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.

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.

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.

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.