Objective:The objective of this study was to examine the effect of the postsurgical administration of Shenyi capsules on the outcome and overall survival of patients with nonsmall cell lung cancer(NSCLC).Materials and...Objective:The objective of this study was to examine the effect of the postsurgical administration of Shenyi capsules on the outcome and overall survival of patients with nonsmall cell lung cancer(NSCLC).Materials and Methods:This was a multicenter,randomized,placebo-controlled,double-blind clinical trial.Patients with stages I–IIIA NSCLC were randomized to Shenyi or placebo groups(treatment duration:6 months)and followed up for 10 years.One-year,2-year,5-year,and 10-year survival rates and survival times were calculated.Symptoms,quality of life,traditional Chinese medicine(TCM)syndrome,and recurrence were evaluated.Results:A total of 361 patients(treatment group,n=185;placebo group,n=176)were randomized and followed up for 10 years.The two groups had similar baseline demographic and clinical characteristics.Among all 361 patients,the treatment group had significantly longer median survival(31 months,respectively)than the placebo group(22.3 months,P<0.01).In stage II or III patients,recurrence and metastasis rates in the treatment group were lower than those in the placebo group(P<0.05).The treatment group also had significantly longer 1-year and 2-year survival rates based on the full analysis set and per-protocol set;however,there was no statistically significant difference in the 5-year and 10-year survival rates(P<0.01 for all comparisons).Multivariate analysis of variance showed that the interaction between stage and age had a significant impact on overall survival(P<0.05).Compared with the placebo group,the treatment group showed a significant decrease in TCM syndrome(P<0.01)and a significant increase in the Karnofsky Performance Score(P<0.01)and body weight(P<0.05).Conclusions:Adjunctive therapy with Shenyi capsules significantly prolonged the 1-year and 2-year survival rates after surgery and improved the quality of life.Moreover,none of the patients experienced severe adverse effects.These results suggest that Shenyi capsules may have clinical applications in treating patients with NSCLC.展开更多
Objective：To assist decision-makers interpret and choose among conflicting meta-analyses,as well as to offer treatment recommendations based on current best evidence by performing a systematic review of overlapping m...Objective：To assist decision-makers interpret and choose among conflicting meta-analyses,as well as to offer treatment recommendations based on current best evidence by performing a systematic review of overlapping meta-analyses regarding Shenyi Capsule（参一胶囊,SC） plus chemotherapy versus chemotherapy of non-small cell lung cancer（NSCLC）.Methods：A literature search was conducted to select systematic reviews comparing SC plus chemotherapy with chemotherapy for NSCLC.Meta-analyses only composed of randomized controlled trials（RCTs） met the inclusion criteria.Two authors individually estimated the quality of meta-analysis and extracted data.The Jadad decision algorithm was applied to guarantee which meta-analysis provided the best original evidence.Results：A total of 5 meta-analyses were included.All the studies composed of RCTs or quasi-RCTs and were regarded as level-Ⅱ evidence.The scores of the Assessment of Multiple Systematic Reviews ranged from 3 to 6（median 4）.A high-quality meta-analysis with more RCTs was chosen,which suggested that SC plus chemotherapy could increase incidence of short-term efficacy,improve the quality of life and survival rate in comparison to chemotherapy.However,there was no statistically significant difference between SC plus chemotherapy and chemotherapy regarding chemotherapy-induced side effect,such as liver and kidney function obstacle,leukopenia,hemoglobin decrement and gastrointestinal adverse reaction.Conclusions：Based on the best available evidence,treatment effect of SC plus chemotherapy was better than chemotherapy and did not increase side effects.Therefore,SC plus chemotherapy may be superior to chemotherapy for treating NSCLC.However,due to some limitations,SC plus chemotherapy should be cautiously considered,and further high-quality meta-analyses are needed.展开更多
目的:探讨参一胶囊联合一线化疗方案与单独化疗治疗不能手术的晚期IIIb/Ⅳ初治非小细胞肺癌(NSCLC)患者血清基质金属蛋白酶9(MMP-9)及组织蛋白酶抑制剂-1(TIMP-1)水平变化,并观察其近期疗效和治疗后不良反应。方法:采用酶联免疫吸附法(E...目的:探讨参一胶囊联合一线化疗方案与单独化疗治疗不能手术的晚期IIIb/Ⅳ初治非小细胞肺癌(NSCLC)患者血清基质金属蛋白酶9(MMP-9)及组织蛋白酶抑制剂-1(TIMP-1)水平变化,并观察其近期疗效和治疗后不良反应。方法:采用酶联免疫吸附法(ELISA)检测89例肺癌患者化疗前后血浆MMP-9及TIMP-1水平。结果:两组有效率无显著性差异(P>0.05),两组疾控率比较差异有显著性(P<0.05)。全部CR+PR、SD、PD患者治疗前血清MMP-9、TIMP-1水平比较,无显著性差异(P>0.05),治疗后差异均具有有显著性(P<0.05),随疗效降低呈升高趋势。两组相比疗前与疗后两次血清MMP-9水平,参一联合化疗组下降更明显,差异有显著性(P<0.05),而血清TIMP-1水平差异无显著性(P>0.05)。IV期患者比IIIb期患者外周血清MMP-9水平明显增高,差异有显著性(P<0.05)。但外周血清TIMP-1在IIIb期和IV期无统计学差异。其他因素如年龄、性别、ECOG评分、病理与MMP-9、TIMP-1水平均未发现显著性差异。患者治疗后出现常见不良反应及生活质量(quality of life,QOL)观察:观察组(即参一胶囊联合化疗组)在胃肠道反应(如恶心、呕吐、腹胀等),骨髓抑制(如白细胞减少、贫血、血小板下降等)方面均较单独化疗组减轻(P<0.05),参一联合组在改善QOL方面也明显高于对照组,且有统计学差异(P<0.05)。结论:参一胶囊联合化疗组患者外周血清MMP-9水平下降更明显,且有统计学差异,而患者血清TIMP-1水平变化无统计学差异。血清MMP-9、TIMP-1水平治疗后随疗效降低呈升高趋势,因此,两者对患者疗效判定具有一定的参考价值。两组外周血清MMP-9、TIMP-1水平变化不受性别、年龄、ECOG评分影响。肺癌患者TNM分期对NSCLC患者外周血清MMP-9水平变化有影响,分期越晚,其外周血清MMP-9水平值越高。因此,MMP-9血清值越高,提示预后越差。外周血清TIMP-1水平与MMP-9水平在化疗前后NSCLC患者呈正相关。参一胶囊对非小细胞肺癌患者可以增加疗效,减少毒副反应,生活质量得到提高,不良反应如消化道症状及骨髓抑制均可以减轻。展开更多
背景:从中药人参中提制的参一胶囊已被证实具有抑制肿瘤血管生成的作用,对多种肿瘤具有治疗作用,但关于参一胶囊对食管癌疗效的研究较少见。目的:观察参一胶囊辅助吉西他滨联合顺铂(gemcitabine plus cisplatin,GP)治疗进展期食管癌的...背景:从中药人参中提制的参一胶囊已被证实具有抑制肿瘤血管生成的作用,对多种肿瘤具有治疗作用,但关于参一胶囊对食管癌疗效的研究较少见。目的:观察参一胶囊辅助吉西他滨联合顺铂(gemcitabine plus cisplatin,GP)治疗进展期食管癌的疗效。设计、场所、对象和干预措施:将河南省肿瘤医院及河南中医学院第一附属医院收治的60例进展期食管癌住院患者随机分为治疗组和对照组各30例,治疗组采用参一胶囊联合 GP 方案治疗,对照组则单行 GP 方案化疗。主要结局指标:治疗后进行疗效评价,检测血管内皮细胞生长因子(vascular endothelial growth factor,VEGF)水平,并评价毒副反应和生活质量,进行生存期随访。结果:治疗组和对照组总有效率比较,差异无统计学意义(P=0.297);两组治疗后血清 VEGF 水平均低于治疗前,而治疗组治疗后 VEGF 水平又低于对照组治疗后(P=0.002):治疗组白细胞和血小板下降率,以及恶心呕吐发生率均低干对照组,差异有统计学意义(P=0.045、0.036、0.037);治疗组生活质量改善明显优于对照组,差异有统计学意义(P=0.028);治疗组1年生存率高于对照组,差异有统计学意义(P=0.047)。结论:参一胶囊辅助 GP 方案是治疗进展期食管癌的一种新的安全有效的方法,有提高总有效率趋势,可抑制食管癌新生血管形成,减少化疗副反应,改善患者生活质量,提高患者生存率,优于单纯化疗。展开更多
基金financially supported by the Capital Medical Development Fund,the Innovation Project of China Academy of Chinese Medical Sciences(ZD199902)。
文摘Objective:The objective of this study was to examine the effect of the postsurgical administration of Shenyi capsules on the outcome and overall survival of patients with nonsmall cell lung cancer(NSCLC).Materials and Methods:This was a multicenter,randomized,placebo-controlled,double-blind clinical trial.Patients with stages I–IIIA NSCLC were randomized to Shenyi or placebo groups(treatment duration:6 months)and followed up for 10 years.One-year,2-year,5-year,and 10-year survival rates and survival times were calculated.Symptoms,quality of life,traditional Chinese medicine(TCM)syndrome,and recurrence were evaluated.Results:A total of 361 patients(treatment group,n=185;placebo group,n=176)were randomized and followed up for 10 years.The two groups had similar baseline demographic and clinical characteristics.Among all 361 patients,the treatment group had significantly longer median survival(31 months,respectively)than the placebo group(22.3 months,P<0.01).In stage II or III patients,recurrence and metastasis rates in the treatment group were lower than those in the placebo group(P<0.05).The treatment group also had significantly longer 1-year and 2-year survival rates based on the full analysis set and per-protocol set;however,there was no statistically significant difference in the 5-year and 10-year survival rates(P<0.01 for all comparisons).Multivariate analysis of variance showed that the interaction between stage and age had a significant impact on overall survival(P<0.05).Compared with the placebo group,the treatment group showed a significant decrease in TCM syndrome(P<0.01)and a significant increase in the Karnofsky Performance Score(P<0.01)and body weight(P<0.05).Conclusions:Adjunctive therapy with Shenyi capsules significantly prolonged the 1-year and 2-year survival rates after surgery and improved the quality of life.Moreover,none of the patients experienced severe adverse effects.These results suggest that Shenyi capsules may have clinical applications in treating patients with NSCLC.
文摘Objective：To assist decision-makers interpret and choose among conflicting meta-analyses,as well as to offer treatment recommendations based on current best evidence by performing a systematic review of overlapping meta-analyses regarding Shenyi Capsule（参一胶囊,SC） plus chemotherapy versus chemotherapy of non-small cell lung cancer（NSCLC）.Methods：A literature search was conducted to select systematic reviews comparing SC plus chemotherapy with chemotherapy for NSCLC.Meta-analyses only composed of randomized controlled trials（RCTs） met the inclusion criteria.Two authors individually estimated the quality of meta-analysis and extracted data.The Jadad decision algorithm was applied to guarantee which meta-analysis provided the best original evidence.Results：A total of 5 meta-analyses were included.All the studies composed of RCTs or quasi-RCTs and were regarded as level-Ⅱ evidence.The scores of the Assessment of Multiple Systematic Reviews ranged from 3 to 6（median 4）.A high-quality meta-analysis with more RCTs was chosen,which suggested that SC plus chemotherapy could increase incidence of short-term efficacy,improve the quality of life and survival rate in comparison to chemotherapy.However,there was no statistically significant difference between SC plus chemotherapy and chemotherapy regarding chemotherapy-induced side effect,such as liver and kidney function obstacle,leukopenia,hemoglobin decrement and gastrointestinal adverse reaction.Conclusions：Based on the best available evidence,treatment effect of SC plus chemotherapy was better than chemotherapy and did not increase side effects.Therefore,SC plus chemotherapy may be superior to chemotherapy for treating NSCLC.However,due to some limitations,SC plus chemotherapy should be cautiously considered,and further high-quality meta-analyses are needed.
文摘目的:探讨参一胶囊联合一线化疗方案与单独化疗治疗不能手术的晚期IIIb/Ⅳ初治非小细胞肺癌(NSCLC)患者血清基质金属蛋白酶9(MMP-9)及组织蛋白酶抑制剂-1(TIMP-1)水平变化,并观察其近期疗效和治疗后不良反应。方法:采用酶联免疫吸附法(ELISA)检测89例肺癌患者化疗前后血浆MMP-9及TIMP-1水平。结果:两组有效率无显著性差异(P>0.05),两组疾控率比较差异有显著性(P<0.05)。全部CR+PR、SD、PD患者治疗前血清MMP-9、TIMP-1水平比较,无显著性差异(P>0.05),治疗后差异均具有有显著性(P<0.05),随疗效降低呈升高趋势。两组相比疗前与疗后两次血清MMP-9水平,参一联合化疗组下降更明显,差异有显著性(P<0.05),而血清TIMP-1水平差异无显著性(P>0.05)。IV期患者比IIIb期患者外周血清MMP-9水平明显增高,差异有显著性(P<0.05)。但外周血清TIMP-1在IIIb期和IV期无统计学差异。其他因素如年龄、性别、ECOG评分、病理与MMP-9、TIMP-1水平均未发现显著性差异。患者治疗后出现常见不良反应及生活质量(quality of life,QOL)观察:观察组(即参一胶囊联合化疗组)在胃肠道反应(如恶心、呕吐、腹胀等),骨髓抑制(如白细胞减少、贫血、血小板下降等)方面均较单独化疗组减轻(P<0.05),参一联合组在改善QOL方面也明显高于对照组,且有统计学差异(P<0.05)。结论:参一胶囊联合化疗组患者外周血清MMP-9水平下降更明显,且有统计学差异,而患者血清TIMP-1水平变化无统计学差异。血清MMP-9、TIMP-1水平治疗后随疗效降低呈升高趋势,因此,两者对患者疗效判定具有一定的参考价值。两组外周血清MMP-9、TIMP-1水平变化不受性别、年龄、ECOG评分影响。肺癌患者TNM分期对NSCLC患者外周血清MMP-9水平变化有影响,分期越晚,其外周血清MMP-9水平值越高。因此,MMP-9血清值越高,提示预后越差。外周血清TIMP-1水平与MMP-9水平在化疗前后NSCLC患者呈正相关。参一胶囊对非小细胞肺癌患者可以增加疗效,减少毒副反应,生活质量得到提高,不良反应如消化道症状及骨髓抑制均可以减轻。
文摘背景:从中药人参中提制的参一胶囊已被证实具有抑制肿瘤血管生成的作用,对多种肿瘤具有治疗作用,但关于参一胶囊对食管癌疗效的研究较少见。目的:观察参一胶囊辅助吉西他滨联合顺铂(gemcitabine plus cisplatin,GP)治疗进展期食管癌的疗效。设计、场所、对象和干预措施:将河南省肿瘤医院及河南中医学院第一附属医院收治的60例进展期食管癌住院患者随机分为治疗组和对照组各30例,治疗组采用参一胶囊联合 GP 方案治疗,对照组则单行 GP 方案化疗。主要结局指标:治疗后进行疗效评价,检测血管内皮细胞生长因子(vascular endothelial growth factor,VEGF)水平,并评价毒副反应和生活质量,进行生存期随访。结果:治疗组和对照组总有效率比较,差异无统计学意义(P=0.297);两组治疗后血清 VEGF 水平均低于治疗前,而治疗组治疗后 VEGF 水平又低于对照组治疗后(P=0.002):治疗组白细胞和血小板下降率,以及恶心呕吐发生率均低干对照组,差异有统计学意义(P=0.045、0.036、0.037);治疗组生活质量改善明显优于对照组,差异有统计学意义(P=0.028);治疗组1年生存率高于对照组,差异有统计学意义(P=0.047)。结论:参一胶囊辅助 GP 方案是治疗进展期食管癌的一种新的安全有效的方法,有提高总有效率趋势,可抑制食管癌新生血管形成,减少化疗副反应,改善患者生活质量,提高患者生存率,优于单纯化疗。
