【摘要】目的 探讨胃食反流管病(GERD)患者牙周疾病的发生情况,以及GERD与牙周炎之间的关系。方法2008年7月2009年6月对360例GERD患者,396名正常人进行牙周健康状况和全身一般情况检查,牙周检查以社区牙周指数(CPI)和附着丧失(AL)作为诊断标准。结果GERD患者牙周炎患病率及严重程度、牙列缺损率及缺牙数目均高于正常人, GERD患者无牙颌比例高于正常人。结论长期患GERD可能是牙周病的危险因素。
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。
目的 观察盐酸氨基葡萄糖治疗膝骨关节炎（KOA）的临床疗效。 方法 2010年5月－2012年7月将130例经膝关节镜清理术后的KOA患者随机分成A、B两组，每组65例。A组联合口服盐酸氨基葡萄糖胶囊750 mg，2次/d，6周为1个疗程，治疗3个疗程；B组联合口服尼美舒利胶囊0.1 g，2次/d，服用12周。采用Lequesne指数作为疗效评定指标，观察治疗前后膝关节体征及症状变化，休息痛、运动痛、压痛、肿胀、晨僵和行走能力的改善情况。 结果 B组患者在治疗早期症状改善优于同期A组，且在第3个月有统计学意义（P＜0.05），随着治疗时间的延长，A组患者总有效率在1、3、6个月分别为70.8%、76.9%和92.3%，均呈逐渐上升趋势，且第6个月疗效较前2个时间点差异有统计学意义（P＜0.05）。分别停药后继续随访至1年，两组患者总有效率均有所下降，但A组疗效仍优于B组，且有统计学意义（P＜0.05）。A组出现不良反应2例，B组4例，均较轻微，无严重不良事件发生。 结论 盐酸氨基葡萄糖在改善OA患者膝关节症状等方面效果肯定，且疗效较稳定，安全性良好；但远期疗效仍需随访观察。
Objective To understand the current status of the preferences and opinions on the investigator-initiated trails (IIT) of the neurosurgeons participating in INTERACT3 in China, as well as the design preference for IIT projects, and to provide a basis for the design and organization of multi-center clinical studies in the future. Methods Neurosurgeons with different seniority and professional titles from 89 domestic research institutions participating in the INTERACT3 project were collected from September to October 2023. The questionnaires were collected by questionnaire star. Results A total of 56 valid questionnaires were collected from 29 units. Among the 56 respondents, 52 neurosurgeons (92.86%) were from teaching hospitals and 45 (80.36%) were from grade A tertiary hospitals. 30 neurosurgeons (53.57%) had experience in conducting various clinical studies, and 55 neurosurgeons (98.21%) had experience in participating in various clinical studies. The main purposes of presiding over or participating in clinical research focused on “accumulating relevant experience and preparing for future projects” and “standardizing clinical diagnosis and treatment”, which were 89.29% and 83.93%. Respectively, regarding the way the case report form completing, respondents preferred to use electronic data collection systems (83.93%). Conclusions The purpose of the neurosurgeons interviewed to host or participate in clinical research is mainly to assist clinical and scientific research. Economic reasons have little impact on whether to participate in clinical research. The rationality and ease of operation of the trail design are the keys to attracting respondents to participate in clinical researches, and the level of remuneration has little impact on the decision-making of the respondents. The safety of clinical studies and the difficulty of enrolling subjects are the key factors that hinder respondents’ participation in clinical studies.
Objective To investigate the current situation of clinical studies on puerarin for ischemic stroke and the reliability of these evidence. Methods By electronic searching and handsearching, we collected all the published clinical study reports on puerarin for ischemic stroke and assessed all the included reports according to clinical epidemiologic standard. Results 35 RCTs, 22 non-randomized controlled trials and 17 case serials studies were included and analysed. Conclusions Current quality of clinical studies of puerarin for ischemic stroke is not good enough to provide reliable evidence.
Objective To analyze the adverse drug reactions (ADR) of Ciwujia injection and the relative influence factors. Methods We searched all clinical studies and ADR reports of Ciwujia injection from the China National Knowledge Infrastructure (CNKI) database. The relevant information such as the diseases for treatment; menstruum, dosage and compatibility of Ciwujia injection; the age, gender and allergic history of patients; and the category, treatment and prognosis of ADR were collected and analyzed. Results In the 800 clinical studies, only 97 (12.1%) reported 285 ADR cases, 144 ADR reports including 236 ADR cases. Of the ADR cases, the male to female ratio was 1׃1.34, mainly in 40 to 69 years group; The ADR cases mainly including anaphylactic shock and local pain in ADR reports and clinical studies, respectively; 72.3 percent ADR cases were Ⅲ to Ⅳ class, 4 anaphylactic shock cases died; the diseases for treatment of ADR cases mainly were coronary artery heart disease and cerebral infarction; 27 (11.4%) ADR cases had allergic history; The menstruum of Ciwujia injection mainly were 5% glucose, 0.9% NaCl and 10% glucose, drug incompatibility in 36 ADR cases; The usual dosage of Ciwujia injection was 20-60 ml; 196 (83.0%) ADR cases occurred in first time medication, mainly in the early 30 minutes of medication used. Conclusion (1) In both ADR reports and clinical studies of Ciwujia injection, there are some problems of ADR and adverse drug events (AE) were not easily distinguishable, key information of total prescriptions divided by drug persons were lacking, so we can’t calculate the ADR rate, the reporting quality remained to be improved. (2) To support the rational drug use, the basic researches of Ciwujia injection remains to be further studied, especially the dose-finding studies. (3) As one of the most frequently reported ADR of traditional Chinese medicine (TCM) injection, high quality ADR monitoring, normative ADR reporting and timely analyzing the ADR reason of Ciwujia injection is extremely urgent.
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.
The 12th Asian Conference on Pharmacoepidemiology (ACPE) has been successfully held from October 11st to 13rd, 2019 in Kyoto, Japan. More than 600 representatives from 33 countries and regions participated in the meeting. The arrangement of this conference mainly included: education session program, contributed papers report, symposium and poster presentation, which provided good opportunity for participants to communicate. Moreover, it promoted the dissemination and utilization of advanced methods and technologies of global pharmacoepidemiology, especially in Asia region, and provided technical support in order to ensure the safety and efficacy of public. Moreover, it was the first time that the symposium on herbal and Traditional Medicines has been set up in the ACPE. This paper introduced the main details of the contents
Establishing and improving the quality control system of drug clinical trial institutions is the key to ensure the quality of clinical trial. In recent years, the number of drug clinical trial has been continuously improved, and the quality control requirements have been continuously improved. However, in clinical work, the workload of medical staff is heavy, and the energy devoted to clinical trial is limited. Clinical research coordinator (CRC), as a participant and coordinator of clinical trial, has carried out transactional work related to non-medical judgment under the authorization and guidance of researchers, and has undertaken any specific work in clinical trial. Based on the quality control management experience of nosocomial CRC and hospital drug clinical trial institutions in West China Hospital of Sichuan University, this paper discusses the mode of nosocomial CRC participating in clinical trial quality control. By participating in the quality control of clinical trial, the nosocomial CRC has improved the quality control efficiency, enriched the quality control team and improved the overall level of CRC. This model enriches the quality control system of drug clinical trial.