循证医学方法在股骨粗隆间骨折外科治疗决策中的初步应用
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摘要
目的:初步探讨循证医学原理和方法在股骨粗隆间骨折治疗决策中的应用和意义。
方法:按实践循证医学的方法和步骤提出临床需要解决的问题:1、手术治疗与保守治疗的选择;2、手术内固定方法的评价;3、术前牵引的必要性;4、预防下肢血栓的药物和方法;5、术后预防感染的意义;6、维生素D及钙剂预防和治疗髋部骨折的作用;在Cochrane系统评价和New Zealand Guidelines Group (NZGG)制作的髋部骨折循证指南中查询最佳证据,依据循证医学三结合原则(最佳的研究证据、医师的临床专业知识和病人的意愿相结合),实际应用证据,指导临床治疗决策。股骨粗隆间骨折患者35例,骨折按Jensen-Michaelsen改良的Evans分型,ⅠA型2例,ⅠB型4例,ⅡA型8,ⅡB型12,Ⅲ9例。其中骨质疏松15例。全部病例依据循证医学原理,进行有针对性治疗治疗,治疗后随访,采用Kuderna改良Merli D'Aubigne标准进行髋关节功能评分,并观察采用不同治疗方法后各组的髋关节功能,住院时间,经济学指标及患者满意率等指标。并对其进行比较。
循证结果:1.与髋部滑动螺钉相比,外固定架和髁-头型尤其Ender钉已不再适用粗隆间骨折。2.头-髁型髓内钉,Gamma钉与DHS相比,DHS在粗隆间骨折中显示出明显优势。3.不能证明人工关节置换和内固定何者占优。但有限的证据表明,人工关节置换适合不稳定关节囊外髋部骨折。半髋和全髋何者占优尚无定论。4.术前使用下肢牵引没有必要。5.肝素、低分子量肝素可以预防下肢深静脉血栓形成。6.术后应当应用抗生素,一代头孢菌素具有最佳成本-效益比。7.维生素D及钙剂可以降低高危人群髋部骨折风险,应每天服用。
临床结果:依循证医学证据为指导,采用DHS(包括解剖钣)治疗24例,无内固定物断裂、骨不愈合及延迟愈合的情况发生。无死亡病例。肺部感染2例,心梗1例,滑动螺钉自颈部切出1例。平均住院时间:22天。髋内翻发生率4.1%。平均手术花费:1.7万元,患者满意率98%。髋关节疗效优良率91.6%。采用人工关节置换5例,术后无卧床相关并发症发生。无髋关节后脱位、假体松动、假体周围骨折等情况发生。平均住院时间:14天。无髋内翻发生。平均手术花费:3.5万元,患者满意率100%。髋关节疗效优良率100%。骨牵引等保守治疗6例。1例肾衰透析病人死于晚期并发症,1例不同意手术病人,于骨折后2个月死于家中。平均住院时间:82天。髋内翻发生率50%。平均手术花费:2.3万元,患者满意率98%。髋关节疗效优良率33.3%。
结论:应用循证医学原理和方法对股骨粗隆间骨折做出外科决策,不仅可以避免传统医学模式中以临床经验指导临床决策,忽视患者的人文心理因素的趋势。而且可以针对不同患者实施个体化治疗,实现患者利益最大化。在避免医疗资源浪费的同时,减轻患者及家属经济负担,有利于改善医患关系。
Objective To preliminary disscus the application and the significance of evidence-based medicine(EBM) principle and methods in the treatment
Method According to the methods and steps of practizing EBM, the problems which need to be solved in clinic were put forward as follow : 1. operative treatment or conservative treatment; 2. evaluation of internal fixation methods; 3. the necessity of pre-operative traction; 4. medicines and methods of preventing deep vein thrombosis; 5. The significance of preventing infection after operations; 6. Functions of vitamin D and Calcium in preventing and curing hip fractures. Then, the best evidence is inquired in Cochrane review and the best evidence-based guideline made by New Zealand guidelines Group (NZGG). Finally, according to the three associated principles of evidence-based medicine (the best evidence, individual clinical expertise, patients’predicaments), the evidence is used to direct treatment decision-making.
There were 35 patients with intertrochanteric femoral fractures. Their Evans types improved by Jensen-Michaelsen: Type IA 2, Type IB 4, Type IIA 8, Type IIB 12, Type III 9. 15 patients out of them with osteoporosis. All the cases were treated individually according to the EBM principle and were followed up after treatment. The patients’hip founction was evaluated with Merli D’Aubigne criterion improved by Kuderna. At the same time, the hip joint founction, the time of hospitalization, economy and the patients’satisfaction rates were observed and compared.
Evidence-based results 1. Compared with sliding hip screws, external fixators and condylocephalic nails, especially Ender nails, were not appropriate for intertrochanteric femoral fractures any longer. 2. Compared with cephalocondylic nails, especially Gamma nails, DHS is obviously advanced in intertrochanteric femoral fractures. 3. There was insufficient evidence that could prove which was more suitable between replacement arthroplasty and internal fixation. But the limited evidence showed that replacement arthroplasty appropriated for unstable fractures. It could not be seen which was better between hemiarthroplasty and total hip replacement. 4. It was not necessary to use pre-operative traction. 5. Heparin and low molecular weight heparin could be used to prevent deep vein thrombosis following surgery for hip fractures. 6. Prophylaxis with ceftriaxone is a cost-effective intervention. 7. Vitamin D and calcium can marginally reduce the risk of hip fractures and they should be taken every day.
Clinical Results Directed by EBM, the 35 cases received different treatments on the basis of their individual disease in three groups. In the DHS group, among 24 cases, there were no cases of broken internal fixators and fracture nonunion; no cases of death; lung infection in two cases; heart disease in one case; worn-off femoral neck by screw in one case. The average time of hospitalization was 22 days. During this period, the rate of coxa vara was 4.1%; the average cost was RMB 17,000; the rate of the patients’satisfaction was 98%; The excellent and good rate was 91.6%. Arthroplasty in five cases; no complications caused by staying in bed; no dislocation of hip, no prosthesis loosing,no peri-prosthesis fracture;the average time of hospitalization was 14 days. During this period, no case of coxa vara; the average cost was RMB 35,000; the rate of the patients’satisfaction was 100%; The excellent and good rate was 100%. Six cases in traction group,; one case dead of kidney failure; disagreement with operation in one case, which died after two months; the average time of hospitalization was 82 days. During this period, the rate of coxa vara was 50%; the average cost was RMB 23,000; the patients’satisfaction rate was 98%; The excellent and good rate was 33.3%.
Conclusion Appling the EBM principle and method to make the surgical decision of intertrochanteric femoral fractures can not only avoid the current trend of making clinical decision by clinical experience , ignoring patients’humanity psychology in traditional medical model, but also can perform individuation treatment for different patients to realize their most benefit. In addition, waste of medical resources can be avoided; economic load of patients and their relatives can be lightened; all this can do benefit to improving doctor-patient relationships.
方法:按实践循证医学的方法和步骤提出临床需要解决的问题:1、手术治疗与保守治疗的选择;2、手术内固定方法的评价;3、术前牵引的必要性;4、预防下肢血栓的药物和方法;5、术后预防感染的意义;6、维生素D及钙剂预防和治疗髋部骨折的作用;在Cochrane系统评价和New Zealand Guidelines Group (NZGG)制作的髋部骨折循证指南中查询最佳证据,依据循证医学三结合原则(最佳的研究证据、医师的临床专业知识和病人的意愿相结合),实际应用证据,指导临床治疗决策。股骨粗隆间骨折患者35例,骨折按Jensen-Michaelsen改良的Evans分型,ⅠA型2例,ⅠB型4例,ⅡA型8,ⅡB型12,Ⅲ9例。其中骨质疏松15例。全部病例依据循证医学原理,进行有针对性治疗治疗,治疗后随访,采用Kuderna改良Merli D'Aubigne标准进行髋关节功能评分,并观察采用不同治疗方法后各组的髋关节功能,住院时间,经济学指标及患者满意率等指标。并对其进行比较。
循证结果:1.与髋部滑动螺钉相比,外固定架和髁-头型尤其Ender钉已不再适用粗隆间骨折。2.头-髁型髓内钉,Gamma钉与DHS相比,DHS在粗隆间骨折中显示出明显优势。3.不能证明人工关节置换和内固定何者占优。但有限的证据表明,人工关节置换适合不稳定关节囊外髋部骨折。半髋和全髋何者占优尚无定论。4.术前使用下肢牵引没有必要。5.肝素、低分子量肝素可以预防下肢深静脉血栓形成。6.术后应当应用抗生素,一代头孢菌素具有最佳成本-效益比。7.维生素D及钙剂可以降低高危人群髋部骨折风险,应每天服用。
临床结果:依循证医学证据为指导,采用DHS(包括解剖钣)治疗24例,无内固定物断裂、骨不愈合及延迟愈合的情况发生。无死亡病例。肺部感染2例,心梗1例,滑动螺钉自颈部切出1例。平均住院时间:22天。髋内翻发生率4.1%。平均手术花费:1.7万元,患者满意率98%。髋关节疗效优良率91.6%。采用人工关节置换5例,术后无卧床相关并发症发生。无髋关节后脱位、假体松动、假体周围骨折等情况发生。平均住院时间:14天。无髋内翻发生。平均手术花费:3.5万元,患者满意率100%。髋关节疗效优良率100%。骨牵引等保守治疗6例。1例肾衰透析病人死于晚期并发症,1例不同意手术病人,于骨折后2个月死于家中。平均住院时间:82天。髋内翻发生率50%。平均手术花费:2.3万元,患者满意率98%。髋关节疗效优良率33.3%。
结论:应用循证医学原理和方法对股骨粗隆间骨折做出外科决策,不仅可以避免传统医学模式中以临床经验指导临床决策,忽视患者的人文心理因素的趋势。而且可以针对不同患者实施个体化治疗,实现患者利益最大化。在避免医疗资源浪费的同时,减轻患者及家属经济负担,有利于改善医患关系。
Objective To preliminary disscus the application and the significance of evidence-based medicine(EBM) principle and methods in the treatment
Method According to the methods and steps of practizing EBM, the problems which need to be solved in clinic were put forward as follow : 1. operative treatment or conservative treatment; 2. evaluation of internal fixation methods; 3. the necessity of pre-operative traction; 4. medicines and methods of preventing deep vein thrombosis; 5. The significance of preventing infection after operations; 6. Functions of vitamin D and Calcium in preventing and curing hip fractures. Then, the best evidence is inquired in Cochrane review and the best evidence-based guideline made by New Zealand guidelines Group (NZGG). Finally, according to the three associated principles of evidence-based medicine (the best evidence, individual clinical expertise, patients’predicaments), the evidence is used to direct treatment decision-making.
There were 35 patients with intertrochanteric femoral fractures. Their Evans types improved by Jensen-Michaelsen: Type IA 2, Type IB 4, Type IIA 8, Type IIB 12, Type III 9. 15 patients out of them with osteoporosis. All the cases were treated individually according to the EBM principle and were followed up after treatment. The patients’hip founction was evaluated with Merli D’Aubigne criterion improved by Kuderna. At the same time, the hip joint founction, the time of hospitalization, economy and the patients’satisfaction rates were observed and compared.
Evidence-based results 1. Compared with sliding hip screws, external fixators and condylocephalic nails, especially Ender nails, were not appropriate for intertrochanteric femoral fractures any longer. 2. Compared with cephalocondylic nails, especially Gamma nails, DHS is obviously advanced in intertrochanteric femoral fractures. 3. There was insufficient evidence that could prove which was more suitable between replacement arthroplasty and internal fixation. But the limited evidence showed that replacement arthroplasty appropriated for unstable fractures. It could not be seen which was better between hemiarthroplasty and total hip replacement. 4. It was not necessary to use pre-operative traction. 5. Heparin and low molecular weight heparin could be used to prevent deep vein thrombosis following surgery for hip fractures. 6. Prophylaxis with ceftriaxone is a cost-effective intervention. 7. Vitamin D and calcium can marginally reduce the risk of hip fractures and they should be taken every day.
Clinical Results Directed by EBM, the 35 cases received different treatments on the basis of their individual disease in three groups. In the DHS group, among 24 cases, there were no cases of broken internal fixators and fracture nonunion; no cases of death; lung infection in two cases; heart disease in one case; worn-off femoral neck by screw in one case. The average time of hospitalization was 22 days. During this period, the rate of coxa vara was 4.1%; the average cost was RMB 17,000; the rate of the patients’satisfaction was 98%; The excellent and good rate was 91.6%. Arthroplasty in five cases; no complications caused by staying in bed; no dislocation of hip, no prosthesis loosing,no peri-prosthesis fracture;the average time of hospitalization was 14 days. During this period, no case of coxa vara; the average cost was RMB 35,000; the rate of the patients’satisfaction was 100%; The excellent and good rate was 100%. Six cases in traction group,; one case dead of kidney failure; disagreement with operation in one case, which died after two months; the average time of hospitalization was 82 days. During this period, the rate of coxa vara was 50%; the average cost was RMB 23,000; the patients’satisfaction rate was 98%; The excellent and good rate was 33.3%.
Conclusion Appling the EBM principle and method to make the surgical decision of intertrochanteric femoral fractures can not only avoid the current trend of making clinical decision by clinical experience , ignoring patients’humanity psychology in traditional medical model, but also can perform individuation treatment for different patients to realize their most benefit. In addition, waste of medical resources can be avoided; economic load of patients and their relatives can be lightened; all this can do benefit to improving doctor-patient relationships.
引文
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50.魏强李幼平第五讲循证医学在外科领域中的应用中国医院2002年10月第6卷第10期61-63
51.胡建昆陈心足李幼平王莉。第三讲:循证外科的实践与探索。医学与哲学(临床决策论坛版)2006年8月第27卷第8期总第315期。79-81。
52.谢求恩何爱咏循证医学思维方法在骨科中的应用医学与哲学(临床决策论坛版)2007年7月第28卷第7期总第337期54-55
53.刘振东马梦然张志诚从骨折愈合论理论医学的萌芽中华创伤骨科杂志2004年12月第6卷第12期1393-1395
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47.刘鸣应正确评价和使用循证医学证据.中国循证医学杂志2006年第6卷第2期77-79
48. Gordon Guyat循证医学:过去、现在和未来(二)。中国循证医学杂志。2004年第4卷第1期。7-9
49.王家良主编.循证医学.北京:人民卫生出版社,2005.8.5-6
50.魏强李幼平第五讲循证医学在外科领域中的应用中国医院2002年10月第6卷第10期61-63
51.胡建昆陈心足李幼平王莉。第三讲:循证外科的实践与探索。医学与哲学(临床决策论坛版)2006年8月第27卷第8期总第315期。79-81。
52.谢求恩何爱咏循证医学思维方法在骨科中的应用医学与哲学(临床决策论坛版)2007年7月第28卷第7期总第337期54-55
53.刘振东马梦然张志诚从骨折愈合论理论医学的萌芽中华创伤骨科杂志2004年12月第6卷第12期1393-1395
1. Cochrane AL. Effectiveness and efficiency :random reflections on health services. London :Nuffield Provincial Hospitals Trust , 1972.
2.王吉耀循证医学与临床实践.北京:科学出版社,2002.1
3. Sackett DL Evidence-Based Medicine Working Group. Evidence-based medicine: A new approach to teaching the practice of medicine. JAMA 1992; 268:2420-5
4. Sackett DL Evidence based medicine: what it is and what it isn't: It's about integrating individual clinical expertise and the best external evidence。BMJ 1996;312(7023):71-72.
5. Sackett DL, et al . Evidence-based Medicine :how to practice and teach evidence-based medicine.(2nd edition) [M] .London :Churchill Livingstone , 2000.1-2
6. Sackett DL, Richardson WS, Rosenberg W, et al. Evidence-based medicine. How to practice and teach EBM[M]. Edinburgh: Chrurchill Livingston, 1997: 1-60.
7.高慧萍网络环境下的循证医学与医院图书馆,图书情报,第15卷,第7期,2002年7月,P. 447-44
8.毛宗福丁元林临床诊断试验论著质量分析,中华医院管理杂志,第14卷,第2期,1998年,P. 105-10
9. Melander H, Ahlqvist-Rastad J, Meijier G, et al. Evidence based medicine- selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications.BMJ, 2003, 326: 1171-1175.
10.张鸣明李幼平等。循证医学与外科临床。中华外科杂志.2001年2月第39卷第2期166-168
11.杨克虎主编循证医学北京:人民卫生出版社2007.9 192-202
12.严小蓉蒋凌云贾卫国运用循证医学构建和谐医患关系中国循证医学杂志2007年第7卷第3期233-236
13. Gordon Guyat循证医学:过去、现在和未来(二)。中国循证医学杂志。2004年第4卷第1期。7-9
14.杨岫岩在临床流行病学的基础上谈循证医学中国实用内科杂志2007年5月第27卷第10期806-808
15.杨岫岩.循证医学与临床文献的评阅[J].中华风湿病学杂志,2000, 4(5): 264-265.
16.吴泰相刘关键关于循证医学的问题与思考中国循证医学杂志2005年第5卷第8期636-640
17.刘鸣应正确评价和使用循证医学证据.中国循证医学杂志2006年第6卷第2期77-79
18.张鸣明,等编译:循证医学的概念和起源.华西医学1998;13(3):265
19. Guyatt G, et al. Grading strength of recommendations and quality of evidence in clinical guidelines: report from an american college of chest physicians task force. Chest, 2006, 129( I):174-181
20. Schunemann HJ, et al. An official ATS statement; grading the quality of evidence and strength of recommendations in ATS guidelines and recommendations. Am J Respir Crit Care Med,2006,174( 5 ): 605-614.
21. Gordon Guyatt MSc, M D. An EmergingConsensus on Grading Recommendations? Chin J Evid-based Med, 2007, 7(I): I-8.
22. GordonGuyatt et al循证医学进展下一个十年将同样精彩。中国循证医学杂志2005年第5卷第8期583-584
23.王家良主编.循证医学.北京:人民卫生出版社,2005.8.49-59
24. Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.0 [updated February 2008]
25.张鸣明等:Cochrane系统评价精萃:循证医学实践高质量的实时证据.中国循证医学2002,2(1):63-64
26. Review Manager(RevMan).http://www.cochrane.org/cochrane/Revman.htm
27.何俐.Coehrane系统评价软件RevMan简介.中国循证医学2001,1(3):168-169
28.李静等:系统评价的基本方法.中国循证医学2001,1(1):34-38
29. CochraneLibrary.http://www.cochranelirary.com
30.王家良主编.循证医学.北京:人民卫生出版社,2005.8.20-24
31. Guyatt G,Rennie D.editors.Users’guides to the medical literature:a manual for evidencebased clinical practice[M].Evidence-Based Medicine Working Group. Chicago:American Medical Association Press,2002,27-38
32.卫茂玲Cochrane系统评价在中国的现状与问题.中国循证医学杂志.2006年第6卷第2期150-151
33. Gordon Guyat循证医学的五个发展方向.中国循证医学杂志2006年第6卷第3期。159-161
34.唐金陵循证医学:医学实践的新模式.中华医学杂志.2005年1月26日第85卷第4期.276-278
35. Sackett DL, Richardson WS, Rosenberg W, et al. Evidence-based medicine. How to practice and teach EBM[M]. Edinburgh: Chrurchill Livingston, 1997: 91-96.
36.谢求恩何爱咏循证医学思维方法在骨科中的应用.医学与哲学(临床决策论坛版)2007年7月第28卷第7期总第337期.54-55.
37.王家良主编.循证医学.北京:人民卫生出版社,2005.8.5-6
38. Cordon Guyatt MSc, M.D.循证决策就是个体化的临床决策。中国循证医学杂志。2007年第7卷第2期.93-98。
39. Urschel J D,et al. Evidence-Based Surgery Working Group. Users’guide to evidence-based surgery:how to use an article evaluating surgical interventions [J].Can J Surg,2001,44:95-100
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