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Oral chemotherapy for second-line treatment in patients with gemcitabine-refractory advanced pancreatic cancer 被引量:2
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作者 Se Jun Park Hyunho Kim +2 位作者 Kabsoo Shin Myung Ah Lee Tae Ho Hong 《World Journal of Gastrointestinal Oncology》 SCIE CAS 2019年第11期1021-1030,共10页
BACKGROUND There is no standard therapy for second-line treatment of gemcitabine-refractory pancreatic cancer patients with poor performance status.A combination of chemotherapy drugs 5-fluorouracil(5-FU),leucovorin,i... BACKGROUND There is no standard therapy for second-line treatment of gemcitabine-refractory pancreatic cancer patients with poor performance status.A combination of chemotherapy drugs 5-fluorouracil(5-FU),leucovorin,irinotecan,and oxaliplatin(FOLFIRINOX)or 5-fluorouracil/leucovorin plus nanoliposomal irinotecan can be considered as second-line treatment for such patients;however,due to toxicity,none of the regimens are recommended for patients with poor performance.Capecitabine or S-1 has relatively low toxicity and can be considered a treatment option for gemcitabine-refractory pancreatic cancer.AIM To investigate the efficacy and toxicity of oral chemotherapy as second-line treatment in patients with pancreatic cancer.METHODS Patients who had progressive disease after first-line gemcitabine-based chemotherapy were retrospectively analyzed between January 2011 and December 2018.They were treated with capecitabine or S-1 as the second-line treatment.Capecitabine was administered as a 2500 mg/m2 divided dose on days 1-14,followed by a 1-wk rest.S-1 was taken orally based on the patient’s body surface area for 28 d,followed by 2-wk of rest.Progression-free survival and overall survival were used to compare efficacy of capecitabine and S-1.RESULTS Of the 81 patients,41 were treated with capecitabine and 40 with S-1.The median time to treatment failure in both groups was 1.5 mo(P=0.425).The objective response rate was similar in the two groups:9.8%with capecitabine and 2.5%with S-1(P=0.359).Median progression-free survival was longer in the S-1 group than in the capecitabine group(S-12.7 mo,capecitabine 2.0 mo,P=0.003).There was no significant difference in the median overall survival between the capecitabine and S-1 groups(4.3 mo vs 5.0 mo,P=0.092).Grade 3 or 4 hand-foot syndrome was significantly more common in the capecitabine group than in the S-1 group(14.6%vs 0%,P=0.026).CONCLUSION Capecitabine or S-1 can be used as a second-line treatment for patients with advanced pancreatic cancer with poor performance status after progression to a gemcitabine-based regimen. 展开更多
关键词 PANCREATIC cancer Gemcitabine-refractory CAPECITABINE S-1 second-line treatment
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Metastatic gastric cancer treatment: Second line and beyond 被引量:10
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作者 Marwan Ghosn Samer Tabchi +1 位作者 Hampig Raphael Kourie Mustapha Tehfe 《World Journal of Gastroenterology》 SCIE CAS 2016年第11期3069-3077,共9页
Advanced gastric cancer(a GC), not amenable to curative surgery, is still a burdensome illness tormenting afflicted patients and their healthcare providers. Whereas combination chemotherapy has been shown to improve s... Advanced gastric cancer(a GC), not amenable to curative surgery, is still a burdensome illness tormenting afflicted patients and their healthcare providers. Whereas combination chemotherapy has been shown to improve survival and tumor related symptoms in the frontline setting, second-line therapy(SLT) is subject to much debate in the scientific community, mainly because of the debilitating effects of GC, which would impede the administration of cytotoxic therapy. Recent data has provided sufficient evidence for the safe use of SLT in patients with an adequate performance status. Taxanes, Irinotecan and even some Fluoropyrimidine analogs were found to provide a survival advantage in this subset of patients. Most importantly, quality of life measures were also improved through the use of adequate therapy. Even more pertinent were the findings involving antiangiogenic agents, which would add measurable improvements without significantly jeopardizing the patients' well-being. Further lines of therapy are cause for much more debate nowadays, but specific targeted agents have shown considerable promise in this context. We herein review noteworthy published data involving the use of additional lines of the therapy after failure of standard frontline therapies in patients with a GC. 展开更多
关键词 Advanced GASTRIC cancer treatment second-line CYTOTOXIC TARGETED therapy
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Fourteen- vs seven-day bismuth-based quadruple therapy for second-line Helicobacter pylori eradication 被引量:3
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作者 Jae Jin Hwang Dong Ho Lee +4 位作者 Ae-Ra Lee Hyuk Yoon Cheol Min Shin Young Soo Park Nayoung Kim 《World Journal of Gastroenterology》 SCIE CAS 2015年第26期8132-8139,共8页
AIM: To compare the efficacy of 14- and 7-d bismuthbased quadruple therapies as second-line eradication treatment for Helicobacter pylori(H.pylori) infection.METHODS: Between 2004 and 2014,the medical records of 790 p... AIM: To compare the efficacy of 14- and 7-d bismuthbased quadruple therapies as second-line eradication treatment for Helicobacter pylori(H.pylori) infection.METHODS: Between 2004 and 2014,the medical records of 790 patients who had experienced failure of first-line proton pump inhibitor(PPI)-based eradication therapy and were then treated with bismuth-based quadruple therapy were retrospectively reviewed.Those who received bismuth-based quadruple therapy [PPI,bismuth,metronidazole,and tetracycline(PBMT)] for either 7 d or 14 d were assigned to a PBMT-7 group(n = 543) or a PBMT-14 group(n = 247),respectively.The eradication rates for both groups were determined by intention-to-treat(ITT) and per-protocol(PP) analyses.ITT analysis compared the treatment groups as originally allocated while the PP analysis including only those patients who had completed the treatment as originally allocated.Successful eradication therapy for H.pylori infection was defined as a negative 13C-urea breath test 4 wk after the end of eradication treatment.RESULTS: The overall ITT eradication rate was 69.1%(546/790).Final ITT eradication rates were 67.4%(366/543; 95%CI: 63.1%-71.7%) in the PBMT-7 group and 72.8%(180/247; 95%CI: 67.4%-78.2%) in the PBMT-14 group(P = 0.028).The overall PP eradication rate was 80.0%(546/682),and the final PP eradication rates were 78.2%(366/468; 95%CI: 72.1%-84.0%) in the PBMT-7 group and 84.1%(180/214; 95%CI: 76.8%-90.8%) in the PBMT-14 group(P = 0.009).The H.pylori eradication rates in the PBMT-14 group weresignificantly higher than in the PBMT-7 group according to both ITT(P = 0.028) and PP analysis(P = 0.009).Compliance was similar in both groups(PBMT-7 group: 97.9%; PBMT-14 group: 96.4%).Adverse event rates were 10.7%(51/478) and 17.1%(38/222) in the PBMT-7 and PBMT-14 groups,respectively(P = 0.487).CONCLUSION: The 14-d bismuth-based quadruple therapy is a significantly more effective second-line eradication treatment for H.pylori infection than the 7-d alternative. 展开更多
关键词 HELICOBACTER PYLORI treatment failure second-line treatment BISMUTH ERADICATION rate
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Efficacy of 14-d vs 7-d moxifloxacin-based triple regimens for second-line Helicobacter pylori eradication 被引量:2
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作者 Jae Jin +15 位作者 Hwang Dong Ho Lee Ae-Ra Lee Hyuk Yoon Cheol Min Shin Young Soo Park Nayoung Kim 《World Journal of Gastroenterology》 SCIE CAS 2015年第18期5568-5574,共7页
AIM: To evaluate the efficacy of the 14-d moxifloxacinbased triple therapy for the second-line eradication of Helicobacter pylori(H. pylori) infection.METHODS: Between 2011 and 2013, we conducted a retrospective revie... AIM: To evaluate the efficacy of the 14-d moxifloxacinbased triple therapy for the second-line eradication of Helicobacter pylori(H. pylori) infection.METHODS: Between 2011 and 2013, we conducted a retrospective review of the medical records of 160 patients who had experienced failure of their first-line proton pump inhibitor-based eradication therapy and subsequently received the moxifloxacin-based triple therapy as a second-line eradication treatment regimen. The patients who were treated with the moxifloxacinbased triple therapy(oral 20 mg rabeprazole b.i.d., 1000 mg amoxicillin b.i.d., and 400 mg moxifloxacin q.d.) for 7 d were assigned to the RAM-7 group(n = 79) while those who took them for 14 days were assigned to RAM-14 group(n = 81). The eradication rates for both groups were determined by intentionto-treat(ITT) and per-protocol(PP) analyses. ITT analysis compared the treatment groups as originally allocated while the PP analysis including only those patients who had completed the treatment as originally allocated. Successful eradication therapy for H. pylori infection was defined as the documentation of a negative 13C-urea breath test 4 wk after the end of the eradication treatment.RESULTS: The overall ITT eradication rate was 76.2%(122/160). The final ITT eradication rates were 70.8%(56/79; 95%CI: 63.3%-77.1%) in the RAM-7 group and 81.4%(66/81; 95%CI: 74.6%-88.3%) in the RAM-14 group(P = 0.034). The overall PP eradication rate was 84.1%(122/145), and the final PP eradication rates were 77.7%(56/72; 95%CI: 70.2%-85.3%) in the RAM-7 group and 90.4%(66/73; 95%CI: 82.8%-98.1%) in the RAM-14 group(P = 0.017). The H. pylori-eradication rates in the RAM-14 group were significantly higher compared with that of the RAM-7 group according to both the ITT(P = 0.034) and the PP analyses(P = 0.017). Both groups exhibited good treatment compliance(RAM-7/RAM-14 group: 100%/100%). The adverse event rates were19.4%(14/72)and 20.5%(15/73)in the RAM-7 and RAM-14 groups,respectively(P=0.441).Adverse events occurred in 14 of the 72 patients(19.4)in the RAM-7 group and in 15 of the 73 patients(20.5)in the RAM-14 group.No statistically significant differences(P=0.441)were observed.CONCLUSION:The 14-d moxifloxacin-based triple therapy is a significantly more effective secondline eradication treatment as compared to the 7-d alternative for H.pylori infection in South Korea. 展开更多
关键词 HELICOBACTER PYLORI treatment failure second-line treatment MOXIFLOXACIN Eradication rate
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Safety and Efficacy of Racotumomab-Alum Vaccine as Second-Line Therapy for Advanced Non-Small Cell Lung Cancer
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作者 Eduardo Santiesteban Leslie Perez +10 位作者 Sailyn Alfonso Elia Neninger Soraida Acosta Yoana Flores Maurenis Hernandez Carmen Viada Robin García Meylán Cepeda Daymys Estevez Yoisbel Moreno Amparo Macías 《International Journal of Clinical Medicine》 2014年第14期844-850,共7页
Despite extensive clinical research in non-small cell lung cancer (NSCLC), overall survival is still poor. Racotumomab-alum is an anti-idiotypic cancer vaccine that targets NeuGcGM3 tumor associated ganglioside. The a... Despite extensive clinical research in non-small cell lung cancer (NSCLC), overall survival is still poor. Racotumomab-alum is an anti-idiotypic cancer vaccine that targets NeuGcGM3 tumor associated ganglioside. The aim of this study was to evaluate safety and efficacy of racotumomab-alum in advanced NSCLC patients with progressive disease. This expanded access program included 86 histologically confirmed NSCLC patients, 18 years or older age, with advanced disease and without therapeutic option, with ECOG performance status ≤3, adequate organ functions and signed informed consent. The primary endpoint was overall survival and toxicity was measure assessed treatment-related toxicity according CTCAEv3. The study was approved by ethical review boards of participant institutions. Racotumomab-alum treatment consisted in 5 biweekly intradermal doses (1 mg/mL) during the induction phase of treatment (2 months). The maintenance phase consisted in monthly re-immunizations until unacceptable toxicity or PS worsening. The median overall survival time of all patients treated with racotumomab-alum was 8.96 months. The survival rates at 12 and 24 months were 42.8% and 28.0%, respectively. Patients that completed the induction phase of treatment (five doses or more) reached a median OS of 12.1 months. The most common adverse events were injection site reaction, bone pain, cough and asthenia. Racotumomab-alum cancer vaccine could be considered an effective and safe treatment option as second-line therapy for advanced NSCLC. Further clinical studies should be conducted to confirm this result. 展开更多
关键词 NON-SMALL Cell LUNG CANCER CANCER VACCINE second-line treatment
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德曲妥珠单抗对比化疗方案二线治疗HER-2低表达晚期乳腺癌的经济学评价
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作者 李雪 贾才凤 +3 位作者 郑颖 张森 王美祺 王明霞 《中国药房》 CAS 北大核心 2024年第19期2383-2390,共8页
目的 从我国卫生体系角度出发,评价德曲妥珠单抗方案对比医生选择化疗(TPC)方案二线治疗人表皮生长因子受体2(HER-2)低表达晚期乳腺癌的经济性。方法 基于DESTINY-Breast04临床试验数据构建动态Markov模型,模拟时限为10年,循环周期为3... 目的 从我国卫生体系角度出发,评价德曲妥珠单抗方案对比医生选择化疗(TPC)方案二线治疗人表皮生长因子受体2(HER-2)低表达晚期乳腺癌的经济性。方法 基于DESTINY-Breast04临床试验数据构建动态Markov模型,模拟时限为10年,循环周期为3周。以成本、质量调整生命年(QALY)、增量成本-效果比(ICER)作为模型产出指标,采用5%的贴现率,以3倍2023年我国人均国内生产总值(GDP)作为意愿支付(WTP)阈值,采用成本-效用分析法分析激素受体阳性队列和所有患者队列中两种治疗方案的经济性,再通过不确定性分析验证基础分析结果的稳健性。结果 基础分析结果显示,德曲妥珠单抗方案与TPC方案相比,在激素受体阳性队列和所有患者队列中的ICER值分别为1 045 655.76、906 404.99元/QALY,均高于WTP阈值(268 074元/QALY)。单因素敏感性分析结果显示,疾病无进展状态效用值、德曲妥珠单抗价格、疾病进展状态效用值等参数对模型结果影响较大。概率敏感性分析结果显示,当WTP阈值为3倍2023年我国人均GDP时,德曲妥珠单抗方案具有经济性的概率为0。情境分析结果显示,在考虑援助计划时,德曲妥珠单抗方案具有经济性的概率为0;当德曲妥珠单抗价格降低70%时,该方案具有经济性的概率显著提高至82.80%。结论 在以3倍2023年我国人均GDP作为WTP阈值时,德曲妥珠单抗方案相对于TPC方案二线治疗HER-2低表达晚期乳腺癌不具有经济性;按地区适当降低德曲妥珠单抗的价格,可以提高其经济性。 展开更多
关键词 德曲妥珠单抗 晚期乳腺癌 HER-2低表达 二线治疗 MARKOV模型 药物经济学
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10-羟基喜树碱为主的非铂方案治疗复治非小细胞肺癌前瞻性临床研究 被引量:4
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作者 沈洁 韩宝惠 +11 位作者 姜丽岩 赵怡卓 顾爱琴 周箴 冯光丽 施春雷 纪灏 熊丽纹 钟华 储天晴 张伟 李蓉 《上海医学》 CAS CSCD 北大核心 2005年第6期469-471,共3页
目的评价10-羟基喜树碱(拓僖,HCPT)联合异环磷酰胺(IFO)化疗方案治疗进展期铂类耐药非小细胞肺癌(NSCLC)的有效性及安全性。方法经组织和(或)细胞学证实的Ⅲb~Ⅳ期NSCLC患者,曾有≥2次标准含铂方案联合化疗史。化疗方案为HCPT6mg/m2,d1~... 目的评价10-羟基喜树碱(拓僖,HCPT)联合异环磷酰胺(IFO)化疗方案治疗进展期铂类耐药非小细胞肺癌(NSCLC)的有效性及安全性。方法经组织和(或)细胞学证实的Ⅲb~Ⅳ期NSCLC患者,曾有≥2次标准含铂方案联合化疗史。化疗方案为HCPT6mg/m2,d1~4;IFO1.2g/m2,d1~3;每4周重复1次。结果29例患者入组,化疗后部分缓解(PR)3例、无变化(NC)20例、疾病进展(PD)6例,治疗总有效率为13.6%,疾病控制率为72.7%,中位生存期为10.3个月。中位疾病进展时间为4.2个月。化疗的毒副反应主要为白细胞计数中度下降、轻或中度胃肠道反应及皮疹。结论HCPT联合IFO作为铂类耐药的复治方案治疗进展期NSCLC有较好的疗效及安全性。 展开更多
关键词 10-羟基喜树碱 非铂方案 非小细胞肺癌 毒副反应 化学治疗
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单药PD-1抑制剂对比化疗二线治疗晚期食管鳞状细胞癌的Meta分析 被引量:1
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作者 魏瑜 刘娟 +3 位作者 马晓丽 曹雷雨 高艳 张莉 《中国肿瘤生物治疗杂志》 CAS CSCD 北大核心 2022年第4期338-344,共7页
目的:系统评价单药程序性死亡受体1(PD-1)抑制剂对比化疗二线治疗晚期食管鳞状细胞癌(ESCC)患者的疗效及安全性,以期为临床决策提供最佳循证医学证据。方法:计算机检索The Cochrane Library、Web of Science、PubMed、EMbase、CNKI和万... 目的:系统评价单药程序性死亡受体1(PD-1)抑制剂对比化疗二线治疗晚期食管鳞状细胞癌(ESCC)患者的疗效及安全性,以期为临床决策提供最佳循证医学证据。方法:计算机检索The Cochrane Library、Web of Science、PubMed、EMbase、CNKI和万方等数据库,同时检索J Clin Oncol、N England Oncol、Lancet Oncol等杂志以及ASCO、EMSO会议摘要中有关单药PD-1抑制剂对比传统化疗二线治疗晚期ESCC患者的临床随机对照试验(RCT),筛选文献,提取资料,采用RevMan5.3进行Meta分析。结果:共纳入5项RCT研究(1732例患者)。与化疗组比,单药PD-1抑制剂二线治疗晚期ESCC可显著延长患者的总生存期(OS)(HR=0.75,95%CI:0.67~0.83,P<0.00001)。以PD-L1不同表达程度进行亚组分析,在延长OS方面,TPS<1%时,单药PD-1抑制剂二线治疗晚期ESCC无明显优势;而TPS≥1%、TPS<5%、TPS≥5%、TPS<10%、TPS≥10%时,单药PD-1抑制剂二线治疗均可显著延长晚期ESCC患者的OS,且PD-L1表达程度越高,疗效获益更显著。然而,与化疗组比,单药PD-1抑制剂在延长晚期ESCC患者的无进展生存期(PFS)(HR=0.93,95%CI:0.79~1.10,P=0.41)及提高客观有效率(ORR)(RR=1.62,95%CI:0.95~2.74,P=0.07)等方面,差异均无统计学意义。但单药PD-1抑制剂组3~5级不良反应发生率低(RR=0.37,95%CI:0.28~0.50,P<0.00001)。结论:单药PD-1抑制剂二线治疗晚期ESCC患者可显著延长患者的OS;PD-L1高表达者PD-1抑制剂可作为二线治疗的优先选择,且具有良好的安全性。 展开更多
关键词 PD-1抑制剂 化疗 二线治疗 晚期食管鳞癌 META分析
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基于两种模型的帕博利珠单抗二线治疗晚期肝细胞癌的成本-效用分析 被引量:6
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作者 孟蕊 周挺 +3 位作者 石丰豪 王子婧 罗孟捷 马爱霞 《中国药房》 CAS 北大核心 2021年第22期2761-2766,共6页
目的:评价帕博利珠单抗二线治疗我国晚期肝细胞癌患者的经济性。方法:从我国卫生体系角度出发,同时建立三状态分区生存模型及Markov模型,评价帕博利珠单抗对比安慰剂二线治疗我国晚期肝细胞癌患者的成本及效用,模型循环周期为3周,研究... 目的:评价帕博利珠单抗二线治疗我国晚期肝细胞癌患者的经济性。方法:从我国卫生体系角度出发,同时建立三状态分区生存模型及Markov模型,评价帕博利珠单抗对比安慰剂二线治疗我国晚期肝细胞癌患者的成本及效用,模型循环周期为3周,研究时限为终生;采用单因素敏感性分析、概率敏感性分析以及情境分析验证基础分析结果的稳健性。结果:分区生存模型分析结果表明,使用帕博利珠单抗二线治疗我国晚期肝细胞癌患者的增量成本-效果比(ICER)为1266846.18元/QALY,远超3倍2020年我国人均国内生产总值(GDP)。单因素敏感性分析结果表明,对ICER影响最大的3个参数分别为安慰剂组无进展生存期(PFS)状态效用值、帕博利珠单抗组PFS状态效用值以及帕博利珠单抗成本。概率敏感性分析结果验证了基础分析的稳健性。情境分析结果表明,在考虑帕博利珠单抗慈善赠药的情况下,其治疗成本大幅下降,虽仍不具经济性,但其ICER接近于3倍2020年我国人均GDP。当意愿支付阈值分别为1、3倍我国人均GDP时,帕博利珠单抗(100 mg)具有经济性的价格分别为4157.67、5829.24元。Markov模型分析结果与分区生存模型相似。结论:在1~3倍2020年我国人均GDP的意愿支付阈值下,帕博利珠单抗方案用于我国晚期肝细胞癌患者的二线治疗不具经济性。 展开更多
关键词 帕博利珠单抗 晚期肝细胞癌 二线治疗 分区生存模型 MARKOV模型 成本-效用分析 情境分析
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Autoimmune hepatitis: standard treatment and systematic review of alternative treatments 被引量:26
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作者 Benedetta Terziroli Beretta-Piccoli Giorgina Mieli-Vergani Diego Vergani 《World Journal of Gastroenterology》 SCIE CAS 2017年第33期6030-6048,共19页
Autoimmune hepatitis is a rare chronic inflammatory liver disease,affecting all ages,characterised by elevated transaminase and immunoglobulin G levels,positive autoantibodies,interface hepatitis at liver histology an... Autoimmune hepatitis is a rare chronic inflammatory liver disease,affecting all ages,characterised by elevated transaminase and immunoglobulin G levels,positive autoantibodies,interface hepatitis at liver histology and good response to immunosuppressive treatment. If untreated,it has a poor prognosis. The aim of this review is to summarize the evidence for standard treatment and to provide a systematic review on alternative treatments for adults and children. Standard treatment is based on steroids and azathioprine,and leads to disease remission in 80%-90% of patients. Alternative first line treatment has been attempted with budesonide or cyclosporine,but their superiority compared to standard treatment remains to be demonstrated. Second-line treatments are needed for patients not responding or intolerant to standard treatment. No randomized controlled trials have been performed for second-line options. Mycophenolate mofetil is the most widely used second-line drug,and has good efficacy particularly for patients intolerant to azathioprine,but has the major disadvantage of being teratogenic. Only few and heterogeneous data on cyclosporine,tacrolimus,everolimus and sirolimus are available. More recently,experience with the anti-tumour necrosis factoralpha infliximab and the anti-CD20 rituximab has been published,with ambivalent results; these agents may have severe side-effects and their use should be restricted to specialized centres. Clinical trials with new therapeutic options are ongoing. 展开更多
关键词 Autoimmune hepatitis Standard treatment second-line treatment ADULTS CHILDREN
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Prevalence and Risk Factors of Adverse Drug Reactions Associated Multidrug Resistant Tuberculosis Treatments in Selected Treatment Centers in Addis Ababa Ethiopia
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作者 Haregewoin Bezu Daniel Seifu +1 位作者 Getnet Yimer Tesfamariam Mebrhatu 《Journal of Tuberculosis Research》 2014年第3期144-154,共11页
Introduction: The key to successful elimination of tuberculosis (TB) is treatment of cases with optimum chemotherapy. Irrational anti-TB drug use over time has led to drug-resistant TB. The treatment of MDR-TB with se... Introduction: The key to successful elimination of tuberculosis (TB) is treatment of cases with optimum chemotherapy. Irrational anti-TB drug use over time has led to drug-resistant TB. The treatment of MDR-TB with second line drugs is long, complex and costly, and has a considerable rate of adverse effects. The level of ADR reporting is low in Ethiopia due to different factors. This Study conducted in a selected treated area in Addis Ababa, Ethiopia and helped the health care centers to understand the prevalence of ADR related MDR-TB and be aware of those adverse effects in order to detect them early and be prepared to take proper steps when they occur. Aim of the Study: To determine the prevalence and risk factor of adverse drug reactions associated treatments of Multidrug Resistant tuberculosis. Method: This was a cross sectional study, which was conducted between March 2012 and February 2013 at St. Peter TB specialized hospital and AHRI/ALERT. 73 MDR TB patients, who were on MDR TB treatments, enrolled to the study. Adverse Drug Reactions associated MDR TB treatments were assessed by patient history review and questionnaire. Chemistry laboratory was used to test renal function, thyroid function, liver enzyme and potassium level. Result: In 72 patients, at least two ADRs were found. The mean age of the study population (Mean ± SD) was 28 ± 8.8. In this study the most commonly found adverse drug reactions (ADRs) were: Anorexia 83.3%, Nausea and vomiting 82%, Gastritis 64%, Arteralgia 47%, Skin rash and itching 45%, Headache 29.2%, Depression 22.2% and Blurred vision 19.4%. Using binary logistic regression model older age (COR 8.71, 95% [CI] 1.06 - 71.9), alcoholism (COR 4.05, 95% [CI] 1.05 - 15.6), smoking (COR 0.24, 95% [CI] 0.06 - 0.87) and concomitant drug intake (COR 0.14, 95% [CI] 0.03 - 0.76) were independent predictors for ADRs. Conclusion: The prevalence of ADRs related MDR TB treatments is high. To minimize ADR occurrence, ADR predictors should be integrated into the clinical pathway. Monitoring of liver function, renal function, TSH and level of potassium during MDR TB treatment, helps to avoid complication caused by therapy and increase the adherence to the treatment. 展开更多
关键词 MDR TB ADR second line Anti-TB treatment
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含泊马度胺全口服方案二线治疗多发性骨髓瘤的疗效与安全性分析
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作者 肖洁 王秀菊 +5 位作者 谢双锋 李益清 张国扬 杨文娟 刘红云 聂大年 《中山大学学报(医学科学版)》 CAS CSCD 北大核心 2024年第6期902-911,共10页
【目的】评价含泊马度胺全口服治疗方案二线治疗多发性骨髓瘤的疗效与安全性。【方法】回顾性分析2020年3月至2023年12月在我中心接受含泊马度胺全口服方案作为二线治疗的多发性骨髓瘤患者共22例,评价其疗效与安全性。【结果】22例患中... 【目的】评价含泊马度胺全口服治疗方案二线治疗多发性骨髓瘤的疗效与安全性。【方法】回顾性分析2020年3月至2023年12月在我中心接受含泊马度胺全口服方案作为二线治疗的多发性骨髓瘤患者共22例,评价其疗效与安全性。【结果】22例患中位年龄为71.5岁,含泊马度胺的全口服二线治疗方案包括IPD 7例,PCD 11例,XPD 2例,PD 2例,中位治疗周期数为14,二线治疗ORR为63.64%,VGPR以上疗效为36.36%。有来那度胺暴露史的13例患者中,ORR为53.85%,VGPR以上疗效为23.08%;无来那度胺暴露史的9例患者中,ORR为77.78%,VGPR以上疗效为55.56%;两组ORR比较,差异无统计学意义(P=0.38)。伴遗传学高危的患者12例,ORR为50%,VGPR以上疗效为16.67%。整体中位随访时间10.6(2.0,39.3)个月,10例出现疾病进展,其中6例因原发病进展死亡,中位无进展生存期(PFS)尚未达到;其中来那度胺暴露的13例患者,中位PFS为10.6个月;非来那度胺暴露的9例患者,中位PFS未达到。≥3级不良事件占18.18%,包括粒细胞缺乏、血小板减少及肺部感染。没有导致死亡的治疗相关不良事件的发生。【结论】含泊马度胺全口服方案二线治疗多发性骨髓瘤具有较好的疗效及安全性,对有居家治疗意愿的老年多发性骨髓瘤患者具有积极的意义。 展开更多
关键词 泊马度胺 多发性骨髓瘤 二线治疗 疗效 安全性
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尼洛替尼与达沙替尼二线治疗慢性髓性白血病的成本效用分析
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作者 马玲 赵燕鸿 +1 位作者 刘佳 屠文莲 《昆明医科大学学报》 CAS 2024年第4期92-98,共7页
目的评估费城染色体阳性慢性髓性白血病慢性期(Ph+CML-CP)患者中对伊马替尼耐药或不耐受的二线尼洛替尼与达沙替尼的成本效果。方法建立状态转移马尔可夫(Markov)模型进行成本效用分析,模型包括4种健康状态:慢性期(CP),加速期(AP),急变... 目的评估费城染色体阳性慢性髓性白血病慢性期(Ph+CML-CP)患者中对伊马替尼耐药或不耐受的二线尼洛替尼与达沙替尼的成本效果。方法建立状态转移马尔可夫(Markov)模型进行成本效用分析,模型包括4种健康状态:慢性期(CP),加速期(AP),急变期(BP)和死亡。尼洛替尼与达沙替尼治疗的无进展生存率,疾病进展发生率,总生存率等有关临床参数来源于既往发表的研究和专家意见,健康状态效用值来源于文献。通过Treeage软件以增量成本效果比(ICER)作为评价指标,对尼洛替尼和达沙替尼2个方案的总产出和总成本进行评价,并通过单变量、概率敏感性分析评估模型稳定性。结果与选用达沙替尼治疗相比,选用尼洛替尼治疗的ICER为182487.71元·QALY^(-1),低于3倍2021年全国人均GDP。敏感性分析显示主要的影响参数有贴现率,达沙替尼价格和尼洛替尼价格,模型结果稳定。结论选用尼洛替尼相对达沙替尼用于对伊马替尼耐药或不耐受的Ph+CML-CP患者治疗具有成本效用优势。 展开更多
关键词 尼洛替尼 达沙替尼 慢性髓性白血病 成本效果分析 二线治疗
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帕博利珠单抗和纳武利尤单抗二线治疗晚期非小细胞肺癌的经济性评价
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作者 曾晨欣 朱亚兰 +1 位作者 张照伟 张霞 《实用药物与临床》 CAS 2024年第9期648-654,共7页
目的评价晚期非小细胞肺癌二线治疗药物帕博利珠单抗、纳武利尤单抗的经济性。方法基于医疗卫生角度,构建动态Markov模型,模拟至99%患者死亡时,产生的医疗成本和质量调整生命年(Qualityadjusted life years,QALYs)。临床参数来自临床试... 目的评价晚期非小细胞肺癌二线治疗药物帕博利珠单抗、纳武利尤单抗的经济性。方法基于医疗卫生角度,构建动态Markov模型,模拟至99%患者死亡时,产生的医疗成本和质量调整生命年(Qualityadjusted life years,QALYs)。临床参数来自临床试验和间接比较。成本数据和效用值取自相关网站和已发表的文献。敏感性分析用于评估模型参数的不确定性。结果基础分析结果显示,纳武利尤单抗方案的治疗成本为278634元,获得的QALYs为0.88,帕博利珠单抗方案的治疗成本为232596元,QALYs为0.86,两者的增量成本-效果比(Incremental cost effectiveness ratio,ICER)为2301900元/QALY,均远高于支付阈值(257094元)。单因素敏感性分析显示,药品价格、无进展生存期对ICER的影响较大。结论在当前支付阈值下,纳武利尤单抗较帕博利珠单抗无经济性优势,两者的成本和QALYs值差异不大,药品价格变动极有可能逆转经济性结论。 展开更多
关键词 非小细胞肺癌 二线治疗 MARKOV模型 成本-效用分析
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卡瑞利珠单抗联合白蛋白结合型紫杉醇二线治疗晚期胃癌的疗效及安全性探讨
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作者 王品昊 《中国现代药物应用》 2024年第16期103-106,共4页
目的观察晚期胃癌治疗中采用卡瑞利珠单抗联合白蛋白结合型紫杉醇二线治疗的效果。方法80例晚期胃癌患者,以随机数字表法分组为对照组和联合组,每组40例。对照组采用卡瑞利珠单抗注射治疗,联合组采用卡瑞利珠单抗联合白蛋白结合型紫杉... 目的观察晚期胃癌治疗中采用卡瑞利珠单抗联合白蛋白结合型紫杉醇二线治疗的效果。方法80例晚期胃癌患者,以随机数字表法分组为对照组和联合组,每组40例。对照组采用卡瑞利珠单抗注射治疗,联合组采用卡瑞利珠单抗联合白蛋白结合型紫杉醇二线治疗。对比两组患者临床疗效、治疗前后肿瘤标志物指标及不良反应发生率。结果经治疗联合组治疗总有效率95.00%高于对照组的77.50%,数据差异显著(P<0.05)。治疗后,联合组甲胎蛋白(26.45±5.52)μg/L、癌胚抗原(7.29±2.12)μg/L、前列腺特异抗原(6.20±1.28)μg/L、癌抗原19-9(38.46±7.12)U/ml低于对照组的(35.42±5.67)μg/L、(10.44±3.18)μg/L、(9.88±2.20)μg/L、(46.76±7.33)U/ml,数据差异显著(P<0.05)。治疗后联合组不良反应发生率25.00%高于对照组的20.00%,但无明显数据差异(P>0.05)。结论对晚期胃癌患者采用卡瑞利珠单抗联合白蛋白结合型紫杉醇二线治疗方案,可实现对患者肿瘤标志物水平的调节,有效改善临床症状,提升临床疗效,同时不良反应同单一用药方法相比相近,呈现出一定安全性,值得临床应用。 展开更多
关键词 卡瑞利珠单抗 白蛋白结合型紫杉醇 二线治疗 晚期胃癌 疗效 安全性
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泽布替尼二线治疗套细胞淋巴瘤的临床观察
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作者 邱流进 赖咏婷 +2 位作者 詹涛 肖威 曾庆芳 《中国现代医生》 2024年第29期69-72,91,共5页
目的探讨泽布替尼二线治疗套细胞淋巴瘤的临床疗效。方法选取2020年10月至2021年12月赣州市肿瘤医院收治的套细胞淋巴瘤患者80例作为研究对象。采用抽签法将患者分为观察组与对照组,每组40例。对照组患者采取套细胞淋巴瘤的一线联合苯... 目的探讨泽布替尼二线治疗套细胞淋巴瘤的临床疗效。方法选取2020年10月至2021年12月赣州市肿瘤医院收治的套细胞淋巴瘤患者80例作为研究对象。采用抽签法将患者分为观察组与对照组,每组40例。对照组患者采取套细胞淋巴瘤的一线联合苯达莫司汀治疗,观察组患者在一线治疗基础上联合泽布替尼进行二线治疗,随访时间2年,评估比较两组患者的临床疗效、肿瘤标志物水平、免疫功能、生存周期、治疗安全性。结果观察组患者的客观缓解率、疾病控制率均高于对照组(P<0.05)。治疗后,观察组患者的乳酸脱氢酶、β2微球蛋白、癌胚抗原均低于对照组(P<0.05)。治疗后,观察组患者的免疫功能指标优于对照组(P<0.05)。观察组患者的无进展生存期、总生存期均高于对照组(P<0.05)。两组的不良反应发生率差异无统计学意义(P>0.05)。结论泽布替尼二线治疗套细胞淋巴瘤效果良好,可降低肿瘤标志物水平,改善患者的免疫功能,延长预后生存期,治疗安全性好。 展开更多
关键词 套细胞淋巴瘤 二线治疗 泽布替尼 临床疗效
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恩沃利单抗联合阿帕替尼二线治疗复发/转移程序性死亡受体配体1阳性晚期宫颈癌患者的效果
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作者 万晶晶 韩永清 《癌症进展》 2024年第10期1123-1126,共4页
目的 探讨恩沃利单抗联合阿帕替尼二线治疗复发/转移程序性死亡受体配体1(PD-L1)阳性晚期宫颈癌患者的效果。方法 根据治疗方法的不同将70例复发/转移PD-L1阳性晚期宫颈癌患者分为观察组(n=39,恩沃利单抗联合阿帕替尼二线治疗)和对照组(... 目的 探讨恩沃利单抗联合阿帕替尼二线治疗复发/转移程序性死亡受体配体1(PD-L1)阳性晚期宫颈癌患者的效果。方法 根据治疗方法的不同将70例复发/转移PD-L1阳性晚期宫颈癌患者分为观察组(n=39,恩沃利单抗联合阿帕替尼二线治疗)和对照组(n=31,阿帕替尼二线治疗),比较两组患者的肿瘤标志物[血管内皮生长因子(VEGF)、鳞状细胞癌抗原(SCCA)]水平、免疫功能指标(CD3^(+)、CD4^(+)、CD8^(+)、CD4^(+)/CD8^(+))、临床疗效及不良反应发生情况。结果 治疗后,两组患者VEGF、SCCA、CD8^(+)水平均低于本组治疗前,CD3^(+)、CD4^(+)水平及CD4^(+)/CD8^(+)均高于本组治疗前,观察组患者VEGF、SCCA、CD8^(+)水平均低于对照组,CD3^(+)、CD4^(+)水平及CD4^(+)/CD8^(+)均高于对照组,差异均有统计学意义(P﹤0.05)。观察组患者的总有效率高于对照组,差异有统计学意义(P﹤0.05)。两组患者的不良反应总发生率比较,差异无统计学意义(P﹥0.05)。结论 恩沃利单抗联合阿帕替尼二线治疗复发/转移PD-L1阳性晚期宫颈癌患者,能够降低肿瘤标志物水平,提高患者的免疫功能,具有较好的临床疗效,且安全性高。 展开更多
关键词 恩沃利单抗 阿帕替尼 宫颈癌 程序性死亡受体配体1 二线治疗
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雷替曲塞或氟尿嘧啶联合伊立替康二线治疗晚期结直肠癌疗效分析 被引量:19
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作者 王俊斌 吴穷 +3 位作者 邹维艳 汪子书 杨燕 郑荣生 《肿瘤防治研究》 CAS CSCD 北大核心 2014年第12期1335-1338,共4页
目的观察雷替曲塞或氟尿嘧啶联合伊立替康二线治疗晚期结直肠癌的近期疗效和不良反应。方法对蚌埠医学院第一附属医院收治的52例经一线FOLFOX方案治疗失败的晚期结直肠癌患者进行二线治疗。A组(25例)化疗方案为雷替曲塞联合伊立替康,B组... 目的观察雷替曲塞或氟尿嘧啶联合伊立替康二线治疗晚期结直肠癌的近期疗效和不良反应。方法对蚌埠医学院第一附属医院收治的52例经一线FOLFOX方案治疗失败的晚期结直肠癌患者进行二线治疗。A组(25例)化疗方案为雷替曲塞联合伊立替康,B组(27例)化疗方案为氟尿嘧啶联合伊立替康及亚叶酸钙,比较两组二线治疗的临床疗效、不良反应及生存情况。结果 A组和B组有效率分别为36%和11.5%,差异有统计学意义(P﹤0.05),疾病控制率分别为76.0%和57.7%,差异无统计学意义(P>0.05),中位疾病进展时间分别为6.0月和4.5月,差异无统计学意义(P>0.05)。结论雷替曲塞联合伊立替康方案二线治疗晚期结直肠癌疗效肯定,不良反应能耐受,使用方便,值得临床上推荐使用。 展开更多
关键词 结直肠癌 二线治疗 雷替曲塞 伊立替康 氟尿嘧啶 亚叶酸钙
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三药联合化疗和单药拓扑替康二线治疗小细胞肺癌的疗效和安全性比较 被引量:18
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作者 张良 刘显红 +2 位作者 柳影 白连伟 程颖 《中国肿瘤临床》 CAS CSCD 北大核心 2019年第3期133-137,共5页
目的:比较顺铂、依托泊苷、伊立替康联合化疗方案和单药拓扑替康二线治疗敏感复发型小细胞肺癌(smalll cell lung cancer,SCLC)的疗效和安全性。方法:收集2014年9月至2017年9月吉林省肿瘤医院就诊78例患者资料,筛选敏感复发型小细胞肺... 目的:比较顺铂、依托泊苷、伊立替康联合化疗方案和单药拓扑替康二线治疗敏感复发型小细胞肺癌(smalll cell lung cancer,SCLC)的疗效和安全性。方法:收集2014年9月至2017年9月吉林省肿瘤医院就诊78例患者资料,筛选敏感复发型小细胞肺癌患者,其中36例患者给予顺铂、依托泊苷、伊立替康联合化疗方案,42例患者给予单药拓扑替康化疗。联合化疗组药物用法:顺铂25mg/m^2,第1天、第8天静脉滴注;依托泊苷60mg/m^2,第1、2、3天静脉滴注;伊立替康90mg/m^2,第8天静脉滴注,连续给予5个2周方案的化疗。单药拓扑替康组药物用法:拓扑替康1.5mg/m^2,第1~5天静脉滴注,每3周1个周期。评价两组治疗方案的无进展生存时间(progression-free survival,PFS)、总生存时间(overall survival,OS)及安全性。结果:联合化疗组中位无进展生存时间(mPFS)5.3个月(95%CI:4.3~5.8),拓扑替康组mPFS 3.2个月(95%CI:2.7~4.0),差异具有统计学意义(P=0.003 0);联合化疗组中位总生存时间(mOS)16.3个月(95%CI:13.8~19.1),拓扑替康组mOS 13.1个月,差异具有统计学意义(P=0.009 7)。联合化疗组和单药拓扑替康组常见的3/4级不良事件主要有中性粒细胞下降[31例(86.1%)vs. 28例(66.7%)]、白细胞下降[29例(80.6%)vs. 21例(50.0%)]、贫血[26例(72.2%)vs. 10例(23.8%)]、血小板下降[13(36.1%)vs. 11(26.2%)]。联合化疗组发生1例治疗相关死亡(发热性中性粒细胞下降合并肺部感染),拓扑替康组无治疗相关的死亡发生。结论:顺铂、依托泊苷、伊立替康联合化疗方案比单药拓扑替康疗效更好,可考虑作为敏感复发型SCLC患者二线化疗的备选方案之一。两种化疗方案毒性均可耐受,但联合化疗组不良事件发生率更高,应进一步探索更为合适的化疗剂量。 展开更多
关键词 小细胞肺癌 敏感复发型 二线治疗 联合化疗 拓扑替康
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多西他赛联合异环磷酰胺方案与多西他赛单药方案二线治疗晚期非小细胞肺癌 被引量:22
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作者 崔成旭 张湘茹 +7 位作者 朱允中 杨树军 张祥福 徐光川 黄诚 刘端琪 郑玉红 储大同 《中国癌症杂志》 CAS CSCD 2006年第10期855-858,共4页
背景与目的:多西他赛(多西紫杉醇,进口药泰索帝,TXT)单药是晚期非小细胞肺癌二线治疗的标准治疗。本研究探讨多西他赛联合异环磷酰胺(IFO)方案与多西他赛单药治疗晚期非小细胞肺癌的疗效和不良反应。方法:随机对照研究56例非小细胞肺癌... 背景与目的:多西他赛(多西紫杉醇,进口药泰索帝,TXT)单药是晚期非小细胞肺癌二线治疗的标准治疗。本研究探讨多西他赛联合异环磷酰胺(IFO)方案与多西他赛单药治疗晚期非小细胞肺癌的疗效和不良反应。方法:随机对照研究56例非小细胞肺癌病例。共设立两组,T组:多西他赛单药方案;TI组:多西他赛联合异环磷酰胺方案。结果:PR:T组6例(23.0%);TI组7例(23.3%)。NC:T组9例(34.6%);TI组14例(46.7%)。PD:T组8例(30.8%);TI组8例(26.7%)。NE:T组3例(11.5%);TI组1例(3.3%)。两组相比,差异无显著性(P=0.6425)。1年生存率:T组21.2%;TI组22.0%。中位生存期:T组237.0 d;TI组226.0 d。两组相比,差异无显著性(P=0.8815)。中位肿瘤进展时间:T组157.1 d;TI组69.8 d。差异有显著统性(P=0.0039)。T组Ⅲ/Ⅳ度血小板减少为53.8%,TI组为16.7%,差异有非常显著性(P=0.0056)。T组Ⅲ/Ⅳ度中性粒细胞减少为65.4%,TI组为33.3%,差异有显著性(P=0.0137)。结论:多西他赛联合异环磷酰胺方案在非小细胞肺癌二线治疗中是安全、有效的,但是与多西他赛单药方案比较,有效率和生存期差异均无显著性。 展开更多
关键词 多西他赛 异环磷酰胺 非小细胞肺癌 二线治疗
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