In recent years, clinical research in traditional Chinese medicine (TCM) has witnessed vigorous development, with increasingly close integration with clinical epidemiological methodologies. However, certain controversies persist, such as the difficulty in aligning epidemiology’s population-based perspective with TCM’s principle of syndrome differentiation and treatment and the characteristics of individualized diagnosis and treatment. This paper reviews the development and current status of TCM clinical research, integrating the practice rules of TCM, and analyzes the manifestations and applicability of the basic characteristics of epidemiology in TCM clinical research. The study shows that epidemiological concepts and characteristics are fully compatible with the practical features of TCM clinical practice and its research needs. Moreover, epidemiological techniques can effectively uncover and elucidate the scientific basis of TCM clinical practice. Building on these analyses, we propose future directions for TCM clinical research, aiming to promote the integration of epidemiology and TCM clinical research and advance TCM clinical research to a higher level.
Rare diseases are mostly genetic disorders that often manifest in childhood, characterized by severe conditions, difficulties in diagnosis and treatment, and poor homogeneity in clinical management. Clinical research on rare diseases contributes to enhancing the diagnosis and treatment capabilities for rare diseases in China and promotes the development of rare disease medicine. Clinical research on rare diseases in China started relatively late, and there is currently no mature and comprehensive system for clinical research on rare diseases. This article analyzes the current state of clinical research on rare diseases in China, identifies existing problems and research difficulties, and proposes ideas and key measures for the construction of China’s clinical research system on rare diseases, aiming to provide opinions and suggestions for the construction of China’s clinical research system on rare diseases.
Master protocol with adaptive design is a new complex innovative trial design that combines an adaptive treatment strategy and master protocol. It is more flexible and adjustable. In the complex clinical trial environment, the dynamics emphasized in this design are consistent with the idea of traditional Chinese medicine (TCM) syndrome differentiation and treatment. In this study, we summarized its concept, characteristics and advantages, and we also discussed its application in TCM clinical research. We hope this paper can provide more thinking and suggestions for TCM clinical trials.
ObjectiveTo evaluate the safety of shearing fracture ligation combining procedure for prolapse and hemorrhoids （PPH） in treatment for mixed hemorrhoids via a multicenter clinical study. MethodsTwo hundred and fortysix patients with mixed hemorroids were included from four a level of firstclass hospitals, which were averagely divided into shearing fracture ligation combining PPH group, PPH group, and shearing fracture ligation group according to the order of admission. The occurrence status of rectovaginal fistula, urethrorectal fistula, postoperative bleeding, acute urinary retention, anorectal stenosis, and anal incontinence were observed. And the anal function was evaluated by the anorectal pressure measurement. ResultsNo rectovaginal fistula or urethrorectal fistula happened among three groups. No anorectal stenosis happened in the shearing fracture ligation combining PPH group or the PPH group. The score of anorectal stenosis and anal incontinence in these two groups were lower than those in the shearing fracture ligation group (Plt;0.05). The rate of postoperative bleeding in the shearing fracture ligation combining PPH group was lower than that in the shearing fracture ligation group (Plt;0.05). There were acute urinary retentions happened among three groups, but without significant differences among them (Pgt;0.05). The anal canal resting pressure after operation was lower than that before operation among three groups (Plt;0.01), which in the shearing fracture ligation combining PPH group was lower than that in the shearing fracture ligation group after operation (Plt;0.05). There were no significant differences of the rectum feeling capacity or maximum rectum capacity between the shearing fracture ligation combining PPH group and PPH group before and after operation (Pgt;0.05), but compared with the level before operation in the shearing fracture ligation group, the rectum feeling capacity obviously decreased after operation (Plt;0.05), the maximum rectum capacity obviously increased (Plt;0.05). There were no significant differences of the maxinum anal canal systolic blood pressure between before and after operation in three groups and among three groups (Pgt;0.05). ConclusionsThe operation of shearing fracture ligation combined with PPH can protect the tissue of rectal cushion, remain the normal anatomy structure of anal canal. It has better clinical effect and is much safer than other methods.
Segmentectomy is the removal of certain segments of the lung with lesions and retaining the normal lung tissue of the lobe. Lung segmentectomy is considered difficult due to the lack of clear anatomical boundaries between lung segments. Segmentectomy has a variety of indications, such as lung cancer, metastatic lung tumors, and many non-malignant diseases. In the treatment of early stage lung cancer, segmentectomy was initially considered only as a treatment option for patients not suitable for conventional lobectomy. As more evidence emerged, the indications for segmentectomy have continued to change over time, and segmentectomy has been widely performed in patients with early stage lung cancer. Theoretically, segmentectomy leads to better preservation of lung function than lobectomy, but the risk of incomplete tumor resection is higher, so the indication of segmentectomy has become a focus of debate. This article will introduce the surgical techniques of segmentectomy and summarize the published and unpublished clinical studies on segmentectomy for the treatment of early stage lung cancer.
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.
Neurofibromatosis type 1 (NF1) is an autosomal dominant genetic disease caused by mutations in the NF1 gene. The disease is characterized by neurofibromatosis, which simultaneously affects multiple systems such as nerves, skin, and bone, and has complex clinical manifestations. Since the National Institutes of Health (NIH) established diagnostic criteria in 1988, the diagnosis and treatment of NF1 have progressed significantly. However, due to the complexity of the disease and the lack of effective treatments, the diagnosis and treatment of NF1 still face many challenges. Strengthening multidisciplinary collaboration, improving and popularizing disease diagnosis and treatment strategies, and developing more effective drugs and treatment methods are the keys to further improve the treatment level of NF1 diseases.
The pre-market approval and clinical application of innovative medical devices should be based on high-quality evidence, proving their reliability, safety and effectiveness. In 2016, the IDEAL (Idea, Development, Exploration, Assessment and Long-term follow-up) collaboration modified the original IDEAL framework and recommendation to the IDEAL-D methodological framework for the entire life cycle evaluation of innovative medical devices. The framework included five stages, namely the preclinical development stage, idea stage, exploration stage, assessment stage and long-term follow-up stage. This paper aims to interpret the study purpose, content and design at each step of the IDEAL-D framework based on IDEAL framework and recommendation (2019) to provide practical methodological guidance for the design and conduct of clinical research on innovative medical devices.
Objective
To investigate current status and latest progress of clinical research on distal femoral fractures.
Methods
The related literature was extensively reviewed to summarize the trend of the researches and their clinical application in the treatment of distal femoral fractures.
Results
Distal femoral fractures are likely to occur in young people who suffer from high-energy damage and the elderly with osteoporosis, which is always comminuted and unstable fractures, and often involved in the articular surface and combined with serious soft tissue injury. Therefore, the treatment faces many challenges. External fixation is now used as a temporary means of controlling injury. The vast majority of patients are feasible to internal fixation, including plates system and intramedullary nail system. Different internal fixator also has its own characteristics, such as double plates can strengthen the medial support of the femur, less invasive stabilization system protects the blood supply of fractures, distal cortial locking plate is theoretically more fit for the requirements of bone healing, retrograde intramedullary nail can resist varus and valgus.
Conclusion
The treatment of distal femoral fractures should be based on the type of fracture and the characteristics of internal fixators.
New interventions are rapidly progressing into clinical practice through the preclinical study stage. The animal experiments should be comprehensive and critically evaluated for their pivotal role in this process. To integrate the evidence of animal studies by systematic review throws light on intervention outcomes and could decrease risk of participants in human trials. The methodological weakness of animal studies is easy to highlight but robust methods to synthesize evidence is essential. Here, we discuss some problems in systematic review of animal experiments and whether animal models of diverse species contribute to bias of meta-analysis conclusions.
