近年来,随着医疗环境的改变及公民法律意识的提高,医疗纠纷不时发生。本研究旨在通过探讨医疗纠纷死亡病例的特点,尤其是尸检量、在各级医院和不同科室中的分布、患者年龄和死亡原因,以及医疗过失等方面的特点,为制定政策法规与完善诊疗规范提供依据,为改进医疗纠纷尸检工作提供经验。同时,本研究还希望通过探讨致死性肺栓塞病例的临床与病理特点,尤其是获得性与遗传性高危因素方面的特点,为临床预防及治疗肺栓塞提供帮助。为此,本研究对北京大学病理学系自2002年1月1日至2008年9月30日所承担的医疗纠纷尸体解剖病例进行回顾性总结分析,并针对医疗纠纷尸检工作应该着重注意的关键问题进行探讨;用限制性长度多态性(RFLP)的方法对致死性肺栓塞病例及随机对照成人病例进行FV Leiden突变和FⅡ G20210A突变检测。本研究主要结果如下: 1.2002年1月1日至2008年9月30日共完成了 275例医疗纠纷尸体解剖,病例量逐年增加;二、三级医院的外科、妇产科及一级医院的门、急诊为死亡纠纷好发科室;围生期胎儿及1岁以内幼童死亡病例比其他年龄组死亡病例更易导致纠纷;国际疾病分类表(ICD-10)中心血管系统疾病、围生期疾患、外伤或医疗过程附加因素三个大类在纠纷病例死亡原因中多于其他大类;手术相关死亡病例的医疗纠纷占非围生期死亡纠纷的37.6% (79/210),常规手术及择期手术比复杂手术与急诊手术更易导致纠纷,接近3/4的病例死亡发生在术中或术后7天以内,44.3%(35/79)的手术病例的死亡与外伤或医疗过程附加因素有关,多数手术相关病例死亡原因为各种术后并发症;91.6% (252/275)的死亡病例通过尸体解剖可以明确死亡原因,绝大多数死亡是疾病自然转归的结果,医疗过失行为与患者死亡存在密切关系的病例只占13.5% (37/275),这些医疗过失行为主要表现为手术方式与手术操作失误(48.6%,18/37)、误诊和漏诊(32.4%,12/37)。 2.在同期275例医疗纠纷尸检中,有21例为致死性肺动脉血栓栓塞病例,占同期尸检总病例的7.64% (21/275),占同期成人尸检病例的12.96% (21/162)。每例均至少存在1项已知的高危因素,多数病例存在2项以上的高危因素。主要的获得性高危因素包括:手术、创伤骨折、恶性肿瘤、妊娠及产褥期、老年人、高血压、糖尿病、感染等。以同期成人病例为总样本(n=162)的多因素分析结果表明创伤骨折、手术、妊娠分娩、恶性肿瘤及老年人(≥60岁)是相对危险度较高的致死性肺栓塞的危险因素,其比数比(OR值)及95%置信区间分别为7.87 (2.22~27.93), 25.69 (6.88~95.90)、1.64 (0.43~6.32), 1.40 (0.37~5.321.22 (0.41~3.65)。而性别与肥胖并不是本组病例的危险因素。21例致死性肺栓塞病例及6例对照病例均未检测出FV Leiden突变与FⅡ G20210A突变。21例患者中生前只有6例进行了 D-二聚体检查,6例均明显升高。21例患者只有1例患者使用药物进行预防性抗凝。 本研究做为国内首个针对医疗纠纷尸检为研究对象的博士课题,首次采用了国际疾病分类(ICD-10)系统对纠纷死亡病例的死亡原因进行分类分析。结果表明,医疗纠纷尸检可以明确死因,保留证据,对解决纠纷至关重要;大多数病患死亡是疾病自然转归的结果,患者死亡突然和医患之间缺乏信任是导致纠纷的重要原因,只有少数病例存在明确的医疗过失。因此,加强沟通理解、强化责任意识、提高诊疗水平可以有效减少医疗过失、避免医疗纠纷的发生。详细采集临床信息,有针对性的尸检,科学规范的诊断、严谨审慎的死因分析是做好医疗纠纷尸检工作的关键。致死性肺动脉血栓栓塞是临床科室尤其是手术科室引起纠纷的重要原因。中国人发生致死性肺栓塞主要与创伤骨折、手术等获得性因素有关,遗传性因素FV Leiden突变和FⅡ G20210A突变不是中国人发生致死性肺栓塞的主要原因。对存在肺栓塞高危因素(尤其是创伤骨折及手术)的患者,合理评估患者的危险因素,做好预防性措施,并尽可能的早期诊断与处理或可减少因致死性肺栓塞引发的医疗纠纷。 关键词:尸体解剖、肺栓塞、医疗纠纷、医疗过失
In recent years, with the changes of the medical environment and enhancement of the legal awareness among citizens, medical disputes occur from time to time. This study was designed to investigate the characteristics of the death cases with medical disputes, in particular the characteristics of distribution of autopsy cases according to years, hospitals and clinical units involved, ages of patients, causes of death and medical malpractice, to provide a basis for development of policies and regulations and improvement of medical performance, and also provide experiences of further improvement of medical disputes autopsy work. At the same time, this study was to explore the clinical and pathological characteristics of the cases of fatal pulmonary embolism, especially the contribution of acquired and genetic risk factors to fatal pulmonary embolism, in order to provide some useful information for clinical prevention and treatment of pulmonary embolism. Therefore, the medical disputes autopsy cases performed at the Department of Pathology, School of Basic Medical Sciences, Peking University from January 1, 2002 to September 30, 2008 were retrospectively analyzed. The aspects of medical dispute autopsy which must be paid more attention to were especially focused on. FV ( factor Ⅴ ) Leiden mutation and FⅡ ( factor Ⅱ ) G20210A mutation were detected by using methods of PCR and restriction fragment length polymorphism (RFLP) in fatal pulmonary embolism cases, as well as random selected control cases of adult autopsy. The main results of this study are as follows: 1.275 cases of medical disputes autopsy were performed from January 1, 2002 to September 30, 2008. The autopsy cases associated with medical dispute increased year by year. Among 275 medical dispute autopsy cases, more cases were treated in departments of surgery, gynecology and obstetrics in the hospital of grade 2 or grade 3, and emergency room in the hospital of grade 1. Death of perinatal fetus and children with age less than 1 year more frequently caused medical dispute than any other age group. According to the international classification of diseases (ICD-10), diseases of the circulatory system, certain conditions occuring in the perinatal period and external causes of morbidity and mortality were the three major categories of death causes in autopsy cases of medical disputes. Surgery-related cases accounted for 37.6% (79/210) of non-perinatal deaths. Conventional surgery and the selective surgery more easily leaded to medical disputes than complex surgery and emergency surgery. Nearly 3/4 patients died during the process of operation or within seven days after operation. 44.3%(35/79) causes of death of surgical cases belonged to external causes of morbidity and mortality. The majority of causes of death of surgery-related cases were some kinds of post-operative complications. In 91.6% (252/275) cases, the causes of death were clear by autopsy. The vast majority of deaths were the results of natural disease. Medical malpractice had a close relationship with death only in 13.5% (37/275) cases. The medical-malpractice mainly presented as the error of operation mode or operative procedure (48.6%, 18/37), misdiagnosis or missed diagnosis (32.4%, 12/37). 2.The causes of death of 21 cases were fatal pulmonary thromboembolism, accounting for 7.64% (21/275) of total cases and 12.96% (21/162) of adult cases. In these cases, there were at least one of the known risk factors in each case and more than two risk factors could be found in most cases. The acquired risk factors such as surgery, trauma and fractures, cancer, pregnancy and puerperium, the elderly, hypertension, diabetes, infections could be found in these patients. Of all adult autopsy cases (n=162) performed at the same period of time, the multi-factor analysis of risk factors were performed. The results showed that patients with trauma and fracture, surgery, pregnancy and puerperium, malignancy and the elderly (≥ 60 years) had a higher risk of suffering from fatal pulmonary embolism than other patients without them, and the odds ratios (95% confidence interval) were 7.87 (2.22~27.93), 25.69 (6.88~95.90), 1.64 (0.43~6.32), 1.40 (0.37~5.32), 1.22 (0.41~3.65 ), respectively. Gender and obesity were not risk factors in this group. FV Leiden mutation and FⅡ G20210A mutation were not detected in any of 21 cases of fatal pulmonary embolism cases and six control cases. Of all 21 cases, Quantitative D-dimer measurement was performed only in six patients and D-dime level of all these six samples was significantly increased. According to the records, there was only 1 patient was treated by preventive anticoagulants in 21 patients. This study was the first research project which focused on autopsy cases of medical dispute in domestic autopsy research, and, for the first time, classified the causes of death of medical dispute cases according to the International Classification of Diseases (ICD-10) system .Our results showed that autopsy could clear the cause of death and retained the evidence of medical malpractice, which were essential to resolve the medical dispute. The majority of patients were died of natural diseases and the death was too sudden and unexpected to be accepted by relatives. At the same time the relative lack of trust between doctors and patients was one of the important reasons for medical dispute. Only a small number of cases were concluded as medical malpractice. Fatal pulmonary thromboembolism was an important reason for medical dispute. Fractures and trauma, surgery and other acquired factors were the main reasons of fatal pulmonary embolism in Chinese. Genetic factors FV Leiden mutation and FⅡ G20210A mutations was not the reason in Chinese suffering from fatal pulmonary embolism. Assessment of risk factors (especially traumatic fractures and surgical intervention) of pulmonary embolism may play an important role in taking appropriate preventive procedure, early diagnosis and reasonable treatment and reduce the rate of medical dispute caused by fatal pulmonary embolism. Keywords: autopsy, pulmonary embolism, medical dispute, medical malpractice