Inherited retinal diseases (IRDs) are a group of severe retinal degenerative diseases leading to permanent visual impairment. IRDs are the major cause of irreversible blindness in children and working age groups. Gene therapy is a new clinical treatment method and currently the only clear and effective treatment for IRDs, while, there are still risks in clinical research and application. How to standardize perioperative management and reduce the potential risks of treatment is one of the keys to ensure the safety and effectiveness of treatment. However, there is no systematic and standardized guidance on the perioperative management for IRDs gene therapy. Therefore, in order to standardize the perioperative management, the Fundus Disease Group of Ophthalmology Society of Chinese Medical Association and Chinese Medical Doctor Association organized domestic experts to put forward standardized opinions on the perioperative management of IRDs gene therapy in China after repeated discussion and combined with domestic and foreign research experience, so as to provide clinicians with reference and application in clinical research and practice.
Rapid development of recently emerging precision medicine techniques represented by gene therapy has brought hope for the treatment of rare blinding eye diseases such as inherited retinal diseases (IRDs) for which there was no effective treatment previously. Although the globally growth of clinical trials for IRDs has increased rapidly over the past decade, due to the highly genetic and clinical phenotypic heterogeneity, as well as limited data on epidemiology and natural history of the disease, along with severe loss of vision function of majority patients for which the established measurements may not be appropriate, such studies lack standard outcome measurements and endpoints to asses clinical meaningful effectiveness, posing great challenges in terms of study design and evaluation of treatment efficacy, as well as clinical practice application. At present, there is no systematic nor standardized guidance on safety measures, clinical outcomes and endpoints of visual function for clinical trial design in IRDs. Therefore, in order to standardize the validated evaluation of IRDs clinical efficacy outcome measurements and endpoints, the Fundus Disease Group of Chinese Medical Association Ophthalmology Branch and Fundus Disease Committee of Chinese Medical Doctor Association Ophthalmology Branch organized domestic experts to put forward consensus and recommendations on standardizing outcome measurements and endpoints for clinical study design in IRDs, aiming to advance the study design of IRDs natural history research and clinical trials and to effectively evaluate disease progression and intervention efficacy. Along with the development of medical science and clinical trials, relevant content will be improved and updated accordingly.
The National Comprehensive Cancer Network (NCCN) updates the "NCCN clinical practice guidelines in oncology: Lung cancer screening" annually, and the second edition of 2024 was released in October 2023. The 2024 edition of the guidelines builds on the 2023 edition with some updates on description and assessment of risk factors for lung cancer, evaluation and follow-up of lung nodules found during initial and subsequent screening, and low-dose CT screening protocols and imaging modalities. In this article, we will introduce the above updates and provide reference for lung cancer screening in China by combining the relevant guidelines and consensus in China.
Objective To investigate the curative effects of homograft of the mesenchymal stem cells(MSCs) compbined with the medical collagen membrane of the guided tissue regeneration(MCMG) on the full thickness defects of the articular cartilage. Methods MSCs derived from New Zealand rabbits aged 3-4 months weighing 2.1-3.4 kg were cultured in vitro with a density of 5.5×108/ml and seeded onto MCMG. The MSC/MCMG complex was cultured for 48 h and transplanted into the fullthickness defects on the inboardcondyle and trochlea. Twenty-seven healthy New Zealand rabbits were randomly divided into 3 groups of 9rabbits in each. The cartilage defects in the inboard condyle and trochlea werefilled with the auto bone marrow MSCs and MCMG complex (MSCs/ MCMG) in Group A (Management A), with only MCMG in Group B (Management B)and with nothing in Group C (Management C). Three rabbits were killed at 4, 8 and 12 weeks after operation in each group, and the reparative tissue samples evaluated grossly,histologically and immunohistochemically were graded according tothe gross and histological scale. Results Four weeks after transplantation, the cartilage and subchondralbone were regenerated in Group A;for 12 weeks, the regenerated cartilage gradually thicked; 12 week after transplantation, the defect was repaired and the structures of the carticular surface and subchondral bone was in integrity.The defects in Group A were repaired by the hylinelike tissue and the defects in Groups B and C were repaired by the fibrous tissues. Glycosaminoglycan and type Ⅱcollagen in Groups A,B and C were reduced gradually.The statistical analysis on the gross at 12 weeks and the histologicalgradings at 4 weeks,8 weeks and 12 weeks showed that the inboardcondylar repairhad no significant difference compared with the rochlearepair(Pgt;0.05).Management A was significantly better than Managements B and C (Plt;0.05), and Management B was better than Management C(Plt;0.05). Conclusion Transplantation of the MSCs combined with MCMG on the full thickness defects of the articular cartilage is a promising approach to the the treatment of cartilage defects. MCMG can satisfy the demands of the scaffold for the tissue-engineered cartilage.
ObjectiveTo compare the effectiveness and safety of electromagnetic navigation-guided localization and CT-guided percutaneous localization for pulmonary nodules.MethodsThe literature published from the inception to January 2021 about the comparison between electromagnetic navigation-guided localization and CT-guided percutaneous localization for pulmonary nodules in the PubMed, The Cochrane Library, Web of Science, EMbase, Chinese Wanfang database and CNKI database was searched. RevMan (version 5.4) software was used for meta-analysis. Nonrandomized controlled trials were evaluated using methodological index for nonrandomized studies (MINORS).ResultsA total of six retrospective studies (567 patients) were included in this meta-analysis. MINORS scores of all studies were all 17 points and above. There were 317 patients in the CT-guided percutaneous localization group and 250 patients in the electromagnetic navigation-guided localization group. The complication rate of the CT-guided percutaneous localization group was significantly higher than that in the electromagnetic navigation-guided localization group (OR=11.08, 95%CI 3.35 to 36.65, P<0.001). There was no significant difference in the success rate of localization (OR=0.48, 95%CI 0.16 to 1.48, P=0.20), localization time (MD=0.30, 95%CI –6.16 to 6.77, P=0.93) or nodule diameter (MD=–0.07, 95%CI –0.19 to 0.06, P=0.29) between the two groups.ConclusionElectromagnetic navigation can be used as an effective preoperative positioning method for pulmonary nodules, which has the advantage of lower complication rate compared with the traditional CT positioning method.
The number of clinical guidelines developed and published in different countries is increasing worldwide. Too many guidelines do not remain in regular use, even though the aim is to implement them in clinical practice. The scientific validity and reliability of the guidelines need to be reviewed. Here is a case presented to show how to optimally use the evidence-based guideline to improve clinical decision making.
Patient values and preferences is one of the elements of evidence-based medicine research, which is also an important part that should be considered in the development of evidence-based guidelines in the present and future. However, the research in this field in China has just begun. This article gives a brief introduction of its concepts, methods, influence factors based on the international researches of patient values and preferences and a brief description of the development in China, in order to provide references for the development of evidence-based guidelines based on the consideration of patient values and preferences in the future.
ObjectiveTo systematically review the quality of evidence-based guidelines (EBGs) on medication therapy for children with vitamin D deficiency, and to compare differences and similarities of the drugs recommended, in order to provide guidance for clinical practice. MethodsDatabases such as the TRIP, PubMed, EMbase, CNKI, VIP, WanFang Data, CBM, National Guideline Clearinghouse and Guidelines International Network were searched to collect EBGs on medication therapy for children with vitamin D deficiency. The methodological quality of the guideline was evaluated according to the AGREE Ⅱ instrument, and the differences between recommendations were compared. ResultsA total of 9 EBGs were included. Among them, 3 guidelines were developed by America, 1 by Europe, 1 by France, 1 by China, 1 by Poland, 1 by Canadian and 1 guideline was by Australia and New Zealand. Seven guidelines were developed specially for children, while others were for people of different ages. According to the AGREE Ⅱ instrument, only "Scope and purpose" and "clarity and presentation" were scored more than 60%. The recommendations of different guidelines were of large different. ConclusionThe quality of included guidelines concerning children with vitamin D deficiency is vary. Although only the America 2011 guideline is of high quality, the strength of recommendation is not high. Thus, the development of national guidelines is urgently needed.