To promote the development of extracellular vesicles of herbal medicine especially the establishment of standardization, led by the National Expert Committee on Research and Application of Chinese Herbal Vesicles, research experts in the field of herbal medicine and extracellular vesicles were invited nationwide with the support of the Expert Committee on Research and Application of Chinese Herbal Vesicles, Professional Committee on Extracellular Vesicle Research and Application, Chinese Society of Research Hospitals and the Guangdong Engineering Research Center of Chinese Herbal Vesicles. Based on the collation of relevant literature, we have adopted the Delphi method, the consensus meeting method combined with the nominal group method to form a discussion draft of "Consensus statement on research and application of Chinese herbal medicine derived extracellular vesicles-like particles (2023)". The first draft was discussed in online and offline meetings on October 12, 14, November 2, 2022 and April and May 2023 on the current status of research, nomenclature, isolation methods, quality standards and research applications of extracellular vesicles of Chinese herbal medicines, and 13 consensus opinions were finally formed. At the Third Academic Conference on Research and Application of Chinese Herbal Vesicles, held on May 26, 2023, Kewei Zhao, convenor of the consensus, presented and read the consensus to the experts of the Expert Committee on Research and Application of Chinese Herbal Vesicles. The consensus highlights the characteristics and advantages of Chinese medicine, inherits the essence, and keeps the righteousness and innovation, aiming to provide a reference for colleagues engaged in research and application of Chinese herbal vesicles at home and abroad, decode the mystery behind Chinese herbal vesicles together, establish a safe, effective and controllable accurate Chinese herbal vesicle prevention and treatment system, and build a bridge for Chinese medicine to the world.

Background::Although overnight fasting is recommended prior to endoscopic retrograde cholangiopancreatography (ERCP), the benefits and safety of high-carbohydrate fluid diet (CFD) intake 2 h before ERCP remain unclear. This study aimed to analyze whether high-CFD intake 2 h before ERCP can be safe and accelerate patients’ recovery.Methods::This prospective, multicenter, randomized controlled trial involved 15 tertiary ERCP centers. A total of 1330 patients were randomized into CFD group ( n = 665) and fasting group ( n = 665). The CFD group received 400 mL of maltodextrin orally 2 h before ERCP, while the control group abstained from food/water overnight (>6 h) before ERCP. All ERCP procedures were performed using deep sedation with intravenous propofol. The investigators were blinded but not the patients. The primary outcomes included postoperative fatigue and abdominal pain score, and the secondary outcomes included complications and changes in metabolic indicators. The outcomes were analyzed according to a modified intention-to-treat principle. Results::The post-ERCP fatigue scores were significantly lower at 4 h (4.1 ± 2.6 vs. 4.8 ± 2.8, t = 4.23, P <0.001) and 20 h (2.4 ± 2.1 vs. 3.4 ± 2.4, t= 7.94, P <0.001) in the CFD group, with least-squares mean differences of 0.48 (95% confidence interval [CI]: 0.26–0.71, P <0.001) and 0.76 (95% CI: 0.57–0.95, P <0.001), respectively. The 4-h pain scores (2.1 ± 1.7 vs. 2.2 ± 1.7, t = 2.60, P = 0.009, with a least-squares mean difference of 0.21 [95% CI: 0.05–0.37]) and positive urine ketone levels (7.7% [39/509] vs. 15.4% [82/533], χ2 = 15.13, P <0.001) were lower in the CFD group. The CFD group had significantly less cholangitis (2.1% [13/634] vs. 4.0% [26/658], χ2 = 3.99, P = 0.046) but not pancreatitis (5.5% [35/634] vs. 6.5% [43/658], χ2 = 0.59, P = 0.444). Subgroup analysis revealed that CFD reduced the incidence of complications in patients with native papilla (odds ratio [OR]: 0.61, 95% CI: 0.39–0.95, P = 0.028) in the multivariable models. Conclusion::Ingesting 400 mL of CFD 2 h before ERCP is safe, with a reduction in post-ERCP fatigue, abdominal pain, and cholangitis during recovery.Trail Registration::ClinicalTrials.gov, No. NCT03075280.

Objective:To review the outcome of intravitreous anti-vascular endothelial growth factor (VEGF) treatment in patients with X-linked retinoschisis (XLRS) complicated with vitreous hemorrhage (VH).Methods:A retrospective clinical study. From March 1, 2016 to April 1, 2022, 18 patients (19 eyes) diagnosed with XLRS complicated with vitreous hemorrhage in Beijing Tongren Hospital, Capital Medical University of Eye Center were included. All the patients were male, with a median age of 7.05±3.8 years. Best corrected visual acuity (BCVA) and wide-angle fundus photography were performed in all the patients. BCVA was carried out using international standard visual acuity chart, and converted into logarithm of minimum resolution angle (logMAR) in statistics analysis. According to whether the patients received intravitreal injection of ranibizumab (IVR), the patients were divided into injection group and observation group, with 11 eyes in 10 cases and 8 eyes in 8 cases, respectively. In the injection group, 0.025 ml of 10 mg/ml ranibizumab (including 0.25 mg of ranibizumab) was injected into the vitreous cavity of the affected eye. Follow-up time after treatment was 24.82±20.77 months. The VH absorption time, visual acuity changes and complications were observed in the injection group after treatment. Paired sample t test was used to compare BCVA before and after VH and IVR treatment. Independent sample t test was used to compare the VH absorption time between the injection group and the observation group. Results:LogMAR BCVA before and after VH were 0.73±0.32 and 1.80±0.77, respectively. BCVA decreased significantly after VH ( t=-3.620, P=0.006). LogMAR BCVA after VH and IVR were 1.87±0.55 and 0.62±0.29, respectively. BCVA was significantly improved after IVR treatment ( t=6.684, P<0.001). BCVA records were available in 5 eyes before and after IVR, and the BCVA values after VH and IVR were 0.58±0.31 and 0.48±0.20, respectively, with no statistically significant difference ( t=1.000, P=0.374). BCVA increased in 1 eye and remained unchanged in 4 eyes after treatment. BCVA records were available in 5 eyes before VH and after VH absorption in the 8 eyes of the observation group. LogMAR BCVA before VH and after VH absorption were 0.88±0.28 and 0.90±0.26, respectively, with no significant difference ( t=-1.000, P=0.374). After VH absorption, BCVA remained unchanged in 4 eyes and decreased in 1 eye. The absorption time of VH in the injection group and the observation group were 1.80±1.06 and 7.25±5.04 months, respectively. The absorption time of VH was significantly shorter in the injection group than in the observation group, the difference was statistically significant ( t=-3.005, P=0.018). Multivariate linear regression analysis showed that IVR treatment was significantly correlated with VH absorption time ( B=-6.66, 95% confidence interval -10.93--2.39, t=-3.40, P=0.005). In the injection group, VH recurrence occurred in 1 eye after IVR treatment. Vitrectomy (PPV) was performed in one eye. In the 8 eyes of the observation group, VH recurrence occurred in 2 eyes, subsequent PPV in 1 eye. The rate of VH recurrence and PPV was lower in the injection group, however, the difference was not statistically significant( P=0.576, 1.000). In terms of complications, minor subconjunctival hemorrhage occurred in 2 eyes and minor corneal epithelial injury occurred in 1 eye in the injection group, and all recovered spontaneously within a short time. In the injection group, 9 eyes had wide-angle fundus photography before and after IVR treatment. There was no significant change in the range of peripheral retinoschisis after treatment. No obvious proliferative vitreoretinopathy, infectious endophthalmitis, retinal detachment, macular hole, complicated cataract, secondary glaucoma or other serious complications were found in all the treated eyes, and there were no systemic complications. Conclusion:Intravitreous anti-VEGF treatment may accelerate the absorption of vitreous hemorrhage in patients with XLRS. No impact is found regarding to the peripheral retinoschisis.

Objective    To investigate the prognostic value and consistency of prognostic nutritional index (PNI) and patient-generated subjective global assessment (PG-SGA) in perioperative nutritional status of patients with esophageal cancer. Methods    Clinical data of 224 patients, including 186 males and 38 females with an average age of 63.08±8.42 years, who underwent esophageal cancer surgery in our hospital from November 2017 to August 2018 were retrospectively reviewed. The PNI was calculated according to the results of the first time blood and biochemical tests, and the PG-SGA assessment was also performed. According to the PNI value, the patients were divided into a good nutrition group (PNI≥45, 60 patients) and a malnutrition group (PNI<45, 164 patients). According to the PG-SGA score, the patients were divided into a good nutrition group (PG-SGA<4, 75 patients) and a malnutrition group (PG-SGA≥4, 149 patients). Nutrition-related haematological indexes and body mass index (BMI) were compared between the two groups, and the consistency of PNI and PG-SGA for nutritional assessment was analyzed. Results    The nutrition-related haematological indexes in different PNI groups were statistically different in the perioperative period (P<0.01). The longitudinal changes of prealbumin in patients of different PG-SGA groups were statistically different (P<0.05); the BMI of patients in different PG-SGA groups was statistically different in the perioperative period (P<0.01). The Kappa coefficient of the two indicators was 0.589 (P<0.001). Conclusion    Both PNI and PG-SGA can predict the nutritional risk of patients with esophageal cancer to some extent. PNI is an objective monitoring indicator, and PG-SGA is a subjective evaluation indicator, the combined use of which can more comprehensively reflect and predict the nutritional status of patients, and provide an important reference to the development of individualized nutrition support programs.

Objective To investigate the CT findings of primary orbital lipid prolapse. Methods The CT data of 13 patients with primary orbital lipid prolapse in Jiaxing Traditional Chinese Medicine Hospital Affiliated to Zhejiang Chinese Medical University from January 2012 to June 2018 were retrospectively analyzed. Results In all of the 13 cases of primary orbital lipid prolapse, there were 12 cases of bilateral orbital lipid prolapse and 1 case of unilateral orbital lipid prolapse. The CT images showed that the fat density masses in the posterior orbital septum were herniated from the outer quadrant of the orbit. The tumor was crescent shaped and connected with the orbital adipose tissue. The mass and the orbital adipose tissue were natural and homogeneous. Conclusions CT has distinctive imaging findings in the diagnosis of primary orbital lipid prolapse, and it is helpful for the diagnosis and differential diagnosis of this disease.

Objective: To investigate the incidence and prognosis of cognitive impairment and to find out the risk factors associated with the outcome for better understanding and preventing cognitive impairment in maintenance hemodialysis (MHD) patients. Methods: The patients who met the criteria as below: MHD patients (≥3 months) in Renji Hospital, Shanghai Jiao Tong University School of Medicine from January 2000 to July 2014, ≥18 years old were enrolled and could carry on the montreal cognitive assessment (MoCA) of voluntary cooperation. According to the score of MoCA, all enrolled patients were divided into two groups: cognitive impairment (MoCA<26) group and non-cognitive impairment (MoCA≥26) group. The follow-up period was 3 years. There were 130 males, and the incidence, demography data, medical history, hemodialysis data, laboratory examination and prognosis of cognitive impairment in hemodialysis patients were prospectively compared and analyzed. Logistic regression analysis was used to investigate the risk factors of cognitive impairment. Kaplan-Meier survival curve and Cox regression model were used for prognostic analysis. Results: A total of 219 MHD patients were enrolled. The incidence of cognitive impairment in MHD patients was 51.6%. There were 130 males, and the ratio of male to female was 1.46∶1. Age was (60.07±12.44) years old and dialysis vintage was (100.79±70.23) months. Compared with non-cognitive impairment group (n=106), patients in cognitive impairment group (n=113) were older, and had higher proportion of education status<12 years, history of diabetes and anuria (all P<0.05); however, the post-dialysis systolic pressure, pre-dialysis diastolic pressure, post-dialysis diastolic pressure, platelet and spKt/V were lower (all P<0.05). Multivariate logistic regression analysis showed that education status<12 years (OR=3.428, 95%CI 1.919-6.125, P<0.001), post-dialysis diastolic pressure<73 mmHg (OR=2.234, 95%CI 1.253-3.984, P=0.006) and spKt/V<1.72(OR=1.982, 95%CI 1.102-3.564, P=0.022) were the independent risk factors for cognitive impairment in MHD patients. The Kaplan-Meier survival curve analysis showed that the survival rate of patients with cognitive impairment was lower than that of non-cognitive impairment group in MHD patients during 3 years follow-up (χ²=3.977, P=0.046). Multivariate Cox regression analysis showed that cognitive impairment was an independent risk factor for death in MHD patients (RR=2.661, 95%CI 0.967-7.321, P=0.058). Conclusions Cognitive impairment is one of the common complications and an independent risk factor for death in MHD patients. The mortality is high in patients who suffer cognitive impairment. Education status<12 years, post-dialysis diastolic pressure<73 mmHg and spKt/V<1.72 are the independent risk factors for cognitive impairment in MHD patients.

Objective:To optimize the clinical dosage regimen of amoxicillin and clavulanate potassium extended release ( ER) tablets based on the PK/PD parameters. Methods:Totally 30 healthy subjects ( half male and half female) were randomly divided into three groups, and orally administered the ER tablets respectively under fasting condition, before the meal and after the meal, and the optimal administration time was determined by comparing the pharmacokinetic characteristics. The subjects in the three groups were ad-ministered the ER tablets respectively at low, medium and high dosage, and the optimal dosage and dosing interval were determined based on the PK/PD parameters. Results:Under fasting condition, the AUC of amoxicillin [(32.2 ±15.0) μg·h·ml-1] was sig-nificantly lower than that before the meal [(41.7 ±1.92) μg·h·ml-1] and that after the meal [(42.6 ±17.7) μg·h·ml-1]. In contrast, the AUC of clavulanate acid after the meal [(1.89 ±0.54) μg·h·ml-1] was significantly lower than that under fasting condition [(2.55 ±0.76) μg·h·ml-1] and that before the meal [(2.58 ±0.76) μg·h·ml-1] (P<0.05). Amoxicillin and clavulanic acid displayed linear pharmacokinetics within the range of 1000-4000 mg and 62. 5-250 mg, respectively. After a single o-ral administration of amoxicillin and clavulanate potassium ER tablets at low, medium and high dose, the duration of blood concentra-tion above the minimum inhibitory concentration (MIC, 2. 0 μg·ml-1) (T> MIC) in 12 h was 5. 5, 7 and 10 h, and the percentage was 46%, 58% and 83%, respectively, and T> MIC in 12 h was 4. 5, 6 and 8 h, and the percentage was 38%, 50% and 67%, re-spectively when MIC was 4. 0μg·ml-1 . Conclusion:It is suggested that amoxicillin and clavulanate potassium ER tablets be taken at the start of a standard meal, 2 tablets per time, twice daily, which is sufficient to achieve T> MIC of 40% -50%.

Objective To evaluate and compare the clinical outcomes of concurrent chemoradiotherapy with different radiation doses for esophageal carcinoma. Methods 78 cases of esophageal carcinoma receiving primary definitive treatment in our department between May 1 , 2005 to June 31 2007 were analyzed retrospectively. The patients with esophageal carcinoma were divided into high- ( > 50 Gy, median dose of 64 Gy) and low-dose (50 Gy) groups according to their prescription doses (n = 35, 43, respectively). Chemotherapy regimen consisted of cisplatin (75 mg/m2, d1) and 5-FU (500 ~ 600 mg/m2, D2 ~ 5) starting at days 1, 28, 49 and 70 after the beginning of radiotherapy with 2 ~ 4 cycles. The two groups were compared in terms of the early treatment outcomes, the side effects and survival rates. Results The 1,3 and 5-year survival rates for the high and low dose groups were 71.4%, 34.3%, 25.7%and 76.7%, 41.9%, 30.2%, respectively. The median survival time was 19 and 22 months respectively without statistical difference. The high dose group was more likely to have higher incidence rate of grade Ⅲ to Ⅳ myelosuppression in spite of the statistical difference. The high dose group had significantly higher incidence of esophagitis than did the low dose group (P=0.040). Conclusion For esophageal carcinoma with only indications of concurrent chemoradiotherapy, te low dose radiation (50 Gy) has comparable outcomes and less side effects compared with the high dose radiation (>50 Gy).

Objective To investigate the diagnostic value of prenatal ultrasound for fetal structural abnormalities.Methods The clinical data of 3 101 fetus with structural malformations, diagnosed by prenatal ultrasound and confi rmed after induced labor, and 856 cases of missed diagnosis were analyzed. All these data were collected in Maternal and Child Health Hospital of Tangshan City from January 2010 to June 2014. The types and number of fetal structural abnormalities were recorded. The rates of detection and missed diagnosis for the fetal structural abnormalities were calculated and the reasons for missed diagnosis were analyzed.ResultsA total of 3101 cases (4 171 positions) were diagnosed as fetal structural abnormalities by prenatal ultrasound. The detection rate was 11.51‰ (3 101/269 501). There were 856 cases (947 positions) of fetal structural abnormalities were missed, and the missed diagnosis rate was 3.18‰ (856/269 501). The incidence of fetal structural abmormalities was 14.68‰ (3 957/269 501). In terms of anatomy systems, the top five were cardiovascular system abnormalities (851 cases), the central nervous system abnormalities (691 cases), facial abnormalities (562 cases), urinary system abnormalities (476 cases), and respiratory system abnormalities (134 cases). In terms of single abnormalities, the top five were cleft lip and palate (549 cases), ventricular septal defect (519 cases), hydronephrosis (331 cases), spina bifi da (212 cases), and atrial-ventricular septal defect (163 cases). The top five of missed deformities were polydactylia/symphysodactylia (285 cases), ear deformities (108 cases), hypospadias (93 cases), foot abnormalities (92cases), and ventricular septal defect (52 cases).Conclusions There is a high detection rate for fetal structural abnormalities with prenatal ultrasound. Prenatal ultrasound is an indispensable means for the diagnosis of fetal malformation, but it also has some limitations. There is a high rate of missed diagnosis for polydactylia/symphysodactylia, microtia, and hypospadias.

Objective To evaluate the characteristic appearance and diagnosis value of central neurocytoma on magnetic resonance imaging (MRI).Methods MRI data of 9 patients with central neurocytoma confirmed surgically and pathologically were retrospectively reviewed.Results All the lesions located in the lateral ventricle septum pellucidum,adjacent to Monro hole,in the anterior 1/3 to 2/3 of the lateral ventricle.Most of them were irregularity,sublobe and sharpness of border.They presented as inhomogeneous intense signal on MRI,with slight to equal enhancement on enhancement.DWI could be high or slightly high signal.Conclusion Central neurocytoma has the characteristic appearances on MRI,being helpful to the diagnosis.