Objective：To investigate the efficacy of Aidi Injection（艾迪注射液） on overexpression of P-glycoprotein（P-gp） induced by vinorelbine and cisplatin（NP） regimen in patients with non-small cell lung cancer（NSCLC...Objective：To investigate the efficacy of Aidi Injection（艾迪注射液） on overexpression of P-glycoprotein（P-gp） induced by vinorelbine and cisplatin（NP） regimen in patients with non-small cell lung cancer（NSCLC）, and study the difference between intravenous administration and targeting intratumor administration of Aidi Injection with thoracoscope. Methods：Totally 150 patients with NSCLC were randomly assigned to the control group, the intravenous group and the intratumor group by the random envelope method, 50 cases in each group. The patients were treated with NP regimen（2 cycles）, NP regimen（2 cycles） plus Aidi intravenous injection, or NP regimen（2 cycles） plus Aidi intratumor injection with thoracoscope, respectively for 6 weeks. The clinical efficacy was observed based on Response Evaluation Criteria in Solid Tumors（RECIST） rules, the expression of P-gp in the tumor tissue was tested before, 3 and 6 weeks after treatment, the safety was evaluated by monitoring the toxicity in the process of treatment, and the progressionfree survival（PFS） was measured. Results：Fifteen cases dropped out because of the irreconcilable conditions which had no relationship with the treatment, 4 in the control group, 5 in the intravenous group, and 6 in the intratumor group, respectively. Compared with the control group, the response rates（complete remission ＋ partial response） and the disease control rates（complete remission ＋ partial response ＋ stable disease） were significantly higher, the P-gp expressions were significantly decreased after 3 and 6 weeks of treatment, and the Kaplan-Meier survival curves of PFS were significantly longer in the intravenous and intratumor groups（P〈0.05 or P〈0.01）, and the intratumor group showed better effects than the intravenous group（P〈0.05 or P〈0.01）. Compared with the control group, the occurrences of rash, nausea and leukocytopenia were significantly decreased in the intravenous and intratumor groups（P〈0.05）, but without significant difference between the intravenous and intratumor groups（P〉0.05）. Conclusion：Aidi Injection not only improves the efficacy of NP regime, but also has the function of reducing adverse events and preventing against overexpression of P-gp induced by chemotherapy of NP regimen.展开更多
目的为临床使用紫杉醇联合顺铂(TP)方案治疗非小细胞肺癌(NSCLC)提供依据。方法检索PubMed、The Cochrane Library、Embase、Web of Science、中国知网(CNKI)、维普(VIP)、万方(WanFang)、中国生物医学文献服务系统(SinoMed)中相关系统...目的为临床使用紫杉醇联合顺铂(TP)方案治疗非小细胞肺癌(NSCLC)提供依据。方法检索PubMed、The Cochrane Library、Embase、Web of Science、中国知网(CNKI)、维普(VIP)、万方(WanFang)、中国生物医学文献服务系统(SinoMed)中相关系统评价/Meta分析,检索时限为各数据库自建库起至2022年4月7日。采用AMSTAR-2量表和GRADE评估工具分别进行方法学质量和证据质量评价。结果纳入9篇文献,包括英文文献1篇、中文文献8篇;系统评价4篇、Meta分析5篇,发表时间均为2010年至2020年。方法学质量,8篇为极低,1篇为中等;证据质量,纳入文献的结局指标共46个,高、中、低、极低级质量指标分别有7,15,11,13个。导致证据等级降级的因素主要为局限性(54.35%)、不一致性(34.78%)、不精确性(41.30%)及发表偏倚(39.13%)。Meta分析结果显示,TP方案较其他药物联合顺铂方案可显著降低血小板减少发生率[OR=0.35,95%CI(0.15,0.77),P=0.01]及贫血发生率[OR=0.55,95%CI(0.31,0.98),P=0.04],而在有效率、1年生存率、白细胞减少发生率、中性粒细胞减少发生率、恶心呕吐发生率等方面两者无显著差异(P>0.05)。结论相比于其他药物联合顺铂,TP方案治疗NSCLC可显著降低血小板减少发生率和贫血发生率,但因纳入文献的方法学质量及证据质量普遍较低,该方案的有效性及安全性仍需更多高质量研究进一步证实。展开更多
目的观察顺铂（Cisplatin，DDP）单次大剂量给药和分次小剂量给药方案引起的化疗所致恶心呕吐（chemotherapy-induced nausea and vomiting，CINV）和对患者生活功能的影响。方法2011年10月-2012年6月间对武汉同济医院肿瘤中心行含DDP...目的观察顺铂（Cisplatin，DDP）单次大剂量给药和分次小剂量给药方案引起的化疗所致恶心呕吐（chemotherapy-induced nausea and vomiting，CINV）和对患者生活功能的影响。方法2011年10月-2012年6月间对武汉同济医院肿瘤中心行含DDP联合化疗方案的101例患者进行问卷调查，根据DDP给药方案，分为两组，A组：DDP75mg／m^2，静脉滴注，d1；B组：DDP25mg／m2，静脉滴注，d1～3。化疗第2天和第6天分别记录CINV事件，并于第6天填写呕吐生活功能指数（functional living indexemesis，FLIE）。结果单次给药组急性期恶心、呕吐缓解率和延迟期恶心、呕吐缓解率依次为69．4％、77．6％、32．7％、55．1％；分次给药组依次为88．5％、92．3％、34．6％、71．2％。对以上指标进行χ^2检验，急性CINV缓解率差异均有统计学意义，延迟性CINV缓解率差异无统计学意义。两组患者生活功能受到CINV负面影响的比例分别为46．9％和28．8％，χ^2检验显示差异无统计学意义。结论与DDP单次给药相比，分次给药能够减轻急性CINV，但是对于延迟性CINV和整个化疗过程CINV对患者生活功能的影响，两种给药方式无明显差别。展开更多
基金Supported by the 2011 National Key Specialty Construction of Clinical Projects of China,Science and Technology Projects of Traditional Chinese Medicine Bureau in Jiangsu Province of China(No.LB13042)
文摘Objective：To investigate the efficacy of Aidi Injection（艾迪注射液） on overexpression of P-glycoprotein（P-gp） induced by vinorelbine and cisplatin（NP） regimen in patients with non-small cell lung cancer（NSCLC）, and study the difference between intravenous administration and targeting intratumor administration of Aidi Injection with thoracoscope. Methods：Totally 150 patients with NSCLC were randomly assigned to the control group, the intravenous group and the intratumor group by the random envelope method, 50 cases in each group. The patients were treated with NP regimen（2 cycles）, NP regimen（2 cycles） plus Aidi intravenous injection, or NP regimen（2 cycles） plus Aidi intratumor injection with thoracoscope, respectively for 6 weeks. The clinical efficacy was observed based on Response Evaluation Criteria in Solid Tumors（RECIST） rules, the expression of P-gp in the tumor tissue was tested before, 3 and 6 weeks after treatment, the safety was evaluated by monitoring the toxicity in the process of treatment, and the progressionfree survival（PFS） was measured. Results：Fifteen cases dropped out because of the irreconcilable conditions which had no relationship with the treatment, 4 in the control group, 5 in the intravenous group, and 6 in the intratumor group, respectively. Compared with the control group, the response rates（complete remission ＋ partial response） and the disease control rates（complete remission ＋ partial response ＋ stable disease） were significantly higher, the P-gp expressions were significantly decreased after 3 and 6 weeks of treatment, and the Kaplan-Meier survival curves of PFS were significantly longer in the intravenous and intratumor groups（P〈0.05 or P〈0.01）, and the intratumor group showed better effects than the intravenous group（P〈0.05 or P〈0.01）. Compared with the control group, the occurrences of rash, nausea and leukocytopenia were significantly decreased in the intravenous and intratumor groups（P〈0.05）, but without significant difference between the intravenous and intratumor groups（P〉0.05）. Conclusion：Aidi Injection not only improves the efficacy of NP regime, but also has the function of reducing adverse events and preventing against overexpression of P-gp induced by chemotherapy of NP regimen.
文摘目的为临床使用紫杉醇联合顺铂(TP)方案治疗非小细胞肺癌(NSCLC)提供依据。方法检索PubMed、The Cochrane Library、Embase、Web of Science、中国知网(CNKI)、维普(VIP)、万方(WanFang)、中国生物医学文献服务系统(SinoMed)中相关系统评价/Meta分析,检索时限为各数据库自建库起至2022年4月7日。采用AMSTAR-2量表和GRADE评估工具分别进行方法学质量和证据质量评价。结果纳入9篇文献,包括英文文献1篇、中文文献8篇;系统评价4篇、Meta分析5篇,发表时间均为2010年至2020年。方法学质量,8篇为极低,1篇为中等;证据质量,纳入文献的结局指标共46个,高、中、低、极低级质量指标分别有7,15,11,13个。导致证据等级降级的因素主要为局限性(54.35%)、不一致性(34.78%)、不精确性(41.30%)及发表偏倚(39.13%)。Meta分析结果显示,TP方案较其他药物联合顺铂方案可显著降低血小板减少发生率[OR=0.35,95%CI(0.15,0.77),P=0.01]及贫血发生率[OR=0.55,95%CI(0.31,0.98),P=0.04],而在有效率、1年生存率、白细胞减少发生率、中性粒细胞减少发生率、恶心呕吐发生率等方面两者无显著差异(P>0.05)。结论相比于其他药物联合顺铂,TP方案治疗NSCLC可显著降低血小板减少发生率和贫血发生率,但因纳入文献的方法学质量及证据质量普遍较低,该方案的有效性及安全性仍需更多高质量研究进一步证实。
文摘目的观察顺铂（Cisplatin，DDP）单次大剂量给药和分次小剂量给药方案引起的化疗所致恶心呕吐（chemotherapy-induced nausea and vomiting，CINV）和对患者生活功能的影响。方法2011年10月-2012年6月间对武汉同济医院肿瘤中心行含DDP联合化疗方案的101例患者进行问卷调查，根据DDP给药方案，分为两组，A组：DDP75mg／m^2，静脉滴注，d1；B组：DDP25mg／m2，静脉滴注，d1～3。化疗第2天和第6天分别记录CINV事件，并于第6天填写呕吐生活功能指数（functional living indexemesis，FLIE）。结果单次给药组急性期恶心、呕吐缓解率和延迟期恶心、呕吐缓解率依次为69．4％、77．6％、32．7％、55．1％；分次给药组依次为88．5％、92．3％、34．6％、71．2％。对以上指标进行χ^2检验，急性CINV缓解率差异均有统计学意义，延迟性CINV缓解率差异无统计学意义。两组患者生活功能受到CINV负面影响的比例分别为46．9％和28．8％，χ^2检验显示差异无统计学意义。结论与DDP单次给药相比，分次给药能够减轻急性CINV，但是对于延迟性CINV和整个化疗过程CINV对患者生活功能的影响，两种给药方式无明显差别。
