奥沙利铂联合替吉奥治疗晚期胰腺癌疗效观察

目的评价奥沙利铂联合替吉奥治疗晚期胰腺癌的临床疗效。方法选取50例晚期胰腺癌患者随机分为奥沙利铂联合替吉奥组(观察组)和吉西他滨单药组(对照组),每组25例。观察组患者化学治疗方案为奥沙利铂130 mg·m-2,静脉滴注,第1天,替吉奥40 mg·m-2,口服,每日2次,第1天至第14天,21 d为1个周期;对照组患者化学治疗方案为吉西他滨1 000 mg·m-2,静脉滴注,第1天,第8天,21 d为1个周期。观察2组患者的无进展生存期、客观缓解率、总生存期及药物安全性。结果观察组患者中位无进展生存期明显长于对照组(6.2个月vs 3.6个月,RR=0.64,P=0.036);观察组患者的客观缓解率为28.0%,高于对照组的8.0%(P=0.035);观察组患者的中位总生存期长于对照组(13.0个月vs 8.5个月,RR=0.72,P=0.104),但差异无统计学意义(P>0.05)。2组患者3/4级不良反应相似。结论奥沙利铂联合替吉奥治疗晚期胰腺癌与吉西他滨单药相比,疗效更优,且不良反应相似,联合用药未增加药物毒性,值得进一步开展大规模的Ⅲ期临床研究。     

奥沙利铂联合亚叶酸钙、替加氟对胃肠道肿瘤行时辰化疗的临床观察

目的观察奥沙利铂联合亚叶酸钙和替加氟时辰输注法治疗胃肠道肿瘤的近期疗效及毒性反应。方法 80例患者随机分为时辰化疗组40例,采用时辰化疗法给予奥沙利铂、亚叶酸钙、替加氟;常规化疗组40例,常规给予奥沙利铂、亚叶酸钙、替加氟,均21 d为1周期,3个周期后评定两组的近期疗效和不良反应。结果时辰化疗组与常规化疗组的有效率分别为57.5%和32.5%（P〈0.05）,KPS评分显效率分别是62.5%和35%（P〈0.05）,不良反应发生率分别是15.3%和29.7%（P〈0.05）。结论奥沙利铂联合亚叶酸钙、替加氟的时辰化疗方案有效率高,不良反应小。     

喃氟啶和尿嘧啶复方制剂的紫外分光解线性方程法测定

在中性缓冲溶液中，用紫外分光解线性方程法，直接同时测定复方胶囊中喃氟啶（１）和尿嘧啶（２）的含量。辅料无干扰，方法简便、快速、准确。     

Oral uracil‐tegafur plus leucovorin vs fluorouracil bolus plus leucovorin for advanced colorectal cancer: a meta‐analysis of five randomized controlled trials

Aim The aim of this study was to evaluate systematically the efficacy and safety of oral uracil‐tegafur (UFT) plus leucovorin (LV) compared with infusional fluorouracil (5‐FU) plus LV for advanced colorectal cancer. Method Eligible studies were identified from Medline, Embase and the Cochrane Library. The end‐points included overall survival and overall tumour response rate, and toxicity including leucopenia, febrile neutropenia, stomatitis/mucositis and diarrhoea. Results Five randomized controlled trials were identified. Pooled data demonstrated no difference in overall survival between the oral UFT plus LV regimen and the 5‐FU bolus plus LV regimen [hazard ratio 1.013; 95% confidence interval (CI) 0.911–1.127].The fixed‐effect pooled estimate for overall tumour response rate showed no significant difference between the two regimens (relative risk 0.893; 0.672–1.187). Grade 3–4 leucopenia [odds ratio (OR) 0.126; 955 CI 0.048–0.326], grade 1–4 leucopenia (OR 0.089; 95% CI 0.067–0.119) and grade1–4 febrile neutropenia (OR 0.020; 95% CI 0.004–0.102) were significantly less prominent in the oral UFT regimens. For nonhaematological toxicities, grade 3–4 stomatitis/mucositis (OR 0.075; 95% CI 0.039–0.146), grade 3–4 infection (OR 0.484; 95% CI 0.310–0.758), grade 1–4 infection (OR 0.672; 95% CI 0.547–0.826, P < 0.001), grade 1–4 diarrhoea (OR 0.743; 95% CI 0.626–0.881) were also less likely to happen in patients in the oral UFT plus LV regimen, while there was no significant difference between the two treatment regimens with respect to grade 1–4 stomatitis/mucositis (OR 0.278; 95% CI 0.053–1.456) and grade 3–4 (OR 1.174; 95% CI 0.983–1.403) diarrhoea. Conclusion Oral UFT or 5‐FU bolus combined with LV results in similar overall survival and tumour response rates for advanced colorectal cancer. The former treatment regimen is greatly superior in terms of toxicity, especially haematological toxicity.     

替加氟对中晚期食管癌放疗增敏效果及副作用观察

目的观察口服抗代谢药替加氟在中晚期食管癌放疗中的增敏效果及对放疗副作用的影响。方法将128例初治中晚期食管癌病人随机分为2组,均采用直线加速器6MV-X线进行外照射放疗,靶区剂量为60～64Gy/（6～7）周。实验组自放疗当日口服替加氟,每次0.1～0.2g,每天3次,至放疗结束。对照组在放疗同时伍用顺铂20mg快速静滴,每周2次,按病人对药物的反应及耐受性给予4～6周的增敏。结果两组病人近期疗效差异无显著性,而骨髓抑制和胃肠道不良反应差异有统计学意义（χ2=10.25、3.75,P〈0.05）。结论中晚期食管癌放疗并用替加氟增敏效果与顺铂相近,副作用轻微,病人耐受性较好。     

奥替拉西钾血药和尿药浓度的测定及其药代动力学和药物蓄积性评价

本实验建立了人血浆及尿液中奥替拉西钾（potassium oxonate,Oxo）的LC-MS/MS测定方法,研究单次及多次给药替吉奥胶囊（S-1）后,Oxo在晚期胃癌患者体内的药代动力学特征,并评价多次给药后Oxo在人体内的药物蓄积情况。12名晚期胃癌患者分别按体表面积（BSA）口服S-1：单次给药,受试者于早餐后给药60 mg;多次给药,连续28d,每天2次,于早餐后给药60mg;晚餐后给药60 mg（BSA≥1.5m ²）或40 mg（1.25m ² 2）。采用LC-MS/MS法分别测定血浆及尿液中Oxo药物浓度,计算其药代动力学参数,评价其药代动力学特征和药物蓄积现象。血浆及尿液中Oxo测定的线性范围为分别为2~400 ng/mL,0.02~10 μg/mL。单次给药后 c_max为（110.5±100.8）ng/mL,t_1/2为（3.4±1.4）h,t_max为（2.2 ±0.7）h,36 h内有（1.7±1.2）%的Oxo以原型方式从尿中排出;多次给药后,稳态平均血药浓度c_ss-av为（36.89±29.35）ng/mL,稳态血药浓度波动度(DF)为2.4±0.8,经统计分析,多次给药28 d后Oxo在胃癌患者体内药代动力学特征与单次给药相比并未发生变化,多次给药后未产生药物蓄积现象。与文献数据对照,Oxo在中国晚期胃癌患者与国外患者体内的药代动力学参数基本一致。     

Efficacy and safety of anlotinib plus S-1as thirdly-line or later-line treatmentin advanced non-small cell lung cancer

Objective Anlotinib,an oral vascular endothelial growth factor receptor 2(VEGFR2)inhibitor,has confirmed antitumor activity in lung cancer in both in vitro and in vivo assays,and has been recommended as third-line treatment agent in non-oncogene driven non-small cell lung cancer(NSCLC).This prospective study aimed to investigate the efficacy and safety of anlotinib plus S-1 for third-or later-line treatment in patients with advanced NSCLC.Methods Patients with histologically or cytologically confirmed NSCLC,and documented disease progression following second-line chemotherapy,and/or epidermal growth factor receptor-tyrosine kinase inhibitor(EGFR-TKI)treatment were enrolled in this study.The patients were treated anlotinib(8 mg daily d 1–14)and S-1(60 mg/m^2 d 1–14)and the treatment was repeated every 3 weeks.Treatment was continued until disease progression or unacceptable toxicity occurred.The objective response rate(ORR),disease control rate(DCR),progression-free survival(PFS),and adverse events(AEs)were reviewed and evaluated.Results Forty-one patients were enrolled in the study between June 2018 and December 2018.The total ORR and DCR were 26.8%and 80.5%,respectively.The median PFS was 5.2 months[95%confidence interval(CI),3.9 to 6.6 months].In the univariate analysis,there was a significant difference in the median PFS between patients with brain metastases and those without brain metastases(4.8 months vs 5.9 months,respectively;P=0.039).The Eastern Cooperative Oncology Group(ECOG)performance status(P=0.002),lines of therapy(P=0.015),and therapeutic evaluation(P=0.014)were independent factors that influenced PFS.The most common AEs were hypertension,proteinuria,myelosuppression,gastrointestinal reactions,fatigue,and mucositis.Conclusion Anlotinib plus S-1 is an effective and safe regimen for advanced NSCLC as third-or later-line therapy.     

替吉奥治疗30例PS=2-3老年晚期胃癌临床观察

目的：观察替吉奥胶囊对PS=2-3老年晚期胃癌的治疗疗效及不良反应。方法：采用替吉奥治疗30例PS=2-3老年晚期进展期胃癌患者,对比16例最佳支持治疗患者,化疗2周期后评定疗效,并随访两组患者1年生存状况。结果：治疗组30例中28例可评价疗效和不良反应,治疗组和对照组的近期有效率分别为60.7%和43.8%（P〈0.05）,1年生存率分别为57.1%和50.0%（P〉0.05）。两组PS评分变化无统计学差异,治疗组不良反应轻微,患者能耐受。结论：单药替吉奥方案是疗效较好的治疗PS=2-3老年晚期胃癌的化疗方案,不良反应轻,患者易于耐受。     

不同新辅助化疗方案治疗结肠癌临床对照观察研究

目的:观察两种不同新辅助化疗方案联合手术治疗结肠癌的疗效。方法:收集结肠癌患者42例,根据随机数字表分配分为治疗组(23例)和对照组(19例)。治疗组术前静脉滴注奥沙利铂联合替吉奥口服,术后2周开始追加4个周期的化疗。对照组术前静脉滴注奥沙利铂联合5-氟尿嘧啶及甲酰四氢叶酸口服,术后2周开始追加4个周期的化疗。随访3年,从不良反应、化疗前后瘤体直径变化、手术时间、术中出血量、实体肿瘤疗效评价标准RECIST等方面进行疗效评价。结果:化疗前治疗组肿瘤直径20～32 mm(25.87±3.37) mm,对照组19～34 mm(26.58±3.83) mm。化疗后治疗组肿瘤直径15～22 mm(17.22±2.41) mm,对照组18～30 mm(23.00±3.26) mm,两组经化疗前后瘤体缩小程度组内及组间对比均存在统计学差异(P0.001)。两组手术时间、术中出血量无差异。结论:新辅助化疗对于缩小结肠癌瘤体有效,可认为奥沙利铂联合替吉奥用于新辅助化疗在减少骨髓抑制、消化道反应发生率及降期效果上优于奥沙利铂联合FL。