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子宫肌瘤全子宫切除术中西医结合临床路径的构建和评价性研究

The Construction and Evaluation of Optimized Management of Integrated Chinese and Western Medicine for Patients with Panhysterectomy

【作者】 宋燕

【导师】 黄健玲;

【作者基本信息】 广州中医药大学 , 中医妇科学, 2011, 博士

【摘要】 背景如何使病人用低廉的费用享受到优质的医疗护理服务,满足以“病人为中心”的要求和高质量有效率的医疗服务,已成为卫生行业的重大课题。医护管理者必须思考如何在医疗服务过程中,让病人最大限度地合理使用“医疗费用”。针对某一病种和手术采取临床路径是一种行之有效的途径,可以达到改善病人服务和有效利用卫生资源的目的。临床路径(Clinical Pathways, CP)是一种诊疗标准化方法,以缩短平均住院日、合理支付医疗费用为特征,按病种设计最佳的医疗和护理方案,根据病情合理安排住院时间和费用。业已证实临床路径不仅能有效降低住院时间和住院费用,同时也能显著提高医疗服务质量,受到各国医学界的重视,成为21世纪以来的一种崭新的医疗模式。子宫肌瘤全子宫切除病人因住院天数长、住院费用高,给社会和家庭带来了沉重的医疗费用负担。如何规范住院管理流程,在保证医疗质量的前提下,缩短住院天数,降低住院费用,已成为当务之急。本课题通过构建子宫肌瘤全子宫切除术中西医结合临床路径,探讨中医院构建临床路径的方法,对于提高其中西医结合治疗水平和卫生管理方法,不断提高医疗服务质量和水平,构建和谐医患关系具有重要意义。目的(一)根据临床路径构建的科学性原则,对子宫肌瘤全子宫切除术具有中西医结合特色的诊疗方案进行优化,初步形成证据充分、共识度高、推广性强的诊疗方案,为临床路径的构建提供核心内容。(二)对子宫肌瘤全宫切除术临床路径进行临床观察,通过与回顾性病案分析结果的比较,客观评价子宫肌瘤全子宫切除术中西医结合临床路径的临床效益,为子宫肌瘤全子宫切除术中西医结合临床路径的推广提供科学依据。内容与方法本研究为两部分,第一部分研究重点在于运用专家咨询方法对子宫肌瘤全子宫切除术诊疗方案进行优化,为临床路径的构建提供核心内容。第二部分研究是采用非同期非随机研究方法对构建的子宫肌瘤全子宫切除术中西医结合临床路径进行了临床观察,与回顾性病案统计结果进行对照研究,对该路径治疗方案有效性进行评估。(一)子宫肌瘤全子宫切除术中西医结合临床路径构建的优化研究1专家咨询研究针对共识度较低、尚无充分文献证据支持的诊疗措施进行专家咨询。制定专家咨询问卷,选择国内中医或中西医结合专家以书面的形式进行咨询。通过两轮咨询后,征求专家的认可意见,形成诊疗方案。2在优化的诊疗方案的基础上构建临床路径结合我院回顾性研究结果,确定临床路径的管理时限和时间点,制定路径纳入标准、排除标准。设计路径实施流程图。根据2009年卫生部下发的临床路径实施方案,制定子宫肌瘤全子宫切除术临床路径表单。(二)子宫肌瘤全子宫切除术中西医结合临床路径的临床观察研究收集2009年1月至2010年10月6家医院纳入临床路径的子宫肌瘤患者,共450例作为路径组,其中行腹式全宫病人376例,阴式全宫27例,腹腔镜手术42例,退出5蒯。同时纳入该6家医院的2007年1月至2008年12月符合回顾性纳入标准的连续性病例544例为回顾组,其中行腹式全宫病人487例,阴式全宫9例,腹腔镜手术48例。运用临床流行病学/DME方法,进行回顾性和路径性对照研究,对子宫肌瘤全宫切除术中西医结合优化治疗方案的有效性进行评估。结果(一)专家咨询研究通过两轮专家咨询,两次咨询表回收率均为100%,根据两轮专家咨询意见,对1个二级指标、15个条目进行了修改,初步形成了3个一级指标,8个二级指标共28个条目。(二)子宫肌瘤全宫切除术临床路径评价研究1临床路径对各术式平均住院天数影响比较1.1腹式全宫回顾组平均住院天数11.77±3.79天,路径组平均住院天数10.57±2.05天,两组平均住院天数比较,差异有统计学差异(P<0.05)。1.2阴式全宫回顾组平均平均住院天数9.5±3.89天,路径组平均住院天数8.81±2.06天,两组平均住院天数比较,差异有统计学差异(P<0.05)。1.3腹腔镜全宫回顾组平均住院天数10.77±2.31天,路径组平均住院天数9.33±1.97天,两组平均住院天数比较,差异有统计学差异(P<0.05)。各术式临床路径组平均住院时间与回顾组相比较,差异有统计学意义(P<0.05),说明临床路径能更有效的降低住院时间。2临床路径对各术式住院费用影响比较2.1腹式全宫平均住院总费用:回顾组为9385.50±2047.67元,路径组为9024.41±2902.47元,两组住院费用比较,差异有统计学意义(P<0.05);西药费:回顾组为1225.17±837.47元,路径组为1310.46±674.98元,两组西药费用比较,差异有统计学意义(P<0.05);检查费:回顾组为413.70±358.09元,路径组为316.04±235.47元,两组检查费用比较,差异有统计学意义(P<0.05);治疗费:回顾组为1735.28±920.34元,路径组为1221.48±606.62元,两组治疗费用比较,差异有统计学意义(P<0.05)。2.2阴式全宫平均住院总费用:回顾组为7728.16±1934.25元,路径组为9111.9674±2533.95元,两组住院费用比较,差异无统计学意义(P>0.05);西药费:回顾组为1254.81±306.73元,路径组为1172.50±375.25元,两组西药费用比较,差异有统计学意义(P<0.05);检查费:回顾组为359.06±299.18元,路径组为315.11±303.82元,两组检查费用比较,差异有统计学意义(P<0.05);治疗费:回顾组为1214.06±769.44元,路径组为1002.59±593.47元,两组治疗费用比较,差异有统计学意义(P<0.05)。2.3腹腔镜全宫平均住院总费用:回顾组为9154.05±1749.86元,路径组为12497.68±3238.05元,两组住院费用比较无统计学意义(P>0.05);西药费:回顾组为1049.86±604.27元,路径组为1703.48±670.85元,两组西药费用比较,差异无统计学意义(P>0.05);检查费:回顾组为403.43±304.89元,路径组为358.23±189.83元,两组检查费用比较,差异有统计学意义(P<0.05);治疗费:回顾组为1548.89±595.58元,路径组为1807.49±1280.92元,两组治疗费用比较无统计学意义(P>0.05)。3临床路径对各术式术后恢复指标比较3.1腹式全宫首次下床活动时间:回顾组为46.21±11.35小时,路径组为33.56±9.58小时,两组在首次下床活动时间比较,差异有统计学意义(P<0.05);排气时间:回顾组为51.62±12.33小时,路径组为43.71±13.58小时,两组在排气时间比较,差异有统计学意义(P<0.05);排便时间:回顾组为90.70±22.89小时,路径组为77.25±24.02小时,两组在排便时间比较,差异有统计学意义(P<0.05)。3.2阴式全宫首次下床活动时间:回顾组为31.29±7.53小时,路径组为26.53±7.14小时,两组在首次下床活动时间比较,差异有统计学意义(P<0.05);排气时间:回顾组为42.58±11.93小时,路径组为35.37±12.31小时,两组在排气时间比较,差异有统计学意义(P<0.05);排便时间:回顾组为88.26±25.76小时,路径组为74.59±19.79小时,两组在排便时间比较,差异有统计学意义(P<0.05)。3.3腹腔镜全宫首次下床活动时间:回顾组为32.14±9.56小时,路径组为28.45±8.43小时,两组在首次下床活动时间比较,差异有统计学意义(P<0.05);排气时间:回顾组为49.41±12.78小时,路径组为36.42±13.71小时,两组在排气时间比较,差异有统计学意义(P<0.05);排便时间:回顾组为84.91±18.31小时,路径组为69.38±24.13小时,两组在排便时间比较,差异有统计学意义(P<0.05)。3.4临床路径对各术式术后并发症的影响各术式路径组病人在术后并发症发生率上明显低于回顾组,差异有统计学意义(P<0.05)。3.5临床路径对路径组满意度调查的影响病人对医疗过程、等候时间、服务态度及整体满意度均较高,各项满意度均达到95%以上,总体满意度为97.55%。3.6路径组变异调查450例子宫肌瘤全子宫切除病例中,通过对变异来源的统计分析,得出目前变异种类按发生率由高到低的排序为:医务人员39.3%(177/450)>医院系统22.2%(100/450)>病人需求20%(90/450)>疾病转归10.2%(46/450)>退出1%(5/450)。按照对变异的管理难易分类,可控变异的发生率较高,为61.6%(277/450)。结论(一)子宫肌瘤全子宫切除术中西医结合临床路径的核心是具有中西医特色的诊疗方案。本研究在既往文献研究及科室经验基础上通过专家咨询研究,初步确定了子宫肌瘤全子宫切除中西医诊疗方案。该方案主要包括路径执行、疗效评价、效率评价、围手术期中医药治疗部分。对子宫肌瘤全子宫切除术式选择标准、抗生素应用时间、术后中医治疗、路径疗效及效率评价等指标进行了确定。(二)在优化方案的基础上,结合我院回顾性研究及国家卫生部发布的路径表单格式,制定路径目标人群及退出路径标准,路径总时限,路径实施流程。完成路径表单。(三)实施临床路径,规范了我们的住院管理流程,减少住院费用(主要是腹式)、缩短住院天数,同时病人术后胃肠功能恢复状态改善明显,减少术后并发症,提高病人满意度。

【Abstract】 Object ivesHow to make the patient enjoys the superior quality of the medical treatment nursing service by the cheap expenses, satisfy "take patient as the center" of request and high quantity serve efficiently, have become an important topic of the health profession.The governor must consider how to let the patient reasonable to use "the medical treatment expenses" with maximum limit throught the medical treatment service process. Aim at the some disease grows to adopt with surgical operation, the clinical pathway is a valid path to get the purposes of improving the serve for patient and making use of the health resources effectively. Clinical pathways(CP) is a standardization method of diagnose and treat, and its main charceteristics is to shorten average hospitalization days and pay medical cost reasonably, to design the most reasonale medical and nurse scheme by entity, to arrange the hospitalization days and medical cost reasonably and to improve medical service quality. Every country has pay attention to the use of CP, and CP has become a new medical mode in new century.The patients of the panhysterectomy, with long and complex course, often has longer inpatient days, higher hospital expense. Shaping the clinical pathway, to standard hospital management process, short inpatient days, reduce hospitalization fees, has become a top priority.It has a great significance to educe dominance of western medicine and Chinese medicine by constructing panhysterectomy clinical pathways of integrated traditional Chinese and western medicine, to explore the construction method of panhysterectomy inhospital of traditional Chinese medicine, to improve the therapy level of integrated traditional Chinese and western medicine, methods of health supervision, quality and level of medical service.Research purposes1. According to the scientific principle of clinical pathway consruction, we optimized the TCM diagnosis scheme of panhysterectomy, and initially formed a TCM therapy with high degree of consensus, sufficient evidence, and powerful generalization, for providing the core content of clinical pathway.2. With preliminary clinical observation of panhysterectomy pathway, we preliminary discuss clinical effect of panhysterectomy clinical pathway of nondialytic period, Which provide a basis for the form to the A panhysterectomy clinical pathway with integrated Chinese and Western Medicine.Research contentThis research is divided into two parts. The first part of the research focuses optimization of panhysterectomy nondialytic treatment scheme of TCM. The second part of the research is to carry on the preliminary clinical observation of panhysterectomy combine traditional Chinese and western medicine clinical pathway.1. Constructing optinal research of clinical pathwayWith regard to the retrospective study results, we determine the management time of clinical pathway, and formulate inclusion and exclusion criteria, and then design implamentation flow path. According to the clinical pathway issued by health ministry 2009, we formulate clinical pathway of panhysterectomy of nondialytic period.2. Clinical observation research of clinical pathwayWe collect six hospitals about 450 patients with panhysterectomy of clinical pathway from December of 2009 to October in 2010, which content 376 cases of TAH、27 cases of TVA、42 cases of LH, withdrow 5cases. Also we included 544 cases records with path into standard from the serial of January 2007 to December 2008 in the hospitals, which content 487 cases of TAH、9 cases of TVA and 48 cases of LH. and analysis the record number, hospitalization costand improved hospital lab index before hospitalization and after. Through the comparison, we discussed the clinical benefits of clinical pathway.The efficacy of the optimized management of Integrated Chinese and Western Medicine for patients with panhysterectomy was evaluated by retrospective and prospective controllled study according to clinical epidemiology or DME approach.Research results1.The research of expert consultationThe results showed that the respond rates of the two expert consul tation was both 100%. After the two-round meetings, one second-class indicators was modified and 15 items were revised. At last, the 28-items were developed which covers 3-first-class indicators and 8-second-class indicators.2. Assessment on Clinical Pathway of the panhysterectomy2.1 The effect of CP on length of stay in different surgery type:(1) TAHThere was statistically significant difference between retrospective group and CP group in the average hospitals day(11.77±3.79days vs.10.57±2.05days,P<0.05).(2) TVAThe comparison between retrospective group and CP group in the average hospitals day showed statistically significant difference (9.5±3.89days vs.8.81±2.06days, P<0.05).(3) LHThe comparison between retrospective group and CP group in the average hospitals day showed statistically significant difference (10.77±2.31days vs.9.33±1.97days, P<0.05). there was statistical difference in total length of stay between CP group and retrospective group (P<0.05) in the different suegical type. It mean that CP could reduce length of day.2.2 The effect of CP on hospitalization expenses(1) TAHThe average total expenses:The comparison between retrospective group and CP group in average total expenses showed statistically significant difference(9385.50±2047.67Yuan vs.9024.41±2902.47 Yuan, P<0.05); medicine expenses:There was statistically significant difference between two groups (1225.17±837.47Yuan vs.1310.46±674.98 Yuan, P<0.05);check fee:The comparison between retrospective group and CP group in check fee showed statistically significant difference(413.70±358.09Yuan vs.316.04±235.47 Yuan, P<0.05);cure expenses:There was statistically significant difference between two groups in cure expenses (1735.28±920.34Yuan vs.1221.48±606.62 Yuan, P<0.05).(2) TVAThe average total expenses:The comparison between retrospective group and CP group in average total expenses showed statistically significant difference(7728.16±1934.25Yuan vs.9111.9674±2533.95 Yuan, P<0.05); medicine expenses:There was statistically significant difference between two groups (1254.81±306.73Yuan vs.1172.50±375.25Yuan(P<0.05);check fee:The comparison between retrospective group and CP group in check fee showed statistically significant difference (359.06±299.18Yuan vs.315.11±303.82Yuan, P<0.05); cure expenses:There was statistically significant difference between two groups in cure expenses (1214.06±769.44Yuan vs.1002.59±593.47Yuan, P<0.05).(3-) LHThe average total expenses:The comparison between retrospective group and CP group in average total expenses showed statistically significant difference (9154.05±1749.86Yuan vs.12497.68±3238.05 Yuan, P<0.05); medicine expenses:There was no statistically significant difference between two groups (1049.86±604.27Yuan vs.1703.48±670.85 Yuan, P>0.05);check fee:The comparison between retrospective group and CP group in check fee showed statistically significant difference(403.43±304.89Yuan vs.358.23±189.83Yuan, P<0.05); cure expenses:There was no statistically significant difference between two groups in cure expenses (1548.89±595.58Yuan vs.1807.49±1280.92Yuan, P>0.05)2.3 The effect of CP on recovery of gastrointestinal function:(1) TAHFirst bad time:The comparison between retrospective group and CP group in First bad time showed statistically significant difference(46.21±11.35hour vs.33.56±9.58 hour, P<0.05); first exhaust time: There was statistically significant difference between two groups in first exhaust time (51.62±12.33hour vs.43.71±13.58hour, P<0.05); first defecate time:There was statistically significant difference between two groups in first defecate time (90.70±22.89hour vs.77.25±24.02hour, P<0.05).(2) TVAFirst bad time:The comparison between retrospective group and CP group in First bad time showed statistically significant difference (31.29±7.53hour vs.26.53±7.14hour, P<0.05); first exhaust time:There was statistically significant difference between two groups in first exhaust time (42.58±11.93hour vs.35.37±12.31hour, P<0.05); first defecate time:There was statistically significant difference between two groups in first defecate time (88.26±25.76hour vs.74.59±19.79hour, P<0.05).(3) LHFirst bad time:The comparison between retrospective group and CP group in First bad time showed statistically significant difference (32.14±9.56hour vs.28.45±8.43hour, P<0.05); first exhaust time:There was statistically significant difference between two groups in first exhaust time (49.41±12.78hour vs.36.42±13.71hour, P<0.05); first defecate time:There was statistically significant difference between two groups in first defecate time (84.91±18.31hour vs.69.38±24.13hour, P<0.05).2.4 The effect of CP on postoperative complications:There was statistieal difference between two groups in complitions (P<0.05)2.5 the result of satisfaction survey:The patients are satisfy at every item, the total satisfaction reach to 97.55%.2.6 The result of CP on variance:In 450 cases, Through the statistical analysis of the variances, it was found that the incidence of variance categories in present research which ranged from high to low practitioners 27.1%(122/450)>hospital system22.2%(100/450)>patients’ requirements20%(90/450)>disease progress 10.2%(46/450)>and withd rawcases1%(5/450). The incidence of the controllable variances were higher incidence of the controllable variances were higher (25.50%(38/149)) than the uneontrollable, according to the manage ability of variance62.01%(142/229).Conclusion1. The core of the clinical pathway is the treatment scheme which has the characteristics of intergrated Chinese and Western Medicine.The research through expert consultation which based on literature research and clinical experience of department preliminary made of therapy, which include implement of CP、the evalution of effection、the evalution of efficiency and the part of perioperative medical treatment. We preliminary determine the surgical selection criteria、the time of using antibiatics、Chinese medicine treatment after surgery、efficacy and efficiency evaluation.2. With regard to the retrospective study, we determine target population and the exit criteria of path, total path time limit, implement processes of path on the basis of optimized seheme. Also we form path form, according to pathform format issued by the state ministry.3. The clinical pathway regulates the management of our hospital process, reduces hospital expenses (main reduce the expenses of TAH);shortens hospitalization days, improves patient clinical symptoms; ensure the quality of medical treatment. Explanation of clinical pathway standardized management and strengthen the characteristies of the application.

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