桥梁治疗在妇科手术围手术期的临床应用研究
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摘要
背景
     随着医学科学技术的进步,传统医学上的许多禁区已经开放,术前的常规抗凝治疗不再是妇科手术的禁区,妇科手术也面临越来越多的术前口服抗凝剂治疗的患者。有文献表明,应用抗凝剂之前月经正常的妇女,其经期与经血量大都不受服用抗凝剂的干扰。在原有妇科疾病情况下,服用抗凝剂可使经期延长及经期血量增多,流血不止,最终导致贫血、血液凝血功能变化。由于妇科特殊疾病及特殊手术方式影响,口服抗凝剂的患者如进行妇科手术,医生既要考虑手术前后可能出现的出血情况,又要避免因暂时停用抗凝药物而发生血栓栓塞,还要考虑患者自身疾病及手术方式的影响,因此,此类患者手术成功的关键是抗凝剂的使用情况及手术时间的选择。目前国内外的研究发现,服用抗凝剂再次接受手术的患者的围手术期管理可采用桥梁治疗方案,即在围手术期临时替代性的使用低分子量肝素或普通肝素进行抗凝治疗,而且,低分子肝素作为围手术期抗凝治疗的桥梁已被大多数学者所接受。但关于妇科此类患者的围手术期管理仍缺乏相关报道。因此,妇科手术患者的术前评估,术中、术后管理具有重要的临床意义。
     目的
     本研究通过对口服抗凝剂的患者再次进行妇科手术围手术期凝血系统指标的检测,观察此类患者围手术期机体凝血系统功能发生的变化,探讨口服抗凝剂的妇科手术患者围手术期管理方法,评估低分子肝素作为桥梁的桥梁疗法在此类患者围手术期的安全性及有效性。
     方法
     对照组选择来自郑州大学第一附属医院妇产科的手术患者50例,均为体检正常的女性;研究组选择2009年9月至2010年10月因需接受妇科手术而暂停口服抗凝剂的患者51例,分非恶性肿瘤组及恶性肿瘤组,其中非恶性肿瘤组39例,恶性肿瘤组12例。本组患者华法林用量2.5~5.0mg或氯吡格雷用量50~100mg,服用抗凝剂后临床上无血栓栓塞形成的迹象和无出血倾向,为药物剂量使用合适者。正常对照组术前、术后24小时、3天、5天、7天分别采血检测凝血酶原时间(PT)、凝血酶原国际标准化比值(INR)。研究组入院时、术前、术后24小时、3天、5天、7天分别采血检测PT、INR。服用抗凝剂的择期手术患者入院后即停止服用抗凝药物,给予低分子肝素5000iu,每12小时1次,皮下注射,连续5-7天,术前12小时停止低分子肝素应用,检测PT、INR正常后手术。急诊手术于术前2~4h肌注维生素K120mg,术前复查PT、INR正常后手术。术后第1天(术后24小时后),皮下注射低分子肝素5000iU,口服抗凝剂开始使用。术后第2天,低分子肝素开始全剂量使用。术后5天,当INR为2.5时,低分子肝素应用停止。统计方法:数据以均数加减标准差(x±SD)表示,应用SPSS17.0软件进行统计分析。组内比较采用自身配对资料t检验,组间比较采用LSD-t检验(最小有意义差异t检验)。
     结果
     (1)、组内比较:PT、INR值在对照组术后24小时升高,与术前比较差异有统计学意义(P<0.05),但术后3天下降至正常值范围。PT、INR值在非恶性肿瘤组术后24小时升高,与术前比较差异有统计学意义(P<0.05),术后5天升高至入院时水平,与入院时比较差异无统计学意义。PT、INR值在恶性肿瘤组术后24小时及术后3天轻微降低,与术前相比差异无统计学意义(P>0.05),之后进行性升高,于术后7天升高至入院时水平,与入院时比较差异无统计学意义。组间比较:在术后24小时及术后3天,除对照组与非恶性肿瘤组外,其他各比较组之间在围手术期PT、INR水平的差异有统计学意义。余各时间点三比较组之间差异无统计学意义。
     (2)、研究者患者5例出现术中出血量多,术中、术后输血后达到止血目的。2例患者出现下肢静脉血栓,予以溶栓、抗凝治疗后治愈。术后均未发生消化道出血、腹腔内出血、阴道出血及伤口渗血等并发症。伤口全部甲级愈合。术后随诊3月,体格检查及超声扫描检查均未发现血栓形成。
     结论
     (1)、口服抗凝剂的妇科患者围手术期加强实验室凝血系统指标的监测是非常必要的。
     (2)、恶性肿瘤患者应采用桥梁治疗方案,其他如无血栓形成高危因素者,可能可采用暂停抗凝方案。
     (3)、低分子肝素作为抗凝治疗的桥梁,在服用抗凝剂患者再次行妇科手术的围手术期应用是安全的。
Background
     Traditional medicine has been opened on many areas along with the progress of modern science and technology, which had been forbidden to use before. Conventional anticoagulant therapy before gynecologic surgery is no longer restricted, Gynecological surgeon also face a growing number of patients treated with oral anticoagulants. The literature shows that the application of normal menstruation women before anticoagulants, the menstrual period and menstrual volume does not changed by taking anticoagulant interference. But with the influence of gynecological diseases, the use of anticoagulation can cause classics blood overmuch, menses is lengthened, and finally it leads to Anemia, blood coagulation function changes. Because of the specific disease and the surgical methods of gynecological, if oral anticoagulants in patients need a gynecological surgery, doctors not only have to balance individual risk for thromboembolism and bleeding, but also consider the gynecological disease and the way of surgery. Therefore, how to use anticoagulation and to select proper timing is the key to successful. The current study found that Low-molecular-weight heparin (LMWH) as the bridge of anticoagulant therapy in perioperation has been accepted by most of scholars, and the periprocedural bridging therapy can be used in patients receiving chronic oral anticoagulation therapy. However, the perioperative management of gynecological patients is still lack of relevant reports. Therefore, it is an important and clinical significance in preoperative evaluation and perioperative management in gynecological surgery.
     Objective
     In this study, we will detect the patient's perioperative indicators of coagulation and fibrinolysis, who is taking oral anticoagulants having a gynecological surgery soon, observe the perioperative blood coagulation and fibrinolysis changes of patients, explore perioperative management in gynecological surgery, assess safety and efficacy of bridging therapy, that Low- molecular- weight heparin (LMWH) as the bridge of anticoagulant therapy in perioperation.
     Methods
     We select 50 patients with gynecological surgery as the control group, which come from the first affiliated hospital of Zhengzhou university and are all normal female. We select 51 patients from September 2009 to October 2010 as the study group, which will be done a gynecological surgery and need to suspend the oral anticoagulants. We group them of non- malignant and malignant tumor groups, the non- malignant tumor group has 39 patients, while the other one has 12 patients. The patient have 2.5~5.0 mg pre day or clopidogrel 50~100mg per day without thromboembolism formation signs and no bleeding tendency. They are the right one to use the suitable doses. We respectively collect the control group patient blood in preoperative and postoperative 24 hours, three days, five days,7 days to detect prothrombin time (PT) and international normalized ratio (INR). And we respectively collect the study group patients blood in admission and preoperative postoperative 24 hours, three days, five days,7 days to detect prothrombin time (PT) and international normalized ratio (INR). The elective surgery patients who is taking anticoagulants stop their drugs after admission, giving 5000iu Low- molecular-weight heparin (LMWH) by subcutaneous every 12 hours once, which continuous 5-7 days when PT, INR are normal,then stop Low- molecular- weight heparin (LMWH) in preoperative 12 hours. The Emergency surgery use vitamin K120 mg in preoperative 2~4 h, and take the operation after PT、INR normal. We can use 5000iu Low- molecular- weight heparin (LMWH) at Post-operative day 1 (post-operative after 24 hours),and begin to use oral anticoagulants. At Post-operative day 2, Low-molecular- weight heparin (LMWH) can be use in full dose. At Postoperative day 5, Low- molecular- weight heparin (LMWH) can be stop when INR is 2.5. Statistical methods:All of the analyses was completed by statistical software package type SPSS 17.0, and data were expressed as the mean value±SD. In the group, the data compared use self matching material t-test, and comparison between groups use the LSD- t-test (the smallest meaningful difference t test).
     Result
     (1).Intraclass comparison:In the control group, PT、INR increased postoperative 24 hours, which have statistically significant comparative differences (P< 0.05), but after 3 days it fell to normal range. In the non-malignant tumor group, PT、INR increased postoperative 24 hours, which have statistically significant comparative differences (P< 0.05), but it rise to admission level at postoperative day 5, which compared with admission difference was not statistically significant. In the malignant tumor group, PT、INR increased postoperative 24 hours and 3 days, which have no statistically significant comparative differences (P<0.05), but it rise to admission level at postoperative day 7 progressively, which compared with admission difference was not statistically significant. Comparison between groups:At postoperative 25 hours and 3 days, in addition to the control group and the non-malignant tumor group, the other groups have statistically significant comparative differences (P<0.05). In other time points, three comparison groups have no statistically significant comparative differences (P<0.05);
     (2).5 researchers patients appear peri-operative bleeding, who have hemostatic by blood transfusion at intra-operation or postoperation. Two patients appear lower limb vein thrombus, who cured by thrombolysis and anticoagulants. All patients did not happen complications, such as gastrointestinal bleeding, abdominal bleeding, vaginal bleeding complications and wound bleeding. All wound has a good heal. We give all patients Physical examination and ultrasound scan, and all did not discover thrombosis after post- operation 3 month.
     Conclusion
     (1). It is very necessary for gynecological patients who are taking oral anticoagulants to monitor the laboratory clotting system index in perioperation.
     (2).Treatment of patients with malignant tumors should be a bridge program.If there is no other high risk factors of thrombosis,it may be possible to have a suspension of anticoagulation.
     (3). Low-molecular-weight heparin (LMWH) as the bridge of anticoagulant therapy play an important role in perioperative for gynecological patients who are taking oral anticoagulants.It is safely for gynecological surgery who are taking oral anticoagulants.
引文
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