The number of investor initiated trial(IIT)in the field of traditional Chinese medicine(TCM)in China has been increasing year by year,but there are still many problems about their scientific validity.Scientific review is the top priority of IIT management,which is of great significance to improve the quality of IIT.Considering the characteristics of IIT in the field of TCM,randomized controlled trials and discuss common methodological problems in the scientific review process of IIT are focused on,such as non-standard placebo setting,unclear research hypothesis or improper selection of hypothesis test type,inappropriate sample size estimation methods,insufficient characteristics of TCM in outcome measures,unreasonable statistical analysis methods,etc.At the same time,corresponding solutions are proposed to increase the scientific and credibility of IIT,thus improving the research quality of IIT in TCM.

OBJECTIVE To evaluate the value of BRAF V600E mutation detection combined with liquid-based thin-preparation cytologic test(LCT)in the preoperative diagnosis of papillary thyroid carcinoma(PTC)and the related pathological characteristics of BRAF V600E mutation.METHODS Clinical data of 428 patients with thyroid nodules who underwent surgery at the First Affiliated Hospital of Xiamen University from January 2023 to December 2023 were retrospectively analyzed.All patients underwent ultrasound-guided fine needle aspiration and liquid-based cytology diagnosis and BRAF V600E gene mutation detection simultaneously before surgery.RESULTS The results of BRAF V600E mutation were significantly correlated with the results of liquid-based cytology diagnosis in patients(P<0.01).The area under the curve(AUC value)of LCT was 0.88,and the AUC value of BRAF V600E was 0.84.The sensitivity and specificity of LCT for preoperative diagnosis of PTC were 0.80 and 0.96,respectively.The sensitivity and specificity of BRAF V600E for preoperative diagnosis of PTC were 0.72 and 0.96,respectively.The AUC value of LCT combined with BRAF V600E for the diagnosis of PTC was 0.93 while the sensitivity and specificity were 0.88 and 0.92,respectively.The combined diagnosis significantly improved the sensitivity and specificity of thyroid nodule disease diagnosis,with a statistically significant difference(Z=-5.50,-4.60,P<0.001).In addition,BRAF V600E mutation was associated with the age of patients,the maximum diameter of nodules,and whether the capsule was invaded,with significant statistical differences between groups(P<0.05),but was not associated with gender,whether the nodules were multifocal,whether lymph node metastasis occurred,or whether Hashimoto's thyroiditis was present.CONCLUSION The combination of FNA liquid-based thin-preparation cytologic test and BRAF V600E detection can significantly improve the preoperative diagnostic accuracy of PTC.

Objective To summarize the experience in carotid endarterectomy(CEA)for the treatment of carotid artery stenosis,in order to decrease postoperative complications and enhance clinical efficacy.Methods The clinical data of 64 cases receiving surgical treatment for carotid artery stenosis from January 2022 to December 2024 were analyzed retrospectively.Clinical data including age,gender,condition of underlying diseases,degree of carotid artery stenosis,degree of coronary artery stenosis,cerebral blood flow before operation,characteristics of carotid plaques before operation,usage of antiplatelet drugs during perioperative period,usage of carotid shunt during operation,intraoperative carotid artery occlusion time,operation time,postoperative complications and follow-up results were collected.Results All 64 patients underwent CEA successfully.Among them,14 cases underwent shunt during operation,48 cases received single antiplatelet therapy during perioperative period and 16 cases received dual antiplatelet therapy.The median operation time was 161.50(138.00,186.50)min,the clamping time was(28.42±10.72)min.The incidence of postoperative complications included 1 case of incisional infection(1.56%),1 case of incisional hematoma(1.56%),1 case of internal carotid artery occlusion(1.56%),1 case of cerebral hypoperfusion(1.56%).There were no cerebral infarction,no cerebral hyperperfusion,no cardiac events and no brain nerve injury.There was no one case of postoperative complications in the patients who underwent shunt during operation.All patients were followed up for 3～38 months.Among them,there were 2 cases of stroke and there was no death during the fellow-up period.The clamping time was significantly shorter in shunting group than in non-shunting group[(18.43±6.64)min vs.(31.22±9.98)min,P<0.05)],there were no significant differences in remaining clinical data between two groups(P>0.05).The degree of carotid artery stenosis was more severe in the dual antiplatelet group than in the single antiplatelet group[on operation side(χ2=-2.377,P<0.05),on contralaternal side(χ2=-2.261,P<0.05)],there were no significant differences in remaining clinical data between two groups(P>0.05).Conclusions CEA is an effective treatment for carotid artery stenosis,shunting during CEA is safe.Meticulous perioperative management and operative procedures could help to reduce the rate of postoperative complications.

Objective To summarize the experience in carotid endarterectomy(CEA)for the treatment of carotid artery stenosis,in order to decrease postoperative complications and enhance clinical efficacy.Methods The clinical data of 64 cases receiving surgical treatment for carotid artery stenosis from January 2022 to December 2024 were analyzed retrospectively.Clinical data including age,gender,condition of underlying diseases,degree of carotid artery stenosis,degree of coronary artery stenosis,cerebral blood flow before operation,characteristics of carotid plaques before operation,usage of antiplatelet drugs during perioperative period,usage of carotid shunt during operation,intraoperative carotid artery occlusion time,operation time,postoperative complications and follow-up results were collected.Results All 64 patients underwent CEA successfully.Among them,14 cases underwent shunt during operation,48 cases received single antiplatelet therapy during perioperative period and 16 cases received dual antiplatelet therapy.The median operation time was 161.50(138.00,186.50)min,the clamping time was(28.42±10.72)min.The incidence of postoperative complications included 1 case of incisional infection(1.56%),1 case of incisional hematoma(1.56%),1 case of internal carotid artery occlusion(1.56%),1 case of cerebral hypoperfusion(1.56%).There were no cerebral infarction,no cerebral hyperperfusion,no cardiac events and no brain nerve injury.There was no one case of postoperative complications in the patients who underwent shunt during operation.All patients were followed up for 3～38 months.Among them,there were 2 cases of stroke and there was no death during the fellow-up period.The clamping time was significantly shorter in shunting group than in non-shunting group[(18.43±6.64)min vs.(31.22±9.98)min,P<0.05)],there were no significant differences in remaining clinical data between two groups(P>0.05).The degree of carotid artery stenosis was more severe in the dual antiplatelet group than in the single antiplatelet group[on operation side(χ2=-2.377,P<0.05),on contralaternal side(χ2=-2.261,P<0.05)],there were no significant differences in remaining clinical data between two groups(P>0.05).Conclusions CEA is an effective treatment for carotid artery stenosis,shunting during CEA is safe.Meticulous perioperative management and operative procedures could help to reduce the rate of postoperative complications.

The number of investor initiated trial(IIT)in the field of traditional Chinese medicine(TCM)in China has been increasing year by year,but there are still many problems about their scientific validity.Scientific review is the top priority of IIT management,which is of great significance to improve the quality of IIT.Considering the characteristics of IIT in the field of TCM,randomized controlled trials and discuss common methodological problems in the scientific review process of IIT are focused on,such as non-standard placebo setting,unclear research hypothesis or improper selection of hypothesis test type,inappropriate sample size estimation methods,insufficient characteristics of TCM in outcome measures,unreasonable statistical analysis methods,etc.At the same time,corresponding solutions are proposed to increase the scientific and credibility of IIT,thus improving the research quality of IIT in TCM.

Discipline construction is the power source to realize the high quality development of public hospitals,and high quality scientific research management is the inevitable path to realize the connotative development of public hospitals.The quality improvement of scientific research project process management is step-by-step,and mid-term inspection is a representative work.This paper applies PDCA cycle theory to the mid-term inspection of scientific research projects,analyzes the problems encountered in the mid-term inspection of scientific research projects from the four stages of plan,implementation,check and act,and develops effective intervention measures.The mid-term inspection mode,which combines publicity activities of scientific research norms with self-examination by researchers and on-the-spot inspection by the scientific research department,should be carried out to standardize the process of mid-term inspection of scientific research projects and promote the high-quality development of scientific research in hospitals.

Spinal surgical site infection (SSI), especially deep SSI after internal fixation is difficult in treatment, with long course of disease and poor prognosis. At present, there are many controversies in the diagnosis and treatment of spinal SSI, with unsatisfactory overall efficacy of its diagnosis and treatment. Besides, no diagnosis and treatment guideline based on evidence-based medicine has been in existence. To this end, the Spinal Infection Group of the Orthopedic Branch of the Chinese Medical Doctor Association and the Spinal Infection Group of the Spinal Surgery Branch of the Chinese Rehabilitation Medicine Association jointly organized relevant experts to formulate Evidence-based clinical guideline for the diagnosis and treatment of surgical site infection in spinal trauma ( version 2024) based on an evidence-based approach. A total of 10 recommendations were proposed on the diagnosis and treatment of spinal SSI, so as to provide a clinical reference for the diagnosis and treatment of spinal SSI.

Spinal surgical site infection (SSI), especially deep SSI after internal fixation is difficult in treatment, with long course of disease and poor prognosis. At present, there are many controversies in the diagnosis and treatment of spinal SSI, with unsatisfactory overall efficacy of its diagnosis and treatment. Besides, no diagnosis and treatment guideline based on evidence-based medicine has been in existence. To this end, the Spinal Infection Group of the Orthopedic Branch of the Chinese Medical Doctor Association and the Spinal Infection Group of the Spinal Surgery Branch of the Chinese Rehabilitation Medicine Association jointly organized relevant experts to formulate Evidence-based clinical guideline for the diagnosis and treatment of surgical site infection in spinal trauma ( version 2024) based on an evidence-based approach. A total of 10 recommendations were proposed on the diagnosis and treatment of spinal SSI, so as to provide a clinical reference for the diagnosis and treatment of spinal SSI.

Xiyanping injection, a traditional Chinese medicine injection made of andrographolide sulfonate, consisting of well-defined ingredients with antiviral, antibacterial, anti-inflammatory and antipyretic efficacy, has been widely used for treating infectious diseases of respiratory and digestive systems. However, its wide applications may easily lead to unreasonable clinical medication. In order to guide the precise clinical application and rational use of Xiyanping injection, experts in related fields conducted systematically literature review, evaluated and deliberated the application of Xiyanping injection in treating acute infectious diseases using evidence-based medicine method, and jointly drafted the consensus to summarize types of acute infectious diseases in children and adults that can be treated with Xiyanping injection, and recommend the intervention time, usage and dosage, course of treatment and combined medication of the injection. Besides, the consensus elucidates the safety, precautions and contraindications of the injection, so as to provide guidance for clinical use.

Objective:To investigate the efficacy of Da Vinci robot-assisted surgery for mediastinal tumor, and summarize the value of Da Vinci system in mediastinal surgery.Methods:The clinical data of 339 cases of robot-assisted mediastinal mass in Shanghai Chest Hospital from April 2015 to September 2020 were retrospectively analyzed, to compare perioperative outcomes of robotic surgery and conventional video-assisted thoracoscopic surgery 2 949 cases.Results:All the operations were successfully completed as planned. No residual lesions, conversion or second operation was observed in the consecutive cohort. The operating time[(81.8±36.8)min vs.(95.6±58.3)min, P=0.015]and post-operation stay[(3.1±1.9)days vs.(3.8±2.3)days, P=0.002] were statistically shorter in robotic group than those inconventional thoracoscopic group. Intraoperative blood loss in two groups was similar[(43.2±22.6)ml vs.(44.0±33.4)ml, P>0.05]. Conclusion:The Da Vinci robot system in mediastinal surgery is safe and feasible with great perspective in the new age of minimally invasive thoracic surgery. Compared with thoracoscopic surgery, it can shorten the operation time and reduce the postoperative hospital stay. It has certain advantages in operator experience and patient recovery.