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.Safety of high-carbohydrate fluid diet 2 h versus overnight fasting before non-emergency endoscopic retrograde cholangiopancreatography: A single-blind, multicenter, randomized controlled trial
Wenbo MENG ; W. Joseph LEUNG ; Zhenyu WANG ; Qiyong LI ; Leida ZHANG ; Kai ZHANG ; Xuefeng WANG ; Meng WANG ; Qi WANG ; Yingmei SHAO ; Jijun ZHANG ; Ping YUE ; Lei ZHANG ; Kexiang ZHU ; Xiaoliang ZHU ; Hui ZHANG ; Senlin HOU ; Kailin CAI ; Hao SUN ; Ping XUE ; Wei LIU ; Haiping WANG ; Li ZHANG ; Songming DING ; Zhiqing YANG ; Ming ZHANG ; Hao WENG ; Qingyuan WU ; Bendong CHEN ; Tiemin JIANG ; Yingkai WANG ; Lichao ZHANG ; Ke WU ; Xue YANG ; Zilong WEN ; Chun LIU ; Long MIAO ; Zhengfeng WANG ; Jiajia LI ; Xiaowen YAN ; Fangzhao WANG ; Lingen ZHANG ; Mingzhen BAI ; Ningning MI ; Xianzhuo ZHANG ; Wence ZHOU ; Jinqiu YUAN ; Azumi SUZUKI ; Kiyohito TANAKA ; Jiankang LIU ; Ula NUR ; Elisabete WEIDERPASS ; Xun LI
Chinese Medical Journal 2024;137(12):1437-1446
Background::Although overnight fasting is recommended prior to endoscopic retrograde cholangiopancreatography (ERCP), the benefits and safety of high-carbohydrate fluid diet (CFD) intake 2 h before ERCP remain unclear. This study aimed to analyze whether high-CFD intake 2 h before ERCP can be safe and accelerate patients’ recovery.Methods::This prospective, multicenter, randomized controlled trial involved 15 tertiary ERCP centers. A total of 1330 patients were randomized into CFD group ( n = 665) and fasting group ( n = 665). The CFD group received 400 mL of maltodextrin orally 2 h before ERCP, while the control group abstained from food/water overnight (>6 h) before ERCP. All ERCP procedures were performed using deep sedation with intravenous propofol. The investigators were blinded but not the patients. The primary outcomes included postoperative fatigue and abdominal pain score, and the secondary outcomes included complications and changes in metabolic indicators. The outcomes were analyzed according to a modified intention-to-treat principle. Results::The post-ERCP fatigue scores were significantly lower at 4 h (4.1 ± 2.6 vs. 4.8 ± 2.8, t = 4.23, P <0.001) and 20 h (2.4 ± 2.1 vs. 3.4 ± 2.4, t= 7.94, P <0.001) in the CFD group, with least-squares mean differences of 0.48 (95% confidence interval [CI]: 0.26–0.71, P <0.001) and 0.76 (95% CI: 0.57–0.95, P <0.001), respectively. The 4-h pain scores (2.1 ± 1.7 vs. 2.2 ± 1.7, t = 2.60, P = 0.009, with a least-squares mean difference of 0.21 [95% CI: 0.05–0.37]) and positive urine ketone levels (7.7% [39/509] vs. 15.4% [82/533], χ2 = 15.13, P <0.001) were lower in the CFD group. The CFD group had significantly less cholangitis (2.1% [13/634] vs. 4.0% [26/658], χ2 = 3.99, P = 0.046) but not pancreatitis (5.5% [35/634] vs. 6.5% [43/658], χ2 = 0.59, P = 0.444). Subgroup analysis revealed that CFD reduced the incidence of complications in patients with native papilla (odds ratio [OR]: 0.61, 95% CI: 0.39–0.95, P = 0.028) in the multivariable models. Conclusion::Ingesting 400 mL of CFD 2 h before ERCP is safe, with a reduction in post-ERCP fatigue, abdominal pain, and cholangitis during recovery.Trail Registration::ClinicalTrials.gov, No. NCT03075280.
3.Long-term clinical value of composite biomaterial mesh in inguinal hernia repair: a multi-center prospective randomized controlled study
Yunxiao MENG ; Xianke SI ; Ding PING ; Hongbing XIAO ; Lei HUA ; Shaojie LI ; Lei HUANG ; Zhao CAI ; Shaochun LI ; Jianxiong TANG
Chinese Journal of Digestive Surgery 2023;22(9):1069-1074
Objective:To investigate the long-term clinical value of composite biomaterial mesh in inguinal hernia repair.Methods:The prospective randomized controlled non-inferiority study was conducted. The clinical data of 172 adult patients with inguinal hernia who were admitted to 3 medical centers, including Huadong Hospital Affiliated to Fudan University et al, from July 2014 to February 2015 were selected. Based on random number table, patients were divided into two groups. Patients underwent technique of abdominal wall reinforcement with biological mesh. Patients using the electrospun composite biomaterial mesh were allocated into experimental group, and patients using the small intestinal submucosa mesh were allocated into control group. Observation indicators: (1) grouping situations of the enrolled patients; (2) endpoint of the study. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was conducted using the independent sample t test. Count data were described as absolute numbers or percentages, and comparison between groups was conducted using the chi-square test or Fisher exact probability. Comparison of ordinal data was conducted using the non-parameter rank sum test. Taking the recurrence rate of hernia at 6 years after surgery as the basis of efficacy evaluation, the Cochran-Mantel-Haenszel test was used for comparison between groups. The confidence interval method was used to conduct non-inferiority statistical analysis. If the lower limit of 95% confidence interval of the difference of recurrence rate of hernia between the experiment group and the control group was more than -10%, the experiment group was considered to be non-inferior to the control group. If the lower limit of 95% confidence interval is more than 0, the experiment group was considered to be superior to the control group. Results:(1) Grouping situations of the enrolled patients. A total of 172 adult patients with inguinal hernia were selected for eligibility. They were males, aged (61±2)years. All 172 patients were randomly divided into to the experimental group and the control group with 86 cases in each group. At 6 years after surgery, 20 patients in the experi-mental group and 19 patients in the control group was lost to follow-up. (2) Endpoint of the study. ① The primary endpoint of study. At 6 years after surgery, no patient had recurrence in the 66 patients of experimental group and 4 patients had recurrence in the 67 patients of control group. Results of non-inferiority statistical analysis showed that the 95% confidence interval of the difference of recurrence rate of hernia between the two groups was 0.27% to 14.41%, with the lower limit as 0.27%, which was more than -10% and simultaneously more than 0. ② The secondary endpoint of study. There was no significant difference in the simple verbal scale between the two groups after 6 months and 6 years at rest or cough status ( P>0.05). At a follow-up of 6 months after surgery, 2 cases of the experimental group and 5 patients of the control group had complications, showing no significant difference between the two groups( χ2=1.38, P>0.05). At a follow-up of 6 years after surgery, no complication occurred in either group. Conclusion:Composite biological mesh in inguinal repair is safe and feasible, which can have low long-term recurrence and achieve good long-term efficacy.
4.Self-reported quality of life in patients with coronary heart disease and analysis of the associated factors.
Ye Fa LIU ; Rong Jing DING ; Xiao Ping MENG ; Le Min WANG ; Xiao Yu SHEN ; Lin SHEN ; Xiao Jun CAI ; Rui Hua YUE ; Yu Qin SHEN ; Dan Yan XU ; Da Yi HU
Chinese Journal of Internal Medicine 2023;62(4):384-392
Objective: To investigate the quality of life and associated factors in patients with coronary heart disease (CHD) in China. Methods: A cross-sectional study of 25 provinces and cities in China was performed from June to September 2020. A questionnaire was used to collect the socio-demographic and clinical information of patients with CHD, while the European Five-dimensional Quality of Life Scale (EQ-5D) was used to assess the quality of life. Multiple linear regression model was performed to analyze the associated factors. Results: The median age of the 1 075 responders was 60 (52, 67) years, and 797 (74.1%) were men. The EQ-5D and EQ-VAS indices were 0.7 (0.5, 0.8) and 60.0 (40.0, 80.0). Among the five dimensions in the quality of life scale, the frequency of anxiety/depression was the highest (59.8%), while problems in self-care was the lowest (35.8%). In the multiple linear regression model, female, increasing age, obesity, comorbidity(ies), anxiety/depression, social media channels, and receiving the CABG therapy were associated with the lower EQ-5D index (all P<0.05). In addition, increasing age, obesity, comorbidity (ies), depression, anxiety and depression, social media channels, and receiving the CABG therapy were associated with lower EQ-VAS index (all P<0.05). Conclusion: Over half of the patients with CHD in China have a low quality of life, which is related to gender, age, obesity, treatment pathway, the presence or absence of comorbidity (ies), and psychological state. In addition to managing the adverse effects of traditional socio-demographic factors on the quality of life, clinical practices should pay attention to the psychological state of patients. Moreover, establishing a WeChat group for doctor-patient communication could improve the quality of life of CHD patients.
Male
;
Humans
;
Female
;
Quality of Life/psychology*
;
Self Report
;
Cross-Sectional Studies
;
Coronary Disease
;
Surveys and Questionnaires
;
Obesity
5.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
;
Infant
;
Infant, Extremely Premature
;
Infant, Newborn
;
Pregnancy
;
Respiratory Distress Syndrome, Newborn/epidemiology*
;
Retrospective Studies
;
Treatment Outcome
6.Influence of Acupuncture on Microcirculation Perfusion of Pericardium Meridian and Heart in Acute Myocardial Ischemia Model Rats.
Yi ZHUANG ; Jie ZHOU ; Yu-Mei ZHOU ; Jiao CHEN ; Ping WU ; Pei-Ran LYU ; Min WAN ; Liao-Jun LUO ; Ding-Jun CAI ; Fan-Rong LIANG
Chinese journal of integrative medicine 2022;28(1):69-75
OBJECTIVE:
To observe the influence of acupuncture on microcirculation perfusion of the pericardium meridian and heart in acute myocardial ischemia (AMI) rats and evaluate whether acupuncture can simultaneously affect the meridians and corresponding viscera. Additionally, acupoints at different meridians were compared and whether they exert the same effects was discussed.
METHODS:
Totally 32 Sprague-Dawley rats were subjected to left anterior descending (LAD) ligation to develop an AMI model. Rats were divided into 4 groups, including AMI, acupuncture Neiguan (PC 6), Lieque (LU 7) and Qiansanli (LI 10) groups (n=8). Eight rats received only thoracotomy (sham-operated group). The rats in the acupuncture groups received manual acupuncture at PC 6, LU 7 and LI 10 acupoints for 15 min, respectively. The microcirculation perfusion of pericardium meridian and heart was monitored by laser speckle perfusion imager (LSPI) before, during and after acupuncture manipulation for 15 min. Subsequently, the perfusion unit (PU) was calculated and analyzed by PSI System.
RESULTS:
After LAD, compared to pre-acupuncture stage, the heart microcirculation perfusion (HMP) in the AMI group decreased continuously at during-acupuncture (P>0.05) and post-acupuncture stages (P<0.05), and the pericardium meridian microcirculation perfusion (PMP) showed no significant differences at 3 stages (P>0.05). Compared to pre-acupuncture stage, the PMP and HMP in PC 6 group significantly increased during acupuncture manipulation (both P<0.05), and PMP decreased obviously after acupuncture (P<0.05). The PMP in the LU 7 and LI 10 groups were slightly elevated (both P>0.05); however, they were significantly reduced after acupuncture manipulation (both P<0.05). Additionally, HMP of LI 10 group was decreased significantly during acupuncture, especially compared to pre-acupuncture stage (P<0.05).
CONCLUSIONS
Acupuncture at PC 6 obviously increased the PMP and HMP in AMI rats, and the effects were superior to at LU 7 and LI 10 acupoints. It was further confirmed that acupuncture promoted qi and blood circulation, indicating that acupoint specificity exists and features a meridian-propagated effect.
Acupuncture Points
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Acupuncture Therapy
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Animals
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Electroacupuncture
;
Meridians
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Microcirculation
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Myocardial Ischemia
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Perfusion
;
Pericardium
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Rats
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Rats, Sprague-Dawley
8.Analysis of malaria cases re-examination results of malaria diagnostic reference laboratory in Nantong, Jiangsu
CAO Cai-qun ; DING Gui-sheng ; LU Jin ; GU Ya-ping
China Tropical Medicine 2022;22(09):870-
Abstract: Objective To analyze the laboratory microscopic re-examination results of malaria cases in Nantong of the National Notifiable Disease Report System from 2014 to 2021 by Nantong Malaria Diagnostic Reference Laboratory, so as to evaluate the malaria diagnosis ability of Nantong Malaria Diagnostic Reference Laboratory. Methods The blood smear and blood samples of malaria cases in Nantong from 2014 to 2021 of the National Notifiable Disease Report System were collected. Nantong Malaria Diagnostic Reference Laboratory and Jiangsu Institute of Parasitic Diseases carried out the re-examination of municipal and provincial laboratories, taking the results of provincial laboratory as the standard to compare and analyze the re-examination results of Nantong Malaria Diagnostic Reference Laboratory. Results From 2014 to 2021, the two-level laboratories in Nantong city and Jiangsu Province re-examined the blood samples of 297 malaria cases. The microscopic examination and PCR re-examination results at the provincial level were the same:292 positive cases and 5 negative cases. The qualitative coincidence rate between Nantong microscopic re-examination results and the provincial re-examination results was 100% (297/297), without misjudgment and omission. The coincidence rate of Plasmodium typing was 96.23% (281/292). The coincidence rate of P. falciparum, P. vivax, P. ovale and P. malaria were 99.57% (234/235), 62.50% (5/8), 89.47% (34/38) and 72.73% (8/11) respectively. The consistency test results showed that the Kappa value of Plasmodium typing results between municipal and provincial laboratories was 0.89. The Kappa values of P. falciparum, P. vivax, P. ovale and P. malaria were 0.98, 0.58, 0.87 and 0.79 respectively. Conclusion The malaria diagnosis ability of Nantong Malaria Diagnostic Reference Laboratory is generally good, and it is necessary to improve the ability of Plasmodium typing.
9.Characteristics of fat free mass among middle and high school adolescents in Yinchuan City
DONG Yangyang, CAI Rongrong, MA Ping, YANG Qingmei, JIA Leina, DING Wenqing
Chinese Journal of School Health 2021;42(8):1216-1219
Objective:
To elucidate age and sex specific characteristics in fat free mass (FFM) among middle and high school adolescents in Yinchuan City, China, and to provide a scientific basis for healthy development, chronic disease prevention and intervention in children and adolescents.
Methods:
Using a convenient cluster sampling method, 1 175 middle and high school adolescents, aged 10 to 20 years old, from Yinchuan, China, were selected to participate in a questionnaire survey and physical examination, which involved body composition by bioelectrical impedance analysis(BIA).
Results:
For adolescents aged 12 to 18 years, FFM and the fat free mass percentage (FFMP) of boys increased with age(from 39.78 to 52.63 kg; 77.51% to 83.80%, respectively), the age trends of the FFM and FFMP of body parts were in the similar pattern, and were significantly higher than those of girls(all P <0.05). In girls, the FFM reached a peak of 40.96 kg at 15 years old, and decreased slightly between the ages of 15 and 18 years, the age trends of the FFM of body parts were in the similar pattern, and the FFMP decreased with age (from 75.63% to 71.91 %). In addition, in girls, the age trends of the FFMP of left and right legs were the same as the general trend, while the FFMP of left and right arms increased with age. The FFMP of the trunk reached a minimum of 29.93% at 15 years old and increased from 15 to 18 years old(all P <0.05).
Conclusion
For middle and high school adolescents aged 12 to 18 years old in Yinchuan City, China, the distribution of FFM changed in accordance with age and gender differences, in accordance with the characteristics of the adolescents growth and development.
10. Corrigendum to “Selection of quality markers of Jasminum amplexicaule based on its anti-diarrheal and anti-inflammatory activities: Effect-target affiliation-traceability-pharmacokinetics strategy” Chinese Herbal Medicines 11 (2019) 379–386 (Chinese Herbal Medicines (2019) 11(4) (379–386), (S167463841930070X), (10.1016/j.chmed.2019.08.002))
Ai-li XU ; Ping DING ; Ai-li XU ; Dong-mei SUN ; Xiao-li BI ; Da-ke CAI ; Zhao CHEN ; Xue-jun HUANG ; Jie-yi JIANG ; Ai-li XU ; Dong-mei SUN ; Xiao-li BI ; Da-ke CAI ; Zhao CHEN ; Xue-jun HUANG ; Jie-yi JIANG ; Ai-li XU ; Dong-mei SUN ; Xiao-li BI ; Da-ke CAI ; Zhao CHEN ; Xue-jun HUANG ; Jie-yi JIANG ; Bu-ming LIU
Chinese Herbal Medicines 2021;13(2):293-293
When this paper was first published the following ethical statement was omitted in error: All animal experimental protocols were approved by the Animal Ethics Committee of Guangdong Provincial Engineering Technology Institute of Traditional Chinese Medicine (Guangzhou, Guangdong, China, Approval NO: 048483). Further, all methods were performed in accordance with the relevant guidelines and regulations. NIH mice were purchased from the Guangdong Medical Laboratory Animal Center (Guangzhou, Guangdong, China, Certificate NO.44007200031795). The authors would like to apologise for any inconvenience caused.


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