Clinical Effects of Shenqi Fuzheng Injection in the Neoadjuvant Chemotherapy for Local Advanced Breast Cancer and the Effects on T-lymphocyte Subsets

Objective： To evaluate clinical effects of Shenqi Fuzheng Injection （参芪抉正注射液） in the neoadjuvant chemotherapy for local advanced breast cancer and the effects on T-lymphocyte subsets. Methods： During the period from 2000 to 2005, 126 patients with local advanced breast cancer were treated with the neoadjuvant chemotherapy. They were randomly divided into the following two groups： a control group of 61 cases treated by chemotherapy alone and a study group of 65 cases treated by chemotherapy plus Shenqi Fuzheng Injection, All the cases of both groups were given the CEF （CTX 500 mg/m^2, d1, 8; EP140 mg/m^2, d1, 8; and 5-Fu 500 mg/m^2, d1,8） regimen. The clinical effects, the effects on T-lymphocyte subgroup and NK cells, and the toxic side effects were observed. Results： All the patients completed two cycles of the chemotherapy, and the efficacy and the toxic side effects were evaluated. For the primary tumor in the breast, the total effective rate was 69.2% （45/65） in the study group and 49.2% （30/61） in the control group with a statistically significant difference in the intergroup comparison （x^2=5.251, P=0.022, 〈 0.05）. There was no progression of the disease in both the groups, and there were no grade IV toxic side effects in the two groups. The major toxic responses were myelosuppression and gastrointestinal reaction, which were milder in the study group than the control group, and with a shorter recovery course in the former than the latter. Besides, an obvious rise of the T-lymphocyte subgroup and NK cells was found in the study group after the neoadjuvant chemotherapy, with a very significant difference from the controls （P〈0.01）. Conclusions： Shenqi Fuzheng Injection can improve and regulate immune function of the patients with local advanced breast cancer given the neoadjuvant chemotherapy, and therefore it can enhance the curative effect and reduce the side effect as well.

Shenqi Fuzheng Injection Ameliorates Radiation-induced Brain Injury

Shenqi Fuzheng injection(SFI)has been confirmed to be able to alleviate brain injury in mice.This study examined the brain-protective effect of SFI on patients after cranial radiation.Lung cancer patients with brain metastasis were randomly assigned to two groups.The SFI group received cranial radiation in combination with SFI.The control group received cranial radiation alone.The changes in cognitive function were evaluated pre- and post-radiation against the Mini-Mental State Exam(MMSE),Montreal Cognitive Assessement(MoCA),Zung Self-Rating Depression Scale(SDS)and Zung Self-Rating Anxiety Scale(SAS).The changes in inflammatory factors,such as TGF-β1,TNF-α and IL-10,were also detected before,during and after radiation(15Gy/5F).The results showed that 6 months after cranial radiation,the total scores on the MMSE and MoCA scales of the patients decreased,especially memory ability.The control group experienced a more evident decline,the memory ability being the greatest.TGF-β1 and TNF-α increased shortly after radiation and decreased one month later,and the change was more conspicuous in SFI group than in control group.IL-10 increased after radiation and stayed at a high level one month later in both groups,the level being higher in the SFI group than in the control group.Our study indicated that cognitive functions,especially memory ability,were impaired after cranial radiation.SFI could alleviate radiation-induced brain injury by regulating inflammatory factors.

Meta-analysis of Shenqi Fuzheng Injection Combined with Chemotherapy in Treatment of Colorectal Cancer

[Objectives] To make a systematic evaluation of the clinical efficacy and safety of Shenqi Fuzheng Injection in the treatment of colorectal cancer. [Methods] Databases,such as China National Knowledge Infrastructure( CNKI),Wanfang,China biomedical literature service system( CBM),CQVIP,Medline,and Cochrane,were searched for the time before April 2017. The randomized controlled trial( RCT) that met the inclusion criteria was screened. Then,quality evaluation was made based on the modified Jadad scale. Data were extracted and meta-analysis was made with the aid of Review Manager 5. 3. [Results] Finally,21 papers met the inclusion criteria,including 2 high quality papers. The average Jadad score was 2. 5 points,1 589 patients were included. Meta-analysis results showed that the intervention of the experimental group could improve the quality of life[OR = 3. 32,95% CI( 2. 33,4. 74),P < 0. 000 01]; improve the short-term efficacy[OR =1. 68,95% CI( 1. 26,2. 24),P =0. 000 4]; reduce the incidence of adverse chemotherapy reactions such as reducing the gastrointestinal reactions[OR = 0. 33,95% CI( 0. 25,0. 43),P < 0. 000 01],reducing myelosuppressive reactions[OR = 0. 33,95% CI( 0. 24,0. 46),P < 0. 000 01]; improve the immune functions,such as increasing CD4/CD8 cell ratio[WMD = 1. 19,95% CI( 0. 24,0. 41),( P <0. 000 01) ],and increasing the number of NK cells[WMD =1. 72,95% CI( 5. 62,14. 30),( P <0. 000 01) ]. [Conclusions]The clinical effect of Shenqi Fuzheng Injection in the treatment of colorectal cancer is better than that of chemotherapy alone,but it needs more highquality RCTs to improve the level of research.

Neuroprotective effect of Shenqi Fuzheng injection pretreatment in aged rats with cerebral ischemia/reperfusion injury

Shenqi Fuzheng injection is extracted from the Chinese herbs Radix Astragali and Radix Codonopsis. The aim of the present study was to investigate the neuroprotective effects of Shenqi Fuzheng injection in cerebral ischemia and reperfusion. Aged rats（20–22 months） were divided into three groups： sham, model, and treatment. Shenqi Fuzheng injection or saline（40 m L/kg） was injected into the tail vein daily for 1 week, after which a cerebral ischemia/reperfusion injury model was established. Compared with model rats that received saline, rats in the treatment group had smaller infarct volumes, lower brain water and malondialdehyde content, lower brain Ca2＋ levels, lower activities of serum lactate dehydrogenase and creatine kinase, and higher superoxide dismutase activity. In addition, the treatment group showed less damage to the brain tissue ultrastructure and better neurological function. Our findings indicate that Shenqi Fuzheng injection exerts neuroprotective effects in aged rats with cerebral ischemia/reperfusion injury, and that the underlying mechanism relies on oxygen free radical scavenging and inhibition of brain Ca2＋ accumulation.

Clinical study of Shenqi Fuzheng injection decreasing side-effects of chemotherapy for patients with ovarian epithelial cancer

Objective: The aim of the study was to observe the clinical effects of Shenqi Fuzheng injection decreasing sideeffects of chemotherapy for patients with ovarian epithelial cancer. Methods: The 36 cases of ovarian epithelial cancer in The Third Affiliated Hospital of SUN Yat-sen University(Guangzhou, China) from June 2010 to June 2013, were randomly divided into the study group and the control group. The study group contained 18 cases using Shenqi Fuzheng injection combined with TP(Taxol + Carboplatin/cisplatin) chemotherapy, and the control group contained 18 cases only using TP chemotherapy without Shenqi Fuzheng injection. During and after chemotherapy, the side-effects and therapy effects were observed. Results: The grade II of nausea and vomit were less in the study group than that in the control group, which was significantly different(P < 0.05). But there were no significantly differences in grade I of nausea and vomit between the two groups(P > 0.05). There was less degree of decrease of lymphocyte in the study group than that in the control group, which was significantly different(P < 0.05). But between two groups, there were no significant differences in the drop of white blood cells and red blood cells, the incidence of allergic reaction, liver and renal functions, nerve lesion and phalacrosis(P > 0.05). There was no significant difference in chemotherapy effect between the two groups(P > 0.05). Conclusion: Shenqi Fuzheng injection can in some degree relieve the side effects of TP chemotherapy for the patients with ovarian epithelial cancer, including relieving nausea and vomiting, protecting lymphocytes, and has no conflict effect on chemotherapy efficacy.

Effect of Shenqi Fuzheng Injection and naloxone and BiPAP ventilator on serum inflammatory factors, immune function and blood gas analysis indexes in patients with AECOPD with type Ⅱ respiratory failure

Objective: To investigate the effect of Shenqi Fuzheng Injection combined with naloxone and BiPAP ventilator on serum inflammatory factors, immune function and blood gas analysis indexes in treatment of AECOPD with type Ⅱ respiratory failure. Methods: A total of 82 patients with AECOPD and type Ⅱ respiratory failure were divided into control group (n=40) and observation group (n=42) according to random data table, patients in the control group received naloxone and BiPAP ventilator therapy, and observation group patients were treated with Shenqi Fuzheng Injection on the basis of control group. The levels of serum inflammatory factors, immune function and blood gas analysis indexes were compared between the two groups before and after treatment. Results: There were no significant difference in levels of CRP, TNF-α, IL-6, CD3+, CD4+, CD8+, CD4+/CD8+, PaO2, PaCO2, SaO2 and pH before and after treatment in the two groups. After treatment, the levels of CRP, TNF-α, IL-6, CD8+and PaCO2 in two groups were significantly lower than those in same group before treatment, moreover observation group was significantly lower than control group;and levels of CRP, TNF-α, IL-6, CD8+ and PaCO2 in the observation group was significantly lower than those of the control group, the difference was statistically significant;When compared with the group before treatment, CD3+, CD4+, CD4+/CD8+, PaO2, SaO2 and pH levels of both groups after treatment were significantly increased, and the level of each index of observation group after treatment were significantly higher than the control group, the difference was statistically significant. Conclusion: The clinical effect of Shenqi Fuzheng Injection Combined with naloxone and BiPAP ventilator in treatment of AECOPD with type II respiratory failure is significant, can effectively reduce the body's inflammatory reaction, improve immune function, regulate blood gas analysis index, with a certain clinical value.

Effects of Shenqi Fuzheng injection on oxidative stress after hepatic ischemia-reperfusion injury

Objective:In order to determine Shenqi Fuzheng injection’s clinical effects and explore the impact on the SOD、MDA and liver function of patients,who underwent Hepatic ischemiareperfusion injury during the surgical operation.Methods:Forty patients were collected who were treated in Oncology Surgery of Bayi Hospital from January 2019 to August 2019.These patients were divided into control group and therapy group(Shenqi Fuzheng Injection)randomly,with 20 cases in each group.In the control group,one was switched to RF treatment during operation,one was only partially blocked during operation,and the remaining 38 cases completed the study.These remained patients were all operated with Pringle maneuver,then were treated with anti-infection,liver protection,acid suppression,fluid replacement,intravenous nutrition support and other symptomatic treatment after surgery.In addition,for the patients in the therapy group,the treatment of Shenqi Fuzheng injection were added once a day,which lasted 5 days.During the perioperative period,we would record their general conditions,SOD and MDA levels;liver function(ALT、AST、LDH).These data were analyzed statistically by SPSS 21.0 statistical software.Results:There was no statistically significant difference in general indicators related to the perioperative period between the two groups of patients(P>0.05).There was no significant difference in SOD and MDA levels between the two groups(P>0.05).,but at 1d,3d,and 5d after operation,the SOD level in the observation group was significantly higher than that in the control group(both P<0.05)and The MDA level in the observation group was significantly lower than the control group.The differences were statistically significant(all P<0.05).There was no significant difference in ALT and AST levels between the two groups before and after surgery(P>0.05),while the LDH levels in the two groups were not statistically different before surgery,on the first day after surgery,and on the third day after surgery(P>0.05),while there were statistical differences on the fifth day after surgery(P<0.05).Conclusions:For the pathients who received hepatectomy with Pringle maneuver,using Shenqi Fuzheng injection could improve the activity of antioxidant enzymes in the body,reduce the production of lipid peroxides,inhibit the oxidative stress response in the process of HIRI,thus it played a role in protecting the liver and accelerated the recovery.

Effects of Shenqi Fuzheng injection combined with chemotherapy on peripheral blood, immune function and tumor markers in patients with breast cancer

Objective: To investigate the effects of Shenqi Fuzheng Injection Combined with chemotherapy on peripheral blood, immune function and tumor markers in patients with breast cancer. Methods: A total of 92 cases of breast cancer treated by modified radical mastectomy in our hospital from January 2017 to December 2017 were selected as the research subjects and were randomly divided into 46 cases in the observation group and 46 cases in the control group. The patients in the control group began chemotherapy after 2 weeks of surgery, and the observation group was given Shenqi Fuzheng Injection on the basis of the control group. The levels of leukocyte, platelet, hemoglobin, T cell subgroup, carcinoembryonic antigen (CEA), cancer antigen 153 (CA153) and carbohydrate antigen 125 (CA125) were measured and compared of patients in two groups. Results: Before treatment, there was no significant difference in white blood cell, platelet and hemoglobin between the two groups. After treatment, the white blood cells, platelets and hemoglobin in the observation group were (3.56±0.10)×109/L, (137.47±23.58)×109/L, (116.72±15.75) g/L, and the white cells, platelets and hemoglobin in the control group were (2.85±0.18)×109/L, (126.76±21.34)×109/L, (103.36±20.51) g/L, respectively, all the indexes decreased than before treatment, moreover the decrease of control group is more obvious than observation group, and the difference was statistically significant. Before treatment, there was no significant difference in CD3+, CD4+, CD8+and CD4+/CD8+between the two groups. After treatment, the CD3+, CD4+and CD4+/CD8+in the observation group were (58.02±12.77)%, (50.79±7.45)% and (2.13±0.69), which were significantly higher than those before the treatment, and increased compared with the control group in the corresponding period, the difference was statistically significant. Before treatment, there was no significant difference in CEA, CA153 and CA125 between the two groups. After treatment, the CEA, CA153 and CA125 of the observation group were (16.70±3.71) μg/L, (13.11±3.70) U/mL and (11.25±1.73) U/mL, and in the control group they were (21.71±4.24) μg/L, (20.31±4.21) U/mL and (17.78±2.36) U/mL, respectively, the CEA, CA153 and CA125 in two groups were all lower than those before treatment, and the indexes of the observation group were decreased more significantly than those of the control group, the differences were statistically significant. Conclusion: Shenqi Fuzheng Injection Combined with chemotherapy in peripheral blood and immune function significantly improved in patients with breast cancer, and a significant decrease in the level of tumor markers.

Effect of Shenqi Fuzheng Injection combined with chemotherapy on peripheral blood cell level, tumor markers and immune function in patients with gastric cancer

Objective:To investigate the effects of Shenqi Fuzheng Injection combined with chemotherapy on peripheral blood cell level, tumor markers and immune function in patients with gastric cancer.Methods: Eighty patients with gastric cancer admitted to our hospital from May 2016 to October 2017 were selected as the research object and randomly divided into observation group and control group, 40 cases in each group. Control group was treated by DCF chemotherapy, while the observation group by Shenqi Fuzheng Injection based on the DCF chemotherapy. The levels of peripheral blood cells, tumor markers and immune function indexes in both groups were detected and compared before and after treatment.Results: There were no significant differences in serum RBC, WBC, PLT, Hb, NSE, CYFRA21-1, CA199, CEA, CD3+, CD4+, CD8+ and CD4+/CD8+ levels before treatment in both groups. Compared with the pretreatment group, the levels of RBC, WBC, PLT and Hb in both groups decreased to some extent after treatment, and the levels in the observation group were significantly higher than those in the control group;Compared with the same group before treatment, the levels of NSE, CYFRA21-1, CA199 and CEA in the two groups were significantly decreased, and the observation group was significantly lower than the control group;CD3+, CD4+, CD4+/CD8+ levels in control group and observation group increased to some extent after treatment, and the levels in observation group were significantly higher than those in control group. The levels of CD8+ in both groups after treatment were significantly lower than those before treatment, and the observation group was significantly lower than the control group after treatment. The above data for statistical analysis had significant differences.Conclusions: Shenqi Fuzheng injection combined with chemotherapy helps to clear and kill cancer cells, enhance immunity and reduce hematological toxicity after chemotherapy, which can be used as an adjuvant chemotherapy for gastric cancer.

参芪扶正注射液联合信迪利单抗对晚期胃癌化疗患者的增效减毒作用

目的探讨参芪扶正注射液联合信迪利单抗对晚期胃癌化疗患者的增效和减毒作用。方法选取2022年8月至2023年6月南阳市中心医院收治的140例晚期胃癌化疗患者作为研究对象,采用随机数表法分为观察组70例、对照组70例。两组患者均予以FOLFOX6化疗,对照组患者同时予以信迪利单抗治疗,观察组患者则予以参芪扶正注射液联合信迪利单抗,以21 d为一个周期,连续治疗3个周期。治疗3个周期后比较两组患者的临床疗效和毒副反应发生率,同时比较两组患者治疗前后的血清肿瘤标志物[糖链抗原19-9(CA19-9)、糖链抗原125(CA125)、癌胚抗原(CEA)、糖链抗原72-4(CA72-4)]、免疫功能[CD3^(+)、CD4^(+)、免疫球蛋白A(IgA)、免疫球蛋白G(IgG)]和胃蛋白酶原水平(胃蛋白酶原Ⅰ、胃蛋白酶原Ⅱ)以及生存质量[卡氏行为状态(KPS)]。结果治疗3个周期后,观察组患者的客观缓解(ORR)率、疾病控制(DCR)率分别为64.29%、81.43%,明显高于对照组的45.71%、65.71%,而各项毒副反应发生率明显低于对照组,差异均有统计学意义(P<0.05);治疗3个周期后,观察组患者的血清CA19-9、CA125、CEA、CA72-4、胃蛋白酶原Ⅱ水平分别为(26.13±3.02)U/mL、(28.94±3.26)U/mL、(3.05±0.74)ng/mL、(5.46±1.03)U/mL、(12.07±1.05)ng/mL,明显低于对照组的(31.27±3.54)U/mL、(34.96±3.88)U/mL、(5.74±1.02)ng/mL、(8.12±1.34)U/mL、(15.69±1.78)ng/mL,差异均有统计学意义(P<0.05);与治疗前比较,观察组患者治疗1个周期、3个周期后的血清CD3^(+)、CD4^(+)、IgA、IgG水平明显高于对照组,差异均有统计学意义(P<0.05);观察组治疗1个周期、3个周期后血清胃蛋白酶原Ⅰ水平高于对照组,胃蛋白酶原Ⅱ水平明显低于对照组,差异有统计学意义(P<0.05);治疗3个周期后,观察组患者的生存质量总有效率为81.43%,明显高于对照组的58.57%,差异有统计学意义(P<0.05)。结论参芪扶正注射液联合信迪利单抗治疗晚期胃癌化疗患者,可增强抗肿瘤疗效,减少毒副反应发生,减轻胃黏膜损伤,并可提高免疫力,改善生存质量。

参芪扶正注射液辅助治疗胃癌化疗后癌因性疲乏患者效果观察

目的:探讨参芪扶正注射液辅助治疗胃癌化疗后癌因性疲乏(CRF)患者效果观察及对免疫功能和生存质量的影响。方法:选自本院于2021年3月—2022年10月胃癌化疗后CRF患者110例,依据随机表法分为观察组55例与对照组55例。对照组患者静脉滴注甘露聚糖肽10 mg/次,1次/d;观察组患者在对照组基础上静脉滴注参芪扶正注射液250 ml/次,1次/d。两组治疗周期4周。比较两组治疗前后Piper疲乏修订量表(PFS-R)评分、简易疲乏量表(BFI)和Kolcaba舒适状况量表(GCQ)评分、免疫功能、肿瘤标志物及欧洲生活质量协作组癌症核心量表(QLQ-C30)评分变化。结果:两组治疗前认知、感觉、情感、行为和整体疲乏度评分比较无显著差异(P>0.05);两组治疗后认知、感觉、情感、行为和整体疲乏度评分低于治疗前(P<0.05);观察组治疗后认知、感觉、情感、行为和整体疲乏度评分低于对照组(P<0.05)。两组治疗前BFI量表和GCQ量表评分比较无显著差异(P>0.05);两组治疗后BFI量表评分低于治疗前,而GCQ量表评分高于治疗前(P<0.05);观察组治疗后BFI量表评分低于对照组,而GCQ量表评分高于对照组(P<0.05)。两组治疗前CD3^(+)、CD4^(+)和CD4^(+)/CD8^(+)比较无显著差异(P>0.05);两组治疗后CD3^(+)、CD4^(+)和CD4^(+)/CD8^(+)高于治疗前(P<0.05);观察组治疗后CD3^(+)、CD4^(+)和CD4^(+)/CD8^(+)高于对照组(P<0.05)。两组治疗前CEA和CA-724水平比较无显著差异(P>0.05);两组治疗后CEA和CA-724水平低于治疗前(P<0.05);观察组治疗后CEA和CA-724水平低于对照组(P<0.05)。两组治疗前躯体功能、角色功能、社会功能、认知功能和情感功能评分比较无显著差异(P>0.05);两组治疗后躯体功能、角色功能、社会功能、认知功能和情感功能评分高于治疗前(P<0.05);观察组治疗后躯体功能、角色功能、社会功能、认知功能和情感功能评分高于对照组(P<0.05)。结论:参芪扶正注射液辅助治疗胃癌化疗后CRF患者治疗效果显著,可显著改善患者疲乏症状,显著改善患者免疫功能,显著改善患者生存质量。

参芪扶正注射液联合经动脉化疗栓塞治疗中晚期肝癌患者的效果及安全性

目的:分析参芪扶正注射液联合经动脉化疗栓塞(TACE)治疗中晚期肝癌患者的效果和安全性。方法:选择2021年1月—2022年12月于广州市第一人民医院接受治疗的98例中晚期肝癌患者为研究对象,采用随机数表法均分为研究组和对照组,各49例。对照组仅予以TACE治疗,研究组在TACE的基础上予以静脉参芪扶正注射液联合治疗。比较两组的临床有效率、肝功能指标[谷丙转氨酶(ALT)、谷草转氨酶(AST)]、免疫学指标(CD3^(+)、CD4^(+)、CD8^(+)和CD4^(+)/CD8^(+))、不良反应发生率和生活质量。结果:研究组临床总有效率为79.59%,高于对照组的63.27%,差异有统计学意义(P<0.05)。术后2周,两组ALT、AST均低于术前1 d,且研究组上述指标均低于对照组,差异有统计学意义(P<0.05)。术后2周,研究组CD3^(+)、CD4^(+)和CD4^(+)/CD8^(+)高于术前1 d和对照组,而CD8^(+)水平低于术前1 d和对照组,差异有统计学意义(P<0.05)。研究组不良反应总发生率为30.61%,低于对照组的57.14%,差异有统计学意义(P<0.05)。研究组生活质量改善率为91.84%,高于对照组的65.31%,差异有统计学意义(P<0.05)。结论:参芪扶正注射液联合TACE治疗能够提高中晚期肝癌患者的临床有效率,保护患者的肝功能,减少患者TACE后不良反应,提高患者的免疫学水平和临床生活质量。

基于UPLC-Q-TOF-MS的参芪扶正注射液主要成分鉴定及其治疗三阴性乳腺癌的网络药理学研究

目的 应用超高效液相色谱串联四极杆飞行时间质谱联用(UPLC-Q-TOF-MS)技术和网络药理学方法,鉴定参芪扶正注射液的主要成分,探究其治疗三阴性乳腺癌(TNBC)的作用机制,为其药效物质基础研究提供依据。方法 (1)参芪扶正注射液主要成分鉴定:采用UPLC-Q-TOF-MS技术,结合天然产物高分辨质谱数据库及相关文献,明确参芪扶正注射液的主要成分。(2)网络药理学研究:基于中药系统药理学数据库与分析平台(TCMSP)、中草药化合物蛋白质靶标数据库(HIT)、有机小分子生物活性数据库(PubChem)、化合物靶点预测平台(Swiss Target Prediction)、本草组鉴数据库(HERB)获取参芪扶正注射液主要成分的潜在靶点,利用人类基因综合数据库(GeneCards)、在线人类孟德尔遗传数据库(OMIM)、治疗靶点数据库(TTD)获得TNBC疾病潜在靶点,二者相结合得到参芪扶正注射液治疗TNBC的潜在靶点;运用蛋白互作关系数据库(STRING)平台、Cytoscape 3.9.1软件构建蛋白互作网络图并进行网络拓扑分析,获得参芪扶正注射液治疗TNBC的关键靶点;运用R语言进行京都基因与基因组百科全书(KEGG)通路富集分析。(3)动物实验验证:制备异种移植瘤乳腺癌小鼠模型,分为模型组与参芪扶正注射液低、中、高剂量(20、40、60 mL/kg)组,干预4周后取肿瘤组织,运用Western blot方法检测肿瘤组织中磷酸化磷脂肌醇3激酶(p-PI3K)、磷脂肌醇3激酶(PI3K)、P-糖蛋白(P-gp)、乳腺癌耐药蛋白(ABCG2)表达情况,并对预测潜在靶点进行实验验证。结果 (1)参芪扶正注射液的主要成分为党参炔苷、鸟苷、毛蕊异黄酮苷、壬二酸、黄芪甲苷、美迪紫檀苷等。(2)网络药理学研究结果显示,参芪扶正注射液的主要成分主要作用于肿瘤蛋白p53(TP53)、白介素-2(IL-2)、白介素-6(IL-6)、白介素-10(IL-10)、己糖激酶2(HK2)、缺氧诱导因子1亚基α(HIF1A)、半胱氨酸天冬氨酸蛋白酶9(CASP9)、ABCG2、ATP结合盒转运体B1(ABCB1)、原癌基因(MYC)等关键靶点,调控磷脂酰肌醇3-激酶/蛋白激酶B(PI3K/Akt)、缺氧诱导因子-1(HIF-1)、T细胞受体等信号通路。(3)动物实验验证结果显示,参芪扶正注射液降低了实验动物肿瘤组织中p-PI3K水平,抑制了P-gp和ABCG2的表达。结论 参芪扶正注射液中的主要成分为党参炔苷、鸟苷、毛蕊异黄酮苷、壬二酸、黄芪甲苷、美迪紫檀苷等,其抗TNBC的作用机制与其通过调控PI3K信号通路和调节耐药相关蛋白表达有关。

联合网络药理学和转录组学探讨参芪扶正注射液改善顺铂诱导的急性肾损伤的分子机制

目的:运用网络药理学和转录组学方法,探究参芪扶正注射液改善顺铂诱导的急性肾损伤(AKI)的潜在作用靶点,为进一步指导临床提供实验依据。方法:(1)网络药理学分析:在本草组鉴数据库(HERB)、中药系统药理学数据库与分析平台(TCMSP)、中草药化合物蛋白质靶标数据库(HIT)、化合物靶点预测平台(Swiss Target Predictio)、有机小分子生物活性数据库(PubChem)、蛋白质分析数据库(UniProt)、蛋白质相互作用(PPI)关系数据库(STRING)中检索得到参芪扶正注射液主要成分的潜在靶点;使用在线人类孟德尔遗传数据库(OMIM)、人类基因综合数据库(GeneCards)、治疗靶点数据库(TTD)检索获得AKI的潜在靶点;利用STRING数据库和Cytoscape 3.9.1软件构建参芪扶正注射液主要成分和AKI共同潜在靶点的PPI网络图并进行网络拓扑分析;使用R语言软件进行基因本体(GO)功能富集分析和京都基因与基因组百科全书(KEGG)通路富集分析。(2)动物实验和转录组学分析:建立4T1乳腺癌荷瘤小鼠模型,分为4组(模型组、参芪扶正注射液组、顺铂组、参芪扶正注射液联合顺铂组),给药4周后取血检测肌酐(CRE)与尿素氮(BUN),取肾脏组织进行转录组学测序分析,运用实时荧光定量聚合酶链式反应(qRT-PCR)法进行实验验证。结果:通过网络药理学数据库和Cytoscape 3.9.1软件预测出65个参芪扶正注射液主要成分和AKI的共同潜在靶点。PPI网络图和共同潜在靶点网络图表明,参芪扶正注射液的主要成分和AKI与65个共同潜在靶点之间存在着多种作用关系。GO功能富集分析和KEGG通路富集分析结果表明,参芪扶正注射液改善AKI的作用与氧化和抗氧化、炎性和免疫反应以及T细胞受体信号通路、缺氧诱导因子-1信号通路等途径密切相关。顺铂组血清CRE、BUN水平均高于模型组(P<0.05)。参芪扶正注射液组血清CRE水平低于模型组(P<0.05)。参芪扶正注射液组血清CRE、BUN水平均低于顺铂组(P<0.05)。参芪扶正注射液联合顺铂组血清CRE、BUN水平均低于顺铂组(P<0.05)。参芪扶正注射液联合顺铂组血清CRE水平高于参芪扶正注射液组(P<0.05)。参芪扶正注射液联合顺铂组血清BUN水平与参芪扶正注射液组比较,差异无统计学意义(P>0.05)。4组小鼠肾脏组织HE染色结果表明,参芪扶正注射液改善了顺铂诱导的肾组织损伤。结合网络药理学和转录组学分析,得到9个共同潜在靶点,其中参芪扶正注射液下调基因包括黄嘌呤脱氢酶、白细胞介素10、E-钙黏蛋白、干扰素因子-γ、雌激素受体α基因、前列腺素内过氧化物合酶1,上调基因包括过氧化物酶体增殖物激活受体-γ、白细胞介素6、CD4^(+)T细胞。结论:参芪扶正注射液能够通过影响氧化应激、炎性与免疫反应来改善顺铂诱导的AKI,且具有多途径、多靶点的优势。

硼替佐米基础化疗方案联合参芪扶正注射液治疗多发性骨髓瘤伴肾功能不全的疗效及安全性分析

目的:探究以硼替佐米为基础的三联化疗联合参芪扶正注射液治疗多发性骨髓瘤伴肾功能不全患者的疗效及不良反应发生情况。方法:纳入103例气血两虚型多发性骨髓瘤伴肾功能不全患者,随机分为对照组(51例)与研究组(52例)。对照组采用以硼替佐米为基础的三联化疗,研究组加用参芪扶正注射液。比较两组患者疗效、中医证候积分、生活质量评分、造血功能、肾功能、免疫功能及不良反应发生情况。结果:对照组临床总缓解率(70.83%)与研究组临床总缓解率(79.17%)比较,差异无统计学意义(P>0.05)。治疗后,两组患者中医证候积分、NRS均低于治疗前,KPS高于治疗前,且研究组变化幅度高于对照组(P<0.05)。治疗后,两组患者WBC、Hb、PLT均低于治疗前,且研究组治疗后WBC、Hb、TLT均高于对照组(P<0.05)。治疗后,两组患者Scr、BUN、24 h尿蛋白量均低于治疗前,且研究组治疗后Scr、BUN、24 h尿蛋白量均低于对照组(P<0.05)。治疗后,两组患者CD3^(+)、CD4^(+)、CD4^(+)/CD8^(+)水平均显著高于治疗前,且研究组治疗后CB3^(+)、CD4^(+)、CD4^(+)/CD8^(+)均高于对照组(P<0.05)。研究组骨髓抑制发生率(18.75%vs39.58%)、恶心呕吐发生率(14.58%vs33.33%)、Ⅲ-Ⅳ级周围神经病变发生率(10.42%vs29.17%)显著低于对照组(P<0.05)。结论:硼替佐米三联化疗联合参芪扶正注射液治疗能够显著提高多发性骨髓瘤伴肾功能不全患者生活质量,减轻化疗对患者骨髓造血功能的抑制,改善肾功能,提高细胞免疫功能,降低化疗相关不良反应的发生率。

Shenqi Fuzheng Injection(参芪扶正注射液) for Advanced Gastric Cancer:A Systematic Review of Randomized Controlled Trials

Objective： To evaluate the effectiveness of Shenqi Fuzheng Injection （参芪扶正注射液, SFI） combined with chemotherapy for advanced gastric cancer. Methods： Randomized controlled trials （RCTs） from 10 databases were searched for this meta-analysis till December 31, 2012 without language restriction. Grey literature and potential unpublished literature was also searched. The key search terms were ＂chemotherapy＂, ＂Shenqi Fuzheng Injection＂ and ＂advanced gastric cancer＂. Criteria were built to select these clinical trials, in which SFI combined with chemotherapy was compared with chemotherapy alone for advanced gastric cancer. The methodological quality of each RCT was assessed using the Cochrane risk of bias tool. RevMan 5.1 software was applied for data analyses. Results： Thirteen RCTs involving 860 patients met the selection criteria （all articles were from Chinese databases）. The meta-analysis showed positive results for the use of SFI combined with chemotherapy according to quality of life in terms of the scores when compared with chemotherapy alone. Positive results were also obtained for the combination treatment, in terms of complete remission and partial remission efficacy rate, body weight and decreased adverse events including nausea and vomiting at grade 3-4, oral mucositis at grade 1-2, leucopenia at grade 3-4, and myelo-suppression at grade 1-2. Conclusions： This systematic review found encouraging albeit limited evidence for SFI combined with chemotherapy. However, to obtain stronger evidence without the drawbacks of trial design and the quality of studies, we recommend comparative effectiveness researches to test the effectiveness of combination treatment.

Clinical Study on Treatment of Mammary Cancer by Shenqi Fuzheng Injection (参芪扶正注射液) in Cooperation with Chemotherapy

Objective： To study the effect of Shenqi Fuzheng Injection （参芪扶正注射液,SFI） on cellular immune in patients with mammary cancer （MC） after chemotherapy. Methods： One hundred and ten patients with MC were randomly assigned to two groups. The 58 patients in the tested group were treated with SFI in cooperation with chemotherapy of CAF protocol （Cyclophosphamide, Doxorubicin and Fluorouracil）, while the 52 patients in the control group were treated with chemotherapy of the same protocol alone. Changes of the patients＇ quality of life （QOF）, adverse reaction that occurred, peripheral lymphocyte count and killing activity of single karyocyte before and after treatment between the two groups were compared. Results： Patients＇ QOF elevating rate after treatment in the tested group and the control group was 34.5% and 13.5% respectively; The lowering of peripheral blood cell count of WBC, platelet and lymphocyte as well as that of the killing activity of single peripheral karyocyte on various kinds of MC cells were all milder and recovery sooner than those in the control group. Conclusion： SFI in combination with chemotherapy in treating MC could reduce the occurrence of adverse reaction to chemotherapy, improve clinical symptoms, elevate QOF and enhance immunity in patients with MC.

Shenqi Fuzheng Injection Combined with Chemotherapy for Acute Leukemia:A Meta-Analysis

Objective:To evaluate to the efficacy and safety of Shenqi Fuzheng Injection(SFI)combined with chemotherapy in the treatment of acute leukemia(AL)by meta-analysis.Methods:Pub Med,Cochrane library,Embase,Sino Med,China National Knowledge Infrastructure(CNKI),VIP Journal Integration Platform,Wanfang Database were searched from establishment to November 1,2018.The randomized controlled trials(RCTs)of SFI combined with chemotherapy in the treatment of AL were included.The Cochrane risk assessment form(Rev Man 5.1)was used to evaluate the quality of included studies.Results:A total of 14 RCTs and 1,088 patients was included.The quality evaluation was mostly low risk or unclear.Meta-analysis showed that compared with chemotherapy alone,SFI combined with chemotherapy can improve the total clinical effective rate in patients with AL(RR=1.15,95%CI:1.056–1.177;P=0.0001),and relieve adverse reactions caused by chemotherapy drugs,including infection(RR=0.561,95%CI:0.397–0.792;P=0.001),nausea and vomiting(RR=0.662,95%CI:0.524–0.835;P=0.001),bleeding(RR=0.548,95%CI:0.39–0.768;P=0.0001),cardiotoxicity(RR=0.230,95%CI:0.080–0.660;P=0.006)and hyperhidrosis(RR=0.348,95%CI:0.208–0.581;P=0.0001).The incidence rates of adverse reactions in SFI combined with chemotherapy group were significantly lower than that of the chemotherapy alone group(P<0.01).Conclusions:Shenqi Fuzheng Injection combined with chemotherapy has good efficacy and safety for AL,and it can alleviate the adverse reactions caused by chemotherapy.However,subject to the limitations of the methodological quality of the literature,the conclusions of this study need to be further verified by large-scale and multi-center RCTs.

The therapeutic efficacy of the Shenqi Fuzheng injection for treating chronic heart failure: A systematic review and meta-analysis

Chronic heart failure(CHF) is a cardiovascular disease which is hard to treat and which threatens public health. It is imperative to seek a new treatment for CHF. The Shenqi Fuzheng compound injection(SQFZI) is often used in China for treating patients with this condition. We used a meta-analysis to evaluate the therapeutic efficacy of SQFZI combined with conventional therapy for the treatment of chronic heart failure. Researchers searched the databases for randomized controlled trials(RCTs) of SQFZI combined with conventional therapy for treating CHF. There were no language or regional restrictions. Quality assessment was conducted according to the Cochrane Handbook, and data analysis was carried out using RevMan 5.3 software. Fifteen RCTs were selected, which included 1198 patients. Using meta-analysis, we found that the clinical efficacy of the experimental group(SQFZI combined with conventional therapy) was better than the control group(conventional therapy alone). Additionally,SQFZI combined with conventional therapy improved left ventricular ejection fraction, left ventricular end-diastolic dimension, cardiac output, stroke volume, brain natriuretic peptide, N-terminal pro-brain natriuretic peptide, and other cardiac indexes. Two trials reported non-serious adverse events, the others reported no adverse events. Based on this meta-analysis, we suggest that SQFZI combined with conventional therapy can effectively improve the efficacy of treatment for CHF patients. However, due to insufficient evidence regarding its safety, more trials of SQFZI for treating CHF are needed.

卡瑞利珠单抗联合参芪扶正注射液治疗晚期非鳞非小细胞肺癌患者的疗效和安全性评价

目的 探究卡瑞利珠单抗联合参芪扶正注射液方案对晚期非鳞非小细胞肺癌(NSCLC)的临床疗效和安全性。方法 选取2018年1月至2023年1月西安交通大学第一附属医院肿瘤科诊治的晚期非鳞NSCLC患者为研究对象,所有患者均行培美曲塞联合卡铂化疗。根据治疗方案,将患者分为卡瑞利珠单抗组(Camrelizumab)和卡瑞利珠单抗联合参芪扶正注射液组(Camrelizumab+SFI)。以客观反应率(ORR)、疾病控制率(DCR)、无进展生存期(PFS)和总生存期(OS)进行短期疗效和长期疗效评价。生存资料采用Kaplan-Meier法进行分析,根据不良事件通用术语标准(CTCAE 4.03)评估药品不良反应的发生情况。结果 共纳入95例晚期非鳞NSCLC患者,Camrelizumab组48例,Camrelizumab+SFI组47例。Camrelizumab+SFI组和Camrelizumab组患者的ORR分别为59.57%和45.83%(χ^(2)=1.799,P=0.180),DCR分别为78.72%和58.33%(χ^(2)=4.569,P=0.033)。Camrelizumab+SF组患者的中位PFS(8.87个月vs.6.30个月,P=0.001 7)和中位OS(9.13个月vs.7.73个月,P=0.037)均显著高于Camrelizumab组。两组之间药品不良反应发生情况差异无统计学意义(P> 0.05)。结论 卡瑞利珠单抗联合参芪扶正注射液治疗可提升晚期非鳞NSCLC患者DCR,延长患者的PFS和OS。