【作者】 王旭；

【导师】 李云涛；

【作者基本信息】 河北医科大学 ， 外科学， 2017， 硕士

【摘要】 目的:乳腺癌是中国女性发病率第一,死亡率第五的恶性肿瘤。现阶段,乳腺癌的治疗方式以手术为主,并根据病理情况辅以化疗、放疗、内分泌治疗及靶向治疗。其中内分泌治疗因其疗效肯定,副作用小,更容易被患者接受。影响内分泌治疗效果的因素很多,而且国外研究显示,内分泌治疗依从性好的患者,预后好,反之,则预后差,复发转移和乳腺癌相关死亡风险增加。但在我国关于内分泌治疗依从性的研究较少,而且多为小样本、短期随访研究,缺乏大样本5年及以上的随访研究。如今,随着我国人口老龄化加重,绝经后乳腺癌发病率逐年上升,人们对绝经后乳腺癌患者生存质量及预后也日益重视。因此,本研究针对绝经后进行内分泌治疗的乳腺癌患者进行调查,期望了解其内分泌治疗的依从现状,分析影响依从性的因素,为保障内分泌治疗的疗效提供一定依据。方法:对河北医科大学第四医院2010年1月1日至2011年12月31日行手术治疗并经病理学证实存在内分泌治疗指证并有完整资料的患者进行电话随访或面对面随访。自制调查问卷,内容涉及患者的一般状况(包括年龄,婚姻状况,职业,居住地类型,是否与子女同住,教育水平,经济水平,医疗形式,生活能否自理,能否坚持复查,是否合并其他慢性疾病)、治疗过程(主要有手术方式,AJCC分期,ER及PR状态(++/+-/-+),口服药物,副反应情况)及依从性情况(服药持续时间,是否了解内分泌治疗的目的及疗程,是否有忘记服药、有意不服药、停药超过1个月、用其他药物及保健品替代、愿意坚持服药至疗程结束)。依从性好的标准设定为:(1)服用医生推荐的药物;(2)按照规定的剂量服用;(3)持续用药时间,≥4年;(4)漏服率<20%,<6天/月;(5)愿意坚持至疗程结束(尚未完成5年的病人)。对可能影响患者内分泌治疗依从性的各个变量进行单因素分析,采用2?检验,然后将单因素分析有显著性差异的变量进行Logistic回归分析。结果:2010年1月1日至2011年12月31日间共有689例绝经后乳腺癌患者符合入组标准,随访547例,随访率79.39%。内分泌治疗期间死亡67例,拒绝调查者4例,问卷调查成功率87.02%。成功调查476例应该接受内分泌治疗患者,用药第一到第五年的药物持有率分别为85.92%、82.35%、76.89%、68.07%、50.63%。其中从未进行内分泌治疗35例,占随访比例7.35%。内分泌治疗依从性相关因素有:1居住类型,在城镇居住者依从性好(77.42%,216/279),高于在乡村居住者(64.47%,127/197,p=0.002)。2教育水平,大专及以上学历者依从性最好(81.82%,63/77),中学学历依从性居中(78.53%150/191),小学及以下学历依从性最低(62.50%,130/208),三者间差异有统计学意义(p=0.000)。3城市医保患者依从性(78.23%,194/248)好于新农合患者依从性(62.83%,120/191,p=0.001)。4职业,在职人员依从性最好(84.13%53/63),非在职人员依从性(76.59%,157/205),农民依从性最差(63.94%,133/208),三者间差异有统计学意义(p=0.001)。5他莫昔芬更换芳香化酶抑制剂即联合用药的患者依从率最高(81.82%,27/33),芳香化酶抑制剂依从率居中(78.15%,304/389),他莫昔芬依从率最低(63.16%,12/19),三者之间无统计学差异(p=0.260)。6药物副反应,服药期间出现药物副反应的依从性(69.79%,67/96),要差于没有出现副反应的依从性(80.00%,276/345,p=0.033)。7患者对内分泌治疗的认识:是否了解内分泌治疗的目的及意义、是否知道疗程、是否愿意坚持足疗程、是否定期复查,均有统计学意义(p=0.000)。8内分泌治疗依从性好的患者复发率(4.01%,13/324)低于内分泌治疗依从性差的患者(5.26%,8/152,p=0.536)。9年龄、婚姻状况、是否合并其他疾病、是否独居、经济状况、生活能否自理、疾病本身特点(手术方式及病理分期)等均没有统计学意义,p>0.05。结论:1绝经后乳腺癌患者内分泌治疗的依从性逐年下降,从第1年至第5年的药物持有率分别为85.92%、82.35%、76.89%、68.07%、50.63%。多种因素能够影响绝经后乳腺癌患者内分泌治疗的依从性。2患者受教育水平高,居住于城镇地区,享受医疗保险保障,对乳腺癌疾病本身及内分泌治疗意义理解透彻,并可以遵照医嘱定时、定量的足疗程的完成内分泌治疗,并能及时定期复查,其依从性好。3年龄、婚姻状况、是否合并其他疾病、是否独居、经济状况、生活能否自理、疾病本身特点(手术方式及病理分期)等与依从性没有关联,P>0.05。4本研究未发现内分泌治疗依从性好与差的患者复发率的区别,可能与随访病例少、随访时间短有关,其预后与依从性的关联需进一步随访观察。更多还原

【Abstract】 Objective: Breast cancer is ranking the first in morbidity and fifth in mortality for female’s cancer in China.At present,the main treatment of breast cancer is surgery,chemotherapy and radiotherapy,endocrine therapy and targeted therapy are added according to the pathological conditions.Endocrine therapy is more easily accepted by patients because of its more efficacy and less side effects.There are many factors that influence the effect of endocrine therapy,and foreign studies show that patients with good compliance to endocrine therapy can make good prognosis,on the contrary,bad prognosis.However,there are few studies on the compliance to endocrine therapy in China,and most of them are small samples,short-term follow-up studies,lack of follow-up study of 5 years or more.Nowadays,with the aging of population in our country,the incidence of postmenopausal breast cancer has been increasing year by year,and the quality of life and prognosis of patients with postmenopausal breast cancer have been paid more and more attention.Therefore,the research on postmenopausal endocrine therapy for breast cancer patients were investigated to understand the status of compliance to endocrine therapy,to analyze the factors influencing to compliance,and then to provide a certain evidence to protect the effect of endocrine therapy.Method: Patients who underwent surgical treatment from January 1,2010 to December 31,2011 in the fourth hospital of Hebei Medical University were confirmed by pathological examination and had complete data.The questionnaire was completed by phone call or face-to-face follow-up,which including the general condition of patients(including age,marital status,occupation,residence type,whether to live with their children,education level,economic level,medical forms,life can take care of themselves,can adhere to the review,if combined with other chronic diseases),treatment(includingsurgery,AJCC staging,ER and PR(++/+-/-+),oral drug adverse reactions)and compliance(duration,whether to understand the purpose and course of endocrine therapy whether medication,medication,do not forget to stop more than 1 months,with other drugs and health care products,is willing to substitute medication adherence to treatment end).Good compliance standards set as follows:(1)the doctor recommended taking drugs;(2)taken in accordance with the provisions of the dose;(3)the duration of time,more than4 years;(4)missed rate <20%,<6 days / month;(5)to adhere to the end of the treatment(not yet completed 5 years patient).Univariate analysis was used to analyze the factors that might influence the compliance of patients with endocrine therapy,and the2? test was used,and then the univariate regression analysis was performed by Logistic regression analysis.Result: From January 1,2010 to December 31,2011,689 cases of postmenopausal breast cancer patients were in line with the inclusion criteria.547 cases were followed up with the rate 79.39%.There were 67 patients died during the follow up and there were 4 patients refused to answer the investigation.The success rate of the questionnaire was about 87.02%(476/547).The compliance of the 476 cases from the first to the fifth year during the period taking the endocrine medication were 85.92%,82.35%,76.89%,68.07%,50.63% respectively.Endocrine therapy was not performed by 35 cases,accounting for the proportion of follow-up of 7.35%.Related factors to the compliance to Endocrine therapy as follow:1 The type of residential,urban residents with good compliance(77.42%,216/279),higher than rural residents(64.47%,127/197,P=0.002).2 The level of education,junior college degree or above the highest compliance(81.82%,63/77),secondary education compliance center(78.53%,150/191),primary school and the degree of compliance of the minimum(62.50%,130/208),there was significant difference between the three(P=0.000).3 The compliance of urban medical insurance patients(78.23%,194/248)was higher than that of the new rural cooperative medical care(62.83%,120/191,P=0.001).4 Occupation,staff compliance highest(84.13% 53/63),non working staff compliance(75.61%,155/205),the minimum compliance(63.94%,133/208),there was significant difference between the three(P=0.001).5 Tamoxifen replacement patient compliance is the best combination of aromatase inhibitors(81.82%,27/33),aromatase inhibitors compliance center(78.15%,304/389),tamoxifen compliance is the worst(63.16%,12/19),no significant differences between the three groups(P= 0.260).6 The side effects of medication,the compliance of drug adverse reactions(69.79%,67/96)were lower than those without side effects(80.00%,276/345,P=0.033).7 Patient understanding of endocrine therapy: understanding the purpose and significance of endocrine therapy,to know whether the treatment,is willing to adhere to the schedule,periodic review,were statistically significant(P=0.000).8 The recurrence rate of patients with good compliance with endocrine therapy(4.01%,13/324)was lower than that of endocrine therapy(5.26%,8/152,P=0.536).9 There was no significant difference in age,marital status,combined with other diseases,whether to live alone,economic status,life can take care of themselves,the characteristics of the disease(surgery and pathological stage),P>0.05.Conclusion:1 The compliance of endocrine therapy in postmenopausal women with breast cancer decreased year by year,and the rate of taking medicine from the first year to the fifth year was 85.92%,82.35%,76.89%,68.07%,50.63%respectively.2 With higher education,living in urban areas,to enjoy medical insurance,for breast cancer disease and endocrine therapy meaning thoroughly,and can follow the completion of endocrine therapy schedule timing,quantitative order,and timely follow-up,the good compliance.3 No relationship was found between compliance and age,marital status,combined with other diseases,whether to live alone,economic status,life can take care of themselves,the characteristics of the disease itself(surgery and pathological staging)(P>0.05 all).4 There was no difference in the recurrence rate between patients with good compliance and poor endocrine therapy,which may be related to fewer follow-up cases and shorter follow-up time.The association between prognosis and compliance needs further follow-up observation.更多还原