Objective： To explore the effect and mechanism of ginsenoside Rg3 （Shenyi Capsule, 参一胶囊） on the postoperative life span of patients with non-small cell lung cancer （NSCLC）. Methods： The prospective, randomiz...Objective： To explore the effect and mechanism of ginsenoside Rg3 （Shenyi Capsule, 参一胶囊） on the postoperative life span of patients with non-small cell lung cancer （NSCLC）. Methods： The prospective, randomized, controlled method was adopted. One hundred and thirty- three patients with NSCLC were randomly assigned to 3 groups： Shenyi Capsule group （43 cases）, combined therapy group （Shenyi Capsule plus chemotherapy, 46 cases）, and chemotherapy group （44 cases）. The survival rates, immune function and the correlation between vascular endothelial growth factor （VEGF） expression and clinical effect were analyzed in the three groups. Results： （1） The 1-year survival rate in the Shenyi group, the combined group and the chemotherapy group was 76.7% （33/43）, 82.6% （38/46）, and 79.5% （35/44）, respectively; the 2-year survival rate was 67.4% （29/43）, 71.7% （33/46）, and 70.5% （31/44）, respectively; and the 3-year survival rate was 46.5% （20/43）, 54.3% （25/46）, and 47.7% （21/44）, respectively. There was no significant difference among the 3 groups （P〉0.05）. （2） NK cells were increased to different degrees and the ratio of CD4/CD8 was normal in the Shenyi Capsule group and the combined group, while the ratio of CD4/CD8 was disproportional in the chemotherapy group. （3） In the chemotherapy group, the 3-year survival rate was lower in patients with positive expression of VEGF than in patients with negative expression （37.0% vs 64.7%, χ^2=17.9, P〈0.01）, but no significant statistical difference was shown in the other two groups （53.6% vs 55.6%, P〉0.05; 44.4% vs 50.0%, P〉0.05）. Conclusion： Shenyi Capsule, especially in combination with chemotherapy, can improve the life span of patients with NSCLC after operation. The mechanism might be correlated with improving the immune function and anti-tumor angiogenesis.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
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
背景狼疮肾炎(LN)是系统性红斑狼疮严重并发症之一,相关研究表明中药复方肾怡(SY)可以调节机体免疫及抑制肾脏纤维化。目前运用复方SY治疗LN的疗效及机制尚不清楚。目的探究复方SY对LN小鼠的治疗作用及补体旁路途径激活的影响。方法2021...背景狼疮肾炎(LN)是系统性红斑狼疮严重并发症之一,相关研究表明中药复方肾怡(SY)可以调节机体免疫及抑制肾脏纤维化。目前运用复方SY治疗LN的疗效及机制尚不清楚。目的探究复方SY对LN小鼠的治疗作用及补体旁路途径激活的影响。方法2021年4—7月,选取35只SPF级MRL/lpr小鼠(8周龄)、6只SPF级C57BL/6J小鼠(8周龄)进行实验。将MRL/lpr小鼠依据随机数字表法分为MRL/lpr组(n=8)及SY低剂量组(n=9)、SY中剂量组(n=9)、SY高剂量组(n=9),C57BL/6J小鼠为正常对照组(n=6)。SY低、中、高剂量组分别以15.34、46.02、92.04 g/kg剂量进行复方SY汤剂灌胃,正常对照组及MRL/lpr组以0.5 ml 0.9%氯化钠溶液灌胃。从小鼠12周龄开始干预,1次/d,持续14周。观察各组动物体征,检测尿蛋白与肌酐比值(UPCR),血清抗双链DNA抗体(anti-dsDNA)、抗核抗体(ANA)水平,肾脏组织病理情况,肾脏组织C3、免疫球蛋白G(IgG)、C5b-9免疫沉积情况,肾脏组织α平滑肌肌动蛋白(α-SMA)、Ⅰ型胶原蛋白(CollagenⅠ)、Fibronectin及补体蛋白水平。结果截至干预结束,正常对照组6只小鼠存活,MRL/lpr组3只小鼠存活,SY低、中、高剂量组分别有5、7、9只小鼠存活。(1)正常对照组、SY中剂量组、SY高剂量组小鼠体征量化分值均低于MRL/lpr组(P<0.05)。(2)正常对照组、SY各剂量组小鼠干预第9、10、11、12、13周UPCR均低于MRL/lpr组(P<0.05)。(3)正常对照组、SY低剂量组、SY高剂量组小鼠干预14周后血清anti-dsDNA水平低于MRL/lpr组(P<0.05);正常对照组、SY各剂量组小鼠干预14周后血清ANA水平低于MRL/lpr组(P<0.05)。(4)干预14周后,HE染色可见MRL/lpr组小鼠肾小球内有免疫复合物沉积,PAS染色可见肾小球内有新月体形成;HE染色可见SY各剂量组小鼠肾小球大致正常,而PAS染色可见SY中、高剂量组小鼠肾小球内有系膜细胞增生,伴少量炎细胞浸润。(5)正常对照组、SY各剂量组小鼠干预14周后�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�展开更多
文摘Objective： To explore the effect and mechanism of ginsenoside Rg3 （Shenyi Capsule, 参一胶囊） on the postoperative life span of patients with non-small cell lung cancer （NSCLC）. Methods： The prospective, randomized, controlled method was adopted. One hundred and thirty- three patients with NSCLC were randomly assigned to 3 groups： Shenyi Capsule group （43 cases）, combined therapy group （Shenyi Capsule plus chemotherapy, 46 cases）, and chemotherapy group （44 cases）. The survival rates, immune function and the correlation between vascular endothelial growth factor （VEGF） expression and clinical effect were analyzed in the three groups. Results： （1） The 1-year survival rate in the Shenyi group, the combined group and the chemotherapy group was 76.7% （33/43）, 82.6% （38/46）, and 79.5% （35/44）, respectively; the 2-year survival rate was 67.4% （29/43）, 71.7% （33/46）, and 70.5% （31/44）, respectively; and the 3-year survival rate was 46.5% （20/43）, 54.3% （25/46）, and 47.7% （21/44）, respectively. There was no significant difference among the 3 groups （P〉0.05）. （2） NK cells were increased to different degrees and the ratio of CD4/CD8 was normal in the Shenyi Capsule group and the combined group, while the ratio of CD4/CD8 was disproportional in the chemotherapy group. （3） In the chemotherapy group, the 3-year survival rate was lower in patients with positive expression of VEGF than in patients with negative expression （37.0% vs 64.7%, χ^2=17.9, P〈0.01）, but no significant statistical difference was shown in the other two groups （53.6% vs 55.6%, P〉0.05; 44.4% vs 50.0%, P〉0.05）. Conclusion： Shenyi Capsule, especially in combination with chemotherapy, can improve the life span of patients with NSCLC after operation. The mechanism might be correlated with improving the immune function and anti-tumor angiogenesis.
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.
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.
文摘背景狼疮肾炎(LN)是系统性红斑狼疮严重并发症之一,相关研究表明中药复方肾怡(SY)可以调节机体免疫及抑制肾脏纤维化。目前运用复方SY治疗LN的疗效及机制尚不清楚。目的探究复方SY对LN小鼠的治疗作用及补体旁路途径激活的影响。方法2021年4—7月,选取35只SPF级MRL/lpr小鼠(8周龄)、6只SPF级C57BL/6J小鼠(8周龄)进行实验。将MRL/lpr小鼠依据随机数字表法分为MRL/lpr组(n=8)及SY低剂量组(n=9)、SY中剂量组(n=9)、SY高剂量组(n=9),C57BL/6J小鼠为正常对照组(n=6)。SY低、中、高剂量组分别以15.34、46.02、92.04 g/kg剂量进行复方SY汤剂灌胃,正常对照组及MRL/lpr组以0.5 ml 0.9%氯化钠溶液灌胃。从小鼠12周龄开始干预,1次/d,持续14周。观察各组动物体征,检测尿蛋白与肌酐比值(UPCR),血清抗双链DNA抗体(anti-dsDNA)、抗核抗体(ANA)水平,肾脏组织病理情况,肾脏组织C3、免疫球蛋白G(IgG)、C5b-9免疫沉积情况,肾脏组织α平滑肌肌动蛋白(α-SMA)、Ⅰ型胶原蛋白(CollagenⅠ)、Fibronectin及补体蛋白水平。结果截至干预结束,正常对照组6只小鼠存活,MRL/lpr组3只小鼠存活,SY低、中、高剂量组分别有5、7、9只小鼠存活。(1)正常对照组、SY中剂量组、SY高剂量组小鼠体征量化分值均低于MRL/lpr组(P<0.05)。(2)正常对照组、SY各剂量组小鼠干预第9、10、11、12、13周UPCR均低于MRL/lpr组(P<0.05)。(3)正常对照组、SY低剂量组、SY高剂量组小鼠干预14周后血清anti-dsDNA水平低于MRL/lpr组(P<0.05);正常对照组、SY各剂量组小鼠干预14周后血清ANA水平低于MRL/lpr组(P<0.05)。(4)干预14周后,HE染色可见MRL/lpr组小鼠肾小球内有免疫复合物沉积,PAS染色可见肾小球内有新月体形成;HE染色可见SY各剂量组小鼠肾小球大致正常,而PAS染色可见SY中、高剂量组小鼠肾小球内有系膜细胞增生,伴少量炎细胞浸润。(5)正常对照组、SY各剂量组小鼠干预14周后�
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�
