OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs， and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization （WHO）， strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States， and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions； research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center， and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions， including topic selection， evaluation implementation， evidence evaluation， and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs， which can effectively guide the high-quality and high-efficient development of this work， enhance the standardized output and transformation application value of evaluation evidence， and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.

Mycophenolic acid (MPA), the active moiety of both mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS), serves as a primary immunosuppressant for maintaining solid organ transplants. Therapeutic drug monitoring (TDM) enhances treatment outcomes through tailored approaches. This study aimed to develop an evidence-based guideline for MPA TDM, facilitating its rational application in clinical settings. The guideline plan was drawn from the Institute of Medicine and World Health Organization (WHO) guidelines. Using the Delphi method, clinical questions and outcome indicators were generated. Systematic reviews, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence quality evaluations, expert opinions, and patient values guided evidence-based suggestions for the guideline. External reviews further refined the recommendations. The guideline for the TDM of MPA (IPGRP-2020CN099) consists of four sections and 16 recommendations encompassing target populations, monitoring strategies, dosage regimens, and influencing factors. High-risk populations, timing of TDM, area under the curve (AUC) versus trough concentration (C₀), target concentration ranges, monitoring frequency, and analytical methods are addressed. Formulation-specific recommendations, initial dosage regimens, populations with unique considerations, pharmacokinetic-informed dosing, body weight factors, pharmacogenetics, and drug‍-‍drug interactions are covered. The evidence-based guideline offers a comprehensive recommendation for solid organ transplant recipients undergoing MPA therapy, promoting standardization of MPA TDM, and enhancing treatment efficacy and safety.
Mycophenolic Acid/administration & dosage* ; Drug Monitoring/methods* ; Humans ; Organ Transplantation ; Immunosuppressive Agents/administration & dosage* ; Delphi Technique

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Objective:To analyze the application value of autophagy related molecular markers in placenta tissue in predicting fetal growth restriction in pregnant women with preeclampsia.Methods:A total of 46 pregnant women admitted to Changsha Hospital for Maternal and Child Health Care from January 2021 to August 2023 were collected. A cross-sectional study was conducted, and they were divided into a normal delivery group (control group, 23 cases) and an observation group with preeclampsia combined with fetal growth restriction (observation group, 23 cases) based on pregnancy outcomes. Transmission electron microscopy was used to observe the occurrence of autophagic vesicles in trophoblast cells in the placental tissue of both groups; The expression of Beclin-1, LC3, and P62 in placental tissues of two groups was detected by immunohistochemistry, real-time fluorescence quantitative polymerase chain reaction (qRT-PCR), and Western blot.Results:The transmission electron microscopy results showed that the presence of autophagic vesicles could be observed in the placental trophoblast cells of both the control group and the observation group, but the number of autophagic vesicles in the trophoblast cells of the observation group was higher than that in the control group ( P<0.05). The immunohistochemical results showed that the colorimetric values of Beclin-1 and LC3 in the placental tissue sections of the observation group were higher than those of the control group (all P<0.001), while the colorimetric values of p62 were lower than those of the control group ( P<0.001). The qRT-PCR and Western blot results showed that the mRNA and protein expression levels of Beclin-1 and LC3 in the observation group were significantly higher than those in the control group (all P<0.001), while the expression levels of p62 mRNA and protein were lower than those in the control group (all P<0.001). Conclusions:The autophagy activity of placental tissue trophoblasts in patients with preeclampsia combined with fetal growth restriction is enhanced, indicating a close correlation between elevated autophagy levels and the occurrence of preeclampsia combined with fetal growth restriction. Excessive autophagy may be involved in the occurrence of preeclampsia combined with fetal growth restriction.

Objective:To investigate the changes of different cytokines in systemic juvenile idiopathic arthritis（SJIA）and their role in early diagnosis.Methods:A retrospective study was conducted to select pediatric patients with fever accompanied by elevated levels of CRP，erythrocyte sedimentation rate（ESR），and ferritin who visited the Department of Renal Immunology，Children's Hospital of Soochow University from November 2019 to January 2023.Compare the differences in CRP，ESR，ferritin，and 34 plasma cytokines levels between children with SJIA and other autoimmune diseases.Cytokine risk was analyzed by regression；Correlation analysis was performed to determine whether cytokines were associated with lymphocyte subsets and disease activity.Results:During the study period，118 children with fever accompanied by elevated CRP，ESR and ferritin were eligible，among whom 20 children with SJIA were diagnosed，and 98 children with other autoimmune diseases were diagnosed.There was no statistically significant difference in CRP and ESR between SJIA patients and children with other autoimmune diseases（Z values were 0.721 and 0.345，all P>0.05）；There were significant differences in ferritin，IL-27，IL-17A，IL-31，IFN-γ，IL-18 between children with SJIA and those with other autoimmune diseases（Z values were 2.628，-2.052，-2.763，-2.135，4.067，4.419，all P<0.05）.Univariate Logistic regression analysis showed that IL-18（ OR=1.003，95% CI：1.002~1.004， P<0.001），IFN-γ（ OR=1.004，95% CI：1.001~1.007， P=0.004），IL-27（ OR=0.846，95% CI：0.716~0.999， P=0.049），IL-31（ OR=0.657，95% CI：0.451~0.959， P=0.028）were closely related to the occurrence of SJIA，and stepwise Logistic regression analysis indicated that the increase of IL-18（ OR=1.005，95% CI：1.003~1.009， P=0.004）increased the risk of SJIA，and the increase of IL-5（ OR=0.619，95% CI：0.402~0.953， P=0.029）decreased the risk.IL-18（ r=0.673， P=0.020），IL-27（ r=0.486， P=0.041）and TNF-α（ r=0.560， P=0.016）were positively correlated with the activity of SJIA. Conclusion:IL-18 presents a characteristic cytokine positively correlated with the risk of SJIA，while IL-5 presents a protective cytokine against SJIA.Both cytokines have independent predictive power for the risk.

Objective To investigate the effect of dynamic lung compliance(Cdyn)-guided indi-vidualized positive end-expiratory pressure(PEEP)on postoperative atelectasis in children undergoing craniofacial reconstruction.Methods Eighty children under general anesthesia undergoing craniofacial re-construction were selected,52 males and 28 females,aged≤1 year,ASA physical status Ⅰ or Ⅱ,anes-thesia duration≥2 hours.According to the random number table method,the children were divided into two groups:Cdyn-guided individualized PEEP group(group Ⅰ)and fixed PEEP group(group P),40 chil-dren in each group.PEEP titration was performed in group Ⅰ after assessing the lung ultrasound(LUS)score 5 minutes after intubation,and the PEEP corresponding to the highest value of Cdyn was an individualized PEEP.In group P,PEEP was fixed 6 cmH2O.The parapleural consolidation score,the B-line score,the total score of LUS,and the incidence of atelectasis were recorded 5 minutes after intubation and at the end of the operation.Cdyn,Ppeak,HR and MAP were recorded 5 minutes after intubation and after PEEP was established.Oxygenation index(OI)was recorded 5 minutes after intubation and at the end of the operation.The incidence of postoperative pulmonary complications within 72 hours after operation were recorded.Results Median individualized PEEP with highest dynamic compliance during titration was 9 cmH2O in group Ⅰ.Compared with 5 minutes after intubation,the total parapleural consolidation score,posterior tho-racic parapleural consolidation score,total B-line score and anterior lateral posterior chest B-line score,and total score of LUS were significantly decreased in both groups at the end of the operation(P＜0.05).Com-pared with group P,the total score of parapleural consolidation,posterior chest parapleural consolidation score,total score of B-line and posterior chest B-line score,and total score of LUS,the incidence of atelec-tasis were significantly decreased in group I at the end of the operation(P＜0.05).Compared with group P,Cdyn and Ppeak in group Ⅰ were significantly increased after PEEP establishment(P＜0.05),OI at the end of the operation was significantly increased(P＜0.05),and the incidence of postoperative pulmonary complications within 72 hours after operation was significantly decreased in group Ⅰ(P＜0.05).Conclusion Intraoperative application of Cdyn-guided individualized PEEP can effectively reduce LUS score and atelectasis at the end of craniofacial reconstruction in children,improve oxygenation function,and reduce the incidence of postoperative pulmonary complications.

Hip fracture is considered as the most severe osteoporotic fracture characterized by high disability and mortality in the elderly. Improved surgical techniques and multidisciplinary team play an active role in alleviating prognosis, which places higher demands on perioperative nursing. Dysfunction, complications, and secondary impact of anaesthesia and surgery add more difficulties to clinical nursing. Besides, there still lack clinical practices in perioperative nursing for elderly patients with hip fracture in China. In this context, led by the Orthopedic Nursing Committee of Chinese Nursing Association, the Expert consensus on clinical practice in perioperative nursing for elderly patients with hip fracture ( version 2023) is developed based on the evidence-based medicine. This consensus provides 11 recommendations on elderly patients with hip fracture from aspects of perioperative health education, condition monitoring and inspection, complication risk assessment and prevention, and rehabilitation, in order to provide guiding advices for clinical practice, improve the quality of nursing and ameliorate the prognosis of elderly patients with hip fracture.

Evidence-based Practice Guideline of Medication Therapy of High-dose Methotrexate in China was published in the British Journal of Clinical Pharmacology in February 2022. The guideline followed the latest definition of clinical practice guideline and the methodology specification for the guideline development of WHO. The Grading of Recommendations Assessment ， Development，and Evaluation （GRADE）approach was applied to rate the quality of evidence and determine the strength of recommendations. Finally ，this guideline presents 28 recommendations covering the whole process of clinical medication of high-dose methotrexate ，involving evaluation prior to administration （liver and renal function ，pleural effusion and ascites ， comedication，genetic testing ），pre-treatment and routine dosing regimen （pretreatment of hydration and alkalization ，urine alkalization，routine dosing regimen ），therapeutic drug monitoring （necessity，method，timing，target concentration ），leucovorin rescue（rescue timing ，rescue regimen ，rescue dose optimization ），and management of toxicities （liver and kidney function monitoring，supportive treatment ，blood purification treatment ）. This article aims to summarize and interpret the recommendations of this guideline ，so as to promote the better promotion and implementation of this guideline and provide comprehensive technical support and suggestions for whole-course individualized administration of high-dose methotrexate in China.

Patients undergoing elective coronary artery bypass grafting may experience the further decline in physical function while they wait for surgery, affecting the prognosis of the disease. Pre-rehabilitation refers to surgical nursing that is performed before a patient has undergone surgery, even before admission to the hospital, including exercise, nutrition, and psychology. It has been carried out in some areas abroad and in China. This article reviews the implementation methods, effects and applications of strength training-based pre-rehabilitation in patients with coronary artery bypass grafting, so as to provide a theoretical basis for Chinese medical and nursing staff to carry out pre-rehabilitation.

Objective:To investigate the MRI manifestations of lymphoepithelioma-like intrahep cholangiocarcinoma (LEL-ICC).Methods:MR images of 26 cases with LEL-ICC confirmed pathologically at Zhongshan Hospital Affiliated with Fudan University between March 2011 and March 2021 were retrospectively analyzed. The number, location, size, morphology, edges of lesions, non-scan signal intensity, cystic necrosis, enhancement mode, peak, and capsule, vascular invasion, lymph node metastasis, and other MR images were included for analysis. The apparent diffusion coefficient (ADC) value of the lesion and the surrounding normal liver parenchyma were measured. A paired-sample t-test was used to statistically analyze the measurement data. Results:All 26 cases of LEL-ICC had solitary lesions. Mass-type LEL-ICC was the most common [ n=23, lesion size (4.02±2.32) cm] with distribution along the bile duct [ n=3, lesion size (7.23±1.40 cm)]. Among the 23 lesions of mass type LEL-ICC, most of the lesions were close to the liver capsule ( n=20), round ( n=22), clearly bordered ( n=13), and cystic necrosis ( n=22). In the three lesions of LEL-ICC distributed along the bile duct, most of them were close to the liver capsule ( n=2), irregular ( n=3), blurred edges ( n=3), and cystic necrosis ( n=3). All 26 lesions showed a low/slightly low signal on T 1WI, a high/slightly high signal on T 2WI, and a slightly high or high signal on DWI. Three lesions showed fast-in and fast-out enhancement modes, and 23 lesions showed continuous enhancement. Twenty-five lesions showed peak enhancement in the arterial phase, and one lesion appeared in the delayed phase. The ADC value of 26 lesions and adjacent normal liver parenchyma was (1.112±0.274)×10 -3 mm 2/s and (1.482±0.346)×10 -3 mm 2/s, respectively, and the both had a statistically significant difference ( P<0.05). Conclusion:Certain manifestations of LEL-ICC in magnetic resonance imaging are advantageous for diagnosis and differential diagnosis.