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多西他賽聯(lián)合順鉑用于局部晚期胃癌患者圍手術(shù)期治療完成后復(fù)發(fā)或轉(zhuǎn)移患者的療效及安全性分析

發(fā)布時(shí)間:2018-07-18 14:05
【摘要】:目的:胃癌是世界范圍內(nèi)常見的惡性腫瘤。在我國,發(fā)病率更是有逐年上升的趨勢(shì)。眾所周知,胃癌發(fā)病時(shí)癥狀不明顯,較為隱秘,多數(shù)患者就診時(shí)病情已進(jìn)入晚期失去手術(shù)機(jī)會(huì)。目前為止,對(duì)于局部晚期胃癌患者最主要的治療手段仍手術(shù)為主的綜合治療。但是多由于患者就診時(shí)間較晚及胃癌病理的特點(diǎn),部分患者會(huì)在其完成手術(shù)及圍手術(shù)期化療后1-3年便出現(xiàn)復(fù)發(fā)或轉(zhuǎn)移的情況,此時(shí)多數(shù)患者已失去再次手術(shù)機(jī)會(huì),治療手段相對(duì)單一。對(duì)于大多數(shù)患者會(huì)選擇再次行全身化療。但是,針對(duì)完成手術(shù)及圍手術(shù)期化療后又復(fù)發(fā)轉(zhuǎn)移的局部晚期胃癌患者的化療方案、療程、具體適應(yīng)癥等方面尚未形成一個(gè)金標(biāo)準(zhǔn),其療效及安全性亦無大宗臨床試驗(yàn)得到證實(shí),所以本研究旨在以上這些方面進(jìn)行研究探討,進(jìn)一步證實(shí)多西他賽聯(lián)合順鉑用于局部晚期胃癌患者圍手術(shù)期治療完成后復(fù)發(fā)或轉(zhuǎn)移患者的療效及安全性,為胃癌患者提供更好的治療理論及方法。方法:選擇河北醫(yī)科大學(xué)第四醫(yī)院外三科2012年1月1日至2015年5月31日確診為進(jìn)展期胃癌患者后經(jīng)D2根治術(shù)及氟尿嘧啶聯(lián)合奧沙利鉑圍手術(shù)期治療后復(fù)發(fā)轉(zhuǎn)移患者60例,分為實(shí)驗(yàn)組(治療組)46例和對(duì)照組(支持組)14例。實(shí)驗(yàn)組接受多西他賽+注射用順鉑的治療方案:多西他賽60-75mg/m2+濃度為0.9%的氯化鈉溶液250ml靜脈滴注,第1天。注射用順鉑60-75mg/m2+濃度為0.9%的氯化鈉溶液500ml,第1天。第2天給予水化治療,目的在于盡可能的減少患者化療副反應(yīng),降低患者不適程度。21天為1個(gè)周期。多西他賽給藥前D1、D2、D3天晚22點(diǎn)給予地塞米松片(0.75mg/片)20片,口服,早7點(diǎn)給予地塞米松片(0.75mg/片)10片,口服。觀察實(shí)驗(yàn)組治療后的近期療效、遠(yuǎn)期療效及不良反應(yīng);比較兩組ORR和DCR的差別;隨訪比較兩組的短期總生存期(OS)和疾病進(jìn)展時(shí)間(TTP)。具體臨床療效評(píng)價(jià)指標(biāo)如下:1實(shí)驗(yàn)組患者治療前后通過對(duì)復(fù)發(fā)轉(zhuǎn)移病灶的CT、MRI結(jié)果比較,評(píng)價(jià)治療有效率和疾病的控制率。2通過對(duì)比患者治療前后腫瘤標(biāo)記物變化情況評(píng)價(jià)治療效果。3通多觀察患者治療前后癥狀、主訴來評(píng)價(jià)疾病變化情況。4通過觀察、隨訪患者在治療過程中出現(xiàn)的不適對(duì)治療進(jìn)行不良反應(yīng)的評(píng)價(jià)。5通過對(duì)比患者在治療過程中血常規(guī)、電解質(zhì)及生化全項(xiàng)等觀察指標(biāo)來評(píng)價(jià)化療方案的安全性。6通過觀察、隨訪比較兩組的OS及TTP的差別。結(jié)果:1兩組病人60例患者均獲得隨訪,實(shí)驗(yàn)組46例隨訪總共247.1個(gè)月,人均5.37個(gè)月,中位隨訪時(shí)間5.2個(gè)月;對(duì)照組隨訪總月份67.1個(gè)月,人均4.79個(gè)月,中位隨訪時(shí)間4.8個(gè)月。實(shí)驗(yàn)組46例患者均獲療效評(píng)價(jià),其中完全緩解0例,部分緩解8例,病情穩(wěn)定18例,20例進(jìn)展?陀^緩解率為13.04%(8/46),疾病控制率為56.52%(26/46)。對(duì)照組14例患者均獲療效評(píng)價(jià),其中完全緩解0例,部分緩解0例,病情穩(wěn)定2例,12例進(jìn)展?陀^緩解率為0.00%(0/14),疾病控制率為14.29%(2/14)。2實(shí)驗(yàn)組與對(duì)照組比較,ORR不具有統(tǒng)計(jì)學(xué)差異,P值為0.179,DCR具有統(tǒng)計(jì)學(xué)差異,P值為0.006。3中位疾病進(jìn)展時(shí)間為5.2個(gè)月(3.8-8.2個(gè)月),中位生存時(shí)間為8.35個(gè)月(5.6-12.8個(gè)月)。4實(shí)驗(yàn)組與對(duì)照組比較,TTP和OS均具有統(tǒng)計(jì)學(xué)意義。P0.055多西他賽聯(lián)合順鉑作為局部晚期胃癌患者圍手術(shù)期治療完成后復(fù)發(fā)或轉(zhuǎn)移的再治療方案,毒副反應(yīng)小,可耐受。結(jié)論:1多西他賽聯(lián)合順鉑化療方案用于局部晚期胃癌患者圍手術(shù)期治療完成后復(fù)發(fā)或轉(zhuǎn)移患者一定程度上可以控制疾病的發(fā)展。2多西他賽聯(lián)合順鉑化療方案毒副反應(yīng)較小,安全性好。3多西他賽聯(lián)合順鉑化療方案用于局部晚期胃癌患者圍手術(shù)期治療完成后復(fù)發(fā)或轉(zhuǎn)移患者有延長疾病進(jìn)展時(shí)間和總生存期的趨勢(shì),是晚期胃癌患者安全有效的治療模式。
[Abstract]:Objective: gastric cancer is a common malignant tumor in the world. In China, the incidence of the disease is increasing year by year. It is well known that the symptoms of gastric cancer are not obvious and are more secretive. Most of the patients have entered the late stage and lose the operation opportunity. So far, the most important treatment for patients with advanced gastric cancer is still operating. However, due to the late diagnosis and pathological features of the gastric cancer, some patients will have a recurrence or metastasis 1-3 years after the operation and perioperative chemotherapy, and most patients have lost the chance of reoperation and the treatment is relatively simple. For most patients, they will choose to do their whole body again. Chemotherapy, however, has not formed a gold standard for the chemotherapy regimen, course of treatment and specific indications for patients with locally advanced gastric cancer after surgery and chemotherapy after perioperative chemotherapy. The efficacy and safety of the patients have not been confirmed by large clinical trials. To confirm the efficacy and safety of docetaxel combined with cisplatin in patients with local advanced gastric cancer after perioperative treatment, and to provide better therapeutic theory and methods for patients with gastric cancer. Methods: selected patients from fourth hospitals in Hebei Medical University from January 1, 2012 to May 31, 2015 were diagnosed as advanced gastric cancer patients. 60 cases of recurrent and metastatic patients after D2 radical resection and fluorouracil combined with oxaliplatin were divided into the experimental group (treatment group) and the control group (14 cases). The experimental group received docetaxel + Cisplatin for Injection treatment regimen: Docetaxel 60-75mg/m2+ concentration of 0.9% Sodium Chloride Solution 250ml intravenous drip, first days. Sodium Chloride Solution 500ml with cisplatin 60-75mg/m2+ concentration of 0.9%, first days and second days to be treated with hydration, the aim was to reduce the side effects of chemotherapy and reduce the patient's discomfort to 1 cycles for.21 days. 20 tablets (0.75mg/) were given at 22 points before D1, D2, D3 days, and 7 points were given to dexamethasone. 10 tablets of 0.75mg/ tablets were taken orally. The short-term effect, the long-term effect and the adverse reaction of the experimental group were observed. The difference between the two groups was compared with that of the DCR. The short-term total survival time (OS) and the disease progression time (TTP) were compared between the two groups. The specific clinical efficacy evaluation indexes were below: 1 in the 1 experimental group, after the treatment of the recurrence and metastasis of CT, M RI comparison, evaluation of therapeutic effectiveness and control rate of disease.2 by comparing the changes of tumor markers before and after the treatment of patients, the treatment effect was evaluated.3 through observation of the symptoms of the patients before and after treatment, the main complaint was to evaluate the change of the disease, and.4 was observed, and the patients were followed up in the treatment process to evaluate the adverse reactions to the treatment. .5 evaluated the safety of chemotherapy by comparing patients' blood routine, electrolyte and biochemical indexes during the treatment process to evaluate the safety of chemotherapy.6 through observation, followed up and compared the difference between the two groups of OS and TTP. Results: 1 two groups of patients were followed up, 46 cases in the experimental group were followed up for a total of 247.1 months, 5.37 months per person, and median follow-up time 5.. 2 months, the control group was followed up for a total of 67.1 months, 4.79 months per person, and median follow-up time of 4.8 months. 46 patients in the experimental group were evaluated, including 0 cases of complete remission, 8 cases of partial remission, 18 cases of stable condition and 20 progress. The objective remission rate was 13.04% (8/46), and the control rate of disease was 56.52% (26/46). All patients in the control group received efficacy evaluation, There were 0 cases of complete remission, 0 cases of partial remission, 2 cases of stable condition and 12 progress. The objective remission rate was 0% (0/14), the rate of disease control was 14.29% (2/14).2 experimental group compared with the control group, ORR did not have statistical difference, P value was 0.179, DCR had statistical difference, P value was 5.2 months (3.8-8.2 months), median of 0.006.3 median disease (3.8-8.2 months), median The survival time was 8.35 months (5.6-12.8 months).4 experimental group compared with the control group, TTP and OS had statistical significance.P0.055 docetaxel combined with cisplatin as a local advanced gastric cancer patients with recurrent or metastatic retreatment after perioperative treatment, the side effects were small and tolerable. Conclusion: 1 docetaxel combined with cisplatin chemotherapy regimen is used. Patients with locally advanced gastric cancer patients with recurrent or metastases after perioperative treatment can control the development of the disease to a certain extent..2 docetaxel combined with cisplatin chemotherapy regimen has less side effects. Safe and good.3 docetaxel combined with cisplatin chemotherapy regimen is used for local advanced gastric cancer patients after perioperative treatment to relapse or metastases. Patients who have prolonged trend of disease progression and overall survival are safe and effective treatment modalities for patients with advanced gastric cancer.
【學(xué)位授予單位】:河北醫(yī)科大學(xué)
【學(xué)位級(jí)別】:碩士
【學(xué)位授予年份】:2016
【分類號(hào)】:R735.2

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