清肠解毒方对大肠癌术后复发化疗患者肿瘤标记物水平及生活质量的影响

摘 要 目的: 探讨清肠解毒方对大肠癌术后复发化疗患者的生活质量及肿瘤标记物水平的影响。方法:选取出现复发的大肠癌患者60例，随机分为观察组与对照组各30例。两组化疗方案均为奥沙利铂联合卡培他滨或者盐酸伊立替康联合卡培他滨，观察组加用清肠解毒方治疗。比较两组患者治疗前后血清CEA、AFP、CA 125、CA 199水平与ECOG评分变化。结果: 两组患者治疗后血清CEA、AFP、CA 125、CA 199水平显著低于治疗前（P＜0.05）。此外，治疗后观察组患者的血清CEA和CA 199水平显著低于对照组（P＜0.05）。生活质量方面，治疗后两组患者ECOG评分均显著低于治疗前，差异有统计学意义（P＜0.05）；且观察组患者治疗后ECOG评分显著低于对照组，差异有统计学意义（P＜0.05）。结论: 清肠解毒方能够明显改善大肠癌术后化疗患者的生活质量，降低血清肿瘤标记物浓度，值得临床应用。     

A Phase II Clinical Trial on the Combination Therapy of PHY906 Plus Capecitabine in Hepatocellular Carcinoma

Lessons Learned

• A PHY906 and capecitabine combination could be effective as a salvage therapy for patients with hepatocellular carcinoma (HCC) previously treated with multiple systemic therapies.
• This traditional Chinese medicine formulation can work with Western cancer chemotherapeutic agents to improve clinical outcomes or alleviate side effects for patients with advanced HCC.

BackgroundThis study aimed to evaluate efficacy and safety of capecitabine combined with a PHY906 (a pharmaceutical‐grade formulation of four traditional Chinese herbs) in the treatment of advanced hepatocellular carcinoma (HCC) in Asian patients who were positive for hepatitis B virus (HBV).MethodsThis study was an open‐label, phase II safety and efficacy clinical trial of PHY906 and capecitabine in patients with advanced HCC. Patients received 750 mg/m² capecitabine b.i.d. 14 days plus 800 mg of PHY906 b.i.d. on days 1–4 and days 8–11 every 21‐day cycle. The primary endpoint was 6‐month survival rate, and secondary endpoints were progression‐free survival, overall survival, disease control rate, and safety.ResultsThirty‐nine subjects completed the study with a 46.2% stable disease rate. The median progression‐free survival was 1.5 months, and median overall survival (mOS) was 6 months with a 51.3% 6‐month survival rate. The most common adverse events included lower hemoglobin, diarrhea, pain, abdomen (not otherwise specified), fatigue, increased aspartate aminotransferase, and bilirubin. Patients who (a) had not received previous chemotherapies or targeted therapy or (b) had lower starting alpha‐fetoprotein (AFP) levels or (c) had HBV infection showed better clinical outcome.ConclusionOur data showed that PHY906 increases the therapeutic index of capecitabine by enhancing its antitumor activity and reduces its toxicity profile in advanced HCC.     

Effects of Proton Pump Inhibitors on FOLFOX and CapeOx Regimens in Colorectal Cancer

Background

First-line adjuvant chemotherapy options for early-stage colorectal cancer (CRC) include CapeOx (capecitabine, intravenous oxaliplatin) and FOLFOX (intravenous 5-fluorouracil, leucovorin, oxaliplatin). Capecitabine is an oral prodrug analog of 5-fluorouracil, and recent studies have suggested that proton pump inhibitors (PPIs) may detrimentally affect capecitabine efficacy. Conversely, some literature suggests that PPIs may negatively affect CRC itself. To gain insight into the nature of PPIs’ effect on capecitabine and CRC, we investigated their effects on effectiveness of CapeOx versus FOLFOX chemotherapy.

中医药治疗手足综合征随机对照试验的Meta分析

目的：评价中医药治疗手足综合征的疗效。方法：计算机检索2007年1月1日至2019年1月1日国内外发表的关于中医药治疗HFS的临床随机对照研究文献，根据Cochrane Handbook 5.0版有关随机对照试验的质量评价标准，对纳入的研究进行方法学质量评价，并采用Stata 12.0软件进行Meta分析。结果：共纳入12篇文献，总的比较研究间存在较大异质（I2=83.1%,P=0.00），敏感性分析结果显示1篇文献的研究结果与其他文献存在较大异质性；将所剩余11篇文献按引起HFS的不同因素，分为卡培他滨、靶向治疗、化疗或靶向治疗3个亚组进行Meta分析，结果显示虽然合并Meta分析显示各研究间仍存在较大异质性（I2=73.4%,P=0.000）；但是卡培他滨亚组（I2=31.6%,P=0.232）、靶向治疗亚组（I2=40.5%,P=0.151）、化疗或靶向治疗亚组（I2=47.3%,P=0.150）各亚组间不存在大的异质性，且各亚组实验组与对照组间差异有统计学意义（P<0.01）。结论：中医药治疗HFS有效，且总有效率要优于单纯西药治疗；对于不同发生机制的HFS在临床治疗或研究中要区分治疗或研究。     

沙利度胺联合XELOX方案治疗晚期胃癌的临床研究

目的探讨沙利度胺联合XELOX方案(奥沙利铂+卡培他滨)治疗晚期胃癌的临床疗效。方法选取2013年1月—2016年1月丹阳市人民医院收治晚期胃癌患者180例,随机分为对照组和治疗组,每组各90例。对照组患者静脉滴注注射用奥沙利铂,130 mg/m2,1次/14 d,同时口服卡培他滨片,每次1 250 mg/m2,2次/d,持续治疗14 d。治疗组在对照组基础上睡前口服沙利度胺片,200 mg/次,1次/d,14 d为1个疗程,连续治疗2个疗程。观察两组患者临床疗效,同时比较治疗前后两组患者KPS评分及血管内皮生长因子(VEGF)、内皮细胞特异性分子-1(ESM-1)、神经纤毛蛋白-1(NRP-1)水平。结果治疗后,对照组客观缓解率为35.6%,显著低于治疗组的51.1%,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者KPS评分显著升高(P0.05),且治疗后治疗组KPS评分明显高于对照组(P0.05)。治疗后,两组患者VEGF、ESM-1和NRP-1水平均显著降低(P0.05),且治疗组血清VEGF、ESM-1和NRP-1水平明显低于对照组(P0.05)。结论沙利度胺联合XELOX方案能够有效抑制肿瘤新生血管生成,降低血清ESM-1、NRP-1表达,具有一定的临床推广应用价值。     

乌苯美司联合XEC化疗方案治疗三阴性乳腺癌的临床研究

目的探讨乌苯美司联合XEC化疗方案治疗三阴性乳腺癌患者的临床疗效及其对外周血T淋巴细胞亚群及血清骨桥蛋白(OPN)水平变化的影响。方法选取河南科技大学第一附属医院2015年6月—2017年1月收治的三阴性乳腺癌患者83例,随机分成对照组(41例)和治疗组(42例)。对照组患者给予XEC化疗方案治疗,第1天静脉滴注注射用环磷酰胺500 mg/m~2,同时静脉滴注注射用盐酸表柔比星100 mg/m~2,第1~14天口服卡培他滨片1 g/m~2,疗程为21 d。治疗组在对照组的基础上口服乌苯美司片,30 mg/次,1次/d,疗程为21 d。两组均持续治疗4个疗程。观察两组患者临床疗效,比较治疗前后两组患者SF-36评分、外周血T淋巴细胞亚群表达水平和OPN水平。结果治疗后,对照组和治疗组临床总有效率分别为75.61%、95.24%,两组比较差异具有统计学意义(P0.05)。治疗后,两组躯体疼痛、躯体功能、睡眠质量、生命活力、生理职能、心理健康等生活质量评分均显著升高,同组治疗前后比较差异具有统计学意义(P0.05);且治疗后治疗组生活质量评分显著高于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者CD~(3+)、CD~(4+)、CD~(4+)/CD~(8+)水平均显著升高,CD~(8+)水平显著下降,同组治疗前后比较差异具有统计学意义(P0.05);且治疗组T淋巴细胞亚群水平显著优于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组血清OPN水平显著下降,同组治疗前后比较差异具有统计学意义(P0.05);且治疗组血清OPN水平显著低于对照组,两组比较差异具有统计学意义(P0.05)。结论乌苯美司联合XEC化疗方案治疗三阴性乳腺癌患者效果显著,可有效改善患者外周血T淋巴细胞亚群和血清OPN水平,且安全性较高,具有一定的临床推广应用价值。