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.
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.
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.
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.
Chinese Medical Association guideline for clinical diagnosis and treatment of lung cancer (2022 edition) has been published this year. The 2022 edition has been updated in the aspects of lung cancer screening, pathology, standards of thoracic surgery, treatment of metastatic lung cancer. In this study, we tried to introduce those updated aspects in the guideline of 2022 edition.
Clinical pharmacy practice guidelines have developed rapidly in recent years. They provide a series of recommendations for optimizing drug treatment management and improving pharmaceutical care appropriateness and are widely employed in clinical practice. Based on literature review and the experience of guideline development, this paper summarized the meaning, formulation methods, formulation status, and registration of clinical pharmacy practice guidelines, and provided suggestions for the development of guidelines.
ObjectiveTo investigate the effectiveness of digital three-dimensional (3D) printing osteotomy guide plate assisted total knee arthroplasty (TKA) in treatment of knee osteoarthritis (KOA) patients with femoral internal implants. Methods The clinical data of 55 KOA patients who met the selection criteria between July 2021 and October 2023 were retrospectively analyzed. Among them, 26 cases combined with femoral implants were treated with digital 3D printing osteotomy guide plate assisted TKA (guide plate group), and 29 cases were treated with conventional TKA (control group). There was no significant difference in gender, age, body mass index, side, Kellgren-Lawrence classification, preoperative visual analogue scale (VAS) score, Hospital for Special Surgery (HSS) knee score, knee range of motion, and other baseline data between the two groups (P>0.05). The operation time, intraoperative blood loss, incision length, postoperative first ambulation time, surgical complications; VAS score, knee HSS score, knee range of motion before operation, at 1 week and 3 months after operation, and at last follow-up; distal femoral lateral angle, proximal tibial medial angle, hip-knee-ankle angle and other imaging indicators at last follow-up were recorded and compared between the two groups. ResultsThe operation time, incision length, intraoperative blood loss, and postoperative first ambulation time in the guide plate group were significantly lower than those in the control group (P<0.05). In the control group, there were 1 case of incision rupture and bleeding and 1 case of lower limb intermuscular venous thrombosis, which was cured after symptomatic treatment. There was no complication such as neurovascular injury, incision infection, or knee prosthesis loosening in both groups. Patients in both groups were followed up 12-26 months, with an average of 16.25 months. The VAS score, HSS score, and knee range of motion improved at each time point after operation in both groups, and further improved with time after operation, the differences were significant (P<0.05). The above indicators in the guide plate group were significantly better than those in the control group at 1 week and 3 months after operation (P<0.05), and there was no significant difference between the two groups at last follow-up (P>0.05). At last follow-up, the distal femoral lateral angle, the proximal tibial medial angle, and the hip-knee-ankle angle in the guide plate group were significantly better than those in the control group (P<0.05). Conclusion The application of digital 3D printing osteotomy guide plate assisted TKA in the treatment of KOA patients with femoral implants can simplify the surgical procedures, overcome limitations of conventional osteotomy guides, reduce surgical trauma, achieve individualized and precise osteotomy, and effectively restore lower limb alignment and knee joint function.