中药临床试验是中医药研究中发展较快的一个领域，临床研究协调员（CRC）在中药临床试验中有重要作用，其工作范围涉及到中药临床试验的各个方面。由于中药临床试验有着不同于西药临床试验的特点，CRC在中药临床试验中的作用也有其特殊性，对提高临床试验的安全性、科学性及试验数据的可信度方面起重要作用。
Thirty patients with obstructive jaundice were investigated for serum complement-3 (C3) and plasma fibronectin (FN).The levels of C3 and FN of the juandiced patients were higher than that of thirty patients without obstructive jaundice (Ｐ＜0.01). As compared to pre-operation, the level of C3 of the jaundiced patients decreased obviously within two weeks after operation(Ｐ＜0.01), and recovered in the third week after operation. The level of FN of the juandice patients decreased evidently within one week(Ｐ＜0.01), and recovered in the second week after operation. However, the levels of C3 and FN of the patients without obstructive jaundice changed slightly after operation (Ｐ＜0.05). The high levels of C3 and FN of jaundiced patients may be relative to the latent infection. Consumption and immune imparing may be the reasons of C3 and FN to decrease.
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.
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.
ObjectiveTo collect the data of esophageal foreign body patients, and to evaluate the clinical effects of two different surgical methods in our hospital.MethodsThe clinical data of 294 patients who were treated in Gansu Provincal Hospital from January 2012 to June 2018 were analyzed retrospectively. The clinical data were collected and analyzed by SPSS 22.0. In order to to evaluate the efficacy of flexible esophagoscope (FE) and rigid esophagoscope (RE) in the treatment of esophageal foreign bodies.The patients were divided into two groups: a RE group including 118 patients with 62 males and 56 females at age of 6 (3-37) years and a FE group including 176 patients with 84 males and 92 females at age of 6 (3-59) years.ResultsThere was no significant difference in age, age stratification, gender and foreign body type between the two groups. There was a statistical difference in the initial clinical symptoms (P=0.041) or in esophageal foreign bodies position (P=0.037) between the two groups. The success rate of foreign body removal was similar between the two groups (P=0.632). The success rate was 88.9% (105/118) in the RE group, 87.5% (154/176) in the FE group. The operation time was significantly longer in the RE group than that in the FE group (10.8 ±17.4 min vs. 17.5±21.6 min, P<0.001). The postoperative hospitalization time in the RE groups was longer than that in the FE group (21.5 ±24.2 hours vs. 12.5 ±21.3 hours, P<0.05). There was a statistical difference in the incidence of postoperative complications between the two groups (P=0.034). In the RE group, the main complication was mucosal edema (15.3%). And the rate of bleeding was higher (15.9%) in the FE group. There were 30 patients (25.5%) in the RE group with minor postoperative complications versus the FE group with 40 patients (22.7%); and 1 patient (0.8%) in the RE group with severe complications versus the FE group with 5 paients (2.8%).ConclusionBased on the analysis of this study, it is found that RE has higher safety. But the indications are strict, the professional requirements of the operator and the selection of patients are stronger. The FE is convenient to use, the operation crowd is wide, and the suitable crowd is wide. Therefore, for specific patients, after improving the relevant examination and preoperative evaluation of patients, clinicians need to choose appropriate surgical methods to ensure the success of the operation, and reduce the postoperative complications as far as possible.
目的:评价硫普罗宁钠治疗急慢性肝炎的有效性与安全性。方法:采用随机、双盲模拟、阳性药平行对照试验方法。硫普罗宁钠200mg静滴Qd,对照组用凯西莱(硫普罗宁)200mg静滴Qd。疗程均为4周,停药后随访4周。结果:共治疗急性肝炎患者7例,慢性肝炎患者18例。急性肝炎组:试验组与对照组4周末ALT下降率分别为69.14±39.23％及68.23±45.12％,试验组显效率33.33％,总有效率100％,对照组显效率25％,总有效率100%,两组疗效比较无显著性差异(Pgt;0.05)。慢性肝炎组:试验组与对照组4周末ALT下降率分别为44.34±53.1％及35.01±74.67％,试验组显效率22.2％,总有效率77.8％,对照组显效率11.11％,总有效率66.67％,两组疗效比较无显著性差异(Pgt;0.05)。急性肝炎组未见不良反应,慢性肝炎组中试验组及对照组不良反应发生率均为5.00%。结论: 硫普罗宁钠具有保肝降酶作用,临床上用于治疗急慢性肝炎患者安全有效。
Objective To identify, describe, and evaluate the evidence of traditional Chinese medicine (TCM) interventions for cancer-related fatigue (CRF) using an evidence mapping approach. Methods The CNKI, WanFang Data, VIP, SinoMed, PubMed, Web of Science and Embase databases were electronically searched to collect studies on TCM interventions for CRF from inception to June 4, 2024. Evidence mapping was employed to present the characteristics of study populations, interventions, studies included in systematic review/meta-analysis (SR/MA), and conclusions. Results A total of 94 randomized controlled trials (RCT) and 17 SR/MA/network MA were included. The number of publications has shown an overall fluctuating upward trend in the past 15 years. The RCT included literature with a high focus on mixed cancers, involving a total of 51 TCM therapeutic measures, including 40 herbal treatments, 5 external TCM treatments, and 5 TCM integrative therapies. The outcome indicators were classified into 14 categories, with the most frequent ones being CRF scores, TCM syndrome scores, clinical efficacy, quality of life scores, immune function indicators, adverse event rates, and serum indicators. The SR/MA included 7-81 original studies with sample sizes of 551-7 547 cases, involving 5 intervention measures: herbal medicine (9 studies), moxibustion (3 studies), TCM injection (2 studies), moxibustion (2 studies), and acupuncture (1 study). The quality of RCT and SR/MA was generally low, and the evidence quality was low. Most studies showed that TCM interventions for CRF had potential efficacy, but there was still a lack of definitive clinical evidence. Conclusion The results suggest that TCM interventions for CRF have advantages but also problems. There is still a lack of high-quality research. More large-sample, multicenter RCT and high-quality SR/MA are needed to further explore the advantages of TCM interventions for CRF and provide strong support for the effectiveness and safety of TCM interventions for CRF.