【摘要】：目的通過觀察接受健脾解毒通絡(luò)方聯(lián)合替加氟維持治療的晚期胃癌患者,回顧性分析該方案對(duì)晚期胃癌患者PFS、OS、生存質(zhì)量及毒性反應(yīng)的影響;并通過單因素分析,探索與晚期胃癌預(yù)后相關(guān)的臨床病理因素,近而為晚期胃癌的維持治療提供一定的臨床研究證據(jù)。方法搜集2010年1月至2015年1月就診于安徽省立醫(yī)院中醫(yī)腫瘤科門診或病房、有明確病理診斷、臨床分期為Ⅲ~Ⅳ期、已接受一線化療且達(dá)到疾病控制后采用健脾解毒通絡(luò)方聯(lián)合替加氟治療的30例晚期胃癌患者。觀察其接受該方案維持治療后的PFS、OS、生存質(zhì)量及毒性反應(yīng)。通過建立生存曲線,分析與晚期胃癌預(yù)后相關(guān)的單因素,進(jìn)一步通過多因素分析,最終確定影響預(yù)后的獨(dú)立因素。結(jié)果PFS方面,30例患者的平均PFS為29.689±5.684個(gè)月,中位PFS是15.000±4.674個(gè)月。OS方面,30例的平均OS為33.230±4.916個(gè)月,中位OS是27.000±5.439個(gè)月,截止到觀察期,30例患者中仍存活11人。在存活人群中,OS超過5年(76月、75月、72月)且繼續(xù)存活的有3人;達(dá)到4年(48月)的1人;達(dá)到2年(24月)的1人;超過1年(16月、17月、19月)的有3個(gè);另有3人未滿1年(4月、6月、8月),仍需繼續(xù)觀察;已死亡的19例患者中OS最長(zhǎng)達(dá)56個(gè)月,最短6個(gè)月,其中生存期超過1年的有15人,占比78.94%;生存期超過2年的有7例,占比36.84%;生存期達(dá)3年的有2人,占比10.52%。生存期超5年的3人,占比10%。預(yù)后相關(guān)因素方面,本研究從性別、年齡、KPS評(píng)分、有無手術(shù)治療、病理類型、組織分級(jí)、淋巴結(jié)轉(zhuǎn)移、臟器轉(zhuǎn)移等單因素對(duì)PFS和OS的影響進(jìn)行分析,結(jié)果顯示,影響PFS的單因素是有無手術(shù)治療、淋巴結(jié)轉(zhuǎn)移的位置和臟器轉(zhuǎn)移情況(P=0.014、P=0.005、P=0.005)。而淋巴結(jié)轉(zhuǎn)移的位置和臟器轉(zhuǎn)移情況(P=0.005、P=0.005)是影響OS的兩個(gè)單因素。進(jìn)一步行多因素COX回歸模型分析顯示,只有臟器轉(zhuǎn)移情況是決定PFS、OS長(zhǎng)短的獨(dú)立因素(P=0.002、P=0.005)。生活質(zhì)量改善方面,經(jīng)過中醫(yī)的辨證施治,以及合理的遣方處藥,全部患者在服藥期間生活狀態(tài)改善明顯。毒副反應(yīng)方面,30例患者對(duì)替加氟的耐受良好,偶見Ⅰ-Ⅱ度的血液毒性及Ⅰ度的消化道反應(yīng),未出現(xiàn)因藥物毒性反應(yīng)而停藥,化療相關(guān)性死亡0人。結(jié)論健脾解毒通絡(luò)方聯(lián)合替加氟維持治療可以提高晚期胃癌患者近期療效,改善生存質(zhì)量,延長(zhǎng)疾病無進(jìn)展生存時(shí)間,總生存期也有延長(zhǎng)趨勢(shì),且毒副作用低,耐受性好。通過多因素回歸分析模型探討影響預(yù)后的相關(guān)因素,結(jié)果顯示臟器轉(zhuǎn)移情況是影響預(yù)后的獨(dú)立因素。此維持治療方案對(duì)晚期胃癌患者安全、有效且易于接受,值得進(jìn)行進(jìn)一步研究并推廣應(yīng)用。
[Abstract]:Objective to observe the effects of Jianpi jiedu Tongluo recipe combined with tegafur on the quality of life (QOL) and toxicity of PFS,OS, in patients with advanced gastric cancer. Through univariate analysis, to explore the clinicopathological factors related to the prognosis of advanced gastric cancer, and to provide some clinical research evidence for the maintenance and treatment of advanced gastric cancer. Methods from January 2010 to January 2015, the clinic and ward of traditional Chinese medicine oncology department of Anhui Provincial Hospital were collected. Thirty patients with advanced gastric cancer were treated with Jianpi jiedu Tongluo recipe combined with tegafur after receiving first-line chemotherapy and achieving disease control. The quality of life (QOL) and toxicity of PFS,OS, treated with this regimen were observed. The survival curve was established to analyze the univariate factors related to the prognosis of advanced gastric cancer, and the independent factors affecting the prognosis were finally determined by multivariate analysis. Results in PFS, the mean PFS of 30 patients was 29.689 鹵5.684 months, the median PFS was 15.000 鹵4.674 months, the mean OS of 30 patients was 33.230 鹵4.916 months and the median OS was 27.000 鹵5.439 months. Eleven of the 30 patients were still alive. Among the survivors, 3 survived for more than 5 years (76, 75, 72 months), 1 for 4 years (48 months), 1 for 2 years (24 months), 3 for more than 1 year (16 months, 17 months, 19 months), 3 for more than 1 year (16 months, 17 months, 19 months), 1 person for 4 years (48 months), 2 years (24 months) and over 1 year (16 months, 17 months, 19 months). Of the 19 patients who had died, the longest OS was 56 months and the shortest was 6 months, of which 15 (78.94%) survived more than one year, among which 15 (78.94%) lived longer than one year. The number of patients who had died was 56 months and the shortest was 6 months, while the other 3 patients had less than one year (April, June, August), which still needed to be observed. The survival time was more than 2 years in 7 cases (36.84%) and 3 years in 2 cases (10.52%). The survival time was more than 5 years, accounting for 10%. In terms of prognostic factors, the effects of sex, age, KPS score, surgical treatment, pathological type, histological grade, lymph node metastasis and organ metastasis on PFS and OS were analyzed. The single factor influencing PFS was surgical treatment, location of lymph node metastasis and organ metastasis (P = 0.014, P = 0.005, P = 0.005). The location of lymph node metastasis and organ metastasis (P = 0.005, P = 0.005) were the two single factors affecting OS. Further multivariate COX regression analysis showed that only organ metastasis was an independent factor in determining the length of PFS,OS (P < 0. 002, P < 0. 005). In the aspect of improving the quality of life, the improvement of life condition of all patients was obvious after the treatment of syndrome differentiation of traditional Chinese medicine and the rational treatment of prescription. In terms of toxicity and side effects, 30 patients had good tolerance to tegafur. I-II degree of blood toxicity and 鈪，

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