Comparison of acute toxicities between two postoperative concurrent chemoradiotherapy regimens of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer

Objective To compare the acute toxicities between two prospective, non-randomize phase Ⅱ trials on adjuvant radiochemotherapy of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer. Methods From March 2005 to November 2007,based on two fulfilled phase Ⅰ studies,two phase Ⅱ trials were launched respectively to further observe the tolerance and toxicity. In one tria1,118 patients were treated with concurrent capecitabine and radiotherapy (Cap-CRT trial), with radio-therapy of DT50 Gy/25 F/5 wks to the pelvis, and capecitabine at a dose of 1600 mg/m2/d(d1-d14,3 weeks per cycle). In the other trial, 90 patients received concurrent oxaliplatin, capecitabine and radiothera-py(Cap-Oxa-CRT trial), with the same radiotherapy schedule, while oxaliplatin at a dose of 70 mg/m2(d1, d8) and capecitabine of 1300 mg/m2/d(d1-d14,3 weeks per cycle). Results There was no significant difference in the delay of radiotherapy (10.2% vs 6.7%, X2=0.80, P=0.460) or chemotherapy (9.3% vs 19.1%, X2=4.80,P=0.090) between Cap-CRT and Cap-Oxa-CRT trials. Grade 1-4 leukopenia,diar-rhea and nausea were the most common acute side-effects in the both trials, accounting for 70.2%, 65.9% and 42.3%, respectively. When comparing with Cap-CRT trial, Cap-Oxa-CRT trial had significantly more grade 1-4 non-hemotological toxicities, mainly in Gl,including nausea (68.9% vs 22.0%, X2=46.90, P= 0.000), diarrbea(76.7% vs 57.6%, X2=13.50, P=0.009), fatigne(47.8% vs 13.7%, X2=18.90,P= 0.000), hand-foot syndrome (14.4% vs 4.2%, X2=7.10, P=0.029), and inappetence (50.0% vs. 27.9%, X2 = 25.70, P=0.000), but not in hematological toxities of leukopenia, anemia or thrombocytope-nia. Of all the patients,grade 3 and grade 4 toxicities were diarrhea(24.0% and 1.0%),leukopenia(4.3% and 0.0%),radiation-induced dermatitis(3.8% and 0.0%),cramping abdominal pain(1.0% and 0.0%) and fatigue(0.5% and 0.0%). Only grade 3 and 4 diarrhea was significantly more in Cap-Oxa-CRT trial than in Cap-CBT trial(33.0% vs 18.6%, X2=5.90,P=0.023). Conclusions For patients with stage Ⅱ and Ⅲ rectal cancer,both the postoperative concurrent radiochemotherapy regimens are tolerable,though Cap-Oxa-CRT trial has more grade 3 and 4 diarrhea.     

Comparison of acute toxicities between two postoperative concurrent chemoradiotherapy regimens of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer

Objective To compare the acute toxicities between two prospective, non-randomize phase Ⅱ trials on adjuvant radiochemotherapy of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer. Methods From March 2005 to November 2007,based on two fulfilled phase Ⅰ studies,two phase Ⅱ trials were launched respectively to further observe the tolerance and toxicity. In one tria1,118 patients were treated with concurrent capecitabine and radiotherapy (Cap-CRT trial), with radio-therapy of DT50 Gy/25 F/5 wks to the pelvis, and capecitabine at a dose of 1600 mg/m2/d(d1-d14,3 weeks per cycle). In the other trial, 90 patients received concurrent oxaliplatin, capecitabine and radiothera-py(Cap-Oxa-CRT trial), with the same radiotherapy schedule, while oxaliplatin at a dose of 70 mg/m2(d1, d8) and capecitabine of 1300 mg/m2/d(d1-d14,3 weeks per cycle). Results There was no significant difference in the delay of radiotherapy (10.2% vs 6.7%, X2=0.80, P=0.460) or chemotherapy (9.3% vs 19.1%, X2=4.80,P=0.090) between Cap-CRT and Cap-Oxa-CRT trials. Grade 1-4 leukopenia,diar-rhea and nausea were the most common acute side-effects in the both trials, accounting for 70.2%, 65.9% and 42.3%, respectively. When comparing with Cap-CRT trial, Cap-Oxa-CRT trial had significantly more grade 1-4 non-hemotological toxicities, mainly in Gl,including nausea (68.9% vs 22.0%, X2=46.90, P= 0.000), diarrbea(76.7% vs 57.6%, X2=13.50, P=0.009), fatigne(47.8% vs 13.7%, X2=18.90,P= 0.000), hand-foot syndrome (14.4% vs 4.2%, X2=7.10, P=0.029), and inappetence (50.0% vs. 27.9%, X2 = 25.70, P=0.000), but not in hematological toxities of leukopenia, anemia or thrombocytope-nia. Of all the patients,grade 3 and grade 4 toxicities were diarrhea(24.0% and 1.0%),leukopenia(4.3% and 0.0%),radiation-induced dermatitis(3.8% and 0.0%),cramping abdominal pain(1.0% and 0.0%) and fatigue(0.5% and 0.0%). Only grade 3 and 4 diarrhea was significantly more in Cap-Oxa-CRT trial than in Cap-CBT trial(33.0% vs 18.6%, X2=5.90,P=0.023). Conclusions For patients with stage Ⅱ and Ⅲ rectal cancer,both the postoperative concurrent radiochemotherapy regimens are tolerable,though Cap-Oxa-CRT trial has more grade 3 and 4 diarrhea.     

“迈瑞”全自动生化分析仪的偏倚评估研究

目的 对“迈瑞”多个型号的全自动生化分析仪进行偏倚评估,为遴选优秀国产生化设备提供实验依据.方法 参照CLSI EP9-A2文件,以“贝克曼”AU5400为参比检测系统,“迈瑞”4个型号(BS200、BS380、BS480和BS820)为实验检测系统,对15项常规生化项目进行比对分析.通过比较两个检测系统的决定系数R2、线性回归方程斜率和医学决定水平处的偏差进行偏倚评估.结果 实验检测系统和参比检测系统的相关性良好.两个检测系统间存在一定的系统偏差,但以我国卫生行业标准为质量目标,只有血清总蛋白、白蛋白和钙3个项目与参比检测系统不具可比性(即TP、ALB、CA的质量目标分别是5％、6％、5％,BS200、BS380、BS480和BS820中TP的平均偏倚分别为8.74％、4.59％、5.85％、8.26％,ALB的平均偏倚分别为12.66％、14.07％、11.66％、12.99％,CA的平均偏倚分别为6.79％、7.85％、7.7％、8.96％,3个项目在4台仪器均出现1个或多个医学决定水平的偏倚大于质量目标),其余12个项目具有可比性.结论 “迈瑞”与“贝克曼”检测系统的偏倚在临床可接受范围内,可在基层医院推广使用.     

对“Excel2000软件在即刻法质控中的应用与改良”一文的两点改进

在看了《现代检验医学杂志》2003年第18卷第5期登载的文章“Excel2000软件在即刻法质控中的应用与改良”一文后，感觉很受用，文章里介绍了怎样应用Excel2000软件对质控数据的自动统计、分析及评价并绘制出即时累积的L—J质控图，这一方法对于没有自带质控软件的仪器和项目尤其适用。但笔者从看完到自己制作却费了很多周折，     

Ⅱ+Ⅲ期直肠癌根治术后卡培他滨单药±奥沙利铂同期放化疗疗效对比

目的 比较Ⅱ、Ⅲ期直肠癌根治术后卡培他滨 ±奥沙利铂同期放化疗疗效。方法 回顾分析2002—2010年分别接受卡培他滨术后同期放化疗(单药组,427例)和奥沙利铂+卡培他滨术后同期放化疗(双药组,248例)的临床资料。治疗模式均为全直肠系膜切除术+同期放化疗 ±辅助化疗。放疗方法为真骨盆 45.0~50.4 Gy分25次。结果 采用倾向评分配比法按1∶1平衡基线特征后产生单双药组各 248例,其中单药、双药组 5年样本数分别为81、104例。匹配后单、双药组的 5年OS (78.1%∶74.9%)、DFS (74.4%∶67.9%)、LRC (94.5%∶92.8%)和DMFS (77.1%∶70.9%)均相近(P=0.547、0.292、0.484、0.364),但双药组3、4级不良反应发生率显著高于单药组(38.3%∶24.6%,P=0.001)。结论 Ⅱ、Ⅲ期直肠癌根治术后卡培他滨+奥沙利铂同期放化疗疗效未优于卡培他滨单药同期放化疗,而不良反应增加。单药卡培他滨同期放化疗仍为标准方案。     

降阶梯防控措施在控制烧伤病房多重耐药鲍曼不动杆菌院内感染中的应用

目的观察应用降阶梯防控措施控制烧伤病房多重耐药鲍曼不动杆菌院内感染的疗效,探讨多重耐药鲍曼不动杆菌院内感染防控的有效方法。方法收集2008—2011年烧伤患者创面分泌物细菌学检查结果及对抗菌药物耐药情况,对比分析在烧伤病房实施降阶梯防控措施前后的效果。结果 2008—2011年共检出鲍曼不动杆菌199株,其中多重耐药鲍曼不动杆菌感染者13例(6.5%),均为重度烧伤。2011年实施降阶梯防控措施后,多重耐药阳性率由2010年的13.2%(7/53)降至2011年的2.6%(2/78),二者阳性率比较差异有统计学意义(P0.05);2011年亚胺培南和美罗培南耐药率下降,分别为15.4%和24.4%,与2010年比较差异有统计学意义(P均0.05),氨苄西林/舒巴坦和哌拉西林/他唑巴坦耐药率下降为75.6%和25.6%,复方新诺明耐药率降为62.8%,与2010年比较差异有统计学意义(P均0.05)。结论降阶梯防控措施可降低多重耐药鲍曼不动杆菌院内感染机会,降低部分抗生素耐药率。     

早期结外鼻型NK／T细胞淋巴瘤治疗后淋巴结失败患者的预后分析

目的分析Ⅰ-Ⅱ期原发上呼吸消化道NK／T细胞淋巴瘤（UADT—NKTCL）治疗后淋巴结失败患者的生存和预后因素。方法1988年4月至2012年12月40例Ⅰ-Ⅱ期UADT—NKTCL患者在接受治疗后的随访中出现了淋巴结失败,对失败后的生存和预后进行分析。采用Kaplan—Meier法计算生存率。结果40例患者中,8例单纯区域淋巴结失败,26例单纯远处淋巴结失败,6例同时合并区域和远处淋巴结失败。57．1％（8／14）的患者区域淋巴结失败合并局部复发,71．9％（23／32）的患者远处淋巴结失败合并远处器官失败。全组患者淋巴结失败后中位生存时间为8．7个月,2年总生存率29．8％。预后分析显示,淋巴结失败时患者B症状和美国东部肿瘤协作组（ECOG）评分是预后因素。有B症状的患者中位生存时间为6．6个月,而无B症状的患者为16．3个月,两者差异有统计学意义（P=0．034）。ECOG评分0～1分的患者中位生存时间显著长于ECOG评分1〉2分的患者,分别为31．6个月和4．1个月（P〈0．001）。综合治疗的预后显著优于单纯化疗,2年生存率分别为68．6％和15．0％（P〈0．001）。结论早期UADT-NKTCL治疗后出现淋巴结失败的患者总体预后差,挽救性综合治疗可取得较好效果。     

化浊解毒消痤方治疗寻常痤疮172例临床观察

目的 观察运用化浊解毒消痤方治疗寻常痤疮的临床疗效.方法采用随机对照开放式试验纳入344例寻常痤疮患者.分为治疗组和对照组各172例,治疗组给予化浊解毒消痤方水煎口服,对照组给予维胺酯胶囊口服.均治疗30天,分别于治疗前及治疗后的第一、二、三周末及第30天末进行皮损疗效判定.结果 治疗组在第1周末、第2周末、第3周末、第30天末有效率分别为43.02%、70.24%、88.19%、94.41%;对照组分别是14.19%、31.36%、70.13%、90.91%,两组比较差异有统计学意义(p<0.05).治疗组症状体征积分明显低于对照组(p<0.05),对照组不良反应发生率明显高于治疗组(p<0.05).结论 化浊解毒消痤方治疗寻常痤疮疗效肯定,起效快,不良反应低,优于维胺脂胶囊     

肛管癌的疗效和预后因素分析

目的 回顾分析原发性肛管癌患者的疗效和预后因素。方法 2000—2011年本中心经治肛管癌患者3l例,鳞癌23例、腺癌8例。Ⅰ~Ⅲ期患者首程采用放疗为主治疗16例、手术为主治疗11例、化疗3例。结果 随访率为90%,随访时间满3年的样本数21例。全组3年总生存(OS)率和无进展生存(PFS)率分别为76%、56%。单因素分析显示临床分期和T分期为OS预后因素(χ²=12.11,P=0.001和χ²=4.64,P=0.031),并与PFS有相关趋势(χ²=2.91,P=0.088和χ²=2.75,P=0.097)。Ⅰ~Ⅲ期鳞癌患者首程放疗为主与手术为主治疗的3年OS率和PFS率均相似(80%与80%,χ²=0.08,P=0.776和78%与67%,χ²=0.17,P=0.697)。放疗患者3级皮肤或黏膜急性不良反应为37%,晚期肛门感觉或功能异常为9%。结论 临床分期、T分期是影响肛管癌患者预后的最主要因素,同期放化疗应作为肛管鳞癌患者根治性治疗手段的首选疗法,应用调强放疗技术有利于患者按计划完成放疗并避免发生严重不良反应。