At the end of 2022, the National Medical Products Administration (NMPA), in conjunction with the National Cancer Center, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College raised for the first time the important issue of clinical research globally: whether the source of the death time of clinical trials based on the simple follow-up records is credible, and proposed a consensus document on the source of the death time of clinical trials. The results were published in The Lancet Regional Health-Western Pacific, which attracted wide attention and recognition from the international industry. This is the first time that the China consensus on quality standards for clinical research has been ahead of the U.S. Food and Drug Administration and other international colleagues. The NMPA has been leading China in promoting the scientific development of clinical research, so as to constantly establish and improve the scientific regulatory system and ecological system, and promote China's full integration into the global pharmaceutical research and development system. China clinical research institutions and the whole industry are also gradually from standardized development to scientific development, high-quality development process. In this study, we summarized the scientific and subject-oriented development of China clinical research industry in recent years, and continuously strengthened the international competitiveness of China pharmaceutical industry. It is suggested that scientific thinking model should be used to deal with the normative problems in clinical research and promote the development of medical model to scientific model.
Objective To compare the treatment effect of patellar resurfacing versus patellar non-resurfacing in total knee arthroplasty. Methods We identified eligible studies in PubMed (1950 to 2008.6), OVID MEDLINE (1950 to 2008.6), OVID CINAHL (1950 to 2008.6), OVID EBM (2nd Quarter 2008), CBMdisk (1978 to 2008.6), and CNKI (1981 to 2008.6), and handsearched some Chinese orthopedic journals to identified randomize controlled trials (RCTs) comparing patellar resurfacing versus patellar non-resurfacing in total knee arthroplasty. Data were extracted and methodological quality was critically assessed by two reviewers independently. Meta-analyses were performed using Stata 10.0 software. Outcomes of interest included the number of reoperations for patellofemoral problems, the prevalence of postoperative anterior knee pain, and the improvement in HSS knee score. Results Thirteen RCTs involving 1 566 patients were included. The scores of methodological quality respectively were more than 13. The results of meta-analyses showed that patellar resurfacing could decrease the re-operation rate for patellofemoral problems (RR=0.30, 95%CI 0.14 to 0.62, Plt;0.01). The rate of postoperative anterior knee pain and the improvement in HSS knee score were comparable between patellar resurfacing and patellar non-resurfacing. Conclusion The outcome identified is re-operations for patellofemoral problems. The resurfaced patella performs better, and we find an increased relative risk for re-operation when the patella is left un-resurfaced. No differences are observed between the two groups for the prevalence of postoperative anterior knee pain, and the improvement in HSS knee score. Further well-designed and large-scale RCTs are required to determine the effects of patellar resurfacing and non-resurfacing on these outcomes.
Pain is one of the common complications of most diseases. Due to the unknown mechanism of pain, its treatment has been controversial. Repeated peripheral magnetic stimulation for pain has the advantages of non-invasiveness, painlessness, and well-targeted. However, the parameters of repeated peripheral magnetic stimulation for pain are not uniform due to various factors such as frequency, location of action, and coil type. In this paper, the parameters and efficacy of repeated peripheral magnetic stimulation for various kinds of pain such as acute and chronic low back pain, myofascial pain, migraine, peripheral neuralgia and post-traumatic pain are described, in order to providea theoretical basis for future research. In addition, the mechanism of repeated peripheral magnetic stimulation for pain has not been known, and this article will briefly summarize and explain on this.
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.