医院管理

某医院临床试验用药品规范管理体系的构建与实践

Construction and practice of standardized management system of drugs for clinical trials from a hospital

:1000-1005
 
       目的   通过分析广州某三甲医院临床试验用药品规范管理体系构建前后试验用药品超温次数及质控发现缺陷项数量变化情况,为药物临床试验规范开展提供参考。方法   结合某医院临床试验用药品管理实践,以试验用药品超温次数、质控发现缺陷项数量占项目比为评价指标,使用卡方检验进行比较。结果   某医院实施临床试验用药品规范管理体系后,发生试验用药品超温次数由实施前的9次下降至3次,呈明显下降趋势,2018—2020年试验用药品管理方面质控发现缺陷项数量占项目比为70.25%,2021—2023年占项目比为18.90%,实施前后组间比较差异有统计学意义(P<0.001)。结论   构建临床试验用药品规范管理体系,可以减少试验用药品超温次数和试验用药品管理方面质控发现缺陷项数量,从而保证药物临床试验的质量。
       Objective   To analyze the changes in the number of excessive temperature incidents and the proportion of quality control issues in drug management before and after the establishment of construction and practice of standardized management system in a tertiary hospital in Guangzhou,to provide a reference for drug clinical trials standard development.Methods  Based on the management practice of investigational medicinal products from a hospital,the number of excessive temperature incidents and the proportion of quality control issues in drug management were taken as evaluation index and compared using chi-square tests.Results  After implementing the standardized management system for investigational drugs,the number of temperature exceeding incidents decreased from 9 times to 3 times,showing an obvious decreasing trend,and from 2018 to 2020,the  proportion of quality control issues in drug management accounted for 70.25%,while from 2021 to 2023,it accounted for 18.90%.There was a statistically significant difference between the groups before and after the implementation(P<0.001).Conclusions  The establishment of  standardized management  system for investigational medicinal  products can  reduce the  number of excessive temperature incidents and the proportion of quality control issues in drug management,and ensure the quality of drug clinical trials.
论著

早产儿败血症的临床特征和不良结局影响因素分析

Analysis of clinical features and adverse outcome risk factors of sepsis in premature infants

:898-905
 
        目的   探讨出生胎龄<37周早产儿发生败血症时的临床特征及其不良结局的危险因素。方法   收集2020年1月—2023年12月安徽医科大学第一附属医院本部新生儿科收治出生胎龄<37周且发生败血症早产儿的临床资料;根据败血症发生时间分为早发型败血症(EOS)49例,晚发型败血症(LOS)150例;根据是否出现不良结局,分为结局不良组90例,结局良好组109例。分析EOS和LOS败血症的临床特征,并采用多因素Logistic回归分析早产儿败血症出现不良结局的危险因素。结果  早产儿败血症中EOS患儿出生胎龄更小,生后1 min Apgar评分更低,孕母羊水污染、胎膜早破≥18 h发生率较LOS更高(P<0.05);早产儿败血症临床表现无特异性,但LOS患儿休克发生率更高(P<0.05);早产儿易发生革兰阴性菌感染,合并先天性心脏病(OR=2.490,P<0.05)、出生胎龄<30周(OR=4.851,P<0.05)、出生体质量小于1 500 gOR=4.169,P<0.05)是早产儿败血症发生不良结局的危险因素。结论  早产儿败血症临床表现无特异性,更易发生革兰阴性菌感染,出生胎龄越小、体质量越低发生不良结局的风险更高。
       Objective  To analyze the clinical characteristics and  risk factors of adverse outcomes of  sepsis in premature infants with gestational age < 37 weeks.Methods  Clinical data of preterm infants < 37 weeksof gestational age admitted to the Department of Neonatology of the First Affiliated Hospital of Anhui Medical University from January 2020 to December 2023 were collected.According to the timing of sepsis,49 cases with early-onset sepsis(EOS)and 150 cases with late-onset sepsis(LOS)were diagnosed.According to the outcome,90 cases were divided into the adverse outcome group and 109 cases were good outcome group.The clinical characteristics of EOS and LOS were analyzed,and the risk factors of adverse outcomes were analyzed by multivariate logistic regression.Results The gestational age of EOS infants was smaller at birth,the 1 minute Apgar score was lower ,and the incidence of amniotic fluid contamination and premature rupture of membranes ≥18h were higher than those in LOS infants(P<0.05).The clinical manifestations of sepsis in premature infants were not specific,but the incidence of shock was higher in LOS children(P<0.05).Preterm infants were more likely to develop gram-negative bacterial infection,congenital heart disease(OR=2.490,P<0.05),gestational age <30 weeks(OR=4.851,P<0.05),and birth weight < 1500g(OR=4.169,P<0.05)were identified as significant risk factors for adverse sepsis outcomes in preterm infants.Conclusions The clinical manifestations of septicemia in preterm infants are non-specific,and they are more likely to suffer from gram-negative bacterial infection.The younger the gestational age and lower the birth weight of preterm infants,the higher the risk of adverse outcomes after sepsis.
论著

单克隆免疫球蛋白血症患者 M 蛋白质量浓度检测的临床意义

Clinical significance of detecting M protein concentration in patients with monoclonal gammopathy

:669-674
 
       目的   探讨单克隆免疫球蛋白血症患者M蛋白质量浓度检测的临床意义。方法   选取2018年6月—2023年6月龙岩人民医院收治的88例单克隆免疫球蛋白血症患者为研究对象,其中意义未明单克隆免疫球蛋白血症(MGUS)21例,具有肾脏意义单克隆免疫球蛋白血症(MGRS)50例,血液系统恶性肿瘤17例。对比其M蛋白质量浓度及临床实验室相关指标表达水平,采用Spearman相关分析法分析临床实验室相关指标的与M蛋白的相关性,对所有患者进行半年随访,以预后情况作为因变量,纳入Logistics回归模型分析M蛋白质量浓度对单克隆免疫球蛋白血症预后的预测价值。结果   不同病种M蛋白水平分别为(2.42±0.55)(2.57±0.64)(4.36±0.64)g/L、24 h尿蛋白分别为(1.45±0.16)(2.98±0.68)(2.43±0.44)g/24 h、血清白蛋白质量浓度分别为(31.01±3.06)(35.03±5.04)(39.05±7.08)g/L、总胆固醇水平分别为(3.42±1.25)(3.87±0.64)、(4.16±0.64)mmol/L、血肌酐水平分别为(114.35±23.23)(81.18±12.12)(146.36±21.12)μmol/L、血红蛋白质量浓度分别为(148.12±15.26)(141.69±12.15)(133.34±15.31)g/L,组间对比差异均有统计学意义(F分别为23.890,19.700,12.044,25.767,36.572,10.267,P<0.05)。MGUS患者24h尿蛋白与M蛋白有相关性(r=-0.384,P=0.033),24 h尿蛋白、血清白蛋白、总胆固醇、血肌酐与MGRS患者M蛋白有相关性(r=-0.586,P=0.006;r=0.431,P=0.018;r=-0.457,P=0.020;r=0.523,P=0.009),血清白蛋白、总胆固醇、血红蛋白与血液系统恶性肿瘤患者M蛋白有相关性(r=0.374,P=0.029;r=-0.617,P=0.001;r=-0.414,P=0.024);年龄、M蛋白为单克隆免疫球蛋白血症患者预后的影响因素(P<0.05)。结论   不同单克隆免疫球蛋白血症患者M蛋白水平存在差异,其中血液系统恶性肿瘤患者的M蛋白水平最高,且M蛋白为单克隆免疫球蛋白血症预后的独立影响因素。  
       Objective  To explore the clinical significance of detecting M protein concentration in patients with monoclonal gammopathy.Methods  From June 2018 to June 2023,88 patients with monoclonal gammopathy admitted to the hospital were selected as the study subjects.Among them,21 cases of monoclonal gammopathy with undetermined  significance(MGUS),50 cases of monoclonal gammopathy with renal significance(MGRS),and 17 cases of hematological malignancies were selected.Concentration of M protein and the expression levels of clinical laboratory related indicators were compared,Spearman correlation analysis was used to analyze the correlation between clinical laboratory related indicators and M protein.All patients were followed up for six months,with prognosis as the dependent variable,included in the logistic regression model to analyze the predictive value of M protein concentration on the prognosis of monoclonal gammopathy.Results  There were significant differences in the expression levels of M protein([2.42±0.55],[2.57±0.64],[4.36±0.64])g/L,24-hour urine protein([1.45±0.16],[2.98±0.68],[2.43±0.44])g/24 h,serum albumin([31.01±3.06],[35.03±5.04],[39.05±7.08])g/L,total cholesterol([3.42±1.25],[3.87±0.64],[4.16±0.64])mmol/L,blood creatinine([114.35±23.23],[81.18±12.12],[146.36±21.12])μmol/L,and hemoglobin([148.12±15.26],[141.69±12.15],[133.34±15.31])g/L among different diseases(F=23.890,19.700,12.044,25.767,36.572,10.267;P<0.05).There was a significant correlation between 24 h urinary protein and M protein in MGUS patients(r=-0.384,P=0.033).Urinary protein,serum albumin,serum cholesterol and blood creatinine were significantly associated with M protein in MGRS patients(r=-0.586,P=0.006;r=0.431,P=0.018;r=-0.457,P=0.020;r=0.523,P=0.009),Serum albumin,total cholesterol,and hemoglobin were significantly associated with M protein in patients with hematological malignancies(r=0.374,P=0.029;r=-0.617,P=0.001;r=-0.414,P=0.024;P<0.05).Age and M protein were independent  risk factors for the prognosis of patients with monoclonal gammopathy(P<0.05).Conclusions  There are significant differences in the concentration of M protein among patients with different levels of monoclonal gammopathy,with the highest level observed in patients with hematological malignancies.M protein is an independent prognostic factor for monoclonal gammopathy.
论著

免疫及靶向药物联合肝动脉灌注化疗治疗晚期肝癌的临床分析

Clinical analysis of immune and targeted drugs combined with hepatic artery infusion chemotherapy in the treatment of advanced liver cancer

:662-668
 
       目的   探讨免疫及靶向药物联合肝动脉灌注化学治疗(化疗)治疗晚期肝癌的临床疗效。方法   选取甘肃省武威市人民医院2021年1月—2024年1月收治的78例晚期肝癌患者进行回顾性分析,其中20例患者采取单纯肝动脉灌注化疗(HAIC)治疗为单化疗组,30例患者采取HAIC联合程序性细胞死亡受体-1(PD-1)抗体治疗为免疫组,28例患者采取HAIC联合PD-1抗体免疫治疗与甲磺酸仑伐替尼胶囊靶向治疗为联合组。对比三组临床疗效、治疗前后胚抗原(CEA)、糖类抗原125(CA125)、甲胎蛋白(AFP)表达水平,不良反应发生率,并采用Piper疲乏修正量表(PFS-R)、世界卫生组织生存质量量表简表(WHOQOL-BREF)对两组癌因性疲乏程度及生存质量进行评价。结果   单纯化疗组、免疫组、联合组客观缓解率分别为15.00%、40.00%、64.29%,疾病控制率为30.00%、66.67%、82.14%,联合组高于单纯化疗组与免疫组(χ 2 =11.720,P=0.003;χ 2 =13.890,P<0.001);治疗后三组患者CEA、CA125、AFP水平均降低,且联合组[CEA:(13.62±4.24)ng/mL、CA125:(31.62±13.66)U/mL、AFP:(35.21±5.93)ng/mL]低于免疫组[(17.85±3.32)ng/mL、(59.26±9.35)U/mL、(42.12±4.12)ng/mL]及单纯化疗组[(23.73±4.79)ng/mL、(64.57±5.23)U/mL、(47.46±5.32)ng/mL],对比差异有统计学意义(F=7.698,P<0.001;F=11.480,P<0.001;F=14.952,P<0.001;P<0.05);所有患者均无5级不良反应及严重肝功能损害出现,且三组血小板减少、白细胞减少、腹痛、呕吐、消化道出血、厌食等不良反应发生率对比差异无统计学意义(P>0.05);治疗后三组患者PFS-R评分均降低,联合组(3.85±1.13)分低于免疫组(5.39±1.25)分及单纯化疗组(6.33±1.26)分,WHOQOL-BREF评分均升高,联合组(348.58±66.12)分高于免疫组(297.24±72.21)分及单纯化疗组(256.35±41.67)分,对比差异有统计学意义F=2.526,P=0.014;F=2.167,P=0.033)。结论   免疫及靶向药物联合肝动脉灌注化疗治疗晚期肝癌疗效显著,可有效控制疾病进展的同时,降低机体肿瘤标志物水平,安全性可控,同时可改善患者生存质量,减轻癌因性疲乏程度。
       Objective  To explore the clinical efficacy of immune and targeted drugs combined with hepatic artery infusion chemotherapy(HAIC)in the treatment of advanced liver cancer.Methods  A retrospective analysis was conducted on 78 patients with advanced liver cancer admitted to our hospital from January 2021 to January 2024.Among them,20 patients were treated with simple HAIC and divided into a single chemotherapy group.Thirty patients were treated with HAIC combined with PD-1 antibody,and divided into an immune group.Twenty-eight patients were treated with HAIC combined with PD-1 antibody immunotherapy and lenvatinib mesylate capsule targeted therapy,and divided into a combination group.The clinical efficacy of three groups,the expressionlevels of CEA,CA125,AFP,and incidence of adverse reactions before and after treatment were compared.Piper Fatigue Correction Scale(PFS-R)and the WHO QOL-BREF were used to assess cancer-related fatigue in both groups.The degree of fatigue and quality of life were assessed.Results  The objective response rates of the simple chemotherapy group,the immune group,and the combination group were 15.00%,40.00% and 64.29%,respectively.The disease control  rates were 30.00%,66.67% and 82.14%,respectively.The indicators above of the combination group was significantly higher than those in the simple chemotherapy group and the immune group(χ 2 =11.720,P=0.003;χ 2 =13.890,P<0.001;P<0.05).After treatment,the levels of CEA,CA125 and AFP were all decreased in the three groups,and those in the combined group (CEA[13.62±4.24]ng/mL,CA125[31.62±13.66]U/mL,AFP:Ng/mL[35.21±5.93])were lower than those in the immune group(17.85±3.32 ng/mL,59.26±9.35 U/mL,/ 42.12±4.12 ng/mL)and single chemotherapy group(23.73±4.79 ng/mL,64.57±5.23 U/mL47.46±5.32]ng/mL),the differences were statistically significant(F=7.698,P<0.001;F=11.480,P<0.001;F=14.952,P<0.001;P<0.05).All patients had no grade 5 adverse reactions or severe liver function damage,and there was no statistically significant difference in the incidence adverse reactions such as thrombocytopenia,leukopenia,abdominal pain,vomiting,gastrointestinal bleeding,and anorexia among the three groups(P>0.05).After treatment,the PFS-R score of the three groups was decreased,and the combined group(3.85±1.13)score was lower than that of the immune group(5.39±1.25)and the chemotherapy group(6.33±1.26).While the WHOQOL-BREF score was increased,the score of combination group(348.58±66.12)was higher than that of immune group(297.24±72.21)and chemotherapy group(256.35±41.67),and the difference was statistically significant(F=2.526,P=0.014;F=2.167,P=0.033;P<0.05).Conclusions  The combination of immune and targeted drugs with hepatic artery infusion chemotherapy has a significant therapeutic effect on advanced liver cancer.It can effectively control disease progression,reduce tumor marker levels in the body,improve patient quality of life,and alleviate cancer-related fatigue,with controllable safety
论著

腕踝针联合揿针治疗带状疱疹后遗痛的临床疗效观察

Clinical efficacy of wrist and ankle acupuncture combined with thumbtack needle in the treatment of postherpetic herpes zoster pain

:650-655
 
       目的   探究腕踝针联合揿针治疗带状疱疹后遗痛的临床疗效观察。方法   选取上海市黄浦区中西医结合医院2021年10月—2024年4月收治的80例带状疱疹后遗神经痛患者为研究对象,按随机数表法分为研究组、对照组,各40例。对照组采用口服甲钴胺治疗;研究组采用腕踝针联合揿针治疗。比较两组治疗疗效;治疗前后采用视觉模拟评分(VAS)与阿森斯失眠量表评分(AIS)、皮肤病生活质量指数(DLQI)、汉密尔顿抑郁量表评分(HAMD)、汉密尔顿焦虑量表评分(HAMA)。结果   研究组治疗总有效率为92.5%,对照组治疗总有效率为75%。比较差异有统计学意义(P<0.05)。两组患者治疗后VAS、AIS均比治疗前改善,研究组VAS评分为(1.00±0.45)、AIS评分为(7.15±0.89),优于对照组VAS(2.15±0.36)和AIS(5.65±0.70),比较差异有统计学意义(P<0.05)。相较于治疗前,两组患者DLQI评分均有改善,研究组[休闲活动评分(1.73±0.45)、人际交往评分(1.13±0.34)、工作学习评分(0.94±0.25)、自觉症状评分(1.83±0.38)、日常活动评分(0.98±0.28)]优于对照组[休闲活动评分(2.06±0.40)、人际交往评分(1.81±0.39)、工作学习评分(1.08±0.38)、自觉症状评分(2.01±0.34)、日常活动评分(1.10±0.30)],差异有统计学意义(P<0.05)。两组患者HAMD评分、HAMA评分,相较于治疗前均有改善,研究组HAMD评分为(34.63±2.61)、HAMA评分为(35.75±2.48),优于对照组HAMD评分(47.68±3.21)和HAMA评分(46.90±3.31),差异有统计学意义(P<0.05)。结论   腕踝针联合揿针治疗带状疱疹后遗神经痛的临床疗效显著,可有效改善患者生活质量、疼痛程度、焦虑及抑郁程度,提升患者睡眠质量。
       Objective  To investigate the clinical efficacy of wrist and ankle acupuncture combined with thumbtack needle in the treatment of postherpetic herpes zoster pain.Methods  Eighty patients with postherpetic neuralgia admitted to Shanghai Huangpu District Hospital of Integrative Medicine from October 2021 to April 2024 were selected for the study,and were divided into a study group and a control group of 40 cases each according to the random number table method.The control group was treated with oral mecoblamin tables;the study group was treated with wrist and ankle acupuncture combined with thumbtack needle.The efficacy of treatment between the two groups was compared;before and after treatment,the visual analogue score(VAS)and Asens Insomnia Scale(AIS),Dermatological Quality of Life Index(DLQI),Hamilton Depression Scale(HAMD),Hamilton Anxiety Scale(HAMA)were compared.Results  The treatment efficiency was 92.5% in the study group and 75% in the control group.The difference was statistically significant(P<0.05).VAS scores and AIS scores of patients in both groups improved after treatment,and VAS score(1.00±0.45),AIS score(7.15±0.89)of the study group were better than VAS score(2.15±0.36),AIS score(5.65±0.70)of the control group.The differences were statistically significant(P<0.05).The DLQI scores of both groups improved after treatment,and the score of study group(leisure activity score[1.73±0.45],interpersonal interaction score[1.13±0.34],work-study score[0.94±0.25],self-perceived symptom score[1.83±0.38],daily activities score[0.98±0.28])were higher than those of the control group(leisure activity score[2.06±0.40],interpersonal score[1.81±0.39],work-study score[1.08±0.38],conscious symptom score[2.01±0.34],daily activity score[1.10±0.30]).The differences were statistically significant(P<0.05).HAMD scores and HAMA scores of patients in both groups,showed significant improvement after treatment,and HAMD scores(34.63±2.61)and HAMA scores(35.75±2.48)of the study group were better than HAMD scores(47.68±3.21)and HAMA scores(46.90±3.31)of the control group.The difference was statistically significant(P<0.05).Conclusions  The clinical efficacy of wrist and ankle acupuncture combined with thumbtack needle in the treatment of postherpetic pain is remarkable,effectively improving the quality of life,pain,anxiety and depression,and enhancing the quality of sleep of patients.
论著

达泊西汀联合达克罗宁胶浆治疗早泄的临床研究

Clinical study on the treatment of premature ejaculation with dapoxetine combined with dacronine mucilage

:523-528
 
       目的   探讨盐酸达泊西汀联合达克罗宁胶浆治疗早泄的临床疗效。方法   选取男科门诊146例早泄患者,随机分组,对照组服用达泊西汀片,研究组为达泊西汀片和达克罗宁胶浆联合治疗,再将研究组分为阴茎头敏感度高组和敏感度正常组,记录各组治疗前、治疗8周后早泄相关指标。结果   治疗后对照组阴道内射精潜伏期(IELT)、早泄诊断量表(PEDT)和早泄指数量表(IPE)中Q6+Q7分别为(4.68±2.79)、(9.52±2.14)、(6.48±1.30),研究组IELT、PEDT和Q6+Q7分别为(6.09±3.09)、(7.52±1.92)、(7.85±1.36),各组相关指标均较治疗前改善(P<0.05),研究组各指标改善程度优于对照组(P<0.05);治疗后敏感度高组IELT、PEDT和Q6+Q7分别为(6.76±2.99)、(6.84±1.53)、(8.16±1.10),敏感度正常组IELT、PEDT和Q6+Q7分别为(5.13±3.02)、(8.50±2.03)、(7.40±1.59),敏感度高组各指标改善程度优于敏感度正常组(P<0.05);对照组、研究组总有效率分别为69.86%(51/73)、84.93%(62/73),研究组治疗效果优于对照组(P<0.05);敏感度高组、敏感度正常组总有效率分别为93.02%(40/43)、73.33(22/30),敏感度高组治疗效果优于敏感度正常组(P<0.05)。结论    达泊西汀联合达克罗宁胶浆治疗早泄效果显著,阴茎头敏感患者联合达克罗宁胶浆治疗受益更大。
       Objective  To investigate the clinical efficacy of dapoxetine hydrochloride combined with dclonine mucilage in the treatment of premature ejaculation.Methods  A total of 146 patients from andrology department with premature ejaculation were selected and randomly divided into control group and research group.The control group was treated with dapoxetine alone,while the research group was treated with dapoxetine combined with dacronine mucilage.The  research group was divided into high sensitivity group and normal sensitivity group.The indexes  related to premature ejaculation were  recorded before treatment and 8 weeks after treatment.Results  After treatment,intravaginal ejaculatory latency time(IELT),Premature Ejaculation Diagnosis Tool(PEDT)and Q6+Q7 of the index of premature ejaculation(IPE)in control group were(4.68±2.79),(9.52±2.14)and (6.48±1.30),respectively,while IELT,PEDT and Q6+Q7 in research group were(6.09±3.09),(7.52±1.92) and (7.85±1.36),respectively.The relevant indexes in all groups were significantly improved compared with those before treatment(P<0.05),and the improvement of all indexes in research group was better than that in control group(P<0.05).After treatment,IELT,PEDT and Q6+Q7 in the highly sensitivity group were(6.76±2.99),(6.84±1.53)and(8.16±1.10),respectively,while IELT,PEDT and Q6+Q7 in the normal sensitivity group were(5.13±3.02),(8.50±2.03)and(7.40±1.59),respectively.The improvement of all indexes in the high sensitivity group was better than that in the normal sensitivity group(P<0.05).The total effective rate of the control group and the research group was 69.86%(51/73)and 84.93%(62/73),respectively.The therapeutic effect of the research group was significantly better than that of the control group(P<0.05).The total effective rate of the high sensitivity group and the normal sensitivity group was 93.02%(40/43)and 73.33%(22/30),respectively.The therapeutic effect of the high sensitivity group was significantly better than that of the normal sensitivity group(P<0.05).Conclusions  Dapoxetine combined with dacronine mucilage has significant effect in the treatment of premature ejaculation,and the patients with high sensitivity of penile head will benefit more from combined dacronine mucilage therapy.
论著

早产儿呼吸窘迫综合征拔管后 NIPPV 和 NCPAP 作为无创呼吸支持过渡的临床效果对比

Comparison of the clinical effects of NIPPV and NCPAP as a noninvasive respiratory support for preterm infants after extubation

:516-522
 
       目的    探究经鼻间歇正压通气(NIPPV)和经鼻持续正压通气(NCPAP)作为早产儿呼吸窘迫综合征气管插管机械通气拔管后无创呼吸支持过渡的临床效果的差异。方法   纳入2021年1月—2023年6月在广东省吴川市妇幼保健计划生育服务中心治疗的新生儿呼吸窘迫综合征早产儿66例,用随机数字表法将患儿分为NIPPV组(33例)和NCPAP组(33例)。NIPPV组患儿予经鼻间歇正压通气作为过渡期无创呼吸支持,NCPAP组患儿则予以经鼻持续正压通气作为过渡期无创呼吸支持。对比两组患儿治疗前后血气分析结果、脱机失败率、无创呼吸支持时间、无创后吸氧时间、总给氧时间等指标。结果  接受无创呼吸支持12 h后,NIPPV组患儿的PaO2升至(76.46±1.10)mmHg,高于NCPAP组患儿的(75.51±2.15)mmHg(t=2.249,P=0.028)。此外,NIPPV组患儿的SaO2升至(96.36±0.52)%,也高于NCPAP组患儿的(96.07±0.59)%(t=2.138,P=0.034)。而NIPPV组患儿的PaCO2则降至(41.39±0.74)mmHg,较NCPAP组患儿的(41.87±0.95 )mmHg低(t=-2.230,P=0.025)。NIPPV组无创呼吸支持时间为(3.09±0.52)d,短于NCPAP组的(3.45±0.62)d,且该差异有统计学意义(t=2.584,P=0.012)。同样的,NIPPV组总给氧时间(9.52±0.76)天较NCPAP组的(10.00±0.79)天短,且该差异有统计学意义(t=-2.548,P=0.013)。而两组在脱机失败率、无创呼吸支持后吸氧时间、不良反应发生率等方面比较差异无统计学意义(均P>0.05)。结论   与NCPAP模式相比,早产儿拔管后应用NIPPV模式进行无创呼吸支持取得的临床效果更优。
      Objective  To explore the difference of clinical effect of nasal intermittent positive pressure ventilation(NIPPV)and nasal continuous positive pressure ventilation(NCPAP)as non-invasive respiratory support mode after extubation in preterm infants with endotracheal intubation.Methods   Sixty-six cases of preterm infants with neonatal respiratory distress syndrome treated in our hospital from January 2021 to June 2023 were included.All the subjects were randomly divided into NIPPV groupn=33)and NCPAP group(n=33).The blood gas analysis results,weaning failure rate,non-invasive respiratory support time,oxygen inhalation time after noninvasive ventilation,total oxygen administration time.were compared between the two groups.Results   After 12 hours of noninvasive respiratory support,PaO2 in the NIPPV group increased to(76.46±1.10)mmHg,which was significantly higher than that(75.51±2.15)mmHg in the NCPAP group(t=2.249,P=0.028).In addition,SaO2 in the NIPPV group increased to (96.36±0.52)%,which was also significantly higher than that(96.07±0.59)% in the NCPAP group(t=2.138,P=0.034).The PaCO2 in the NIPPV group decreased to (41.39±0.74)mmHg,which was lower than that(41.87±0.95)mmHg in the NCPAP group(t=-2.230,P=0.025).The  duration of  non-invasive  respiratory  support in the NIPPV group(3.09±0.52) days was shorter than that(3.45±0.62)days in the NCPAP group,and the difference was statistically significant(t=2.584,P=0.012).Similarly,the total duration of oxygen administration in the NIPPV group(9.52±0.76)days was shorter than that(10.00±0.79)days in the NCPAP group,and the difference was statistically significant(t=-2.548,P=0.013).There were no significant differences in weaning failure rate,oxygen inhalation time after noninvasive respiratory support,and incidence of adverse reactions between the two groups(P>0.05).Conclusions   Compared with NCPAP mode,NIPPV mode for non-invasive respiratory support in preterm infants after extubating has better clinical effect,and it is worthy of clinical application.
论著

三阴性乳腺癌 Cox 回归临床预测模型的构建与验证:基于SEER 数据库

Construction and validation of a Cox regression clinical prediction model for triple-negative breast cancer:based on the SEER database

:457-468
 
目的   基于SEER数据库分析三阴性乳腺癌(TNBC)的预后,并建立Cox回归临床预测模型且进行内部验证。方法   使用SEER*Stat软件(8.4.2版)筛选2010—2015年诊断为TNBC的病例,进行单因素和Cox多因素回归以及向后逐步回归分析,明确与生存相关的独立危险因素,构建预测TNBC患者3年和5年癌症特异生存(CSS)率的Nomogram图,并用受试者工作特征曲线,Harrell’s一致性指数,临床预测模型校准曲线以及决策曲线对该模型进行评估及内部验证,以评估该模型的临床预测效能。结果   共筛选出符合纳入标准的TNBC患者5 564例,按照7∶3的比例随机拆分为训练集(n=3 894)和验证集(n=1 670)。通过单因素,多因素分析显示TNM分期、放射治疗、化学治疗以及手术和其他治疗的先后顺序是与TNBC患者CSS显著相关的独立危险因素(P<0.05)。利用上述预后相关因素建立Nomogram图模型。训练集的C-index为0.731(95%CI:0.712~0.749),验证集的C-index为0.719(95%CI:0.688~0.749),训练集和验证集3年和5年生存ROC曲线的曲线下面积均>0.7,区分度较好,且校准曲线拟合良好。结论  TNM分期、放射治疗、化学治疗以及手术和其他治疗的先后顺序是TNBC的独立预后因素,基于此建立的Nomogram图临床预测模型区分度、准确度以及临床适用性较好,能较好地预测TNBC患者的生存预后。
    Objective  To analyze the prognosis of triple negative breast cancer(TNBC)based on the SEER database,and to establish a Cox regression clinical prediction model with internal validation.Methods  Cases diagnosed with TNBC from 2010 to 2015 were screened using SEER*Stat software(version 8.4.2),and univariate and Cox multifactorial  regression as well as backward stepwise regression analyses were performed to identify the independent risk factors associated with survival,and to construct a clinical prediction model for predicting the three- and five-year cancer specific survival(CSV)of TNBC patients.Survival(CSS)rates of TNBC patients at 3 and 5 years,and the model was evaluated and internally validated using the ROC curve,Harrell’s consistency index(C-index),clinical prediction model calibration curve,and decision-making curve(DCA curve)to assess the predictive efficacy of the model for clinical prediction.Results  A total of 5 564 TNBC patients meeting the inclusion criteria were screened and randomly split into a training set(n=3 894)and a validation set(n=1 670)according to a 7∶3 ratio.By univariate,multivariate analysis showed that T-stage,N-stage,M-stage,radiotherapy,chemotherapy,and the sequence of surgery and other treatments were independent risk factors significantly associated with CSS in TNBC patients.The above prognostic-related factors were utilized to build a Nomogram plot model.The C-index was 0.731(95%CI:0.712-0.749)for the training set and 0.719(95%CI:0.688-0.749)for the validation set,and the areas under the curves of the 3- and 5-year survival ROC curves of both the training and validation sets were >0.7,which was a good differentiation,and the calibration curves were well-fitted.Conclusions  T-stage,N-stage,M-stage,radiotherapy,chemotherapy,and the  sequence of  surgery and other treatments are independent prognostic factors for TNBC,and the Nomogram clinical prediction model based on this has good differentiation,accuracy,and clinical utility,and can better predict the survival prognosis of TNBC patients.
论著

基于 BCVA 和角膜水肿程度探讨改良与常规小梁切除术治疗急性闭角型青光眼的临床价值

Based on BCVA and modified with conventional corneal edema degree to explore the clinical value of treatment of acute angle-closure glaucoma trabeculectomy

:366-371
 
       目的   基于最佳矫正视力(BCVA)、角膜水肿程度对比改良与常规小梁切除术治疗急性闭角型青光眼(AACG)的疗效。方法   回顾性收集2021年12月—2023年6月期间信阳爱尔眼科医院收治的112例AACG患者作为研究对象,依据1∶1匹配原则,将接受常规小梁切除术的56例患者作为对照组,接受改良小梁切除术的56例患者作为观察组,统计两组围术期BCVA、眼压、术后浅前房形成状况、角膜水肿程度以及并发症状况。结果   术后3个月,观察组视力为(0.63±0.04)logMAR,高于对照组(0.50±0.03)logMAR,眼压为(16.22±2.28)mmHg,低于对照组(19.95±2.31)mmHg(t=19.457、8.600,均P<0.05);观察组浅前房发生率为8.93%,低于对照组的26.79%(χ 2 =6.087,P=0.014);观察组角膜水肿状况优于对照组(Z=2.737,P=0.006);观察组脉络膜脱离率、滤道阻塞率、前房积血率、虹膜炎症率依次为1.79%、5.36%、16.07%、10.71%,均低于对照组17.86%、23.21%、32.14%、35.71%(χ 2 =8.166、7.292、3.953、9.818,均P<0.05)。结论   较常规小梁切除术,改良小梁切除术治疗AACG患者,有助于改善视力、降低眼压、减轻角膜水肿、减少浅前房发生,且安全性较高。
       Objective  To compare the efficacy of modified and conventional trabeculectomy in the treatment of acute angle-closure glaucoma(AACG)based on best-corrected visual acuity(BCVA)and degree of corneal edema.Methods  A total of 112 patients with AACG admitted to the hospital during December 2021 to June 2023 were retrospectively selected as study objects.According to the 1∶1 matching principle,56 patients receiving conventional trabeculectomy were selected as control group,and 56 patients receiving modified trabeculectomy were selected as observation group.Perioperative BCVA,intraocular pressure,postoperative shallow anterior chamber formation,degree of corneal edema and complications were analyzed.Results  At three months postoperatively,visual acuity in the observation group was(0.63±0.04)logMAR,which was higher than that in the control group(0.50±0.03)logMAR,and intraocular pressure was(16.22±2.28)mmHg,which was lower than that in the control group(19.95±2.31)mmHg(t=19.457,8.600,P<0.05);the incidence of shallow anterior chamber in the observation group was 8.93%,which was lower than that of the control group(26.79%)(χ 2 =6.087,P=0.014);the corneal edema status in the observation group was better than that of the control group(Z=2.737,P=0.006);the rates of choroidal detachment,filtering channel obstruction,hyphema,and iris inflammation in the observation group were 1.79%,5.36%,16.07%,and 10.71%,respectively,which were lower than those of the control group(17.86%,23.21%,32.14%,and 35.71%)(χ 2 =8.166,7.292,3.953,and 9.818,P<0.05).Conclusions  Compared with conventional trabeculectomy,modified trabeculectomy can improve visual acuity,reduce intraocular pressure,relieve corneal edema,and reduce the occurrence of shallow anterior chamber in patients with AACG,with higher safety.
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结直肠癌肝转移的分子机制及临床治疗的研究进展

Advances in the emerging mechanisms and treatment progress on liver metastasis of colorectal cancer

:288-299
 
       结直肠癌(CRC)是全球第三大最常见的癌症,也是癌症相关死亡的第二大常见原因。结直肠癌肝转移(CRLM)是导致CRC患者死亡的主要原因,根治性肝切除术是目前有望治愈CRLM的唯一途径,但大部分患者不能进行根治性肝切除术。通过早期发现并进行针对性干预,能够改善患者的治疗效果及预后。文章通过综述CRLM的发病机制、诊疗现状及最新纳米诊疗方法,为深入探索高效诊疗方法提供思路。
      Colorectal cancer(CRC)is the third most common cancer and the second most common cause of cancer-related death worldwide.Colorectal cancer liver metastases(CRLM)are the leading cause of death in patients with CRC.Radical hepatectomy is the only way to cure CRLM so far,while most patients cannot undergo radical hepatectomy.CRLM treatment efficacy and prognosis can be improved by early diagnosis and specialized intervention.This paper reviews the pathogenesis,diagnosis,and treatment status of CRLM and the latest nano-diagnosis and treatment methods so as to provide ideas for in-depth exploration of efficient diagnosis and treatment methods.
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