ObjectiveTo compare the current status of clinical studies regarding lung cancer between China and the United States in 2019, and to indicate the weakness, trend and future development direction of clinical studies drug treatment in China.MethodsThe data of lung cancer clinical studies from January 1st to November 30th, 2019 in China and the United States were retrieved and analyzed through Informa pharmaprojects database.ResultsThe United States was superior on the number of projects (128 vs. 156) and research institutions (743 vs. 2 250). Compared with the United State, there were more phase Ⅲ confirmatory researches (19.5% vs. 10.3%), bioequivalent drug researches (3.1% vs. 0%), and researches initiated by academic institutions (39.8% vs. 28.1%) in China. The United States exhibited advantages in phaseⅠ andⅠ/Ⅱstudies (25.8% vs. 60.3%), immunodrugs (49.2% vs. 60.3%), primary tested drug ratio (61.7% vs. 93.6%), targets abundance (32.9% vs. 69.6%), and chimeric antigen receptor-T (CAR-T, 0.7% vs. 7.1%).ConclusionCompared with the United States, China should pay more attention to innovative drug investigations in early phase of clinical studies, especially novel immune agents, vaccines, and CAR-T.
Objective To summarize the progress and trend on clinical drug trials of esophageal squamous cell carcinoma in China. Methods Based on the clinical drug trial registration and information disclosure platform and the drug data query system of the National Medical Products Administration, the characteristics of clinical trials, investigational drugs and listed drugs of esophageal squamous cell carcinoma in China from 2012 to 2021 were analyzed. Results From 2012 to 2021, a total of 49 clinical drug trials of esophageal squamous cell carcinoma were registered in China, accounting for 1.6% of all clinical trials of anticancer drugs. Among them, there were 39 (79.6%) trials initiated by domestic pharmaceutical enterprises, 6 (12.2%) for adjuvant and neoadjuvant treatment, and 9 (18.4%) for local treatment. There were differences in the treatment line distribution between global and domestic enterprise-initiated trials (P=0.032). The above trials covered 29 investigational drugs, including 23 (79.3%) targeted drugs, most of which targeted programmed death-1, programmed death-ligand 1 and epidermal growth factor receptor. From 2012 to 2021, there were 2 drugs for esophageal squamous cell carcinoma listed in China, both of which were approved for the first-line and second- line treatment. Conclusion Great achievements have been made in the clinical development of esophageal squamous cell carcinoma drugs in China. It is suggested that domestic enterprises increase the investment of esophageal squamous cell carcinoma, pay attention to adjuvant and local treatment, explore novel targets and drug categories, and focus on the details of pivotal trials.
Objective To investigate the risk factors for early progression in patients with acute respiratory distress syndrome (ARDS), and to provide a reference for early detection and intervention of high-risk patients with ARDS progression. Methods Data from multicenter mechanically ventilated patients with mild to moderate ARDS were retrospectively analyzed. According to the severity grade of 72 h ARDS, the patients were divided into an early progressive group and a non-progressive group. Chi-square test was used to compare the risk factors of ARDS patients and the prognosis of the two groups were analyzed by Logistic regression. Results A total of 355 patients with mild to moderate ARDS were included in invasive mechanical ventilation, of which 97 patients (27.3%) progressed after 72 hours. 78.4% were female in the progressive group and 64.0% were female in the non-progressive group. Compared with the non-progressive group, the patients with ARDS in the progressive group had shorter 28-day no mechanical ventilation, higher ICU mortality, and lower survival rate at 30 days and 60 days（P<0.05）, but there was no significant difference in the length of ICU stay between the two groups (P>0.05). Univariate and multivariate regression analysis showed that the patients with ARDS in the progressive group had lower baseline oxygenation index (OR=0.979, 95%CI 0.961 - 0.986, P<0.01), higher peak airway pressure (OR=1.068, 95%CI 1.017 - 1.121, P<0.01), higher lactate level (OR=1.224, 95%CI 1.057 - 1.417, P<0.01), higher tidal volume (OR=1.159, 95%CI 1.002 - 1.341, P<0.05), higher age (OR=1.373, 95%CI 1.051 - 1.082, P<0.01), and more male patients (OR=2.583, 95%CI 1.336 - 4.995, P<0.05). Conclusions Early progression is common in mild to moderate ARDS patients with mechanical ventilation. The progressive group has shorter duration of 28 days without mechanical ventilation, higher ICU mortality and lower 30-day and 60-day survival rate than the non-progressive group. Male, low baseline oxygenation index levels, high peak airway pressure, tidal volume, lactate levels, and higher age are risk factors for early progression in patients with mild to moderate ARDS.