1.Evaluation of the anticoagulant effect of nafamostat mesylate in continuous veno-venous hemofiltration with different dilution methods for uremic patients
Li SHEN ; Yao ZHANG ; Jun WANG ; Hong ZHU ; Yong QIN ; Yuewu TANG ; Ni DU
China Pharmacy 2026;37(3):350-355
OBJECTIVE To evaluate the anticoagulant efficacy and safety of nafamostat mesylate (NM) in the treatment of uremic patients at high risk of bleeding undergoing continuous veno-venous hemofiltration (CVVH) with different methods (pre- dilution and post-dilution). METHODS A total of 130 uremic patients at high risk of bleeding who underwent CVVH treatment in the nephrology department of Chongqing University Three Gorges Hospital from July 2023 to September 2024 were selected. They were divided into pre-dilution group and post-dilution group according to the random number table method, with 65 cases in each group. Both groups of patients received CVVH treatment under NM anticoagulation. The pre-dilution group adopted the pre-dilution replacement method, while the post-dilution group adopted the post-dilution replacement method. The coagulation, pressure, and usage duration of the filter and dialysis circuit venous reservoirs were compared between the two groups. The changes in prothrombin time (PT), prothrombin time-international normalized ratio (PT-INR), activated partial thromboplastin time (APTT), and fibrinogen (FIB) in the peripheral venous blood before the heparin pump and after the filter at 1, 4 and 7 h of CVVH treatment, as well as 20 min after the end of treatment, were compared between the two groups. The single-compartment urea clearance rate (spKt/V), β2-microglobulin (β2-MG) clearance rate and the incidence of adverse reactions were duni2007@foxmail.com compared between the two groups. RESULTS Both the pre-dilution and post-dilution groups had 60 patients who completed the study. The incidence of grade Ⅱ-Ⅲ coagulation of the filter and venous reservoirs, as well as the number of patients with transmembrane and venous pressure alarm intervention in the post- dilution group were significantly higher or more than those in the pre-dilution group (P<0.05), while usage time of the filter and the pipeline in the post-dilution group was significantly shorter than that in the pre-dilution group (P<0.05). The APTT values before the heparin pump as well as PT and APTT values after the filter at 1 h, 4 h, and 7 h of CVVH treatment in the post-dilution group were significantly higher than those in the pre-dilution group (P<0.001). There were no significant differences in PT, PT- INR, APTT and FIB between the two groups of patients 20 min after the end of treatment (P>0.05). The spKt/v and β2-MG clearance rates in the post-dilution group were significantly higher than those in the pre-dilution group (P<0.001). There was no significant difference in the incidence of adverse reactions between the two groups (P>0.05). CONCLUSIONS When NM is used as an anticoagulant in the CVVH treatment of uremic patients at high risk of bleeding, compared with the pre-dilution treatment method, the post-dilution treatment method has a higher incidence of filter and dialysis tubing venous reservoir, a shorter usage time of the filter and pipeline, and a greater impact on extracorporeal coagulation, but has a higher solute clearance rate. Clinically, different dilution methods can be selected according to the different treatment needs of patients.
2.Clinical observation of mycophenolate mofetil combined with Budesonide enteric capsules in the treatment of high-risk progressive IgA nephropathy
Li SHEN ; Yao ZHANG ; Yaping XIAO ; Yuewu TANG ; Ni DU
China Pharmacy 2026;37(7):927-932
OBJECTIVE To observe the clinical efficacy of mycophenolate mofetil (MMF) combined with Budesonide enteric capsules in the treatment of high-risk progressive immunoglobulin A nephropathy (IgAN). METHODS A total of 150 adult patients with high-risk progressive IgAN who attended the Department of Nephrology, Chongqing University Three Gorges Hospital, between August 1, 2024 and March 1, 2025 were enrolled in this study. The control group ( n =94) received MMF combined with glucocorticoid, while the observation group ( n =56) received MMF combined with Budesonide enteric capsules. The 24-hour urine protein (24 h UP), estimated glomerular filtration rate (eGFR), and albumin (ALB) levels of patients in both groups were compared at 1, 2, 3, and 6 months post-treatment. The complete response (CR) rate and overall response rate were calculated for both groups at 1, 2, 3, and 6 months post-treatment. Adverse reactions occurring during treatment were compared between the two groups. RESULTS Compared with before treatment, 24 h UP decreased significantly in both groups at different time points after treatment ( P <0.05), and ALB increased significantly ( P <0.05). However, there was no significant change in eGFR ( P >0.05). The 24 h UP in the observation group at 1, 2, and 3 months after treatment was significantly lower than that of the control group ( P <0.05), while the ALB level was significan tly higher ( P <0.05). However, at 6 months after treatment, there was no statistically significant difference in these two indicators between the two groups ( P >0.05). There was no statistically significant difference in eGFR between the two groups at different time points after treatment ( P >0.05). The overall response rates in the observation group at 1 and 2 months after treatment were significantly higher than those in the control group ( P <0.05). There was no statistically significant difference in the overall response rate at the remaining treatment time points and the CR rate at all time points between the two groups ( P >0.05). Patients in the observation group had significantly lower rates of skin abnormalities, elevated blood glucose, and overall adverse reactions compared with the control group ( P <0.05). CONCLUSIONS Compared with MMF combined with glucocorticoids, MMF combined with Budesonide enteric capsules for the treatment of high-risk progressive IgAN patients can reduce proteinuria and improve serum ALB levels more quickly, significantly increase the early overall response rate, and significantly reduce glucocorticoid-related skin adverse reactions, blood glucose elevation, and the overall incidence of adverse reactions, demonstrating a better short-term benefits.
3.Proteomics and Network Pharmacology Reveal Mechanism of Xiaoer Huatan Zhike Granules in Treating Allergic Cough
Youqi DU ; Yini XU ; Jiajia LIAO ; Chaowen LONG ; Shidie TAI ; Youwen DU ; Song LI ; Shiquan GAN ; Xiangchun SHEN ; Ling TAO ; Shuying YANG ; Lingyun FU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(3):69-79
ObjectiveTo explore the pharmacological mechanism involved in the treatment of allergic cough (AC) by Xiaoer Huatan Zhike granules (XEHT) based on proteomics and network pharmacology. MethodsAfter sensitization by intraperitoneal injection of 1 mL suspension containing 2 mg ovalbumin (OVA) and 100 mg aluminum hydroxide, a guinea pig model of allergic cough was constructed by nebulization with 1% OVA. The modeled guinea pigs were randomized into the model, low-, medium- and high-dose (1, 5, 20 g·kg-1, respectively) XEHT, and sodium montelukast (1 mg·kg-1) groups (n=6), and another 6 guinea pigs were selected as the blank group. The guinea pigs in drug administration groups were administrated with the corresponding drugs by gavage, and those in the blank and model groups received the same volume of normal saline by gavage, 1 time·d-1. After 10 consecutive days of drug administration, the guinea pigs were stimulated by 1% OVA nebulization, and the coughs were observed. The pathological changes in the lung tissue were observed by hematoxylin-eosin staining. The enzyme-linked immunosorbent assay was performed to measure the levels of C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), superoxide dismutase (SOD), and malondialdehyde (MDA) in the bronchoalveolar lavage fluid (BALF) and immunoglobulin G (IgG) and immunoglobulin A (IgA) in the serum. Immunohistochemistry (IHC) was employed to observe the expression of IL-6 and TNF-α in the lung tissue. Transmission electron microscopy was employed observe the alveolar type Ⅱ epithelial cell ultrastructure. Real-time PCR was employed to determine the mRNA levels of IL-6, interleukin-1β (IL-1β), and TNF-α in the lung tissue. Label-free proteomics was used to detect the differential proteins among groups. Network pharmacology was used to predict the targets of XEHT in treating AC. The Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analysis was performed to search for the same pathways from the results of proteomics and network pharmacology. ResultsCompared with the blank group, the model group showed increased coughs (P<0.01), elevated levels of CRP, TNF-α, IL-6, and MDA and lowered level of SOD in the BALF (P<0.05, P<0.01), elevated levels of IgA and IgG in the serum (P<0.05, P<0.01), congestion of the lung tissue and infiltration of inflammatory cells, increased expression of IL-6 and TNF-α (P<0.01), large areas of low electron density edema in type Ⅱ epithelial cells, obvious swelling and vacuolization of the organelles, karyopyknosis or sparse and dissolved chromatin, and up-regulated mRNA levels of IL-6, IL-1β, and TNF-α (P<0.01). Compared with the model group, the drug administration groups showed reduced coughs (P<0.01), lowered levels of CRP, TNF-α, IL-6, and MDA and elevated level of SOD in the BALF (P<0.05, P<0.01), alleviated lung tissue congestion, inflammatory cell infiltration, and type Ⅱ epithelial cell injury, and decreased expression of IL-6 and TNF-α (P<0.01). In addition, the medium-dose XEHT group and the montelukast sodium group showcased lowered serum levels of IgA and IgG (P<0.05, P<0.01). The medium- and high-dose XEHT groups and the montelukast sodium showed down-regulated mRNA levels of IL-6, IL-1β, and TNF-α and the low-dose XEHT group showed down-regulated mRNA levels of IL-6 and TNF-α (P<0.05, P<0.01). Phospholipase D, mammalian target of rapamycin (mTOR), and epidermal growth factor receptor family of receptor tyrosine kinase (ErbB) signaling pathways were the common pathways predicted by both proteomics and network pharmacology. ConclusionProteomics combined with network pharmacology reveal that XEHT can ameliorate AC by regulating the phospholipase D, mTOR, and ErbB signaling pathways.
4.FTO-regulated m6A modification of pri-miR-139 represses papillary thyroid carcinoma metastasis.
Jiale LI ; Ping ZHOU ; Juan DU ; Hongwei SHEN ; Yongfeng ZHAO ; Shanshan YU
Journal of Central South University(Medical Sciences) 2025;50(5):815-826
OBJECTIVES:
Increasing detection of low-risk papillary thyroid carcinoma (PTC) is associated with overdiagnosis and overtreatment. N6-methyladenosine (m6A)-mediated microRNA (miRNA) dysregulation plays a critical role in tumor metastasis and progression. However, the functional role of m6A-miRNAs in PTC remains unclear. This study aims to elucidate the regulatory mechanism of m6A-miR-139-5p expression in PTC, determine its association with PTC metastasis, and evaluate its potential as a diagnostic biomarker for PTC metastasis, thereby providing experimental evidence for precision diagnosis and therapy.
METHODS:
Expression profiles of m6A-miRNAs were compared between the The Cancer Genome Atlas (TCGA) and GSE130512 cohorts to identify metastasis-associated candidates. Clinical specimens from 13 metastasis and 18 non-metastasis PTC patients were analyzed to assess m6A-miR-139-5p expression and its correlation with metastasis. Functional experiments were conducted to investigate the effect of fat mass and obesity-associated protein (FTO) on pri-miR-139 methylation and processing, clarifying its regulatory role in miR-139-5p expression. In TPC-1 cells, MTT assays were performed to evaluate whether miR-139-5p overexpression could counteract FTO-mediated cell proliferation. Transwell invasion assays were used to determine the impact of miR-139-5p on PTC cell invasion, exploring whether it functions through the ZEB1/E-cadherin axis.
RESULTS:
By comparing TCGA and GSE130512 cohorts, it was found that circulating m6A-miR-139-5p could serve as a biological indicator for detecting PTC metastasis. Detection of 13 metastatic and 18 non-metastatic clinical specimens showed that FTO inhibited the processing of pri-miR-139 by reducing its methylation level, leading to the dysregulation of miR-139-5p in PTC (P<0.05). In TPC-1 cells, MTT assay showed that overexpression of miR-139-5p could partially reverse FTO overexpression-mediated cell proliferation (P<0.05). In addition, miR-139-5p inhibited the invasive ability of PTC cells by targeting the ZEB1/E-cadherin axis, while FTO overexpression could partially weaken this inhibitory effect.
CONCLUSIONS
Circulating miR-139-5p can be a potential marker for evaluating PTC metastasis. FTO affects the expression and function of miR-139-5p by regulating m6A modification of pri-miR-139, but its clinical value needs further verification.
Humans
;
MicroRNAs/metabolism*
;
Thyroid Cancer, Papillary/metabolism*
;
Alpha-Ketoglutarate-Dependent Dioxygenase FTO/metabolism*
;
Thyroid Neoplasms/metabolism*
;
Cell Line, Tumor
;
Neoplasm Metastasis
;
Adenosine/genetics*
;
Gene Expression Regulation, Neoplastic
;
Female
;
Male
;
Cadherins/metabolism*
;
Cell Proliferation
;
Zinc Finger E-box-Binding Homeobox 1/genetics*
5.Progress of researches on mechanisms underlying immune escape of Plasmodium
Yuhuang WU ; Jing HE ; Xinghang CAO ; Juntong LI ; Shuchu SHEN ; Youqin DU ; Chao TAN
Chinese Journal of Schistosomiasis Control 2025;37(3):325-331
Malaria, a parasitic disease caused by infection with the species of Plasmodium and transmitted by Anopheles mosquito bites, is one of the major public health challenges that seriously threaten human health. Malaria parasites present diverse immune escape strategies to escape from the recognition and clearance of the host immune system, which poses a great challenge to the malaria control programme. This review presents the advances in the mechanisms underlying the immune escape of Plasmodium, including antigenic variation, epigenetic regulation, antagonism against IgM antibody, activation of the cyclic guanosine monophosphate-adenosine monophosphate (GMP-AMP) synthase-stimulator of interferon genes (cGAS-STING) signaling, suppression of splenic immune functions, and molecular camouflage, so as to provide insights into development of malaria vaccines and antimalarial agents and formulation of the malaria control strategy.
6.Comparison of Protein and Polypeptide Components and Antithrombotic Activity In Vitro of Three Preparations Containing Hirudo
Wanling ZHONG ; Yunnan MA ; Jinhong YE ; Xiaoyu FAN ; Huijuan SHEN ; Rui YUAN ; Yaxuan ZHANG ; Zhuyuan LIU ; Shouying DU ; Pengyue LI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(20):184-194
ObjectiveTo compare the contents and relative molecular weight distributions of proteins and polypeptides in Naoxuekang dropping pills, Huoxue Tongmai capsules and Maixuekang capsules of Hirudo single medicinal preparations, to evaluate the in vitro anticoagulant, antiplatelet and fibrinolytic activities of the three preparations, and to investigate the effects of temperature, pH and digestive enzymes on the anticoagulant activities of the three preparations. MethodsThe contents of soluble proteins and polypeptides in the three preparations were determined by bicinchoninic acid assay(BCA) and Bradford method, and the relative molecular weight distributions of the three preparations were determined by electrophoresis combined with gel chromatography. The antithrombin activity of the three preparations was evaluated by fibrinogen-thrombin time(Fibg-TT) method, and their anticoagulant activities were further assessed by the elongations of activated partial thromboplastin time(APTT), prothrombin time(PT) and thrombin time(TT). The antiplatelet aggregation activities of the three preparations were measured by turbidimetry and the fibrinolytic activities were measured by fibrin plate method. Relative TT was used as index to investigate the effects of temperature, pH and digestive enzyme buffer on anticoagulant activities of the three preparations. ResultsAt the lowest single dosage, the contents of proteins and polypeptides were in the order of Maixuekang capsules>Huoxue Tongmai capsules>Naoxuekang dropping pills. Both Huoxue Tongmai capsules and Maixuekang capsules had 11 electrophoretic bands between 4.0 kDa and 90 kDa, the bands of Maixuekang capsules were more clear in the range of >25 kDa, and there was 1 obvious band at 14 kDa for the two capsules. Huoxue Tongmai capsules had one specific band at 9.0 kDa and Maixuekang capsules had one specific band at 48.0 kDa. Naoxuekang dropping pills only had 2 electrophoretic bands at 6.5 kDa and 8.5 kDa, primarily containing peptides below 2 kDa, most of which were oligopeptides. The anticoagulant activity concentrations of the three preparations exhibited a certain dose-dependent effect. At the lowest single dosage, The anticoagulant activity concentrations were ranked as Naoxuekang dropping pills>Huoxue Tongmai capsules>Maixuekang capsules. The prolongation effect of the three preparations on coagulation time was dose-dependent. At the same concentration, the prolongation effect of Naoxuekang dropping pills and Huoxue Tongmai capsules was APTT prolongation rate>TT prolongation rate>PT prolongation rate, whereas for Maixuekang capsules, the sequence was TT prolongation rate>APTT prolongation rate>PT lengthening rate. At the single minimum dosage, the order of APTT prolongation rate was Maixuekang capsules>Huoxue Tongmai capsules≈Naoxuekang dropping pills, the order of PT prolongation rate was Naoxuekang dropping pills≈Maixuekang capsules>Huoxue Tongmai capsules, and the order of TT prolongation rate was Maixuekang capsules>Huoxue Tongmai capsules>Naoxuekang dropping pills. The three preparations showed dose-dependent effects on platelet aggregation induced by adenosine diphosphate(ADP) and arachidonic acid(AA), and the effect induced by ADP was stronger than that induced by AA. The anti-platelet aggregation effect of Naoxuekang dropping pills was significantly stronger than that of Maixuekang capsules(P<0.01), whereas Huoxue Tongmai capsules had the effect of promoting platelet aggregation. None of the three preparations had the ability to dissolve fibrin. The anticoagulant activity of Naoxuekang dropping pills was least affected by heating, while the activities of the two capsules decreased significantly within 5 min above 80 ℃, and continued to decrease within 2 h. Compared with pure water, the anticoagulant activities of the three preparations could be increased by 1-3 times under strong acidity(pH 1-3). In the pepsin buffer, the anticoagulant activity of Naoxuekang dropping pills could be increased by 1-3 times, while the anticoagulant activities of Huoxue Tongmai capsules and Maxuekang capsules were significantly decreased, the lowest levels were about 60% and 20%, respectively. In trypsin buffer, the anticoagulant activities of Naoxuekang dropping pills, Huoxue Tongmai capsules and Maixuekang capsules decreased significantly, and the lowest levels decreased to about 41%, 41% and 35%, respectively. ConclusionThe contents of proteins and polypeptides and relative molecular weights of the preparations derived from lyophilized fresh Hirudo powder, dried Hirudo powder and reflux extract of Hirudo decrease sequentially, and the anticoagulant activity decrease gradually, but the anticoagulant pathway is different. And the anti-platelet aggregation activity of the reflux extract is significantly enhanced. The heat resistance and gastrointestinal stability of the three preparations increase successively, and the first two are suitable for enteric-soluble preparations, while the latter is suitable for routine oral administration. The above results can provide data reference for the rationality of different preparation methods, active substances, pharmacodynamics and mechanism of Hirudo preparations.
7.Application and research progress of artificial intelligence in the assessment of subsolid nodules
Fei LI ; Zhen BAI ; Jin-Long LIU ; Dan-Yang SU ; Shen-Yu YANG ; Yuan-Bo MA ; Ya-Man LI ; Yu-Fang DU ; Xiao-Peng YANG
Medical Journal of Chinese People's Liberation Army 2025;50(10):1243-1249
Lung cancer has the highest incidence and mortality among malignant tumors in China.Persistent subsolid nodules(SSNs)are closely associated with early-stage lung adenocarcinoma.Artificial intelligence(AI),as an emerging technology,is capable of performing in-depth analysis of large-scale imaging data through autonomous learning and possesses the ability to predict outcomes from new data,demonstrating great potential and application prospects in the assessment of SSNs.AI can not only effectively assist radiologists in diagnosis and treatment,but also improve work efficiency while reducing misdiagnosis and missed diagnosis rates.This review summarizes the recent applications and research progress of AI in the assessment of SSNs,to provide new insights for the diagnosis and treatment of SSNs.
8.Efficacy and safety of PEMD regimen in newly diagnosed early-stage non-upper respiratory digestive tract or advanced extranodal natural killer/T-cell lymphoma
Xinyi ZHANG ; Kaixin DU ; Haorui SHEN ; Jiazhu WU ; Yue LI ; Hua YIN ; Li WANG ; Jinhua LIANG ; Jianyong LI ; Wei XU
Chinese Journal of Hematology 2025;46(2):147-151
Objective:To evaluate the efficacy and safety of the pegaspargase, etoposide, methotrexate, and dexamethasone (PEMD) regimen in patients with early-stage nonupper respiratory digestive tract or advanced extranodal natural killer/T-cell lymphoma (ENKTL) .Methods:This retrospective analysis included 38 patients with newly diagnosed early-stage non-upper respiratory digestive tract or advanced ENKTL who received PEMD regimen for induction chemotherapy at the First Affiliated Hospital of Nanjing Medical University from January 2016 to December 2022. Survival outcomes and prognostic factors were examined by Kaplan-Meier, and the Log-rank test was used to compare survival.Results:The study population had a median age of 48 years (range, 26-72 years) and included 30 males (78.9%) and 8 females (21.1%). 7 patients’ age >60 years (18.4%). The Eastern Cooperative Oncology Group (ECOG) performance score was >1 in 7 patients (18.4%) ; 20 patients (52.6%) had elevated lactate dehydrogenase levels; and 37 patients (97.4%) exhibited extranodal involvement. Using the Ann Arbor staging system, 37 patients (97.4%) were classified as stage Ⅲ-Ⅳ. The median number of treatment cycles was 5 (1-6), and the median follow-up duration was 60 months (24 - 101 months). Interim efficacy assessment revealed an overall response rate of 52.7%. At 2 and 4 years, the progression-free survival (PFS) rates were 34.2% (95% CI 22.0%-53.2%) and 25.5% (95% CI 14.7%-44.4%), respectively, and the overall survival rates were 50.0% (95% CI 36.4%-68.7%) and 45.5% (95% CI 31.4%-65.7%), respectively. The risk factors for worse PFS were ECOG performance score >1 [ HR=3.711 (95% CI 1.494-9.218), P=0.005]; bone marrow infiltration [ HR=2.251 (95% CI 1.026 - 4.938), P=0.043]; and Prognostic Index for Natural Killer/T-Cell Lymphoma score of 3 - 5 [ HR=2.350 (95% CI 1.009 - 5.476), P=0.048]. Multivariate analysis identified ECOG performance score >1 as an independent risk factor for PFS [ HR=7.971 (95% CI 2.222 - 28.591), P=0.001]. The main adverse effect was anemia in 31 patients (81.6%) . Conclusion:The PEMD regimen was safe and effective for patients with newly diagnosed early-stage non-upper respiratory digestive tract or advanced ENKTL.
9.Optimal regimen screening of acupuncture and moxibustion for obstructive sleep apnea hypopnea syndrome.
Yuqiang SONG ; Yuanbo FU ; Sanfeng SUN ; Yali WEN ; Yinxia LIU ; Jie SUN ; Xin DU ; Xueting ZHANG ; Linbo SHEN ; Baijie LI ; Han YU ; Qingdai LI
Chinese Acupuncture & Moxibustion 2025;45(2):242-248
OBJECTIVE:
To screen the optimal regimen of acupuncture and moxibustion for obstructive sleep apnea hypopnea syndrome (OSAHS), so as to provide the evidences for clinical decision-making.
METHODS:
From 7 databases in Chinese and English i.e. the Full-Text Database of China Journal Network (CNKI), Wanfang Data Knowledge Service Platform (Wanfang), VIP Information Chinese Journal Service Platform (VIP), Chinese Biomedical Literature Database (SinoMed), PubMed, Web of Science (WOS) and Cochrane Library, randomized controlled trial (RCT) articals of OSAHS treated with acupuncture and moxibustion were searched. The quality of evidence was evaluated with the modified Jadad scale, the evaluation index was established and the optimal regimen of acupuncture and moxibustion for OSAHS was screened by multi-index decision analysis.
RESULTS:
A total of 10 RCTs were included, and the filiform needling therapy was optimal in treatment of OSAHS. The acupoints included Lianquan (CV23), Danzhong (CV17), Zhongwan (CV12), and bilateral Kongzui (LU6), Pishu (BL20), Fenglong (ST40), Zusanli (ST36), Yinlingquan (SP9) and Zhaohai (KI6). Zusanli (ST36) received the reinforcing method, Pishu (BL20) and Fenglong (ST40) were stimulated with the reducing technique, and the rest acupoints with the uniform reinforcing-reducing. Each acupoint was manually manipulated once every 10 min during the needle retention for 30 min. Acupuncture was delivered once a day, 5 times a week and for consecutive 4 weeks. Among the included literature, the severity of disease was not reported in detail, the filiform needling was the dominant intervention, the local acupoints such as Lianquan (CV23) and Panglianquan (Extra) were mainly selected. The apnea-hypopnea index and the minimum oxygen saturation were taken as the evaluation indexes, and the effect was evaluated in reference to the generally accepted standards. The attention to safety evaluation was insufficient, the report on methodology was not adequate and the quality was low.
CONCLUSION
Filiform needling is the dominant therapy of acupuncture and moxibustion for OSAHS, and the local acupoints are considered specially. But the quality of clinical research should be improved.
Humans
;
Moxibustion
;
Acupuncture Therapy
;
Sleep Apnea, Obstructive/therapy*
;
Acupuncture Points
;
Randomized Controlled Trials as Topic
10.Long-term safety and effectiveness of roxadustat in Chinese patients with chronic kidney disease-associated anemia: The ROXSTAR registry.
Xiaoying DU ; Yaomin WANG ; Haifeng YU ; Jurong YANG ; Weiming HE ; Zunsong WANG ; Dongwen ZHENG ; Xiaowei LI ; Shuijuan SHEN ; Dong SUN ; Weimin YU ; Detian LI ; Changyun QIAN ; Yiqing WU ; Shuting PAN ; Jianghua CHEN
Chinese Medical Journal 2025;138(12):1465-1476
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

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