An open non-randomized study of recombinant activated factor VII in major postpartum haemorrhage

BACKGROUND: Empirical off-label use of recombinant activated factor VII (rFVIIa) has been reported to be effective in some cases of severe postpartum haemorrhage (PPH). Successful management of these patients has lead to more wide-spread use of rFVIIa in less severe cases without any evidence for the advantages of its administration. METHODS: Until November 2006, we had administered rFVIIa to 38 parturients. Based on our initial experience with the first 12 patients, we prepared guidelines for the use of rFVIIa. During the existence of these guidelines, we made a retrospective comparison of the 26 women who received rFVIIa with another 22 women who were treated during the same time period without using rFVIIa. RESULTS: The total amount of blood loss was significantly higher (11.3 +/- 4.5 vs. 8.0 +/- 3.1 l), and the coagulation screen revealed significantly longer partial thromboplastin time (APTT) and prothrombin time (PT) values and significantly lower fibrinogen values in patients receiving rFVIIa. The need for red blood cells, platelets and fibrinogen concentrate was significantly higher in these women. Although the response was considered good in two-thirds of the women, several patients received rFVIIa with a poor or no response as a result of arterial bleeding. CONCLUSION: The decision to use rFVIIa resulted from a more profound haemorrhage. We did not gain any evidence to extend the use of rFVIIa into less severe cases of PPH. Furthermore, this policy would result in a profound increase in the overall costs of the treatment. Randomized placebo-controlled trials are urgently needed to optimize the use of rFVIIa in obstetric haemorrhage.     

Recommandations européennes pour l'utilisation du facteur VII activé recombinant comme thérapeutique adjuvante du saignement majeur

Objective

To develop consensus guidelines for use of recombinant activated factor VII (rFVIIa) in massive hemorrhage.

Methods

A guidelines committee derived the recommendations using clinical trial and case series data identified through searches of available databases. Guidelines were graded on a scale of A-E according to the strength of evidence available. Consensus was sought among the committee for each recommendation.

Results

A recommendation for use of rFVIIa in blunt trauma was made (grade B). rFVIIa might also be beneficial in post-partum hemorrhage (grade E), uncontrolled bleeding in surgical patients (grade E) and bleeding following cardiac surgery (grade D). rFVIIa could not be recommended for use: in penetrating trauma (grade B); prophylactically in elective surgery (grade A) or liver surgery (grade B); or in bleeding episodes in patients with Child-Pugh A cirrhosis (grade B). Efficacy of rFVIIa was considered uncertain in bleeding episodes in patients with Child-Pugh B and C cirrhosis (grade C). Monitoring of rFVIIa efficacy should be performed visually and by assessment of transfusion requirements (grade E), while thromboembolic adverse events are a cause for concern. rFVIIa should not be administered to patients considered unsalvageable by the treating medical team.

Conclusion

There is a rationale for using rFVIIa to treat massive bleeding in certain indications, however, only adjunctively to the surgical control of bleeding once conventional therapies have failed. Lack of data from randomized, controlled clinical trials, and possible publication bias of the case series data, limits the strength of the recommendations that can be made.     

双极电凝和PK刀用于腹腔镜子宫切除术的比较

目的：比较双极电凝和PK刀在腹腔镜子宫切除术中的应用情况。方法：回顾分析我院2006年1月至12月66例腹腔镜子宫切除患者的临床资料。其中双极电凝组33例,PK刀组33例。比较两组患者的术中出血量、手术时间等指标。结果：所有手术均获成功,无中转开腹及严重并发症发生。PK刀组在手术出血量和手术时间上均显著少于双极电凝组。结论：与双极电凝相比,PK刀具有止血效果佳,热辐射损伤小,器械操作简单、易学等优点,极大提高了妇科腹腔镜子宫切除术的手术质量。     

Coagulation cascade activation triggers early failure of pig hearts expressing human complement regulatory genes

Abstract: Background: Hyperacute rejection (HAR) and early graft failure (EGF) have been described in a minority of pig‐to‐baboon heart transplants using organs transgenic for human complement regulatory proteins (hCRP). Here we investigate the role of coagulation cascade activation in the pathogenesis of HAR and EGF in a consecutive series where a high incidence of these outcomes was observed. Methods: Twenty‐eight naïve wild‐caught Papio anubis baboons received heterotopic heart transplants from pigs transgenic for hDAF (n = 23) or hMCP (n = 5). Immunosuppression consisted of cyclosporine A, cyclophosphamide and MMF (n = 18) or anti‐CD154 mAb (IDEC‐131) and ATG (n = 10). Eleven received anti‐Gal carbohydrates (GAS914, n = 8, or NEX1285, n = 3), of which four also underwent extracorporeal immunoadsorption (EIA), and 12 also received pharmacologic complement inhibitors (C1 INH, n = 9, or APT070, n = 3). Results: Excluding one technical failure, 14 of 27 transplants (11 hDAF, 3 hMCP) exhibited either HAR (n = 10) or EGF (n = 4). Surprisingly, neither complement inhibition (with C1 INH or APT070) nor anti‐Gal antibody depletion with GAS914, NEX1285, or additional EIA consistently prevented HAR or EGF despite low or undetectable complement deposition. Strikingly, most grafts with HAR/EGF exhibited prominent fibrinogen and platelet deposition associated with systemic coagulation cascade activation, consistent with non‐physiologic intravascular coagulation, in many instances despite little evidence for antibody‐mediated complement activation. Conclusion: We conclude that dysregulated coagulation correlates closely with and probably causes primary failure of pig hearts transgenic for hCRP. These data support efforts to define effective strategies to prevent dysregulated coagulation in pig organ xenografts.     

Seminal factor VII and factor VIIa: supporting evidence for the presence of an active tissue factor-dependent coagulation pathway in human semen

Human semen spontaneously coagulates into a semisolid mass and then wholly liquefies in a process that may have some similarity to that of normal blood. This well described phenomenon is referred to as coagulation and liquefaction of semen. Besides other active components of the haemostatic system, semen contains a significant amount of functional tissue factor (TF). However, TF needs factor (F)VII in order to exert it actions. In this study, we assessed human semen for the presence of FVII and FVIIa, and related their levels to conventional fertility parameters. Using a functional, one stage, clotting assay based upon the prolongation of the prothrombin clotting time, using the ACL 300R analyser and an Imubind FVIIa ELISA assay, FVII and FVIIa levels were measured in 97 semen specimens obtained from sub-fertile (sperm counts <20 x 10(6)/mL), normally fertile (sperm counts >or=20 x 10(6) but <60 x 10(6)/mL), fertile sperm donors (sperm counts >or=60 x 10(6)/mL), vasectomized subjects and in a pooled normal semen parameters group (categorization into groups was based on the World Health Organization guidelines on fertility criteria). In addition, conventional semen parameters were analysed on all semen samples. Both FVII and FVIIa were quantifiable in human semen. The mean levels of FVII and FVIIa were 4.4 IU/dL and 12 ng/mL respectively. Despite the observed variations of FVIIa levels in the studied groups they did not meet statistical significance when the groups were tested against each other. However, seminal FVIIa levels showed a significant positive association with semen liquefaction time, sperm motility and semen volume. The anti-sperm antibodies and sperm-agglutination groups were also associated with raised seminal FVIIa levels. We observed no significant relationship between FVIIa levels and total sperm concentration, sperm count per mL (sperm density), sperm progression and days of sexual abstinence. This study demonstrates that human semen contains appreciable amounts of FVII and FVIIa. It is possible to quantify these using commercially available assays. There also appears to be a direct correlation between the levels of these factors and certain seminal parameters. This finding reinforces the concept of an active clotting system in human semen, by establishing the missing link in the activation of a TF-dependent pathway.     

整体护理对于监测胸部恶性肿瘤术后使用低分子肝素患者的护理观察

目的整体护理对于胸部恶性肿瘤患者术后使用低分子肝素减少静脉血栓(VTE)的预防作用。方法研究选择对象为佛山市顺德区两家医院2014年4月至2016年12月收治拟行限期胸部恶性肿瘤根治术的患者110例,分为对照组和观察组,各55例。术后早期给予低分子肝素皮下注射。对照组患者给予常规护理方式,观察组患者给予整体护理模式。记录两组护理效果和患者高凝患者比例及术后血栓性疾病的发生率,观察两组患者不同时间凝血相关指标。结果该项目共有38名外科护士得到参与这项研究检查,平均年龄为32岁(21~55岁)。对照组患者依从性达42.3%,观察组患者为95.0%。在对照组评估中伴有下肢轻度肿胀的5位患者中只有1位被发现,并且6位患者的肢体中有温暖或热量增加的证据都没有记录在护理记录中。在观察组在评估中伴有下肢轻度肿胀的4位患者中全部被发现,8名有肢体温暖证据的患者中只有3名没有记录。两组血液高凝患者比例及血栓性疾病比例差异均无统计学意义(P0.05);两组患者PLT、APTT组间比较及与各自治疗前相比及无显著差异(P0.05);对照组患者PT、D-Dimer术后与术前相比差异均显著(P0.05),观察组PT与术前比较差异不显著,与对照组相比差异显著(P0.05);观察组患者D-Dimer术后1天较术前均上升(P0.05),术后14天与术前相比差异不显著(P0.05),观察组各时间点Fib与术前相比差异不显著(P0.05),对照组术后14天与术前相比增高显著(P0.05)。结论整体护理方式对胸部恶性肿瘤患者术后观察使用低分子肝素后的护理有利于预防术后VTE的发生。     

疏阳化痰方对焦虑女性痤疮(阳郁痰凝证)患者疗效及血清炎性因子的影响

[目的]观察疏阳化痰方治疗焦虑痤疮女性患者80例疗效及对血清炎性因子影响。[方法]纳入2017年1月-2018年1月期间治疗的焦虑女性痤疮患者80例,随机分为治疗组和对照组,每组各40例,对照组常规给予丹参酮胶囊口服,治疗组在对照组基础上给予疏阳化痰方治疗,连续治疗12周;观察治疗前后两组治疗有效率、焦虑评分量表（SAS）、皮肤病生活质量指数（DLQI）、血清炎性因子[白介素-1α（IL-1α）、白介素-6（IL-6）、肿瘤坏死因子-α（TNF-α）]、血清激素水平黄体激素水平（LH）与雌二醇（E₂）、中医证候量表不良反应。[结果]1）治疗后治疗组缓解率为92.5%,对照组缓解率为85.0%,两组在缓解率方面对比无统计学意义（P>0.05）;2）两组治疗后痤疮国际改良分级等级分级比较无统计学差异（P>0.05）;3）两组治疗后DLQI评分、中医证候量表评分、SAS评分对比具有统计学差异（P<0.05）;4）两组治疗前后血清炎性因子（IL-1α、IL-6、TNF-α）、血清激素水平LH与E₂水平变化比较具有统计学差异（P<0.05）;两组治疗前后均未出现不良反应。[结论]疏阳化痰方联合丹参酮胶囊治疗焦虑女性患者痤疮（阳郁痰凝证）效果显著,值得临床应用推广。     

不同孕期阶段孕妇凝血四项及FDP和D-二聚体的变化及临床意义

目的:研究不同孕期阶段(早、中、晚)孕妇凝血四项、血浆纤维蛋白(原)降解产物[plasma fibrin/fibrinogen degradation products, FDP]、D-二聚体的变化及临床意义,为临床诊疗提供理论支持。方法:回顾性分析2021年1月至2021年12月200例孕妇就诊资料中的凝血四项,纤维蛋白原(fibrinogen, FIB)、凝血酶原时间(prothrombin time, PT)、凝血酶时间(thrombin time, TT)、活化部分凝血活酶时间(activated partial thromboplastin time, APTT)。并对FDP与D-二聚体的检测结果进行统计分析,比较孕早期、中期、晚期三个阶段凝血四项、FDP和D-二聚体水平的变化。结果:孕早期、孕中期与孕晚期PT水平比较,差异有统计学意义(P<0.05);孕早期、孕中期与孕晚期三个阶段的TT相比,差异无统计学意义(P>0.05);孕早期的APTT明显长于中期、晚期孕妇,差异有统计学意义(P<0.05);孕早期、中期、晚期孕妇,随着孕周的增加,FIB水平逐渐升高...     

基于DIC评分早期分层抗凝对改善脓毒症预后的有效性和安全性研究

目的探讨基于弥散性血管内凝血(DIC)评分早期分层抗凝对改善脓毒症预后的有效性和安全性。 方法选取脓毒症患者265例,根据DIC和SIC评分分组,将患者分为DIC组84例、脓毒症凝血病(SIC)组92例和对照组84例(正常凝血状态)。其中DIC组给予常规剂量低分子肝素抗凝治疗,SIC组给予半量低分子肝素治疗,对照组不给予抗凝等治疗。 结果DIC组ICU住院时间、呼吸机使用时间和总住院时间较对照组延长(P＜0.05);28天病死率比较,DIC组、SIC组和对照组差异无统计学意义(P＞0.05)。DIC组、SIC组治疗后凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)和D二聚体(D-Dimer,D-D)低于治疗前,且DIC组高于SIC和对照组(P＜0.05),而血小板和纤维蛋白原(FIB)低于SIC组和对照组(P＜0.05)。DIC组、SIC组和对照组治疗后乳酸、BUN和Scr均较治疗前降低,DIC组仍高于SIC组和对照组(P＜0.05)。治疗后急性生理及慢性健康状况评分Ⅱ(APACHEⅡ)评分、序贯器官衰竭评分(SOFA)评分均较治疗前降低,SIC组评分低于对照组,DIC组APACHEⅡ评分高于SIC组和对照组(P＜0.05)。DIC组、SIC组和对照组出血事件总发生率差异无显著性(P＞0.05)。 结论基于脓毒症DIC评分早期分层抗凝在脓毒症治疗中有较好的效果,可减轻患者凝血功能和脏器损功能损害。