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.

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.

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.

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.

Prevalence of clonorchiasis in patients with gastrointestinal disease: A Korean nationwide multicenter survey

AIM: To investigate prevalence of Clonorchis sinensis in patients with gastrointestinal symptoms, and the relation of the infection to hepatobiliary diseases in 26 hospitals in Korea.METHODS: Consecutive patients who had been admitted to the Division of Gastroenterology with gastrointestinal symptoms were enrolled from March to April 2005. Of those who had been diagnosed with clonorchiasis, epidemiology and correlation between infection and hepatobiliary diseases were surveyed by questionnaire.RESULTS: Of 3080 patients with gastrointestinal diseases, 396 (12.9%) had clonorchiasis and 1140 patients (37.2%) had a history of eating raw freshwater fish. Of those with a history of raw freshwater fish ingestion, 238 (20.9%) patients had clonorchiasis. Cholangiocarcinoma was more prevalent in C. sinensis-infected patients than non-infected patients [34/396 (8.6%) vs 145/2684 (5.4%), P = 0.015]. Cholangiocarcinoma and clonorchiasis showed statistically significant positive cross-relation (P = 0.008). Choledocholithiasis, cholecystolithiasis, cholangitis, hepatocellular carcinoma, and biliary pancreatitis did not correlate with clonorchiasis.CONCLUSION: Infection rate of clonorchiasis was still high in patients with gastrointestinal diseases in Korea, and has not decreased very much during the last two decades. Cholangiocarcinoma was related to clonorchiasis, which suggested an etiological role for the parasite.

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.

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.

2019—2020年160例儿童肺炎链球菌脑膜炎临床流行病学多中心研究

目的研究中国儿童肺炎链球菌脑膜炎(pneumococcal meningitis,PM)的临床特征、转归和分离菌株肺炎链球菌(Streptococcus pneumoniae,SP)的药物敏感性。方法回顾性分析2019年1月—2020年12月全国33家三级甲等医院160例<15岁的PM住院患儿的临床信息、实验室资料和微生物学资料。结果160例PM患儿中,男103例,女57例;年龄15 d至15岁,其中3月龄至<3岁109例(68.1%)。脑脊液培养分离SP菌株95例(59.4%),血培养分离SP菌株57例(35.6%)。脑脊液宏基因组二代测序和脑脊液SP抗原检测阳性率分别为40%(35/87)、27%(21/78)。55例(34.4%)患儿存在1个或多个化脓性脑膜炎高危因素;113例(70.6%)患儿有1个或多个颅外感染病灶;18例(11.3%)有明确基础疾病。临床症状以发热最常见(147例,91.9%),其次是精神萎靡(98例,61.3%)、呕吐(61例,38.1%)等。69例(43.1%)患儿住院期间发生颅内并发症,常见并发症为硬膜下积液和/或积脓(43例,26.9%)、脑积水(24例,15.0%)、脑脓肿(23例,14.4%)、脑出血(8例,5.0%)。硬膜下积液和/或积脓和脑积水主要发生在<1岁患儿,分别为91%(39/43)、83%(20/24)。SP菌株对万古霉素(100%,75/75)、利奈唑胺(100%,56/56)、厄他培南(100%,6/6)完全敏感;对左氧氟沙星(81%,22/27)、莫西沙星(82%,14/17)、利福平(96%,25/26)和氯霉素(91%,21/23)敏感率高;对青霉素(16%,11/68)、克林霉素(6%,1/17)敏感率低;对红霉素完全耐药(100%,31/31)。痊愈和好转出院率分别为22.5%(36/160)、66.2%(106/160);18例(11.3%)出现不良结局。结论儿童PM多见于3月龄至<3岁婴幼儿,颅内并发症多发生在<1岁患儿,发热是PM患儿最常见的临床表现,硬膜下积液和/或积脓、脑积水是最常见的并发症。脑脊液非培养检测方法有助于提高病原菌检出率。超过10%PM患儿出现不良结局。SP菌株对万古霉素、利奈唑胺、厄他培南、左氧氟沙星、莫西沙星、利福平、氯霉素敏感率高。

2014-2023年国内外小儿骨科多中心研究的文献计量学分析

目的使用文献计量学方法分析国内外小儿骨科多中心研究论文发表的现状及热点。方法检索中国知网(China National Knowledge Infrastructure,CNKI)、万方医学网、维普数据库和Web of Science(WOS)中的小儿骨科多中心研究相关中文及外文文献,检索时限为2014年1月1日至2023年12月30日。采用Microsoft Excel和CiteSpace进行数据处理,对纳入文献的时间分布、期刊分布、机构分布、国家分布以及关键词等进行统计及可视化分析。结果共纳入文献846篇,其中外文文献716篇、中文文献130篇;美国发文量最高(387篇)。《中华小儿外科杂志》(15篇)和Journal of Pediatric Orthopaedics(119篇)分别是国内、国外刊登小儿骨科多中心研究论文最多的期刊。中文文献关键词主要被聚类为"儿童""外科手术""超声检查""三维成像""内固定器"5个簇;外文文献关键词主要聚类为developmental dysplasia of the hip,natural history,adult spinal deformity,avascular necrosis等13个关键词簇。关键词突现分析表明,当前国内研究的热点在于治疗结果、危险因素、超声检查等方面,国外研究的热点在于早发性脊柱侧凸、诊断、骨病学等方面。结论小儿骨科多中心研究近10年来主要关注点在于手术治疗、特殊疾病、预后结局和诊断等方面,美国在该领域发文最多,中国小儿骨科多中心研究逐渐获得国际认可,未来应继续加强多层次、全方位的科研合作,进一步提高小儿骨科多中心研究的质量。

雄关漫道真如铁 而今迈步从头越——中国儿童骨科临床多中心研究参与体会

中国儿童骨科多中心研究协作组(Chinese Multicenter Pediatric Orthopedic Study Group,CMPOS)作为国内第一个以儿童骨科临床多中心研究为特色的学术组织,自2013年成立以来,致力于推动多中心研究在中国的开展。经过10年的耕耘,不仅在各成员单位内完成了从临床研究理论培训、病例资料收集整理的均质化建设,到青年医师科研思维及人才梯队培养,还取得了在The New England Journal of Medicine等国际知名学术期刊发表多篇中国儿童骨科多中心临床研究论文的成绩。本文旨在回顾该学术组织近10年的发展历程,将该组织探索并实践的儿童骨科多中心临床研究之路分享给读者,以资借鉴。

耳穴压丸联合耳穴揿针疗法治疗儿童青少年近视的多中心随机对照研究

目的 观察耳穴压丸联合耳穴揿针疗法对儿童青少年近视的临床疗效和安全性。方法 纳入2021年7月—2022年10月中国中医科学院眼科医院等6家医院诊治的低度近视和近视前期患儿156例(156只眼),随机分为试验组和对照组,每组78例(78只眼)。对照组予健康宣教+足矫配镜(近视前期患儿只予健康宣教);试验组在对照组的基础上联合耳穴压丸+耳穴揿针治疗。分别于治疗前、治疗后6周、12周和24周检测受试者的裸眼远视力(UCDVA)、等效球镜度(SE)、眼轴(AL)和全身症状评分,并进行统计分析。结果 2组患儿治疗前的UCDVA、SE、AL和全身症状评分比较,差异均无统计学意义(P>0.05)。(1)UCDVA:治疗前后比较,试验组各时间节点UCDVA较治疗前比较,差异均无统计学意义(P>0.05)。对照组治疗后12周和24周UCDVA均较治疗前降低,差异均有与统计学意义(Z12_(周)=3.495,Z24_(周)=3.950,均P=0.000)。2组间比较,试验组治疗后6周、12周和24周UCDVA均高于对照组,差异均有统计学意义(Z6_(周)=2.655,P=0.008;Z12_(周)=3.441,P=0.001;Z24_(周)=2.933,P=0.003)。(2)SE:治疗前后比较,试验组治疗后12周和24周SE均较治疗前升高,差异均有统计学意义(t12_(周)=2.349,P=0.020;t24_(周)=3.643,P=0.000)。对照组治疗后各时间节点SE均较治疗前升高,差异均有统计学意义(t6_(周)=5.861、t12_(周)=7.640、t24_(周)=9.845,均P=0.000)。2组间比较,试验组治疗后6周、12周和24周SE均低于对照组,差异均有统计学意义(t6_(周)=3.392,P=0.001;t12_(周)=3.468,P=0.001;t24_(周)=3.968,P=0.000)。2组治疗后24周与治疗前的SE差值比较,差异有统计学意义(t=4.529,P=0.000)。(3)AL:2组AL治疗后各时间节点与治疗前的比较及组间比较,差异均无统计学意义(P>0.05)。2组间差值比较,试验组治疗后24周与治疗前的AL差值低于对照组,差异有统计学意义(t=2.035,P=0.044)。(4)全身症状评分:治疗前后比较,试验组治疗后6周、12周和24周全身症状评分均较治疗前降低,差异均有统计学意义(Z6_(周)=5.358、Z12_(周)=5.690、Z24_(周)=5.886,均P=0.000)。对照组治疗后6周、12周全身症状评分均较治疗前降低,差异均有统计学意义(Z6_(周)=4.411, P=0.000;Z12_(周)=3.259, P=0.001)。2组间比较,试验组治疗后12周和24周的全身症状评分均低于对照组,差异均有统计学意义(Z12_(周)=1.999, P=0.046;Z24_(周)=3.093, P=0.002)。(5)不良反应及依从性:2组均无不良反应发生;2组依从性比较,差异无统计学意义(P>0.05)。结论耳穴压丸联合耳穴揿针疗法具有防控儿童青少年近视进展作用,能够控制屈光度增加、延缓眼轴增长度、稳定视力、改善全身症状体征,安全性高,依从性好,值得推广应用。

慢性阻塞性肺疾病患者睡眠质量和焦虑抑郁情况及其影响因素:一项多中心横断面研究

背景慢性阻塞性肺疾病(以下简称慢阻肺)易使患者睡眠质量下降,并产生焦虑抑郁症状,但常被医护人员和患者自身忽视。了解慢阻肺患者睡眠质量和焦虑抑郁情况及其影响因素,有助于提高患者的生活质量,但相关多中心研究尚少。目的调查慢阻肺患者的睡眠质量和焦虑、抑郁情况,并探究其影响因素。方法采用方便抽样,对2022年8—11月在安徽省7家医院呼吸与危重症医学科就诊的慢阻肺患者进行招募,收集患者的人口学特征、呼吸困难等级、气流受限严重程度、营养不良风险、身体活动水平、疫苗接种和近1年急性加重情况。分别采用匹兹堡睡眠质量指数(PSQI)和医院焦虑抑郁量表(HADS)评估慢阻肺患者的睡眠质量和焦虑抑郁症状,并采用多因素Logistic回归分析其影响因素。结果共调查慢阻肺患者248例,其中睡眠质量差的发生率为60.9%(151/248),仅8.9%(22/248)的患者认为自己有很好的睡眠质量,一半以上的患者实际睡眠时间不足(54.4%)或睡眠效率低(60.1%);29.4%(73/248)的慢阻肺患者至少存在焦虑或抑郁其中一种症状,其中35例存在焦虑症状,61例存在抑郁症状,23例同时存在焦虑和抑郁两种症状。多因素Logistic回归分析结果显示,年龄大(OR=1.052,95%CI=1.018~1.086)、有营养不良风险(OR=3.393,95%CI=1.855~6.206)是慢阻肺患者睡眠质量差的危险因素,有规律的身体活动是慢阻肺患者睡眠质量差的保护因素(OR=0.450,95%CI=0.242~0.834)(P<0.05)。近1年急性加重次数≥2次(OR=2.220,95%CI=1.093~4.510)、有营养不良风险(OR=1.961,95%CI=1.044~3.683)是慢阻肺患者发生焦虑抑郁症状的危险因素(P<0.04)。慢阻肺患者PSQI评分与焦虑症状得分(HADS-A)(r_(s)=0.413)、抑郁症状得分(HADS-D)(r_(s)=0.430)存在正相关关系,HADS-A评分和HADS-D评分存在正相关关系(r_(s)=0.719,P<0.05)。结论慢阻肺患者中睡眠质量差和焦虑抑郁症状的发生率较高,年龄、营养不良风险、规律的身体活动和近1年急性加重次数是重要的影响因素。医护人员、家属和患者自身应提高对睡眠质量和焦虑抑郁的认识,对重点患者积极开展筛查和干预工作,以改善患者的睡眠质量和心理健康。