1.Efficacy and safety of Shenyankangfu Tablet, a Chinese patent medicine, for primary glomerulonephritis: A multicenter randomized controlled trial.
Jie WU ; Shu-Wei DUAN ; Hong-Tao YANG ; Yue-Yi DENG ; Wei LI ; Ya-Ni HE ; Zhao-Hui NI ; Yong-Li ZHAN ; Shan LIN ; Zhi-Yong GUO ; Jun ZHU ; Jing-Ai FANG ; Xu-Sheng LIU ; Li-Hua WANG ; Rong WANG ; Nian-Song WANG ; Xiao-Hong CHENG ; Li-Qun HE ; Ping LUO ; Shi-Ren SUN ; Ji-Feng SUN ; Ai-Ping YIN ; Geng-Ru JIANG ; Hong-Yu CHEN ; Wen-Hu LIU ; Hong-Li LIN ; Meng LIANG ; Lu MA ; Ming CHEN ; Li-Qun SONG ; Jian CHEN ; Qing ZHU ; Chang-Ying XING ; Yun LI ; Ji-Ning GAO ; Rong-Shan LI ; Ying LI ; Hao ZHANG ; Ying LU ; Qiao-Ling ZHOU ; Jun-Zhou FU ; Qiang HE ; Guang-Yan CAI ; Xiang-Mei CHEN
Journal of Integrative Medicine 2021;19(2):111-119
BACKGROUND:
Shenyankangfu Tablet (SYKFT) is a Chinese patent medicine that has been used widely to decrease proteinuria and the progression of chronic kidney disease.
OBJECTIVE:
This trial compared the efficacy and safety of SYKFT, for the control of proteinuria in primary glomerulonephritis patients, against the standard drug, losartan potassium.
DESIGN, SETTING, PARTICIPANTS AND INTERVENTION:
This was a multicenter, double-blind, randomized, controlled clinical trial. Primary glomerulonephritis patients, aged 18-70 years, with blood pressure ≤ 140/90 mmHg, estimated glomerular filtration rate (eGFR) ≥ 45 mL/min per 1.73 m
MAIN OUTCOME MEASURES:
The primary outcome was change in the 24-hour proteinuria level, after 48 weeks of treatment.
RESULTS:
A total of 735 participants were enrolled. The percent decline of urine protein quantification in the SYKFT group after 48 weeks was 8.78% ± 2.56% (P = 0.006) more than that in the losartan 50 mg group, which was 0.51% ± 2.54% (P = 1.000) less than that in the losartan 100 mg group. Compared with the losartan potassium 50 mg group, the SYKFT plus losartan potassium 50 mg group had a 13.39% ± 2.49% (P < 0.001) greater reduction in urine protein level. Compared with the losartan potassium 100 mg group, the SYKFT plus losartan potassium 100 mg group had a 9.77% ± 2.52% (P = 0.001) greater reduction in urine protein. With a superiority threshold of 15%, neither was statistically significant. eGFR, serum creatinine and serum albumin from the baseline did not change statistically significant. The average change in TCM syndrome score between the patients who took SYKFT (-3.00 [-6.00, -2.00]) and who did not take SYKFT (-2.00 [-5.00, 0]) was statistically significant (P = 0.003). No obvious adverse reactions were observed in any group.
CONCLUSION:
SYKFT decreased the proteinuria and improved the TCM syndrome scores of primary glomerulonephritis patients, with no change in the rate of decrease in the eGFR. SYKFT plus losartan potassium therapy decreased proteinuria more than losartan potassium therapy alone.
TRIAL REGISTRATION NUMBER
NCT02063100 on ClinicalTrials.gov.
2. Occupational exposure limit of trimethyltin chloride in workplace air
Bang-hua WU ; Wei-feng RONG ; Zi-qun ZHANG ; Jia-heng HE ; An-ping MA ; Qian-ling ZHENG ; Ai-chu YANG ; Guan-chao LAI
China Occupational Medicine 2021;48(01):33-38
OBJECTIVE: To establish the occupational exposure limit for trimethyltin chloride(TMT) in workplace air. METHODS:According to the GBZ/T 210.1-2008 Guide for Establishing Occupational Health Standards--Part 1: Occupational Exposure Limits for Airborne Chemicals in the Workplace, the relevant literatures on toxicology, population epidemiology and foreign occupational exposure limit of TMT were collected and analyzed. A total of 276 workers with TMT occupational exposure were selected as the exposure group and 25 workers without TMT occupational exposure were selected as the control group.Worksite survey of occupational health and occupational medical examination were carried out. Combined with the literature data, the occupational exposure limit of TMT in the workplace air was calculated by using the 90% medical reference level(internal exposure limit) of the urine TMT level of workers who exposed to TMT without moderate hypokalemia. RESULTS: The time-weighted average of TMT in the workplace air is 0.100 mg/m~3 and the short-term exposure limit is 0.200 mg/m~3 in the United States based on total organic tin. The highest concentration of TMT in the workplace air in Germany is 0.005 mg/m~3. The literature data analysis results showed that the incubation period of TMT poisoning is mostly 3-6 days, and the main symptoms of TMT poisoning are hypokalemia in the early stage, followed by neuropsychiatric symptoms such as headache, memory loss and aggressive behavior. The median(M) and the 0-100 th percentile(P_0-P_(100)) of exposure to TMT were 8.35(< 0.20-91.40) μg/m~3 in the exposure group. The individual TMT exposure level of workers in different positions from high to low were crushing, granulation, withdrawal and assembly positions. The M(P_0-P_(100)) of urinary TMT level in the exposure group was 16.94(<0.50-591.14) μg/L. There was a positive correlation between the individual TMT exposure level and urine TMT level in the exposure group(Spearman correlation coefficient=0.62, P<0.01). The detection rate of hypokalemia in the exposure group was higher than that in the control group(26.1% vs 4.0%, P < 0.05). However, there was no significant difference in the detection rate of moderate hypokalemia between the two groups(3.3% vs 0.0%, P>0.05). The 90% medical reference value of urine TMT was 89.90 μg/L in workers exposed to TMT without moderate hypokalemia. CONCLUSION: In order to prevent acute hypokalemia damage caused by TMT, we recommended that the occupational exposure limit of TMT in the workplace air should be set at 0.025 mg/m~3 in China, and this limit should be the maximum allowable concentration.
3.A 14-year multi-institutional collaborative study of Chinese pelvic floor surgical procedures related to pelvic organ prolapse.
Zhi-Jing SUN ; Xiu-Qi WANG ; Jing-He LANG ; Tao XU ; Yong-Xian LU ; Ke-Qin HUA ; Jin-Song HAN ; Huai-Fang LI ; Xiao-Wen TONG ; Ping WANG ; Jian-Liu WANG ; Xin YANG ; Xiang-Hua HUANG ; Pei-Shu LIU ; Yan-Feng SONG ; Hang-Mei JIN ; Jing-Yan XIE ; Lu-Wen WANG ; Qing-Kai WU ; Jian GONG ; Yan WANG ; Li-Qun WANG ; Zhao-Ai LI ; Hui-Cheng XU ; Zhi-Jun XIA ; Li-Na GU ; Qing LIU ; Lan ZHU
Chinese Medical Journal 2021;134(2):200-205
BACKGROUND:
It has been a global trend that increasing complications related to pelvic floor surgeries have been reported over time. The current study aimed to outline the development of Chinese pelvic floor surgeries related to pelvic organ prolapse (POP) over the past 14 years and investigate the potential influence of enhanced monitoring conducted by the Chinese Association of Urogynecology since 2011.
METHODS:
A total of 44,594 women with POP who underwent pelvic floor surgeries between October 1, 2004 and September 30, 2018 were included from 22 tertiary academic medical centers. The data were reported voluntarily and obtained from a database. We compared the proportion of each procedure in the 7 years before and 7 years after September 30, 2011. The data were analyzed by performing Z test (one-sided).
RESULTS:
The number of different procedures during October 1, 2011-September 30, 2018 was more than twice that during October 1, 2004-September 30, 2011. Regarding pelvic floor surgeries related to POP, the rate of synthetic mesh procedures increased from 38.1% (5298/13,906) during October 1, 2004-September 30, 2011 to 46.0% (14,107/30,688) during October 1, 2011-September 30, 2018, whereas the rate of non-mesh procedures decreased from 61.9% (8608/13,906) to 54.0% (16,581/30,688) (Z = 15.53, P < 0.001). Regarding synthetic mesh surgeries related to POP, the rates of transvaginal placement of surgical mesh (TVM) procedures decreased from 94.1% (4983/5298) to 82.2% (11,603/14,107) (Z = 20.79, P < 0.001), but the rate of laparoscopic sacrocolpopexy (LSC) procedures increased from 5.9% (315/5298) to 17.8% (2504/14,107).
CONCLUSIONS:
The rate of synthetic mesh procedures increased while that of non-mesh procedures decreased significantly. The rate of TVM procedures decreased while the rate of LSC procedures increased significantly.
TRIAL REGISTRATION NUMBER
NCT03620565, https://register.clinicaltrials.gov.
China
;
Female
;
Gynecologic Surgical Procedures/adverse effects*
;
Humans
;
Pelvic Floor/surgery*
;
Pelvic Organ Prolapse/surgery*
;
Surgical Mesh/adverse effects*
;
Treatment Outcome
;
Vagina
4.A multicenter survey of antibiotic use in very and extremely low birth weight infants in Hunan Province.
Ming-Jie WANG ; Shao-Jie YUE ; Jin LIN ; Xi-Rong GAO ; Xiao-Ming PENG ; Meng-Yu CHEN ; Hua-Bao PENG ; Bei CAO ; Yun-Qing ZENG ; Shu-Lian WANG ; Bo WEN ; Xi-Lin HUANG ; Xiao-Ping LI ; Ai-Zhen ZHANG ; Ting CAO ; Yi-Hua CHEN ; Tie-Qiang CHEN ; Chun-Hua YE ; Tao BO ; De-Lin JIANG ; Xiu-Qun HUANG ; Na-Fang REN ; Long-Zhang TAO ; Fang YAO ; Chang-Jun TIAN ; Hong-Ming LI ; Ai-Min ZHANG ; Fu-Rong HUANG ; Wei-Guo ZHANG ; Xiang-Hong CHEN ; Yu-Chan LIU ; Zheng-Lin LIU ; Yan-Shan XU ; Jing-Song MING ; Li CHEN ; Ning-Yi ZHU ; Jun-Min HE ; Sai-Jun YI ; Tuan-Mei WANG ; Zhao-Hui LI ; Gui-Tian WANG
Chinese Journal of Contemporary Pediatrics 2020;22(6):561-566
OBJECTIVE:
To investigate the current status of antibiotic use for very and extremely low birth weight (VLBW/ELBW) infants in neonatal intensive care units (NICUs) of Hunan Province.
METHODS:
The use of antibiotics was investigated in multiple level 3 NICUs of Hunan Province for VLBW and ELBW infants born between January, 2017 and December, 2017.
RESULTS:
The clinical data of 1 442 VLBW/ELBW infants were collected from 24 NICUs in 2017. The median antibiotic use duration was 17 days (range: 0-86 days), accounting for 53.0% of the total length of hospital stay. The highest duration of antibiotic use was up to 91.4% of the total length of hospital stay, with the lowest at 14.6%. In 16 out of 24 NICUs, the antibiotic use duration was accounted for more than 50.0% of the hospitalization days. There were 113 cases with positive bacterial culture grown in blood or cerebrospinal fluid, making the positive rate of overall bacterial culture as 7.84%. The positive rate of bacterial culture in different NICUs was significantly different from 0% to 14.9%. The common isolated bacterial pathogens Klebsiella pneumoniae was 29 cases (25.7%); Escherichia coli 12 cases (10.6%); Staphylococcus aureus 3 cases (2.7%). The most commonly used antibiotics were third-generation of cephalosporins, accounting for 41.00% of the total antibiotics, followed by penicillins, accounting for 32.10%, and followed by carbapenems, accounting for 13.15%. The proportion of antibiotic use time was negatively correlated with birth weight Z-score and the change in weight Z-score between birth and hospital discharge (r=-0.095, -0.151 respectively, P<0.01), positively correlated with death/withdrawal of care (r=0.196, P<0.01).
CONCLUSIONS
Antibiotics used for VLBW/ELBW infants in NICUs of Hunan Province are obviously prolonged in many NICUs. The proportion of routine use of third-generation of cephalosporins and carbapenems antibiotics is high among the NICUs.
Anti-Bacterial Agents
;
Birth Weight
;
Humans
;
Infant
;
Infant, Extremely Low Birth Weight
;
Infant, Newborn
;
Intensive Care Units, Neonatal
;
Surveys and Questionnaires
5.Effects of Niaoduqing Particles () on Delaying Progression of Renal Dysfunction: A Post-trial, Open-Label, Follow-up Study.
Ying ZHENG ; Nian-Song WANG ; Yu-Ning LIU ; Li-Qun HE ; Gui-Hua JIAN ; Xu-Sheng LIU ; Zhao-Hui NI ; Xiao-Hong CHENG ; Hong-Li LIN ; Wen-Hua ZHOU ; Ya-Ping WANG ; Jing-Ai FANG ; Ya-Ni HE ; Hong-Tao YANG ; Li-Juan ZHAO ; Han-Lu DING ; Li-Hua WANG ; Ren-Huan YU ; Wen-Ge LI ; Zhi-Ming YE ; Wang GUO ; Yong-Li ZHAN ; Hui-Juan MAO ; Zhao HU ; Chen YAO ; Guang-Yan CAI ; Xiang-Mei CHEN
Chinese journal of integrative medicine 2019;25(3):168-174
OBJECTIVE:
To follow up the participants of the randomized clinical trial "Efficacy and Safety of Niaoduqing Particles () for Delaying Moderate-to-Severe Renal Dysfunction", and assess the long-term effects of Niaoduqing Particles on delaying the progression of renal dysfunction.
METHODS:
Participants, who had previously been randomly assigned to receive Niaoduqing Particles or placebo for 24 weeks (146 cases in each group), were invited to follow-up and all were administered Niaoduqing Particles 5 g thrice daily and 10 g before bedtime for 24 weeks. The primary endpoints were changes in baseline serum creatinine (Scr) and estimated glomerular filtration rate (eGFR) after completion of the open-label treatment period.
RESULTS:
After the double-blind period, the median (interquartile range) changes in Scr were 1.1 (-13.0-24.1) and 11.7 (-2.6-42.9) μmol/L for the Niaoduqing Particle and placebo groups, respectively (P=0.008), and the median changes in eGFRs were-0.2 (-4.3-2.7) and-2.21 (-5.7-0.8) mL•min•1.73 m, respectively (P=0.016). There were significant differences in the double-blind period changes in renal function between groups. After the open-label period, the median changes in Scr were 9.0 (-10.0-41.9) and 17.5 (-6.0-50.0) μmol/L for the Niaoduqing Particle and placebo groups according to baseline grouping, respectively (P=0.214), and the median changes in eGFRs were-2.3 (-6.4-1.9) and-3.7 (-7.5-1.1) mL•min•1.73 m, respectively (P=0.134). There were no statistical differences in the open-label period changes in renal function between groups. The eGFR reduction of participants who accepted Niaoduqing Particle treatment for 48 weeks was projected to 2.5 mL•min•1.73 m per year.
CONCLUSION
Niaoduqing Particles appear to have long-term efficacy for patients with moderate-to-severe renal dysfunction. Although there was no statistical difference, the early use of Niaoduqing Paticles seems to ameliorate the worsening of renal function. (Trial registration No. ChiCTR-TRC-12002448).
Adult
;
Disease Progression
;
Double-Blind Method
;
Drugs, Chinese Herbal
;
therapeutic use
;
Female
;
Follow-Up Studies
;
Glomerular Filtration Rate
;
drug effects
;
Humans
;
Kidney Diseases
;
drug therapy
;
physiopathology
;
Male
;
Middle Aged
;
Outcome Assessment (Health Care)
6.Urinary Extracellular Vesicle: A Potential Source of Early Diagnostic and Therapeutic Biomarker in Diabetic Kidney Disease.
Wei-Cheng XU ; Ge QIAN ; Ai-Qun LIU ; Yong-Qiang LI ; He-Qun ZOU
Chinese Medical Journal 2018;131(11):1357-1364
ObjectiveDiabetic kidney disease (DKD) has become one of the major causes of end-stage renal disease. Urinary extracellular vesicles (uEVs) contain rich biological information which could be the ideal source for noninvasive biomarkers of DKD. This review discussed the potential early diagnostic and therapeutic values of proteins and microRNAs in uEVs in DKD.
Data SourcesThis review was based articles published in PubMed, Embase, Cochrane, and Google Scholar databases up to November 20, 2017, with the following keywords: "Diabetic kidney disease", "Extracellular vesicle", and "Urine".
Study SelectionRelevant articles were carefully reviewed, with no exclusions applied to the study design and publication type.
ResultsThere is no "gold standard" technology to separate and/or purify uEVs. The uEVs contain a variety of proteins and RNAs and participate in the physiological and pathological processes of the kidney. UEVs, especially urinary exosomes, may be useful biomarkers for early diagnosis and treatment to DKD. Furthermore, the uEVs has been used as a therapeutic target for DKD.
ConclusionProteins and nucleic acids in uEVs represent promising biomarker for the diagnosis and treatment of DKD.
Biomarkers ; metabolism ; Databases, Factual ; Diabetic Nephropathies ; diagnosis ; metabolism ; Extracellular Vesicles ; metabolism ; Humans
7.Effects of two screening models for eye diseases in premature infants
Hai-Bo LIN ; Wen-Lin LI ; Xiao ZHUO ; Ai-Qun HE ; Mu-Dan CHEN
International Eye Science 2018;18(3):596-598
·AIM:To investigate and compare the application of two screening models in the detection of retinopathy of prematurity (ROP). ·METHODS: The clinical data of 600 premature infants (1200 eyes) who underwent screening of eye diseases in the Department of Ophthalmology during the period from January 2016 to January 2017 were analyzed retrospectively. The fundus lesions were examined with binocular indirect ophthalmoscope (BIO) and the third generation of wide-angle digital retinal imaging system (RetCam Ⅲ). The examination results and adverse events during operation were statistically analyzed. ·RESULTS:In 1200 eyes of 600 patients,the probabilities of ROP detected by BIO and RetCam Ⅲ were 10.92% and 10.75%, respectively (P>0.05). With BIO as the golden standard, the accuracy, sensitivity, specificity, positive predictive value and negative predictive value of RetCam Ⅲ in examining ROP were 98.67%, 93.13%, 99.35%, 94.57% and 99.16%, respectively. There was no significant difference in the stage of ROP detected by BIO or RetCam Ⅲ (P>0.05). The probabilities of non-ROP lesions examined by BIO and RetCam Ⅲ were 4.83% and 4.58%, respectively (P>0.05). With BIO as the golden standard, the accuracy, sensitivity, specificity, positive predictive value and negative predictive value of RetCam Ⅲ in examining fundus non-ROP diseases were 99.67%, 94.83%, 99.91%, 98.21% and 99.74%, respectively. During the screening of BIO and RetCam Ⅲ,there were 17 cases (2.83%) and 7 cases(1.17%) with adverse events, respectively (P<0.05).·CONCLUSION: The examination results of RetCam Ⅲ are basically the same as those of BIO for ROP and non-ROP diseases. However,RetCam Ⅲ has more advantages in reducing adverse events during operation.
8.Effect of different incision phacoemulsification on corneal endothelial function and tear film function in senile cataract patients
Hai-Bo LIN ; Wen-Lin LI ; Xiao ZHUO ; Ai-Qun HE
International Eye Science 2018;18(7):1257-1260
·AIM: To explore the effect of different incision phacoemulsification on corneal endothelial function and tear film function in senile cataract (SC) patients. ·METHODS: Totally 90 SC patients (90 eyes) admitted to our hospital were randomly divided into the 2. 2mm group ( n = 47, 47 eyes, 2. 2mm corneal micro - incision phacoemulsification) and the 3. 0mm group ( n= 43, 43 eyes, 3. 0 mm clear corneal micro - incision phacoemulsification). The indexes of corneal endothelial function and tear film function were compared between the two groups before and after operation. ·RESULTS: There was no statistical difference on the average phacoemulsification time (APT), mean effective phacoemulsification time( EPT ),average phacoemulsification energy ( AVE) and preoperative and postoperative intraocular pressure between the two groups (P>0. 05). There were statistical differences on the tear break-up time (BUT), basal tear secretion test (ST-Ⅱ), corneal sodium fluorescein staining (SCSF) score, corneal endothelial cell count, central corneal thickness and the variation coefficient of corneal endothelial cells between the two groups (P<0. 05). At 1wk and 1mo after operation, the BUT in the two groups was significantly lower than that before operation (P<0. 05) while the ST-Ⅱ was significantly higher than that before operation ( P< 0. 05), and the SCSF first increased and then decreased (P < 0. 05 ), and corneal endothelial cell count was significantly lower than that before operation (P<0. 05), and the central corneal thickness and the variation coefficient of corneal endothelial cells significantly increased (P<0. 05). The changed degrees of BUT, ST-Ⅱ, SCSF score, corneal endothelial cell count, central corneal thickness and corneal endothelial cell variation coefficient in the 2. 2mm group were less than those in the 3. 0mm group (P<0. 05). ·CONCLUSION: Phacoemulsification for SC patients can cause some damage in corneal endothelial function and tear film function, and 2. 2mm corneal micro-incision have less damage and faster early recovery.
9.Effects of Remind-to-move Treatment on Functional Recovery after Stroke
An-Qin DONG ; Hai-Yan CAO ; Ai-Qun HE ; Jing-Bo LI ; Tian-Cui NIE ; Yi XIE ; Qi-Xing YING
Chinese Journal of Rehabilitation Theory and Practice 2018;24(3):328-332
Objective To explore the effect of remind-to-move treatment on upper limb motor function,activities of daily living and participation in patients with subacute stroke. Methods From February,2016 to October,2017,45 patients with mild to medium upper limbs dysfunction after stroke were randomly assigned to control group(n=23)and experimental group(n=22).The control group accepted rou-tine occupational therapy,while the experimental group wore a wristwatch on the hemiplegic forearm to encour-age the predetermined training programs,for three weeks.They were measured with Fugl-Meyer Assessment-Up-per Extremity(FMA-UE),Function Independence Measurement(FIM),Motor Activity Log(MAL),and Stroke Impact Scale(SIS)before and after treatment. Results Both groups improved in part of the scores of three scales after treatment(P<0.05),and improved more in the experimental group than in the control group in scores of FMA-UE and FIM,and some sub-scores of MAL and SIS(t>1.183,P<0.05),with no significant difference in other indexes(P>0.05). Conclusion Remind-to-move treatment can promote the recovery of upper limb motor function,activities of daily living and participation in the patients with subacute stroke.
10.Association between hypertriglyceridemic waist?to?height ratio phenotype and chronic kidney disease in a community population in South China: a cross-sectional study.
Xiao-Fei SHAO ; Bi-Fang WU ; Ai-Qun LIU ; Bin LI ; Yong-Qiang LI ; Qin ZHOU ; He-Qun ZOU
Journal of Southern Medical University 2017;37(10):1382-1385
OBJECTIVETo investigate the relationship between hypertriglyceridemic waist to height ratio phenotype (HWHtR) and chronic kidney disease (CKD) in a community population in South China.
METHODSA cross sectional study was conducted among 2142 residents in Zhuhai (Guangdong Province, China) from June to October of 2012. The HWHtR phenotype was defined as a waist to height ratio(WHtR) ≥0.55 and triglyceride level ≥2.0 mmol/L, based on which the participants were divided into HWHtR group and nonHWHtR group. CKD was defined as an eGFR<60 mL/min per 1.73 m2 or an ACR ≥30 mg/g. A logistic regression model was established to investigate the relationship between chronic kidney disease and HWHtR phenotype.
RESULTSCompared with the nonHWHtR group, the HWHtR group had a higher prevalence of chronic kidney disease (11.1% vs 33%, P<0.001). Analysis using the logistic regression model showed that HWHtR was significantly associated with CKD in the unadjusted analyses (OR=3.23, 95% CI: 2.32-4.48, P<0.001). After adjustment for age, sex, history of hypertension, history of diabetes, systolic blood pressure, diastolic blood pressure, drinking, physical exercise, education and current smoking, HWHtR was significantly associated with CKD (OR=2.36, 95% CI: 1.52-3.67, P<0.001); the association of HWHtR and CKD was still significant after further adjustment for BMI (OR=2.12, 95%CI: 1.34-3.35, P<0.001).
CONCLUSIONOur finding suggests that HWHtR is associated with CKD in this community population.

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