1.Efficacy and safety of recombinant human anti-SARS-CoV-2 monoclonal antibody injection(F61 injection)in the treatment of patients with COVID-19 combined with renal damage:a randomized controlled exploratory clinical study
Ding-Hua CHEN ; Chao-Fan LI ; Yue NIU ; Li ZHANG ; Yong WANG ; Zhe FENG ; Han-Yu ZHU ; Jian-Hui ZHOU ; Zhe-Yi DONG ; Shu-Wei DUAN ; Hong WANG ; Meng-Jie HUANG ; Yuan-Da WANG ; Shuo-Yuan CONG ; Sai PAN ; Jing ZHOU ; Xue-Feng SUN ; Guang-Yan CAI ; Ping LI ; Xiang-Mei CHEN
Chinese Journal of Infection Control 2024;23(3):257-264
Objective To explore the efficacy and safety of recombinant human anti-severe acute respiratory syn-drome coronavirus 2(anti-SARS-CoV-2)monoclonal antibody injection(F61 injection)in the treatment of patients with coronavirus disease 2019(COVID-19)combined with renal damage.Methods Patients with COVID-19 and renal damage who visited the PLA General Hospital from January to February 2023 were selected.Subjects were randomly divided into two groups.Control group was treated with conventional anti-COVID-19 therapy,while trial group was treated with conventional anti-COVID-19 therapy combined with F61 injection.A 15-day follow-up was conducted after drug administration.Clinical symptoms,laboratory tests,electrocardiogram,and chest CT of pa-tients were performed to analyze the efficacy and safety of F61 injection.Results Twelve subjects(7 in trial group and 5 in control group)were included in study.Neither group had any clinical progression or death cases.The ave-rage time for negative conversion of nucleic acid of SARS-CoV-2 in control group and trial group were 3.2 days and 1.57 days(P=0.046),respectively.The scores of COVID-19 related target symptom in the trial group on the 3rd and 5th day after medication were both lower than those of the control group(both P<0.05).According to the clinical staging and World Health Organization 10-point graded disease progression scale,both groups of subjects improved but didn't show statistical differences(P>0.05).For safety,trial group didn't present any infusion-re-lated adverse event.Subjects in both groups demonstrated varying degrees of elevated blood glucose,elevated urine glucose,elevated urobilinogen,positive urine casts,and cardiac arrhythmia,but the differences were not statistica-lly significant(all P>0.05).Conclusion F61 injection has initially demonstrated safety and clinical benefit in trea-ting patients with COVID-19 combined with renal damage.As the domestically produced drug,it has good clinical accessibility and may provide more options for clinical practice.
2.Dietary assessment of patients with chronic kidney disease
Hui HUANG ; Qian WANG ; Ya-Yong LUO ; Zheng-Chun TANG ; Fang LIU ; Rui-Min ZHANG ; Zhe-Yi DONG ; Xiang-Mei CHEN
Medical Journal of Chinese People's Liberation Army 2024;49(8):946-951
Chronic kidney disease(CKD)commonly used dietary assessments including 24-hour dietary recall(24 h DR)/3-day dietary recall(3DDR),food frequency questionnaire(FFQ),dietary records,and estimation of dietary protein intake based on nitrogen balance.Given the high prevalence of CKD patients in Asian population and the scarcity of research using FFQ method,it is crucial to develop an FFQ suitable for Chinese CKD patients.This review summarizes the advantages and disadvantages of dietary assessment methods for CKD,the current research status,and the content and steps involved in establishing an FFQ,with the aim of providing reference for the modification of FFQ for Chinese CKD patients.
3.Prediction of proximal junctional kyphosis after degenerative scoliosis surgery based on MRI or CT
Zhe WANG ; Qian CHEN ; Yong HUANG ; Ruibang WU ; Yize ZHAO ; Limin LIU ; Yueming SONG ; Ganjun FENG
Chinese Journal of Orthopaedics 2024;44(11):748-755
Objective:To explore the measurement method and its diagnostic performance based on MRI and CT measurement of vertebral bone density in patients to predict proximal junctional kyphosis after degenerative scoliosis surgery.Methods:Retrospectively included patients who underwent long-segment fixation and fusion surgery at the Department of Orthopedics, West China Hospital of Sichuan University from January 2010 to December 2020 and had complete preoperative whole-spine X-rays, CT, MRI and other imaging examination results, and were followed up on schedule. 68 cases of adult degenerative scoliosis, 16 male, 52 women, aged 66.87±6.65 years (range, 54-80 years). The patients were measured based on preoperative lumbar spine MRI T 1WI bone quality score (vertebral bone quality score, VBQ) and CT-based Hounsfield (HU) value, and the patients were divided into postoperative proximal junction kyphosis group or non-proximal junction kyphosis group based on the results of postoperative imaging examinations. The age, gender, BMI, comorbidities, lumbar spine VBQ score, L 1 CT HU value and various imaging parameters before and after surgery were compared between the two groups of patients, including pelvic incident, lumbar lordosis, sagittal vertical axis, pelvic tilt, sacral slope, pelvic incidence-lumbar lordosis, T 1 pelvic angle, Upper instrumented vertebrae screw angle, etc. The receiver operating characteristic curve (ROC) was drawn to analyze the diagnostic efficacy, sensitivity and specificity of VBQ score, HU value and their combined indicators. Results:Seventeen cases were included in the PJK group and 51 cases in the non-PJK group. The preoperative VBQ and HU values of the PJK group were 3.10±0.43 and 99.76±16.34 respectively, while those of the non-PJK group were 2.62±0.37 and 115.27±13.46 respectively. The differences were statistically significant ( t=3.896, P<0.001; t=4.482, P<0.001). The area under curve (AUC) of VBQ was 0.773 [95% CI(0.633, 0.914)], the sensitivity and specificity are 82.4% and 70.6% respectively, the AUC of HU value was 0.814 [95% CI(0.680, 0.949)], the sensitivity and specificity are 76.5% and 76.5% respectively. The AUC of the two combined indicators was 0.895 [95% CI(0.795, 0.995)], and the sensitivity and specificity were 94.1% and 82.4% respectively. The maximum Youden index and the critical value were respectively, VBQ value 0.530, 2.895, HU value 0.530, 110.0, the combined index 0.765, 0.734. Conclusion:Both VBQ and L 1 HU value can accurately predict proximal junctional kyphosis after degenerative scoliosis surgery. The accuracy of HU value was slightly higher than that of VBQ value. The diagnosis accuracy of the combined index was the highest.
4.Fibular great toe flap carrying partial subcutaneous fascial flap in reconstruction of soft tissue defects in palmar side of thumbs and fingers
Muwei LI ; Zhe ZHANG ; Chuang MENG ; Yong LIANG ; Shaogeng HUANG ; Ziqing ZHANG
Chinese Journal of Microsurgery 2024;47(5):555-559
Objective:To discuss the method and clinical outcomes in reconstruction of soft tissue defects on palmar side of thumbs and fingers by transfer of combined full-thickness skin grafting with a great toe fibular flap carrying partial subcutaneous fascial flap.Methods:From December 2019 to December 2023, 11 patients with soft tissue defects on the palmar side of thumbs and fingers were treated in the Department of Hand Surgery Ward One, the Longgang Orthopaedics Hospital of Shenzhen. The patients were 7 males and 4 females, aged 16-55 years old with 26 years old in average. Fibular great toe flaps carrying partial fascial subcutaneous flap were employed. The soft tissue defects of thumbs and fingers were 4.0 cm×3.0 cm-6.0 cm×4.0 cm in size. Fibular great toe flaps carrying partial fascial subcutaneous tissue flap were harvested for reconstruction of the soft tissue defects in palmar digits. The sizes of flaps were 4.0 cm×1.5 cm-6.0 cm×2.0 cm, and the extended area by subcutaneous tissue flap was 4.0 cm×1.5 cm-6.0 cm×2.0 cm. Eight medial foot skins and 3 medial calf skins were applied. All donor sites were directly sutured. All patients were included in the scheduled postoperative follow-up by regular visis of outpatient clinic, and by video and telephone to observe the appearance, function and healing of the flaps and donor sites.Results:All 11 flaps survived, including 1 that had partial necrosis, and healed after dressing changes. The follow-up ranged from 6 to 18 months, with an average of 9 months. Good shape, texture and elasticity of the flaps were achieved. The grasping, pinching and holding functions of digits were all good. According to the British Medical Research Council (BMRC) sensory recovery criteria, the sensation of the flap was recovered to S 3+, with 6 skin graft areas recovered to S 3 and 5 recovered to S 3+. Eight patients had no cold intolerance but 3 had mild cold intolerance with Cold Intolerance Symptom Severity (CISS) scores of 4, 12 and 36, respectively. According to the Evaluation Trial Standards of Upper Limb Partial Functional of Hand Surgery of Chinese Medical Association, 10 patients were in excellent and 1 in good. Linear scars were left at the donor sites. The Vancouver Scar Scale (VSS) score at the final follow-up was 2.42 points±0.75 points. The scars were flat or less than 1-2 mm above the skin with the colour close to that of the surrounding normal skin with good softness and without itchiness or pain. Conclusion:The combination of a fibular flap of the great toe with a fasciocutaneous flap and a full-thickness skin graft for reconstruction of the soft tissue defects on the palmar side of the thumbs and fingers can avoid skin grafting from a donor site hence reduce a damage to the donor site. It can be applied as an alternative surgical procedure.
5.Evidence-based guideline for clinical diagnosis and treatment of acute combination fractures of the atlas and axis in adults (version 2023)
Yukun DU ; Dageng HUANG ; Wei TIAN ; Dingjun HAO ; Yongming XI ; Baorong HE ; Bohua CHEN ; Tongwei CHU ; Jian DONG ; Jun DONG ; Haoyu FENG ; Shunwu FAN ; Shiqing FENG ; Yanzheng GAO ; Zhong GUAN ; Yong HAI ; Lijun HE ; Yuan HE ; Dianming JIANG ; Jianyuan JIANG ; Weiqing KONG ; Bin LIN ; Bin LIU ; Baoge LIU ; Chunde LI ; Fang LI ; Feng LI ; Guohua LYU ; Li LI ; Qi LIAO ; Weishi LI ; Xiaoguang LIU ; Yong LIU ; Zhongjun LIU ; Shibao LU ; Fei LUO ; Jianyi LI ; Yong QIU ; Limin RONG ; Yong SHEN ; Huiyong SHEN ; Jun SHU ; Yueming SONG ; Tiansheng SUN ; Jiang SHAO ; Jiwei TIAN ; Yan WANG ; Zhe WANG ; Zheng WANG ; Xiangyang WANG ; Hong XIA ; Jinglong YAN ; Liang YAN ; Wen YUAN ; Jie ZHAO ; Jianguo ZHANG ; Yue ZHU ; Xuhui ZHOU ; Mingwei ZHAO
Chinese Journal of Trauma 2023;39(4):299-308
The acute combination fractures of the atlas and axis in adults have a higher rate of neurological injury and early death compared with atlas or axial fractures alone. Currently, the diagnosis and treatment choices of acute combination fractures of the atlas and axis in adults are controversial because of the lack of standards for implementation. Non-operative treatments have a high incidence of bone nonunion and complications, while surgeries may easily lead to the injury of the vertebral artery, spinal cord and nerve root. At present, there are no evidence-based Chinese guidelines for the diagnosis and treatment of acute combination fractures of the atlas and axis in adults. To provide orthopedic surgeons with the most up-to-date and effective information in treating acute combination fractures of the atlas and axis in adults, the Spinal Trauma Group of Orthopedic Branch of Chinese Medical Doctor Association organized experts in the field of spinal trauma to develop the Evidence-based guideline for clinical diagnosis and treatment of acute combination fractures of the atlas and axis in adults ( version 2023) by referring to the "Management of acute combination fractures of the atlas and axis in adults" published by American Association of Neurological Surgeons (AANS)/Congress of Neurological Surgeons (CNS) in 2013 and the relevant Chinese and English literatures. Ten recommendations were made concerning the radiological diagnosis, stability judgment, treatment rules, treatment options and complications based on medical evidence, aiming to provide a reference for the diagnosis and treatment of acute combination fractures of the atlas and axis in adults.
6.Evaluation of Renal Impairment in Patients with Diabetic Kidney Disease by Integrated Chinese and Western Medicine.
Yi-Lun QU ; Zhe-Yi DONG ; Hai-Mei CHENG ; Qian LIU ; Qian WANG ; Hong-Tao YANG ; Yong-Hui MAO ; Ji-Jun LI ; Hong-Fang LIU ; Yan-Qiu GENG ; Wen HUANG ; Wen-Hu LIU ; Hui-di XIE ; Fei PENG ; Shuang LI ; Shuang-Shuang JIANG ; Wei-Zhen LI ; Shu-Wei DUAN ; Zhe FENG ; Wei-Guang ZHANG ; Yu-Ning LIU ; Jin-Zhou TIAN ; Xiang-Mei CHEN
Chinese journal of integrative medicine 2023;29(4):308-315
OBJECTIVE:
To investigate the factors related to renal impairment in patients with diabetic kidney disease (DKD) from the perspective of integrated Chinese and Western medicine.
METHODS:
Totally 492 patients with DKD in 8 Chinese hospitals from October 2017 to July 2019 were included. According to Kidney Disease Improving Global Outcomes (KDIGO) staging guidelines, patients were divided into a chronic kidney disease (CKD) 1-3 group and a CKD 4-5 group. Clinical data were collected, and logistic regression was used to analyze the factors related to different CKD stages in DKD patients.
RESULTS:
Demographically, male was a factor related to increased CKD staging in patients with DKD (OR=3.100, P=0.002). In clinical characteristics, course of diabetes >60 months (OR=3.562, P=0.010), anemia (OR=4.176, P<0.001), hyperuricemia (OR=3.352, P<0.001), massive albuminuria (OR=4.058, P=0.002), atherosclerosis (OR=2.153, P=0.007) and blood deficiency syndrome (OR=1.945, P=0.020) were factors related to increased CKD staging in patients with DKD.
CONCLUSIONS
Male, course of diabetes >60 months, anemia, hyperuricemia, massive proteinuria, atherosclerosis, and blood deficiency syndrome might indicate more severe degree of renal function damage in patients with DKD. (Registration No. NCT03865914).
Humans
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Male
;
Diabetes Mellitus, Type 2
;
Diabetic Nephropathies
;
Hyperuricemia
;
Kidney
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Proteinuria
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Renal Insufficiency, Chronic/complications*
7.Effect of Circular RNA hsa_circ_0067582 on the Proliferation and Invasion Ability of Gastric Cancer Cells.
Rong-Dan LU ; Zhe HUANG ; Jia-Min LU ; Hai-Qiang ZHANG ; Yong-Fu SHAO
Acta Academiae Medicinae Sinicae 2022;44(1):81-90
Objective To investigate the effects on cell proliferation and invasion of the circular RNA hsa_circ_0067582 in gastric cancer(GC). Methods After hsa_circ_0067582 overexpression (Oe-circ_0067582) plasmid was transfected into AGS and SGC-7901 cells,the cell viability,proliferation,invasion ability,and apoptosis were detected by CCK-8,colony formation and EdU assays,Transwell assay,and flow cytometry,respectively.Western blotting was employed to detect the expression levels of proteins related to the cell apoptosis and epithelial-mesenchymal transition(EMT).The effect of Oe-circ_0067582 on the growth of SGC-7901 cells in nude mice was observed.Bioinformatics tools were used to predict the binding target miRNA of hsa_circ_0067582,and the competing endogenous RNA(ceRNA)regulatory network was established.Finally,functional enrichment was performed to analyze the biological functions of the target genes of the predicted miRNA. Results Compared with the pLO-ciR(empty plasmid)group,the Oe-circ_0067582 group in AGS and SGC-7901 cells attenuated the cell viability(t=7.883,P=0.001;t=5.679,P=0.005),proliferation(t=6.709,P=0.003;t=5.857,P=0.003),and invasion ability(t=7.782,P=0.002;t=6.342,P=0.003)and induced cell apoptosis(t=7.225,P=0.002;t=11.509,P=0.001).Western blotting showed that the Oe-circ_0067582 group in AGS and SGC-7901 cells up-regulated the protein levels of cysteinyl aspartate specific proteinase (Caspase) 3(t=6.863,P=0.002;t=7.024,P=0.001),Caspase 7(t=3.295,P=0.04;t=6.008,P=0.004),Caspase 9(t=4.408,P=0.012;t=6.278,P=0.004),and E-cadherin(t=12.453,P=0.002;t=10.867,P=0.001),while down-regulated those of Vimentin(t=7.242,P=0.002;t=5.694,P=0.004)and N-cadherin(t=6.480,P=0.003;t=7.446,P=0.001).Furthermore,Oe-circ_0067582 significantly inhibited the growth of tumor in the SGC-7901 tumor-bearing nude mice(t=3.526,P=0.017).The prediction based on TargetScan and miRnada suggested that hsa_circ_0067582 can competitively bind to hsa-miR-181b-3p,hsa-miR-337-3p,hsa-miR-421,and hsa-miR-548d-3p.The functional enrichment indicated that the target genes of miRNA were involved in multiple cancer-related biological processes including negative regulation of apoptotic process,gene expression,transcriptional misregulation in cancer,transforming growth factor-β,and p53 signaling pathways. Conclusion Oe-circ_0067582 can inhibit the proliferation and attenuate EMT process to reduce the invasion ability of AGS and SGC-7901 cells,which provides a new target for the treatment of GC.
Animals
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Cell Proliferation
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Gene Expression Regulation, Neoplastic
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Mice
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Mice, Nude
;
RNA, Circular
;
Stomach Neoplasms/pathology*
8.Clinical treatment outcomes and their changes in extremely preterm twins: a multicenter retrospective study in Guangdong Province, China.
Bi-Jun SHI ; Ying LI ; Fan WU ; Zhou-Shan FENG ; Qi-Liang CUI ; Chuan-Zhong YANG ; Xiao-Tong YE ; Yi-Heng DAI ; Wei-Yi LIANG ; Xiu-Zhen YE ; Jing MO ; Lu DING ; Ben-Qing WU ; Hong-Xiang CHEN ; Chi-Wang LI ; Zhe ZHANG ; Xiao RONG ; Wei SHEN ; Wei-Min HUANG ; Bing-Yan YANG ; Jun-Feng LYU ; Hui-Wen HUANG ; Le-Ying HUO ; Hong-Ping RAO ; Wen-Kang YAN ; Xue-Jun REN ; Yong YANG ; Fang-Fang WANG ; Dong LIU ; Shi-Guang DIAO ; Xiao-Yan LIU ; Qiong MENG ; Yu WANG ; Bin WANG ; Li-Juan ZHANG ; Yu-Ge HUANG ; Dang AO ; Wei-Zhong LI ; Jie-Ling CHEN ; Yan-Ling CHEN ; Wei LI ; Zhi-Feng CHEN ; Yue-Qin DING ; Xiao-Yu LI ; Yue-Fang HUANG ; Ni-Yang LIN ; Yang-Fan CAI ; Sha-Sha HAN ; Ya JIN ; Guo-Sheng LIU ; Zhong-He WAN ; Yi BAN ; Bo BAI ; Guang-Hong LI ; Yue-Xiu YAN
Chinese Journal of Contemporary Pediatrics 2022;24(1):33-40
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*
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Female
;
Gestational Age
;
Humans
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Infant
;
Infant, Extremely Premature
;
Infant, Newborn
;
Pregnancy
;
Respiratory Distress Syndrome, Newborn/epidemiology*
;
Retrospective Studies
;
Treatment Outcome
9.Cross-sectional study of association between dietary pattern and cognitive performance in people aged 50 and above years in Shanghai.
Yong Fa QIN ; Yan Fei GUO ; Ye RUAN ; Shuang Yuan SUN ; Zhe Zhou HUANG ; Fan WU
Chinese Journal of Epidemiology 2022;43(5):674-680
Objective: To investigate the association between dietary pattern and cognitive performance in local residents aged ≥50 years in Shanghai. Methods: Data were obtained from the second round of Study of Global Ageing and Adult Health (SAGE) survey in Shanghai. Dietary patterns were surveyed by factor analysis. Cognitive tests were conducted to assess subjects' cognitive performance, including verbal recall, verbal fluency and digit test. Multiple linear regression analysis was used to evaluate the relationship between dietary patterns and cognition performance. Results: A total of 4 132 subjects with complete dietary and cognitive performance test data were included. Factor analysis was used to obtain three dietary patterns: including plant-based pattern, high animal-food pattern, high salt-oil pattern. After controlling for gender, age, education level and other factors, it was found that plant-based pattern (β=0.26,95%CI: 0.17-0.36) and high animal-food pattern (β=0.18, 95%CI:0.06-0.29) were positively associated with total cognitive test score while high salt-oil pattern (β=-0.28, 95%CI:-0.85--0.07) was negatively associated with verbal fluency test score. Conclusion: A dietary pattern with high intake of plant food and appropriate intake of animal food might be associated with better cognitive function of residents aged ≥50 years.
Aging
;
Animals
;
China/epidemiology*
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Cognition
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Cross-Sectional Studies
;
Diet
;
Humans
10.Naoxintong Capsule for Secondary Prevention of Ischemic Stroke: A Multicenter, Randomized, and Placebo-Controlled Trial.
Xiao-Fei YU ; Xu-Ying ZHU ; Can-Xing YUAN ; Dan-Hong WU ; Yu-Wu ZHAO ; Jia-Jun YANG ; Chang-de WANG ; Wei-Wen WU ; Xue-Yuan LIU ; Zhen-Guo LIU ; Zhi-Yu NIE ; Ben-Qiang DENG ; Huan BAO ; Long-Xuan LI ; Chun-Yan WANG ; Hong-Zhi ZHANG ; Jing-Si ZHANG ; Ji-Han HUANG ; Fan GONG ; Ming-Zhe WANG ; Yong-Mei GUO ; Yan SUN ; Ding-Fang CAI
Chinese journal of integrative medicine 2022;28(12):1063-1071
OBJECTIVE:
To examine whether the combination of Naoxintong Capsule with standard care could further reduce the recurrence of ischemic stroke without increasing the risk of severe bleeding.
METHODS:
A total of 23 Chinese medical centers participated in this trial. Adult patients with a history of ischemic stroke were randomly assigned in a 1:1 ratio using a block design to receive either Naoxintong Capsule (1.2 g orally, twice a day) or placebo in addition to standard care. The primary endpoint was recurrence of ischemic stroke within 2 years. Secondary outcomes included myocardial infarction, death due to recurrent ischemic stroke, and all-cause mortality. The safety of drugs was monitored. Results were analyzed using the intention-to-treat principle.
RESULTS:
A total of 2,200 patients were enrolled from March 2015 to March 2016, of whom 143 and 158 in the Naoxintong and placebo groups were lost to follow-up, respectively. Compared with the placebo group, the recurrence rate of ischemic stroke within 2 years was significantly lower in the Naoxintong group [6.5% vs. 9.5%, hazard ratio (HR): 0.665, 95% confidence interval (CI): 0.492-0.899, P=0.008]. The two groups showed no significant differences in the secondary outcomes and safety, including rates of severe hemorrhage, cerebral hemorrhage and subarachnoid hemorrhage (P>0.05).
CONCLUSION
The combination of Naoxintong Capsule with standard care reduced the 2-year stroke recurrence rate in patients with ischemic stroke without increasing the risk of severe hemorrhage in high-risk patients. (Trial registration No. NCT02334969).
Adult
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Humans
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Secondary Prevention/methods*
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Ischemic Stroke
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Stroke/prevention & control*
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Cerebral Hemorrhage/complications*
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Double-Blind Method
;
Platelet Aggregation Inhibitors

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