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1.
Summary: A randomized controlled trial was undertaken comparing the efficacy and safety of low molecular weight (LMW) heparin (Fragmin) with sodium heparin for prophylaxis against postoperative thromboembolic disease after major gynaecological surgery. Women were randomized to receive subcutaneous injections of 5,000 U of either once daily LMW heparin or twice daily sodium heparin. A total of 566 women were recruited, of whom 552 completed the study. Most women (461) had malignant disease and 430 of these underwent radical surgery. The remainder underwent major, but not radical surgery. There were 5 thromboembolic events in the LMW heparin group and 2 in the sodium heparin group, with no significant difference between these groups. No significant difference was found in the incidence of intraoperative or postoperative transfusion in the 2 groups. The decision of which heparin to use in routine practice cannot be made on clinical grounds.  相似文献   

2.
Abstract. Ailawadi M, Del Priore G. A comparison of thromboembolic prophylaxis in gynecologic oncology patients.
The objective of this study was to compare two methods of thromboembolic prophylaxis: sequential compression devices alone (SCDs) vs. SCDs with subcutaneous low-dose unfractionated heparin (UH). A retrospective cohort study was conducted of 168 patients who had undergone surgery for suspected gynecological malignancies. These patients were examined for associated risk factors, method of prophylaxis, and incidence of clinically significant thromboembolic events. Of these patients, 94 (56%) received perioperative and postoperative sequential compression devices alone, while 74 (44%) received both SCDs and subcutaneous low-dose UH. The postoperative course of these patients, while in the hospital and after discharge, was followed for clinically evident thromboembolic complications. Univariate and multivariate analyses were performed. The two groups were comparable in terms of most risk factors, including age, stage, height, weight, body surface area, estimated blood loss, total anesthesia time, and nodal disease. Six of 94 patients (6.4%) in the SCDs group suffered from venous thromboembolism, while four of 74 patients (5.4%) who received both SCDs and low-dose UH had a thromboembolic event (χ2 P = 0.79). There was no difference in postoperative changes in platelet counts between the two groups. Heparin added additional cost, 105 extra minutes of nursing time per patient per admission, and additional pain for the patient. In conclusion, the addition of subcutaneous low-dose unfractionated heparin to SCDs for prophylaxis against deep venous thrombosis in women undergoing surgery for gynecologic malignancies does not improve the outcome. Adding heparin was more expensive, time consuming, and painful. Heparin should not be used with SCDs unless an additional benefit can be demonstrated in a randomized controlled trial.  相似文献   

3.
OBJECTIVE: The purpose of this study was to conduct pilot studies for large randomized controlled trials to compare low-molecular-weight heparin with placebo for antenatal thromboprophylaxis (trial 1), and for thromboprophylaxis after cesarean delivery (trial 2). STUDY DESIGN: Multicenter randomized controlled trials (trial 1, 23 units; trial 2, 8 units) were conducted. Pregnant women at increased risk for thromboembolic disease were eligible for trial 1; women who underwent cesarean delivery were eligible for trial 2. The interventions were once daily injections of low-molecular-weight heparin or placebo. Primary outcomes were as follows: trial 1, confirmed symptomatic thromboembolic events and symptomatic osteoporotic fractures; trial 2, confirmed symptomatic thromboembolic events and wound complications. RESULTS: Sixteen women were recruited for trial 1; 1 woman in the placebo group had a symptomatic thromboembolic event. One hundred forty-one women were recruited for trial 2; 1 woman in the low molecular weight heparin group had a symptomatic thromboembolic event. CONCLUSION: Poor recruitment indicates that large-scale trials using these designs would be difficult. Collection of data on the number of women that are eligible and the reasons for nonrecruitment in future trials of these interventions would allow a better understanding of the reasons for poor recruitment.  相似文献   

4.
Venous thromboembolic events (deep vein thrombosis [DVT] and pulmonary embolism) are serious preventable complications associated with gynecologic surgery. Preoperative risk assessment of the individual patient will provide insight into the level of risk and the potential benefits of prophylaxis. Common risks include a history of venous thromboembolism, age, major surgery, cancer, use of oral contraceptives or hormone therapy, and obesity. Based on the presence of risk factors, the patient should be categorized into one of four risk groups and appropriate thromboprophylaxis prescribed. Randomized clinical trials in gynecologic surgery and general surgery have established the significant value of thromboprophylaxis. For moderate- and high-risk patients undergoing surgery for benign gynecologic conditions, low-dose unfractionated heparin, low molecular weight (LMW) heparins, intermittent pneumatic leg compression, and graded compression stockings all have demonstrated benefit. If using low-dose unfractionated heparin in high-risk patients, the heparin should be administered 5,000 units every 8 hours. Because DVT often begins in the perioperative period, it is important to initiate low-dose unfractionated heparin or administer the first LMW heparin dose either 2 hours preoperatively or 6 hours after the surgical procedure. Low molecular weight heparin has the advantage of being administered once daily but is more expensive than low-dose unfractionated heparin. In addition, LMW heparin has not been shown to be more effective and has similar risk of bleeding complications when compared with low-dose unfractionated heparin. In the very high-risk patient, a combination of two prophylactic methods may be advisable and continuing LMW heparin for 28 days postoperatively appears to be of added benefit.  相似文献   

5.
One hundred eighty-five patients undergoing operation for gynecologic malignancy participated in a randomized controlled trial of low-dose heparin prophylaxis. Prospective surveillance for deep venous thrombosis was performed with daily fibrinogen 125I counting in the legs and impedance plethysmography. Twelve of 97 (12.4%) patients in the control group and 13 of 88 (14.8%) patients in the low-dose heparin group developed a venous thromboembolic complication. There was no statistical difference in the incidence of proximal deep vein thrombosis, calf vein thrombosis, or pulmonary emboli between the control and low-dose heparin groups. Low-dose heparin does not afford any prophylactic benefit to patients undergoing major pelvic operative procedures for gynecologic malignancy.  相似文献   

6.
The relationship between tumor stage and the concentration of circulating heparin achieved after subcutaneous administration and its effect on fibrin generation were studied in 24 women with gynecologic malignancy. A single subcutaneous injection of 5000, 7500, and 10,000/U of sodium heparin was given in random order on different days. Plasma specimens for antithrombin III, fibrinopeptide A, and heparin were obtained serially over an 11-hour interval. Women with a Stage III or IV malignancy had significantly lower circulating heparin after the 5000 and 10,000/U doses. There was a significant decline in fibrinopeptide A as the concentration of circulating heparin increased. Thirty-three percent of women with a Stage III or IV malignancy had no detectable circulating heparin at any point examined over the 11 hours after 5000/U of heparin. Likewise, 16.7% and 8.4% had no detectable circulating heparin after 7500 and 10,000/U, respectively. A similar percentage was noted in a smaller group of women with Stage II malignancy. Next, a known quantity of heparin was added to the plasma from these patients and the concentration of heparin was determined. A significant amount of heparin-neutralizing activity was documented. We conclude that a large percentage of women with an advanced gynecologic malignancy are able to neutralize heparin administered for the prevention of thromboembolic disease. This heparin-neutralizing activity may account for the failure of low-dose heparin to prevent thromboembolic complications in this patient population.  相似文献   

7.
In a double blind, randomized trial the hemorrhagic complications of a reduced dose of low molecular weight heparin (LMWH) (Fragmin, KabiPharmacia) were compared to those of the conventional dose of unfractionated heparin (UH). 2500 anti-XaU of LMWH was given once daily and UH in a dose of 5000 anti-XaU twice daily. During a one year period 141 patients undergoing gynecological surgery were included in this study. The patients were examined clinically for hematomas and for deep venous thrombosis (DVT) on the third and fifth day. Venography was performed when DVT was suspected. No patients developed clinical DVT. One woman in the LMWH group had pulmonary embolism 3 days after the prophylaxis was stopped. Two women in the LMWH group died, one from a stroke on day 2, one from cancer on day 39. There was no significant difference in serious bleeding complications between the two regimens, 20% in the LMWH group and 14% in the UH group. Even with the reduced dose of LMWH the mean plasma concentration of heparin in the LMWH group was higher (mean 0.14 anti-XaU/ml) than in the UH group (0.029 anti-XaU/ml) 3 hours after injection on the 2nd postoperative day. A reduced dose of LMWH (2500 anti XaU once daily) does not cause more bleeding complications than the conventional heparin regimen to prevent thrombosis, as was the case in our previous study with 5000 anti XaU of LMWH once daily.  相似文献   

8.
In a period of five years a general medical prevention of postoperative venous thromboembolic disease was tested in major gynaecological operations, in patients undergoing radium insertions for gynaecological cancer and in patients with caesarean section. Preoperatively was the beginning of the daily therapy with Dihydroergotamine (DHE) and every four days the therapy with Acetylsalicylic acid (ASS). The results of 2,346 therapy-cycles with medical prevention of thromboembolic disease in 2,280 patients are reported. Risks of thromboembolic disease were in 63% of the gynaecologic patients (mean age 52.4 +/- 8.9 years) and in 34% of the obstetrical patients (mean age 24.6 +/- 5.1 years). Postoperative bleeding complications occurred in 12 cases (0.5%) and the number of reoperations was lower than 1 0/00). Postoperative thromboembolic complications were found clinically and radiologically in 0.3% of the patients. Letal embolism of the lung happened in 2 patients (0.9 0/00). A general medical prevention of thromboembolic disease with DHE and ASS can be recommended because of the low rate of postoperative bleeding complications and of the reduced rate of postoperative thromboembolic disease. A prevention of thromboembolic disease by individual dosage of heparin must be considered in patients at high risk for thromboembolic disease.  相似文献   

9.
This prospective study was designed to investigate the effect of glucocorticoids, promethazine (Phenergan), hyskon, heparin, and Ringer's lactated solution in the prevention of pelvic adhesion formation after pelvic surgery. The patients were divided into two groups: The first consisted of 396 patients who had laparotomy for different types of pelvic surgery, and the second group consisted of 546 patients who had operative laparoscopy for different types of pelvic disease. Patients in these two major groups were divided prospectively into different subgroups with different modalities of adjuvant therapy to prevent postoperative pelvic adhesions. A second-look laparoscopy was performed for some of the patients who failed to conceive in each of these subgroups. Pregnancy rate and adhesion formation were compared between these subgroups with no statistical difference noted. It is concluded that glucocorticoids, promethazine, heparin, and hyskon have no therapeutic advantage over Ringer's lactated solution in the prevention of postoperative pelvic adhesion formation.  相似文献   

10.
This study evaluated the analgesic efficacy of administering preoperatively rofecoxib or naproxen sodium to patients undergoing abdominal hysterectomy. A randomized, double-blinded prospective study was conducted with 60 women undergoing elective abdominal hysterectomy under general anesthesia. Patients were randomly allocated into one of three equally sized groups. Patients in the first group received rofecoxib 50 mg 1 h before operation (group R), patient in the second group received naproxen sodium 550 mg 1 h before surgery (group N) and patients in the third group received a placebo tablet in the same time (group P). Total amount of used morphine mixture was higher in placebo group (93±6 ml) than in the group R (50±4 ml) and group N (64±6 ml). There were significant difference for total amount of used morphine mixture between group P and other two groups. There was significant difference in the volumes of morphine mixture used in the first 12 h in group P and other two groups. The occurrence of side effects such as, dyspepsia, epigastric discomfort, heartburn, were similar in group R and group P. However, this side effects were increased in group N. Rofecoxib receiving preoperatively was provided clinical efficacy for postoperative pain control and well tolerated for gastrointestinal side effects comparable with naproxen sodium.  相似文献   

11.
The efficacy of intravenous infusion of dextran 70 or subcutaneous administration of low-dose heparin in preventing postoperative thromboembolic complications has been investigated in a prospective randomized trial. During part 1 of the study, 232 patients over the age of 40 years who were undergoing major gynecologic surgery underwent a complete test protocol. The 125I fibrinogen uptake test (FUT) was used for the diagnosis of deep vein thrombosis (DVT) in 117 patients in the dextran and 115 patients in the heparin group. Heparin was significantly more effective than dextran for reducing DVT (P less than .001). During part 2 of the study no FUT was done but the incidence of clinical and fatal pulmonary embolism (PE) and the number of complications were studied. Of 444 patients (parts 1 and 2) 1 fatal and 2 nonfatal pulmonary emboli were diagnosed. All the emboli occurred in the dextran group. The benefit: hazard ratio appeared to favor heparin for the prophylaxis of DVT.  相似文献   

12.
目的 探讨低感染风险剖宫产产妇围手术期预防性应用抗生素的必要性及最佳用药方案.方法 前瞻性随机对照研究低感染风险子宫下段剖宫产产妇围手术期抗生素应用与否以及不同用药方案与术后病率和术后感染的关系.抗生素选择头孢唑肟钠或克林霉素,均为静脉给药.共纳入2007年11月至2008年10月在南京大学医学院附属鼓楼医院妇产科分娩的产妇720例,随机分成4组:A组176例,围手术期不使用抗生素,B组190例,术前30 min一次给药,术后不再使用;C组180例,术前30 min开始给药,术后继续使用2 d;D组174例,手术结束后开始给药,共5d.比较4组产妇术后体温恢复正常的时间、术后病率、术后感染及术后住院天数.统计学分析采用方差分析、卡方检验及Fisher精确概率法. 结果 720例产妇术后感染率、术后病率分别为0.83%(6/720)和4.58%(33/720),4组产妇剖宫产术后感染发生率差异无统计学意义(P>0.05),B组和C组产妇术后体温恢复正常时间、术后病率及术后平均住院天数均分别显著低于A组和D组[B组:(41.9±31.6)h、1.05 oA(2/190)、(4.8±1.1)d;C组:(41.1±36.5)h、1.11%(2/180)、(4.7±0.9)d;A组:(67.0±40.6)h,7.39%(13/176)、(5.7±1.0)d,D组:(70.1±39.9)h、9.20%(16/174)、(5.9±1.1 d),P均<0.01].但B、C组之间和A,D组之间各项指标比较差异无统计学意义(P>0.05). 结论 低感染风险产妇剖宫产术前30 min静脉使用抗生素能显著降低术后病率的发生,且一次性用药即可,无需对低感染风险的剖宫产产妇在术后重复应用抗生素预防感染.  相似文献   

13.
Objective. To evaluate the benefit of combined low-molecular-weight (LMW) heparin and aspirin for prophylaxis in women carriers of thrombophilia who had previously suffered from severe obstetric complications.

Methods. The 33 studied women had an earlier pregnancy complicated by severe preeclampsia, abruptio placentae, intrauterine growth retardation, or intrauterine fetal death. All were subsequently diagnosed as carrying inherited thrombophilias. In their subsequent pregnancy, prophylactic therapy consisting of LMW heparin 40 mg/day (Enoxaparin, Rhone-Poulenc-Rorer, France) and aspirin was administered. Patients who were found to be homozygotes for the methylenetetrahydrofolate reductase mutation also received folic acid supplementation throughout their pregnancy.

Results. Low-molecular-weight heparin was well tolerated and none of the women or the newborns developed any hemorrhagic complications. Only three (9.1%) of the women developed pregnancy complications. The mean gestational age and the mean birth weight at delivery in the previously complicated pregnancies were 32.1 ± 5.0 weeks and 1175 ± 590 g, respectively, compared to 37.6 ± 2.3 weeks and 2719 ± 526 g, respectively, in the treated pregnancies (p ≤ 0.001).

Conclusions. This uncontrolled trial suggests that patients with obstetric complications and an inherited thrombophilia may benefit from treatment with combined LMW heparin and aspirin in subsequent pregnancies. However, this needs to be verified by controlled trials before considering clinical application.  相似文献   

14.
Objective: To compare the maternal and neonatal outcomes arising from the use of low molecular weight heparin (LMWH) or unfractioned heparin (UFH) in the treatment of acute venous thromboembolism (VTE) in pregnancy.Study Design: A retrospective review of the charts of all women treated for acute VTE in pregnancy at the Ottawa Hospital from January 1990 to December 1999.Results: Twenty-three cases were identified, of which 11 were treated with LMWH and 12 with UFH. Maternal and fetal outcomes were similar between the two groups. Hospital length of stay was shorter in the LMWH group. There was no difference in delivery management between the two groups. There was minor bleeding in 2 women in the UFH group and none in the LMWH group. There was one recurrent VTE during treatment in each of the groups.Conclusion: There is no difference in complication rate between LMWH and UFH in the treatment of acute VTE in pregnancy.  相似文献   

15.
目的:探讨低分子肝素钠治疗复发性流产对前置胎盘及早产的影响。方法:回顾性分析2015年1月至2016年1月就诊我院并分娩的孕妇中,符合纳入及排除标准的50例有复发性流产史的孕妇,予以低分子肝素钠治疗为治疗组,既往有复发性流产史,未予低分子肝素钠治疗的孕妇50例为对照组,随机选取同期我院正常分娩的孕妇200例为正常组。对照组给予常规保胎治疗,治疗组在对照组的基础上给予低分子肝素钠治疗;比较3组病例前置胎盘、产后出血及早产发生率。结果:对照组前置胎盘发生率(30%)明显高于治疗组(12%),两者比较差异有统计学意义(P0.05);治疗组早产发生率(0)明显低于对照组(14%),差异有统计学意义(P0.05);对照组前置胎盘、产后出血及早产发生率均高于正常组,差异有统计学意义(P0.05)。结论:复发性流产患者前置胎盘、产后出血及早产发生率比正常妊娠孕妇高,应用低分子肝素钠有可能降低复发性流产患者前置胎盘和早产的发生率。  相似文献   

16.
Postoperative venous thromboembolic complications are a major problem for the gynecologic oncologist. External pneumatic calf compression (EPC), when applied intraoperatively and left on the patient's legs for 5 days postoperatively, has been previously demonstrated to significantly reduce the incidence of venous thromboembolic complications in patients undergoing surgery for pelvic malignancies. The purpose of this study is to evaluate whether a short perioperative course of EPC is also effective in preventing venous thromboembolic complications. One hundred ninety-four patients participated in a randomized controlled trial of perioperative external pneumatic calf compression. 125I-labeled fibrinogen scanning and impedance plethysmography were used as prospective surveillance methods in both groups. Venous thromboembolic complications were diagnosed in 12.4% of control group patients and in 18.6% of EPC group patients. External pneumatic calf compression when used only in the perioperative period appears to be of no benefit in reducing the incidence of postoperative venous thromboembolic complications.  相似文献   

17.

Objective

To compare low-molecular-weight (LMW) heparin plus low-dose aspirin with intravenous immunoglobulin (IVIG) in the treatment of antiphospholipid antibody syndrome in women with recurrent spontaneous abortions before 10 weeks of gestation.

Method

This prospective, multicenter trial conducted between 2002 and 2006 included 85 patients aged 18-39 years. The women were allocated randomly to receive LMW heparin plus low-dose aspirin, or IVIG. Data were compared using the t test and Fisher exact test.

Results

The women treated with LMW heparin plus low-dose aspirin had a higher rate of live births than those treated with IVIG (P = 0.003). Of those who completed the study, 29/40 (72.5%) and 15/38 (39.5%), respectively, had live births. Intent-to-treat analysis revealed a significant difference between the 2 groups (OR 1.802; 95%CI, 1.14-2.84; P = 0.007).

Conclusions

LMW heparin plus low-dose aspirin resulted in a higher live birth rate than IVIG in the treatment of antiphospholipid antibody syndrome in women with recurrent abortion.  相似文献   

18.
OBJECTIVE: This study aimed to compare the haemorrhagic complications and efficacy of enoxaparin, a low molecular weight heparin (LMWH), and conventional standard heparin (SH) in gynaecological oncologic surgery. MATERIALS METHODS: A double blind, randomised trial was performed on 102 consecutive women undergoing gynaecologic cancer surgery with pelvic and paraaortic lymphadenectomy. The women were separated into those who were given 2,500 IU enoxaparin once daily and SH in a dose of 5,000 IU three times daily. The groups were analysed for intraoperative blood loss, drainage, transfusion requirements, perioperative haemoglobin decrease, wound haematoma, and clinical deep venous thrombosis. RESULTS: The two groups were well matched for age, weight, and other factors, which could predispose to the development of deep venous thrombosis (DVT) and haemorrhage. No patient developed clinical significant DVT, wound haematoma or intra-abdominal bleeding. There was no significant difference in bleeding complications between the two regimens. The antiFXa level in the plasma was correlated strongly with patient weight. CONCLUSIONS: A dose of 2,500 IU enoxaparin/day does not cause more bleeding complications than SH 5,000 IU three times daily when used to prevent thrombosis. However, the dose of enoxaparin must be adjusted to the patient's weight.  相似文献   

19.
OBJECTIVE: To investigate the effect of subcutaneous heparin treatment on calcium homeostasis in pregnancy. DESIGN: A longitudinal case-control observational study. SETTING: Department of Obstetrics and Gynaecology, Karolinska Hospital, Stockholm, Sweden. SUBJECTS: 36 pregnant women with previously verified thromboembolic complications and 23 healthy pregnant control women similar in age, parity, weight, and smoking habit. INTERVENTIONS: Thromboprophylaxis during pregnancy and 6 weeks post partum was given with subcutaneous heparin twice daily to the 36 women with a history of thromboembolic complications, 16 received an average dose of 24,500 IU/day and 20 a mean dose of 17,300 IU/day. Venous blood and urine samples were obtained every 4 weeks. MAIN OUTCOME MEASURES: Serum concentrations of total calcium, ionized calcium, calcitonin and urinary calcium. RESULTS: Women on high-dose heparin treatment showed significantly higher concentrations of total and ionized calcium and of calcitonin in serum and significantly lower concentrations of calcium in urine than did 23 normal pregnant controls. The differences were most pronounced in the third trimester. The results obtained in the low-dose heparin group were between those in the high-dose and the control groups. At 8 weeks postpartum there were no significant differences between the heparin-treated women and the controls. No significant differences were found during pregnancy in haematocrit, liver or renal function, serum levels of albumin, phosphate, magnesium, alkaline phosphatase, parathyroid hormone or urinary cyclic AMP. CONCLUSIONS: Heparin treatment during pregnancy results in changes in calcium homeostasis and a dose-dependent response is suggested.  相似文献   

20.
OBJECTIVE: The purpose of this study was to compare early oral intake and the traditional timing of feeding after major gynecologic surgery and the effects on the length of hospital stay. STUDY DESIGN: Gynecologic oncology and urogynecology patients who underwent major abdominal gynecologic surgery were prospectively randomized to 1 of 2 groups. The traditional feeding group (group A, 49 patients) received nothing by mouth until documentation of bowel function. They were then advanced slowly to solid diet. The patients allocated to the early feeding regimen (group B, 47 patients) began clear fluids on the first postoperative day. Once 500 mL of clear fluid was tolerated, they received a regular diet. The groups were compared with regard to length of hospital stay, postoperative day that solids were tolerated, and the incidence of adverse effects. Statistical analyses were performed with the chi(2) test, the Fisher exact test, the Student t test, and analysis of variance. RESULTS: The demographic characteristics of the 2 groups were similar. There was a statistically significant reduction in the length of hospital stay for those patients on the early feeding regimen. The median length of stay for group A was 6.0 days and for group B was 4.0 days (P =.0001). There was no difference in the incidence of emesis, ileus, or other postoperative complications between the 2 groups. CONCLUSION: Early postoperative dietary advancement after major abdominal gynecologic surgery results in a decreased length of hospital stay and appears to be safe, with no increased adverse effects.  相似文献   

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