1.Analysis of syncopal DRVR in blood donors: multicenter hemovigilance data (2020—2023)
Junhong YANG ; Qing XU ; Wenqin ZHU ; Fei TANG ; Ruru HE ; Zhenping LU ; Zhujiang YE ; Fade ZHONG ; Gang WU ; Guoqiang FENG ; Xiaojie GUO ; Jia ZENG ; Xia HUANG
Chinese Journal of Blood Transfusion 2025;38(8):1071-1076
Objective: Data on syncopal donation-related vasovagal reaction (DRVR) collected from 74 blood centers between 2020 and 2023 was statistically analyzed to provide a reference for developing preventive strategies against syncopal DRVR. Methods: Data on blood donation adverse reactions and basic information of donors from 2020 to 2023 were collected through the information management system at monitoring sentinel sites. Statistical analysis was performed on the following aspects of syncopal DRVR: characteristics of donors who experienced syncope, reported incidence, triggers, duration, presence and occurrence time of syncope-related trauma, clinical management including outpatient and inpatient treatment, and severity grading. Results: From 2020 to 2023, 45 966 donation-related adverse reactions were recorded. Of these, 1 665 (3.72%) cases were syncopal DRVR. The incidence of syncopal DRVR decreased with age, being the highest in the 18-22 age group. Incidence was significantly higher in female donors than male donors, in first-time donors than repeat donors, and in university and individual donors than group donors (all P<0.05). There was no statistically significant difference among different blood donation locations (P>0.05). The top three triggers were tension, fatigue, and needle phobia or fear of blood. Among syncopal DRVR cases, 60.36% occurred during blood collection, 87.63% lasted for less than 60 seconds, and 5.05% were accompanied by trauma. Notably, 57.14% of these traumas occurred after donor had left the blood collection site. Syncope severity was graded based on required treatment: grade 1 (fully recovered without treatment, 95.50%); grade 2 (recovered after outpatient treatment, 4.02%); and grade 3 (recovered after inpatient treatment, 0.48%). Conclusion: By analyzing the data of syncopal DRVR cases, it is possible to provide a reference for formulating blood donor safety policies.
2.A multi-center epidemiological study on pneumococcal meningitis in children from 2019 to 2020
Cai-Yun WANG ; Hong-Mei XU ; Gang LIU ; Jing LIU ; Hui YU ; Bi-Quan CHEN ; Guo ZHENG ; Min SHU ; Li-Jun DU ; Zhi-Wei XU ; Li-Su HUANG ; Hai-Bo LI ; Dong WANG ; Song-Ting BAI ; Qing-Wen SHAN ; Chun-Hui ZHU ; Jian-Mei TIAN ; Jian-Hua HAO ; Ai-Wei LIN ; Dao-Jiong LIN ; Jin-Zhun WU ; Xin-Hua ZHANG ; Qing CAO ; Zhong-Bin TAO ; Yuan CHEN ; Guo-Long ZHU ; Ping XUE ; Zheng-Zhen TANG ; Xue-Wen SU ; Zheng-Hai QU ; Shi-Yong ZHAO ; Lin PANG ; Hui-Ling DENG ; Sai-Nan SHU ; Ying-Hu CHEN
Chinese Journal of Contemporary Pediatrics 2024;26(2):131-138
Objective To investigate the clinical characteristics and prognosis of pneumococcal meningitis(PM),and drug sensitivity of Streptococcus pneumoniae(SP)isolates in Chinese children.Methods A retrospective analysis was conducted on clinical information,laboratory data,and microbiological data of 160 hospitalized children under 15 years old with PM from January 2019 to December 2020 in 33 tertiary hospitals across the country.Results Among the 160 children with PM,there were 103 males and 57 females.The age ranged from 15 days to 15 years,with 109 cases(68.1% )aged 3 months to under 3 years.SP strains were isolated from 95 cases(59.4% )in cerebrospinal fluid cultures and from 57 cases(35.6% )in blood cultures.The positive rates of SP detection by cerebrospinal fluid metagenomic next-generation sequencing and cerebrospinal fluid SP antigen testing were 40% (35/87)and 27% (21/78),respectively.Fifty-five cases(34.4% )had one or more risk factors for purulent meningitis,113 cases(70.6% )had one or more extra-cranial infectious foci,and 18 cases(11.3% )had underlying diseases.The most common clinical symptoms were fever(147 cases,91.9% ),followed by lethargy(98 cases,61.3% )and vomiting(61 cases,38.1% ).Sixty-nine cases(43.1% )experienced intracranial complications during hospitalization,with subdural effusion and/or empyema being the most common complication[43 cases(26.9% )],followed by hydrocephalus in 24 cases(15.0% ),brain abscess in 23 cases(14.4% ),and cerebral hemorrhage in 8 cases(5.0% ).Subdural effusion and/or empyema and hydrocephalus mainly occurred in children under 1 year old,with rates of 91% (39/43)and 83% (20/24),respectively.SP strains exhibited complete sensitivity to vancomycin(100% ,75/75),linezolid(100% ,56/56),and meropenem(100% ,6/6).High sensitivity rates were also observed for levofloxacin(81% ,22/27),moxifloxacin(82% ,14/17),rifampicin(96% ,25/26),and chloramphenicol(91% ,21/23).However,low sensitivity rates were found for penicillin(16% ,11/68)and clindamycin(6% ,1/17),and SP strains were completely resistant to erythromycin(100% ,31/31).The rates of discharge with cure and improvement were 22.5% (36/160)and 66.2% (106/160),respectively,while 18 cases(11.3% )had adverse outcomes.Conclusions Pediatric PM is more common in children aged 3 months to under 3 years.Intracranial complications are more frequently observed in children under 1 year old.Fever is the most common clinical manifestation of PM,and subdural effusion/emphysema and hydrocephalus are the most frequent complications.Non-culture detection methods for cerebrospinal fluid can improve pathogen detection rates.Adverse outcomes can be noted in more than 10% of PM cases.SP strains are high sensitivity to vancomycin,linezolid,meropenem,levofloxacin,moxifloxacin,rifampicin,and chloramphenicol.[Chinese Journal of Contemporary Pediatrics,2024,26(2):131-138]
3.Comparison of the efficacy of small incision lenticule extraction and implantable collamer lens implantation in the treatment of high myopia with low astigmatism
Qing LI ; Qian YANG ; Zhong YUE ; Jingyun GUO
International Eye Science 2024;24(9):1392-1396
AIM: To compare the clinical effect of small incision lenticule extraction(SMILE)and implantable collamer lens(ICL)implantation on efficacy, safety and visual quality in patients with high myopia complicated with low astigmatism.METHODS: Retrospective study. A total of 80 cases(159 eyes)of high myopia and low astigmatism treated in the hospital from January 2021 to January 2022 were included, and they were divided into 46 cases(91 eyes)in SMILE group and 34 cases(68 eyes)in ICL implantation group by means of different surgical methods. The spherical equivalent, uncorrected visual acuity(UCVA), best corrected visual acuity(BCVA), higher order aberrations of cornea and optical quality index, effectiveness and safety index were compared between the two groups before surgery and at 3 and 6 mo after surgery, and the surgical complications were counted.RESULTS: The spherical equivalent, UCVA and BCVA of both groups were all improved at 6 mo postoperatively(all P<0.05). At 6 mo after surgery, there were no differences in UCVA, BCVA, spherical equivalent, effectiveness and safety index between both groups(all P>0.05). The root mean square values of total higher order aberration, spherical aberration, coma, vertical coma and horizontal coma in the SMILE group were higher than those in the ICL implantation group, and Strehl ratio(SR)in the ICL implantation group was higher than that in the SMILE group at 3 and 6 mo after surgery(all P<0.05). CONCLUSION: SMILE and ICL implantation have good surgical efficacy in the treatment of patients with high myopia and low astigmatism, and both methods can achieve good postoperative visual acuity and objective visual quality. Furthermore, the ICL implantation has better postoperative visual quality than SMILE.
4.Stability study of umbilical cord mesenchymal stem cells formulation in large-scale production
Wang-long CHU ; Tong-jing LI ; Yan SHANGGUAN ; Fang-tao HE ; Jian-fu WU ; Xiu-ping ZENG ; Tao GUO ; Qing-fang WANG ; Fen ZHANG ; Zhen-zhong ZHONG ; Xiao LIANG ; Jun-yuan HU ; Mu-yun LIU
Acta Pharmaceutica Sinica 2024;59(3):743-750
Umbilical cord mesenchymal stem cells (UC-MSCs) have been widely used in regenerative medicine, but there is limited research on the stability of UC-MSCs formulation during production. This study aims to assess the stability of the cell stock solution and intermediate product throughout the production process, as well as the final product following reconstitution, in order to offer guidance for the manufacturing process and serve as a reference for formulation reconstitution methods. Three batches of cell formulation were produced and stored under low temperature (2-8 ℃) and room temperature (20-26 ℃) during cell stock solution and intermediate product stages. The storage time intervals for cell stock solution were 0, 2, 4, and 6 h, while for intermediate products, the intervals were 0, 1, 2, and 3 h. The evaluation items included visual inspection, viable cell concentration, cell viability, cell surface markers, lymphocyte proliferation inhibition rate, and sterility. Additionally, dilution and culture stability studies were performed after reconstitution of the cell product. The reconstitution diluents included 0.9% sodium chloride injection, 0.9% sodium chloride injection + 1% human serum albumin, and 0.9% sodium chloride injection + 2% human serum albumin, with dilution ratios of 10-fold and 40-fold. The storage time intervals after dilution were 0, 1, 2, 3, and 4 h. The reconstitution culture media included DMEM medium, DMEM + 2% platelet lysate, 0.9% sodium chloride injection, and 0.9% sodium chloride injection + 1% human serum albumin, and the culture duration was 24 h. The evaluation items were viable cell concentration and cell viability. The results showed that the cell stock solution remained stable for up to 6 h under both low temperature (2-8 ℃) and room temperature (20-26 ℃) conditions, while the intermediate product remained stable for up to 3 h under the same conditions. After formulation reconstitution, using sodium chloride injection diluted with 1% or 2% human serum albumin maintained a viability of over 80% within 4 h. It was observed that different dilution factors had an impact on cell viability. After formulation reconstitution, cultivation in medium with 2% platelet lysate resulted in a cell viability of over 80% after 24 h. In conclusion, the stability of cell stock solution within 6 h and intermediate product within 3 h meets the requirements. The addition of 1% or 2% human serum albumin in the reconstitution diluent can better protect the post-reconstitution cell viability.
5.Small incision lenticule extraction for the treatment of myopic anisometropia
Qing LI ; Zhong YUE ; Jingyun GUO
International Eye Science 2024;24(4):656-660
AIM: To explore the clinical effect of small incision lenticule extraction(SMILE)on the treatment of myopic anisometropia.METHODS: Clinical data of 76 patients(146 eyes)with myopic anisometropia who received SMILE or femtosecond assisted laser in situ keratomileusis(FS-LASIK)in our hospital from January 2021 to December 2022 were retrospectively analyzed. The patients were divided into SMILE group(39 cases, 77 eyes)and FS-LASIK group(37 cases, 69 eyes)according to surgical methods. Uncorrected visual acuity(UCVA), diopter, anisometropia, corneal aberration and occurrence of postoperative complications were compared between the two groups at 1 wk, 1 and 3 mo after surgery.RESULTS: The UCVA of the two groups was improved after surgery compared with that before surgery, and the coma, trefoil, spherical aberration and total higher-order aberration were significantly increased compared to those before surgery(P<0.05), and the coma, trefoil, spherical aberration and total higher-order aberration in the FS-LASIK group were significantly higher than those in the SMILE group(P<0.05). After follow-up to 3 mo after surgery, the incidence of postoperative complications was significantly lower in the SMILE group than that in the FS-LASIK group(5.2% vs 15.9%, P<0.05).CONCLUSION: Both SMILE and FS-LASIK can effectively enhance the UCVA and improve the visual quality in patients with myopic anisometropia, but SMILE has lower corneal higher order aberrations, lower incidence of postoperative complications and better overall effect.
6.Latent tuberculosis infection among close contacts of positive etiology pul-monary tuberculosis in Chongqing
Rong-Rong LEI ; Hong-Xia LONG ; Cui-Hong LUO ; Ben-Ju YI ; Xiao-Ling ZHU ; Qing-Ya WANG ; Ting ZHANG ; Cheng-Guo WU ; Ji-Yuan ZHONG
Chinese Journal of Infection Control 2024;23(3):265-270
Objective To investigate the current situation and influencing factors of latent tuberculosis infection(LTBI)among close contacts of positive etiology pulmonary tuberculosis(PTB)patients,provide basis for formula-ting intervention measures for LTBI.Methods A multi-stage stratified cluster random sampling method was used to select close contacts of positive etiology PTB patients from 39 districts and counties in Chongqing City as the study objects.Demographic information was collected by questionnaire survey and the infection of Mycobacterium tuberculosis was detected by interferon gamma release assay(IGRA).The influencing factors of LTBI were analyzed by x2 test and binary logistic regression model.Results A total of 2 591 close contacts were included,the male to female ratio was 0.69∶1,with the mean age of(35.72±16.64)years.1 058 cases of LTBI were detected,Myco-bacterium tuberculosis latent infection rate was 40.83%.Univariate analysis showed that the infection rate was dif-ferent among peoples of different age,body mass index(BMI),occupation,education level,marital status,wheth-er they had chronic disease or major surgery history,whether they lived together with the indicator case,and whether the cumulative contact time with the indicator case ≥250 hours,difference were all statistically significant(all P<0.05);infection rate presented increased trend with the increase of age and BMI(both P<0.001),and decreased trend with the increase of education(P<0.05).Logistic regression analysis showed that age 45-54 years old(OR=1.951,95%CI:1.031-3.693),age 55-64 years old(OR=2.473,95%CI:1.279-4.781),other occupations(OR=0.530,95%CI:0.292-0.964),teachers(OR=0.439,95%CI:0.242-0.794),students(OR=0.445,95%CI:0.233-0.851),junior high school education or below(OR=1.412,95%CI:1.025-1.944),BMI<18.5 kg/m2(OR=0.762,95%CI:0.586-0.991),co-living with indicator cases(OR=1.621,95%CI1.316-1.997)and cumu-lative contact time with indicator cases ≥250 hours(OR=1.292,95%CI:1.083-1.540)were the influential fac-tors for LTBI(all P<0.05).Conclusion The close contacts with positive etiology PTB have a high latent infection rate of Mycobacterium tuberculosis,and it is necessary to pay attention to close contacts of high age,farmers,and frequent contact with patients,and take timely targeted interventions to reduce the risk of occurrence of disease.
7.Near-infrared Spectroscopic Quality Control on Coating Process of Vitamin C Yinqiao Tablets
Qing TAO ; Li JIANG ; Youbing ZHONG ; Zhengji JIN ; Xiaoyong RAO ; Wei LIU ; Yan HE ; Yongkun GUO ; Xiaojian LUO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(14):184-190
ObjectiveTo construct a quantitative prediction model of three indicators(moisture absorption rate, film thickness and coating weight gain) during the coating process of Vitamin C Yinqiao tablets(VCYT) by near-infrared spectroscopy(NIRS), and to realize the endpoint judgment. MethodReal-time NIRS data of 4 batches of VCYT during the coating process were collected by diffuse reflection method. The coating method employed was the rolling coating method, and the samples were obtained at the spray stage from the coater's sampling port every 10 minutes, and 57 batches of samples(about 1 800 tablets) were collected at various coating times, the tablets were embedded in molten paraffin, cut longitudinally, and observed by stereomicroscope. The film thickness, with a target value of 38 μm, was then measured using Motic Images Advanced 3.2 software. Furthermore, the mositure absorption rate of samples, aiming for a target value of 3%, was determined in accordance with guiding principles for drug hygroscopicity testing in the 2020 edition of Chinese Pharmacopoeia, and 3 samples were randomly selected from each batch(10 tablets per batch), and the coating weight gain was calculated(target value of 4%). Partial least squares regression(PLSR) was used to construct a quantitative model of the 3 coating indicators, and the predicted values of the coating indicators were smoothed using the moving average method and used to determine the coating endpoints. ResultThe prediction determination coefficients(Rp2) for moisture absorption rate, film thickness and coating weight gain were 0.933 4, 0.932 6 and 0.965 9, the root mean square errors of prediction(RMSEP) were 0.163 5%, 1.870 9 μm and 0.240 3%, the relative percent deviations(RPD) were 3.711 0, 2.760 7 and 5.415 8, respectively. The results of the external validation set demonstrated that the real-time predicted values obtained by the models exhibited the same trend as the measured values, and the coating endpoint could be accurately predicted(with a prediction error of less than 7.32 min and a relative error of less than 5.63%). ConclusionThe established NIRS model exhibits excellent predictive performance and can be used for quality control of VCYT during the coating process.
8.Clinical trial of brexpiprazole in the treatment of adults with acute schizophrenia
Shu-Zhe ZHOU ; Liang LI ; Dong YANG ; Jin-Guo ZHAI ; Tao JIANG ; Yu-Zhong SHI ; Bin WU ; Xiang-Ping WU ; Ke-Qing LI ; Tie-Bang LIU ; Jie LI ; Shi-You TANG ; Li-Li WANG ; Xue-Yi WANG ; Yun-Long TAN ; Qi LIU ; Uki MOTOMICHI ; Ming-Ji XIAN ; Hong-Yan ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(5):654-658
Objective To evaluate the efficacy and safety of brexpiprazole in treating acute schizophrenia.Methods Patients with schizophrenia were randomly divided into treatment group and control group.The treatment group was given brexpiprozole 2-4 mg·d-1 orally and the control group was given aripiprazole 10-20 mg·d-1orally,both were treated for 6 weeks.Clinical efficacy of the two groups,the response rate at endpoint,the changes from baseline to endpoint of Positive and Negative Syndrome Scale(PANSS),Clinical Global Impression-Improvement(CGI-S),Personal and Social Performance scale(PSP),PANSS Positive syndrome subscale,PANSS negative syndrome subscale were compared.The incidence of treatment-related adverse events in two groups were compared.Results There were 184 patients in treatment group and 186 patients in control group.After treatment,the response rates of treatment group and control group were 79.50%(140 cases/184 cases)and 82.40%(150 cases/186 cases),the scores of CGI-I of treatment group and control group were(2.00±1.20)and(1.90±1.01),with no significant difference(all P>0.05).From baseline to Week 6,the mean change of PANSS total score wese(-30.70±16.96)points in treatment group and(-32.20±17.00)points in control group,with no significant difference(P>0.05).The changes of CGI-S scores in treatment group and control group were(-2.00±1.27)and(-1.90±1.22)points,PSP scores were(18.80±14.77)and(19.20±14.55)points,PANSS positive syndrome scores were(-10.30±5.93)and(-10.80±5.81)points,PANSS negative syndrome scores were(-6.80±5.98)and(-7.30±5.15)points,with no significant difference(P>0.05).There was no significant difference in the incidence of treatment-related adverse events between the two group(69.00%vs.64.50%,P>0.05).Conclusion The non-inferiority of Brexpiprazole to aripiprazole was established,with comparable efficacy and acceptability.
9.Improved unilateral puncture PVP based on 3D printing technology for the treatment of osteoporotic vertebral com-pression fracture
Wei-Li JIANG ; Tao LIU ; Qing-Bo ZHANG ; Hui CHEN ; Jian-Zhong BAI ; Shuai WANG ; Jia-Wei CHENG ; Ya-Long GUO ; Gong ZHOU ; Guo-Qi NIU
China Journal of Orthopaedics and Traumatology 2024;37(1):7-14
Objective To investigate the clinical effect of unilateral percutaneous vertebroplasty(PVP)combined with 3D printing technology for the treatment of thoracolumbar osteoporotic compression fracture.Methods A total of 77 patients with thoracolumbar osteoporotic compression fractures from October 2020 to April 2022 were included in the study,all of which were vertebral body compression fractures caused by trauma.According to different treatment methods,they were di-vided into experimental group and control group.Thirty-two patients used 3D printing technology to improve unilateral transpedicle puncture vertebroplasty in the experimental group,there were 5 males and 27 females,aged from 63 to 91 years old with an average of(77.59±8.75)years old.Forty-five patients were treated with traditional bilateral pedicle puncture vertebroplasty,including 7 males and 38 females,aged from 60 to 88 years old with an average of(74.89±7.37)years old.Operation time,intraoperative C-arm X-ray times,anesthetic dosage,bone cement injection amount,bone cement diffusion good and good rate,complications,vertebral height,kyphotic angle(Cobb angle),visual analogue scale(VAS),Oswestry disability index(ODI)and other indicators were recorded before and after surgery,and statistically analyzed.Results All patients were followed up for 6 to 23 months,with preoperative imaging studies,confirmed for thoracolumbar osteoporosis com-pression fractures,two groups of patients with postoperative complications,no special two groups of patients'age,gender,body mass index(BMI),time were injured,the injured vertebral distribution had no statistical difference(P>0.05),comparable data.Two groups of patients with bone cement injection,bone cement dispersion rate,preoperative and postoperative vertebral body height,protruding after spine angle(Cobb angle),VAS,ODI had no statistical difference(P>0.05).The operative time,intra-operative fluoroscopy times and anesthetic dosage were statistically different between the two groups(P<0.05).Compared with the traditional bilateral puncture group,the modified unilateral puncture group combined with 3D printing technology had shorter operation time,fewer intraoperative fluoroscopy times and less anesthetic dosage.The height of anterior vertebral edge,kyphosis angle(Cobb angle),VAS score and ODI of the affected vertebrae were statistically different between two groups at each time point after surgery(P<0.05).Conclusion In the treatment of thoracolumbar osteoporotic compression fractures,3D printing technology is used to improve unilateral puncture PVP,which is convenient and simple,less trauma,short operation time,fewer fluoroscopy times,satisfactory distribution of bone cement,vertebral height recovery and kyphotic Angle correction,and good functional improvement.
10.Association between hearing loss and physical performance in patients on maintenance hemodialysis
Weifeng FAN ; Xiaojing ZHONG ; Qing WU ; Lihong ZHANG ; Zhenhao YANG ; Yong GU ; Qi GUO ; Xiaoyu CHEN ; Chen YU ; Kun ZHANG ; Wei DING ; Hualin QI ; Junli ZHAO ; Liming ZHANG ; Suhua ZHANG ; Jianying NIU
Kidney Research and Clinical Practice 2024;43(3):358-368
The correlation between hearing loss (HL) and physical performance in patients receiving maintenance hemodialysis (MHD) remains poorly investigated. This study explored the association between HL and physical performance in patients on MHD. Methods: This multicenter cross-sectional study was conducted between July 2020 and April 2021 in seven hemodialysis centers in Shanghai and Suzhou, China. The hearing assessment was performed using pure-tone average (PTA). Physical performance was assessed using the Timed Up and Go Test (TUGT), handgrip strength, and gait speed. Results: Finally, 838 adult patients (male, 516 [61.6%]; 61.2 ± 2.6 years) were enrolled. Among them, 423 (50.5%) had mild to profound HL (male, 48.6% and female, 53.4%). Patients with HL had poorer physical performance than patients without HL (p < 0.001). TUGT was positively correlated with PTA (r = 0.265, p < 0.001), while handgrip strength and gait speed were negatively correlated with PTA (r = –0.356, p < 0.001 and r = –0.342, p < 0.001, respectively). Physical performance in patients aged <60 years showed significant dose-response relationships with HL. After adjusting for confounders, the odds ratios (95% confidence intervals) for HL across the TUGT quartiles (lowest to highest) were 1.00 (reference), 1.15 (0.73–1.81), 1.69 (1.07–2.70), and 2.87 (1.69–4.88) (p for trend = 0.005). Conclusion: Lower prevalence of HL was associated with a faster TUGT and a stronger handgrip strength in patients on MHD.

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