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.

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.

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.

Development and Validation of an Automatic Ultrawide-Field Fundus Imaging Enhancement System for Facilitating Clinical Diagnosis:A Cross-Sectional Multicenter Study

In ophthalmology,the quality of fundus images is critical for accurate diagnosis,both in clinical practice and in artificial intelligence(AI)-assisted diagnostics.Despite the broad view provided by ultrawide-field(UWF)imaging,pseudocolor images may conceal critical lesions necessary for precise diagnosis.To address this,we introduce UWF-Net,a sophisticated image enhancement algorithm that takes disease characteristics into consideration.Using the Fudan University ultra-wide-field image(FDUWI)dataset,which includes 11294 Optos pseudocolor and 2415 Zeiss true-color UWF images,each of which is rigorously annotated,UWF-Net combines global style modeling with feature-level lesion enhancement.Pathological consistency loss is also applied to maintain fundus feature integrity,significantly improving image quality.Quantitative and qualitative evaluations demonstrated that UWF-Net outperforms existing methods such as contrast limited adaptive histogram equalization(CLAHE)and structure and illumination constrained generative adversarial network(StillGAN),delivering superior retinal image quality,higher quality scores,and preserved feature details after enhancement.In disease classification tasks,images enhanced by UWF-Net showed notable improvements when processed with existing classification systems over those enhanced by StillGAN,demonstrating a 4.62%increase in sensitivity(SEN)and a 3.97%increase in accuracy(ACC).In a multicenter clinical setting,UWF-Net-enhanced images were preferred by ophthalmologic technicians and doctors,and yielded a significant reduction in diagnostic time((13.17±8.40)s for UWF-Net enhanced images vs(19.54±12.40)s for original images)and an increase in diagnostic accuracy(87.71%for UWF-Net enhanced images vs 80.40%for original images).Our research verifies that UWF-Net markedly improves the quality of UWF imaging,facilitating better clinical outcomes and more reliable AI-assisted disease classification.The clinical integration of UWF-Net holds great promise for enhancing diagnostic processes and patient care in ophthalmology.

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.

Peanut consumption and reduced risk of colorectal cancer in women:A prospective study in Taiwan

AIM： To examine whether peanut consumption is associated with a reduced risk of colorectal cancer in a prospective cohort with a 10-year follow-up. METHODS： In 1990-1992, residents （12026 men and 11917 women aged 30 to 65 years） in 7 townships, Taiwan, were interviewed and recruited into a cancerscreening cohort and annually followed up. Colorectal cancer cases in this cohort were identified from cancer registry and death certificates. Incidence rates of this disease by the end of 2001 were calculated by gender for the primary study variable and covariates. The dietary intake was assessed by means of weekly food frequency measures, including frequently consumed food groups and folk dishes including sweet potato, bean products, peanut products, pickled foodstuffs, nitrated or smoked foodstuffs. RESULTS： During the study period, 107 new colorectal cancer cases （68 men and 39 women） were confirmed. The multivariate Cox＇s proportional hazard model showed that the relative risk （RR） of peanut consumption was 0.73 [95% confidence interval （CI） = 0.44-1.21] for men and 0.42 （95% CI = 0.21-0.84） for women. However, frequent intake of pickled foodstuffs was harmful for women （RR= 2.15, 95% CI=0.99-4.65）. The risk of colorectal cancer was also elevated among cigarette smokers but not significant （P〈 0.05）.CONCLUSION： This study suggests that frequent intake of peanut and its products may reduce colorectal cancer risk in women, demonstrating the anti-proliferating effect of peanut intake.

Combined Effects of Family History of Cardiovascular Disease and Serum C-reactive Protein Level on the Risk of Stroke: A 9.2-year Prospective Study among Mongolians in China

Objective We aimed to evaluate the combined effect of a family history of cardiovascular disease（CVD） and high serum C‐reactive protein（CRP） on the stroke incidence in an Inner Mongolian population in China. Methods A prospective cohort study was conducted from June 2002 to July 2012, with 2,544 participants aged 20 years and over from Inner Mongolia, China. We categorized participants into four groups based on the family history of CVD and CRP levels. Results We adjusted for age; sex; smoking; drinking; hypertension; body mass index; waist circumference; and blood glucose, triglycerides, low‐density lipoprotein cholesterol, and high‐density lipoprotein cholesterol levels. Compared with the group with no family history of CVD/low CRP levels, the group with family history of CVD/high CRP levels had a hazard ratio（HR） of 1.78 [95% confidence interval（CI）, 1.03‐3.07; P = 0.039] of stroke, and an HR of 2.14（95% CI, 1.09‐4.20; P = 0.027） of ischemic stroke. The HRs of hemorrhagic stroke for the other three groups were not statistically significant（all P 〉 0.05）. Conclusion Participants with both a family history of CVD and high CRP levels had the highest stroke incidence, suggesting that high CRP levels may increase stroke risk, especially of ischemic stroke, among individuals with a family history of CVD.

Quality of life after colorectal surgery:A prospective study of patients compared with their spouses

BACKGROUND Although radical surgery for colorectal cancer improves the oncological outcomes,a significant portion of patients suffer from alterations in their quality of life(QoL).There are many studies investigating the QoL of patients who have colorectal cancer but none of these focus on the QoL of spouses.AIM To compare the QoL of patients after colorectal surgery to the QoL of spouses.METHODS This prospective study consisted of patients who were married and who underwent surgery at the University of Ankara,Department of Surgery between March 2006 and November 2010.Patients’spouses were also enrolled.The study was approved by the Ethics Committee of the Faculty of Medicine,Ankara University,and all patients provided written informed consent.The study included patients who underwent curative surgery for colorectal carcinoma[n=100;abdominoperineal excision(n=33),low anterior resection(n=33),left hemicolectomy(n=34)]and their spouses(n=100).The patients and spouses completed the Medical Outcome Study 36-item Short Form Survey(SF-36)and the World Health Organization Disability Assessment Schedule II(WHODAS-II)preoperatively and at postoperative months 15 to 18.RESULTS During this 4.5-year study period,273 patients with sigmoid or rectal cancer were admitted to the hospital.Of these patients,119 were eligible and willing to participate.Eleven patients had either systemic or locally inoperable disease,three patients had a severe surgical complication,and five patients were lost to followup.Therefore,a total of 100 patients completed the follow-up period.There was a statistically significant positive correlation between the disability scores of patients and the scores of their spouses for some of the WHODAS-II subscales,such as“self-care,”“life activities,”and“participation in society,”as well as for the total WHODAS-II score.There was also a positive correlation between the QoL of patients and the QoL of their spouses in most of the SF-36 subscales.Statistically significant correlations were observed for the“bodily pain,”“general health,””vitality,”“social function,”“emotion,”“mental health,”and mental component summary score subscales of the SF-36.When gender differences were evaluated,the QoL of male patients’spouses changed more when compared with female patients’spouses for all of the WHODAS-II subscales.Colorectal cancer surgery has a significant effect on the QoL of both patients and their spouses,these effects were more significant among male patients’spouses.CONCLUSION Preoperative counseling regarding potential problems should therefore collectively address patient and their spouse as a couple rather than the patient alone,particularly for patients undergoing low anterior resection and abdominoperineal resection procedures.

A PROSPECTIVE STUDY TO EVALUATE THE SAFETY AND EFFICACY USING REMOVING BLOOD STASIS HERBALS FOR PATIENTS WITH INTRACRANIAL HEMORRHAGE OF HYPERACUTE STAGE AND RELATIVE FACTORS OF HEMATOMA ENLARGEMENT(A MULTICENTER PROSPECTIVE RANDOMIZED DOUBLE-BLIND PLACEBO

The aim was to investigate whether using a removing blood stasis method in hyperacute intracranial hemorrhage stage can lead to hematoma enlargement and its clinical efficacy.A multicenter retrospective randomized double-blind placebo-controlled clinical study.We recruited patients aged 18 years or older and presenting at less than 6 h from symptom onset in 8 research centers.All the patients

Characteristics and Risk factors of Psychosomatic Symptoms Related to Female Tubal Sterilization in Rural Area in Hunan Province, China: A Prospective Study

Objectives To study characteristics of psychosomatic symptoms related to sterilization, to find out risk factors and their roles ascribed to psychosomatic symptoms, and to establish a mathematic model for screening out susceptible women. Methods: This study enrolled 776 women in rural area at three counties of Linxiang, Qiyang, Changsha of Hunan province in China between February 1990 and April 1992. Brief Neurosis Screening Scale (BNSS), Symptom Checklist 90 (SCL-90), sensitivity to pain, suggestibility were used to indicate subjects' psychological status. Logistic regression model and retrograde discriminant analysis were applied to develop a mathematical model. Results: Prevalence of psychosomatic reactions or symptoms was 54.8% before sterilization, 26.6% at three months and 16.4% at one year after operation respectively. Psychosomatic symptoms were verified to be the result of joint effects of multiple risk factors. The following risk factors were associated with postoperative symptoms: anger-hostility (RR=33.71), high suggestibility (RR=4.53), high neuroticism (RR=3.44), sensitivity to pain (RR=2.14) and operative sites (RR=2.05). A mathematical model to estimate the probability of developing psychosomatic symptoms in sterilization was established.Conclusions: More than half of women suffered from psychosomatic reactions before operation, and some of them did not recover after operation. The postoperative psychosomatic symptoms are the joint effect of multiple risk factors.

Arthroscopic findings after manipulation under anesthesia in idiopathic capsulitis of the shoulder:A prospective study

BACKGROUND Manipulation under anesthesia(MUA)of the shoulder joint is a commonly used method for the treatment of adhesive capsulitis.Though it has been known to be associated with a variety of complications,there is a paucity of studies describing the arthroscopic findings after MUA.AIM To describe the arthroscopic findings in patients with idiopathic adhesive capsulitis of the shoulder after MUA.METHODS We recruited 28 patients with idiopathic adhesive capsulitis who underwent arthroscopic capsular release.Manipulation of the shoulder was performed under anesthesia in all of these patients before capsular release.Intra-articular findings were recorded during arthroscopic capsular release in these patients.RESULTS All patients showed the presence of synovitis.Twenty-seven patients showed tears in the capsule on the anterior aspect.One patient had an avulsion of the anterior rim of the glenoid and labrum following the manipulation.Four patients had partial rotator cuff tears,and one patient showed a superior labrum anterior posterior lesion,which was not diagnosed preoperatively on magnetic resonance imaging.CONCLUSION MUA leads to rupture of the capsule,which is the desired outcome.However,the site of rupture of the capsule is dependent on the maneuvers of MUA.In addition,partial tears of the rotator cuff and osteochondral fractures of the glenoid can also occur.

Effect of Tongluo Shenggu Prescription on ARCO Stage Ⅱ non-traumatic femoral head necrosis: A prospective study

Objective:To observe the clinical results and therapeutic characteristics of Tongluo Shenggu Decoction in the treatment of ARCOⅡnon-traumatic femoral head necrosis.Methods:120 patients with ARCOⅡnon-traumatic femoral head necrosis from January 2016 to January 2017 were studied by prospective matched and controlled design.60 cases in the treatment group were treated with Tongluo Shenggu Formula.The control group(60 cases)received high energy extracorporeal shock wave therapy.The imaging stability rate,Harris score and SF-36 score were used as clinical efficacy indicators,followed up for 24 months,and the follow-up results were statistically analyzed.Results:Among the 120 patients,5 fell off and the rest were followed up.The imaging stability rate is heavy.The imaging stability rate of the patients in the treatment group is 78.95%,while that in the control group is 72.41%.The two groups have the same stability rate(P>0.05).In Harris score,the Harris score of the patients in the treatment group was 92.678.45 points,significantly higher than that of the control group(80.3924.65 points),the difference was statistically significant(p<0.05),and the pain degree,joint function and joint deformity score of the treatment group were better than those of the control group(p<0.05).In the SF-36 score,the scores of physiological function,physiological function,physical pain,overall health,social function and emotional function in the treatment group were significantly higher than those in the control group,the difference was statistically significant(p<0.05).the incidence of adverse events in the treatment period of the two groups was lower and the patients could relieve themselves in the later stage.Conclusion:Tongluo Shenggu prescription has definite curative effect in treating ARCOⅡnon-traumatic femoral head necrosis,especially in improving hip joint function,relieving hip joint pain and improving quality of life.To observe the clinical results and therapeutic characteristics of Tongluo Shenggu Decoction in the treatment of ARCOⅡnon-traumatic femoral head necrosis.Methods:120 patients with ARCOⅡnon-traumatic femoral head necrosis from January 2016 to January 2017 were studied by prospective matched and controlled design.60 cases in the treatment group were treated with Tongluo Shenggu Formula.The control group(60 cases)received high energy extracorporeal shock wave therapy.The imaging stability rate,Harris score and SF-36 score were used as clinical efficacy indicators,followed up for 24 months,and the follow-up results were statistically analyzed.Results:Among the 120 patients,5 fell off and the rest were followed up.The imaging stability rate is heavy.The imaging stability rate of the patients in the treatment group is 78.95%,while that in the control group is 72.41%.The two groups have the same stability rate(P>0.05).In Harris score,the Harris score of the patients in the treatment group was 92.678.45 points,significantly higher than that of the control group(80.3924.65 points),the difference was statistically significant(p<0.05),and the pain degree,joint function and joint deformity score of the treatment group were better than those of the control group(p<0.05).In the SF-36 score,the scores of physiological function,physiological function,physical pain,overall health,social function and emotional function in the treatment group were significantly higher than those in the control group,the difference was statistically significant(p<0.05).the incidence of adverse events in the treatment period of the two groups was lower and the patients could relieve themselves in the later stage.Conclusion:Tongluo Shenggu prescription has definite curative effect in treating ARCOⅡnon-traumatic femoral head necrosis,especially in improving hip joint function,relieving hip joint pain and improving quality of life.

A FIVE-YEAR PROSPECTIVE STUDY ON THE RELATIONSHIP BETWEEN GARLIC AND GASTRIC CANCER

A prospective study on the relationship between garlic and gastric cancer of 4552 subjects was made from Oct., 1980 through 1985. The volunteers, aged 50-59, were healthy males and came from different incidence areas of gastric cancer where they lived for long periods. The result of this study showed that the death rates of gastric cancer in < 2500 g and >500 g groups of annual garlic intake were 10.40/ 10000 and 0, respectively. The relative risk of gastric cancer was significantly much higher in the former than in the latter, and showed a dose-response relationship. Protective effect of garlic for the population equal annual garlic intake was roughly the same in different districts. It was further confirmed that garlic played important role in preventing gastric cancer and had no regional differences.

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).

Prevalence of dysmenorrhea in female students in a Chinese university: a prospective study

This study aimed to investigate the prevalence of dysmenorrhea in a prospective approach. Menstruation-related diary data were obtained from 2640 female college students in North Sichuan Medical College;dysmenorrhea and related factors were analyzed. Dysmenorrhea occurred in 56.4% of students;6.5% of dysmenorrheal students suffered from “hard to bear” (unbearable) menstrual pain, and 6.5% had pre-menstrual dysmenorrhea. The more severe dysmenorrhea was, the longer dysmenorrhea lasted, and the longer the duration of menstruation and the larger the amount of menstrual blood flow appeared to be. Dysmenorrhea occurred on 37% of the menstrual dates on average and was unrelated to irregularity of menstrual cycles. The percentages of students taking medicine with mild, moderate and unbearable dysmenorrhea were 4.0%, 13.3% and 23.7%, respectively.

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.