tbuckley/cabot-search huggingface dataset:
Efficacy and safety of entrectinib in patients (pts) with <i>NTRK</i>-fusion positive (<i>NTRK</i>-fp) solid tumors: An updated integrated analysis.
Authors: Christian Diego Rolfo, Filippo G. De Braud, Robert Charles Doebele, Alexander E. Drilon, Salvatore Siena, Manish Patel, Byoung Chul Cho, Stephen V. Liu, Myung-Ju Ahn, Chao-Hua Chiu, Anna F. Farago, Koichi Goto, Jeeyun Lee, Lyudmila Bazhenova, Tom John, Marwan Fakih, Brian P. Simmons, Bethany Pitcher, Xinhui Huang, George D. Demetri
Journal: Journal of Clinical Oncology (2020)

3605 Background: NTRK gene fusions lead to transcription of chimeric TRK proteins with overexpressed kinase function. Entrectinib is a potent inhibitor of TRKA/B/C. In phase 1/2 studies (ALKA, STARTRK-1, STARTRK-2; EudraCT 2012-000148-88; NCT02097810; NCT02568267), entrectinib was effective in pts with NTRK-fp solid tumors. We present updated data in a larger population with longer follow-up. Methods: In this integrated analysis of adult pts from 3 phase 1/2 trials (data cut-off 31 Oct 2018), tumors were assessed by blinded independent central review (BICR) with RECIST v1.1 (end of cycle 1; then every 8 wks). Primary endpoints were overall response rate (ORR) and duration of response (DOR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), efficacy in pts with/without baseline CNS disease, and safety. Results: There were 74 evaluable pts with advanced/metastatic NTRK-fp solid tumors (Table). Median duration of survival follow-up in all pts was 14.2 mo (range 0.1–29.7). BICR ORR was 63.5% (95% CI 51.5–74.4), with 5 complete responses (6.8%). Median BICR DOR was 12.9 mo (95% CI 9.3–NE); median BICR PFS was 11.2 mo (95% CI 8.0–15.7); median OS was 23.9 mo (16.0–NE). In pts with no baseline CNS disease (investigator-assessed; n=55), BICR ORR was 65.5% (95% CI 51.4–77.8) and median BICR DOR in responders was 12.9 mo (95% CI 9.3–NE). In pts with baseline CNS disease (investigator-assessed; n=19), BICR ORR was 57.9% (95% CI 33.5–79.8) and median BICR DOR in responders was 6.0 mo (95% CI 4.2–NE). Safety was in line with that previously reported; the most common ≥grade 3 treatment-related AEs were weight gain (8, 7.1%), anemia (8, 7.1%), and fatigue (7, 6.2%). Conclusions: In this updated analysis, including more pts and longer follow-up, entrectinib continued to demonstrate clinically meaningful responses in pts with NTRK-fp solid tumors, with and without baseline CNS disease. Clinical trial information: NCT02097810, NCT02568267 . [Table: see text]
Diagnostic values of serum creatine kinase, creatine kinase-MB isoenzyme and cardiac throponin I determinations in neonatal umbilical cord blood
Authors: 张岱, 王秀艳, 杨慧霞, 孙晓梅, 王晓莉
Journal: BMJ (2006)

目的 探讨新生儿脐血心肌酶及肌钙蛋白检测对新生儿缺血缺氧性心肌损伤诊断的意义.方法 选择2003年9月至2004年2月间在我院分娩的234例新生儿,于分娩后即刻留取脐血行肌酸激酶(CK)、肌酸激酶心型同工酶(CK-MB)、心肌肌钙蛋白Ⅰ(cTnI)的测定及分析.结果 新生儿脐血CK、CK-MB、cTnI较成人正常值的范围有明显升高,其分布均呈现偏态分布,中位值CK为256 U/L、CK-MB为6.45 ng/ml、cTnI为0.02 ng/ml,95%正常参考值范围CK为120～552 U/L、CK-MB为2～19.5 ng/ml、cTnI为0.00～0.60 ng/ml.胎儿窘迫及母体合并症对各项心肌酶水平无显著影响(P＞0.05).产钳组CK(中位值265 U/L)明显高于顺产组(220 U/L)及剖宫产(204U/L)组,但分娩方式对CK-MB、cTnI无影响.早产组CK、CK-MB显著低于足月分娩组(P＜0.01),但早产对cTnI无影响.234例中共有7例发生新生儿缺血缺氧性心肌损伤,其脐血心肌酶值均在我们得到的正常范围内.结论 新生儿脐血心肌酶应采用与成人不同的标准,需进行大样本的研究来建立新生儿的脐血心肌酶正常值范围;另一方面,不能单纯根据脐血心肌酶升高判断是否存在新生儿缺血缺氧性心肌损伤。
Increased levels of prostaglandin high mobility group box-1 and high-sensitive C-reactive protein in peritoneal fluid and serum of patients with endometriosis
Authors: 李方英, 华倩, 班开斌, 黄友敏
Journal: BMJ (2011)

The concentrations of prostaglandin in high mobility group box-1 ( HMGB1 ) and highsensitive C-reactive protein (Hs-CRP) in serum and peritoneal fluid were detected in 76 patients with endometriosis (study group) and 30 patients without endometriosis (ovary cysts or uterine myoma, as control group). The peritoneal fluids were collected during laparoscopic operation, and the serum samples were collected before surgery. The HMGB1 and Hs-CRP concentrations in serum and peritoneal fluid of study group were significantly higher than those of control group, ( 8. 2 ± 0. 8) mg/L vs. (2. 1 ±. 0. 2) mg/L、 ( 14. 4 ±3.0) mg/L vs. (4.5 ±2.3) mg/L (both P＜0. 01);HMGB1 and Hs-CRP levels in serum and peritoneal fluid of stage Ⅲ-Ⅳ endometriosis were significantly higher than those of stage Ⅰ-Ⅱ, ( 9. 2 ± 0. 8) mg/L vs.(6.7 ±0.7) mg/L,(18.7 ±2.9) mg/L vs. (11.2 ±2. 8) mg/L,(6.5 ±0.6) mg/L vs. (3.4 ±0.5) mg/L,(8.4 ±2.7) mg/L vs. (5.4 ±2.4) mg/L (all P ＜0.05). The concentrations of HMGB1 were positively correlated with Hs-CRP in endometriosis group (r =0. 72, P ＜0. 01 ). The results indicate that concentrations of HMGB1 and Hs-CRP may be of value in assessing the severity of endometrosis.

Key words: 
Endometriosis ;  High mobility group proteins ;
First-in-class microbial ecosystem therapeutics 4 (MET4) in metastatic solid cancer patients treated with immunotherapy: MET4-IO.
Authors: Daniel Vilarim Araujo, Marc Oliva Bernal, Tira Jing Ying Tan, Alya Abbas Heirali, Pierre H.H. Schneeberger, Thiago Pimentel Muniz, Bo Chen, Lee-Anne Stayner, Kathy Xia, Aaron Richard Hansen, Ben X Wang, David Hogg, Kyla Cochrane, Shawn Langer, Nissim Mashiach, Wei Xu, Lillian L. Siu, Bryan Coburn, Anna Spreafico
Journal: Journal of Clinical Oncology (2020)

3098 Background: Therapeutic augmentation of the intestinal microbiome to improve immunotherapy outcomes is an active area of investigation. Microbial Ecosystem Therapeutics (METs) are consortia of human-derived bacteria designed to be reproducible, scalable and safe alternatives to fecal transplant. MET4 is a first-in-class consortium of taxa associated with immune checkpoint inhibitor (ICI)-responsiveness. Here we describe preliminary results of MET4-IO, an interventional trial assessing the safety and ecological effects of MET4 in ICI recipients. Methods: MET4-IO is a randomized investigator-initiated trial, evaluating MET4 in solid cancer patients treated with ICI. MET4-IO involves 3 cohorts of 65 total patients: Group A, a safety cohort of 5 patients already on ICI; Group B, patients starting ICI, randomized 3:1 to receive MET4 or not; Group C, patients on ICI who experience radiological progression but not clinical deterioration, randomized 1:1 to receive MET4 or not. Stool and blood samples are collected at baseline and 4-5 additional time-points. For this interim analysis, 16S rRNA gene sequencing was performed on fecal specimens. Shannon diversity, relative abundance (RA), number and fold-change of MET4 taxa &gt; RA 0.01 were assessed and compared to controls. Results: As of January 26, 2020, 21 patients were enrolled (A = 5,B = 12,C = 4), and 15 (71%) received MET4. The mean age was 65.9 years, 40% were females, 52% had head and neck cancer and 19% melanoma. Sixteen patients (76%) were treated with an anti-PD1 agent as monotherapy and 5 with a combination of anti-PD1 and anti-CTLA4 antibodies. G3-4 toxicities (CTCAEv5.0) attributed to ICI were observed in 13% vs. 17% of MET4 exposed and control patients, respectively. Three patients (20%) experienced toxicities attributed to MET4, all grade 1 except G2 dyspepsia in 1 patient. A greater number of MET4-associated taxa were detectable in MET4 recipients than controls (p &lt; 0.01), with a trend towards higher cumulative RA (p = 0.10). No significant change in Shannon diversity after MET4 was observed, however controls were more likely to lose diversity overtime than MET4 recipients (p = 0.05). Colonization with MET4 varied by recipient and by taxon. Bifidobacterium, Collinsella and Enterococcus were significantly more common and abundant in MET4 recipients than controls. Conclusions: In this cohort, MET4 treatment was safe and associated with higher MET4-associated taxa in recipients than controls. Further analyses including peripheral blood immunophenotyping are ongoing. Clinical trial information: NCT03686202 .
Effects of continuous positive airway pressure ventilation on cell adhesion molecules and P-selectin in coronary heart disease patients with obstructive sleep apnea-hypopnea syndrome
Authors: 秦蓁, 胡克, 罗彬, 廖渝蓉, 黎燕
Journal: BMJ (2005)

目的 探讨存在阻塞性睡眠呼吸暂停低通气综合征(OSAHS)的冠心病患者外周血白细胞黏附分子β2整合素和血清可溶性细胞间黏附分子-1(sICAM-1)、血管细胞黏附分子-1 (sVCAM-1)、P-选择素的水平以及持续气道正压通气治疗后的变化.方法对住院的76例冠心病患者用多导睡眠监测确定是否存在OSAHS,并与23例对照组一起采用流式细胞仪技术检测外周血白细胞β2 整合素、sICAM-1和sVCAM-1水平,采用酶联免疫吸附法检测P-选择素.对存在中、重度OSAHS的41例冠心病患者使用自动调节持续气道正压通气进行治疗1周.治疗结束后,再次检测上述指标.结果 76例冠心病患者中,41 例呼吸暂停低通气指数(AHI)≥15,35例AHI＜15.冠心病组细胞黏附分子及P-选择素水平明显高于对照组;AHI≥15的冠心病患者β2 整合素、sICAM-1和sVCAM-1、P-选择素的表达均显著高于AHI＜15的冠心病组,在接受持续气道正压通气治疗后这些指标明显下降.结论冠心病患者存在明显外周血管炎性损伤,OSAHS可能加剧冠心病的炎性损伤.对于存在中、重度OSAHS的冠心病患者应当使用持续气道正压通气治疗。
Images of watershed infarctions in internal carotid artery
Authors: 钟利群, 高颖, 邹忆怀, 任毅, 孙塑伦
Journal: BMJ (2008)

脑分水岭梗死(cerebral watershed infarction,CWI)是指发生在2条或3条脑主要动脉末梢交界区的脑梗死.尸检研究发现,皮质型和皮质下型分水岭梗死(也称外分水岭梗死和内分水岭梗死)约占所有脑梗死的10%[1],引入CT、MRI后的研究亦证实了这个结论[2].依照颈内动脉系统和椎基底动脉系统分为幕上和幕下两大类.由于椎基底动脉系统的主要动脉变异较多,故病灶的位置变化也较大,不易确定,临床报道较少.颈内动脉系统的分水岭梗死过去仅依靠病理解剖获得诊断,近年来随着CT、MRI影像技术的快速普及,如今已可在临床中获得快速诊断.分水岭梗死目前公认的治疗常采用中分子羟乙基淀粉和低分子右旋糖苷注射液,疗效可靠,故分水岭梗死的诊断就显得尤其重要.本文对颈内动脉系统的分水岭梗死(以下简称分水岭梗死)的影像学改变及临床诊治方面相关问题进行综述.
Efficacy and safety of olaparib according to age in BRCA-1/2 mutated patients with recurrent platinum-sensitive ovarian cancer: Analysis of the phase III SOLO2 (AGO-OVAR 2.23/ENGOT-Ov21) study.
Authors: Fabian Trillsch, Sven Mahner, Beyhan Ataseven, Rebecca Asher, Coraline Dubot, Andrew R. Clamp, Richard T. Penson, Amit M. Oza, Amnon Amit, Tomasz Huzarski, Antonio Casado, Giovanni Scambia, Michael Friedlander, Nicoletta Colombo, Keiichi Fujiwara, Gabe S. Sonke, Hannelore denys, Elizabeth S. Lowe, Eric Pujade-Lauraine
Journal: Journal of Clinical Oncology (2020)

6068 Background: Adding olaparib as maintenance treatment to BRCA-1/2 mutated patients (pts) with recurrent platinum-sensitive ovarian cancer (PSOC) has significantly improved progression-free survival (PFS) as well as patient-centered endpoints. As BRCA mutated pts tend to be younger, specific information on efficacy and safety of olaparib for elderly pts is of special interest. Methods: 295 pts from the SOLO2 trial that randomly assigned to olaparib or placebo were categorized according to age cutoff at 65 years. The efficacy and tolerability of olaparib relative to placebo within in each age group was assessed based on PFS and toxicity outcomes. Quality of life (QoL) was assessed using EQ-5D-5L descriptive system score and FACT Trial Outcome Index (TOI) and evaluated using generalized estimating equations (GEE) and time without significant symptoms of toxicity (TWiST) analysis. Results: Baseline characteristics were similar in pts ≥65 years (N=62; 21%) compared to pts &lt;65 years (N=233; 79%), except for more BRCA2 mutations in elderly pts (39% vs. 23%). There was no significant difference in the magnitude of PFS benefit from olaparib in elderly as compared with younger pts (interaction P=0.33). The PFS adjusted hazard ratio (HR) of olaparib vs. placebo arms were respectively HR ≥65 0.43 (95%-confidence interval [CI] 0.24-0.81) and HR &lt;65 0.31 (95%-CI 0.22-0.43). Elderly and younger pts also had comparable safety profiles with no significant differences in median time on olaparib treatment (≥65: 27 vs. &lt;65: 33 months), percentage of pts experiencing at least one grade &gt;2 adverse event with olaparib (≥65: 73% vs. &lt;65: 79%), or requiring at least one dose interruption or dose reduction (≥65: 77.5 vs. &lt;65: 77.6%). No differences were found with regards to QoL scores. Quality adjusted TWiST analysis showed only non-significant differences in duration of good QoL under olaparib (≥65: 8.02 vs. &lt;65: 9.24 months, P=0.48). Conclusions: In this large cohort of BRCA mutated PSOC pts treated with a PARP inhibitor within a phase III trial, no significant differences were detected in terms of efficacy, safety, and QoL with olaparib treatment for pts ≥65 years compared to younger pts. This information supports the use of PARP inhibitors as maintenance therapy for PSOC pts irrespective of age. Clinical trial information: NCT01874353.
Digital health care solution for proactive heart failure management with the Cordella Heart Failure System: results of the <scp>SIRONA</scp> first‐in‐human study
Authors: Wilfried Mullens, Faisal Sharif, Matthias Dupont, Alexander M.K. Rothman, William Wijns
Journal: European Journal of Heart Failure (2020)

Incorporation of remote monitoring of pulmonary artery pressure and vital signs has been demonstrated to reduce heart failure (HF) hospitalization and all-cause mortality in selected symptomatic HF patients. The aim of this study is to investigate the safety and accuracy of the new CordellaTM Pulmonary Artery Pressure Sensor (Endotronix, Inc., Chicago, IL, USA) and the usability of the comprehensive CordellaTM Heart Failure System (CHFS).Multicentre, open-label, first-in-human, feasibility study to evaluate the CHFS and the safety and accuracy of the Cordella™ Pulmonary Artery Pressure Sensor in 15 patients with New York Heart Association class III HF. All patients were successfully implanted with the Cordella Pulmonary Artery Pressure Sensor, without sensor failure. No device system-related complications, defined as invasive treatment, device explant or death, occurred. The primary efficacy endpoint of a mean pulmonary artery pressure at 90 days was met in all but one patients with a cohort difference of 2.7 mmHg (Cordella Sensor 22.5 ± 11.8 mmHg, Swan-Ganz catheter 25.2 ± 8.5 mmHg). One patient did not go through the 90-day right heart catheterization for safety reasons. Patient adherence to daily measurement, transmission of vital signs and pulmonary artery pressure sensor readings were recorded 99% of the time.The initial experience of the CHFS incorporating comprehensive vital signs and pulmonary artery pressure monitoring enables safe and accurate monitoring of HF status.
Autophagy-inhibiting polymer as an effective nonviral cancer gene therapy vector with inherent apoptosis-sensitizing ability
Authors: Jiafeng Wang, Xuefei Zhou, Huifang Wang, Qian Xiao, Kefeng Ding, Xue Dong, Shufeng Xu, Bo Shen, Jihong Sun, Zhuxian Zhou, Jianbin Tang, Xiangrui Liu, Youqing Shen
Journal: Biomaterials (2020)
Interventional multicenter study to assess the feasibility of an e-health system (ZEMY) designed to manage symptoms and treatment-related toxicities in patients with breast cancer.
Authors: Luis Teixeira, Christelle Levy, David Coeffic, Rim Ghorbal, Julien Dupin, Nazario Esposito, Olfa Derbel
Journal: Journal of Clinical Oncology (2020)

e14107 Background: There is increasing interest in using e-health systems for symptom monitoring and alert triggering. ZEMY, a new software medical device, was developed to improve symptom management and enhance patient and health care team interactions. Methods: This was a three-month open-label, interventional, single arm study conducted at five French sites. Adult women with breast cancer (BC) initiating oral and/or parenteral cancer treatment received a smartphone with ZEMY installed and verbal training. Patients started cancer treatment on Day 1 and were followed for three months. Patients entered data for ten prespecified symptoms. The ZEMY software made recommendations to patients on the self-management of symptoms and transmitted automatic messages to the health care team. Primary outcome was patient feasibility response at 3 months (completion of ≥3 symptom reports and a report completion rate of ≥60% per patient). Secondary objectives included ZEMY symptom management, usability and satisfaction, and device deficiencies (DDs). Results: Overall, 54 patients were enrolled (Jun 2018 to Jan 2019) and 52 (96.3%) completed the study. Thirty-one (57.4%) patients were responders; this was not significantly higher than the predefined cut-off and ZEMY feasibility was not demonstrated. Forty-seven (87.0%) patients had ≥3 completed symptom reports and 33 (66.0%) patients had a report completion rate of ≥60% (missing: n = 4). In subgroup analyses, 22/30 (73.3%) patients with locally advanced BC and 24/36 (66.7%) patients aged 40–60 years were responders. ZEMY patient recommendations and health care team automatic messages were considered relevant at least once in &gt; 74% of cases for five of the six symptoms that were reported at least once by more than 1/3 of patients (diarrhea, nausea, fatigue, cutaneous and mucosal toxicities, and anxiety/depression). Using a 0–10 visual analogue scale, mean ZEMY satisfaction score was higher for patients than investigators (6.3 ±2.9 vs 4.4 ±1.5). Overall, 95 DDs were reported in 37 (68.5%) patients. Main reasons for DDs were inappropriate recommendations (n = 51) and device malfunction (n = 36). Conclusions: The primary endpoint of the study was not reached; however, higher response rates were observed in subgroups versus the overall population, indicating that ZEMY may be useful in symptom management in these patients. Generally, patients had a favorable opinion of ZEMY. The DD rate observed indicates the need for better user support in the future. Clinical trial information: NCT03558490.
硝酸酯在心血管疾病中规范化应用的专家共识
Authors: 中华医学会心血管病学分会, 中华心血管病杂志编辑委员会
Journal: BMJ (2012)

有机硝酸酯(organic nitrates,简称:硝酸酯)是现代使用最为广泛的抗心肌缺血药物,尽管临床应用已长达百余年,但目前仍存在适应证掌握不严格、用药方法不正确、剂型选择不合理以及对耐药性重视程度不够等问题.为进一步规范和指导硝酸酯在临床实践中的应用,中华医学会心血管病学分会和中华心血管病杂志编辑委员会组织国内专家参考国外相关资料结合我国临床实践经验的基础上,经反复讨论共同制定此共识。
An study on significance of clinical scales in diagnosis for pulmonary embolism
Authors: Ke-bin Cheng, Jin-ming Liu, Bei-lan Gao
Journal: BMJ (2010)

Objective To assess diagnostic value of Wells and Geneva seales in patients with suspected pulmonary embolism(PE).Methods Clinical data of 958 consecutive cases of suspected PE admitted to Shanghai Pulmonary Hospital form January 1,1995 to January 1,2009,were analyzed retrospectively,and all patients were assessed with Wells and Geneva scales,respectively for likelihood of PE,as compared to those diagnosed by lung imaging Results Three hundred and forty-seven patients with PE were diagnosed with lung imaging as gold standard,sensitivity,specificity,and positive and negative predictive values for Wells scale and Geneva scale in diagnosis for PE were 82.4%,58.1%,52.8%and 85.3%.and 88.8%,55.3%,53.1%and 89.7%,respectively,with positive and negative likelihood ratios.Youden index and crude agreement of 1.97,0.30,0.41 and 0.21,and 1.99,0.20,0.44 and 0.25.respectively.Area under the receiver operating characteristic(ROC) curve of Geneva scale(0.79)was significantly more than that of Wells scale(0.73)(Z=2.25,P＜0.05).As compared to Wells scale,sensitivity and specificity for Geneva scale in diagnosis for PE was significantly higher(χ2=7.12 and 6.84,respectively,P＜0.05).Conclusions Although there is a considerable gap in accuracy between clinical scales and lung imaging in diagnosis for PE.both Wells and Geneva scales can be used in clinical screening for PE to save unnecessary cost.however,Geneva scale is more practical and accurate than Wells scale,worthwhile to be popularized clinically.

Key words: 
Pulmonary embolism; Diagnosis;  Scales
Addition of endocrine therapy to dual anti-HER2 targeted therapy in initial treatment of HER2+/HR+ metastatic breast cancer.
Authors: Matthew Loft, Sheau Wen Lok, Richard H. De Boer, Laeeq Malik, Sally Greenberg, Belinda Yeo, Angelyn Anton, Louise M. Nott, Gary Edward Richardson, Ian M. Collins, Javier Torres, Frances Sarah Barnett, Bianca Alix Devitt, Peter Gibbs, Lucy Gately
Journal: Journal of Clinical Oncology (2020)

1038 Background: The combination of dual anti-HER2 targeted therapy and chemotherapy is the current first line standard of care for HER2+ metastatic breast cancer. Endocrine therapy (ET) is the backbone of treatment in hormone receptor positive (HR+) disease, but the role of the addition of endocrine therapy following chemotherapy in HER2+/HR+ disease remains unclear as pivotal first line clinical trials excluded endocrine therapy use. Methods: Data from a multi-site community cohort of consecutive HER2+ metastatic breast cancer patients diagnosed between 1 January 2012 and 31 August 2019 was examined. Patients were treated at clinician discretion. The subset of patients eligible for this analysis were those that were HR+ and had received first line dual anti-HER2 targeted therapy. Results: Of 132 eligible patients included in the analysis, 78 (59.1%) received endocrine therapy and 54 (40.9%) did not. Median follow up was 25.9 months. There were no significant differences between the two groups based on age, performance status, previous therapy or de novo disease (Table), however, patients with bone metastases were more likely to receive ET in conjunction with first line dual anti-HER2 therapy (71% vs 52%, p= .043). The addition of ET was associated with improved progression free (HR 2.1, 95% CI 1.2-3.5, p = 0.007) and overall survival (HR 2.7, 95% CI 1.2-5.5, p = 0.007) in multivariate analysis. No increase in serious adverse events was noted although endocrine therapy related toxicities were not specifically collected. Conclusions: In this real-world series, the addition of ET to first line dual anti-HER2 therapy in HER2+/HR+ metastatic breast cancer was associated with improved progression free and overall survival. Further research is required to validate these findings and examine the role of CDK4/6 inhibitors in this disease, but may provide reassurance to clinicians considering ET in this clinical context. [Table: see text]
Diagnostic value of Geneva score combined with rapid plasma D-dimer assay for pulmonary embolism
Authors: Ke-bin Cheng, Jin-ming Liu, Su-gang Gong, Tong Zhou, Bei-lan Gao
Journal: BMJ (2008)

Objective To study the value of Geneva score assessment combined with simplified rapid plasma D-dimer assay(SRPDDA)for early diagnosis of pulmonary embolism(PE).Methods Clinical data of 658 suspected cases of PE hospitalized at Shanghai Pulmonary Hospital during January 1,1995 to November 30,2007 were retrospectively analyzed.The patients were divided into three categories based on their Geneva score assessment,highly suspected with equal to or greater than 9 scores,intermediately suspected with 5-8 scores and mildly suspected with equal to or less than 4 scores,respectively.Clinical diagnosis for PE of the patients was made based on their probability Geneva score developed by Wicki,SRPDDA,and both Geneva score assessment and SRPDDA,respectively,and compared with results of lung imaging.Results Finally,PE diagnosis was established in 267 cases.Sensitivity for Geneva score and SRPDDA to diagnose PE was 88.4%and 90.3%,with negative predictive value(NPV)of 88.9%and 90.2%and Youden Index(YI)of 51.7%and 51.4%,respectively.And,sensitivity of both Geneva score assessment combined with SRPDDA wag 97.8%,with NPV and YI of 97.3%and 53.8%,respectively,with a likelihood ratio(LR)for both positive test results of 2.62 and a LB for both negative test results of 0.04,respectively.Conclusions As a routine and non-invasive diagnostic test,Geneva score assessment,as well as SRPDDA,play a screening role in early diagnosis for PE,which can help to save unnecessary cost of imping,and complement each other so to improve accuracy of diagnosis and reduce misdiagnosis.

Key words: 
Pulmonary embolism; Diagnosis; Clinical assessment; D-dimer