1.A real-world retrospective study of pelvic floor muscle training efficacy using an APP-based home device
Ji-Qiong ZHENG ; Shi-Ping ZHOU ; Zhong-Yun ZHANG ; Wei-Qing QIAN ; Zheng-Wang ZHANG
Fudan University Journal of Medical Sciences 2024;51(1):96-101
Objective To retrospectively investigate the efficacy of pelvic floor muscle training(PFMT)using APP-based home device in the real-world scenario.Methods A retrospective survey was conducted among 171 000 Chinese female users over 18 years old who freely registered APP and performed PFMT using a domestic manufactured home device from Oct 1,2019 to Mar 31,2021.The Patient Global Impression of Improvement(PGI-I)questionnaires concerning pelvic floor general condition,sexual satisfaction and other three major symptoms related to pelvic floor muscle laxity such as stress urinary incontinence(SUI),pelvic organ prolapse(POP),and vaginal laxity(VL)were broadcast public online for users to self-assess the improvement.The vaginal muscle strength values prior and post training recorded by APP were also reported.All data were collected anonymously for further stratified analysis.Results A total of 984 valid questionnaires were collected by systematic sampling.The PGI-I scores of pelvic floor general condition(P=0.000 1),sexual satisfaction(P=0.009),SUI(P=0.000 1),POP(P=0.044)and VL(P=0.034)were statistically significant in users who reported to use the device for 3 months or more compared with those less than 3 months.In addition,the increase of vaginal muscle strength was related to the improvement of PGI-I scores in SUI and POP with statistical significance.There were no significant difference in subgroups such as age,education,parity,and delivery mode.Conclusion The subjective benefit of pelvic floor function-related symptoms and the improvement of vaginal muscle strength could be observed after PFMT for three months or more using APP-based home device in Chinese women in the real-world scenario.
2.A Comprehensive Study of the Association between LEPR Gene rs1137101 Variant and Risk of Digestive System Cancers
Qiong Wei HU ; Guang Wei ZHOU ; Wei Guang ZHOU ; Xi Jia LIAO ; Xing Jia SHI ; FengYang XIE ; Heng Shou LI ; Yong WANG ; Hong Xian FENG ; Li Xiu GU ; Feng Bi CHEN
Biomedical and Environmental Sciences 2024;37(5):445-456
Objective The leptin receptor,encoded by the LEPR gene,is involved in tumorigenesis.A potential functional variant of LEPR,rs1137101(Gln223Arg),has been extensively investigated for its contribution to the risk of digestive system(DS)cancers,but results remain conflicting rather than conclusive.Here,we performed a case-control study and subsequent meta-analysis to examine the association between rs1137101 and DS cancer risk. Methods A total of 1,727 patients with cancer(gastric/liver/colorectal:460/480/787)and 800 healthy controls were recruited.Genotyping of rs1137101 was conducted using a polymerase chain reaction-restriction fragment length polymorphism(PCR-RFLP)assay and confirmed using Sanger sequencing.Twenty-four eligible studies were included in the meta-analysis. Results After Bonferroni correction,the case-control study revealed that rs1137101 was significantly associated with the risk of liver cancer in the Hubei Chinese population.The meta-analysis suggested that rs1137101 is significantly associated with the risk of overall DS,gastric,and liver cancer in the Chinese population. Conclusion The LEPR rs1137101 variant may be a genetic biomarker for susceptibility to DS cancers(especially liver and gastric cancer)in the Chinese population.
3.Clinical efficacy of wearing base curve aspheric orthokeratology lens in the control of myopia
Rui WANG ; Jiang LIN ; Li LI ; Si-Lin BIAN ; Xue-Mei FU ; Xin-Yao MAO ; Shi-Ping ZHOU ; Qiong WANG
International Eye Science 2023;23(4):563-566
AIM: To evaluate the clinical efficacy of wearing base curve aspheric orthokeratology(OK)lens in the control of myopia.METHODS: A prospective study was conducted. A total of 94 cases(94 eyes)of myopia aged 8~13 years old who were fitted with orthokeratology(OK)lens in our hospital from January 2020 to July 2021 were selected(for patients who received OK lens in one eye, the eye is selected as the observation eye, and for patients who receive OK lens in both eyes, the right eye is used as the observation eye). Patients were divided into two groups according to the design of the OK lens, with 46 cases wearing base curve aspheric OK lens in study group and 48 cases wearing base curve spheric OK lens in control group. The study group and the control group were further divided into low myopia group(-3.00D< SE ≤-0.75D)and moderate myopia group(-6.00D< SE ≤-3.00D)according to the baseline spherical equivalent(SE), with 52 cases(52 eyes)in the low myopia group and 42 cases(42 eyes)in the moderate myopia group. Uncorrected visual acuity(UCVA)was evaluated at 1d, 1wk, 1, 3, 6 and 9mo after wearing lenses, and axial length were measured at 6mo and 1a after wearing lenses respectively.RESULTS: All patients completed follow-up, and there was no significant differences in UCVA(LogMAR)between the study group(-0.12±0.08)and the control group(-0.17±0.07)after wearing the OK lens for 1mo(P>0.05); the mean axial length elongation between the two groups had no significant differences after wearing lenses for 6mo and 1a(all P>0.05). In the low myopia group, the axial length elongation of the study group was 0.19±0.17mm after wearing OK lens for 1a, which was significantly lower than that of the control group(0.31±0.18mm; P<0.05); while in the moderate myopia group, the axial length elongation was 0.22±0.18mm, and it had no significant differences with that in the control group(0.19±0.12mm; P>0.05). There was no significant differences in axial length elongation between the low myopia group and the moderate myopia group in study group after wearing lenses for 6mo and 1a(P>0.05), while there was differences in axial length elongation between low myopia group and moderate myopia group in the control group after wearing lenses for 6mo(0.15±0.13 vs. 0.05±0.12mm)and 1a(0.31±0.18 vs. 0.19±0.12mm; all P<0.05).CONCLUSION: Wearing base curve aspheric OK lens can effectively improve the UCVA and control the elongation of axial length. For patients with low myopia, base curve aspheric OK lens had a better efficacy in controlling the elongation of axial length than the spheric OK lens.
4.Epidemiological Survey of Hemoglobinopathies Based on Next-Generation Sequencing Platform in Hunan Province, China.
Hui XI ; Qin LIU ; Dong Hua XIE ; Xu ZHOU ; Wang Lan TANG ; De Guo TANG ; Chun Yan ZENG ; Qiong WANG ; Xing Hui NIE ; Jin Ping PENG ; Xiao Ya GAO ; Hong Liang WU ; Hao Qing ZHANG ; Li QIU ; Zong Hui FENG ; Shu Yuan WANG ; Shu Xiang ZHOU ; Jun HE ; Shi Hao ZHOU ; Fa Qun ZHOU ; Jun Qing ZHENG ; Shun Yao WANG ; Shi Ping CHEN ; Zhi Fen ZHENG ; Xiao Yuan MA ; Jun Qun FANG ; Chang Biao LIANG ; Hua WANG
Biomedical and Environmental Sciences 2023;36(2):127-134
OBJECTIVE:
This study was aimed at investigating the carrier rate of, and molecular variation in, α- and β-globin gene mutations in Hunan Province.
METHODS:
We recruited 25,946 individuals attending premarital screening from 42 districts and counties in all 14 cities of Hunan Province. Hematological screening was performed, and molecular parameters were assessed.
RESULTS:
The overall carrier rate of thalassemia was 7.1%, including 4.83% for α-thalassemia, 2.15% for β-thalassemia, and 0.12% for both α- and β-thalassemia. The highest carrier rate of thalassemia was in Yongzhou (14.57%). The most abundant genotype of α-thalassemia and β-thalassemia was -α 3.7/αα (50.23%) and β IVS-II-654/β N (28.23%), respectively. Four α-globin mutations [CD108 (ACC>AAC), CAP +29 (G>C), Hb Agrinio and Hb Cervantes] and six β-globin mutations [CAP +8 (C>T), IVS-II-848 (C>T), -56 (G>C), beta nt-77 (G>C), codon 20/21 (-TGGA) and Hb Knossos] had not previously been identified in China. Furthermore, this study provides the first report of the carrier rates of abnormal hemoglobin variants and α-globin triplication in Hunan Province, which were 0.49% and 1.99%, respectively.
CONCLUSION
Our study demonstrates the high complexity and diversity of thalassemia gene mutations in the Hunan population. The results should facilitate genetic counselling and the prevention of severe thalassemia in this region.
Humans
;
beta-Thalassemia/genetics*
;
alpha-Thalassemia/genetics*
;
Hemoglobinopathies/genetics*
;
China/epidemiology*
;
High-Throughput Nucleotide Sequencing
5.A multicenter epidemiological study of acute bacterial meningitis in children.
Cai Yun WANG ; Hong Mei XU ; Jiao TIAN ; Si Qi HONG ; Gang LIU ; Si Xuan WANG ; Feng GAO ; Jing LIU ; Fu Rong LIU ; Hui YU ; Xia WU ; Bi Quan CHEN ; Fang Fang SHEN ; Guo ZHENG ; Jie YU ; Min SHU ; Lu LIU ; Li Jun DU ; Pei LI ; Zhi Wei XU ; Meng Quan ZHU ; Li Su HUANG ; He Yu HUANG ; Hai Bo LI ; Yuan Yuan HUANG ; Dong WANG ; Fang WU ; Song Ting BAI ; Jing Jing TANG ; Qing Wen SHAN ; Lian Cheng LAN ; Chun Hui ZHU ; Yan XIONG ; Jian Mei TIAN ; Jia Hui WU ; Jian Hua HAO ; Hui Ya ZHAO ; Ai Wei LIN ; Shuang Shuang SONG ; Dao Jiong LIN ; Qiong Hua ZHOU ; Yu Ping GUO ; Jin Zhun WU ; Xiao Qing YANG ; Xin Hua ZHANG ; Ying GUO ; Qing CAO ; Li Juan LUO ; Zhong Bin TAO ; Wen Kai YANG ; Yong Kang ZHOU ; Yuan CHEN ; Li Jie FENG ; Guo Long ZHU ; Yan Hong ZHANG ; Ping XUE ; Xiao Qin LI ; Zheng Zhen TANG ; De Hui ZHANG ; Xue Wen SU ; Zheng Hai QU ; Ying ZHANG ; Shi Yong ZHAO ; Zheng Hong QI ; Lin PANG ; Cai Ying WANG ; Hui Ling DENG ; Xing Lou LIU ; Ying Hu CHEN ; Sainan SHU
Chinese Journal of Pediatrics 2022;60(10):1045-1053
Objective: To analyze the clinical epidemiological characteristics including composition of pathogens , clinical characteristics, and disease prognosis acute bacterial meningitis (ABM) in Chinese children. Methods: A retrospective analysis was performed on the clinical and laboratory data of 1 610 children <15 years of age with ABM in 33 tertiary hospitals in China from January 2019 to December 2020. Patients were divided into different groups according to age,<28 days group, 28 days to <3 months group, 3 months to <1 year group, 1-<5 years of age group, 5-<15 years of age group; etiology confirmed group and clinically diagnosed group according to etiology diagnosis. Non-numeric variables were analyzed with the Chi-square test or Fisher's exact test, while non-normal distrituction numeric variables were compared with nonparametric test. Results: Among 1 610 children with ABM, 955 were male and 650 were female (5 cases were not provided with gender information), and the age of onset was 1.5 (0.5, 5.5) months. There were 588 cases age from <28 days, 462 cases age from 28 days to <3 months, 302 cases age from 3 months to <1 year of age group, 156 cases in the 1-<5 years of age and 101 cases in the 5-<15 years of age. The detection rates were 38.8% (95/245) and 31.5% (70/222) of Escherichia coli and 27.8% (68/245) and 35.1% (78/222) of Streptococcus agalactiae in infants younger than 28 days of age and 28 days to 3 months of age; the detection rates of Streptococcus pneumonia, Escherichia coli, and Streptococcus agalactiae were 34.3% (61/178), 14.0% (25/178) and 13.5% (24/178) in the 3 months of age to <1 year of age group; the dominant pathogens were Streptococcus pneumoniae and the detection rate were 67.9% (74/109) and 44.4% (16/36) in the 1-<5 years of age and 5-<15 years of age . There were 9.7% (19/195) strains of Escherichia coli producing ultra-broad-spectrum β-lactamases. The positive rates of cerebrospinal fluid (CSF) culture and blood culture were 32.2% (515/1 598) and 25.0% (400/1 598), while 38.2% (126/330)and 25.3% (21/83) in CSF metagenomics next generation sequencing and Streptococcus pneumoniae antigen detection. There were 4.3% (32/790) cases of which CSF white blood cell counts were normal in etiology confirmed group. Among 1 610 children with ABM, main intracranial imaging complications were subdural effusion and (or) empyema in 349 cases (21.7%), hydrocephalus in 233 cases (14.5%), brain abscess in 178 cases (11.1%), and other cerebrovascular diseases, including encephalomalacia, cerebral infarction, and encephalatrophy, in 174 cases (10.8%). Among the 166 cases (10.3%) with unfavorable outcome, 32 cases (2.0%) died among whom 24 cases died before 1 year of age, and 37 cases (2.3%) had recurrence among whom 25 cases had recurrence within 3 weeks. The incidences of subdural effusion and (or) empyema, brain abscess and ependymitis in the etiology confirmed group were significantly higher than those in the clinically diagnosed group (26.2% (207/790) vs. 17.3% (142/820), 13.0% (103/790) vs. 9.1% (75/820), 4.6% (36/790) vs. 2.7% (22/820), χ2=18.71, 6.20, 4.07, all P<0.05), but there was no significant difference in the unfavorable outcomes, mortility, and recurrence between these 2 groups (all P>0.05). Conclusions: The onset age of ABM in children is usually within 1 year of age, especially <3 months. The common pathogens in infants <3 months of age are Escherichia coli and Streptococcus agalactiae, and the dominant pathogen in infant ≥3 months is Streptococcus pneumoniae. Subdural effusion and (or) empyema and hydrocephalus are common complications. ABM should not be excluded even if CSF white blood cell counts is within normal range. Standardized bacteriological examination should be paid more attention to increase the pathogenic detection rate. Non-culture CSF detection methods may facilitate the pathogenic diagnosis.
Adolescent
;
Brain Abscess
;
Child
;
Child, Preschool
;
Escherichia coli
;
Female
;
Humans
;
Hydrocephalus
;
Infant
;
Infant, Newborn
;
Male
;
Meningitis, Bacterial/epidemiology*
;
Retrospective Studies
;
Streptococcus agalactiae
;
Streptococcus pneumoniae
;
Subdural Effusion
;
beta-Lactamases
6.Investigation on demand for reproductive health-related services of new residents in Shanghai
Yongli ZHOU ; Dongdan WU ; Yuling WU ; Yang GAO ; Jiahua SHI ; Xiufeng SHEN ; Xuequn SHAN ; Yufeng JIN ; Qiong TANG
Shanghai Journal of Preventive Medicine 2022;34(3):268-273
Objective To investigate the fertility history and demand for reproductive health services of new residents in Shanghai. Methods A questionnaire survey was conducted among 1 358 new residents in 36 survey sites in 7 districts of Shanghai from July to September 2020. The content includes fertility history, induced abortion history, demand for reproductive health-related services, awareness rate of the Shanghai Family Planning Association and service access rate, etc. Results Among the new residents themselves and their spouses/sexual partners, 31.3% (374/1 194) had been pregnant once and 33.6% (401/1 194) had been pregnant twice; 46.3% (533/1 194)had one child and 29.7% (355/1 194)had two children. The difference of number of births among new residents with different residence time, those who did or did not possess permanent residency or residence permits, and those from different sources (urban or rural) was statistically significant ( χ 2=158.664, 50.263, 16.011, 114.419, all P <0.001). Among the new residents themselves and their spouses / sexual partners, the proportion of induced abortion of more than once was 36.1%. The difference of the number of abortions of new residents with or without permanent residency was statistically significant ( χ 2=19.389, P <0.001). The awareness rate of new residents of the harm of induced abortion to health was 92.1% (1 100/1 194); There were significant differences in the scientific knowledge of harm of induced abortion to health among new residents with different local residence time and those with or without a residence permit ( χ 2=36.590, 20.926, both P <0.001). The awareness rate of the Family Planning Association was 82.6% (986/1 194), and the service access rate was 51.3% (613/1 194). Permanent residency and residence permits are the main factors that affect the service accessibility of the Shanghai Family Planning Association. 44.8% (535/1 194) of new residents hope to receive reproductive health services in their place of residence, and they are most concerned about knowledge on good prenatal and postnatal care. Conclusion We should further publicize the "three-child" fertility policy, advocate a friendly fertility culture, and provide new residents with people-centered and accurate reproductive health services adapted to their needs through multi-sectoral cooperation, so as to improve their reproductive health level.
7.Location, Pattern and Prognosis of Tumor Metastasis in Dead Patients with Colorectal Cancer
Jia-ming ZHOU ; Xiao-feng WU ; Yuan-hui WU ; Xiao-qiong CHEN ; Shu-yun TAN ; Tuo-yang LI ; Xue-bin SHI ; Mei-jin HUANG
Journal of Sun Yat-sen University(Medical Sciences) 2022;43(2):289-296
ObjectiveIn the past, many studies have reported the mode of colorectal cancer(CRC) metastasis, but there is still a lack of research based on long-term follow-up and death as the end point to summarize the location, mode and related survival data of CRC metastasis. MethodsThe data of 373 dead patients with colorectal cancer in the Sixth Affiliated Hospital of Sun Yat-sen University were reviewed, and the location, mode, incidence and survival data of tumor metastasis were statistically analyzed. Results334 patients (89.5%) died of tumor related death. The liver metastasis rate was 51.5%, the lung metastasis rate was 40.4%, and the peritoneal metastasis rate was 55.7%. The number of patients with liver, lung or peritoneal metastasis only was 27 (8%), 21 (6.3%) and 63 (18.9%) respectively. The prognosis of patients with simple lung metastasis was better (P<0.01). There were 66 patients (19.7%) with simultaneous metastasis of liver, lung and peritoneum, and the prognosis was the worst (P<0.01). ConclusionNot all dead colorectal cancer patients have simultaneous metastasis of liver, lung and peritoneum. There are differences in the location and mode of metastasis in different patients, which is related to survival.
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*
;
Female
;
Gestational Age
;
Humans
;
Infant
;
Infant, Extremely Premature
;
Infant, Newborn
;
Pregnancy
;
Respiratory Distress Syndrome, Newborn/epidemiology*
;
Retrospective Studies
;
Treatment Outcome
9. The transcriptional study of tetramethylpyrazine against cerebral ischemia/reperfusion injury in diabetic rats
Shi-Lin YUAN ; Yu-Jia1 ZHOU ; Xiao YANG ; Miao SUN ; Qiong LIU ; Qing CHANG ; Chang-Chun HEI ; Miao SUN ; Qing CHANG ; Xiao YANG
Chinese Pharmacological Bulletin 2022;38(11):1688-1698
Aim To investigate the protective effect of tetramethylpyrazine ( TMP ) on cerebral ischemia/reper¬fusion ( I/R) injury in diabetes mellitus ( DM ) rats based on full-length transcriptome sequencing tech¬nique and the underlying mechanism. Methods The rat model of DM was induced by intraperitoneal injec- tion of streptozotocin (STZ,50 mg • kg" ) . The global cerebral I/R model of rats was established by double vessel occlusion (2-VO) for 10 min and reperfusion for 16 h. TMP (40 mg • kg ) was injected intraperitone-ally every day. Brain water content detection, HE stai¬ning, Nissl staining and TUNEL staining were used to evaluate the neuroprotective effect of TMP on cerebral I/R injury in DM rats. The differentially expressed genes were screened by full-length transcriptome se¬quencing. The possible candidate genes and metabolic pathways of TMP for cerebral ischemia protection in DM rats were screened by functional annotation and metabolic pathway enrichment analysis, and verified by RT-qPCR and Western blot. Results TMP treatment could reduce the degree of brain edema, increase the number of Nissl bodies and neurons, and significantly reduce cell necrosis and apoptosis after cerebral I/R in DM rats. GO enrichment analysis showed that the dif¬ferentially expressed genes after TMP treatment were mainly enriched in biological functions such as inflam¬matory response, transcription factor complex, growth factor activity and so on. KEGG pathway analysis showed that it was mainly concentrated in apoptosis, Toll-like receptor and other signaling pathways. Among them TMP down-regulated genes included TLR2, MyD88, IL-lp, Caspase-3, etc. The results of RT-qPCR and Western blot confirmed that TMP could down-regulate TLR2, MyD88, NF-KB, IL-10, IL-6 and Caspase-3 , and up-regulate the mRNA and protein expression of Bcl-2. Conclusions TMP may amelio¬rate neuronal apoptosis by inhibiting inflammatory re¬sponse, which improves cerebral I/R injury in DM rats, and the pathway may be TLR2/MyD88/NF-KB signaling pathway.
10.A trial of arbidol hydrochloride in adults with COVID-19
Jingya ZHAO ; Jinnong ZHANG ; Yang JIN ; Zhouping TANG ; Ke HU ; Hui SUN ; Mengmeng SHI ; Qingyuan YANG ; Peiyu GU ; Hongrong GUO ; Qi LI ; Haiying ZHANG ; Chenghong LI ; Ming YANG ; Nian XIONG ; Xuan DONG ; Juanjuan XU ; Fan LIN ; Tao WANG ; Chao YANG ; Bo HUANG ; Jingyi ZHANG ; Shi CHEN ; Qiong HE ; Min ZHOU ; Jieming QU
Chinese Medical Journal 2022;135(13):1531-1538
Background::To date, there is no effective medicine to treat coronavirus disease 2019 (COVID-19), and the antiviral efficacy of arbidol in the treatment for COVID-19 remained equivocal and controversial. The purpose of this study was to evaluate the efficacy and safety of arbidol tablets in the treatment of COVID-19.Methods::This was a prospective, open-label, controlled and multicenter investigator-initiated trial involving adult patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Patients were stratified 1:2 to either standard-of-care (SOC) or SOC plus arbidol tablets (oral administration of 200 mg per time, three times a day for 14 days). The primary endpoint was negative conversion of SARS-CoV-2 within the first week. The rates and 95% confidential intervals were calculated for each variable.Results::A total of 99 patients with laboratory-confirmed SARS-CoV-2 infection were enrolled; 66 were assigned to the SOC plus arbidol tablets group, and 33 to the SOC group. The negative conversion rate of SARS-CoV-2 within the first week in patients receiving arbidol tablets was significantly higher than that of the SOC group (70.3% [45/64] vs. 42.4% [14/33]; difference of conversion rate 27.9%; 95% confidence interval [CI], 7.7%-48.1%; P = 0.008). Compared to those in the SOC group, patients receiving arbidol tablets had a shorter duration of clinical recovery (median 7.0 days vs. 12.0 days; hazard ratio [HR]: 1.877, 95% CI: 1.151-3.060, P = 0.006), symptom of fever (median 3.0 days vs. 12.0 days; HR: 18.990, 95% CI: 5.350-67.410, P < 0.001), as well as hospitalization (median 12.5 days vs. 20.0 days; P < 0.001). Moreover, the addition of arbidol tablets to SOC led to more rapid normalization of declined blood lymphocytes (median 10.0 days vs. 14.5 days; P > 0.05). The most common adverse event in the arbidol tablets group was the elevation of transaminase (5/200, 2.5%), and no one withdrew from the study due to adverse events or disease progression. Conclusions::SOC plus arbidol tablets significantly increase the negative conversion rate of SARS-CoV-2 within the first week and accelerate the recovery of COVID-19 patients. During the treatment with arbidol tablets, we find no significant serious adverse events.Trial registration::Chinese Clinical Trial Registry, NCT04260594, www.clinicaltrials.gov/ct2/show/NCT04260594?term= NCT04260594&draw=2&rank=1

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