1.Clinical research on corneal epithelium remodeling after small incision lenticule extraction and femtosecond laser-assisted in situ keratomileusis
Yangjing ZHANG ; Liwei MA ; Fan ZHANG ; Chunmei KE ; Ruifu WANG ; Lipye ZU
International Eye Science 2025;25(1):37-41
AIM: To compare the changes in corneal epithelial thickness(CET)after small incision lenticule extraction(SMILE)and femtosecond laser-assisted in situ keratomileusis(FS-LASIK).METHODS: A total of 187 patients(187 eyes)who underwent either SMILE or FS-LASIK at Urumqi Aier Eye Hospital between December 2022 and November 2023 were collected. The patients were divided into SMILE group and FS-LASIK group according to surgical methods. The CET of the patients was measured by optical coherence tomography(OCT)system before surgery and at 1 wk, 1, 3, and 6 mo postoperatively.RESULTS: Changes in corneal epithelial thickness(△CET)in the central, paracentral, and mid-peripheral regions were compared at 6 mo postoperatively. The SMILE group was characterized by the most significant thickening in the central area and the least thickening in the mid-peripheral area; while the FS-LASIK group was characterized by the most significant thickening in the paracentral area and the least thickening in the mid-peripheral region. At 1 wk, 1, 3, and 6 mo postoperatively, within the 0-7 mm corneal area, the △CET for both the SMILE and FS-LASIK groups was correlated with the preoperative spherical equivalent.CONCLUSION: Within 6 mo postoperatively, both SMILE and FS-LASIK showed a similar trend in epithelial thickening but with distinct characteristics. The change in corneal epithelial thickness for both procedures was positively correlated with the preoperative diopter.
2.Reference threshold and offspring short-term security of in vitro fertilization-embryo transfer sperm DNA fragmentation index based on live birth
Chao ZHOU ; Shuxian WANG ; Chunmei YU ; Guangyu YU ; Yueyuan JIANG
Chinese Journal of Tissue Engineering Research 2025;29(1):111-119
BACKGROUND:There is a significant correlation between sperm DNA fragmentation index and fertilization,embryonic development potential,embryo implantation,miscarriage,and offspring safety.However,its clinical reference value is affected by many factors,resulting in extremely limited clinical significance.This study took live birth as the outcome,corrected other confounding factors through propensity score matching,constructed the best clinical cutoff value of sperm DNA fragmentation index and live birth,and conducted internal and external tests on it,which has good predictive value and clinical application efficiency. OBJECTIVE:To investigate the reference threshold and offspring short-term security of in vitro fertilization-embryo transfer sperm DNA fragmentation index based on live birth. METHODS:A total of 1 921 patients who received in vitro fertilization and embryo transfer in Changzhou Maternal and Child Health Area Hospital from May 2019 to May 2021 were selected.On the basis of tendency matching tolerance of 0.02 and propensity score matching of 1:1,540 cases were successfully matched in each live birth group and non-live birth group,and the model group was established.135 patients who received in vitro fertilization and embryo transfer in Nanxishan Hospital of Guangxi Zhuang Autonomous Region were selected as the external validation group.The optimal clinical cutoff value of sperm DNA fragmentation index for live birth was investigated by the receiver operating characteristic curve.The accuracy and clinical application efficacy of the cutoff value were evaluated by restricted cubic spline curve,standard curve,clinical decision curve,clinical impact curve and internal and external validation tests. RESULTS AND CONCLUSION:(1)The DNA fragmentation index of sperm in the non-live birth group was significantly higher than that in the live birth group and had a significant negative correlation with live birth(r=-0.444,P<0.001).(2)Receiver operating characteristic curve results showed that the optimal cut-off value of DNA fragmentation index for live birth was 24.33%;the area under the curve was 0.775(0.746,0.804);the specificity was 72.60%;the sensitivity was 78.90%,and the accuracy was 75.70%.(3)Restricted cubic spline curve fitting the results of Logistic regression showed that when the sperm DNA fragmentation index was greater than 24.57%,the risk of clinical non-live birth increased.(4)The probability of Logistic regression analysis results showed that sperm DNA fragmentation index was a risk factor for live birth[OR(95%CI)=0.916(0.904,0.928),P<0.001],and when sperm DNA fragmentation index was greater than 27.78%,the probability of clinical live birth would be less than 50%.With the increase of sperm DNA fragmentation index by 1 unit,the probability of a live birth fell by 8.4%.(5)Internal and external to the validation of the clinical cutoff value showed that the cutoff point had certain clinical predictive value and accuracy.(6)Clinical decision curve and clinical impact curve results exhibited that the prediction model based on the clinical cut-off value had the maximum clinical net benefit value when the threshold probability was 0.22-0.73,and the ratio of loss to gain within the threshold probability range was always less than 1,which confirmed that the prediction model had good clinical application effectiveness.(7)The results of sperm DNA fragmentation index and offspring short-term security analysis showed that sperm DNA fragmentation index had no significant differences with preterm birth,body weight,deformity and sex.(8)These findings suggest that the optimal clinical cut-off value of sperm DNA fragmentation index for in vitro fertilization-embryo transfer live birth was 24.33%.The established clinical prediction model has good differentiation,accuracy and clinical application effectiveness.Sperm DNA fragmentation index has no significant impact on offspring short-term security,but large samples and long-term follow-up evaluation are still needed.
3.Application of "balance-shaped sternal elevation device" in the subxiphoid uniportal video-assisted thoracoscopic surgery for anterior mediastinal masses resection
Jinlan ZHAO ; Weiyang CHEN ; Chunmei HE ; Yu XIONG ; Lei WANG ; Jie LI ; Lin LIN ; Yushang YANG ; Lin MA ; Longqi CHEN ; Dong TIAN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(03):308-312
Objective To introduce an innovative technique, the "balance-shaped sternal elevation device" and its application in the subxiphoid uniportal video-assisted thoracoscopic surgery (VATS) for anterior mediastinal masses resection. Methods Patients who underwent single-port thoracoscopic assisted anterior mediastinal tumor resection through the xiphoid process at the Department of Thoracic Surgery, West China Hospital, Sichuan University from May to June 2024 were included, and their clinical data were analyzed. Results A total of 7 patients were included, with 3 males and 4 females, aged 28-72 years. The diameter of the tumor was 1.9-17.0 cm. The operation time was 62-308 min, intraoperative blood loss was 5-100 mL, postoperative chest drainage tube retention time was 0-9 days, pain score on the 7th day after surgery was 0-2 points, and postoperative hospital stay was 3-12 days. All patients underwent successful and complete resection of the masses and thymus, with favorable postoperative recovery. Conclusion The "balance-shaped sternal elevation device" effectively expands the retrosternal space, providing surgeons with satisfactory surgical views and operating space. This technique significantly enhances the efficacy and safety of minimally invasive surgery for anterior mediastinal masses, reduces trauma and postoperative pain, and accelerates patient recovery, demonstrating important clinical significance and application value.
4.Efficacy and safety of CDK4/6 inhibitors combined with endocrine therapy for HR+/HER2− advanced or metastatic breast cancer: A network meta-analysis
Yanjiao PU ; Hui LI ; Wei CHEN ; Xueyu DUAN ; Chunmei CHEN ; Rui WU ; Xuechang WANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(06):830-838
Objective To compare the efficacy and safety of different cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) combined with endocrine therapy (ET) for the treatment of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) advanced or metastatic breast cancer. Methods Randomized controlled trials (RCTs) on CDK4/6i for the treatment of HR+/HER2− metastatic or advanced breast cancer were retrieved from databases including PubMed, EMbase, Web of Science, The Cochrane Library, CNKI, Wanfang, VIP, and SinoMed, with the search period ranging from database inception to August 2023. Bayesian network meta-analysis was conducted using R 4.2.0 software. Results A total of 18 RCTs from 25 articles, involving 8 031 patients and 11 treatment regimens, were included. There was no significant difference in progression-free survival (PFS) or overall survival (OS) among different CDK4/6i+ET combinations. The highest cumulative probability for PFS was observed with dalpiciclib (DAL)+fulvestrant (FUL), while ribociclib (RIB)+FUL ranked first for OS. In terms of efficacy, abemaciclib (ABE)+aromatase inhibitors (AI) and ABE+FUL ranked first in objective response rate and clinical benefit rate, respectively. Regarding safety, statistically significant difference in grade 3-4 adverse events was observed among certain types of CDK4/6i (P<0.05). Conclusion Current evidence suggests that CDK4/6i+ET is superior to ET alone for the treatment of HR+/HER2− advanced/metastatic breast cancer. Different CDK4/6i+ET combinations demonstrate comparable or similar efficacy; however, the incidence of adverse reactions is higher with combination therapy. Treatment regimens should be selected based on individual conditions.
5.Current management status of Chinese herbal pieces in China’s national healthcare security drug catalog
Chunmei ZHANG ; Liyan TANG ; Xiaoyu WANG ; Xingyu WANG ; Jingjing LIU ; Qingmiao LI
China Pharmacy 2025;36(20):2495-2501
OBJECTIVE To provide references for further improving the management level of Chinese herbal pieces covered by the healthcare security drug catalog (hereinafter referred to as “healthcare security covered Chinese herbal pieces”). METHODS Policy documents related to healthcare security covered Chinese herbal pieces were retrieved from official websites of National Healthcare Security Administration and medical insurance bureaus of various provinces (autonomous regions, municipalities directly under the central government). Using text analysis, the current management status of healthcare security covered Chinese herbal pieces in various provinces was analyzed from two dimensions: management regulations and catalog formats. RESULTS In terms of the management regulations for healthcare security covered Chinese herbal pieces, some provinces implemented both national and provincial standards for Chinese herbal pieces, while a small number of provinces adopted national standards alongside their own provincial standards. Regarding the payment categories of healthcare security covered Chinese herbal pieces, most were classified as category A, though some provinces managed them as category B, and others included both categories A and B or category C. In terms of applicants, there were three kinds: only medical institutions, only herbal piece enterprises, or both medical institutions and herbal piece enterprises being allowed to apply. During the application process, some provinces required preliminary evaluations by local healthcare security departments with recommended lists submitted, while some provinces omitted preliminary evaluations and relied solely on unified evaluation by provincial healthcare security departments. Regarding the methods for catalog formulation and adjustment, there was little variation among the provinces. In terms of the catalog format for healthcare security covered Chinese herbal pieces, some provinces had supplemented the catalog fields based on the national medical insurance catalog. In contrast, some provinces had relatively simple catalogs. Regarding the sorting of the herbal pieces catalog, some catalogs were arranged by the number of Chinese character strokes in the names of the herbal pieces, but most catalogs lacked clear sorting rules. CONCLUSIONS Significant resultshave been achieved in formulating management measures and the catalog of healthcare security covered Chinese herbal pieces. However, there is still a great necessity to develop targeted and adaptable management clauses based on local conditions and the characteristics of Chinese herbal pieces. The content and format of healthcare security drug catalog of Chinese herbal pieces should be improved; in addition, continuous tracking of the latest management policies is also essential to improve the accuracy and operability of formulated catalog.
6.Multi-center Randomized Controlled Clinical Trial of Huangqi Injection Combined with Buzhong Yiqi Acupuncture in Treatment of Chronic Fatigue Syndrome with Qi Deficiency
Chengcheng WANG ; Xing TANG ; Chunmei LI ; Zhongbo WANG ; Yanlin FU ; Min DAI ; Min YANG ; Congcong YU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(7):163-169
ObjectiveTo investigate the clinical efficacy of Huangqi injection combined with Buzhong Yiqi acupuncture in the treatment of chronic fatigue syndrome (CFS) with Qi deficiency and its effects on TCM syndromes, fatigue symptoms, serum superoxide dismutase (SOD), malondialdehyde (MDA), and oxidized low-density lipoprotein (ox-LDL) levels. MethodA total of 200 patients with CFS of Qi deficiency were randomly divided into a control group (100 cases) and an observation group (100 cases). The control group was treated with vitamin B compounds, and the observation group was treated with Huangqi injection combined with Buzhong Yiqi acupuncture for two weeks. The scores of TCM syndromes, fatigue symptoms, levels of serum SOD, MDA, and ox-LDL and the incidence of adverse reactions were observed and compared before and after treatment in two groups. ResultAfter treatment, the total effective rate of the control group was 54.34% (50/92), while that of the observation group was 88.54% (85/96). The total effective rate of the observation group was higher than that of the control group (χ2=27.13,P<0.05). Compared with those in the two groups before treatment, scores of fatigue self-assessment scale (FSAS), physical fatigue and mental fatigue, and sleep/rest response scores of fatigue in the two groups after treatment were significantly decreased (P<0.05). After treatment, scores of FSAS, physical fatigue and mental fatigue, and sleep/rest response scores of fatigue in the observation group were significantly decreased compared with those in the control group (P<0.05). Compared with those in the two groups before treatment, TCM syndrome scores in the two groups after treatment were significantly decreased (P<0.05). After treatment, TCM syndrome scores in the observation group were significantly decreased compared with those in the control group (P<0.05). Compared with those in the two groups before treatment, MDA levels in the two groups were significantly decreased (P<0.05), ox-LDL levels in the observation group were significantly decreased (P<0.05), and SOD levels were significantly increased (P<0.05). After treatment, compared with those in the control group, the serum MDA and ox-LDL levels in the observation group were significantly decreased (P<0.05), and the serum SOD was significantly increased (P<0.05). No serious adverse events or adverse reactions occurred during this clinical trial. ConclusionHuangqi injection combined with Buzhong Yiqi acupuncture has a good clinical curative effect in the treatment of CFS with Qi deficiency, which can effectively improve the fatigue symptoms of patients, increase the level of SOD, and reduce the level of serum MDA and ox-LDL. It is related to the production of antioxidants, inhibiting the production of lipid peroxides, and improving the body's ability to resist oxidative stress.
7.Vocational training for pediatric clinical research coordinators: current status and demand analysis
Wenxiang FAN ; Ji LI ; Rui WANG ; Chunmei LI ; Waner ZHENG ; Chi XU ; Shaoqing NI
Chinese Journal of Medical Education Research 2024;23(3):327-332
Objective:To investigate the current status of vocational training for pediatric clinical research coordinators (CRC), and discuss the construction of base-based pediatric CRC training, and to promote the ability of pediatric CRCs.Methods:From July 25 to October 16, 2023, an anonymous self-designed questionnaire survey was conducted through the Wenjuanxing platform to investigate the current situation of pediatric CRC vocational training and base training needs. The data were collated using Excel. Categorical data were described as numbers and percentages.Results:A total of 328 usable questionnaires were returned. Only 7.62% (25 people) believed that existing CRC training was sufficient and could meet actual work needs; 4.88% (16 people) responded that there was no training; 46.34% (152 people) believed that the training was insufficient to support actual work needs; 87.50% (287 people) believed that continuous CRC training was needed; 46.95% (154 people) preferred experienced CRCs for teaching, who should have at least 3 years of CRC work experience; and 46.95% (154 people) preferred a duration of 3 months for CRC training. The preferred training methods were: practice under the direction of experienced CRCs (90.85%, 298 people), step-by-step teaching of practical skills (88.41%, 290 people), case analysis and discussion (87.20%, 286 people), process simulation (83.23%, 273 people), and lecture-based teaching (76.52%, 251 people). The preferred post-training assessment methods were: case analysis (76.52%, 251 people), operation simulation (74.09%, 243 people), process simulation (73.17%, 240 people), written examination (66.16%, 217 people), and interview (63.72%, 209 people).Conclusions:The current pediatric CRC training is not enough to meet actual work needs. It is urgent to develop and promote a CRC training system that can meet work needs, laying the foundation for the construction of pediatric clinical research ecology in China.
8.Establish of the risk predictive model for varicella outbreaks in primary and middle schools
ZHENG Yongtao, YE Chunmei, NI Zuowei, ZHANG Jiani, LAI Fenhua, GAO Yanmin, YANG Dongbo, WANG Yanmei
Chinese Journal of School Health 2024;45(6):873-877
Objective:
To investigate the epidemiological characteristics of varicella outbreaks in primary and middle schools, and to establish a risk predictive model, so as to provide scientific guidance for the prevention of varicella outbreaks in schools.
Methods:
Based on a nested case-control study, primary and middle schools in 4 districts of Shanghai (Yangpu District and Jingan District) and Hangzhou (Xiaoshan District and Linping District) from January to December 2023 were selected to observe the status of varicella outbreaks. Associated factors of varicella outbreaks were investigated and used for establishing the predictive model, which was evaluated by the Hosmer-Lemeshow(H-L) goodness of fit test, receiver operating characteristic (ROC) curve, Calibration curve, decision curve analysis (DCA).
Results:
A total of 98 varicella outbreaks were included, with 195 schools without varicella outbreaks during the same period as controls. Eight factors, including the availability of warm water in restroom, availability of hand soap in restroom, average class size, duration of student attendance at school per day, presence of a fulltime school doctor, hesitancy of the school principal towards varicella vaccination, and rates of first and second doses of varicella vaccination, were identified as potential factors for school varicella outbreaks, with statistically significant differences (χ2/Z=10.01, 20.49, 17.43, 9.74, 32.17, 6.60, 2.20, 3.39, P<0.05). The 8 variables above were employed to construct a risk predictive model, and Hosmer-Lemeshow goodness of fit test yielded a χ2 value of 5.863 (P>0.05); the area under the ROC curve (AUC) was 0.846 (95%CI=0.799-0.893); Calibration curve analysis indicated good consistency between predicted and actual values of the model. DCA demonstrated favorable predictive performance of the model over a wide range.
Conclusions
The predictive model for school varicella outbreaks demonstrates satisfactory accuracy and efficacy. It suggested to make good use of this prediction model and take relevant measures to reduce the risk of varicella transmission in schools.
9.Meta-synthesis of qualitative research on the experience of kinesiophobia in patients with cardiac rehabilitation
Jianping LIU ; Weiting GUO ; Wei GAO ; Wenjun WANG ; Yuan SHENG ; Chunmei FAN ; Qi LU ; Deshan LIU
Chinese Journal of Nursing 2024;59(4):474-481
Objective To systematically review and synthesize the psychological experience of kinesiophobia in patients with cardiac rehabilitation.Methods PubMed,Web of science,Journals@Ovid,Embase,CINAHL,PsycINFO,Cochrane Library,CNKI,SinoMed,WanFang Database,Vip Database,American Heart Association,European Society of Cardiology and American Association of Cardiovascular and Pulmonary Rehabilitation were searched to collect qualitative research on the psychological experience of cardiac rehabilitation patients with kinesiophobia.The retrieval time was from the establishment of the databases to Jun 2023.The literature was evaluated using the Australian JBI Quality Evaluation Criteria for Qualitative Research in Evidence-based Health Care Centres(2016),and the results were consolidated using an aggregative integration approach.Results A total of 45 results were extracted from 14 studies.Similar results were summarized into 10 groups,and 3 integrated results were synthesized as followed.Kinesiophobia was influenced by many factors;kinesiophobia affects the life experience of patients;strategies to reduce the level of kinesiophobia.Conclusion Nurses should pay more attention to psychological experience of kinesiophobia,and take the corresponding intervention measures to help patients overcome the psychological barriers of kinesiophobia,perfect personalized exercise programs,and improve the level of physical activity.
10.Effect of ursodeoxycholic acid on symptoms after severe acute respiratory syndrome coronavirus 2 infection in patients with primary biliary cholangitis and their family members
Gui JIA ; Chunmei YANG ; Xiufang WANG ; Juan DENG ; Ruiqing SUN ; Linhua ZHENG ; Yulong SHANG ; Ying HAN
Journal of Clinical Hepatology 2024;40(7):1370-1374
Objective To investigate the effect of ursodeoxycholic acid(UDCA)on the symptoms after severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)infection in patients with primary biliary cholangitis(PBC)and their family member.Methods A questionnaire survey was conducted to collect related information from 171 PBC patients who attended The First Affiliated Hospital of Air Force Medical University before March 22,2023 and 128 family members,including demographic information,comorbidities,UDCA administration,SARS-CoV-2 infection,vaccination,symptoms,therapeutic medication,and the changes in liver disease-related symptoms.The independent-samples t test or the Mann-Whitney U test was used for comparison of continuous data between two groups,and the chi-square test or the Fisher's exact test was used for comparison of categorical data between two groups.Results The median age was 51 years in the PBC patients and 49 years in the family members,with no significant difference between the two groups(P>0.05).Compared with the family member group,the PBC group had significantly lower body mass index(22.2±2.4 kg/m2 vs 23.3±2.9 kg/m2,P<0.001)and proportion of male individuals(10%vs 55%,P<0.001).All PBC patients received UDCA at a dose of 13—15 mg/kg,and SARS-CoV-2 infection rate was 100%in both groups.The family members had a significantly higher SARS-CoV-2 vaccination rate than the PBC patients(91%vs 57%,P<0.001).Compared with the family members,the PBC patients had significantly milder symptoms of sneezing,nasal obstruction,chest pain,and abnormal taste(P<0.05).Compared with the family members,the PBC patients had significantly lower rates of use of compound cold medicine(11%vs 20%,P<0.05)and Lianhua Qingwen capsules(12%vs 21%,P<0.05).For the PBC patients after SARS-CoV-2 infection,the liver disease-related symptoms such as fatigue,abdominal distension,dry mouth and dry eyes,pruritus,and yellow skin were aggravated by 37%,2%,27%,10%,and 3%,respectively.Conclusion Compared with the immediate family members of PBC patients who do not take UDCA,the PBC patients receiving UDCA do not show a reduction in SARS-CoV-2 infection rate,but UDCA may have a certain effect on alleviating infection-related symptoms in such patients.PBC patients may still experience the aggravation of liver disease-related symptoms after SARS-CoV-2 infection,and the long-term effect on PBC patients after SARS-CoV-2 infection should be taken seriously in clinical practice.


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