1.Observation on the efficacy of continuous veno-venous hemodia-filtration combined with hemoperfusion HA380 in the treatment of 15 cases of heat stroke with multiple organ dysfunction syndrome
Yuqin HUANG ; Lei LONG ; Qiang HUANG ; Qunbo WANG ; Ke JIN ; Tao JU ; Luting DAI ; Huaqiang XU ; Wenguo WANG ; Quan ZHOU
Chinese Critical Care Medicine 2024;36(5):532-537
Objective:To investigate the clinical efficacy of continuous veno-venous hemodia-filtration (CVVHDF) combined with hemoperfusion (HP) HA380 in the treatment of heat stroke patients with multiple organ dysfunction syndrome (MODS).Methods:A retrospective and observational study was conducted. A total of 15 patients with heat stroke combined with MODS who were admitted to the department of intensive care unit (ICU)of Suizhou Central Hospital/Hubei University of Medicine from July to September 2022 were selected as the study objects. All 15 patients were treated with CVVHDF combined with HA380 based on the comprehensive management strategy for severe illness. Organ function indicators [including total bilirubin (TBil), aspartate aminotransferase (AST), creatine kinase (CK), lactate dehydrogenase (LDH), creatinine (Cr), cardiac troponin T (cTnT), myoglobin (Myo), MB isoenzyme of creatine kinase (CK-MB), sequential organ failure assessment (SOFA)] and inflammatory indicators [including white blood cell count (WBC), neutrophil count (NEU), C-reactive protein (CRP), procalcitonin (PCT), and interleukin-6 (IL-6)] were collected. The improvements of the above indexes at admission, after the first HP, after the second HP, after the third HP, and on the 5th day of treatment were compared. Combined with the clinical outcome of patients, the comprehensive efficacy of CVVHDF combined with HA380 in the treatment of severe heat radiation disease was evaluated.Results:There were 10 males and 5 females among the 15 patients. The average age was (64.5±11.5) years old. There were 6 cases of classical heat stroke and 9 cases of exertional heat stroke. Glasgow coma scale (GCS) was 3-8 at admission; SOFA score was 9-17 within 12 hours after admission; acute physiology and chronic health evaluation Ⅱ(APACHEⅡ) was 25-45 within 24 hours after admission. After treatment, the IL-6 level and SOFA score gradually decreased, and there were significant differences in the decrease after the second HP compared to admission [IL-6 (ng/L): 48.37 (15.36, 113.03) vs. 221.90 (85.87, 425.90), SOFA: 8.3±3.3 vs. 11.1±2.4, both P < 0.05]. The PCT level reached its peak after the first HP [12.51 (6.07, 41.65) μg/L], and then gradually decreased, and the difference was statistically significant after the third HP [1.26 (0.82, 5.40) μg/L, P < 0.05]. Compared those at admission, Cr level significantly improved after the first HP (μmol/L: 66.94±25.57 vs. 110.80±31.13, P < 0.01), Myo significantly decreased after the second HP [μg/L: 490.90 (164.98, 768.05) vs. 3?000.00 (293.00, 3?000.00), P < 0.05], After the third HP, the CK level also showed significant improvement [U/L: 476.0 (413.0, 922.0) vs. 2?107.0 (729.0, 2?449.0), P < 0.05]. After CVVHDF combined with 3 times HP treatment, the patient's inflammatory response was gradually controlled and organ function gradually recovered. On the 5th day of the disease course, WBC, PCT and IL-6 levels were significantly improved compared to admission, and AST, CK, LDH, Cr, Myo, CK-MB, and SOFA score were significantly corrected compared with those on admission. The 24-hour survival rate of 15 patients was 86.67%, and the 24-hour, 7-day and 28-day survival rates were both as high as 73.33%. The average mechanical ventilation time of 11 surviving patients was (101.8±22.0) hours, the average continuous renal replacement therapy (CRRT) time was (58.8±11.0) hours, the average length of ICU stay was (6.3±1.0) days, and the average total hospitalization was (14.6±5.2) days. Conclusion:CVVHDF combined with HP HA380 in the treatment of heat stroke patients with MODS can effectively improve organ function and alleviate the inflammatory storm, which is an effective means to improve the rescue rate and reduce the mortality of severe heat stroke patients.
2.Phenotypically normal couples with recurrent pregnancies of trisomy 21 fetus: genetic analysis and literature review
Ju WANG ; Hongmei ZHAI ; Na LIU ; Jin GU ; Dongyi YU
Chinese Journal of Perinatal Medicine 2024;27(10):842-848
Objective:To investigate the genetic causes in a phenotypically normal couple with three pregnancies of trisomy 21 offspring.Methods:A retrospective analysis was conducted on a phenotypically normal couple who had three pregnancies with trisomy 21 syndrome offspring and were transferred to Shandong Provincial Maternal and Child Health Care Hospital in December 2023. Genetic analysis was performed using quantitative fluorescence polymerase chain reaction (QF-PCR), karyotype analysis, chromosome microarray analysis (CMA), and fluorescence in situ hybridization (FISH). Relevant articles up to December 31, 2023, were retrieved from CNKI, Wanfang Database, Yiigle, and VIP using the terms "recurrent pregnancy", "consecutive pregnancy", "two pregnancies", and "trisomy 21 syndrome (Down syndrome)" in Chinese. Additionally, the English terms "recurrence or recurrent" "trisomy 21 syndrome" and "Down syndrome" were used to retrieve articles from PubMed, Embase, and Web of Science. The genetic causes of recurrent pregnancies with trisomy 21 syndrome fetuses were analyzed and summarized. Results:(1) Case from this hospital: Results of QF-PCR, karyotype analysis, and CMA of amniotic fluid cells in this pregnancy all indicated that the fetus had trisomy 21 syndrome. FISH tests on oral mucosal cells, decidual tissue, and urine sediment cells of the pregnant woman all indicated that she was a mosaic for trisomy 21. Additionally, QF-PCR detection of short tandem repeat (STR) loci on chromosome 21 suggested that there might be gonad mosaicism in the pregnant women, and an extra chromosome 21 in the fetus was derived from gonad mosaicism 21 trisomic cells. (2) Literature review: A total of 13 case reports with detailed records of recurrent pregnancy trisomy 21 syndrome history and related test results of both partners were retrieved, making a total of 14 cases, including seven cases each with a history of 2 and 3 trisomy 21 pregnancies. Translocation trisomy 21 was detected in each pregnancy of two cases. Of the 14 cases, five cases were only detected by peripheral blood samples of the couple, and the results were normal. The other nine cases were also detected by skin fibroblasts (six cases), ovarian tissue cells (two cases), oral mucosa cells (two cases), semen (two cases), and urinary sediment cells (one case), among which six cases indicated that one of the parents was chimeric trisomy 21, and five cases were female chimerism, one case was male chimerism. Only two cases were found to have mosaic trisomy 21 in peripheral blood sample, and the chimerism ratio was lower than that of other samples detected at the same time. In five cases, the extra chromosome 21 was found to be of maternal origin through testing of STR loci on chromosome 21.Conclusions:Parental mosaicism is an important cause of recurrent pregnancies with trisomy 21 syndrome. Testing samples from skin, oral mucosa, blood, semen, and ovaries can help detect low-level mosaicism.
3.Effects of the first dorsal metatarsal artery terminal branch flaps in repairing skin and soft tissue defects of fingers
Haibo WU ; Guangzhe JIN ; Jin LI ; Yan ZHANG ; Kai WANG ; Qiang WANG ; Xiaoqiang TANG ; Jihui JU ; Ruixing HOU
Chinese Journal of Burns 2024;40(10):963-970
Objective:To explore the effects of the first dorsal metatarsal artery terminal branch flaps in repairing skin and soft tissue defects of fingers.Methods:The study was a retrospective observational study. From October 2021 to December 2022, 44 patients with skin and soft tissue defects in 55 fingers who met the inclusion criteria were admitted to Suzhou Ruihua Orthopedic Hospital. There were 39 males (48 fingers) and 5 females (7 fingers), aged 18 to 54 years. The single wound area after debridement ranged from 1.5 cm×1.0 cm to 3.0 cm×2.0 cm. The color Doppler ultrasonography was performed before operation to locate the first dorsal metatarsal artery and its terminal branches, and a first dorsal metatarsal artery terminal branch flap was designed according to the wound condition, with the area of harvested single flap ranged from 1.7 cm×1.2 cm to 3.2 cm×2.2 cm. The wounds in the flap donor areas were transplanted with full-thickness skin grafts from ipsilateral inner calf. The type of flap was recorded, and the diameter of the terminal branch of the first dorsal metatarsal artery was measured during operation. The survival of the flap was observed one week after operation. The wound healing in the flap donor and recipient areas was observed two weeks after operation. At the last follow-up, the functional recovery of the affected fingers was evaluated by the trial standards for evaluation of partial function of upper extremity by the Hand Surgery Society of Chinese Medical Association, the sensory function of the flap was evaluated using the sensory function evaluation standard of British Medical Research Council, the scar in the donor and recipient areas of the flap was evaluated using the Vancouver scar scale (VSS), and the Allen test was conducted in the toe of flap donor area to evaluate the blood flow.Results:The monoblock type flaps in 31 patients and flow-through type flaps in 2 patients were used to repair wounds in single finger, 2 monoblock type flaps in 8 patients were used to repair wounds in 2 fingers at the same time, and the single-pedicle and two-flap type flaps in 3 patients were used to repair wounds in 2 fingers at the same time. The diameter of the fibular terminal branch of the first dorsal metatarsal artery ranged from 0.40 to 1.10 mm, and the diameter of the tibial terminal branch of the first dorsal metatarsal artery ranged from 0.70 to 0.75 mm. All the flaps survived at one week after operation, and all the wounds demonstrated optimal healing in the flap donor and recipient areas at two weeks after operation. All patients were followed up for 6 to 18 months. At the last follow-up, the functional recovery of 48 fingers was evaluated as excellent, and the functional recovery of 7 fingers was evaluated as good; the sensory function of 8 flaps was rated as S2, and the sensory function of 47 flaps was rated as S3, and the two-point discrimination distance of the flaps was 8-14 mm; the VSS scores in the flap recipient areas ranged from 3 to 6, and the VSS scores in the flap donor areas ranged from 4 to 7; the Allen test result of the toes in the donor areas were all negative with normal blood flow.Conclusions:The first dorsal metatarsal artery terminal branch flaps have several advantages, including relatively hidden donor area, shallow anatomical level, simple intraoperative operation, and flexible flap design. The flap is incised without damaging the main artery of the toe, which can repair skin and soft tissue defects of the fingers and ensure the utmost protection of the toes in donor areas. The fingers exhibit improved appearance, texture, sensation, and function after operation.
4.A multicenter study of neonatal stroke in Shenzhen,China
Li-Xiu SHI ; Jin-Xing FENG ; Yan-Fang WEI ; Xin-Ru LU ; Yu-Xi ZHANG ; Lin-Ying YANG ; Sheng-Nan HE ; Pei-Juan CHEN ; Jing HAN ; Cheng CHEN ; Hui-Ying TU ; Zhang-Bin YU ; Jin-Jie HUANG ; Shu-Juan ZENG ; Wan-Ling CHEN ; Ying LIU ; Yan-Ping GUO ; Jiao-Yu MAO ; Xiao-Dong LI ; Qian-Shen ZHANG ; Zhi-Li XIE ; Mei-Ying HUANG ; Kun-Shan YAN ; Er-Ya YING ; Jun CHEN ; Yan-Rong WANG ; Ya-Ping LIU ; Bo SONG ; Hua-Yan LIU ; Xiao-Dong XIAO ; Hong TANG ; Yu-Na WANG ; Yin-Sha CAI ; Qi LONG ; Han-Qiang XU ; Hui-Zhan WANG ; Qian SUN ; Fang HAN ; Rui-Biao ZHANG ; Chuan-Zhong YANG ; Lei DOU ; Hui-Ju SHI ; Rui WANG ; Ping JIANG ; Shenzhen Neonatal Data Network
Chinese Journal of Contemporary Pediatrics 2024;26(5):450-455
Objective To investigate the incidence rate,clinical characteristics,and prognosis of neonatal stroke in Shenzhen,China.Methods Led by Shenzhen Children's Hospital,the Shenzhen Neonatal Data Collaboration Network organized 21 institutions to collect 36 cases of neonatal stroke from January 2020 to December 2022.The incidence,clinical characteristics,treatment,and prognosis of neonatal stroke in Shenzhen were analyzed.Results The incidence rate of neonatal stroke in 21 hospitals from 2020 to 2022 was 1/15 137,1/6 060,and 1/7 704,respectively.Ischemic stroke accounted for 75%(27/36);boys accounted for 64%(23/36).Among the 36 neonates,31(86%)had disease onset within 3 days after birth,and 19(53%)had convulsion as the initial presentation.Cerebral MRI showed that 22 neonates(61%)had left cerebral infarction and 13(36%)had basal ganglia infarction.Magnetic resonance angiography was performed for 12 neonates,among whom 9(75%)had involvement of the middle cerebral artery.Electroencephalography was performed for 29 neonates,with sharp waves in 21 neonates(72%)and seizures in 10 neonates(34%).Symptomatic/supportive treatment varied across different hospitals.Neonatal Behavioral Neurological Assessment was performed for 12 neonates(33%,12/36),with a mean score of(32±4)points.The prognosis of 27 neonates was followed up to around 12 months of age,with 44%(12/27)of the neonates having a good prognosis.Conclusions Ischemic stroke is the main type of neonatal stroke,often with convulsions as the initial presentation,involvement of the middle cerebral artery,sharp waves on electroencephalography,and a relatively low neurodevelopment score.Symptomatic/supportive treatment is the main treatment method,and some neonates tend to have a poor prognosis.
5.Meta analysis and GRADE evidence level evaluation of therapeutic efficacy and safety of plum-blossom needle in treating vitiligo
Shumei CHEN ; Kaizhong ZHANG ; Tingting LI ; Tinglu WEN ; Ju YU ; Jin WANG ; Yuyi WANG
Chongqing Medicine 2024;53(1):121-126
Objective To systematically evaluate the efficacy and safety of plum-blossom needle therapy for vitiligo by using the systematic review and meta analysis.Methods The randomized controlled trials(RCT)on plum-blossom needle for treating vitiligo were systematically retrieved from the databases of the PubMed,China Biological Medicine Database,CNKI,Wanfang Data and VIP database from the database estab-lishment to June 2,2022.The literatures were screened according to the inclusion and exclusion criteria.The finally included literatures conducted the data extraction.The RevMan 5.4 software was used for conducting the data analysis.The methodological quality evaluation on the included trials was performed by the ROB tool.The GRADE method was used to assess the evidence level.Results A total of 7 trials involving 469 pa-tients were finally included.The meta analysis results showed that the plum-blossom needle combined with other therapies(including laser or ultraviolet irradiation,tacrolimus ointment,compound Kaliziran tincture)was superior to the other therapies alone in the aspects of improving vitiligo skin lesion including reducing the of white spot skin lesion area(MD=-1.11,95%CI:-1.92 to-0.30,P=0.007),increasing the repigment-ation rate of vitiliginous lesions(MD=18.09,95%CI:1.55 to 34.63,P=0.030)and enhancing the pigment deposition in vitiligo lesions(MD=0.92,95%CI:0.32 to 1.52,P=0.003),and improving the patients'quali-ty of life(MD=-7.48,95%CI:-8.04 to-6.92,P<0.001),and the differences were statistically signifi-cant.In terms of safety,there was no statistically significant difference in adverse events between plum blos-som acupuncture combined with other therapies and other therapies alone(RR=1.20,95%CI:0.77 to 1.84,P=0.420).Conclusion Low or very low evidence shows that plum-blossom needle combined with other therapies for treating vitiligo may enhance the effect in the aspects of improving the white spot skin lesions and quality of life in the patients with vitiligo,moreover which is relatively safe.
6.Clinical trial of parecoxib sodium combined with dexmedetomidine for surgery in patients with osteoporotic compression fractures
Kai LUO ; Qing WANG ; Gao-Ju WANG ; Jin YANG ; Guang-Zhou LI ; Shi-Jie SONG ; Shun-Gui CAI
The Chinese Journal of Clinical Pharmacology 2024;40(20):2963-2967
Objective To investigate the effects of parecoxib sodium injection combined with dexmedetomidine hydrochloride injection on postoperative cognitive function and stress response in patients with osteoporotic compression fractures.Methods The patients with osteoporotic compression fractures were divided into treatment group and control group according to the treatment plan.The control group was given intravenous injection of dexmedetomidine hydrochloride injection 0.2 μg·kg-1load dose,then micro pump injection 0.2 μg·kg-1·min-1 maintenance dose,until 30 min before the end of the operation;patients in the treatment group were intravenously injected with parecoxib sodium injection 20 mg before local anesthesia and 30 min before the end of operation on the basis of the control group.The pain,sedation,hemodynamics[mean arterial pressure(MAP),heart rate(HR)],cognitive function and safety evaluation were compared between the two groups before operation(T0),2 h after operation(T1),6 h after operation(T2),12 h after operation(T3)and 24 h after operation(T4).Results There were 39 cases in the treatment group and 41 cases in the control group.Visual analogue scale(VAS)scores in treatment group and control group were(3.09±0.55)and(3.41±0.62)scores at T1;VAS scores were(3.02±0.57)and(3.35±0.48)scores at T2;VAS scores were(2.64±0.44)and(2.90±0.46)scores at T3;VAS scores were(2.02±0.41)and(2.35±0.47)scores at T4;MMSE scores were(25.28±1.57)and(24.33±1.42)scores at T2;MMSE scores were(28.16±1.01)and(27.25±0.89)scores at T4;MoCA scores were(24.63±1.60)and(23.59±1.25)scores at T2;MoCA scores were(27.20±0.97)and(26.48±0.83)scores at T4.There were statistically significant differences in the above indexes between the treatment group and the control group(all P<0.05).Adverse drug reactions in the treatment group included bradycardia,hypotension,nausea vomiting and hypokalemia;adverse drug reactions in the control group included bradycardia,hypotension and nausea vomiting.The total incidence rates of adverse drug reactions were 12.82%and 9.76%,without statistically significant difference(P>0.05).Conclusion Compared with using dexmedetomidine alone,parecoxib sodium combined with dexmedetomidine is beneficial for relieving postoperative pain in patients with osteoporotic compression fractures,improving postoperative cognitive function.
7.Disease spectrum and pathogenic genes of inherited metabolic disorder in Gansu Province of China
Chuan ZHANG ; Ling HUI ; Bing-Bo ZHOU ; Lei ZHENG ; Yu-Pei WANG ; Sheng-Ju HAO ; Zhen-Qiang DA ; Ying MA ; Jin-Xian GUO ; Zong-Fu CAO ; Xu MA
Chinese Journal of Contemporary Pediatrics 2024;26(1):67-71
Objective To investigate the disease spectrum and pathogenic genes of inherited metabolic disorder(IMD)among neonates in Gansu Province of China.Methods A retrospective analysis was conducted on the tandem mass spectrometry data of 286 682 neonates who received IMD screening in Gansu Provincial Maternal and Child Health Hospital from January 2018 to December 2021.A genetic analysis was conducted on the neonates with positive results in tandem mass spectrometry during primary screening and reexamination.Results A total of 23 types of IMD caused by 28 pathogenic genes were found in the 286 682 neonates,and the overall prevalence rate of IMD was 0.63‰(1/1 593),among which phenylketonuria showed the highest prevalence rate of 0.32‰(1/3 083),followed by methylmalonic acidemia(0.11‰,1/8 959)and tetrahydrobiopterin deficiency(0.06‰,1/15 927).In this study,166 variants were identified in the 28 pathogenic genes,with 13 novel variants found in 9 genes.According to American College of Medical Genetics and Genomics guidelines,5 novel variants were classified as pathogenic variants,7 were classified as likely pathogenic variants,and 1 was classified as the variant of uncertain significance.Conclusions This study enriches the database of pathogenic gene variants for IMD and provides basic data for establishing an accurate screening and diagnosis system for IMD in this region.
8.Epidemiological investigation of iron deficiency among preschool children in 10 provinces, autonomous regions, or municipalities in China
Lei WANG ; Jie SHAO ; Wenhong DONG ; Shuangshuang ZHENG ; Bingquan ZHU ; Qiang SHU ; Wei CHEN ; Lichun FAN ; Jin SUN ; Yue GAO ; Youfang HU ; Nianrong WANG ; Zhaohui WANG ; Tingting NIU ; Yan LUO ; Ju GAO ; Meiling TONG ; Yan HU ; Wei XIANG ; Zhengyan ZHAO ; Meng MAO ; Fan JIANG
Chinese Journal of Pediatrics 2024;62(5):416-422
Objective:To understand the current status of anemia, iron deficiency, and iron-deficiency anemia among preschool children in China.Methods:A cross-sectional study was conducted with a multi-stage stratified sampling method to select 150 streets or townships from 10 Chinese provinces, autonomous regions, or municipalities (East: Jiangsu, Zhejiang, Shandong, and Hainan; Central: Henan; West: Chongqing, Shaanxi, Guizhou, and Xinjiang; Northeast: Liaoning). From May 2022 to April 2023, a total of 21 470 children, including community-based children aged 0.5 to<3.0 years receiving child health care and kindergarten-based children aged 3.0 to<7.0 years, were surveyed. They were divided into 3 age groups: infants (0.5 to<1.0 year), toddlers (1.0 to<3.0 years), and preschoolers (3.0 to<7.0 years). Basic information such as sex and date of birth of the children was collected, and peripheral blood samples were obtained for routine blood tests and serum ferritin measurement. The prevalence rates of anemia, iron deficiency, and iron-deficiency anemia were analyzed, and the prevalence rate differences were compared among different ages, sex, urban and rural areas, and regions using the chi-square test.Results:A total of 21 460 valid responses were collected, including 10 780 boys (50.2%). The number of infants, toddlers, and preschoolers were 2 645 (12.3%), 6 244 (29.1%), and 12 571 (58.6%), respectively. The hemoglobin level was (126.7±14.8) g/L, and the serum ferritin level was 32.3 (18.5, 50.1) μg/L. The overall rates of anemia, iron deficiency, and iron-deficiency anemia were 10.4% (2 230/21 460), 28.3% (6 070/21 460), and 3.9% (845/21 460), respectively. The prevalence rate of anemia was higher for boys than for girls (10.9% (1 173/10 780) vs. 9.9% (1 057/10 680), χ2=5.58, P=0.018), with statistically significant differences in the rates for infants, toddlers and preschoolers (18.0% (475/2 645), 10.6% (662/6 244), and 8.7% (1 093/12 571), respectively, χ2=201.81, P<0.01), and the rate was significantly higher for children in rural than that in urban area (11.8% (1 516/12 883) vs. 8.3% (714/8 577), χ2=65.54, P<0.01), with statistically significant differences in the rates by region ( χ2=126.60, P<0.01), with the highest rate of 15.8% (343/2 173) for children in Central region, and the lowest rate of 5.3% (108/2 053) in Northeastern region. The prevalence rates of iron deficiency were 33.8% (895/2 645), 32.2% (2 011/6 244), and 25.2% (3 164/12 571) in infants, toddlers, and preschoolers, respectively, and 30.0% (3 229/10 780) in boys vs. 26.6% (2 841/10 680) in girls, 21.7% (1 913/8 821), 40.0% (870/2 173), 27.1% (2 283/8 413), 48.9% (1 004/2 053) in Eastern, Central, Western, and Northeastern regions, respectively, and each between-group showed a significant statistical difference ( χ2=147.71, 29.73, 773.02, all P<0.01). The prevalence rate of iron-deficiency anemia showed a significant statistical difference between urban and rural areas, 2.9% (251/8 577) vs. 4.6% (594/12 883) ( χ2=38.62, P<0.01), while the difference in iron deficiency prevalence was not significant ( χ2=0.51, P=0.476). Conclusions:There has been a notable improvement in iron deficiency and iron-deficiency anemia among preschool children in China, but the situation remains concerning. Particular attention should be paid to the prevention and control of iron deficiency and iron-deficiency anemia, especially among infants and children in the Central, Western, and Northeastern regions of China.
9.Analysis of the modulating effect of lipid-regulating clinical and clinical trial drugs on trimethylamine-oxide in hyperlipidemic hamster based on two-dimensional NMR technique
Yue XU ; Ren-liang XUE ; Hao-wen ZHU ; Xiang-ju JIN ; Ying-hong WANG
Acta Pharmaceutica Sinica 2024;59(12):3354-3360
Studies have shown that a variety of diseases such as cardiovascular disease, renal disease and cancer are closely related to trimethylamine oxide (TMAO). Clinically, abnormal elevation of TMAO has been used as an evaluation index of atherosclerosis (AS) prior to imaging. In this study, we investigated the effects of lipid metabolism disorders as well as pharmacological interventions on urinary TMAO using a hyperlipidemic golden gopher model. The study used 48 Syrian golden hamster modeled with a high-fat diet for 2 weeks, and then ezetimibe, simvastatin, ezetimibe and simvastatin groups were administered for 4 consecutive weeks, as well as the clinical trial drug, IMM-H007, for pharmacological intervention. The animal experiment was conducted in accordance with the regulations of the Ethics Committee for Experimental Animal Management and Animal Welfare of Institute of Materia Medica, Chinese Academy of Medical Sciences (approval number: SCXK (Beijing) 2021-0011). Urine from rats was analyzed for 2D band selective heteronuclear single quantum coherence (2D bs-HSQC) at week 2 and 4 after drug administration. The results indicated that, in comparison to the control group, the high-fat diet significantly elevated urinary TMAO levels in the model group of hamsters after both 2 and 4 weeks of treatment (
10.Lazertinib versus Gefitinib as First-Line Treatment for EGFR-mutated Locally Advanced or Metastatic NSCLC: LASER301 Korean Subset
Ki Hyeong LEE ; Byoung Chul CHO ; Myung-Ju AHN ; Yun-Gyoo LEE ; Youngjoo LEE ; Jong-Seok LEE ; Joo-Hang KIM ; Young Joo MIN ; Gyeong-Won LEE ; Sung Sook LEE ; Kyung-Hee LEE ; Yoon Ho KO ; Byoung Yong SHIM ; Sang-We KIM ; Sang Won SHIN ; Jin-Hyuk CHOI ; Dong-Wan KIM ; Eun Kyung CHO ; Keon Uk PARK ; Jin-Soo KIM ; Sang Hoon CHUN ; Jangyoung WANG ; SeokYoung CHOI ; Jin Hyoung KANG
Cancer Research and Treatment 2024;56(1):48-60
Purpose:
This subgroup analysis of the Korean subset of patients in the phase 3 LASER301 trial evaluated the efficacy and safety of lazertinib versus gefitinib as first-line therapy for epidermal growth factor receptor mutated (EGFRm) non–small cell lung cancer (NSCLC).
Materials and Methods:
Patients with locally advanced or metastatic EGFRm NSCLC were randomized 1:1 to lazertinib (240 mg/day) or gefitinib (250 mg/day). The primary endpoint was investigator-assessed progression-free survival (PFS).
Results:
In total, 172 Korean patients were enrolled (lazertinib, n=87; gefitinib, n=85). Baseline characteristics were balanced between the treatment groups. One-third of patients had brain metastases (BM) at baseline. Median PFS was 20.8 months (95% confidence interval [CI], 16.7 to 26.1) for lazertinib and 9.6 months (95% CI, 8.2 to 12.3) for gefitinib (hazard ratio [HR], 0.41; 95% CI, 0.28 to 0.60). This was supported by PFS analysis based on blinded independent central review. Significant PFS benefit with lazertinib was consistently observed across predefined subgroups, including patients with BM (HR, 0.28; 95% CI, 0.15 to 0.53) and those with L858R mutations (HR, 0.36; 95% CI, 0.20 to 0.63). Lazertinib safety data were consistent with its previously reported safety profile. Common adverse events (AEs) in both groups included rash, pruritus, and diarrhoea. Numerically fewer severe AEs and severe treatment–related AEs occurred with lazertinib than gefitinib.
Conclusion
Consistent with results for the overall LASER301 population, this analysis showed significant PFS benefit with lazertinib versus gefitinib with comparable safety in Korean patients with untreated EGFRm NSCLC, supporting lazertinib as a new potential treatment option for this patient population.

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