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.
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.
The western medicine are main drugs in treatment of infectious diseases, but the combination of Traditional Chinese and western medicine are used in China. In recent years, proportion of proprietary Chinese medicine increased significantly in this field. However, the classification of proprietary Chinese medicine and matching with the counterparts of western medicine were difficult, and the package inserts were less scientific and normative. By searching the terms of "Qing kai ling" and "Infection", the paper found the quality of post-marketing clinical researches was low. The use proportion of Qing kai ling combined with other drugs was more than 50%, 70% of which was western medicine. The further studies are needed to explore some proprietary Chinese medicine with obvious competitive advantage and improve the quality of methodology and reporting, in order to standardize and guide the rational use of proprietary Chinese medicine in infectious diseases.
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.
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.
ObjectiveTo review the clinical research progress of mesenchymal stem cells (MSCs) in the treatment of chronic wounds.MethodsThe literature related to the chronic wound repair with MSCs at home and abroad in recent years was extensively reviewed, and the possible mechanism of MSCs in the treatment of chronic wounds, as well as its application and existing problems were summarized.ResultsMSCs can participate in all aspects of chronic wound healing to promote wound healing, and has shown broad application prospects in clinical trials. MSCs commonly used in clinical research include bone marrow-derived MSCs, adipose-derived tissue MSCs, and umbilical cord-derived MSCs.ConclusionMSCs treatment is a promising strategy for the chronic wounds, but there are still many problems in its widespread clinical application that require further research.
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.
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.
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.
With the continuous development of China's aging society and the prevalence of unhealthy lifestyles, the incidence of cardiovascular disease in China has been increasing in recent years. Among them, atrial fibrillation (AF) is the most common arrhythmia disease. In recent years, pulsed field ablation ( PFA ) has been continuously applied to AF treatment as a novel treatment. This paper first introduces the principle of PFA applied to AF treatment, and introduces the research progress of PFA in different directions, such as the comparison of different ablation methods, the study of physical parameters, the study of ablation area, the study of tissue specificity and clinical research. Then, the clinical priori research of PFA is discussed, including the use of simulation software to obtain the simulation effect of different parameters, the evaluation of ablation effect during animal research, and finally the current AF treatment. Various priori studies and clinical studies are summarized, and suggestions are made for the shortcomings found in the study of AF treatment and the future research direction is prospected.