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.
Diffuse large B-cell lymphoma is highly heterogeneous and is diagnosed according to the 2016 World Health Organization Classification of Tumours of Haematopoietic and Lymphoid Tissues. The decision of treatment should be upon age, International Prognostic Index score and the tolerability of chemotherapy. High-dose chemotherapy and autologous stem cell transplantation is the standard care for relapsed, chemotherapy sensitive patients. Clinical trials are recommended in specific conditions.
Laparoscopic sleeve gastrectomy (LSG) is an effective and lasting method for treating obesity, type 2 diabetes and other obesity related metabolic diseases. The symmetrical three-port LSG has been proven to be a simple, safe, and effective surgical procedure. However, China still lacks standardized surgical operation guidelines for this method. This guideline provides a detailed description of the various steps and key details of the symmetrical three-port LSG, aiming to standardize and normalize the symmetrical three-port LSG in the bariatric and metabolic field in China, and to provide standardized surgical procedures for clinical surgeons in this field.
Objective To explore the clinical value and experience of ultrasound guided combined with laparoscopic microwave ablation in treatment for special site liver cancer．Methods The clinical data of 9 patients with liver cancer treated by ultrasound guided combined with laparoscopic microwave ablation in our hospital from February 2008 to October 2010 were analyzed retrospectively．Results There were 6 cases of primary liver cancer， 3 cases of metastatic hepatic carcinoma. Eight cases of multiple tumors， 1 case of single tumor．There were one or more lesions invading liver capsular，a total of 13 lesions in all the patients． Among them，6 lesions located in diaphragm， 3 closed to bowel， 2 neared stomach，1 located in gallbladder bed and 1 in hilar．No serious complications and no death happened during operation．The following-up time was （9.2±4.7） months （4 to 18 months）， there were 2 lesions of part residual， including 1 case of microwave ablation again，1 case of percutaneous ethanol ablation， and 11 lesions of complete ablation （84.6%，11/13） 1 month after operation by CT examination．Four cases recurred 3 months after operation by CT examination， including 2 cases of microwave ablation again，1 case of percutaneous ethanol ablation，1 patient with pulmonary metastasis and giving up treatment，1 patient with poor liver function and died of liver failure 6 months after operation；1 patient with multiple lesions died of brain metastases 10 months after operation； the rest were still alive．Conclusions Ultrasound guided combined with laparoscopic microwave ablation is a safe and effective method in the treatment for special site liver cancer，the curative effect is good and worth of spread．
ObjectivesTo investigate the citation status of systematic reviews (SRs)/meta-analyses in clinical practice guidelines and consensuses of traditional Chinese medicine (TCM).MethodsWe electronically searched PubMed, CBM, WanFang Data and CNKI databases to collect TCM guidelines and consensus from January 1st, 2009 to December 31st, 2018. Two reviewers independently screened literature and extracted data. Citation analysis method was used to analyze the citation status of SRs/meta-analysis in TCM guidelines and consensuses.ResultsA total of 142 TCM guidelines and consensuses were included, of which 39 (26.5%) failed to provide relevant citations. Of the 103 (72.5%) TCM guidelines and consensuses providing citations, 48 (34.3%) cited SRs/meta-analyses, and 43 cited outdated SRs/ meta-analyses. Four TCM guidelines and consensuses cited Cochrane reviews. In terms of citations, the average citations of guidelines and consensuses were 35.1 and 42.2, respectively; and the average SRs/meta-analyses citations of guidelines and consensuses were 3.8 and 5.5, respectively.ConclusionsTCM guidelines and consensuses citation report rates and the proportion of citation SRs/meta-analyses still require increase. TCM guidelines developers should strengthen the role and significance of SRs, especially Cochrane reviews, in supporting recommendations.
The formulation process of recommendations in evidence-based clinical practice guidelines was often complex and cumbersome. This paper described the evolution of levels of evidence and strength of recommendations in medical research and analyzed existing problems when making recommendations. We also summarized and introduced the method of formulating the final recommendation. At present, there isn’t a perfect and uniform method to guide the formulation of recommendations. But some organizations provided different content frameworks or auxiliary tools to guide formulation of recommendations. Developers of evidence-based clinical practice guidelines can learn from their experiences, combine with their own characteristics of guidelines such as specific target population and specific clinical situations, establish a rational method of recommendations formation.