1.Real-world Study of the Safety and Efficacy of Pembrolizumab in the Treatment of Advanced Non-small Cell Lung Cancer
WAN NING ; WANG BING ; GUO YA ; HE ZIJIAN ; YANG CHEN ; YANG NING ; LU LIQING ; LIANG HONGYI ; XIAO WEIBIN ; YANG DANDAN ; CHEN ZHUOJIA ; FANG WENFENG ; LIANG WEITING
Chinese Journal of Lung Cancer 2024;27(10):745-754
Background and objective Pembrolizumab(PEM)has been shown to be effective in clinical trials for the treatment of advanced non-small cell lung cancer(NSCLC),but clinical trials were based on cohorts of patients selected on specific criteria,and whether the findings are consistent with real-world patients is debatable.The aim of this study is to evaluate the efficacy and safety of PEM in the treatment of advanced NSCLC based on real-world data.Methods A retro-spective collection of real-world data from patients with advanced NSCLC receiving PEM was conducted.Propensity score matching was used to eliminate inter-group differences and assess the efficacy and safety of PEM compared to chemotherapy.Results Among 450 matched patients,the incidence rates of any-grade adverse events were 79.87%in the PEM group and86.71%inthe chemotherapy group,while the incidence rates of grade>3 adverse events were 4.03%and 7.31%,respectively.The objective response rates were 48.63%for PEM and 36.00%for chemotherapy(P=0.011).The median progression-free survival was 15.5 months for PEM and 8.8 months for chemotherapy(P<0.001),and the median overall survival was not reached for PEM and 26.2 months for chemotherapy(P<0.001).Conclusion PEM treatment for advanced NSCLC demonstrates favorable survival outcomes and acceptable safety in real-world clinical practice.
2.Effects of paroxetine on the safety of mothers and infants in the second and third trimesters of pregnancy:a meta-analysis
Liqing LU ; Ning WAN ; Bo JI ; Jin YUAN ; Huiying WEN ; Weibin XIAO
China Pharmacy 2023;34(3):361-365
OBJECTIVE To systematically evaluate the safety of paroxetine in the treatment of pregnant patients with depression in the second and third trimesters of pregnancy, and provide reference for rational clinical use of it. METHODS Retrieved from Cochrane Library, PubMed, Embase, VIP, CNKI, Wanfang database and SinoMed database, by manual search, randomized controlled studies or observational studies were collected on depression patients who were given paroxetine vs. selective serotonin reuptake inhibitor (SSRI) in the second and third trimesters of pregnancy during the inception to Aug. 2022. Methodological qualities of the included studies were assessed by Cochrane Handbook 5.1.0 or Newcastle-Ottawa Scale (NOS). Meta-analysis was performed with RevMan 5.4.1 software. RESULTS Finally, 9 observational studies were included, and all included studies were of high quality in NOS scale. Meta-analysis was performed on 8 cohort studies. Meta-analysis showed that the total incidence of adverse pregnancy outcomes of mothers and infants [RR=0.99, 95%CI(0.89,1.10),P=0.87], total incidence of maternal adverse pregnancy outcomes [RR=0.98, 95%CI (0.87,1.10), P=0.69] and premature birth [RR=0.89, 95%CI (0.43, 1.83), P=0.75] in the second and third trimesters of pregnancy were lower than that with other SSRI, without statistical significance. The incidence of neonatal complications with paroxetine in the second and third trimesters of pregnancy was higher than that with other SSRI, but the difference was not statistically significant [RR=1.02, 95%CI (0.82,1.29), P=0.84]. One study reported that the incidence of neonatal pulmonary hypertension in paroxetine group was higher than that in other SSRI group (0.4% vs. 0.3%). CONCLUSIONS The safety of peroxetine in the second and third trimesters of pregnancy is comparable with that of other SSRI, but it is necessary to be alert to the occurrence of neonatal pulmonary hypertension.
3.Case analysis of a patient with osimertinib-induced interstitial pneumonia who re-used EGFR-TKI therapy
Yongbang CHEN ; Ning WAN ; Bing WANG ; Lijun PENG ; Ning YANG ; Weibin XIAO ; Fei XIE ; Jianping ZHANG ; Bo JI
China Pharmacy 2023;34(5):595-599
OBJECTIVE To explore the way to re-use epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKI) in patients with EGFR-TKI-induced interstitial pneumonia (IP), using osimertinib as an example. METHODS The IP treatment regimen and re-use of EGFR-TKI regimen in a patient who developed IP after the use of osimertinib were analyzed. And a literature review was made by combining the characteristics of the cases which reported in the literature and the characteristics of this case. RESULTS The patient’s IP symptoms due to treatment with osimertinib had resolved after treatment. The patient’s IP symptoms also did not worsen after using almonertinib in combination with hormones as re-use of EGFR-TKI regimen. However, almonertinib was discontinued as the patient experienced disease progression. The adverse reactions of IP needed to be dealt with in time, the EGFR-TKI should be discontinued and symptomatic treatment should be given. CONCLUSIONS EGFR-TKI targeted therapy could be re-selected by replacing EGFR-TKI, adjusting the dose of EGFR-TKI, and using hormones in combination. EGFR-TKI-induced adverse drug reactions of IP are rare, but need to be observed closely. If other EGFR-TKI is used, close monitoring of adverse reactions and curative effects are also required in order to adjust the patient’s treatment plan in time.
4.Relationship between clinical blood demand and its influencing factors
Shuhong XIE ; Sijing ZHANG ; Qi XIAO ; Weibin YAN
Chinese Journal of Blood Transfusion 2023;36(3):249-253
【Objective】 To study the relationship between the key influencing factors and the short, medium and long term blood demand, so as to provide basis for building a blood demand prediction model with less prediction error and practical guidance. 【Methods】 Through literature research, the influencing factors of blood demand were preliminarily determined. Questionnaires were designed and distributed to relevant experts, and factor analysis was carried out on the survey results to obtain key influencing factors through Delphi method. 【Results】 Through literature research, 19 influencing factors of clinical blood demand were obtained, including policy factors, medical service demand, medical technology level, regional population, population characteristics, population structure, medical resource, number of beds, culture, natural environment, operation, patients outside the region, blood use in different departments, blood infusion, time trend, emergencies and disasters, the condition of disasters, hospitals in disaster area, limited diagnosis and treatment ability. Through Delphi method and data analysis, six key factors affecting blood demand were obtained, namely sudden disaster, medical resource, environmental factor, population, bed number and blood infusion. 【Conclusion】 The influence of key factors on clinical blood demand was divided into multiple hierarchies. Blood infusion and sudden disaster were short-term influencing factors. Medical resource, population and number of beds were medium influencing factors. Environmental factor was long-term influencing factor. Short, medium and long-term influencing factors were interrelated, and have different impacts on clinical blood demand. Based on the interaction relationship, a three-dimensional mathematical model of influencing factors of clinical blood demand was established, which provided a preliminary research basis for building a blood demand prediction model with less prediction error and practical guidance.
5.Moderation effect of antecedent rainfall conditions on incidence of bacillary dysentery following heavy rainfall in Anhui Province
Yuchen LIU ; Lei GONG ; Jiabing WU ; Yongkang XIAO ; Li LIU ; Weibin LI ; Wenjun MA ; Cunrui HUANG ; Lianping YANG
Journal of Environmental and Occupational Medicine 2022;39(3):304-308
Background Climate change leads to frequent heavy rainfall events, and higher incidences of bacillary dysentery after heavy rainfall have been observed. The impacts of heavy rainfall and its antecedent rainfall conditions on the disease are worth paying attention to. Objective To quantitatively analyze how the relationship between heavy rainfall events and bacillary dysentery occurrence is modified by antecedent rainfall conditions in Anhui Province and explore the different moderation effects in urban and rural contexts. Methods CN05.1 meteorological data of Anhui Province and cases of bacillary dysentery of the same area were collected from January 1, 2006 to August 31, 2017. An exposure-response Poisson regression model of heavy rainfall events and the number of daily cases was constructed to explore the moderation effect of antecedent rainfall conditions on the incidence of bacillary dysentery, and further stratified by urban and rural areas. Results This study included 129 459 cases of bacillary dysentery, with a daily average of 30.39. Compared with dry antecedent conditions without heavy rainfall, dry antecedent conditions with heavy rainfall had no obvious different effect on the incidence of bacillary dysentery for the whole province (P>0.05). But wet antecedent conditions significantly increased the risk of bacillary dysentery for the whole province after heavy rainfall (wet antecedent conditions without heavy rainfall: RR=1.281, 95%CI: 1.264-1.298; wet antecedent conditions with heavy rainfall: RR=1.267, 95%CI: 1.167-1.376). After urban and rural stratification, antecedent rainfall conditions also showed a significant moderation effect on the incidence of bacillary dysentery following heavy rainfall events. Compared with dry antecedent conditions without heavy rainfall, dry antecedent conditions with heavy rainfall had no obvious effect on the incidence of bacillary dysentery for the urban and the rural populations (P > 0.05). However, wet antecedent conditions without heavy rainfall (urban: RR=1.391, 95%CI: 1.362-1.421; rural: RR=1.222, 95%CI: 1.201-1.243) and wet antecedent conditions with heavy rainfall (urban: RR=1.364, 95%CI: 1.193-1.559; rural: RR=1.218, 95%CI: 1.098-1.352) significantly increased the risk of bacillary dysentery in both rural and urban areas. Conclusion In the influence of heavy rainfall on the incidence of bacillary dysentery in Anhui Province, antecedent rainfall conditions have a certain moderation effect in the whole province and in both urban and rural areas, and the risk of bacillary dysentery is increased under wet antecedent conditions.
6.Life History Recorded in the Vagino-cervical Microbiome Along with Multi-omes
Jie ZHUYE ; Chen CHEN ; Hao LILAN ; Li FEI ; Song LIJU ; Zhang XIAOWEI ; Zhu JIE ; Tian LIU ; Tong XIN ; Cai KAIYE ; Zhang ZHE ; Ju YANMEI ; Yu XINLEI ; Li YING ; Zhou HONGCHENG ; Lu HAORONG ; Qiu XUEMEI ; Li QIANG ; Liao YUNLI ; Zhou DONGSHENG ; Lian HENG ; Zuo YONG ; Chen XIAOMIN ; Rao WEIQIAO ; Ren YAN ; Wang YUAN ; Zi JIN ; Wang RONG ; Liu NA ; Wu JINGHUA ; Zhang WEI ; Liu XIAO ; Zong YANG ; Liu WEIBIN ; Xiao LIANG ; Hou YONG ; Xu XUN ; Yang HUANMING ; Wang JIAN ; Kristiansen KARSTEN ; Jia HUIJUE
Genomics, Proteomics & Bioinformatics 2022;20(2):304-321
The vagina contains at least a billion microbial cells,dominated by lactobacilli.Here we perform metagenomic shotgun sequencing on cervical and fecal samples from a cohort of 516 Chinese women of reproductive age,as well as cervical,fecal,and salivary samples from a second cohort of 632 women.Factors such as pregnancy history,delivery history,cesarean section,and breastfeeding were all more important than menstrual cycle in shaping the microbiome,and such information would be necessary before trying to interpret differences between vagino-cervical micro-biome data.Greater proportion of Bifidobacterium breve was seen with older age at sexual debut.The relative abundance of lactobacilli especially Lactobacillus crispatus was negatively associated with pregnancy history.Potential markers for lack of menstrual regularity,heavy flow,dysmenor-rhea,and contraceptives were also identified.Lactobacilli were rare during breastfeeding or post-menopause.Other features such as mood fluctuations and facial speckles could potentially be predicted from the vagino-cervical microbiome.Gut and salivary microbiomes,plasma vitamins,metals,amino acids,and hormones showed associations with the vagino-cervical microbiome.Our results offer an unprecedented glimpse into the microbiota of the female reproductive tract and call for international collaborations to better understand its long-term health impact other than in the settings of infection or pre-term birth.
7.Expert Concensus on Triune Personalized Treatment of Pelvic Tumor Based on Three-Dimensional Printing
Songtao AI ; Zhengdong CAI ; Feiyan CHEN ; Kerong DAI ; Yang DONG ; Lingjie FU ; Yongqiang HAO ; Yingqi HUA ; Wenbo JIANG ; Jiong MEI ; Yuhui SHEN ; Wei SUN ; Rong WAN ; Yichao WANG ; Zhiwei WANG ; Haifeng WEI ; Wen WU ; Jianru XIAO ; Wangjun YAN ; Xinghai YANG ; Chunlin ZHANG ; Weibin ZHANG
Journal of Medical Biomechanics 2021;36(1):E001-E005
The adjacent anatomy of the pelvis is complicated, with digestive, urinary, reproductive and other organs as well as important blood vessels and nerves. Therefore, accurate resection of pelvic tumors and precise reconstruction of defects after resection are extremely difficult. The development of medical 3D printing technology provides new ideas for precise resection and personalized reconstruction of pelvic tumors. The “triune” application of 3D printing personalized lesion model, osteotomy guide plate and reconstruction prosthesis in pelvic tumor limb salvage reconstruction treatment has achieved good clinical results. However, the current lack of normative guidance standards such as preparation and application of 3D printing personalized lesion model, osteotomy guide plate and reconstruction prosthesis restricts its promotion and application. The formulation of this consensus provides normative guidance for 3D printing personalized pelvic tumor limb salvage reconstruction treatment.
8.Clinical study on 3D printing technology in percutaneous nephrolithotripsy for complicated renal calculi
Zhenghua WAN ; Liming XU ; Peide BAI ; Shunqiang XIE ; Jiguang XIAO ; Kuifu CHEN ; Weibin ZHANG ; Bin CHEN
Chinese Journal of Urology 2021;42(3):170-175
Objective:To explore the clinical application value of 3D printing technology in percutaneous nephrolithotomy(PCNL) to complex renal calculi.Methods:The clinical data of 41 patients with complex renal calculi from May 2018 to October 2019, in the First Affiliated Hospital of Xiamen University and Xiang'an District of the First Affiliated Hospital of Xiamen University were retrospectively analyzed. There were 19 cases underwent PCNL after 3D printing (3D printing group), and 22 cases during the same period did not undergo 3D printing before operation (control group). Before operation, the two groups underwent CT plain scan enhanced examination. In 3D printing group, 3D printing technology was used to obtain 3D renal models, then 3D renal models were used for preoperative design and simulation of surgical puncture and preoperative conversation.The control group only underwent PCNL after routine examination.The ages of the patients in 3D printing group and control group were (42.9±2.5) vs. (41.3±2.9) years old, male/female ratio 11/8 vs. 12/10, body mass index (22.4±1.1) vs. (23.2±1.4) kg/m 2, serum creatinine (42.9±2.5) vs. (78.2±4.5) μmol/L, stone size (5.0±1.2) vs. (5.2±1.3) cm, the CT values of the stones was (930±210) vs.(950±200) HU. The difference of above parameters was not statistically significant ( P>0.05). The following indexes were compared between the two groups: score of questionnaire on satisfaction of preoperative conversation, and datas about operation and postopetation. Results:All the operations were successfully completed. The time of locating the target calyces in 3D printing group and control group was (3.3±1.3) vs. (5.3±3.1) min, and the coincidence of puncture calices was 94.7% (18/19) vs. 54.5%(12/22), and the stone removal rate of the 3D printing group was 78.9% (17/19) vs. 36.4% (8/22), 3D printing group was better than the control group in these respects( P < 0.05). However, there were no significant differences in postoperative complications [21.0% (4/19) vs. 13.6% (3/22)], multi-channel[89.4% (17/19) vs. 86.4% (19/22)], operation time [(121.8±20.2) vs. (132.1±18.5) min], time of hospitalization [(7.6±1.3) vs. (8.0±1.8)d] and time of extubation for renal fistula [(3.8±1.7)vs. (4.5±2.0 )d] (all P > 0.05). During preoperative conversation between the 3D printing group and the control group , the time spent on signing the consent [(17.0±3.9) vs.(21.0±3.3) min], the degree of understanding of the stone condition [(2.5±0.6)vs.(2.0±1.2) points], the degree of understanding of the PCNL surgical process and complications [(2.6±0.6) vs.(1.8±1.3) points] and the degree of satisfaction with the doctor’s preoperative conversation effects [(2.4±0.9) vs.(1.7±1.6) points]were significantly different in comparisons ( P<0.05). Conclusions:3D printing technology can be used in PCNL to directly display the internal anatomical relationship of renal calculi, guide accurate preoperative designing, help improve the operation efficiency and stone clearance rate, and can also be used as a mold in preoperative conversation to improve communication efficiency.
9.The Local Alternative Ti-6Al-4V Alloy Coating of Surgery Steel Instruments for Laser Deposition Forming.
Ying XU ; Jian WU ; Feng XIAO ; Xiaofeng GU ; Wenmin LU ; Weibin REN
Chinese Journal of Medical Instrumentation 2020;44(3):205-209
Aiming at the medical practice problems of the surgical steel medical instruments, such as the crevice corrosion, the poor mechanical compatibility and the Ni, Cr plasma exudation, the laser deposition of Ti-6Al-4V alloy cladding layer at the local functional area as alternative coating was proposed and realized as a new process method. The accurate element content and good formability Ti-6Al-4V cladding powder was chosen, the low power and high duty cycle optimized laser process was adopt, the alternative coating of good fusion and low dilution was prepared. Through the elemental line scanning, the interface microstructure analysis and the experiments of basic mechanical properties, the basic properties of the cladding were characterized and verified. The experiments results showed that, the Ti, Al and V contents of the top coating were respectively about 88%, 4.9% and 3.9%, no sensitizing ions such as Cr and Ni were detected. Initial equiaxed α phase, flake β phase dist were distributed in the coating and interface, the α' martensite was precipitated at the boundary of the flake β phase, some refined granular β phase dispersion pinned to the grain boundary of basket structure. The microhardness of cladding layer was 352.08~312.76 HV0.1. The friction coefficient of the cladding layer was about 0.22~0.65. A new technology and method reference for improving and upgrading the performance of surgical medical devices is provided by this research.
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Materials Testing
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Steel
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Titanium
10.Safety and efficacy of mechanical thrombectomy in minor stroke with large vessel occlusion
Guifang WANG ; Xiaoqian YANG ; Yilei XIAO ; Weibin MA ; Shuping LIU ; Zuneng LU
Chinese Journal of Neuromedicine 2020;19(7):711-714
Objective:To explore the efficacy and safety of mechanical thrombectomy (MT) in patients with minor stroke with large vessel occlusion (LVO).Methods:Twenty-three patients with minor stroke with LVO, admitted to our hospital from January 2017 to July 2019, were consecutively collected in our study; patients with contraindications of intravenous thrombolysis should be treated with direct thrombectomy, and the left were given bridging therapy (intravenous thrombolysis combined with MT). NIHSS scores were used to assess the degrees of neurological impairment at admission, and 12 h and 7 d after treatment. Vascular recanalization was assessed by modified cerebral infarction thrombolysis (mTICI) grading, with grading 2B-3 defined as successful recanalization. The prognoses 90 d after treatment were assessed by modified Rankin scale (mRS), and mRS scores≤2 was classified as having good prognosis. Safety indicators included symptomatic intracranial hemorrhage, incidence of complications, and mortality 90 d after treatment.Results:Twenty-two patients had successfully recanalization; 19 patients had mTICI grading 3 and 3 patients had grading 2B. The NIHSS scores were 3 (2, 5) at admission, 2 (2, 3) 12 h after treatment, and 2 (1, 2) 7 d after treatment, with significant difference ( χ2=14.028, P=0.001); NIHSS scores 12 h and 7 d after treatment were significantly lower than those at admission ( P<0.05). Sixteen patients (69.6%) enjoyed good prognosis and 7 patients (30.4%) had poor prognosis. In terms of safety, two patients had symptomatic intracranial hemorrhage,10 had systemic complications, and one died during 90-d of follow-up. Conclusion:MT is effective and safe in minor stroke patients with LVO.

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