成人心脏病患者外科手术后生活质量影响因素的前瞻性研究
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摘要
【目的】
1、本课题通过对成人心脏病患者生活质量的研究，探讨中文版SF-36量在成人心脏病患者的应用价值；2、应用中文版SF-36量表对单纯成人心脏瓣膜病患者外科术后3个月、6个月、12个月生活质量进行随访，探索成人心脏瓣膜病术后生活质量的危险因素；3、应用中文版SF-36量表对单纯冠状动脉旁路移植术（CABG）患者术后3个月、6个月、12个月生活质量进行随访，探索CAD患者CABG术后生活质量的危险因素。
【方法】
（一）中文版SF-36量表应用于成人心脏病患者生活质量研究的价值评定：
1、以2010年1月1日至2010年12月31日间入长海医院胸心外科拟行手术治疗的成人心脏病患者为研究对象，连续性入选400例患者进行SF-36量表生活质量测评。
2、评价SF-36量表应用于成人心脏病患者的信度、效度和反应性，为进一步研究成人心脏病患者术后生活质量的影响因素奠定基础。
（二）成人心脏瓣膜病患者术后生活质量的影响因素：
1、以我科的心脏瓣膜病登记系统为基础，通过科室内部讨论会及专家咨询会方式，制定成人心脏瓣膜病术后生活质量影响因素的前瞻性登记表格，确定入选和排除标准，其中确定要收集的临床指标、定义各指标的收集标准以及明确各指标的收集方式，随访时间和随访方式。
2、以2010年1月1日至2010年12月31日间入长海医院胸心外科拟行手术治疗的成人心脏瓣膜病患者为研究对象，按照入选和排除标准进行术前生活质量的测评、临床指标的收集。
3、对入选的患者进行随访，随访术后3个月、6个月、12个月生活质量，随访术后6个月、12个月心脏功能指标。
4、对数据进行分析，通过重复测量的方差分析对比术后术前生活质量、心功能变化情况，评价手术疗效；对可能影响患者术后生活质量的因素进行单因素分析，P<0.1有显著性统计学差异；以逐步引入—剔除法（引入和剔除的标准分别是0.05和0.10）对进入多元线性逐步回归的影响因素进行多元回归分析，确定各时间点，生活质量各维度的危险因素。
（三）冠心病患者CABG术后生活质量的影响因素：
1、以我科的心脏瓣膜病登记系统为基础，参考参考美国STS NCD数据库及阜外医院的中国冠状动脉旁路移植术登记协作组等国内外大型数据库设计，通过科室内部讨论会及专家咨询会方式，制定冠心病患者CABG术后生活质量影响因素的前瞻性登记表格，确定入选和排除标准，其中确定要收集的临床指标、定义各指标的收集标准以及明确各指标的收集方式，随访时间和随访方式。
2、以2010年1月1日至2010年12月31日间入长海医院胸心外科拟行手术治疗的冠心病患者为研究对象，按照入选和排除标准进行术前生活质量的测评、临床指标收集。
3、对入选的患者进行随访，随访术后3个月、6个月、12个月生活质量，随访术后6个月、12个月心脏功能指标。
4、对数据进行分析，通过重复测量的方差分析对比术后术前生活质量、心功能变化情况，评价手术疗效；对可能影响患者术后生活质量的因素进行单因素分析，P<0.1为有显著性统计学差异；以逐步引入—剔除法（引入和剔除的标准分别是0.05和0.10）对进入多元线性逐步回归的影响因素进行多元回归分析，确定各时间点，生活质量各维度的危险因素。
【结果】
（一）中文版SF-36量表应用于成人心脏病患者生活质量研究的价值评定：
1、信度：半分信度（split–half reliability）：本量表采用奇、偶半分法，分半信度系数Spearman–Brown系数为0.733。内部一致性信度（Internal consistencyreliability）：4个维度（PF、RP、BP、GH）Cronbach’s α系数大于0.8；3个维度（VT、RE、MH）在0.7-0.8之间，接近0.8，仅SF一个维度Cronbach’s α系数小于0.7，为0.648。各维度内部有良好的正相关性。维度之间的相关系数均低于每个维度内部一致性系数。
2、结构效度（construct validity）：中文版SF-36量表8个维度得分经Bartlett检验表明，Bartlett值为χ2=1276.063，P<0.0001，可以进行因子分析。KMO（Kaiser-Meyer-Olkin measure）=0.838，接近于1，表明该因子分析结果较好。使用主成分分析法，经方差最大正交旋转后，产生2个公因子，即生理因子和心理因子，解释了62.96%的方差，与理论假设一致，但各维度在公因子的强度与理论假设有一定差异。
（二）成人心脏瓣膜病患者术后生活质量的影响因素：
1、前瞻性研究平台的建立：2010年1月1日—2010年12月31日间，共395例患者入选，术后12个月随访327例，随访率82.8%。
2、手术对患者术后生活质量变化及心功能的影响：生活质量各维度评分生理功能（PF）、生理职能（RP）、身体疼痛（BP）、总体健康（GH）、活力（VT）、社会功能（SF）、情感职能（RE）、精神健康（MH）、健康变化（HT）、生理健康（PCS）、心理健康（MCS）、生活质量总分（QOL）重复测量方差分析Greenhouse-geisser P值均<0.001，术后生活质量改善明显。BP维度项在术后3个月较术前有所减低。LVEF改善情况采用重复测量方差分析，Greenhouse-geisser P值均<0.001，有显著统计学差异。NYHA心功能(I-II级)患者比列卡方检验，Perarsonχ2=500.661，P<0.001，有显著统计学意义。术后患者生活质量、心功能明显改善。
3、单因素方差分析术后生活质量的影响因素：影响PCS-3的因素为：女性、糖尿病、NYHA心功能分级III-IV级、既往心脏瓣膜手术史、ICU时间延长；影响PCS-6的因素为：女性、糖尿病、既往心脏瓣膜手术史、术后6个月LVEDD≥55mm；影响PCS-12的因素为：女性、糖尿病、术后6个月LVEDD直径≥55mm；影响MCS-3的因素为女性、糖尿病、既往心脏瓣膜手术史；影响MCS-6的因素为：女性、糖尿病、术前LVEF<50%、术前LVEDD≥55mm、术后6个月LVEDD直径≥55mm；影响MCS-12的因素为：女性、糖尿病、心衰史、术前LVEF<50%、术前LVEDD直径≥55mm、术后6个月LVEDD≥55mm；影响QOL-3的因素为：性别、糖尿病、既往心脏瓣膜手术史、ICU时间延长；影响QOL-6的因素为：性别、糖尿病、术后6个月LVEDD直径≥55mm，影响QOL-12的因素为：女性、糖尿病、术前LVEF<50%、术前LVEDD直径≥55mm、术后6个月LVEDD直径≥55mm。
4、多元线性回归分析：YPCS-3=71.268+4.153X男性—9.290X糖尿病，F=3.987，P=0.002<0.05；YPCS-6=83.491+4.556X男性—8.873X糖尿病—7.997X术后6个月LVEDD≥55mm，F=5.391，P=0.001<0.05；方程YPCS-12=87.177+3.582X男性—9.326X糖尿病—6.304X术后6个月LVEDD≥55mm，F=4.875，P=0.000<0.05；方程YMCS-3=67.227+6.185X男性—10.345X糖尿病，F=7.936，P=0.000<0.05；方程YMCS-6=80.289+5.344X男性—10.852X糖尿病， F=5.658，P=0.000<0.05；方程YMCS-12=82.920+4.038X男性—7.665X糖尿病—3.499X术后6个月LVEDD≥55mm， F=4.228，P=0.000<0.05；方程YQOL-3=68.995+5.262X男性—9.938X糖尿病， F=5.78，P=0.000<0.05；方程YQOL-6=84.041+4.323X男性—9.534X糖尿病—6.655X术后6个月LVEDD≥55mm， F=7.537，P=0.000<0.05；方程YQOL-12=85.529+4.368X男性—8.766X糖尿病， F=4.895，P=0.000<0.05。
（三）冠心病患者CABG术后生活质量的影响因素：
1、2010年1月1日—2010年12月31日间，共174例患者入选，术后12个月实际进行统计分析144例，有效随访率82.8%。
2、手术对患者术后生活质量变化及心功能的影响：术后3个月、6个月、12个月随访生活质量，生活质量各维度评分生理功能（PF）、生理职能（RP）、身体疼痛（BP）、总体健康（GH）、活力（VT）、社会功能（SF）、情感职能（RE）、精神健康（MH）、健康变化（HT）、生理类（PCS）评价、心理类（MCS）评价、生活质量总评分（QOL）重复测量方差分析，Greenhouse-geisser P值均<0.001，术后生活质量改善明显。LVEF改善情况采用重复测量方差分析，Greenhouse-geisser P值均<0.001，有显著统计学差异。NYHA心功能(I-II级)患者比列卡方检验，Perarson χ2=500.661，P<0.001，有显著统计学意义。术后患者生活质量、心功能明显改善。BP项在术后3个月较术前有所减低，术后6个月明显改善。
3、单因素方差分析术后生活质量的影响因素：除性别对MCS-3无显著影响外，性别（女性）、吸烟、家族史、糖尿病、心肌梗死病史、桥血管数量对术后PCS-3、PCS-6、PCS-12、MCS-3、MCS-6、MCS-12、QOL-3、QOL-6、QOL-12均有显著性影响，高脂血症对术后PCS-6、PCS-12有显著性影响。
4、多元线性回归分析：YPCS-3=71.918+6.076X男性—8.166X家族史—8.567X糖尿病，F=8.200，P<0.001；YPCS-6=83.234+6.330X男性—5.267X家族史—10.714X糖尿病—1.996X桥血管数， F=12.437，P<0.001；YPCS-12=86.068+6.050X男性—4.847X家族史—10.369X糖尿病—5.591X心梗史， F=11.695，P<0.001；YMCS-3=82.552—5.698X男性—4.847X吸烟—8.161X家族史—9.637X糖尿病， F=11.602，P<0.001；YMCS-6=87.297—4.593X吸烟—6.290X家族史—11.997X糖尿病—5.419X心梗史，F=11.602，P<0.001；YMCS-12=90.734—3.801X吸烟—4.013X家族史—11.307X糖尿病—7.826X心梗史， F=17.313，P<0.001；YQOL-3=76.110+4.856X男性—5.512X吸烟—8.189X家族史—8.819X糖尿病， F=10.225，P<0.001；YQOL-6=85.612+5.015X男性—3.943X吸烟—5.583X家族史—11.611X糖尿病—5.331X心梗史， F=16.640，P<0.001；YQOL-12=88.654+4.635X男性—3.541X吸烟—4.287X家族史—11.024X糖尿病—6.751X心梗史，F=17.256，P<0.001。
【结论】
1.中文版SF-36量表应用于成人心脏病患者具有良好的信度、效度和反应度，可以比较准确全面的反应成人心脏病患者的生活质量。但结构效度不太理想，可进一步修订，在目前国内QOL研究尚处于初级阶段的前提下，可在成人心脏病领域推广应用。
2.成人心脏病患者术后3个月-12个月间，心功能逐渐改善，生活质量逐渐提高，手术治疗效果满意，有指征患者应积极行手术治疗。术后3个月内应注意患者的躯体疼痛治疗。
3.影响成人心脏瓣膜患者术后3个月生活质量生理健康（PCS）、心理健康（MCS）、生活质量总评分（QOL）的影响因素均为：女性、糖尿病。冠心病CABG患者术后3个月生活质量生理健康（PCS）、心理健康（MCS）、生活质量总评分（QOL）的共同影响因素均为：糖尿病、冠心病家族史；另外女性是PCS及QOL总评分的危险因素，吸烟史MCS及QOL的危险因素。
4.成人心脏瓣膜病患者术后6个月生活质量生理健康（PCS）、生活质量总评分（QOL）的影响因素均为：女性、糖尿病、术后6个月LVEDD≥55mm；心理健康（MCS）影响因素为：女性、糖尿病。冠心病CABG术后6个月生活质量生理健康（PCS）为：女性、冠心病家族史、糖尿病、桥血管数目；心理健康（MCS）影响因素为：吸烟、糖尿病、冠心病家族史、心梗史；生活质量总评分（QOL）的影响因素均为：女性、吸烟、糖尿病、冠心病家族史、心梗史。
5.成人心脏瓣膜病患者术后12个月生活质量生理健康（PCS）、生活质量总评分（QOL）的影响因素均为：女性、糖尿病；心理健康（MCS）影响因素为：女性、糖尿病、术后6个月LVEDD≥55mm。冠心病CABG术后12个月生活质量生理健康（PCS）、心理健康（MCS）、生活质量总评分（QOL）的共同影响因素为：糖尿病、冠心病家族史、心梗史；另外女性是PCS-12及QOL-12总评分的危险因素，吸烟史MCS-12及QOL-12的危险因素。
【Objective】
1.In this study, we determine to evaluate the feasibility of Chinese version of MOS36-item short form health survey (SF-36) in the assessment of quality of life in patientswith adult cardiac disease.2. To evaluate the quality of life and explore its proposalinfluence factors in patients with adult cardiac valve disease at three month、six monthand twelve month respectively after surgical treatment.3. To evaluate the quality of lifeand explore its proposal influence factors in patients with coronary artery disease at threemonth、six month and twelve month respectively after coronary artery bypass graft.
【Methods】
1. The assessment of Chinese version of SF-36in patients with adult cardiac disease：
(1) A total of400hundred consecutive patients who received surgical treatment withadult cardiac disease were recruited from1stJan2010to31stDec2010in Department ofCardiothoracic Surgery, Changhai hospital. The Chinese version of SF-36was applied toevaluate the quality of life before surgery..
(2) To evaluate the internal consistent reliability, construct validity, responsibility, andacceptability of Chinese version of SF-36when applied to patients with adult cardiacdisease.
2. The quality of life and its proposal influence factors in patients with adult heart valvedisease after surgical treatment:
(1) On the basis of preexisting data registry system for heart valve disease, aprospective set of data registry table for the clinical data and follow-up information inpatients undergoing heart valve surgery was set up by division discussion and expertcounseling, including definitions of candidate predictor variables, and to determineinclusion and exclusion criteria.
(2) A consecutive series of eligible patients meet the inclusion and exclusion criteriawas recruited from1stJan2010to31stDec2010in Department of Cardiothoracic Surgery,Changhai hospital. To collect their clinical data and finish the assessment of quality of lifewith Chinese version of SF-36preoperatively.
(3) To assess the quality of life and heart function at3month’,6month’, and12month’follow-up respectively.
(4) To assess the effect of surgical treatment by apply repeated measurement tocompare the change of quality of life and heart function preoperative and postoperative.The analysis of proposal influence factors of quality of life using One-way ANOVA andmultiple linear regression analysis..
3. The quality of life and its proposal influence factors in patients with coronary arterydisease after CABG：
(1) On the basis of preexisting data registry system for heart valve disease，and theSTS NCD database of United States, together with CABG database of Fuwai hospital, aprospective set of data registry table for the clinical data and follow-up information inpatients with CAD undergoing CABG was set up by division discussion and expertcounseling, including definitions of candidate predictor variables, and to determineinclusion and exclusion criteria
(2) A consecutive series of eligible patients meet the inclusion and exclusion criteriawas recruited from1stJan2010to31stDec2010in Department of Cardiothoracic Surgery,Changhai hospital. To collect their clinical data and finish the assessment of quality of lifewith Chinese version of SF-36preoperatively.
(3) To assess the quality of life and heart function at3month’,6month’, and12month’follow-up respectively.
(4) To assess the effect of CABG by apply repeated measurement to compare thechange of quality of life and heart function preoperative and postoperative. The analysis ofproposal influence factors of quality of life using One-way ANOVA and multiple linearregression analysis.
【Results】
1. The assessment of Chinese version of SF-36in patients with adult cardiac disease：
(1) Reliability：the Spearman-Brown coefficient of split-half reliability is0.733. theInternal consistency reliability: the Cronbach’s α coefficient of four dimension(PF、RP、BP、GH) are bigger than0.8, and three dimension(VT、RE、MH) are between0.7and0.8,only one dimension(SF) is less than0.7, which is0.648. Each dimension has a goodpositive correlation. The correlation coefficient between the dimensions were all lowerthan the internal consistency efficient of each dimension.
(2) Construct validity：the Bartlett test, χ2=1276.063，P<0.0001, the sample can beanalyzed with factor analysis. KMO（Kaiser-Meyer-Olkin measure）=0.838,2common factor were extracted by factor analysis, a “physical” factor and a “mental” factor, whichcould be used to explain62.96%of the total variance. But these2common factor not inaccordance with their theoretical structure perfectly.
2. the quality of life and its proposal influence factors in patients with adult heart valvedisease after surgical treatment:
(1) A total of395consecutive patients were recruited in this prospective study with327of them finished follow-up at12month after surgery, and the follow-up rate was82.8%.
(2) The influence of surgery on the quality of life and heart function: all of thedimensions, including PF、RP、BP、GH、VT、SF、RE、MH、HT、PCS、MCS and totQOL were increased significantly with repeated measurement Greenhouse-geisser P<0.001except BP dimension which decreased at3month’follow-up and then recovery at month’follow-up. The proportion of patients with NYHA I-II heart function wassignificantly increased with Pearsonχ2=500.661，P<0.001.
(3) One way ANOVA of proposal influence factors: a total of30factors wereanalyzed. The risk factors of PCS-3were: female, DM, NYHA heart function class III-IV,
a history of heart valve surgery，prolonged ICU stay；for PCS-6: female, DM, a history heart valve surgery, LVEDD≥55mm after6month of surgery; for PCS-12: female, DM,LVEDD≥55mm after6month of surgery; for MCS-3: female, DM, a history of heartvalve surgery; for MCS-6: female, DM, preoperative LVEF<50%, preoperative LVEDD55mm, LVEDD≥55mm after6month of surgery; for MCS-12: female, DM, a history ofheart failure, preoperative LVEF<50%, preoperative LVEDD≥55mm; for QOL-3: femalDM, a history of heart valve surgery, prolonged ICU stay; for QOL-6: female, DM,LVEDD≥55mm after6month of surgery; for QOL-12: female, DM, preoperativeLVEF<50%, preoperative LVEDD≥55mm, LVEDD≥55mm after6month of surgery.
(4) The multiple linear regression analysis: YPCS-3=71.268+4.153Xmale—9.290XDM，F=3.987，P=0.002<0.05; YPCS-6=83.491+4.556Xmale—8.873XDM—7.997XLVEDD-6≥55mm，F=5.391，P=0.001<0.05；YPCS-12=87.177+3.582Xmale—9.326XDM—6.304XLVEDD-6≥55mm，F=4.875，P=0.000<0.05; YMCS-3=67.227+6.185Xmale—10.345XDM，F=7.936，P=0.000<0.05YMCS-6=80.289+5.344Xmale—10.852XDM，F=5.658，P=0.000<0.05；YMCS-12=82.920+4.038Xmale—7.665XDM—3.499XLVEDD-6≥55mm，F=4.228，P=0.000<0.05；YQOL-3=68.995+5.262Xmale—9.938XDM，F=5.78，P=0.000<0.05；YQOL-6=84.041+4.323Xmale—9.534XDM—6.655XLVEDD-6≥55mm，F=7.537，P=0.000<0.05； YQOL-12=85.529+4.368Xmale—8.766XDM，F=4.895，P=0.000<0.05.
3. the quality of life and its proposal influence factors in patients with coronary arterydisease after CABG：
(1) A total of174consecutive patients were recruited in this prospective study with144of them finished follow-up at12month after surgery, and the follow-up rate was82.8%.
(2) The influence of CABG on the quality of life and heart function: all of thedimensions, including PF、RP、BP、GH、VT、SF、RE、MH、HT、PCS、MCS and totalQOL were increased significantly with repeated measurement Greenhouse-geisser P<0.001except BP dimension which decreased at3month’follow-up and then recovery at6month’follow-up. The proportion of patients with NYHA I-II heart function wassignificantly increased with Pearsonχ2=500.661，P<0.001.
(3) One way ANOVA of proposal influence factors: a total of10factors were analyzed.Except female have no significant influence on MCS-3, female, DM, smoking，familyhistory of CAD, history of myocardial infraction, number of bypass graft were all have asignificant effect on PCS-3、PCS-6、PCS-12、MCS-3、MCS-6、MCS-12、QOL-3、QOL-6、QOL-12, besides, hyperlipidemia had a significant effect on PCS-6and PCS-12.
(4) The multiple linear regression analysis: YPCS-3=71.918+6.076Xmale—8.166Xfamilyhistory of CAD—8.567XDM，F=8.200，P<0.001；YPCS-6=83.234+6.330Xmale—5.267Xfamilyhistory of CAD—10.714XDM—1.996X桥血管数，F=12.437，P<0.001；YPCS-12=86.068+6.050Xmale—4.847Xfamily history of CAD—10.369XDM—5.591XMI，F=11.695，P<0.001；YMCS-3=82.552—5.698Xmale—4.847Xsmoking—8.161Xfamily history of CAD—9.637XDM，F=11.602，P<0.001；YMCS-6=87.297—4.593Xsmoking—6.290Xfamily history of CAD—11.997XDM—5.419XMI，F=11.602，P<0.001；YMCS-12=90.734—3.801Xsmoking—4.013Xfamily history of CAD—11.307XDM—7.826XMI, F=17.313，P<0.001；YQOL-3=76.110+4.856Xmale—5.512Xsmoking—8.189Xfamily history of CAD—8.819XDM，F=10.225，P<0.001；YQOL-6=85.612+5.015Xmale—3.943Xsmoking—5.583Xfamily history of CAD—11.611XDM—5.331XMI，F=16.640，P<0.001；YQOL-12=88.654+4.635Xmale—3.541Xsmoking—
4.287Xfamily history of CAD—11.024XDM—6.751XMI，F=17.256，P<0.001.
【Conclusions】
1.The Chinese version of SF-36has an acceptable reliability，validity andresponsibility when applied to evaluate the quality of life in patients with adult cardiac disease and it can be promoted in this field although the structure validity of the scale wasnot perfect.
2.The quality of life and heart function can recovery to a satisfied level after thesurgery no matter the operation was cardiac valve surgery or CABG. It is reasonable forpatients who have indication of surgery should receive operation as soon as possible torecovery earlier from the lower quality of life and heart function. And the surgeon shouldpay more attention on the BP recovery during3month postoperatively.
3.The risk factor of PCS-3、MCS-3、QOL-3after adult cardiac valve surgery werefemale and DM. the common risk factors of PCS-3、MCS-3、QOL-3after CABG were DMand family history of CAD; besides, female was risk factors to PCS-3and QOL-3,smoking was risk factors to MCS-3and QOL-3
4.The risk factor of PCS-6、QOL-6after adult cardiac valve surgery were female，DM and preoperative LVEDD≥55mm; for MCS-6, the risk factors were female and DM.To the patients who received CABG, the risk factors of PCS-6were female, DM, familyhistory of CAD, number of bypass graft; the risk factors of MCS-6were: smoking, DM,family history of CAD, history of myocardial infraction; the risk factors of QOL-6were:female, smoking, DM, family history of CAD and history of myocardial infraction.
5. The risk factor of PCS-12、QOL-12after adult cardiac valve surgery were female，DM; for MCS-12, the risk factors were female, DM and preoperative LVEDD≥55mm. Tothe patients who received CABG, the common risk factors of PCS-12, MCS-12, QOL-12were DM, family history of CAD, history of myocardial infraction; besides, female wasrisk factor of PCS-12and QOL-12, and smoking was risk factor of MCS-12and QOL-12
1、本课题通过对成人心脏病患者生活质量的研究，探讨中文版SF-36量在成人心脏病患者的应用价值；2、应用中文版SF-36量表对单纯成人心脏瓣膜病患者外科术后3个月、6个月、12个月生活质量进行随访，探索成人心脏瓣膜病术后生活质量的危险因素；3、应用中文版SF-36量表对单纯冠状动脉旁路移植术（CABG）患者术后3个月、6个月、12个月生活质量进行随访，探索CAD患者CABG术后生活质量的危险因素。
【方法】
（一）中文版SF-36量表应用于成人心脏病患者生活质量研究的价值评定：
1、以2010年1月1日至2010年12月31日间入长海医院胸心外科拟行手术治疗的成人心脏病患者为研究对象，连续性入选400例患者进行SF-36量表生活质量测评。
2、评价SF-36量表应用于成人心脏病患者的信度、效度和反应性，为进一步研究成人心脏病患者术后生活质量的影响因素奠定基础。
（二）成人心脏瓣膜病患者术后生活质量的影响因素：
1、以我科的心脏瓣膜病登记系统为基础，通过科室内部讨论会及专家咨询会方式，制定成人心脏瓣膜病术后生活质量影响因素的前瞻性登记表格，确定入选和排除标准，其中确定要收集的临床指标、定义各指标的收集标准以及明确各指标的收集方式，随访时间和随访方式。
2、以2010年1月1日至2010年12月31日间入长海医院胸心外科拟行手术治疗的成人心脏瓣膜病患者为研究对象，按照入选和排除标准进行术前生活质量的测评、临床指标的收集。
3、对入选的患者进行随访，随访术后3个月、6个月、12个月生活质量，随访术后6个月、12个月心脏功能指标。
4、对数据进行分析，通过重复测量的方差分析对比术后术前生活质量、心功能变化情况，评价手术疗效；对可能影响患者术后生活质量的因素进行单因素分析，P<0.1有显著性统计学差异；以逐步引入—剔除法（引入和剔除的标准分别是0.05和0.10）对进入多元线性逐步回归的影响因素进行多元回归分析，确定各时间点，生活质量各维度的危险因素。
（三）冠心病患者CABG术后生活质量的影响因素：
1、以我科的心脏瓣膜病登记系统为基础，参考参考美国STS NCD数据库及阜外医院的中国冠状动脉旁路移植术登记协作组等国内外大型数据库设计，通过科室内部讨论会及专家咨询会方式，制定冠心病患者CABG术后生活质量影响因素的前瞻性登记表格，确定入选和排除标准，其中确定要收集的临床指标、定义各指标的收集标准以及明确各指标的收集方式，随访时间和随访方式。
2、以2010年1月1日至2010年12月31日间入长海医院胸心外科拟行手术治疗的冠心病患者为研究对象，按照入选和排除标准进行术前生活质量的测评、临床指标收集。
3、对入选的患者进行随访，随访术后3个月、6个月、12个月生活质量，随访术后6个月、12个月心脏功能指标。
4、对数据进行分析，通过重复测量的方差分析对比术后术前生活质量、心功能变化情况，评价手术疗效；对可能影响患者术后生活质量的因素进行单因素分析，P<0.1为有显著性统计学差异；以逐步引入—剔除法（引入和剔除的标准分别是0.05和0.10）对进入多元线性逐步回归的影响因素进行多元回归分析，确定各时间点，生活质量各维度的危险因素。
【结果】
（一）中文版SF-36量表应用于成人心脏病患者生活质量研究的价值评定：
1、信度：半分信度（split–half reliability）：本量表采用奇、偶半分法，分半信度系数Spearman–Brown系数为0.733。内部一致性信度（Internal consistencyreliability）：4个维度（PF、RP、BP、GH）Cronbach’s α系数大于0.8；3个维度（VT、RE、MH）在0.7-0.8之间，接近0.8，仅SF一个维度Cronbach’s α系数小于0.7，为0.648。各维度内部有良好的正相关性。维度之间的相关系数均低于每个维度内部一致性系数。
2、结构效度（construct validity）：中文版SF-36量表8个维度得分经Bartlett检验表明，Bartlett值为χ2=1276.063，P<0.0001，可以进行因子分析。KMO（Kaiser-Meyer-Olkin measure）=0.838，接近于1，表明该因子分析结果较好。使用主成分分析法，经方差最大正交旋转后，产生2个公因子，即生理因子和心理因子，解释了62.96%的方差，与理论假设一致，但各维度在公因子的强度与理论假设有一定差异。
（二）成人心脏瓣膜病患者术后生活质量的影响因素：
1、前瞻性研究平台的建立：2010年1月1日—2010年12月31日间，共395例患者入选，术后12个月随访327例，随访率82.8%。
2、手术对患者术后生活质量变化及心功能的影响：生活质量各维度评分生理功能（PF）、生理职能（RP）、身体疼痛（BP）、总体健康（GH）、活力（VT）、社会功能（SF）、情感职能（RE）、精神健康（MH）、健康变化（HT）、生理健康（PCS）、心理健康（MCS）、生活质量总分（QOL）重复测量方差分析Greenhouse-geisser P值均<0.001，术后生活质量改善明显。BP维度项在术后3个月较术前有所减低。LVEF改善情况采用重复测量方差分析，Greenhouse-geisser P值均<0.001，有显著统计学差异。NYHA心功能(I-II级)患者比列卡方检验，Perarsonχ2=500.661，P<0.001，有显著统计学意义。术后患者生活质量、心功能明显改善。
3、单因素方差分析术后生活质量的影响因素：影响PCS-3的因素为：女性、糖尿病、NYHA心功能分级III-IV级、既往心脏瓣膜手术史、ICU时间延长；影响PCS-6的因素为：女性、糖尿病、既往心脏瓣膜手术史、术后6个月LVEDD≥55mm；影响PCS-12的因素为：女性、糖尿病、术后6个月LVEDD直径≥55mm；影响MCS-3的因素为女性、糖尿病、既往心脏瓣膜手术史；影响MCS-6的因素为：女性、糖尿病、术前LVEF<50%、术前LVEDD≥55mm、术后6个月LVEDD直径≥55mm；影响MCS-12的因素为：女性、糖尿病、心衰史、术前LVEF<50%、术前LVEDD直径≥55mm、术后6个月LVEDD≥55mm；影响QOL-3的因素为：性别、糖尿病、既往心脏瓣膜手术史、ICU时间延长；影响QOL-6的因素为：性别、糖尿病、术后6个月LVEDD直径≥55mm，影响QOL-12的因素为：女性、糖尿病、术前LVEF<50%、术前LVEDD直径≥55mm、术后6个月LVEDD直径≥55mm。
4、多元线性回归分析：YPCS-3=71.268+4.153X男性—9.290X糖尿病，F=3.987，P=0.002<0.05；YPCS-6=83.491+4.556X男性—8.873X糖尿病—7.997X术后6个月LVEDD≥55mm，F=5.391，P=0.001<0.05；方程YPCS-12=87.177+3.582X男性—9.326X糖尿病—6.304X术后6个月LVEDD≥55mm，F=4.875，P=0.000<0.05；方程YMCS-3=67.227+6.185X男性—10.345X糖尿病，F=7.936，P=0.000<0.05；方程YMCS-6=80.289+5.344X男性—10.852X糖尿病， F=5.658，P=0.000<0.05；方程YMCS-12=82.920+4.038X男性—7.665X糖尿病—3.499X术后6个月LVEDD≥55mm， F=4.228，P=0.000<0.05；方程YQOL-3=68.995+5.262X男性—9.938X糖尿病， F=5.78，P=0.000<0.05；方程YQOL-6=84.041+4.323X男性—9.534X糖尿病—6.655X术后6个月LVEDD≥55mm， F=7.537，P=0.000<0.05；方程YQOL-12=85.529+4.368X男性—8.766X糖尿病， F=4.895，P=0.000<0.05。
（三）冠心病患者CABG术后生活质量的影响因素：
1、2010年1月1日—2010年12月31日间，共174例患者入选，术后12个月实际进行统计分析144例，有效随访率82.8%。
2、手术对患者术后生活质量变化及心功能的影响：术后3个月、6个月、12个月随访生活质量，生活质量各维度评分生理功能（PF）、生理职能（RP）、身体疼痛（BP）、总体健康（GH）、活力（VT）、社会功能（SF）、情感职能（RE）、精神健康（MH）、健康变化（HT）、生理类（PCS）评价、心理类（MCS）评价、生活质量总评分（QOL）重复测量方差分析，Greenhouse-geisser P值均<0.001，术后生活质量改善明显。LVEF改善情况采用重复测量方差分析，Greenhouse-geisser P值均<0.001，有显著统计学差异。NYHA心功能(I-II级)患者比列卡方检验，Perarson χ2=500.661，P<0.001，有显著统计学意义。术后患者生活质量、心功能明显改善。BP项在术后3个月较术前有所减低，术后6个月明显改善。
3、单因素方差分析术后生活质量的影响因素：除性别对MCS-3无显著影响外，性别（女性）、吸烟、家族史、糖尿病、心肌梗死病史、桥血管数量对术后PCS-3、PCS-6、PCS-12、MCS-3、MCS-6、MCS-12、QOL-3、QOL-6、QOL-12均有显著性影响，高脂血症对术后PCS-6、PCS-12有显著性影响。
4、多元线性回归分析：YPCS-3=71.918+6.076X男性—8.166X家族史—8.567X糖尿病，F=8.200，P<0.001；YPCS-6=83.234+6.330X男性—5.267X家族史—10.714X糖尿病—1.996X桥血管数， F=12.437，P<0.001；YPCS-12=86.068+6.050X男性—4.847X家族史—10.369X糖尿病—5.591X心梗史， F=11.695，P<0.001；YMCS-3=82.552—5.698X男性—4.847X吸烟—8.161X家族史—9.637X糖尿病， F=11.602，P<0.001；YMCS-6=87.297—4.593X吸烟—6.290X家族史—11.997X糖尿病—5.419X心梗史，F=11.602，P<0.001；YMCS-12=90.734—3.801X吸烟—4.013X家族史—11.307X糖尿病—7.826X心梗史， F=17.313，P<0.001；YQOL-3=76.110+4.856X男性—5.512X吸烟—8.189X家族史—8.819X糖尿病， F=10.225，P<0.001；YQOL-6=85.612+5.015X男性—3.943X吸烟—5.583X家族史—11.611X糖尿病—5.331X心梗史， F=16.640，P<0.001；YQOL-12=88.654+4.635X男性—3.541X吸烟—4.287X家族史—11.024X糖尿病—6.751X心梗史，F=17.256，P<0.001。
【结论】
1.中文版SF-36量表应用于成人心脏病患者具有良好的信度、效度和反应度，可以比较准确全面的反应成人心脏病患者的生活质量。但结构效度不太理想，可进一步修订，在目前国内QOL研究尚处于初级阶段的前提下，可在成人心脏病领域推广应用。
2.成人心脏病患者术后3个月-12个月间，心功能逐渐改善，生活质量逐渐提高，手术治疗效果满意，有指征患者应积极行手术治疗。术后3个月内应注意患者的躯体疼痛治疗。
3.影响成人心脏瓣膜患者术后3个月生活质量生理健康（PCS）、心理健康（MCS）、生活质量总评分（QOL）的影响因素均为：女性、糖尿病。冠心病CABG患者术后3个月生活质量生理健康（PCS）、心理健康（MCS）、生活质量总评分（QOL）的共同影响因素均为：糖尿病、冠心病家族史；另外女性是PCS及QOL总评分的危险因素，吸烟史MCS及QOL的危险因素。
4.成人心脏瓣膜病患者术后6个月生活质量生理健康（PCS）、生活质量总评分（QOL）的影响因素均为：女性、糖尿病、术后6个月LVEDD≥55mm；心理健康（MCS）影响因素为：女性、糖尿病。冠心病CABG术后6个月生活质量生理健康（PCS）为：女性、冠心病家族史、糖尿病、桥血管数目；心理健康（MCS）影响因素为：吸烟、糖尿病、冠心病家族史、心梗史；生活质量总评分（QOL）的影响因素均为：女性、吸烟、糖尿病、冠心病家族史、心梗史。
5.成人心脏瓣膜病患者术后12个月生活质量生理健康（PCS）、生活质量总评分（QOL）的影响因素均为：女性、糖尿病；心理健康（MCS）影响因素为：女性、糖尿病、术后6个月LVEDD≥55mm。冠心病CABG术后12个月生活质量生理健康（PCS）、心理健康（MCS）、生活质量总评分（QOL）的共同影响因素为：糖尿病、冠心病家族史、心梗史；另外女性是PCS-12及QOL-12总评分的危险因素，吸烟史MCS-12及QOL-12的危险因素。
【Objective】
1.In this study, we determine to evaluate the feasibility of Chinese version of MOS36-item short form health survey (SF-36) in the assessment of quality of life in patientswith adult cardiac disease.2. To evaluate the quality of life and explore its proposalinfluence factors in patients with adult cardiac valve disease at three month、six monthand twelve month respectively after surgical treatment.3. To evaluate the quality of lifeand explore its proposal influence factors in patients with coronary artery disease at threemonth、six month and twelve month respectively after coronary artery bypass graft.
【Methods】
1. The assessment of Chinese version of SF-36in patients with adult cardiac disease：
(1) A total of400hundred consecutive patients who received surgical treatment withadult cardiac disease were recruited from1stJan2010to31stDec2010in Department ofCardiothoracic Surgery, Changhai hospital. The Chinese version of SF-36was applied toevaluate the quality of life before surgery..
(2) To evaluate the internal consistent reliability, construct validity, responsibility, andacceptability of Chinese version of SF-36when applied to patients with adult cardiacdisease.
2. The quality of life and its proposal influence factors in patients with adult heart valvedisease after surgical treatment:
(1) On the basis of preexisting data registry system for heart valve disease, aprospective set of data registry table for the clinical data and follow-up information inpatients undergoing heart valve surgery was set up by division discussion and expertcounseling, including definitions of candidate predictor variables, and to determineinclusion and exclusion criteria.
(2) A consecutive series of eligible patients meet the inclusion and exclusion criteriawas recruited from1stJan2010to31stDec2010in Department of Cardiothoracic Surgery,Changhai hospital. To collect their clinical data and finish the assessment of quality of lifewith Chinese version of SF-36preoperatively.
(3) To assess the quality of life and heart function at3month’,6month’, and12month’follow-up respectively.
(4) To assess the effect of surgical treatment by apply repeated measurement tocompare the change of quality of life and heart function preoperative and postoperative.The analysis of proposal influence factors of quality of life using One-way ANOVA andmultiple linear regression analysis..
3. The quality of life and its proposal influence factors in patients with coronary arterydisease after CABG：
(1) On the basis of preexisting data registry system for heart valve disease，and theSTS NCD database of United States, together with CABG database of Fuwai hospital, aprospective set of data registry table for the clinical data and follow-up information inpatients with CAD undergoing CABG was set up by division discussion and expertcounseling, including definitions of candidate predictor variables, and to determineinclusion and exclusion criteria
(2) A consecutive series of eligible patients meet the inclusion and exclusion criteriawas recruited from1stJan2010to31stDec2010in Department of Cardiothoracic Surgery,Changhai hospital. To collect their clinical data and finish the assessment of quality of lifewith Chinese version of SF-36preoperatively.
(3) To assess the quality of life and heart function at3month’,6month’, and12month’follow-up respectively.
(4) To assess the effect of CABG by apply repeated measurement to compare thechange of quality of life and heart function preoperative and postoperative. The analysis ofproposal influence factors of quality of life using One-way ANOVA and multiple linearregression analysis.
【Results】
1. The assessment of Chinese version of SF-36in patients with adult cardiac disease：
(1) Reliability：the Spearman-Brown coefficient of split-half reliability is0.733. theInternal consistency reliability: the Cronbach’s α coefficient of four dimension(PF、RP、BP、GH) are bigger than0.8, and three dimension(VT、RE、MH) are between0.7and0.8,only one dimension(SF) is less than0.7, which is0.648. Each dimension has a goodpositive correlation. The correlation coefficient between the dimensions were all lowerthan the internal consistency efficient of each dimension.
(2) Construct validity：the Bartlett test, χ2=1276.063，P<0.0001, the sample can beanalyzed with factor analysis. KMO（Kaiser-Meyer-Olkin measure）=0.838,2common factor were extracted by factor analysis, a “physical” factor and a “mental” factor, whichcould be used to explain62.96%of the total variance. But these2common factor not inaccordance with their theoretical structure perfectly.
2. the quality of life and its proposal influence factors in patients with adult heart valvedisease after surgical treatment:
(1) A total of395consecutive patients were recruited in this prospective study with327of them finished follow-up at12month after surgery, and the follow-up rate was82.8%.
(2) The influence of surgery on the quality of life and heart function: all of thedimensions, including PF、RP、BP、GH、VT、SF、RE、MH、HT、PCS、MCS and totQOL were increased significantly with repeated measurement Greenhouse-geisser P<0.001except BP dimension which decreased at3month’follow-up and then recovery at month’follow-up. The proportion of patients with NYHA I-II heart function wassignificantly increased with Pearsonχ2=500.661，P<0.001.
(3) One way ANOVA of proposal influence factors: a total of30factors wereanalyzed. The risk factors of PCS-3were: female, DM, NYHA heart function class III-IV,
a history of heart valve surgery，prolonged ICU stay；for PCS-6: female, DM, a history heart valve surgery, LVEDD≥55mm after6month of surgery; for PCS-12: female, DM,LVEDD≥55mm after6month of surgery; for MCS-3: female, DM, a history of heartvalve surgery; for MCS-6: female, DM, preoperative LVEF<50%, preoperative LVEDD55mm, LVEDD≥55mm after6month of surgery; for MCS-12: female, DM, a history ofheart failure, preoperative LVEF<50%, preoperative LVEDD≥55mm; for QOL-3: femalDM, a history of heart valve surgery, prolonged ICU stay; for QOL-6: female, DM,LVEDD≥55mm after6month of surgery; for QOL-12: female, DM, preoperativeLVEF<50%, preoperative LVEDD≥55mm, LVEDD≥55mm after6month of surgery.
(4) The multiple linear regression analysis: YPCS-3=71.268+4.153Xmale—9.290XDM，F=3.987，P=0.002<0.05; YPCS-6=83.491+4.556Xmale—8.873XDM—7.997XLVEDD-6≥55mm，F=5.391，P=0.001<0.05；YPCS-12=87.177+3.582Xmale—9.326XDM—6.304XLVEDD-6≥55mm，F=4.875，P=0.000<0.05; YMCS-3=67.227+6.185Xmale—10.345XDM，F=7.936，P=0.000<0.05YMCS-6=80.289+5.344Xmale—10.852XDM，F=5.658，P=0.000<0.05；YMCS-12=82.920+4.038Xmale—7.665XDM—3.499XLVEDD-6≥55mm，F=4.228，P=0.000<0.05；YQOL-3=68.995+5.262Xmale—9.938XDM，F=5.78，P=0.000<0.05；YQOL-6=84.041+4.323Xmale—9.534XDM—6.655XLVEDD-6≥55mm，F=7.537，P=0.000<0.05； YQOL-12=85.529+4.368Xmale—8.766XDM，F=4.895，P=0.000<0.05.
3. the quality of life and its proposal influence factors in patients with coronary arterydisease after CABG：
(1) A total of174consecutive patients were recruited in this prospective study with144of them finished follow-up at12month after surgery, and the follow-up rate was82.8%.
(2) The influence of CABG on the quality of life and heart function: all of thedimensions, including PF、RP、BP、GH、VT、SF、RE、MH、HT、PCS、MCS and totalQOL were increased significantly with repeated measurement Greenhouse-geisser P<0.001except BP dimension which decreased at3month’follow-up and then recovery at6month’follow-up. The proportion of patients with NYHA I-II heart function wassignificantly increased with Pearsonχ2=500.661，P<0.001.
(3) One way ANOVA of proposal influence factors: a total of10factors were analyzed.Except female have no significant influence on MCS-3, female, DM, smoking，familyhistory of CAD, history of myocardial infraction, number of bypass graft were all have asignificant effect on PCS-3、PCS-6、PCS-12、MCS-3、MCS-6、MCS-12、QOL-3、QOL-6、QOL-12, besides, hyperlipidemia had a significant effect on PCS-6and PCS-12.
(4) The multiple linear regression analysis: YPCS-3=71.918+6.076Xmale—8.166Xfamilyhistory of CAD—8.567XDM，F=8.200，P<0.001；YPCS-6=83.234+6.330Xmale—5.267Xfamilyhistory of CAD—10.714XDM—1.996X桥血管数，F=12.437，P<0.001；YPCS-12=86.068+6.050Xmale—4.847Xfamily history of CAD—10.369XDM—5.591XMI，F=11.695，P<0.001；YMCS-3=82.552—5.698Xmale—4.847Xsmoking—8.161Xfamily history of CAD—9.637XDM，F=11.602，P<0.001；YMCS-6=87.297—4.593Xsmoking—6.290Xfamily history of CAD—11.997XDM—5.419XMI，F=11.602，P<0.001；YMCS-12=90.734—3.801Xsmoking—4.013Xfamily history of CAD—11.307XDM—7.826XMI, F=17.313，P<0.001；YQOL-3=76.110+4.856Xmale—5.512Xsmoking—8.189Xfamily history of CAD—8.819XDM，F=10.225，P<0.001；YQOL-6=85.612+5.015Xmale—3.943Xsmoking—5.583Xfamily history of CAD—11.611XDM—5.331XMI，F=16.640，P<0.001；YQOL-12=88.654+4.635Xmale—3.541Xsmoking—
4.287Xfamily history of CAD—11.024XDM—6.751XMI，F=17.256，P<0.001.
【Conclusions】
1.The Chinese version of SF-36has an acceptable reliability，validity andresponsibility when applied to evaluate the quality of life in patients with adult cardiac disease and it can be promoted in this field although the structure validity of the scale wasnot perfect.
2.The quality of life and heart function can recovery to a satisfied level after thesurgery no matter the operation was cardiac valve surgery or CABG. It is reasonable forpatients who have indication of surgery should receive operation as soon as possible torecovery earlier from the lower quality of life and heart function. And the surgeon shouldpay more attention on the BP recovery during3month postoperatively.
3.The risk factor of PCS-3、MCS-3、QOL-3after adult cardiac valve surgery werefemale and DM. the common risk factors of PCS-3、MCS-3、QOL-3after CABG were DMand family history of CAD; besides, female was risk factors to PCS-3and QOL-3,smoking was risk factors to MCS-3and QOL-3
4.The risk factor of PCS-6、QOL-6after adult cardiac valve surgery were female，DM and preoperative LVEDD≥55mm; for MCS-6, the risk factors were female and DM.To the patients who received CABG, the risk factors of PCS-6were female, DM, familyhistory of CAD, number of bypass graft; the risk factors of MCS-6were: smoking, DM,family history of CAD, history of myocardial infraction; the risk factors of QOL-6were:female, smoking, DM, family history of CAD and history of myocardial infraction.
5. The risk factor of PCS-12、QOL-12after adult cardiac valve surgery were female，DM; for MCS-12, the risk factors were female, DM and preoperative LVEDD≥55mm. Tothe patients who received CABG, the common risk factors of PCS-12, MCS-12, QOL-12were DM, family history of CAD, history of myocardial infraction; besides, female wasrisk factor of PCS-12and QOL-12, and smoking was risk factor of MCS-12and QOL-12
引文
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