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.
ObjectiveTo analyze the safety and effectiveness of ultrasound-guided endovascular treatment for femoropopliteal arteriosclerosis obliteran (ASO). MethodsThe clinical data of patients with femoropopliteal ASO were collected and analyzed. The patients were treated by ultrasound-guided endovascular intervention in the Xijing Hospital of Air Force Military Medical University, from March 2015 to June 2021. The endovascular intervention methods included the arterial balloon dilation (ABD) alone, stent implantation (SI), Rotarex mechanical thrombus removal (Abbreviationas: Rotarex), and thrombolytic catheter implantation (CDT), etc. ResultsAll 112 patients (121 affected extremities) who met the research criteria were collected. Among them, there were 13, 68, and 40 affected extremities by the Rutherford classification of 2, 3, and 4, respectively, while 41, 39, and 41 affected extremities by the Trans-Atlantic Inter-SocietyConsensus Ⅱ classification of A, B, and C, respectively. Among 121 affected extremities, 61 underwent the ABD alone, 27 underwent ABD plus Rotarex, 12 underwent ABD plus SI, 6 underwent ABD plus SI plus Rotarex, 3 underwent ABD plus SI plus CDT, 7 underwent ABD plus CDT plus Rotarex, and 5 underwent ABD plus CDT. The ultrasound-guided endovascular treatments were completed successfully in 118 affected extremities (the success rate was 97.5%), and 3 affected extremities were not completely completed by ultrasound guidance. After operation, 5 affected extremities had pseudoaneurysm and 7 affected extremities had hematoma at the puncture site, which were cured after conservative management. The ankle-brachial index (ABI) of the affected extremities immediately after surgery was statistically higher than that before surgery [0.89±0.13 vs. 0.53±0.09, mean difference (95% confidence interval)=0.36 (0.34, 0.38), paired t-test (t=–25.17), P<0.001]. After a follow-up of 12 months, one patient had a metatarsal amputation and one patient died (acute myocardial infarction). The restenosis rate and reintervention rate of the target lesions were 25.0% (30/120) and 15.0% (18/120) at 12 months postoperatively, and the late loss of diameter was (0.88±0.25) mm. The ABI was still higher than before surgery [0.78±0.13 vs. 0.53±0.09, mean difference (95% confidence interval)=0.25 (0.22, 0.27), paired t-test, t=–17.61, P<0.001]. ConclusionFrom analysis results of this data, it can be seen that, ultrasound-guided endovascular intervention is a safe and effective treatment for selective femoropopliteal ASO.
Clinical practice guidelines are decision-making tools for bridging the gap between current best evidence and clinical practice. Studies have shown poor clinical applicability of existing guidelines, which may not be solved by improving the quality of guidelines alone. National medical management service guidance center is developing clinical practice guidelines of clinical evaluation system of construction projects, based on evidence-based method formulated by the target users of clinical guidelines evaluators’ applicability evaluation system of clinical practice guidelines. It aims to identify guidelines with high clinical applicability and provide the evaluation results of clinical applicability to developers and revisers of clinical guidelines, and then optimize the development and update, eventually improving the clinical applicability of guides and promote Chinese clinical guidelines in clinical application.
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.
The Essential of ACC/AHA Guidelines for the Management of Patients with ST-Elevation Myocardial Infarction was introduced, including epidemology, initial management in the emergency department and hospital management.
Objective To assess the methodological quality of clinical guidelines and consensus of lupus nephritis, to collect the recommendations of each guideline, and to provide references for clinical decision-making. Methods PubMed, CNKI, and CBM databases and related websites such as NGC, NICE, GIN, SIGN, and Medive were electronically searched from January 2012 to December 2020 to collect the clinical guidelines and expert consensus for lupus nephritis. After consistency evaluation by four evaluators, the methodological quality of the included guidelines or expert consensus was evaluated using AGREE Ⅱ. The relevant recommendations, evidence level, and recommended strength of each guideline in treating lupus nephritis were summarized. Results A total of eight guidelines and two consensus statements were included. Among them, eight guidelines or consensus statements were level B (generally recommended guidelines), and two were level C (non-recommended guidelines). Relevant recommendations mainly gave the corresponding treatment scheme according to the pathological type of lupus nephritis. Conclusion The methodological quality of lupus nephritis guideline formulation in China needs to be improved. The included guidelines and consensus can provide reference for clinical decision-makers. However, higher-quality clinical practice guidelines for the Chinese population are needed to be developed in the future.