1.Ultrasonic anatomical study and clinical application of stellate ganglion block via C7 transverse process
Ai-Li HU ; Jun-Li WANG ; Xiao-Ai CHU ; Jie-Qing CHEN ; Zong-Yu ZHA ; Da-Sheng LU ; Qin-Zhong XIA
Journal of Regional Anatomy and Operative Surgery 2024;33(7):571-575
Objective To investigate the high-frequency ultrasonic anatomical features of the adjacent C7 transverse process and its clinical value in stellate ganglion block(SGB).Methods High-frequency ultrasound was applied to obtain ultrasonographic anatomical sonogram features in the plane of bilateral C7 transverse processes in 52 cases(104 sides in total)of healthy adults and then stored for the operator to learn and correctly label each tissue structure.Fifty patients who underwent ultrasound-guided SGB were selected and divided into the BC7 group(25 cases before study)and AC7 group(25 cases after study).The operation time,SGB success rate,number of adjusted needle tips,dosage of anaesthetic and adverse reaction of patients in both group were recorded.Results The main muscles observed in the C7 plane were the longissimus and anterior scalene muscles,the ultrasonographic anatomical relationships of the vagus nerve located in the carotid sheath,the pleura located posterior to the subclavian artery,and the recurrent laryngeal nerve located in the vicinity of the branches of the inferior thyroid artery are described,and the stellate ganglion was illustrated as a flattened hypoechogenic structure visible on the deep surface of the prevertebral fascia in the region of the external cervical longissimus muscle,vertebral artery and vein,and the medial aspect of the anterior oblique muscle,and emanated the sonographic features of several hypoechoic nerve bundles.Ultrasound guided SGB was completed uneventfully in patients of both groups,and all patients developed Horner syndrome,with the SGB success rate of 100%.The operation time[(5.36±1.11)minutes]of patients in the BC7 group was longer than that in the AC7 group[(3.08±0.86)minutes],the number of adjusted needle tips[(4.20±1.00)times]of patients in the BC7 group was more than that in the AC7 group[(2.24±0.87)times],and the dosage of anaesthetic[(1.82±0.28)mL]of patients in the BC7 group was more than that in the AC7 group[(1.64±0.22)mL],all the differences were statistically significant(P<0.05).There was no significant difference in the incidence of adverse reaction between the two groups(P>0.05).Conclusion After ultrasonic learning of adjacent structures through C7 transverse process,SGB is safe and easy to perform.
2.Surveillance of bacterial resistance in tertiary hospitals across China:results of CHINET Antimicrobial Resistance Surveillance Program in 2022
Yan GUO ; Fupin HU ; Demei ZHU ; Fu WANG ; Xiaofei JIANG ; Yingchun XU ; Xiaojiang ZHANG ; Fengbo ZHANG ; Ping JI ; Yi XIE ; Yuling XIAO ; Chuanqing WANG ; Pan FU ; Yuanhong XU ; Ying HUANG ; Ziyong SUN ; Zhongju CHEN ; Jingyong SUN ; Qing CHEN ; Yunzhuo CHU ; Sufei TIAN ; Zhidong HU ; Jin LI ; Yunsong YU ; Jie LIN ; Bin SHAN ; Yunmin XU ; Sufang GUO ; Yanyan WANG ; Lianhua WEI ; Keke LI ; Hong ZHANG ; Fen PAN ; Yunjian HU ; Xiaoman AI ; Chao ZHUO ; Danhong SU ; Dawen GUO ; Jinying ZHAO ; Hua YU ; Xiangning HUANG ; Wen'en LIU ; Yanming LI ; Yan JIN ; Chunhong SHAO ; Xuesong XU ; Wei LI ; Shanmei WANG ; Yafei CHU ; Lixia ZHANG ; Juan MA ; Shuping ZHOU ; Yan ZHOU ; Lei ZHU ; Jinhua MENG ; Fang DONG ; Zhiyong LÜ ; Fangfang HU ; Han SHEN ; Wanqing ZHOU ; Wei JIA ; Gang LI ; Jinsong WU ; Yuemei LU ; Jihong LI ; Qian SUN ; Jinju DUAN ; Jianbang KANG ; Xiaobo MA ; Yanqing ZHENG ; Ruyi GUO ; Yan ZHU ; Yunsheng CHEN ; Qing MENG ; Shifu WANG ; Xuefei HU ; Wenhui HUANG ; Juan LI ; Quangui SHI ; Juan YANG ; Abulimiti REZIWAGULI ; Lili HUANG ; Xuejun SHAO ; Xiaoyan REN ; Dong LI ; Qun ZHANG ; Xue CHEN ; Rihai LI ; Jieli XU ; Kaijie GAO ; Lu XU ; Lin LIN ; Zhuo ZHANG ; Jianlong LIU ; Min FU ; Yinghui GUO ; Wenchao ZHANG ; Zengguo WANG ; Kai JIA ; Yun XIA ; Shan SUN ; Huimin YANG ; Yan MIAO ; Mingming ZHOU ; Shihai ZHANG ; Hongjuan LIU ; Nan CHEN ; Chan LI ; Jilu SHEN ; Wanqi MEN ; Peng WANG ; Xiaowei ZHANG ; Yanyan LIU ; Yong AN
Chinese Journal of Infection and Chemotherapy 2024;24(3):277-286
Objective To monitor the susceptibility of clinical isolates to antimicrobial agents in tertiary hospitals in major regions of China in 2022.Methods Clinical isolates from 58 hospitals in China were tested for antimicrobial susceptibility using a unified protocol based on disc diffusion method or automated testing systems.Results were interpreted using the 2022 Clinical &Laboratory Standards Institute(CLSI)breakpoints.Results A total of 318 013 clinical isolates were collected from January 1,2022 to December 31,2022,of which 29.5%were gram-positive and 70.5%were gram-negative.The prevalence of methicillin-resistant strains in Staphylococcus aureus,Staphylococcus epidermidis and other coagulase-negative Staphylococcus species(excluding Staphylococcus pseudintermedius and Staphylococcus schleiferi)was 28.3%,76.7%and 77.9%,respectively.Overall,94.0%of MRSA strains were susceptible to trimethoprim-sulfamethoxazole and 90.8%of MRSE strains were susceptible to rifampicin.No vancomycin-resistant strains were found.Enterococcus faecalis showed significantly lower resistance rates to most antimicrobial agents tested than Enterococcus faecium.A few vancomycin-resistant strains were identified in both E.faecalis and E.faecium.The prevalence of penicillin-susceptible Streptococcus pneumoniae was 94.2%in the isolates from children and 95.7%in the isolates from adults.The resistance rate to carbapenems was lower than 13.1%in most Enterobacterales species except for Klebsiella,21.7%-23.1%of which were resistant to carbapenems.Most Enterobacterales isolates were highly susceptible to tigecycline,colistin and polymyxin B,with resistance rates ranging from 0.1%to 13.3%.The prevalence of meropenem-resistant strains decreased from 23.5%in 2019 to 18.0%in 2022 in Pseudomonas aeruginosa,and decreased from 79.0%in 2019 to 72.5%in 2022 in Acinetobacter baumannii.Conclusions The resistance of clinical isolates to the commonly used antimicrobial agents is still increasing in tertiary hospitals.However,the prevalence of important carbapenem-resistant organisms such as carbapenem-resistant K.pneumoniae,P.aeruginosa,and A.baumannii showed a downward trend in recent years.This finding suggests that the strategy of combining antimicrobial resistance surveillance with multidisciplinary concerted action works well in curbing the spread of resistant bacteria.
3.Changing resistance profiles of Staphylococcus isolates in hospitals across China:results from the CHINET Antimicrobial Resistance Surveillance Program,2015-2021
Yuling XIAO ; Mei KANG ; Yi XIE ; Yang YANG ; Fupin HU ; Demei ZHU ; Yingchun XU ; Xiaojiang ZHANG ; Ping JI ; Fengbo ZHANG ; Chuanqing WANG ; Pan FU ; Yuanhong XU ; Ying HUANG ; Ziyong SUN ; Zhongju CHEN ; Yuxing NI ; Jingyong SUN ; Yunzhuo CHU ; Sufei TIAN ; Zhidong HU ; Jin LI ; Yunsong YU ; Jie LIN ; Bin SHAN ; Yan DU ; Sufang GUO ; Lianhua WEI ; Fengmei ZOU ; Hong ZHANG ; Chun WANG ; Yunjian HU ; Xiaoman AI ; Chao ZHUO ; Danhong SU ; Dawen GUO ; Jinying ZHAO ; Hua YU ; Xiangning HUANG ; Wen'en LIU ; Yanming LI ; Yan JIN ; Chunhong SHAO ; Xuesong XU ; Chao YAN ; Shanmei WANG ; Yafei CHU ; Lixia ZHANG ; Juan MA ; Shuping ZHOU ; Yan ZHOU ; Lei ZHU ; Jinhua MENG ; Fang DONG ; Zhiyong LÜ ; Fangfang HU ; Han SHEN ; Wanqing ZHOU ; Wei JIA ; Gang LI ; Jinsong WU ; Yuemei LU ; Jihong LI ; Jinju DUAN ; Jianbang KANG ; Xiaobo MA ; Yanping ZHENG ; Ruyi GUO ; Yan ZHU ; Yunsheng CHEN ; Qing MENG ; Shifu WANG ; Xuefei HU ; Jilu SHEN ; Wenhui HUANG ; Ruizhong WANG ; Hua FANG ; Bixia YU ; Yong ZHAO ; Ping GONG ; Kaizhen WEN ; Yirong ZHANG ; Jiangshan LIU ; Longfeng LIAO ; Hongqin GU ; Lin JIANG ; Wen HE ; Shunhong XUE ; Jiao FENG ; Chunlei YUE
Chinese Journal of Infection and Chemotherapy 2024;24(5):570-580
Objective To investigate the changing distribution and antibiotic resistance profiles of clinical isolates of Staphylococcus in hospitals across China from 2015 to 2021.Methods Antimicrobial susceptibility testing was conducted for the clinical isolates of Staphylococcus according to the unified protocol of CHINET(China Antimicrobial Surveillance Network)using disk diffusion method and commercial automated systems.The CHINET antimicrobial resistance surveillance data from 2015 to 2021 were interpreted according to the 2021 CLSI breakpoints and analyzed using WHONET 5.6.Results During the period from 2015 to 2021,a total of 204,771 nonduplicate strains of Staphylococcus were isolated,including 136,731(66.8%)strains of Staphylococcus aureus and 68,040(33.2%)strains of coagulase-negative Staphylococcus(CNS).The proportions of S.aureus isolates and CNS isolates did not show significant change.S.aureus strains were mainly isolated from respiratory specimens(38.9±5.1)%,wound,pus and secretions(33.6±4.2)%,and blood(11.9±1.5)%.The CNS strains were predominantly isolated from blood(73.6±4.2)%,cerebrospinal fluid(12.1±2.5)%,and pleural effusion and ascites(8.4±2.1)%.S.aureus strains were mainly isolated from the patients in ICU(17.0±7.3)%,outpatient and emergency(11.6±1.7)%,and department of surgery(11.2±0.9)%,whereas CNS strains were primarily isolated from the patients in ICU(32.2±9.7)%,outpatient and emergency(12.8±4.7)%,and department of internal medicine(11.2±1.9)%.The prevalence of methicillin-resistant strains was 32.9%in S.aureus(MRSA)and 74.1%in CNS(MRCNS).Over the 7-year period,the prevalence of MRSA decreased from 42.1%to 29.2%,and the prevalence of MRCNS decreased from 82.1%to 68.2%.MRSA showed higher resistance rates to all the antimicrobial agents tested except trimethoprim-sulfamethoxazole than methicillin-susceptible S.aureus(MSSA).Over the 7-year period,MRSA strains showed decreasing resistance rates to gentamicin,rifampicin,and levofloxacin,MRCNS showed decreasing resistance rates to gentamicin,erythromycin,rifampicin,and trimethoprim-sulfamethoxazole,but increasing resistance rate to levofloxacin.No vancomycin-resistant strains were detected.The prevalence of linezolid-resistant MRCNS increased from 0.2%to 2.3%over the 7-year period.Conclusions Staphylococcus remains the major pathogen among gram-positive bacteria.MRSA and MRCNS were still the principal antibiotic-resistant gram-positive bacteria.No S.aureus isolates were found resistant to vancomycin or linezolid,but linezolid-resistant strains have been detected in MRCNS isolates,which is an issue of concern.
4.Epidemiological characteristics of a local cluster epidemic caused by 2019-nCoV Delta variant in Ningbo, 2021.
Dong Liang ZHANG ; Yi CHEN ; Bo YI ; Ai Hong WANG ; Xiao MA ; Yan Ru CHU ; Song LEI ; Yan Wu ZHANG ; Meng Ying LI ; Guo Zhang XU
Chinese Journal of Epidemiology 2022;43(9):1376-1380
Objective: To understand the epidemiological characteristics of a local clustered epidemic caused by 2019-nCoV Delta variant in Ningbo and provide reference for the improvement of COVID-19 epidemic prevention and control. Methods: Case finding was conducted based on case definitions, and field epidemiological investigation of COVID-19 cases was carried out. In which Nasal and oropharyngeal swabs of the cases were collected for pathogen testing, and the results were analyzed with descriptive epidemiological methods. Results: A total of 74 COVID-19 cases were reported in this epidemic, and the cases were mainly mild ones, accounting for 87.84% (65/74), and there were no severe or critical cases. The epidemic curve showed a human-to-human transmission mode, indicating that a transmission for at least six generations had occurred. The age of the COVID-19 patients ranged from 2 years to 80 years, and 27.03% (20/74) of the cases were older than 60 years. The cases were mainly workers (55.41%, 41/74) and housework/the unemployed (27.03%, 20/74). The COVID-19 epidemic was limited, and no further spread to other areas occurred. The transmission chain among the cases was clear, and the gene sequencing results confirmed that the current epidemic was caused by 2019-nCoV Delta variant, which was highly homologous to the strains from other province. Conclusion: The local COVID-19 epidemic in Ningbo was caused by imported cases of COVID-19 from other province, and local community spread occurred through daily contacts between cases and contacts.
COVID-19/epidemiology*
;
Child, Preschool
;
Data Collection
;
Epidemics
;
Humans
;
SARS-CoV-2
5.Spatio-temporal trend of female breast cancer mortality in Shandong Province from 1970 to 2013.
Jie CHU ; Zi Long LU ; Jing LIU ; Zhen Tao FU ; Ting LIU ; Jing DONG ; Jie REN ; Xian Xian CHEN ; Xiao Lei GUO ; Ai Qiang XU
Chinese Journal of Preventive Medicine 2022;56(5):609-613
The mortality of female breast cancer in Shandong Province has increased since the 1970. The differential decomposition analysis found that the slight decline in the crude mortality of breast cancer among women was entirely due to non-demographic factors during the 1970-1990, and the significant increase in the crude mortality was due to a combination of demographic and non-demographic factors since the 1990. The contribution rate of demographic factor has gradually increased from 53.5% in 2004-2005 to 59.5% in 2011-2013, while that of non-demographic factor has decreased from 46.5% to 40.5%. The women aged 45-64 years old were the major population of female breast cancer deaths, accounting for 40%-60% of total breast cancer deaths in different times, and then the mortality in female aged 55-64 years old increased rapidly, with increases of 52.12%, 115.19% and 29.01% in 2011-2013 over the 1970-1974, 1990-1992 and 2004-2005, respectively (Z=-7.342,P<0.001). Compared with 1970-1974, the age-standardized mortality rate of rural women increased by 41.86% in 2011-2013 (Z=-17.933, P<0.001), and that of urban women increased by 18.62% in 2011-2013 (Z=-25.642, P<0.001). The age-standardized mortality rate of breast cancer in urban women was higher than that in rural women in different times (all P<0.05). The spatial scan analysis found that eastern Shandong Province was found to be a sustained high-risk area for death, and other high-risk areas were transferred from north to southwest of Shandong between 1970 and 2013.
Breast Neoplasms/epidemiology*
;
Female
;
Humans
;
Middle Aged
;
Rural Population
;
Spatial Analysis
6.Comparison of the application of different version of diagnostic criteria for occupational noise-induced deafness
ZHANG Xiao xiao YANG Ai chu LIANG Xiao yang XIAO Ming hui CAO Dan yan
China Occupational Medicine 2022;49(06):626-630
Objective - ( )
To explore the influence on the diagnosis of occupational noise induced deafness ONID using three
, Methods
versions of diagnostic criteria in 2002 2007 and 2014. A total of 1 766 workers who asked for ONID diagnosis
were selected as the research subjects using judgment sampling method. The results of pure tone audiometry were collected.
GBZ 49-2002Diagnostic Criteria of Occupational Noise-inducedHearing Loss(
The ONID was diagnosed using hereinafter referred to as
GBZ 49-2002),GBZ 49-2007Diagnostic Criteria of Occupational Noise-induced Deafness( GBZ 49-2007)
hereinafter referred to as
GBZ 49-2014 Diagnostic of Occupational Noise-induced Deafness( GBZ 49-2014),
and hereinafter referred to as and the
Results - - , -
diagnostic results were compared. Compared with GBZ 49 2002 and GBZ 49 2007 diagnosis with GBZ 49 2014 had
( vs , vs , P ), ( vs ,
a higher rate of ONID 57.9% 66.0% 44.8% 66.0% both <0.01 and had a higher rate of mild ONID 47.3% 54.6%
vs , P ) - -
36.0% 54.6% both <0.01 . The diagnostic rate for ONID using GBZ 492014 was higher than those using GBZ 49 2002 and
- ( P )Conclusion -
GBZ 49 2007 in each age groups all <0.01 . GBZ 49 2014 improved the diagnostic rate of ONID compared
- -
with GBZ 49 2002 and GBZ 49 2007. The reason is related to the inclusion of 4 000 Hz hearing threshold with a weight of 0.1
-
as the diagnostic hearing threshold and the use of a new age and gender correction method in GBZ 49 2014.
7.Assessment of occupational health risk of noise in a plastic products enterprise
ZHAN Li chun XIAO Bin YANG Ai chu GUO Jian yu LONG Tai hua XU Guo yong YAN Mao sheng LIU Mao ling
China Occupational Medicine 2022;49(05):553-
Objective
To assess the occupational health risk of noise in a plastic products enterprise and determine the key risk
Methods -
points. The workplace of a plastic products enterprise and its 388 noise exposed workers were selected as the
,
research subjects using a convenient sampling method. The noise intensity in the workplace of the enterprise was measured and
- GBZ/T 229.4-2012
the individual noise exposure level and pure tone hearing test were carried out in the noise exposed workers.
Classification of Occupational Hazards at Workplaces--Part 4: Occupational Exposure to Noise( GBZ/T
hereinafter referred to as
229.4-2012) -
was used to evaluate the hazardous degree of noise in different posts. The risk of high frequency hearing loss
( ) - ( ) - , ,
HFHL and occupational noise induced deafness ONID in noise exposed workers in different posts at 45.0 50.0 55.0 and
WS/T 754-2016 Guideline for Risk Management of Occupational Noise Hazard(
60.0 years of age were predicted using hereinafter
WS/T 754-2016)Results
referred to as . The noise in the workplace of this plastic product enterprise was found to exceed the
-
occupational exposure limits with the rate of 46.6%. The maximum level of normalization of equivalent continuous A weighted
- ( )
sound pressure level to a nominal 40 h working week of exposure to noise in workers of six posts was 84.0 93.0 dB A .
- , , ,
According to GBZ/T 229.4 2012 the noise hazards of the posts including extrusion premixing unloading and utility
- ,
maintenance were mild or moderate except for the film and packaging posts. According to WS/T 754 2016 the risks of HFHL in
, ,
the film and packaging operators at age ≥50.0 years old were at acceptable risk and the risks of HFHL in operators of extrusion
, ,
premixing unloading and utility maintenance at age ≥45.0 years old were at moderate risk or high risk. The risks of ONID for
,
the film packaging and utility maintenance operators at age ≥55.0 years old were at acceptable risk or moderate risk. The risksof ONID for extrusion premixing and unloading operators at age ≥50.0 years old were at high risk. Extrusion operators with
( )
exposure to toluene below the occupational exposure limit had a higher risk of HFHL high risk than unloading operators
( ) Conclusion
moderate risk at age 45.0 years with the same noise intensity. The noise exposure intensity is high in the
,
workplace of the plastic product enterprise. The workers in posts of extrusion premixing and unloading are at high risk levels of
HFHL and ONID.
8. Analysis of the on-site quality inspection results of occupational medical examination institutions in Guangdong Province in 2020
Ming-hui XIAO ; Ai-chu YANG ; Li-hua XIA ; Jia-bin CHEN ; Ji-jun GUO
China Occupational Medicine 2021;48(03):334-339
OBJECTIVE: To analyze the problems existing in the on-site quality inspection of occupational medical examination(OME) institutions in Guangdong Province. METHODS: A total of 96 OME institutions in Guangdong Province were selected as the research subjects using the random number table method. On-site quality inspections were carried out and the results were analyzed. RESULTS: The OME institutions participating in the on-site quality inspection in 2020 accounted for 49.0%(96/196) of total OME institutions in Guangdong Province. Among them, occupational disease prevention and control hospitals/institutions, Centers for Disease Control and Prevention(CDC), public hospitals, and private hospitals accounted for 8.3%, 9.4%, 42.7% and 39.6%, respectively. They were distributed in 17 prefecture-level cities. The registered OME qualifications include dust, chemical factors, physical factors, radiological factors and other categories. Some institutions have registered two or more OME qualifications. The non-qualified rate of the on-site quality inspections in six assessment modules of the 96 OME institutions from high to low were quality management work, equipment(instruments and vehicles) allocation, quality management system, medical and health technical personnel allocation, information report, and on-site professional assessment module, with the non-qualified rate of 24.1%, 22.4%, 20.7%, 15.9%, 15.6% and 1.1% respectively(P<0.01). The problems were mostly concentrated in the CDC, public and private hospitals, and rarely in occupational disease prevention and treatment hospitals/institutes. In addition to the on-site professional assessment module, a total of 696 non-qualified items were detected in the remaining five modules of the 96 OME institutions, with an average of seven items per institution. Occupational disease prevention and treatment hospitals/institutions, CDC, public hospitals, and private hospitals had an average of 2, 9, 8, 7 non-qualified items respectively. CONCLUSION: In the on-site quality assessment of OME institutions in Guangdong Province, there are relatively few problems in all aspects of occupational disease prevention and treatment hospitals/institutes. CDC has certain inadequacies. The public and private hospitals have more prominent problems in aspects of equipment(instruments and vehicles) allocation, quality management system and quality management work.
9.Effect of Mobile Health for Standardized Management on Women with Gestational Diabetes Mellitus.
Fei-Ling HUANG ; Hui-Ying HU ; Su-Han ZHANG ; Li LI ; Li ZHANG ; Xiao-Xia CHEN ; Chu-Ci ZHANG ; Hong-Xiu ZHONG ; Ai-Min YAO ; Cui-Ying LIU ; Ning-Zhi ZHANG ; Xiao-Wen XUE ; Liang-Kun MA
Acta Academiae Medicinae Sinicae 2021;43(4):551-557
Objective To explore the performance of mobile health platform for standardized management of pregnant women with gestational diabetes mellitus(GDM). Methods A randomized controlled trial was conducted,in which 295 women with GDM were randomized into two groups(traditional management group and mobile health management group)by a computer-generated sequence.The traditional management group accepted standardized GDM management,and the mobile health management group was supplemented by mobile health management based on the standardized management.The glycemic control rate and the incidences of low birth weight,macrosomia,preterm birth,premature rupture of membranes,postpartum hemorrhage after cesarean section,neonatal asphyxia,malformation,and admission to the neonatal intensive care unit were compared between the two groups. Results The glycemic control rate in mobile health management group was significantly higher than that in the traditional management group [(67.22±22.76)%
Cesarean Section
;
Diabetes, Gestational/therapy*
;
Female
;
Fetal Macrosomia
;
Humans
;
Infant, Newborn
;
Pregnancy
;
Pregnancy Outcome
;
Premature Birth
;
Telemedicine
10.Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial.
Jia-Bo WANG ; Zhong-Xia WANG ; Jing JING ; Peng ZHAO ; Jing-Hui DONG ; Yong-Feng ZHOU ; Guang YANG ; Ming NIU ; Xu ZHAO ; Tian-Jun JIANG ; Jing-Feng BI ; Zhe XU ; Ping ZHANG ; Dan WU ; Zhao-Fang BAI ; Yu-Ming GUO ; Si-Miao YU ; Yong-Qiang SUN ; Zi-Teng ZHANG ; Xiao-Yan ZHAN ; Peng-Yan LI ; Jin-Biao DING ; Peng-Fei ZHAO ; Xue-Ai SONG ; Jian-Yuan TANG ; Dong-Chu HE ; Zhu CHEN ; En-Qiang QIN ; Rui-Lin WANG ; Xiao-He XIAO
Chinese journal of integrative medicine 2020;26(9):648-655
OBJECTIVES:
To develop a new Chinese medicine (CM)-based drug and to evaluate its safety and effect for suppressing acute respiratory distress syndrome (ARDS) in COVID-19 patients.
METHODS:
A putative ARDS-suppressing drug Keguan-1 was first developed and then evaluated by a randomized, controlled two-arm trial. The two arms of the trial consist of a control therapy (alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir, 400 and 100 mg twice daily, respectively) and a testing therapy (control therapy plus Keguan-1 19.4 g twice daily) by random number table at 1:1 ratio with 24 cases each group. After 2-week treatment, adverse events, time to fever resolution, ARDS development, and lung injury on newly diagnosed COVID-19 patients were assessed.
RESULTS:
An analysis of the data from the first 30 participants showed that the control arm and the testing arm did not exhibit any significant differences in terms of adverse events. Based on this result, the study was expanded to include a total of 48 participants (24 cases each arm). The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).
CONCLUSIONS
Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients. (Trial registration No. NCT04251871 at www.clinicaltrials.gov ).
Administration, Inhalation
;
Adult
;
China
;
Coronavirus Infections
;
diagnosis
;
drug therapy
;
mortality
;
Dose-Response Relationship, Drug
;
Drug Administration Schedule
;
Drugs, Chinese Herbal
;
administration & dosage
;
Female
;
Follow-Up Studies
;
Humans
;
Integrative Medicine
;
Interferon-alpha
;
administration & dosage
;
Lopinavir
;
administration & dosage
;
Male
;
Middle Aged
;
Pandemics
;
Pneumonia, Viral
;
diagnosis
;
drug therapy
;
mortality
;
Risk Assessment
;
Severe Acute Respiratory Syndrome
;
diagnosis
;
drug therapy
;
mortality
;
Severity of Illness Index
;
Survival Rate

Result Analysis
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