简介：AbstractBackground:As a non-invasive and effective diagnostic method for small intestinal bacterial overgrowth (SIBO), wild-use of breath test (BT) has demonstrated a high comorbidity rate in patients with diarrhea-predominant irritable bowel syndrome (IBS-D) and SIBO. Patients overlapping with SIBO respond better to rifaximin therapy than those with IBS-D only. Gut microbiota plays a critical role in both of these two diseases. We aimed to determine the microbial difference between IBS-D overlapping with/without SIBO, and to study the underlying mechanism of its sensitivity to rifaximin.Methods:Patients with IBS-D were categorized as BT-negative (IBSN) and BT-positive (IBSP). Healthy volunteers (BT-negative) were enrolled as healthy control. The patients were clinically evaluated before and after rifaximin treatment (0.4 g bid, 4 weeks). Blood, intestine, and stool samples were collected for cytokine assessment and gut microbial analyses.Results:Clinical complaints and microbial abundance were significantly higher in IBSP than in IBSN. In contrast, severe systemic inflammation and more active bacterial invasion function that were associated with enrichment of opportunistic pathogens were seen in IBSN. The symptoms of IBSP patients were relieved in different degrees after therapy, but the symptoms of IBSN rarely changed. We also found that the presence of IBSN-enriched genera (Enterobacter and Enterococcus) are unaffected by rifaximin therapy.Conclusions:IBS-D patients overlapping with SIBO showed noticeably different fecal microbial composition and function compared with IBS-D only. The better response to rifaximin in those comorbid patients might associate with their different gut microbiota, which suggests that BT is necessary before IBS-D diagnosis and use of rifaximin.Registration:Chinese Clinical Trial Registry, ChiCTR1800017911.

简介：摘要ObjectiveTo evaluate the effectiveness of radial extracorporeal shock wave therapy on ankle flexor spasticity in stroke survivors and to reveal changes in the fibroelastic components of muscle.DesignRandomized controlled trial.SettingInpatient neuro-rehabilitation clinic of a university hospital.ParticipantsStroke patients with ankle flexor spasticity.InterventionsPatients were randomized to three groups; radial extracorporeal shock wave therapy, sham, or control. Active and sham therapy were administered two sessions/week for two weeks. All patients received conventional rehabilitation.Main measuresThe primary outcome was Modified Ashworth Scale. Secondary outcomes were the Tardieu Scale and elastic properties of plantar flexor muscles assessed by elastography (strain index). All assessments were performed before, immediately after the treatment, and four weeks later at follow-up.ResultsFifty-one participants were enrolled (active therapy n＝17, sham n＝17, control n＝17). Modified Ashworth scores showed a significant decrease in the active therapy group (from 2.47±0.72 to 1.41±0.62) compared to sham (from 2.19±1.05 to 2.06±1.12) and control (from 2.06±0.85 to 2.00±0.73) groups immediately after the treatment (P<0.001). Tardieu results were also in concordance (P<0.001), however this effect was not preserved at follow-up. Elastic properties of the ankle flexors were improved in all groups at both assessments after the therapy showing significant decreases in strain index (P<0.001). However, there was no difference among the groups in terms of improvement in elastography.ConclusionRadial extracorporeal shock wave therapy has short-term anti-spastic effects on ankle flexor muscles when used as an adjunct to conventional rehabilitation.

简介：AbstractImportance:Dexmedetomidine inhibits the inflammatory response associated with cardiopulmonary bypass (CPB) and protects neural function. However, the mechanism of dexmedetomidine’s anti-inflammatory pathway is unclear.Objective:To investigate the effect of dexmedetomidine on the cognitive level and expression of inflammatory factors in children with congenital heart disease undergoing intraoperative CPB.Methods:Ninety children with congenital heart disease were recruited and randomly divided into 3 groups of 30 children in each. In Group 1, a 1.0 µg·kg-1·h-1 intravenous bolus of dexmedetomidine was administered 10 minutes after induction of anesthesia, followed by a 0.2 µg·kg-1·h-1 infusion until the surgical incision. In Group 2, a 0.5 µg/kg intravenous bolus of dexmedetomidine was administered 10 minutes after induction of anesthesia, followed by a 0.1 µg·kg-1·h-1 infusion until the surgical incision. The control group was given physiological saline using the same method as in Groups 1 and 2. The serum levels of nuclear factor-kappa B (NF-κB), S-100β protein, neuron-specific enolase (NSE), tumor necrosis factor-α (TNF-α), and interleukin-6 (IL-6) were measured before the surgery (T1), at the end of CPB (T2), 2 hours after CPB (T3), 6 hours after CPB (T4), and 24 hours after CPB (T5). The Wechsler Intelligence Scale for children (WISC) was measured before the operation and at 3, 6, and 12 months after the operation to evaluate the neurodevelopmental state of the children.Results:The levels of the NF-κB, S-100β protein, NSE, TNF-α, IL-6 were significantly higher at T2, T3, or T4 than before the surgery (T1) in the control group or the dexmedetomidine groups. However, the increases of NF-κB, TNF-α, IL-6, S-100β and NSE levels were significantly smaller in the dexmedetomidine groups than those in the control group (P < 0.017). The WISC scores were similar among the three groups before or after the operation.Interpretation:The increases in NF-κB, TNF-α, and IL-6 levels indicated aggravation of the inflammatory reaction and the increase S-100β protein and NSE levels indicated that the nervous system was damaged. Administration of dexmedetomidine to children with congenital heart disease undergoing intraoperative CPB can inhibit the inflammatory response and may ameliorate the neurodevelopmental damage caused by CPB.

简介：AbstractBackground:Norepinephrine infusion decreases hypotension after spinal anesthesia during cesarean section. This study aimed to compare the efficacy of norepinephrine infusion and ephedrine bolus against post-spinal hypotension in parturients.Methods:In this double-blinded, randomized controlled clinical trial, parturients scheduled for elective cesarean section were randomly allocated to receive norepinephrine infusion (0.05 μg·kg-1·min-1) just before spinal anesthesia continuing for 30 min or ephedrine bolus (0.15 mg/kg) just before spinal anesthesia. A rescue bolus (5 μg norepinephrine for the norepinephrine group, and 5 mg ephedrine for the ephedrine group) was administered whenever hypotension occurred. Our primary outcome was the incidence of hypotension within 30 min of spinal anesthesia administration. Secondary outcomes included maternal and neonatal outcomes 30 min after spinal block, and neonatal cerebral oxygenation 10 min after birth.Results:In total, 190 patients were enrolled; of these patients, 177 were included in the final analysis. Fewer patients suffered hypotension in the norepinephrine group than in the ephedrine group (29.5% vs. 44.9%, odds ratio [OR]: 0.51, 95% confidence interval [CI]: 0.28-0.95, P = 0.034). Moreover, the tachycardia frequency was lower in the norepinephrine group than in the ephedrine group (OR: 0.22, 95% CI: 0.11-0.44, P < 0.001), and patients suffered less nausea and vomiting (OR: 0.28, 95% CI: 0.11-0.70, P = 0.004). There was no difference in Apgar scores and umbilical arterial blood gas analysis between the two groups. However, neonatal cerebral regional saturations were significantly higher after birth in the norepinephrine group than in the ephedrine group (mean difference: 2.0%, 95% CI: 0.55%-3.45%, P = 0.008).Conclusion:In patients undergoing elective cesarean section with spinal anesthesia, norepinephrine infusion compared to ephedrine bolus resulted in less hypotension and tachycardia, and exhibited potential neonatal benefits.Trial Registration:ClinicalTrials.gov, NCT02542748; https://clinicaltrials.gov/ct2/show/record/NCT02542748

简介：Acupunctureiswidelyusedtotreatfunctionaldyspepsiawithsatisfactoryoutcomes.CombinationoftheHeandMuacupointsiscommonlyusedandhasasynergisticeffectonfunctionaldyspepsia;however,itsunderlyingmechanismsremainunclear.Therefore,arandomizedcontrolledparallelclinicaltrialiscurrentlyunderwayatChengduUniversityofTraditionalChineseMedicine,China.ThistrialisdesignedtoexploretheefficacyofandcentralresponsestotheHe-Mupointcombinationinpatientswithfunctionaldyspepsiausingfunctionalmagneticresonanceimaging.Atotalof105patientswithfunctionaldyspepsiawillbeallocatedinto3groups:thelow-Hepointgroup(puncturingatZusanli(ST36)),Mupointgroup(puncturingatZhongwan(CV12)),andHe-Mupointcombinationgroup(puncturingatST36andCV12).Everyparticipantwillreceive20sessionsofmanualacupuncturefor4weeks.Theneedleswillbeinsertedperpendicularlytoadepthof1to2cun.Theangleofrotationandtwistingwillrangefrom90to180degrees,whileliftingandthrustingwillrangefrom0.3to0.5cm.Thevariousmanipulationswillbeperformed60to90timesperminute.Theneedleswillremaininplacefor30minutes,duringwhichmanipulationwillbeappliedevery10minutes.Magneticresonanceimagingwillbeperformedbeforeandafter20sessionsofacupuncture.TheprimaryoutcomeissymptomimprovementaccordingtotheChineseversionoftheNepeanDyspepsiaIndex.SecondaryoutcomesincludetheLeedsdyspepsiaquestionnaire,Self-RatingAnxietyScale,Self-RatingDepressionScale,BeckAnxietyInventory,BeckDepressionInventory,andvisualanaloguescalescoresbeforeandafter10and20sessionsofacupuncture.Needlesensationandadverseeventswillbeusedtoassessthetherapeuticeffects.ThisstudywillpromotemorewidespreadawarenessofthebenefitsofacupointcombinationintheclinicalsettingandprovideafurtherexplanationoftheneuromechanismbywhichacupunctureattheHe-Mupointcombinationforfunctio

简介：AbstractObjective:To compare the efficacy of the traditional Chinese medicine SanJieZhenTong (SJZT) capsules versus gonadotropin-releasing hormone analogs (GnRHa) or oral contraceptives (OCs) in the postoperative treatment of moderate-to-severe endometriosis.Methods:In this prospective clinical trial, women with stage III-IV endometriosis according to the revised American Fertility Society scoring system received three doses of GnRHa immediately after laparoscopic conservative surgery, followed by random assignment to receive treatment with SJZT, GnRHa, or OCs for another 6 months. The primary endpoint was 2-year recurrence, and the secondary endpoints were adverse events, changes in physical function, and quality of life (QoL). Recurrence was assessed using Kaplan-Meier curves and log-rank tests. Generalized estimating equations were used to determine the parameters of the secondary endpoints.Results:A total of 66 women were randomly assigned to the SJZT (n = 21), GnRHa (n = 21), and OCs (n = 24) groups. At a median follow-up of 22 months, no difference in recurrence was found (P = 0.72), with one (4.8%), two (9.5%), and one (4.2%) incidence in the SJZT, GnRHa, and OCs groups, respectively. Expectedly, the incidence of side effects such as hot flush, insomnia, and arthralgia in the SJZT and OCs groups was significantly lower than that in the GnRHa group (P = 0.00). In addition, the female sexual function index was significantly improved in the SJZT group, with a higher value than that in the GnRHa (odds ratio [OR] = 5.25, 95% confidence interval [CI]: 2.09-13.14, P = 0.00) and OCs (OR = 3.94, 95% CI: 1.58-9.83, P = 0.00) groups.Conclusions:SJZT showed more effective pain relief and QoL improvement in patients with moderate-to-severe endometriosis than GnRHa or OCs did. Fewer adverse events than those observed with other agents indicate that this alternative medicine, SJZT, could be a novel option for the long-term management of endometriosis.

简介：加在对待腰部的圆盘形成疝(LDH)刺破的指导qi由顶点区别观察acupoint选择的功效。

简介：摘要BACKGROUNDEarly physical rehabilitation in the intensive care unit (ICU) has been shown to improve short-term clinical outcomes but long-term benefit has not been proven and the optimum intensity of rehabilitation is not known.METHODSWe conducted a randomised, parallel-group, allocation- concealed，assessor-blinded, controlled trial in patients who had received at least 48 hours of invasive or non-invasive ventilation. Participants were randomised in a 1∶1 ratio, stratified by admitting ICU, admission type and level of independence. The intervention group had a target of 90 min physical rehabilitation per day, the control group a target of 30 min per day (both Monday to Friday). The primary outcome was the Physical Component Summary (PCS) measure of SF-36 at 6 months.RESULTSWe recruited 308 participants over 34 months: 150 assigned to the intervention and 158 to the control group. The intervention group received a median (IQR) of 161 (67-273) min of physical rehabilitation on ICU compared with 86 (31-139) min in the control group. At 6 months, 62 participants in the intervention group and 54 participants in the control group contributed primary outcome data. In the intervention group, 43 had died, 11 had withdrawn and 34 were lost to follow-up, while in the control group, 56 had died, 5 had withdrawn and 43 were lost to follow-up. There was no difference in the primary outcome at 6 months, mean (SD) PCS 37 (12.2) in the intervention group and 37 (11.3) in the control group.CONCLUSIONSIn this study, ICU-based physical rehabilitation did not appear to improve physical outcomes at 6 months compared with standard physical rehabilitation.

简介：Abducensnervepalsy(ANP)iscommonlyseeninpatientswithdiabetesmellitus.ThevalidityofacupunctureasatraditionalChinesemedicinemethodinperipheralnerverepairiswellestablished.However,itsefficacyinrandomizedcontrolledtrialsremainsunclear.Herein,wedesignedaprotocolforaprospective,single-center,randomizedcontrolledtrialtoinvestigatetheeffectofintraorbitalelectroacupunctureondiabeticANP.Weplantorecruit60patientswithdiabeticANP,andrandomlydividethemintotreatmentandcontrolgroups.Patientsinbothgroupswillcontinuetheirglucose-loweringtherapy.Aneuralnutritiondrugwillbegiventobothgroupsforsixweeks.Thetreatmentgroupwillalsoreceiveintraorbitalelectroacupuncturetherapy.Wewillassessefficacyoftreatment,eyeballmovement,diplopiadeviationandthelevelsoffastingblood-glucoseandglycosylatedhemoglobinbeforetreatmentat2,4,and6weeksaftertreatment.Theefficacyandrecurrencewillbeinvestigatedduringfollow-up(1monthafterintervention).ThisprotocolwasregisteredatChineseClinicalTrialRegistryon16January2015(ChiCTR-IPR-15005836).ThisstudywasapprovedbytheEthicsCommitteeofFirstAffiliatedHospitalofHarbinMedicalUniversityofChina(approvalnumber:201452).AllprotocolswillbeinaccordancewithDeclarationofHelsinki,formulatedbytheWorldMedicalAssociation.Writteninformedconsentwillbeprovidedbyparticipants.WeenvisagethattheresultsofthisclinicaltrialwillprovideevidenceforpromotingclinicaluseofthisnewtherapyformanagementofANP.

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简介：AbstractBackground:Nitinol-containing devices are widely used in clinical practice. However, there are concerns about nickel release after nitinol-containing device implantation. This study aimed to compare the efficacy and safety of a parylene-coated occluder vs. a traditional nitinol-containing device for atrial septal defect (ASD).Methods:One-hundred-and-eight patients with ASD were prospectively enrolled and randomly assigned to either the trial group to receive a parylene-coated occluder (n = 54) or the control group to receive a traditional occluder (n = 54). The plugging success rate at 6 months after device implantation and the pre- and post-implantation serum nickel levels were compared between the two groups. A non-inferiority design was used to prove that the therapeutic effect of the parylene-coated device was non-inferior to that of the traditional device. The Cochran-Mantel-Haenszel chi-squared test with adjustment for central effects was used for the comparison between groups.Results:At 6 months after implantation, successful ASD closure was achieved in 52 of 53 patients (98.11%) in both the trial and control groups (95% confidence interval (CI): [-4.90, 5.16]) based on per-protocol set analysis. The absolute value of the lower limit of the 95% CI was 4.90%, which was less than the specified non-inferiority margin of 8%. No deaths or severe complications occurred during 6 months of follow-up. The serum nickel levels were significantly increased at 2 weeks and reached the maximum value at 1 month after implantation in the control group (P < 0.05 vs. baseline). In the trial group, there was no significant difference in the serum nickel level before vs. after device implantation (P > 0.05).Conclusions:The efficacy of a parylene-coated ASD occluder is non-inferior to that of a traditional uncoated ASD occluder. The parylene-coated occluder prevents nickel release after device implantation and may be an alternative for ASD, especially in patients with a nickel allergy.

简介：AbstractBackground:Treatment of coronary bifurcation lesions remains challenging; a simple strategy has been preferred as of late, but the disadvantage is ostium stenosis or even occlusion of the side branch (SB). Only a few single-center studies investigating the combination of a drug-eluting stent in the main branch followed by a drug-eluting balloon in the SB have been reported. This prospective, multicenter, randomized study aimed to investigate the safety and efficacy of a paclitaxel-eluting balloon (PEB) compared with regular balloon angioplasty (BA) in the treatment of non-left main coronary artery bifurcation lesions.Methods:Between December 2014 and November 2015, a total of 222 consecutive patients with bifurcation lesions were enrolled in this study at ten Chinese centers. Patients were randomly allocated at a 1:1 ratio to a PEB group (n = 113) and a BA group (n = 109). The primary efficacy endpoint was angiographic target lesion stenosis at 9 months. Secondary efficacy and safety endpoints included target lesion revascularization, target vessel revascularization, target lesion failure, major adverse cardiac and cerebral events (MACCEs), all-cause death, cardiac death, non-fatal myocardial infarction, and thrombosis in target lesions. The main analyses performed in this clinical trial included case shedding analysis, base-value equilibrium analysis, effectiveness analysis, and safety analysis. SAS version 9.4 was used for the statistical analyses.Results:At the 9-month angiographic follow-up, the difference in the primary efficacy endpoint of target lesion stenosis between the PEB (28.7% ± 18.7%) and BA groups (40.0% ± 19.0%) was -11.3% (95% confidence interval: -16.3% to -6.3%, Psuperiority <0.0001) in the intention-to-treat analysis, and similar results were recorded in the per-protocol analysis, demonstrating the superiority of PEB to BA. Late lumen loss was significantly lower in the PEB group than in the BA group (-0.06 ± 0.32 vs. 0.18 ± 0.34 mm, P < 0.0001). For intention-to-treat, there were no significant differences between PEB and BA in the 9-month percentages of MACCEs (0.9% vs. 3.7%, P = 0.16) or non-fatal myocardial infarctions (0 vs. 0.9%, P = 0.49). There were no clinical events of target lesion revascularization, target vessel revascularization, target lesion failure, all-cause death, cardiac death or target lesion thrombosis in either group.Conclusions:In de novo non-left main coronary artery bifurcations treated with provisional T stenting, SB dilation with the PEB group demonstrated better angiographic results than treatment with regular BA at the 9-month follow-up in terms of reduced target lesion stenosis.Trial registration:ClinicalTrials.gov, NCT02325817; https://clinicaltrials.gov

简介：AbstractBackground:The incidence of idiopathic membranous nephropathy (IMN) has recently increased remarkably. Immune dysfunction caused by disordered intestinal flora might be an important factor affecting IMN. The Jian Pi Qu Shi Formula (JPQSF) shows promise in treating IMN. Here, we sequenced 16S rRNA genes to compare intestinal flora between patients with IMN and healthy persons. We also conducted a randomized controlled clinical trial to further compare the intestinal flora of patients with IMN treated with traditional Chinese medicine (TCM) and western medicine (WM).Methods:Among 40 patients with IMN treated at Department of Nephrology in Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine between July 2016 and December 2018, we compared 30 of them with 10 healthy persons (controls). The IMN group was randomly assigned to receive JPQSF (TCM) or immunosuppressant WM therapy in (n = 15 per group) for 6 months. Intestinal microbiota diversity was analyzed using alpha diversity and beta diversity. Intestinal flora that significantly differed between the groups was analyzed using MetaStat. The effects and safety of the therapies were determined based on the values for plasma albumin, 24-h urine protein excretion, serum creatinine, urea nitrogen, estimate glomerular filtration rate (eGFR), complete blood count, and liver enzymes. All data were statistically analyzed using Statistical Package for the Social Sciences (SPSS) 20.0 statistical software.Results:Baseline characteristics did not significantly differ between the IMN and healthy groups, or the TCM and WM groups. After six months of treatment, 24-h urinary protein significantly declined in the TCM and WM groups (before and after treatment: 3.24 ± 1.74 vs. 1.73 ± 1.85 g, P < 0.05 and 3.94 ± 1.05 vs. 1.91 ± 1.18 g, P < 0.05, respectively). Plasma albumin was significantly increased in the TCM group (before vs. after treatment: 32.44 ± 9.04 vs. 39.99 ± 7.03 g/L, P < 0.05), but did not significantly change in the WM group (31.55 ± 4.23 vs. 34.83 ± 9.14 g/L, P > 0.05). Values for urea nitrogen, serum creatinine, and eGFR did not significantly change in either group. The alpha diversity index for intestinal flora differed between the IMN and healthy groups, and the TCM and WM groups. Comparisons of multiple samples (beta diversity) revealed differences in intestinal flora between the IMN and healthy groups, and the TCM and WM groups. The Metastat analysis findings showed that the main genera that differed between the IMN group before treatment and the healthy group were Christensenellaceae_R-7_group, Bifidobacterium (77), Dorea, Escherichia-Shigella, Parabacteroides, Bifidobacterium, and Coprococcus_3. After TCM therapy, the main differential genera were Butyricimonas, Bacteroides, Alistipes, and Lachnospira, and after WM therapy, these were Ruminococcus_2, Lachnospiraceae_ND3007_group, Lachnospira, Bifidobacterium, Alistipes, and [Eubacterium]_ventriosum_group.Conclusion:Patients with IMN might have disordered intestinal flora, and JPQSF can regulate intestinal flora in patients with IMN.

简介：AbstractBackground:Cell salvage has recently been recommended for obstetric use in cases with a high risk of massive hemorrhage during cesarean section (CS). However, limited data are available to support the use of one suction device to collect lost blood. This study aimed to investigate the volume of red blood cells (RBCs) salvaged and the components of amniotic fluid (AF) in blood salvaged by one suction device or two devices during CS in patients with placenta previa and/or accrete.Methods:Thirty patients with placenta previa and/or accrete undergoing elective CS in the Women’s Hospital of Zhejiang University School of Medicine were recruited for the present study from November 1, 2017 to December 1, 2018. The patients were randomly assigned to one of the two groups according to an Excel-generated random number sheet: Group 1 (n = 15), in which only one suction device was used to aspirate all blood and AF, and Group 2 (n = 15), in which a second suction device was mainly used to aspirate AF before the delivery of the placenta. Three samples of blood per patient (pre-wash, post-wash, and post-filtration) were collected to measure AF components. The salvaged RBC volumes were recorded. Continuous data of pre-wash, post-wash, and postfiltration samples were analyzed by using one-way analysis of variance with Tukey’s test for multiple comparisons, or Kruskal-Wallis test with Dunn test for multiple comparisons. Comparisons of continuous data between Group 1 and Group 2 were conducted using Student’s t test or Mann-Whitney U test.Results:The salvaged RBC volume was significantly higher in Group 1 than that in Group 2 (401.6 ± 77.2 mL vs. 330.1 ± 53.3 mL, t = 4.175, P < 0.001). In both groups, squamous cells, lamellar bodies, and fat were significantly reduced by washing (all P<0.001) and squamous cells were further reduced by filtering (P < 0.001). Squamous cells were found in six post-filtration samples (three from each group). Lamellar bodies and fat were completely removed by filtering. Insulin-like growth factor binding protein 1, alphafetoprotein, albumin, lactate dehydrogenase, and potassium were significantly reduced post-wash (all P < 0.05), with no further significant reduction after filtration in either group (all P > 0.05). The mean percentage of fetal RBCs post-filtration was (1.8 ± 0.8)% with a range of 1.0% to 3.5% and (1.9 ± 0.9)% with a range of 0.7% to 4.0% in Groups 1 and 2, respectively, showing no significant difference between the two groups (U= 188.5, P = 0.651).Conclusion:Cell salvage performed by one suction device could result in higher volume of salvaged RBCs and can be used safely for CS in patients with placenta previa and/or accrete when massive hemorrhage occurs.

简介：AbstractBackground:Depression is a common mental illness in childhood and adolescence, with an incidence of 4%-5%; it can lead to impairments in learning and social functioning. Transcutaneous auricular vagus nerve stimulation (taVNS) is a commonly used method of auricular acupuncture point stimulation, which is regarded as an effective treatment for adults with depression. The aim of this study was to investigate the efficacy and mechanism of taVNS for adolescents with mild to moderate depression.Methods:This randomized controlled clinical trial will include 120 patients aged 12-16 years, all of whom are diagnosed with mild to moderate depression. Patients will be randomly assigned to a taVNS group and a drug control group (sertraline hydrochloride) at a ratio of 1:1. Patients will be evaluated using the 17-item Hamilton Depression Scale, Hamilton Anxiety Rating Scale, Self-Rating Depression Scale, Self-Rating Anxiety Scale, and Pittsburgh Sleep Quality Index scores at baseline, as well as at the 2nd, 4th, 6th, 8th, and 12th weeks. To investigate the underlying neural mechanisms of taVNS treatment from the perspective of the default mode network, multimodal magnetic resonance imaging (MRI; i.e., structural MRI [sMRI], resting state MRI [rsMRI], and pseudocontinuous arterial spin-labeled [pcASL] MRI) will be used to compare cerebral images among groups. MRI data will also be collected from 40 healthy volunteers to assess whether the participants exhibit normal development of structural and functional components.Discussion:Depression is the most common mental disorder in adolescence. Drug treatment can improve depression symptoms; however, the side effects of drug treatments are often severe. This study proposes a simple physiotherapy that aims to treat adolescents with mild to moderate depression. The mechanism of taVNS in the treatment of depression will also be investigated. The results of this study will provide evidence to guide the application of taVNS in adolescents with depression.

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简介：AbstractBackground:The calcineurin inhibitor (CNI)-based immune maintenance regimen that is commonly used after renal transplantation has greatly improved early graft survival after transplantation; however, the long-term prognosis of grafts has not been significantly improved. The nephrotoxicity of CNI drugs is one of the main risk factors for the poor long-term prognosis of grafts. Sirolimus (SRL) has been employed as an immunosuppressant in clinical practice for over 20 years and has been found to have no nephrotoxic effects on grafts. Presently, the regimen and timing of SRL application after renal transplantation vary, and clinical data are scarce. Multicenter prospective randomized controlled studies are particularly rare. This study aims to investigate the effects of early conversion to a low-dose CNI combined with SRL on the long-term prognosis of renal transplantation.Methods:Patients who receive four weeks of a standard regimen with CNI + mycophenolic acid (MPA) + glucocorticoid after renal transplantation in multiple transplant centers across China will be included in this study. At week 5, after the operation, patients in the experimental group will receive an additional administration of SRL, a reduction in the CNI drug doses, withdrawal of MPA medication, and maintenance of glucocorticoids. In addition, patients in the control group will receive the maintained standard of care. The patients’ vital signs, routine blood tests, routine urine tests, blood biochemistry, serum creatinine, BK virus (BKV)/cytomegalovirus (CMV), and trough concentrations of CNI drugs and SRL at the baseline and weeks 12, 24, 36, 48, 72, and 104 after conversion will be recorded. Patient survival, graft survival, and estimated glomerular filtration rate will be calculated, and concomitant medications and adverse events will also be recorded.Conclusion:The study data will be utilized to evaluate the efficacy and safety of early conversion to low-dose CNIs combined with SRL in renal transplant patients.Trial registration:Chinese Clinical Trial Registry, ChiCTR1800017277.

简介：AbstractBackground:High-dose dual therapy (HDDT) with proton pump inhibitors (PPIs) and amoxicillin has attracted widespread attention due to its favorable efficacy in eradicating Helicobacter pylori (H. pylori). This study aimed to compare the efficacy and safety of high-dose PPI–amoxicillin dual therapy and bismuth-containing quadruple therapy for H. pylori rescue treatment.Methods:This was a prospective, randomized, multicenter, non-inferiority trial. Patients recruited from eight centers who had failed previous treatment were randomly (1:1) allocated to two eradication groups: HDDT (esomeprazole 40 mg and amoxicillin 1000 mg three times daily; the HDDT group) and bismuth-containing quadruple therapy (esomeprazole 40 mg, bismuth potassium citrate 220 mg, and furazolidone 100 mg twice daily, combined with tetracycline 500 mg three times daily; the tetracycline, furazolidone, esomeprazole, and bismuth [TFEB] group) for 14 days. The primary endpoint was the H. pylori eradication rate. The secondary endpoints were adverse effects, symptom improvement rates, and patient compliance.Results:A total of 658 patients who met the criteria were enrolled in this study. The HDDT group achieved eradication rates of 75.4% (248/329), 81.0% (248/306), and 81.3% (248/305) asdetermined by the intention-to-treat (ITT), modified intention-to-treat (MITT), and per-protocol (PP) analyses, respectively. The eradication rates were similar to those in the TFEB group: 78.1% (257/329), 84.2% (257/305), and 85.1% (257/302). The lower 95% confidence interval boundary (–9.19% in the ITT analysis, –9.21% in the MITT analysis, and –9.73% in the PP analysis) was greater than the predefined non-inferiority margin of –10%, establishing a non-inferiority of the HDDT group vs. the TFEB group. The incidence of adverse events in the HDDT group was significantly lower than that in the TFEB group (11.1% vs. 26.8%, P < 0.001). Symptom improvement rates and patients’ compliance were similar between the two groups.Conclusions:Fourteen-day HDDT is non-inferior to bismuth-containing quadruple therapy, with fewer adverse effects and good treatment compliance, suggesting HDDT as an alternative for H. pylori rescue treatment in the local region.Trial registration:Clinicaltrials.gov, NCT04678492.

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