1.Comparison of short-term clinical efficacy between CO external fixation and internal fixation with steel plate in the treatment of unstable distal radius fractures.
Min-Rui FU ; Chang-Long SHI ; Yong-Zhong CHENG ; Ming-Ming MA ; Zheng-Lin NIU ; Hai-Xiang SUN ; Jing-Hua GAO ; Zhong-Kai WU ; Yi-Ming XU
China Journal of Orthopaedics and Traumatology 2025;38(1):10-17
OBJECTIVE:
To evaluate the short-term clinical efficacy of external fixation and internal fixation with steel plate in the treatment of unstable distal radius fractures (AO-23C type), based on the principles of Chinese osteosynthesis (CO).
METHODS:
Forty-eight patients with unstable distal radius fractures between January 2022 and February 2023 were retrospectively analyzed and divided into the CO external fixation group and internal fixation group. CO external fixation group consisted of 25 patients, including 7 males and 18 females, aged from 37 to 56 years old with an average of ( 52.6±11.3) years old. Among them, there were 7 patients of traffic accidents and 18 patients of falls, resulting in a total of 25 patients of closed fractures and no open fractures, the treatment was conducted using closed reduction and CO external fixation. The internal fixation group consisted of 23 patients, comprising 8 males and 15 females, age ranged from 41 to 59 years old, with an average age of(53.3±13.7) years old. Among them, 8 patients resulted from car accidents while the remaining 15 patients were caused by falls. All 23 patients were closed fractures without any open fractures observed. The technique of open reduction and internal fixation with steel plate was employed. The perioperative data, including injury-operation time, operation duration, blood loss, and length of hospital stay, were assessed in both groups. Additionally, the QuickDASH score and visual analogue scale (VAS) were evaluated. Range of motion and grip strength assessment, imaging findings such as palmar inclination angle, ulnar declination angle, radius length, articular surface step, intra-articular space measurements were also examined along with any complications.
RESULTS:
The follow-up duration ranged from 0 to 24 months, with an average duration of (16.0±3.8) months. The CO external fixation exhibited significantly shorter time from injury to operation (2.4±3.3) d vs (7.4±3.7) d, shorter operation duration (56.27±15.23) min vs (74.10±5.26) min, lower blood loss (14.52±6.54) ml vs (32.32±10.03) ml, and reduced hospitalization days (14.04±3.24 )d vs (16.45±3.05) d compared to the internal fixation group (P<0.05). The QuickDASH score at 12 months post-operation was (8.21±1.64) in the CO external fixation group, while no significant difference was observed in the internal fixation group (7.04±3.64), P>0.05. There were no statistically significant differences in VAS between two groups at 6 weeks, as well as 1 and 3 months post-surgery (P>0.05). Additionally, there were no significant disparities observed in terms of range of motion and grip strength between two groups at the 2-year follow-up after the operation (P>0.05). After 12 months of surgery, the CO external fixation group exhibited a significantly smaller palmar inclination angle (17.90±2.18) ° vs (19.87±3.21) °, reduced articular surface step (0.11±0.03) mm vs (0.17±0.02) mm, and shorter radius length (8.16±1.11) mm compared to the internal fixation group (9.59±1.02) mm, P<0.05. The ulnar deviation angle and intra-articular space did not show any significant difference between two groups (P>0.05). The reduced fell within the allowable range between the CO external fixation group (23 out of 25 cases) and the internal fixation group (21 out of 23 cases) was not statistically significant (P=0.29). There was no significant difference in complications between the two groups(P>0.05).
CONCLUSION
Both the CO external fixation and open reduction with plate internal fixation demonstrate clinical efficacy in managing unstable distal radius fractures. The CO external fixation offers advantages in shorter injury-to-operation times, reduced intraoperative blood loss, and decreased surgical durations, while radial shortening is more effectively controlled by internal fixation.
Humans
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Male
;
Female
;
Middle Aged
;
Radius Fractures/physiopathology*
;
Adult
;
Bone Plates
;
Fracture Fixation, Internal/methods*
;
External Fixators
;
Retrospective Studies
;
Fracture Fixation/methods*
;
Wrist Fractures
2.Identification of Rare 3.5 kb Deletion in the β-Globin Gene Cluster.
Yun-Hua FAN ; Cui-Lin DUAN ; Sai-Li LUO ; Shi-Jun GE ; Chong-Fei YU ; Jue-Min XI ; Jia-You CHU ; Zhao-Qing YANG
Journal of Experimental Hematology 2025;33(1):175-179
OBJECTIVE:
To identify the gene mutation types of 4 suspected β-thalassemia patients in Yunnan Province, and to analyze the genotypes and hematological phenotypes.
METHODS:
Whole genome sequencing was performed on the samples of 4 suspected β-thalassemia patients from the Dai ethnic group in a thalassemia endemic area of Yunnan Province, whose hematological phenotypes were not consistent with the results of common thalassemia gene mutations. The mutations of β-globin gene clusters were confirmed by polymerase chain reaction (PCR) and Sanger DNA sequencing technology.
RESULTS:
The 3.5 kb deletion in β-globin gene cluster (NC_000011.10: g. 5224302-5227791del3490bp) was detected in 4 patients' samples, of which 1 case was also detected with HbE mutation and 1 case with CD17 mutation. These 2 patients displayed moderate anemia phenotype, while the two patients with only the 3.5 kb deletion presented with other mild anemia phenotype.
CONCLUSION
Heterozygous carriers with rare 3.5 kb deletion of the β-globin gene cluster may develop mild anemia, compound mutations of the 3.5 kb deletion with other mutations may led to intermediate thalasemia with moderate to sever anemia. In areas with a high incidence of thalassemia, suspected patients should undergo genetic testing to avoid missing or misdiagnosing rare mutations.
Humans
;
beta-Globins/genetics*
;
Multigene Family
;
beta-Thalassemia/genetics*
;
Mutation
;
Genotype
;
Sequence Deletion
;
Phenotype
;
Male
;
Female
3.Study on Differential DNA Methylation Profiles of Patients with High-Altitude Polycythemia.
Jun-Hua JI ; Min YANG ; Yan JIANG ; Ting-Xian YANG ; Xiao-Jing MA ; Qi-Chao YIN ; Hong-Wei YIN ; Lin-Hua JI
Journal of Experimental Hematology 2025;33(2):580-586
OBJECTIVE:
To investigate the whole-genome differential methylation profile of patients with high-altitude polycythemia (HAPC).
METHODS:
In this study, a total of 20 adult male patients with HAPC were included, including 10 Tibetan and 10 Han patients. The control group consisted of 20 healthy adult males, including 10 Tibetan and 10 Han patients. Peripheral blood was collected from each group for DNA extraction and quality inspection, and DNA libraries were constructed. The differential methylation regions (DMRs) between groups were detected using reduced representation bisulfite sequencing, with enriched regions compared to those of the control group. The differential enrichment regions were selected, and the intersection of the enriched regions was associated with genes. The methylation enrichment regions that differed significantly between groups were filtered based on the number of enriched samples in the enriched regions between the groups. GO, KEGG functional, and pathway analysis were performed on the differentially associated gene sets to reveal significant differences between the patients and control groups at the functional and pathway levels.
RESULTS:
In comparison with the control group, 17 152 sites with more than 25% difference and 15 558 sites with less than -25% difference were identified in Tibetan patients. The top 5 genes with the largest methylation differences between the two groups were MCCC2, RP3-399L15.3, ZNF621, RP11-394A14.2 and SLC39A10. The top significantly different pathways annotated in the differentially expressed genes pathway was serotonergic synapse. In comparison with the control group, 2 687 CpG sites with a greater than 25% difference and 2 602 CpG sites with a less than -25% difference were identified in Han patients. The top 5 genes with the largest methylation differences between the two groups were NAA25, CORO2B, PDC, ZNF853, and MLLT10. The top significantly different pathways annotated in the differentially expressed genes pathway were glutamatergic synapse, retrograde endocannabinoid signaling, Rap1 signaling pathway and cholinergic synapse. In comparison with the control group, 3 895 CpG sites with a greater than 25% difference and 3 969 CpG sites with a less than -25% difference were identified in HAPC patients. The maximum methylation difference between the two groups could reach 78.1%, while the minimum was -42.6%. The top 5 genes with the largest methylation differences between the two groups were MCCC2, ARSJ, CTNNA3, SLC39A10, and SWAP70. The top significantly different pathways annotated in the differentially expressed genes pathway was signaling pathways regulating pluripotency of stem cells.
CONCLUSION
The occurrence of HAPC may be related to abnormal changes in DNA methylation, and methylation sites may be helpful for the early diagnosis of HAPC.
Humans
;
DNA Methylation
;
Altitude
;
Polycythemia/genetics*
;
Male
;
Adult
;
CpG Islands
4.A multicenter prospective study on early identification of refractory Mycoplasma pneumoniae pneumonia in children
Dan XU ; Ailian ZHANG ; Jishan ZHENG ; Mingwei YE ; Fan LI ; Gencai QIAN ; Hongbo SHI ; Xiaohong JIN ; Lieping HUANG ; Jiangang MEI ; Guohua MEI ; Zhen XU ; Hong FU ; Jianjun LIN ; Hongzhou YE ; Yan ZHENG ; Lingling HUA ; Min YANG ; Jiangmin TONG ; Lingling CHEN ; Yuanyuan ZHANG ; Dehua YANG ; Yunlian ZHOU ; Huiwen LI ; Yinle LAN ; Yulan XU ; Jinyan FENG ; Xing CHEN ; Min GONG ; Zhimin CHEN ; Yingshuo WANG
Chinese Journal of Pediatrics 2024;62(4):317-322
Objective:To explore potential predictors of refractory Mycoplasma pneumoniae pneumonia (RMPP) in early stage. Methods:The prospective multicenter study was conducted in Zhejiang, China from May 1 st, 2019 to January 31 st, 2020. A total of 1 428 patients with fever >48 hours to <120 hours were studied. Their clinical data and oral pharyngeal swab samples were collected; Mycoplasma pneumoniae DNA in pharyngeal swab specimens was detected. Patients with positive Mycoplasma pneumoniae DNA results underwent a series of tests, including chest X-ray, complete blood count, C-reactive protein, lactate dehydrogenase (LDH), and procalcitonin. According to the occurrence of RMPP, the patients were divided into two groups, RMPP group and general Mycoplasma pneumoniae pneumonia (GMPP) group. Measurement data between the 2 groups were compared using Mann-Whitney U test. Logistic regression analyses were used to examine the associations between clinical data and RMPP. Receiver operating characteristic (ROC) curves were used to analyse the power of the markers for predicting RMPP. Results:A total of 1 428 patients finished the study, with 801 boys and 627 girls, aged 4.3 (2.7, 6.3) years. Mycoplasma pneumoniae DNA was positive in 534 cases (37.4%), of whom 446 cases (83.5%) were diagnosed with Mycoplasma pneumoniae pneumonia, including 251 boys and 195 girls, aged 5.2 (3.3, 6.9) years. Macrolides-resistant variation was positive in 410 cases (91.9%). Fifty-five cases were with RMPP, 391 cases with GMPP. The peak body temperature before the first visit and LDH levels in RMPP patients were higher than that in GMPP patients (39.6 (39.1, 40.0) vs. 39.2 (38.9, 39.7) ℃, 333 (279, 392) vs. 311 (259, 359) U/L, both P<0.05). Logistic regression showed the prediction probability π=exp (-29.7+0.667×Peak body temperature (℃)+0.004×LDH (U/L))/(1+exp (-29.7+0.667×Peak body temperature (℃)+0.004 × LDH (U/L))), the cut-off value to predict RMPP was 0.12, with a consensus of probability forecast of 0.89, sensitivity of 0.89, and specificity of 0.67; and the area under ROC curve was 0.682 (95% CI 0.593-0.771, P<0.01). Conclusion:In MPP patients with fever over 48 to <120 hours, a prediction probability π of RMPP can be calculated based on the peak body temperature and LDH level before the first visit, which can facilitate early identification of RMPP.
5.Nursing study of segmented enteral nutrition combined with fistuloclysis to improve the nutritional status of patients with severe intestinal fistula
Min-Yi ZHOU ; Min QING ; Hong-Lin YAO ; Ze-Hua ZHAO ; Shan-Shan YU
Parenteral & Enteral Nutrition 2024;31(3):162-166
Objective:To study the effect of segmented enteral nutrition combined with fistuloclysis on improving the nutritional status of patients with severe intestinal fistula,to explore the impact of nutritional support methods on the recovery of severe intestinal fistula,and to provide nursing experience for patients with severe intestinal fistula. Methods:96 patients with severe intestinal fistulas complicated by multiple fistulas admitted to the intensive care unit of Research Institute of General Surgery from February 2023 to August 2023 were selected. According to the nutritional support method,they were divided into intervention group (n=47) and control group (n=49). The intervention group used segmented enteral nutrition combined with fistuloclysis,and the control group only used segmented enteral nutrition. After 14 days of enteral nutrition intervention,the nutritional status of the two groups was compared,such as BMI,serum albumin levels,total protein levels,and hemoglobin levels;inflammation levels,such as serum C-reactive protein (CRP) levels,interleukin-6 (IL-6),enteral Incidence of nutritional intolerance symptoms,prognosis such as total ICU length of stay,total hospitalization costs,etc. Results:After 14 days intervention,the serum total protein and hemoglobin of the intervention group were (71.55±7.00) g/L and (106.64±15.59) g/L,which were significantly higher than those of the control group (P<0.05). The BMI of the intervention group was (21.83±4.44)kg/m2,and BMI in the control group was (19.64±3.16)kg/m2. The difference was statistically significant (P<0.05). The CRP level in the intervention group was (35.71±27.77) mg/L,which was significantly lower than that in the control group[(56.78±51.22) mg/L,P<0.05]. The IL-6 level in the intervention group was (30.20±24.47) pg/mL,which was also significantly lower than that in the control group[(76.18±54.36)pg/mL,P<0.05]. Conclusion:Segmented enteral nutrition combined with fistuloclysis is beneficial to improving patients' nutritional status,reducing inflammatory reactions,reducing the incidence of enteral nutrition intolerance,and reducing the length of total hospitalization.
6.Clinical Observation on Acupuncture Combined with Shenqi Huoxue Decoction in the Treatment of Adenomyosis of Qi Deficiency and Blood Stasis Type
Tian-Si WU ; Chun-Min ZHANG ; Xiao-Hua LIN ; Yu-Xuan QIN ; Wen-Hui BIAN ; Feng YUN
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(6):1537-1542
Objective To observe the clinical effect of acupuncture combined with Shenqi Huoxue Decoction in the treatment of adenomyosis of qi deficiency and blood stasis type.Methods Seventy patients with adenomyosis of qi deficiency and blood stasis type were randomly divided into observation group and control group,35 cases in each group.The control group was treated with Levonorgestrel-releasing intrauterine system,and the observation group was treated with acupuncture combined with Shenqi Huoxue Decoction on the basis of the treatment of the control group.One menstrual cycle was a course of treatment,and the treatment lasted for three courses.After 3 months of treatment,the clinical efficacy of the two groups was evaluated,and the changes of Endometriosis Health Profile-5(EHP-5)score,serum superoxide dismutase(SOD)and catalase(CAT)were observed in the two groups before and after treatment.The changes of serum carbohydrate antigen CA125,carbohydrate antigen 199(CA199)and human epididymis protein 4(HE4)levels were compared before and after treatment between the two groups.Results(1)The total effective rate was 97.14%(34/35)in the observation group and 77.14%(27/35)in the control group.The clinical efficacy of the observation group was superior to that of the control group,and the difference was statistically significant(P<0.05).(2)After treatment,the levels of serum CA125,CA199 and HE4 in the two groups were significantly improved(P<0.05),and the improvement of serum CA1 25,CA199 and HE4 levels in the observation group was significantly superior to that in the control group,the difference was statistically significant(P<0.05).(3)After treatment,the levels of serum SOD and CAT in the two groups were significantly improved(P<0.05),and the improvement of serum SOD and CAT levels in the observation group was significantly superior to that in the control group,the difference was statistically significant(P<0.05).(4)After treatment,the EHP-5 score of quality of life in the two groups was significantly improved(P<0.05),and the EHP-5 score of quality of life in the observation group was significantly superior to that in the control group,the difference was statistically significant(P<0.05).Conclusion Acupuncture combined with Shenqi Huoxue Decoction in the treatment of adenomyosis of qi deficiency and blood stasis type can significantly improve the clinical symptoms of patients,regulate the levels of SOD and CAT,so as to improve the quality of life of patients,and the curative effect is significant.
7.Effects of Acupuncture at Zusanli-Zhongwan Combined Matching Points on Gastric Mucosal Function,Oxidative Stress and Inflammatory Response in Rats with Exercise-Induced Stress Gastric Ulcer
Ya-Qin YANG ; Su-Hong LU ; Hua-Shan PAN ; Chun-Xiang JING ; Min-Yi LUO ; Chun LIN ; Jia-Zhou LI
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(9):2401-2409
Objective To observe the therapeutic effect and mechanism of acupuncture at Zusanli-Zhongwan combined matching points on rats with exercise-induced stress gastric ulcer.Methods Forty male SD rats were randomly divided into blank group,model group,acupuncture group and Omeprazole group,with 10 rats in each group.Except for the blank group,the rats in the other groups were used to construct the model of exercise stress gastric ulcer by daily exhaustive swimming.After successful modeling,the acupuncture group was intervened by acupuncture at Zusanli(ST36)and Zhongwan(RN12),once a day,10 minutes each time.Rats in the Omeprazole group were given Omeprazole Enteric-Coated Tablets distilled water suspension by gavage two hours before daily swimming.After continuous 7-day intervention,the overall state and behavior of rats were observed,the gastric mucosal injury index was calculated by Guth method,the pathological morphology of gastric mucosa was observed by hematoxylin-eosin(HE)staining,the contents of superoxide dismutase(SOD),glutathione peroxidase(GSH-PX)and malondialdehyde(MDA)in serum were correspondingly determined by WST-1 method,colorimetry and TBA method,respectively,enzyme-linked immunosorbent assay(ELISA)was used to detect the contents of gastrin(GAS),somatostatin(SS),tumor necrosis factor-α(TNF-α),interleukin-1 β(IL-1β),interleukin-6(IL-6)and interleukin-10(IL-10)in serum,the expression levels of epidermal growth factor receptor(EGFR),matrix metalloproteinase 3(MMP3),nuclear factor erythroid-related factor 2(NRF2),heme oxygenase 1(HO-1)and mitochondrial SOD2,TNF-α,IL-1β,IL-6 and IL-10 mRNA in gastric mucosa were detected by real-time fluorescence quantitative polymerase chain reaction(qPCR).Results Compared with the blank group,the body mass of rats in the model group was increased slowly,the activity distance and activity in the open field test were decreased,the gastric mucosal ulcer index was increased significantly,the gastric mucosal function indexes involving GAS level was increased and SS level was decreased in serum,the mRNA expression level of EGFR in gastric mucosa was decreased and the mRNA expression level of MMP3 in gastric mucosa was increased.The serum levels of antioxidant substances SOD and GSH-PX were decreased significantly,and the serum level of oxidation product MDA was increased significantly.The mRNA expression levels of antioxidant genes NRF2,HO-1 and SOD2 in gastric mucosa were significantly decreased.The serum contents and the gastric mucosa mRNA levels of inflammatory factors TNF-α,IL-1α,IL-6 were significantly increased,while the serum content and the gastric mucosa mRNA level of IL-10 were significantly decreased.The differences were statistically significant(P<0.05 or P<0.01 or P<0.001).HE staining showed obvious gastric mucosal injury.Compared with the model group,the above indexes in the acupuncture group and the Omeprazole group were significantly improved(P<0.05 or P<0.01 or P<0.001).HE staining showed that the gastric mucosal injury was significantly reduced.Conclusion Acupuncture at Zusanli-Zhongwan combined matching points can reduce the local oxidative stress and inflammatory response in rats with exercise-induced stress gastric ulcer,reduce gastric mucosal injury,improve the emotional state of rats,and maintain the overall vitality of rats.
8.Clinical characteristics and prognosis of male dermatomyositis patients with positive anti-melanoma differentiation associated gene 5 antibody
Yitian SHI ; Fenghong YUAN ; Ting LIU ; Wenfeng TAN ; Ju LI ; Min WU ; Zhanyun DA ; Hua WEI ; Lei ZHOU ; Songlou YIN ; Jian WU ; Yan LU ; Dinglei SU ; Zhichun LIU ; Lin LIU ; Longxin MA ; Xiaoyan XU ; Yinshan ZANG ; Huijie LIU ; Tianli REN
Chinese Journal of Rheumatology 2024;28(1):44-49
Objective:To investigate the clinical features and prognosis of male with anti-melanoma differentiation-associated gene 5 (MDA5) autoantibody.Methods:The clinical data of 246 patients with DM and anti-MDA5 autoantibodies hospitalized by Jiangsu Myositis Cooperation Group from 2017 to 2020 were collected and retrospectively analyzed. Chi-square test was performed to compared between counting data groups; Quantitative data were expressed by M ( Q1, Q3), and rank sum test was used for comparison between groups; Single factor survival analysis was performed by Kaplan-Meier method and Log rank test; Cox regression analysis were used for multivariate survival analysis. Results:①The male group had a higher proportion of rash at the sun exposure area [67.1%(47/70) vs 52.8%(93/176), χ2=4.18, P=0.041] and V-sign [50.0%(35/70) vs 30.7%(54/176), χ2=8.09, P=0.004] than the female group. The male group had higher levels of creatine kinase [112(18, 981)U/L vs 57 (13.6, 1 433)U/L, Z=-3.50, P<0.001] and ferritin [1 500 (166, 32 716)ng/ml vs 569 (18, 14 839)ng/ml, Z=-5.85, P<0.001] than the female group. The proportion of ILD [40.0%(28/70) vs 59.7%(105/176), χ2=7.82, P=0.020] patients and the red blood cell sedimentation rate[31.0(4.0, 101.5)mm/1 h vs 43.4(5.0, 126.5)mm/1 h, Z=-2.22, P=0.026] in the male group was lower than that of the female group, but the proportion of rapidly progressive interstitial lung disease (PR-ILD) [47.1%(33/70) vs 31.3%(55/176), χ2=5.51, P=0.019] was higher than that of the female group. ②In male patients with positive anti-MDA5 antibodies,the death group had a shorter course of disease[1.0(1.0, 3.0) month vs 2.5(0.5,84) month, Z=-3.07, P=0.002], the incidence of arthritis [16.7%(4/24) vs 42.2%(19/45), χ2=4.60, P=0.032] were low than those in survival group,while aspartate aminotransferase (AST)[64(22.1, 565)U/L vs 51(14,601)U/L, Z=-2.42, P=0.016], lactate dehydrogenase (LDH) [485(24,1 464)U/L vs 352(170, 1 213)U/L, Z=-3.38, P=0.001], C-reactive protein (CRP) [11.6(2.9, 61.7) mg/L vs 4.95(0.6, 86.4) mg/L, Z=-1.96, P=0.050], and ferritin levels [2 000(681, 7 676) vs 1 125 (166, 32 716)ng/ml, Z=-3.18, P=0.001] were higher than those in the survival group, and RP-ILD [95.8%(23/24) vs 22.2%(10/45), χ2=33.99, P<0.001] occurred at a significantly higher rate. ③Cox regression analysis indicated that the course of disease LDH level, and RP-ILD were related factors for the prognosis of male anti-MDA5 antibodies [ HR (95% CI)=0.203(0.077, 0.534), P=0.001; HR (95% CI)=1.002(1.001, 1.004), P=0.003; HR (95% CI)=95.674 (10.872, 841.904), P<0.001]. Conclusion:The clinical manifestations of male anti-MDA5 antibody-positive patients are different from those of female. The incidence of ILD is low, but the proportion of PR-ILD is high. The course of disease, serum LDH level, and RP-ILD are prognostic factors of male anti-MDA5 antibody-positive patients.
9.Analysis of adverse events of polatuzumab vedotin and fam-trastuzumab deruxtecan-nxki based on OpenFDA database
Mao LIN ; Guan-Min ZHANG ; Gui-Sen YIN ; Cai-Se LING ; Hong-Tao XIAO ; Yan-Hua ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(6):904-908
Objective To mine and analyze the adverse event data of polatuzumab vedotin(Pola)and fam-trastuzumab deruxtecan-nxki(T-Dxd),so as to provide reference for clinical medication safety.Methods The adverse events reported from January 1,2004 to June 7,2023 were extracted based on openFDA database.The suspicious risk signals were screened by the Open Vigil 2.1 data platform and ranked by signal strength and frequency of occurrence;then ADEs were classified by reference to the MedDRA 26.0.Results A total of 7 164 and 22 870 ADE reports related to Pola and T-Dxd were obtained,and 104 and 95 suspicious ADE signals were detected,respectively.According to the signal intensity,cytomegalovirus enterocolitis(ROR=416.94)for Pola and interstitial lung disease[reporting odds ratio(ROR)=82.55]for T-Dxd ranked first,both of which were recorded in the drug instructions.According to the frequency of occurrence,the two drugs were most frequently associated with death(n=111)and nausea(n=285),respectively.The risk of Pola was associated with 12 systems/organs,of which 26 risk signals were not documented in the drug instruction,and the risk of T-Dxd was associated with 13 systems/organs,of which 18 risk signals were not documented in the drug instruction.Conclusion By tapping the ADE after real-world administration of Pola and T-Dxd,physicians are prompted to pay attention to the risk of adverse reactions in clinical use and actively take preventive and therapeutic measures to ensure the safety of patients'medication.
10.Association of cytochrome P450 gene polymorphisms with efficacy in recurrent and metastatic breast cancer
Min HE ; Lin CHAO ; Yi-Hui HUA
The Chinese Journal of Clinical Pharmacology 2024;40(9):1252-1256
Objective To observe the guiding value of cytochrome P450(CYP450)enzyme related gene polymorphism for tamoxifen(TAM)in the precise treatment of relapsed metastatic breast cancer.Methods Patients with recurrent metastatic breast cancer were selected,all of whom were treated with oral TAM,and complete remission and partial remission were included in the sensitive group,while stable and progressive were included in the drug-resistant group.Patients were followed up by outpatient and telephone visits until December 2022,and median survival time was recorded.CYP2D6*10 genotype distribution,general situation,clinicopathological characteristics of sensitive group and drug-resistant group were compared.COX proportional risk regression model was used and Kaplan-Meier curve was drawn to analyze the relationship between CYP2D6*10 genotype distribution and clinical efficacy of TAM in the treatment of recurrent and metastatic breast cancer.Results As of the date of follow-up,the median survival time of patients with CYP2D6*10 genotype C/C+C/T(58 patients)was 18 months(95%CI:14.48-21.52)and that of patients with CYP2D6*10 genotype TT(34 patients)was 13 months(95%CI:10.69-15.31).The survival rate of CYP2D6*10 genotype C/C+C/T patients was higher than that of CYP2D6*10 genotype TT patients,the Log-rank test showed that the difference in Kaplan-Meier curves was statistically significant(x2=6.901,P<0.05).Compared with the sensitive group,the CYP2D6*10 wild-type C/C genotype component ratio decreased,while the mutant homozygous T/T genotype component ratio increased in the drug-resistant group(P<0.05).There was no significant difference in CYP2D6*10 heterozygote C/T genotype composition between the two groups(P>0.05).Compared with sensitive group,the size of primary tumor>5 cm,number of lymph node metastasis ≥4,estrogen receptor positive,progesterone receptor positive,CYP2D6*10 genotype distribution T/T genotype composition ratio were increased in drug-resistant group(P<0.05).COX proportional risk regression model showed that primary tumor size,number of lymph node metastases,estrogen receptor status,progesterone receptor status and CYP2D6*10 genotype distribution were all independent predictors of clinical efficacy of TAM in the treatment of recurrent metastatic breast cancer(P<0.05).Conclusions CYP2D6*10 gene polymorphism is closely associated with the clinical efficacy and median survival of TAM in the treatment of recurrent metastatic breast cancer.

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