Effect of Jianpi Shengxue Tablet on Iron Metabolism and Nutritional Status in Patients with Renal Anemia:A Prospective,Randomized,Open,Parallel Controlled and Multicenter Clinical Study

Objective This study aimed to analyze the clinical efficacy of the Jianpi Shengxue tablet for treating renal anemia.Methods A total of 200 patients with renal anemia from December 2020 to December 2022 were enrolled and randomly divided into two groups.Patients in the control group were treated with polysaccharide-iron complex,and those in the experimental group were administered Jianpi Shengxue tablet.After 8 weeks of continuous treatment,the therapeutic outcomes regarding anemia were compared between the two groups.Results After treatment,the red blood cell(RBC)count,hematocrit(HCT),reticulocyte percentage(RET),ferritin(SF),serum iron(SI),transferrin saturation(TSAT),and serum albumin(ALB)all increased(P<0.01),and the clinical symptom score and total iron binding capacity decreased(P<0.01)in the experimental group.Moreover,the improvements in RBC,HCT,RET,SF,SI,TAST,ALB,and clinical symptoms(fatigue,anorexia,dull skin complexion,numbness of hands and feet)in the experimental group were significantly greater than those in the control group(P<0.05).The total effective rate for treating renal anemia was significantly higher in the experimental group than in the control group(P<0.01).Conclusion The Jianpi Shengxue tablet demonstrates efficacy in treating renal anemia,leading to significant improvements in the laboratory examination results and clinical symptoms of patients with renal anemia.

Current treatment paradigm and survival outcomes among patients with newly diagnosed multiple myeloma in China:a retrospective multicenter study

Objective:Evidence on the prognostic value of autologous stem cell transplantation(ASCT)and minimal residual disease(MRD)dynamics of patients with newly diagnosed multiple myeloma(NDMM)in China is limited.Our objective in the current study was to understand the current care paradigm and outcomes of these patients.Methods:This longitudinal cohort study used historical data from three top-tier hematologic disease care hospitals that contributed to the National Longitudinal Cohort of Hematological Diseases-Multiple Myeloma.Treatment regimens[proteasome inhibitor(PI)-,immunomodulatory drug(IMiD)-,PI+IMiD-based,and conventional],post-induction response,ASCT and MRD status,and survival outcomes[progression-free survival(PFS)and overall survival(OS)]were evaluated.Results:In total,454 patients with NDMM were included(median age,57 years;59.0%males)with a median follow-up of 58.7 months.The overall response rate was 91.0%,83.9%,90.6%,and 60.9%for PI-,IMiD-,PI+IMiD-based,and conventional regimens,respectively.Patients with ASCT during first-line therapy(26.2%)had a longer PFS and OS than patients who did not receive ASCT[median PFS,42.9 vs.21.2 months,P<0.001;median OS,not reached(NR)vs.65.8 months,P<0.001].The median OS was NR,71.5,and 56.6 months among patients with sustained MRD negativity,loss of MRD negativity,and persistent MRD,respectively(P<0.001).Multivariate analysis revealed that the lactic dehydrogenase level,International Staging System stage,extra-medullary disease,and upfront ASCT were independent factors in predicting OS among NDMM patients.Conclusions:Our study showed that novel agent-based regimens,first-line ASCT,and sustained MRD negativity were associated with a superior outcome for patients with NDMM in China(Identifier:NCT04645199).

Efficacy and Safety of the Chinese Herbal Compound TJAOA101 in Treating Diminished Ovarian Reserve: A Protocol for Multicenter, Prospective, and Pre-Post Study

Objective Diminished ovarian reserve(DOR)can lead to early menopause,poor fecundity,and an increased risk of disorders such as osteoporosis,cardiovascular disease,and cognitive impairment,seriously affecting the physical and mental health of women.There is still no safe and effective strategy or method to combat DOR.We have developed a novel Chinese herbal formula,Tongji anti-ovarian aging 101(TJAOA101),to treat DOR.However,its safety and efficacy need to be further validated.Methods In this prospective and pre-post clinical trial,100 eligible patients aged 18–45 diagnosed with DOR will be recruited.All participants receive TJAOA101 twice a day for 3 months.Then,comparisons before and after treatment will be analyzed,and the outcomes,including anti-mullerian hormone(AMH)and follicle-stimulating hormone(FSH)levels and the antral follicle count(AFC),the recovery rate of menopause,and the Kupperman index(KMI),will be assessed at baseline,every month during medication(the intervention period),and 1,3 months after medication(the follow-up period).Assessments for adverse events will be performed during the intervention and follow-up periods.Conclusion A multicenter,prospective study will be conducted to further confirm the safety and efficacy of TJAOA101 in treating DOR and to provide new therapeutic strategies for improving the quality of life in DOR patients.

Acupuncture for stroke cohort construction:a protocol describing a multicenter,prospective,real-world cohort construction study

Background:Acupuncture for stroke has been endorsed by the World Health Organization,and the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018 lists acupuncture for stroke as a Level II recommendation with Level B evidence.The efficacy of acupuncture in the treatment of acute ischaemic stroke needs to be approved by more high-quality studies.However,there are currently no real-world studies of acupuncture for stroke.Methods:Stroke patients who meet the study criteria and are hospitalized from February 2021 to March 2022 in 23 medical institutions across China,including the First Teaching Hospital of Tianjin University of Chinese Medicine.The number of patients planned to be recruited is 3,000.Due to the impact of COVID-19,we have applied to the competent authorities for an extension(recruit patients until December 2022).Basic patient information and treatment information will be registered at admission,at discharge,and on the following dates after the onset of the disease:90±7 days,180±7 days,and 360±7 days after the onset of the disease.Establish a database for statistical analysis.Discussion:This study proposes to conduct a prospective cohort study of acupuncture intervention for stroke in a real-world medical setting.Analysis of the effect pattern of acupuncture intervention on the recovery of neurological function system and swallowing disorder in stroke patients.Evaluate the long-term effects of acupuncture intervention for stroke and recurrence of cardiovascular and cerebrovascular events.

Human umbilical cord mesenchymal stem cells to treat spinal cord injury in the early chronic phase: study protocol for a prospective, multicenter, randomized, placebo-controlled, single-blinded clinical trial

Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promising candidate for the treatment of intractable spinal cord injury(SCI).Clinical studies on patients with early chronic SCI(from 2 months to 1 year post-injury),which is clinically common,are rare;therefore,we will conduct a prospective,multicenter,randomized,placebo-controlled,single-blinded clinical trial at the Third Affiliated Hospital of Sun Yat-sen University,West China Hospital of Sichuan University,and Shanghai East Hospital,Tongji University School of Medicine,China.The trial plans to recruit 66 early chronic SCI patients.Eligible patients will undergo randomization at a 2:1 ratio to two arms:the observation group and the control group.Subjects in the observation group will receive four intrathecal transplantations of stem cells,with a dosage of 1×106/kg,at one calendar month intervals.Subjects in the control group will receive intrathecal administrations of 10 mL sterile normal saline in place of the stem cell transplantations.Clinical safety will be assessed by the analysis of adverse events and laboratory tests.The American Spinal Injury Association(ASIA)total score will be the primary efficacy endpoint,and the secondary efficacy outcomes will be the following:ASIA impairment scale,International Association of Neural Restoration-Spinal Cord Injury Functional Rating Scale,muscle tension,electromyogram,cortical motor and cortical sensory evoked potentials,residual urine volume,magnetic resonance imaging–diffusion tensor imaging,T cell subtypes in serum,neurotrophic factors and inflammatory factors in both serum and cerebrospinal fluid.All evaluations will be performed at 1,3,6,and 12 months following the final intrathecal administration.During the entire study procedure,all adverse events will be reported as soon as they are noted.This trial is designed to evaluate the clinical safety and efficacy of subarachnoid transplantation of hUC-MSCs to treat early chronic SCI.Moreover,it will establish whether cytotherapy can ameliorate local hostile microenvironments,promote tracking fiber regeneration,and strengthen spinal conduction ability,thus improving overall motor,sensory,and micturition/defecation function in patients with early chronic SCI.This study was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2018]-02)on March 30,2018,and was registered with ClinicalTrials.gov(registration No.NCT03521323)on April 12,2018.The revised trial protocol(protocol version 4.0)was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2019]-10)on February 25,2019,and released on ClinicalTrials.gov on April 29,2019.

Burden of diabetic foot ulcer in Nigeria: Current evidence from the multicenter evaluation of diabetic foot ulcer in Nigeria

BACKGROUND Nigeria bears the greatest burden of diabetes prevalence in Sub-Saharan Africa. Diabetic foot ulcer (DFU) is a serious and potentially life-threatening complication of diabetes. Significant improvements in diabetic foot incidence and outcomes have been recorded in many Western countries in the past decade. However, the current burden of DFU in Nigeria is largely unknown. AIM To evaluate the patients’ profile, ulcer characteristics, associated co-morbidities and outcome of patients with DFU in Nigeria. METHODS Multicenter evaluation of diabetic foot ulcer in Nigeria was a one year multicenter observational study of patients hospitalized for DFU in six tertiary health institutions in Nigeria from March 2016 to March 2017. Demographic and diabetes information, ulcer characteristics and associated co-morbidities were assessed. Relevant laboratory and imaging studies were performed. All patients received appropriate multi-disciplinary care and were followed up until discharge or death. Outcome variables of interest were ulcer healing, lower extremity amputation (LEA), duration of hospitalization and mortality. RESULTS A total of 336 patients (55.1% male) with mean age of 55.9 ± 12.5 years were enrolled into this study. Majority (96.1%) had type 2 diabetes. Only 25.9% of the subjects had prior foot care knowledge. Most of the subjects presented late to the hospital and median (IQR) duration of ulcer at presentation was 39 (28-54) d. Ulcers were already advanced (Wagner grades ≥ 3) in 79.2% of the subjects while 76.8% of the ulcers were infected at the time of admission. The commonest comorbidities were systemic hypertension, anemia and hyperglycemic emergencies. One hundred and nineteen subjects (35.4%) suffered LEA while 10.4% left against medical advice. The median (IQR) duration of hospitalization was 52.0 (29-66) d with case fatality rate of 20.5%. CONCLUSION The burden of DFU in Nigeria is very high. The major gaps include low level of foot care knowledge among diabetic patients, overdependence on self-medication and unorthodox medicine following development of foot ulceration, late hospital presentation, and high amputation and mortality rates. Extensive foot care education within the framework of a multi-disciplinary foot care team is highly desirable.

Surgery for gastric cancer patients of age 85 and older: Multicenter survey

AIM To investigate the surgical therapies for gastric cancer(GC) patients of age 85 or older in a multicenter survey.METHODS Therapeutic opportunities for elderly GC patients have expanded in conjunction with extended life expectancy. However, the number of cases encountered in a single institution is usually very small and surgical therapies for elderly GC patients have not yet been standardized completely. In the present study, a total of 134 GC patients of age 85 or older who underwent surgery in 9 related facilities were retrospectively investigated. The relationships between surgical therapies and clinicopathological or prognostic features were analyzed.RESULTS Eighty-nine of the patients(66%) presented with a comorbidity, and 26(19% overall) presented with more than two comorbidities. Radical lymphadenectomy was performed in 59 patients(44%), and no patient received pre- or post-operative chemotherapy. Forty of the patients(30%) experienced perioperative complications, but no surgical or perioperative mortality occurred. Laparoscopic surgery was performed in only 12 of the patients(9.0%). Univariate and multivariate analyses of the 113 patients who underwent R0 or R1 resection identified the factors of p T3/4 and limited lymphadenectomy as predictive of worse prognosis(HR = 4.68, P = 0.02 and HR =2.19, P = 0.05, respectively). Non-cancer-specific death was more common in c Stage Ⅰ patients than in c Stage Ⅱ or Ⅲ patients. Limited lymphadenectomy correlated with worse cancer-specific survival(P = 0.01), particularly in c Stage Ⅱ patients(P < 0.01). There were no relationships between limited lymphadenectomy and any comorbidities, except for cerebrovascular disease(P = 0.07). CONCLUSION N o n- c a n c e r- s p e c i f i c d e a t h w a s n o t n e g l i g i b l e, particularly in c Stage Ⅰ, and gastrectomy with radical lymphadenectomy appears to be an effective treatment for cS tage Ⅱ elderly GC patients.

Rate of anticoagulant use, and factors associated with not prescribing anticoagulant in older Thai adults with non-valvular atrial fibrillation: A multicenter registry

Objectives To investigate the rate of anticoagulant use,the reasons for not prescribing anticoagulant,and the factors associated with non-prescription of anticoagulant in older Thai adults with non-valvular atrial fibrillation.Methods A multicenter registry of patients with non-valvular atrial fibrillation was conducted during 2014 to 2017 in Thailand.Demographic,medical history,antithrombotic medication,non-antithrombotic medication,and laboratory data were collected and analyzed.Data were compared between the older adult (≥ 65 years) and younger adult (< 65 years) groups.The reasons why anticoagulant was not prescribed were collected,and predictive factors were identified.Results A total of 3218 patients (1873 males) with an average age of 67.3 ± 11.3 years were included.Almost two-thirds (61.0%) of patients were in the older adult group.Anticoagulant was prescribed in 2422 patients (75.3%): 81.4% in the older adult group and 65.7% in the younger adult group.The three main reasons for not prescribing anticoagulant were already taking antiplatelets,patient refusal,and bleeding risk.These reasons were more common in older adults as compared to younger adults.Multivariate analysis revealed current use of antiplatelets to be the most important factor that predict the non-prescription of anticoagulant in older population.Conclusions The prevalence of anticoagulant prescription among older Thai adults with atrial fibrillation is 81.4%.Taking antiplatelet drugs was found to be the strongest reason that predicts the non-prescription of anticoagulant in this patient population.A guideline should be developed to optimize the use of anticoagulant and antiplatelet in older adults.

Prognostic analysis of patients with combined hepatocellularcholangiocarcinoma after radical resection:A retrospective multicenter cohort study

BACKGROUND Combined hepatocellular-cholangiocarcinoma(cHCC-CCA)is a form of rare primary liver cancer that combines intrahepatic cholangiocarcinoma(ICC)and hepatocellular carcinoma.AIM To investigate overall survival(OS)and recurrence-free survival(RFS)after radical resection in patients with cHCC-CCA,and the clinicopathological factors affecting prognosis in two center hospitals of China.METHODS We reviewed consecutive patients with cHCC-CCA who received radical resection between January 2005 and September 2021 at Peking Union Medical College and the 5th Medical Center of the PLA General Hospital retrospectively.Regular follow-up and clinicopathological characteristics were systematic collected for baseline and prognostic analysis.RESULTS Our study included 95 patients who received radical resection.The majority of these patients were male and 82.7%of these patients were infected with HBV.The mean tumor size was 4.5 cm,and approximately 40%of patients had more than one lesion.The median OS was 26.8(95%CI:18.5-43.0)mo,and the median RFS was 7.27(95%CI:5.83-10.3)mo.Independent predictors of OS were CA19-9≥37 U/mL(HR=8.68,P=0.002),Child-Pugh score>5(HR=5.52,P=0.027),tumor number>1(HR=30.85,P=0.002),tumor size and transarterial chemoembolization(TACE)after surgery(HR=0.2,P=0.005).CONCLUSION The overall postoperative survival of cHCC-CCA patients is poor,and most patients experience relapse within a short period of time after surgery.Preoperative tumor biomarker(CA19-9,alphafetoprotein)levels,tumor size,and Child-Pugh score can significantly affect OS.Adjuvant TACE after surgery prolongs RFS,suggesting that TACE is a possible option for postoperative adjuvant therapy in patients with cHCC-CCA.

Clinical Features of Oxaliplatin-induced Hypersensitivity Reactions in Chinese Patients: A Retrospective Multicenter Analysis

Objective The characteristics of oxaliplatin-induced hypersensitivity reactions(HSRs)in Chinese patients were investigated to provide a reference for patients treated with oxaliplatin.Methods The study reviewed the records of patients who developed oxaliplatin-induced HSRs in 17 hospitals from May 2016 to May 2017.We collected and analyzed the basic information,history of oxaliplatin administration and premedication treatments,chemotherapy cycles,HSR symptoms,and the management and outcomes of these patients.Results Oxaliplatin-induced HSRs were recorded in 137 patients who had been treated with oxaliplatin-containing regimens.Five different chemotherapy regimens were applied.The median infusion cycle when oxaliplatin-induced HSRs occurred was 7,and HSRs occurred during or shortly after oxaliplatin infusion.Most of the patients experienced grade 1 or grade 2 HSRs with mild symptoms of pruritis(49.64%),flushing(46.72%),chest discomfort(26.28%),and urticaria(25.55%).The majority of the patients completely recovered from HSRs following treatment with antihistamines and dexamethasone.Seven patients completed chemotherapy with oxaliplatin after the symptoms resolved with proper management.Conclusion The results indicate that oxaliplatin-induced HSRs remain an important issue in safely and successfully fulfilling oxaliplatin-containing chemotherapy.Further studies are needed to analyze the risk factors and establish prophylaxis for such reactions.

Efficacy and safety of endoscopic submucosal dissection for gastric tube cancer:A multicenter retrospective study

BACKGROUND Recent improvements in the prognosis of patients with esophageal cancer have led to the increased occurrence of gastric tube cancer(GTC)in the reconstructed gastric tube.However,there are few reports on the treatment results of endoscopic submucosal dissection(ESD)for GTC.AIM To evaluate the efficacy and safety of ESD for GTC after esophagectomy in a multicenter trial.METHODS We retrospectively investigated 48 GTC lesions in 38 consecutive patients with GTC in the reconstructed gastric tube after esophagectomy who had undergone ESD between January 2005 and December 2019 at 8 institutions participating in the Okayama Gut Study group.The clinical indications of ESD for early gastric cancer were similarly applied for GTC after esophagectomy.ESD specimens were evaluated in 2-mm slices according to the Japanese Classification of Gastric Carcinoma with curability assessments divided into curative and non-curative resection based on the Gastric Cancer Treatment Guidelines.Patient characteristics,treatment results,clinical course,and treatment outcomes were analyzed.RESULTS The median age of patients was 71.5 years(range,57-84years),and there were 34 men and 4 women.The median observation period after ESD was 884 d(range,8-4040 d).The median procedure time was 81 min(range,29-334 min),the en bloc resection rate was 91.7%(44/48),and the curative resection rate was 79%(38/48).Complications during ESD were seen in 4%(2/48)of case,and those after ESD were seen in 10%(5/48)of case.The survival rate at 5 years was 59.5%.During the observation period after ESD,10 patients died of other diseases.Although there were differences in the procedure time between institutions,a multivariate analysis showed that tumor size was the only factor associated with prolonged procedure time.CONCLUSION ESD for GTC after esophagectomy was shown to be safe and effective.

Upper gastrointestinal endoscopic findings in celiac disease at diagnosis:A multicenter international retrospective study

BACKGROUND Gastroduodenal endoscopy and biopsy following positive specific serology is considered the gold standard to diagnose celiac disease(CeD)in adults.Whether upper endoscopy helps detect comorbid conditions is unknown.AIM To investigate the prevalence of non-celiac endoscopic findings in patients in whom endoscopy was performed to confirm CeD diagnosis.METHODS This is an observational,descriptive,multicenter,retrospective study that reports endoscopic findings obtained in adult patients enrolled in local registries from four tertiary centers.We collected data reported on first endoscopy,indicated for investigation of CeD.Diagnosis of CeD was performed by histology(≥Marsh 2type mucosal damage)and specific serology.Two European and one North American center included biopsy-confirmed CeD following positive serology.A fourth center(South America)included symptomatic patients undergoing endoscopy,irrespective of CeD serology.The latter cohort included a non-CeD control group.RESULTS A total of 1328 patients(80%female;35 years median age)were enrolled,of whom 95.6%had positive specific serology.In 135 patients,endoscopy revealed 163 abnormalities unrelated to CeD(prevalence:10.1%).Erosive reflux esophagitis(6.4%),gastric erosions(2.0%),and suspicion of esophageal metaplasia(1.2%)were the most common findings.Biopsy-confirmed Barrett’s esophagus was infrequent(0.2%).No endoscopic cancer was detected.Older patients(≥51 years of age)had a higher prevalence of endoscopic findings than those≤50(P<0.01).Within the South American cohort,CeD was associated with a lower rate(8.2%)of comorbid endoscopic findings compared with controls(29.1%;P<0.001).In the adjusted multivariate analysis of this cohort,having CeD was associated with a 72%reduction in the risk of any endoscopic abnormality(P<0.0001),and having alarm symptoms was associated with a 37%reduction in the risk of finding at least one endoscopic lesion(P<0.02).CONCLUSION In this large multicenter study,young adults with positive CeD serology had few comorbid endoscopic findings.Although patients over 51 years had a high prevalence of non-CeD gastroduodenal mucosal damage,no malignancy or premalignant lesions were found.

Clinical and economic impact of infliximab one-hour infusion protocol in patients with inflammatory bowel diseases:A multicenter study

AIM To assess the impact of short infliximab(IFX) infusion on hospital resource utilization and costs.METHODS All inflammatory bowel diseases(IBD) patients who received IFX 1 h infusion from March 2007 to September 2014 in eight centers from Southern Italy were included in the analysis. Demographic, clinical and infusion related data were collected. The potential benefits related to the short infusion protocol were assessed both in terms of time saving and increased infusion unit capacity. In addition, indirect patient-related cost savings were evaluated.RESULTS One hundred and twenty-five patients were recruited(64 with ulcerative colitis and 61 with Crohn's disease). Median duration of disease was of 53 mo and mean age of pts at diagnosis was of 34 years(SD: ± 13). Adverse infusion reactions were reported in less than 4% both before and after short infusion. The total number of infusions across the selected centers was of 2501(30.5% short infusions). In the analyzed cohort, 1143 h were saved(762 in the infusion and 381 in observation phases) through the rapid IFX infusion protocol. This time saving(-15% compared to the standard protocol in infusion phase) represents, from the hospital perspective, an opportunity to optimize infusion unit capacity by allocating the saved time in alternative cost-effective treatments. This is the case of opportunity cost that represents the value of forgone benefit which could be obtained from a resource in its next-best alternative use. Hence, an extra hour of infusion in the case of standard 2-h IFX represents a loss in opportunity to provide other cost effective services. The analysis showed that the short infusion increased the infusion units capacity up to 50% on days when the IFX infusions were scheduled(infusion phase). Furthermore, the analysis showed that the short IFX infusion protocol leads to time savings also in the post-infusion phase(observation) leading to a time saving of 10% on average among the analyzed centers. Finally, the short infusion protocol has been demonstrated to lead to indirect cost savings of €138/patient(average-€17.300 on the whole cohort).CONCLUSION A short IFX infusion protocol can be considered time and cost saving in comparison to the standard infusion protocol both from the hospital's perspective, as it contributes to increase infusion units capacity, and the patients' perspective, as it reduces indirect costs and the impact of treatment on everyday life and work productivity.

Standardized Semi-Quantitative Evaluation of [123I]FP-CIT SPECT in a Multicenter Study

To the best of our knowledge no multicenter studies have been published using standardized semi-quantitative evaluation of [123I]FP-CIT scan (DAT-SPECT). The aims of this study were: 1) to cross-compare semi-quantitative software-assisted evaluations of DAT-SPECTs performed in three centers with different equipments;2) to assess the accuracy of semi-quantitative evaluations of DAT-SPECT and 3) to identify the threshold with the best accuracy, sensitivity and specificity in a patient population with suspected parkinsonian syndrome. Materials and Methods: Two hundred twenty patients (mean age at the time of SPECT acquisition, 67.4 ± 9.5 yy) acquired in three centers (Ospedale San Luigi Gonzaga;Ospedale San Giovanni Battista Molinette;Ospedale Mauriziano Umberto I) were included. All of them underwent DAT-SPECT from January 2006 to July 2010. All exams were analyzed with the freely available software BASGAN and semi-quantitative data were used to predict disease. In particular, analyses were based on the values from the most deteriorated putamen and caudate, normalized for age and corrected for equipment. ROC analysis was performed and area under the curve (AUC) was estimated. Results: Analysis showed high AUCs (0.898, 0.864, 0.900 and 0.891 for each center and for the multicenter setting, respectively) confirming the very good accuracies reached. The best cut-off were 0.72 and 0.82 for putamen and caudate respectively. These thresholds allowed sensitivities and specificities in each center and in the multicenter setting of 76% and 96%, 91% and 82%, 93% and 90%, 86% and 89% respectively. No significant differences were observed between sensibility and specificity in each center. Conclusion: A unique threshold useful for all centers with high and similar sensitivities and specificities is possible after correction for age and equipments. The high accuracy reached in this multicenter trial by the semi-quantitative analysis seems similar to accuracies from qualitative analysis in other multicenter studies.

Screening of Class 1 and Class 2 Integrons in Clinical Isolates of Pseudomonas aeruginosa Collected from Seven Hospitals in Turkey:A Multicenter Study

Pseudomonas aeruginosa is one of the leading nosocomial pathogens worldwide, and their infections are difficult to treat due to acquired resistance to many antibiotics. This study aimed to detect class 1 and 2 integrons and antibiotic susceptibility of clinical isolates of P. aeruginosa. Two hundred and five P. aeruginosa strains were collected from the seven general state hospitals in Turkey. They were characterized by antimicrobial susceptibility testing, screened for class 1 and class 2 integrons, and evaluated for the association between antibiotic resistance phenotypes and the presence of integrons. intI gene was amplified in 10 isolates (4.87%) by PCR and in seven isolates of them (70%) were found different gene cassettes. The aadA gene integrated into the class 1 integrons was most frequently found and it was followed by aac genes and blaOXA family genes. Sequence analysis of variable regions of the class 1 integrons showed five gene cassette arrays;aadA1(99%), aac(3)-Id(82%)-orf-aac(3”)-Ia(99%), aac(3)-Ie(83%)-blaoxa10(100%)- aadA1 (100%), aadA6(99%, 100%), aac(6’)-I(97%)-orf-aadA2(99%). No class 2 integron was detected. This study is the first multicenter study for class 1 integrons and it indicates the low rate of presence of class 1 gene cassette in P. aeruginosa.

A multicenter prospective study on the management of hepatoblastoma in children:a report from the Chinese Children's Cancer Group

Background This study aimed to identify survival risk factors in Chinese children with hepatoblastoma(HB)and assess the effectiveness of the new treatment protocol proposed by the Chinese Children's Cancer Group(CCCG)in 2016.Methods A multicenter,prospective study that included 399 patients with HB from January 2015 to June 2020 was con-ducted.Patient demographics,treatment protocols,and other related information were collected.Cox regression models and Kaplan-Meier curve methods were used.Results The 4-year event-free survival(EFS)and overall survival(OS)were 76.9 and 93.5%,respectively.The 4-year EFS rates for the very-low-risk,low-risk,intermediate-risk,and high-risk groups were 100%,91.6%,81.7%,and 51.0%,respec-tively.The 4-year 0S was 100%,97.3%,94.4%,and 86.8%,respectively.Cox regression analysis found that age,tumor rupture(R+),and extrahepatic tumor extension(E+)were independent prognostic factors.A total of 299 patients had complete remission,and 19 relapsed.Patients with declining alpha-fetoprotein(AFP)>75%after the first two cycles of neoadjuvant chemotherapy had a better EFS and OS than those≤75%.Conclusions The survival outcome of HB children has dramatically improved since the implementation of CCCG-HB-2016 therapy.Age≥8 years,R+,and E+were independent risk factors for prognosis.Patients with a declining AFP>75%after the first two cycles of neoadjuvant chemotherapy had better EFS and OS.

Male reproductive function before and after the adjustment of the COVID-19 prevention policy:a multicenter study in China

At the end of 2022,the adjustment of the coronavirus disease 2019(COVID-19)pandemic control policy in China resulted in alarge-scale increase in public infection.To compare the fertility parameters of male patients before and after the adjustments ofthe COVID-19 pandemic control policy in China,we collected data on patients’medical histories and laboratory examinations ontheir first visits between June 2022 and March 2023 in five different hospitals.Data were divided into five groups according tothe timeline of the policy adjustment.The data we collected from male patients included semen quality and serum reproductivehormone levels,and intergroup comparisons were made using the Mann–Whitney U and Chi-square tests.In total,16784 casesunderwent regular semen analysis,11180 had sperm morphology assessments,and 7200 had reproductive hormone analyses.Thedata showed declining trends in semen volume,sperm motility,and the progressive sperm motility rate after the policy adjustment.Subgroup comparison revealed an initial decrease and gradual recovery in progressive motility rate.Sperm morphology analysisshowed increased neck and tail abnormalities after the policy adjustment.No significant change in hormone levels was observed.Following the adjustment of the COVID-19 prevention policy in China,a decline in sperm motility and morphology was observed.This trend may gradually recover over 2 months.After the policy adjustment,reproductive hormone levels were relatively stablethroughout,except for an increase in luteinizing hormone(LH).These changes in semen parameters suggest that the policyadjustment had a short-to medium-term impact on male reproductive function.

Hybrid argon plasma coagulation for the treatment of Barrett’s esophagus:A prospective,multicenter study

BACKGROUND The incidence of Barrett’s esophagus(BE)in China is lower compared to the Western populations.Hence,studies conducted in the Chinese population has been limited.The current treatment options available for BE treatment includes argon plasma coagulation(APC),radiofrequency ablation and cryoablation,all with varying degrees of success.AIM To determine the efficacy and safety of HybridAPC in the treatment of BE.METHODS The study cohort consisted of patients with BE who underwent HybridAPC ablation treatment.These procedures were performed by seven endoscopists from different tertiary hospitals.The duration of the procedure,curative rate,complications and recurrent rate by 1-year follow-up were recorded.RESULTS Eighty individuals were enrolled for treatment from July 2017 to June 2020,comprising of 39 males and 41 females with a median age of 54 years(range,30 to 83 years).The technical success rate of HybridAPC was 100%and the overall curative rate was 98.15%.No severe complications occurred during the operation.BE cases were classified as short-segment BE and long-segment BE.Patients with short-segment BE were all considered cured without complications.Thirty-six patients completed the one-year follow-up without recurrence.Twenty-four percent had mild dysplasia which were all resolved with one post-procedural treatment.The mean duration of the procedure was 10.94±6.52 min.CONCLUSION Treatment of BE with HybridAPC was found to be a simple and quick procedure that is safe and effective during the short-term follow-up,especially in cases of short-segment BE.This technique could be considered as a feasible alternative ablation therapy for BE.

A multicenter study of the clinicopathological characteristics and a risk prediction model of early-stage breast cancer with hormone receptor-positive/human epidermal growth factor receptor 2-low expression

Background:In light of the significant clinical benefits of antibody-drug conjugates in clinical trials,the human epidermal growth factor receptor 2(HER2)-low category in breast cancers has gained increasing attention.Therefore,we studied the clinicopathological characteristics of Chinese patients with hormone receptor(HR)-positive/HER2-low early-stage breast cancer and developed a recurrence risk prediction model.Methods:Female patients with HR-positive/HER2-low early-stage breast cancer treated in 29 hospitals of the Chinese Society of Breast Surgery(CSBrS)from Jan 2015 to Dec 2016 were enrolled.Their clinicopathological data and prognostic information were collected,and machine learning methods were used to analyze the prognostic factors.Results:In total,25,096 patients were diagnosed with breast cancer in 29 hospitals of CSBrS from Jan 2015 to Dec 2016,and clinicopathological data for 6486 patients with HER2-low early-stage breast cancer were collected.Among them,5629 patients(86.79%)were HR-positive.The median follow-up time was 57 months(4,76 months);the 5-year disease-free survival(DFS)rate was 92.7%,and the 5-year overall survival(OS)rate was 97.7%.In total,412 cases(7.31%)of metastasis were observed,and 124(2.20%)patients died.Multivariate Cox regression analysis revealed that T stage,N stage,lymphovascular thrombosis,Ki-67 index,and prognostic stage were associated with recurrence and metastasis(P<0.05).A recurrence risk prediction model was established using the random forest method and exhibited a sensitivity of 81.1%,specificity of 71.7%,positive predictive value of 74.1%,and negative predictive value of 79.2%.Conclusion:Most of patients with HER2-low early-stage breast cancer were HR-positive,and patients had favorable outcome;tumor N stage,lymphovascular thrombosis,Ki-67 index,and tumor prognostic stage were prognostic factors.The HR-positive/HER2-low early-stage breast cancer recurrence prediction model established based on the random forest method has a good reference value for predicting 5-year recurrence events.Registritation:ChiCTR.org.cn,ChiCTR2100046766.