Objective:To evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection in the treatment of peripheral T-cell lymphoma (PTCL) in a real-world setting.Methods:This was a real-world ambispective cohort study (MOMENT study) (Chinese clinical trial registry number: ChiCTR2200062067). Clinical data were collected from 198 patients who received mitoxantrone hydrochloride liposome injection as monotherapy or combination therapy at 37 hospitals from January 2022 to January 2023, including 166 patients in the retrospective cohort and 32 patients in the prospective cohort; 10 patients in the treatment-na?ve group and 188 patients in the relapsed/refractory group. Clinical characteristics, efficacy and adverse events were summarized, and the overall survival (OS) and progression-free survival (PFS) were analyzed.Results:All 198 patients were treated with mitoxantrone hydrochloride liposome injection for a median of 3 cycles (range 1-7 cycles); 28 cases were treated with mitoxantrone hydrochloride liposome injection as monotherapy, and 170 cases were treated with the combination regimen. Among 188 relapsed/refractory patients, 45 cases (23.9%) were in complete remission (CR), 82 cases (43.6%) were in partial remission (PR), and 28 cases (14.9%) were in disease stabilization (SD), and 33 cases (17.6%) were in disease progression (PD), with an objective remission rate (ORR) of 67.6% (127/188). Among 10 treatment-na?ve patients, 4 cases (40.0%) were in CR, 5 cases (50.0%) were in PR, and 1 case (10.0%) was in PD, with an ORR of 90.0% (9/10). The median follow-up time was 2.9 months (95% CI 2.4-3.7 months), and the median PFS and OS of patients in relapsed/refractory and treatment-na?ve groups were not reached. In relapsed/refractory patients, the difference in ORR between patients with different number of treatment lines of mitoxantrone hydrochloride liposome injection [ORR of the second-line, the third-line and ≥the forth-line treatment was 74.4% (67/90), 73.9% (34/46) and 50.0% (26/52)] was statistically significant ( P = 0.008). Of the 198 PTCL patients, 182 cases (91.9%) experienced at least 1 time of treatment-related adverse events, and the incidence rate of ≥grade 3 adverse events was 66.7% (132/198), which was mainly characterized by hematologic adverse events. The ≥ grade 3 hematologic adverse events mainly included decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, and anemia; non-hematologic adverse events were mostly grade 1-2, mainly including pigmentation disorders and upper respiratory tract infection. Conclusions:The use of mitoxantrone hydrochloride liposome injection-containing regimen in the treatment of PTCL has definite efficacy and is well tolerated, and it is a new therapeutic option for PTCL patients.

H 1-antihistamines are widely used in the treatment of various allergic diseases, but there are still many challenges in the safe and rational use of H 1-antihistamines in pediatrics, and there is a lack of guidance on the prescription review of H 1-antihistamines for children.In this paper, suggestions are put forward from the indications, dosage, route of administration, pathophysiological characteristics of children with individual difference and drug interactions, so as to provide reference for clinicians and pharmacists.

OBJECTIVES: To investigate the clinical treatment outcomes and the changes of the outcomes over time in extremely preterm twins in Guangdong Province, China. METHODS: A retrospective analysis was performed for 269 pairs of extremely preterm twins with a gestational age of <28 weeks who were admitted to the department of neonatology in 26 grade A tertiary hospitals in Guangdong Province from January 2008 to December 2017. According to the admission time, they were divided into two groups: 2008-2012 and 2013-2017. Besides, each pair of twins was divided into the heavier infant and the lighter infant subgroups according to birth weight. The perinatal data of mothers and hospitalization data of neonates were collected. The survival rate of twins and the incidence rate of complications were compared between the 2008-2012 and 2013-2017 groups. RESULTS: Compared with the 2008-2012 group, the 2013-2017 group (both the heavier infant and lighter infant subgroups) had lower incidence rates of severe asphyxia and smaller head circumference at birth (P<0.05). The mortality rates of both of the twins, the heavier infant of the twins, and the lighter infant of the twins were lower in the 2013-2017 group compared with the 2008-2012 group (P<0.05). Compared with the 2008-2012 group, the 2013-2017 group (both the heavier infant and lighter infant subgroups) had lower incidence rates of pulmonary hemorrhage, patent ductus arteriosus (PDA), periventricular-intraventricular hemorrhage (P-IVH), and neonatal respiratory distress syndrome (NRDS) and a higher incidence rate of bronchopulmonary dysplasia (P<0.05). CONCLUSIONS There is a significant increase in the survival rate over time in extremely preterm twins with a gestational age of <28 weeks in the 26 grade A tertiary hospitals in Guangdong Province. The incidences of severe asphyxia, pulmonary hemorrhage, PDA, P-IVH, and NRDS decrease in both the heavier and lighter infants of the twins, but the incidence of bronchopulmonary dysplasia increases. With the improvement of diagnosis and treatment, the multidisciplinary collaboration between different fields of fetal medicine including prenatal diagnosis, obstetrics, and neonatology is needed in the future to jointly develop management strategies for twin pregnancy.
Bronchopulmonary Dysplasia/epidemiology* ; Female ; Gestational Age ; Humans ; Infant ; Infant, Extremely Premature ; Infant, Newborn ; Pregnancy ; Respiratory Distress Syndrome, Newborn/epidemiology* ; Retrospective Studies ; Treatment Outcome

OBJECTIVE: To study the cytokine patterns in patients with rheumatoid arthritis (RA) and healthy individuals and identify candidate serum biomarkers for clinical diagnosis of RA. METHODS: This study was conducted among 59 patients diagnosed with RA in our hospital from 2015 to 2019 with 46 age- and gender-matched healthy subjects who received regular physical examinations in our hospital as the control group. Serological autoimmune profiles of 5 RA patients and 5 healthy control subjects were obtained from human cytokine microarrays. We selected 4 differentially expressed cytokines (LIMPII, ROBO3, Periostin and IGFBP-4) and 2 soluble cytokine receptors of interest (2B4 and Tie-2) and examined their serum levels using enzyme-linked immunosorbent assay in 54 RA patients and 41 healthy control subjects. Spearman correlation test was performed to assess the correlation of serum cytokine and soluble receptor expression levels with the clinical features including rheumatoid factor (RF), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), disease activity score (DAS28) and health assessment questionnaire (HAQ). Receiver operating characteristic (ROC) curve was used to evaluate the diagnostic capability of these cytokines. RESULTS: We identified 6 dysregulated cytokines and soluble receptors (2B4, LIMPII, Tie-2, ROBO3, periostin and IGFBP-4) in RA patients (P < 0.01). The serum levels of LIMPII, ROBO3 and periostin were significantly correlated with the disease activity indicators including RF (P < 0.001), CRP (P < 0.001), DAS28 (P < 0.001) and HAQ (P < 0.001) in RA patients. Among the 6 candidate cytokines, 2B4 showed the largest area under the curve (AUC) of 0.861 for RA diagnosis (P < 0.001), followed then by LIMPII, ROBO3, periostin, Tie-2 and IGFBP-4. CONCLUSION Serum levels of LIMPII, ROBO3 and periostin can be indicative of the disease activity of RA, and serum 2B4, LIMPII, periostin, ROBO3, IGFBP-4 and Tie-2 levels may serve as biomarkers for the diagnosis of RA.
Arthritis, Rheumatoid/diagnosis* ; Biomarkers ; C-Reactive Protein ; Cytokines ; Humans ; Insulin-Like Growth Factor Binding Protein 4 ; Protein Array Analysis ; Receptors, Cell Surface

Objective:To investigate the medium- and long-term efficacy of peroral endoscopic myotomy (POEM) for esophageal diverticulum and the risk factors for postoperative recurrence.Methods:A retrospective study was conducted on 31 cases of esophageal diverticulum who were treated by POEM in Zhongda Hospital, Southeast University from May 1st 2016 to August 1st 2019. The Eckardt score, the operative success rate, and the recurrence rate after the operation were observed and recorded. Multivariate logistic regression analysis was performed to explore the risk factors for postoperative recurrence.Results:POEM was successfully completed in all 31 patients, who were followed up for 30.6±11.1 months (20-63 months). The Eckardt score before the operation was 8.2±2.4, and was 1.4±0.7, 1.4±1.1, 1.3±1.1, and 1.3±0.9 at 1, 6, 12 and 24 months, respectively after the operation, which significantly decreased at all follow-up time points ( P<0.001). The success rates at 1, 6, 12, and 24 months after the operation were 96.8% (30/31), 90.3% (28/31), 90.3% (28/31) and 90.3% (28/31), respectively. Three patients suffered symptom relapse, with an overall recurrence rate of 9.7% (3/31). Logistic regression analysis showed that the disease duration ( P=0.038, OR=1.041, 95% CI: 1.002-1.080) and preoperative Eckardt score ( P=0.024, OR=2.299, 95% CI: 1.117-4.728) were risk factors for postoperative recurrence of POEM. Conclusion:POEM is safe and effective for esophageal diverticulum. Patients with long disease duration and high preoperative Eckardt score are associated with recurrence.

Objective:To investigate the application value of dynamic scintigraphy single-photonemission computed tomography (SPECT) 99m-technetium-galactosyl human serum albumin diethy-lenetriamine pentaacetic ( 99Tc m-GSA) scintigraphy in assessing liver function of perihilar cholangio-carcinoma after portal vein embolization (PVE). Methods:The retrospective and descriptive study was conducted. The clinicopathological data of 16 patients with perihilar cholangiocarcinoma who underwent 99Tc m-GSA scintigraphy after PVE in Beijing Tsinghua Changgung Hospital Affiliated to Tsinghua University from October 2019 to January 2021 were collected. There were 8 males and 8 females, aged from 46 to 78 years, with a median age of 64 years. Observation indicators: (1) liver volume after PVE; (2) liver function after PVE; (3) typical case analysis. Measurement data with normal distribution were represented as Mean± SD. Count data were represented as absolute numbers or percentages. Comparison of data of the same patient was analyzed using the paired t test. Results:(1) Liver volume after PVE:the morphological liver volume and functional liver volume for the 16 patients were (1 420±211)mL and (389±112)mL. The morphological liver volume and functional liver volume were (636±143)mL and (234±106)mL of planning reserved lobe, (784±210)mL and (151±106)mL of planning resection lobe, respectively. The functional liver density (FLD) of planning reserved lobe and planning resection lobe were 0.36±0.12 and 0.19±0.11, showing a significant difference between them ( t=3.794, P<0.05). The planning resection rate of morpholo-gical liver volume and functional liver volume were 37.8%±0.6% and 54.8%±0.2%, showing a significant difference between them ( t=?3.720, P<0.05). (2) Liver function after PVE: 13 of 16 patients completed the indocyanine green (ICG) test, and 3 patients didn't complete the ICG test due to intolerance. For the 13 patients undergoing ICG test, the total ICG-K value was (0.15±0.03)/minutes, and the ICG-K value of planning reserved lobe was (0.07±0.02)/minutes. The total GSA-K value of 16 patients was (0.14±0.10)/minutes, and the GSA-K value of planning reserved lobe was (0.08±0.06)/minutes. (3) Typical case analysis: a 46-year-old male patient with type Bismuth Ⅲa perihilar cholangiocarcinoma was planned to perform perihilar hepatectomy combined with right hepatectomy. The imaging evaluation showed that the volume of reserved liver lobe accounted for 27% of the total liver volume. The serum total bilirubin was 256 μmol/L when admitted and decreased to 118 μmol/L on the day 5 after percutaneous transhepatic biliary drainage. The right anterior and right posterior branches of PVE was performed. SPECT 99Tc m-GSA examination was performed on the day 37 after PVE. The morphological liver volume was 559 mL of planned reserved lobe and 1 461 mL of the whole liver. The planned morphological liver volume resection rate was 61.7%. ICG-K was 0.12/minutes of the whole liver, and 0.04/minutes of planned reserved lobe. The functional liver volume was 134 mL of planned reserved lobe and 309 mL of the whole liver. The planned resection rate of functional liver volume was 56.6%. The GSA-K was 0.20/minutes of the whole liver and 0.09/minutes of planned reserved lobe. R 0 resection was achieved in perihilar hepatectomy combined with right hepatectomy and no liver failure occurred. The survival time of patients was 11 months. Conclusion:Dynamic SPECT 99Tc m-GSA scintigraphy can effectively evaluate the regional function of the reserved liver lobe in patients with perihilar cholangiocarcinoma after PVE.

Objective:To investigate the topological alterations in brain functional networks following comprehensive treatment including brain-computer interface (BCI) training in subacute stroke subjects. Methods:From January, 2018 to June, 2019, 14 subacute stroke patients with moderate to severe upper limbs paralysis accepted routine physical therapy, occupational therapy and BCI training based on motor imagery, for four weeks. They were assessed with Fugl-Meyer Assessment-Upper Extremities (FMA-UE), Action Research Arm Test (ARAT) and Wolf Motor Function Test (WMFT) before and after treatment, while the functional connectivity (FC) was investigated with resting state functional magnetic resonance imaging. Results:The scores of FMA-UE, ARAT and WMFT increased after treatment (|t| > 5.298, Z = -3.297, P < 0.01). The FC also increased across the whole brain, including temporal, parietal, occipital lobes and subcortical regions. The FC between left piriform cortex of parietal lobule (BA5L) and right medial surface of temporal lobe (BA48R), as well as those between left precentral gyrus (BA4L) and right anterior transverse temporal gyrus (BA41R) (r > 0.416, P < 0.05). Conclusion:Comprehensive rehabilitation including BCI training may promote recovery of motor function and activities of FC in brain in subacute stroke patients.

BACKGROUNDOver past two decades, vagus nerve stimulation (VNS) has been widely used and reported to alleviate seizure frequency worldwide, however, so far, only hundreds of patients with pharmaco-resistant epilepsy (PRE) have been treated with VNS in mainland China. The study aimed to evaluate the effectiveness of VNS for Chinese patients with PRE and compare its relationship with age cohort and gender.

METHODSWe retrospectively assessed the clinical outcome of 94 patients with PRE, who were treated with VNS at Beijing Fengtai Hospital and Beijing Tiantan Hospital between November 2008 and April 2014 from our database of 106 consecutive patients. The clinical data analysis was retrospectively examined.

RESULTSSeizure frequency significantly decreased with VNS therapy after intermittent stimulation of the vagus nerve. At last follow-up, we found McHugh classifications of Class I in 33 patients (35.1%), Class II in 27 patients (28.7%), Class III in 20 patients (21.3%), Class IV in 3 patients (3.2%), and Class V in 11 patients (11.7%). Notably, 8 (8.5%) patients were seizure-free while &ge;50% seizure frequency reduction occurred in as many as 60 patients (63.8%). Furthermore, with regard to the modified Engel classification, 12 patients (12.8%) were classified as Class I, 11 patients (11.7%) were classified as Class II, 37 patients (39.4%) were classified as Class III, 34 patients (36.2%) were classified as Class IV. We also found that the factors of gender or age are not associated with clinical outcome.

CONCLUSIONSThis comparative study confirmed that VNS is a safe, well-tolerated, and effective treatment for Chinese PRE patients. VNS reduced the seizure frequency regardless of age or gender of studied patients.

Adolescent ; Adult ; Child ; Child, Preschool ; Drug Resistance ; Epilepsy ; therapy ; Female ; Humans ; Male ; Middle Aged ; Retrospective Studies ; Treatment Outcome ; Vagus Nerve Stimulation ; methods ; Young Adult

BACKGROUNDData on the epidemiology of hypertension in Chinese non-dialysis chronic kidney disease (CKD) patients are limited. The aim of the present study was to investigate the prevalence, awareness, treatment, and control of hypertension in the non-dialysis CKD patients through a nationwide, multicenter study in China.

METHODSThe survey was performed in 61 tertiary hospitals in 31 provinces, municipalities, and autonomous regions in China (except Hong Kong, Macao, and Taiwan). Trained physicians collected demographic and clinical data and measured blood pressure (BP) using a standardized protocol. Hypertension was defined as systolic BP &ge; 140 mmHg and/or diastolic BP &ge; 90 mmHg, and/or use of antihypertensive medications. BP < 140/90 mmHg and < 130/80 mmHg were used as the 2 thresholds of hypertension control. In multivariate logistic regression with adjustment for sex and age, we analyzed the association between CKD stages and uncontrolled hypertension in non-dialysis CKD patients.

RESULTSThe analysis included 8927 non-dialysis CKD patients. The prevalence, awareness, and treatment of hypertension in non-dialysis CKD patients were 67.3%, 85.8%, and 81.0%, respectively. Of hypertensive CKD patients, 33.1% and 14.1% had controlled BP to < 140/90 mmHg and < 130/80 mmHg, respectively. With successive CKD stages, the prevalence of hypertension in non-dialysis CKD patients increased, but the control of hypertension decreased (P < 0.001). When the threshold of BP < 130/80 mmHg was considered, the risk of uncontrolled hypertension in CKD 2, 3a, 3b, 4, and 5 stages increased 1.3, 1.4, 1.4, 2.5, and 4.0 times compared with CKD 1 stage, respectively (P < 0.05). Using the threshold of < 140/90 mmHg, the risk of uncontrolled hypertension increased in advanced stages (P < 0.05).

CONCLUSIONSThe prevalence of hypertension Chinese non-dialysis CKD patients was high, and the hypertension control was suboptimal. With successive CKD stages, the risk of uncontrolled hypertension increased.

Adult ; Aged ; Awareness ; Female ; Humans ; Hypertension ; complications ; epidemiology ; therapy ; Male ; Middle Aged ; Prevalence ; Renal Insufficiency, Chronic ; complications

OBJECTIVETo investigate the feasibility and efficacy of laparoscopic Roux-en-Y gastric bypass(LRYGB) for super obesity(BMI&ge;50 kg/m(2)).

METHODClinical data of 42 patients undergoing LRYGB in the First Affiliated Hospital of Jinan University between 2004 and 2008 were analyzed retrospectively.

RESULTSAll the LRYGB procedures were successfully performed with no conversion to open surgery. Average operation time was 145.1 minutes, volume of blood loss during the surgery was 25.0 ml, and length of postoperative hospital stay was 9.9 days. The cases were followed up for 1 month to 30 months. Body weight and BMI decreased significantly 1 month after the operation and reached a minimum level after 2 years then became stable while excess body weight loss rate(EWL) increased(P<0.05). All the obese-related symptoms were relieved significantly. Four cases(9.5%) showed complications during perioperative period including 1 case of respiratory failure, 2 cases of gastrojejunal anastomotic bleeding, 1 case of umbilical wound infection, and 11 developed long-term complications. All of them were cured by conservative treatment.

CONCLUSIONSTreatment of super obesity by LRYGB is feasible with significant short-term results. But due to the difficulty of the operation and postoperative complications, comprehensive treatment from experienced bariatric surgical team is needed. The long-term outcome needs for further observation.

Adolescent ; Adult ; Female ; Gastric Bypass ; methods ; Humans ; Laparoscopy ; Male ; Middle Aged ; Obesity, Morbid ; surgery ; Retrospective Studies ; Treatment Outcome ; Young Adult