparative studies were enrolled in this Meta-analysis, with a total of 786 flexible endoscopes. The result of Meta-analysis showed that the qualification rate of disinfection of peracetic acid was higher than that of glutaraldehyde with the same disinfection time [relative risk=1.09, 95% confidence interval (1.06, 1.13), P<0.000 01].ConclusionThe disinfection effect of peroxyacetic acid immersion method is better than that of glutaraldehyde.
Objective To investigate levels of 8-isoprostane in serum of patients with bronchial asthma. Methods Eighteen patients diagnosed with acute exacerbation of asthma were enrolled as the experimental group from Department of Respiratory Medicine from February 2009 to August 2009. After treatment all the patients reached remission. Twenty healthy workers from Department of Respiratory Medicine were enrolled as the control group in August 2009. The levels of 8-isoprostane in serum of all subjects were measured, and their FEV1% pred was also evaluated. Results The levels of 8-isoprostane in serum were significantly higher in patients with acute exacerbation of asthma compared with those in remission stage and the healthy control group [ ( 157. 46 ±46. 99) pg/mL vs. ( 43. 52 ±13. 62) pg/mL and( 15. 23 ±1. 96) pg/mL, P lt;0. 01] . Meanwhile the levels of 8-isoprostane in serum of patients with asthma in remission stage were significantly higher compared with the healthy control group ( P lt;0. 05) . The levels of 8-isoprostane in serum were negatively correlated with FEV1% pred in the asthma group( r = - 0. 533,P lt;0. 05) . Conclusions 8-isoprostane as amarker of oxidative stress response involves in the pathogenesis of asthma. Monitoring 8-isoprostane levels in serum may reflect the state of oxidative stress, and may be useful for severity judgment and follow-up of treatment effectiveness in patients with asthma.