BACKGROUND: Chronic kidney disease (CKD)-associated anemia (CKD-anemia) is associated with poor survival, and hemoglobin targets are often not achieved with current therapies. Phase 3 trials have demonstrated the treatment efficacy of roxadustat for CKD-anemia. This phase 4 study aims to evaluate the long-term (52-week) safety and effectiveness of roxadustat in a broad real-world patient population with CKD-anemia with and without dialysis in China. METHODS: This Phase 4 multicenter, open-label, prospective study, conducted from 24 November 2020 to 11 November 2022, evaluated the long-term safety and effectiveness of roxadustat for CKD-anemia in China. Patients aged ≥18 years with CKD-anemia with or without dialysis were included. The initial oral dose was 70-120 mg (weight-based followed by dose adjustment) over 52 weeks. The primary endpoint was safety based on adverse events (AEs). The secondary endpoints were hemoglobin changes from baseline and the proportion of patients who achieved mean hemoglobin ≥100 g/L. Effectiveness evaluable populations 1 (EE1) and EE2 included roxadustat-naïve and previously roxadustat-treated patients, respectively. The safety analysis set (SAF) included all patients who received ≥1 occasion. RESULTS: The EE1, EE2, and SAF populations included 1804, 193, and 2021 patients, respectively. In the SAF, the mean age was 50 ± 14 years, and 1087 patients (53.8%) were male. Mean baseline hemoglobin was 96.9 ± 14.0 g/L in EE1 and 100.3 ± 12.9 g/L in EE2. In EE1, the mean (95% confidence interval) hemoglobin changes from baseline over weeks 24-36 and 36-52 were 14.2 (13.5-14.9) g/L and 14.3 (13.5-15.0) g/L, respectively. Over weeks 24-36 and 36-52, 83.3% and 86.1% of patients in EE1 and 82.7% and 84.7% in EE2 achieved mean hemoglobin ≥100 g/L, respectively. In the SAF, 1643 (81.3%) patients experienced treatment-emergent AEs (TEAEs). Overall, 219 (10.8%) patients experienced drug-related TEAEs. Thirty-eight (1.9%) patients died of TEAEs (unrelated to the study drug). Vascular access thrombosis was uncommon. CONCLUSIONS: Roxadustat (52 weeks) increased hemoglobin and maintained the treatment target in Chinese patients with CKD-anemia with acceptable safety, supporting its use in real-world settings. REGISTRATION Chinese Clinical Trial Registry ( www.chictr.org.cn ) ChiCTR2100046322; CDE ( www.chinadrugtrials.org.cn ) CTR20201568.
Humans ; Male ; Female ; Anemia/etiology* ; Middle Aged ; Renal Insufficiency, Chronic/complications* ; Glycine/adverse effects* ; Isoquinolines/adverse effects* ; Aged ; Prospective Studies ; Adult ; Hemoglobins/metabolism* ; Treatment Outcome ; China ; Registries ; East Asian People

BACKGROUND: While emotional distress, encompassing anxiety and depression, has been associated with negative clinical outcomes, its impact across various clinical departments and general hospitals has been less explored. Previous studies with limited sample sizes have examined the effectiveness of specific treatments (e.g., antidepressants) rather than a systemic management strategy for outcome improvement in non-psychiatric inpatients. To enhance the understanding of the importance of addressing mental health care needs among non-psychiatric patients in general hospitals, this study retrospectively investigated the impacts of emotional distress and the effects of early detection and management of depression and anxiety on hospital length of stay (LOS) and rate of long LOS (LLOS, i.e., LOS >30 days) in a large sample of non-psychiatric inpatients. METHODS: This retrospective cohort study included 487,871 inpatients from 20 non-psychiatric departments of a general hospital. They were divided, according to whether they underwent a novel strategy to manage emotional distress which deployed the Huaxi Emotional Distress Index (HEI) for brief screening with grading psychological services (BS-GPS), into BS-GPS ( n = 178,883) and non-BS-GPS ( n = 308,988) cohorts. The LOS and rate of LLOS between the BS-GPS and non-BS-GPS cohorts and between subcohorts with and without clinically significant anxiety and/or depression (CSAD, i.e., HEI score ≥11 on admission to the hospital) in the BS-GPS cohort were compared using univariable analyses, multilevel analyses, and/or propensity score-matched analyses, respectively. RESULTS: The detection rate of CSAD in the BS-GPS cohort varied from 2.64% (95% confidence interval [CI]: 2.49%-2.81%) to 20.50% (95% CI: 19.43%-21.62%) across the 20 departments, with a average rate of 5.36%. Significant differences were observed in both the LOS and LLOS rates between the subcohorts with CSAD (12.7 days, 535/9590) and without CSAD (9.5 days, 3800/169,293) and between the BS-GPS (9.6 days, 4335/178,883) and non-BS-GPS (10.8 days, 11,483/308,988) cohorts. These differences remained significant after controlling for confounders using propensity score-matched comparisons. A multilevel analysis indicated that BS-GPS was negatively associated with both LOS and LLOS after controlling for sociodemographics and the departments of patient discharge and remained negatively associated with LLOS after controlling additionally for the year of patient discharge. CONCLUSION Emotional distress significantly prolonged the LOS and increased the LLOS of non-psychiatric inpatients across most departments and general hospitals. These impacts were moderated by the implementation of BS-GPS. Thus, BS-GPS has the potential as an effective, resource-saving strategy for enhancing mental health care and optimizing medical resources in general hospitals.
Humans ; Retrospective Studies ; Male ; Length of Stay/statistics & numerical data* ; Female ; Middle Aged ; Adult ; Psychological Distress ; Inpatients/psychology* ; Aged ; Anxiety/diagnosis* ; Depression/diagnosis*

Background/Aims: Total proctocolectomy with ileal pouch-anal anastomosis (IPAA) is widely accepted as a radical surgery for refractory ulcerative colitis (UC). Definite results on the appropriate pouch length for an evaluation of the risk-to-benefit ratio regarding technical complications and long-term quality of life (QOL) are still scarce. Methods: Data on UC patients who underwent IPAA from 2008 to 2022 in four well-established pouch centers affiliated to China UC Pouch Center Union were collected. Results: A total of 208 patients with a median follow-up time of 6.0 years (interquartile range, 2.3 to 9.0 years) were enrolled. The median lengths of the patients’ short and long pouches were 14.0 cm (interquartile range, 14.0 to 15.0 cm) and 22.0 cm (interquartile range, 20.0 to 24.0 cm), respectively. Patients with a short J pouch configuration were less likely to achieve significantly improved long-term QOL (p=0.015) and were prone to develop late postoperative complications (p=0.042), such as increased defecation frequency (p=0.003) and pouchitis (p=0.035). A short ileal pouch was an independent risk factor for the development of late postoperative complications (odds ratio, 3.100; 95% confidence interval, 1.519 to 6.329; p=0.002) and impaired longterm QOL improvement (odds ratio, 2.221; 95% confidence interval, 1.218 to 4.050, p=0.009). Conclusions The length of the J pouch was associated with the improvement in long-term QOL and the development of late post-IPAA complications. A long J pouch configuration could be a considerable surgical option for pouch construction.

Objective:To explore the features of free uroflow(FF) curve patterns in female patients with detrusor underactivity(DU) and their clinical significance.Methods:Data of 275 adult female patients with lower urinary tract symptoms(LUTS) underwent urodynamic studies(UDS) at urology center of our hospital from June 2014 to June 2016 were analyzed retrospectively. The uroflow curve patterns of patients with DU were classified and analyzed in the context of parameters of FF, cystometry (CM), and pressure-flow study(PFS). The prevalence of each abnormal uroflow curve pattern in DU patients were calculated and compared with those in non-DU patients.Results:No bell-shaped curve was found in 141 patients with DU. The abnormal curve patterns can be divided into 5 types: Type Ⅰ (bell-shaped curve with saw tooth) in 20 cases (14.2%), Type Ⅱ (box-like curve) in 34 cases (24.1%), Type Ⅲ (triangle curve with decreasing slop) in 62 cases(43.9%), Type Ⅳ (triangle curve with increasing slop) in 4 cases (4.3%), Type Ⅴ (tide-wave curve)in 19 cases (13.5%). Maximum flow rate of free uroflow(Q max.FF) of type Ⅰ [(28.4±9.7) ml/s] was significantly greater than that of type Ⅱ, Ⅲ and Ⅴ[(17.0±4.1), (15.8±5.4) and (12.9±6.4) ml/s, P<0.05]. Flow time of free uroflow(FT.FF) of type Ⅲ and Ⅴ [(43.7±17.2) and (50.1±28.9)s] were significantly longer than that of type Ⅰ and Ⅱ [(18.5±7.3)s and (27.2±9.7)s, P<0.05]. Post voided residual > 50ml was noted in 19 cases (30.6%) of type Ⅲ, 7 cases (36.8%) of type Ⅴ, 1 case (2.9%) of type Ⅱ and no one in type Ⅰ and Ⅳ. Abnormal manifestations in cystometry mainly included bladder hypersensitivity, detrusor overactivity, and stress urinary incontinence. Detrusor pressure at Q max (Pdet.Q max) of type Ⅴ [(7.4±5.0) cmH 2O] was significantly lower than that of type Ⅰ, Ⅱ, Ⅲ [(11.8±6.7), (12.0±5.3), (12.1±5.0) cmH 2O, P<0.05]. Among 134 cases of non-DU, there were type Ⅰ curves in 88 cases (65.7%), type Ⅱ curves in 4 cases (2.9%), type Ⅲ curves in 15 cases (11.2%), type Ⅳ curves in 1 cases (0.7%), type Ⅴ curves in 7 cases (5.2%). And normal bell-shaped curves in 19 cases(14.2%). The prevalence of type Ⅱ, Ⅲ and Ⅴ in DU patients was significantly higher than that in the non DU patients ( P<0.05). Conclusions:This study reveals that the characteristics of reduced detrusor contractility and duration, prolonged bladder emptying or incomplete emptying can be reflected in the patterns of free uroflow curve in female patients with DU. The abnormalities of these free uroflow curve patterns, especially type Ⅱ, Ⅲ and Ⅴ will be helpful in preliminarily screening DU in females.

Osteoporotic vertebral compression fracture (OVCF) can lead to lower back pain and may be even accompanied by scoliosis, neurological dysfunction and other complications, which will affect the daily activities and life quality of patients. Vertebral augmentation is an effective treatment method for OVCF, but it cannot correct unbalance of bone metabolism or improve the osteoporotic status, causing complications like lower back pain, limited spinal activities and vertebral refracture. The post-operative systematic and standardized rehabilitation treatments can improve curative effect and therapeutic efficacy of anti-osteoporosis, reduce risk of vertebral refracture, increase patient compliance and improve quality of life. Since there still lack relevant clinical treatment guidelines for postoperative rehabilitation treatments following vertebral augmentation for OVCF, the current treatments are varied with uneven therapeutic effect. In order to standardize the postoperative rehabilitation treatment, the Spine Trauma Group of the Orthopedic Branch of Chinese Medical Doctor Association organized relevant experts to refer to relevant literature and develop the "Guideline for postoperative rehabilitation treatment following vertebral augmentation for osteoporotic vertebral compression fracture (2022 version)" based on the clinical guidelines published by the American Academy of Orthopedic Surgeons (AAOS) as well as on the principles of scientificity, practicality and advancement. The guideline provided evidence-based recommendations on 10 important issues related to postoperative rehabilitation treatments of OVCF.

Objective:To investigate the prevalence and risk factors of depression in patients with acute ST-segment elevation myocardial infarction(STEMI) after percutaneous coronary intervention(PCI).Methods:From January 2019 to December 2019, 205 patients with STEMI who underwent PCI were selected randomly in Department of Cardiology of Heilongjiang Provincial Hospital.And 200 health examined people from our hospital at the same time were selected as health control group.The Zung self-rating depression scale(SDS) was used to score the depression in STEMI patients one week after PCI.The social demographic data were investigated, including age, gender, education status, place of residence, medical payments, monthly income, marital status, smoking history, drinking history, diabetic history, cardiovascular and cerebrovascular diseases history.The clinical indicators were measured, including height, weight, waist circumference(WC), hip circumference(HC), body mass index(BMI), waist-hip rate(WHR), fasting plasma glucose(FPG), fasting serum insulin(FINS), homeostasis model assessment-insulin resistance index(HOMA-IR), serum total cholesterol(TC), total triglyceride(TG), low density lipoprotein-C(LDL-C), high density lipoprotein-C, (HDL-C), systolic blood pressure(SBP) and diastolic blood pressure(DBP).Results:The prevalence of depression in the STEMI group was obviously higher than that in the control group(17.07% vs.9.50%, χ 2=5.025, P=0.025). There was statistically significant difference in the severity of depression between the two groups(χ 2=8.360, P=0.039). Multivariate Logistic regression analysis showed that the risk factors for depression in order of OR values were FPG, gender(female), age(65 or old), BMI, monthly income(<5 000 RMB), HOMA-IR, self-paying for medical services ( OR=1.894, 1.812, 1.545, 1.428, 1.335, 1.285, 1.202). Conclusion:The prevalence of depression in STEMI patients after PCI is increased.The risk factors for depression include female, old age, obesity, low income, insulin resistance and self-paying for medical services.

Background/Aims: The risk factors of colorectal stricture associated with ulcerative colitis (UC) carcinogenesis in the long-term disease duration remain unclear. Methods: This study included all UC patients registered from a prospectively maintained database between June 1986 to July 2018. The demographic data, clinical features, and outcomes in patients with dysplasia and stricture were assessed using univariable analysis and multivariate logistic regression models. Results: A total of 246 eligible patients were in-cluded in the analysis. The median follow-up time was 13.0 years (interquartile range [IQR], 9.0 to 16.0). There were 35 cases (14.2%) of colorectal stricture. Patients with stricture had worse clinical outcomes. Stricture formation (odds ratio [OR], 9.350; 95% confidence interval [CI], 2.842 to 30.762), inflammatory polyps (OR, 5.464; 95% CI, 1.692 to 17.638), disease duration of more than 10 years (OR, 3.223; 95% CI, 1.040 to 9.985), and age >40 years at diagnosis (OR, 8.499; 95% CI, 1.903 to 37.956) were significantly associated with high-grade dysplasia or colorectal cancer. In addition, disease duration of more than 5 years (OR, 3.211; 95% CI, 1.168 to 8.881), moderated anemia (OR, 3.373; 95% CI, 1.472 to 7.731), and primary sclerosing cholangitis (OR, 5,842; 95% CI, 1.395 to 24.468) were contributing factors for the development of colorectal stricture. Conclusions Colorectal stricture had the highest risk for malignant transformation.Earlier initiation of colonoscopic surveillance in UC patients with risk factors for stricture should be considered to prevent stricture formation and further malignant transformation.

Objective Establishment of an osimertinib-resistant PC-9/ZDOR cell line of human non-small cell lung cancer (NSCLC) , and exploration of its drug resistance mechanisms and the sensitivity of themotherapeutic drugs. Methods An osimertinib-resistant PC-9/ZDOR cell line was induced by increasing doses of osimertinib to gefitinib-resistant cells PC-9/ZD. Mutation analysis of EGFR genes was performed by NGS. Cell growth was measured by CCK-8 assay and the sensitivity of chemotherapy was determined via analysis of resistance index (RI).The expression of EGFR and its signal transduction protein was determined by western blot. Results (1) An osimertinib-resistant human NSCLC cell line PC-9/ZDOR was successfully established with resistance index of 44. (2) The evidence from NGS data showed the mutation and amplification of EGFR was eliminated in PC-9/ZDOR cells. (3) The data from Western blot showed that the expression of EGFR and its phosphorylated form protein such as P-AKT and P-ERK was significantly decreased in PC-9/ZDOR cells when compared with those in PC-9/ZD cells (P <0.05). (4) The sensitivity of PC-9/ZDOR cell lines to docetaxel, gemcitabine and paclitaxel was significantly higher than that of PC-9/ZD cell lines (P < 0.05) , while the sensitivity of PC-9/ZDOR cell lines to cisplatin and pemetrexed was similar to the one of PC-9/ZD cell lines (P> 0.05). Conclusions The PC-9/ZDOR cell lines is an osimertinibresistant human NSCLC cell line. Elimination of EGFR gene mutation and/or the decrease of protein expressions of EGFR, p-EGFR, p-ERK and p-AKT maybe serve as the mechanisms of acquired resistance to osimertinib. This osimertinib-resistant cell line, PC-9/ZDOR, showed a elevated level of sensitivity to taxanes and gemcitabine.

Objective: To investigate the clinical characteristics during the perioperative period of pheochromocytoma in patients aged 60 years and over. Methods: Data of age, sex, tumor size, anesthesia time, intraoperative bleeding volume, intraoperative blood pressure, complications and hospitalization time from patients with pheochromocytoma in our hospital treated by the retroperitoneal laparoscopic adrenalectomy from January 2008 to October 2018 were retrospectively analyzed.The relationships of age with the intraoperative hemodynamic instability and postoperative complications were analyzed. Results: A total of 203 patients with pheochromocytoma met the inclusion criteria were enrolled.Age over 60 years(OR1.771, 95%CI=1.015-3.089, P=0.044)was an independent risk factor for intraoperative hemodynamic instability. Conclusions Laparoscopic retroperitoneal adrenalectomy is a safe surgical method for pheochromocytoma patients aged 60 years and over.For elderly patients with pheochromocytoma, especially those with a tumor diameter of more than 5 cm, special attention should be paid to the prevention of intraoperative hypertension crisis.

Objective: To investigate the expression of integrin α5 in cervical cancer, and to explore its relationship with clinicopathological characteristics of patients with cervical cancer. Methods: Immunohistochemistry was used to detect the expression of integrin α 5 in cervical cancer tissues of 60 cases and normal cervical paraffin-embeded tissues of 20 cases of benign uterine lesions undergoing hysterectomy from Qingdao Municipal Hospital between January 2014 and December 2017. Real-time quantitative polymerase chain reaction (RT-PCR) was used to detect the mRNA expression level of integrin α5 in 20 fresh cervical cancer tissues and 20 normal cervical tissues collected from benign cervical lesions in Qingdao Municipal Hospital between January 2018 and July 2018. The relationship between the expression of integrin α5 and the clinicopathological characteristics of patients with cervical cancer was analyzed. Results: The positive expression rate of integrin α5 protein in cervical cancer and normal cervical tissues was 63.3% (38/60), 35.0% (7/20), respectively, and the difference was statistically significant (χ ² = 4.893, P < 0.05). The expression of integrin α5 mRNA in cervical cancer was 1.6±0.4 times as high as that in normal cervical tissues (t = 5.529, P < 0.01). The positive expression of integrin α5 protein was associated with lymph node metastasis in cervical cancer patients (Z = -2.636, P = 0.008). Conclusion The high expression of integrin α5 is related to lymph node metastasis of cervical cancer, and integrin α5 may be a new potential target for treatment of cervical cancer.