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Objective:To evaluate the value of age-adjusted Charlson comorbidity index (aCCI) in the clinical prognosis of sepsis and septic shock in the elderly, and to further explore the role of aCCI in evaluating the timing of Shenfu injection in elderly patients with septic shock.Methods:Clinical data of elderly patients with sepsis and septic shock in Dongzhimen Hospital of Beijing University of Chinese Medicine from January 1, 2019 to January 1, 2022 were retrospectively analyzed. With the median aCCI score of all samples as the cutoff value, the patients were divided into the low aCCI score group and high aCCI score group. The prognosis of elderly patients with septic shock and the application timing of Shenfu injection with aCCI score and sequential organ failure assessment (SOFA) were compared.Results:A total of 61 patients were included, including 31 patients in the high aCCI score group. The proportion of septic shock in elderly sepsis patients was lower in the low aCCI score group ( P < 0.05). The aCCI score (95% CI: 1.229-2.615; P< 0.01) was more valuable than SOFA score (95% CI: 1.035-1.607; P< 0.05) in predicting septic shock in elderly patients with sepsis. The 28-day survival rate in the low aCCI score group was higher than that in the high aCCI score group ( P < 0.05). Both the SOFA score (95% CI: 1.010-1.364) and the aCCI score (95% CI: 1.072-10.501) were independent factors affecting the 28-day survival rate. The use of Shenfu injection was associated with 28-day survival outcome in elderly patients with septic shock (95% CI: 0.012-0.788; P < 0.05). Conclusions:aCCI score is more effective than SOFA score in assessing the risk of shock in elderly patients with septic shock, and has a certain predictive value for the survival and prognosis of elderly patients with sepsis. Shenfu injection may be beneficial to the survival and prognosis of elderly patients with septic shock, but it needs to be further verified by large-scale prospective studies.
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OBJECTIVE To systematically evaluate the efficacy and safety of Shenfu injection combined with chemical medicine in the treatment of coronary heart disease combined with heart failure. METHODS Retrieved from CNKI， CBM， VIP， Wanfang， PubMed， Embase and the Cochrane Library， randomized controlled trials （RCTs） about Shenfu injection combined with chemical medicine （trial group） versus chemical medicine （control group） in the treatment of heart failure with coronary heart disease were collected during the inception to August 2022. After literature screening and data extraction， the qualities of included literature were evaluated and rated by using Cochrane manual and GRADE system. Meta-analysis and Egger’s were performed with RevMan 5.3 software， and TSA 0.9.5.10 Beta software was used for trial sequential analysis. RESULTS Seventeen studies were included， with a total sample of 1 355 patients. The quality grade evidence of GRADE was all low. Meta-analysis showed that cardiac function efficacy [RR＝1.23， 95%CI （1.16，1.30）， P＜0.000 01]， the decrease of brain natriuretic peptide [MD＝－96.06， 95%CI （－116.47， －75.64）， P＜0.000 01] and the increase of left ventricular ejection fraction [MD＝5.32， 95%CI （4.03，6.60）， P＜0.000 01] in trial group were significantly better than control group； there was no statistical significance in the incidence of ADR between 2 groups [RR＝0.52，95%CI（0.22，1.22），P＝0.13]. The results of sequential analysis showed that the sample size included in this study met the requirements of meta-analysis； the results of Egger’s test showed that the results were robust and publication bias had no significant effect on the results. CONCLUSIONS Shenfu injection combined with chemical medicine in the treatment of coronary heart disease combined with heart failure can further improve the clinical symptoms and related indicators， and no serious adverse reaction is observed.
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ObjectiveTo compare and observe the effect of Reduning injection （mainly clearing heat）， Shenfu injection （mainly warming Yang） combined with gefitinib on the proliferation， apoptosis， stemness characteristics and metabolism of lung cancer cells. MethodDifferent non-small cell lung cancer （NSCLC） cell lines were selected and intervened with gefitinib （5， 10， 20 μmol·L-1）， Reduning injection （0.6%， 0.9%）， Shenfu injection （0.6%， 0.9%）， gefitinib combined with Reduning injection， and gefitinib combined with Shenfu injection. Cell proliferation in each group was detected by cell counting kit-8 （CCK-8） assay， and cell apoptosis was detected by flow cytometry. The mRNA and protein expressions of lung cancer stem cell markers sex determining region Y-box 2 （Sox2） and aldehyde dehydrogenase family 1 member A1 （ALDH1A1） were determind by real-time quantitative polymerase chain reaction （Real-time PCR） and Western blot， respectively. The redox ratio of lung cancer cells was observed by femtosecond label-free imaging （FLI） and energy metabolism instrument was used to determine the glycolysis level in cells. ResultCompared with the blank group， Reduning injection reduced the survival rate of lung cancer cells （P<0.05）， increased the apoptosis rate （P<0.05）， down-regulated the mRNA and protein expressions of Sox2 and ALDH1A1 （P<0.05）， and up-regulated the redox ratio of cells （P<0.05）， while Shenfu injection exerted no remarkable effect on the above indexes. In addition， compared with gefitinib alone， Reduning injection combined with gefitinib inhibited the survival rate of lung cancer cells （P<0.05）， promoted the cell apoptosis （P<0.05）， down-regulated the mRNA and protein expressions of Sox2 and ALDH1A1 （P<0.05）， up-regulated the redox ratio of cells （P<0.05）， and lowered the proton efflux rate of glycolysis （P<0.05）， while Shenfu injection combined with gefitinib failed to affect these indexes of lung cancer cells significantly. ConclusionReduning injection may inhibit stemness characteristics of tumor cells by regulating their metabolism to enhance the proliferation-inhibiting and pro-apoptotic effects of gefitinib on lung cancer cells， while Shenfu injection had no significant enhancing effect on gefitinib. This indicates that epidermal growth factor receptor tyrosine kinase inhibitors （EGFR-TKIs） should be used in combination with heat-clearing Chinese medicines.
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Objective:This study aimed to systematically evaluate the efficacy of Chinese medicine injection (CMI) in the treatment of heart failure (HF) after acute myocardial infarction (AMI).Methods:China National Knowledge Infrastructure (CNKI), WanFang Data, VIP, The Cochrane Library, PubMed, and EMbase databases were electronically searched from inception to October 2021 to identify randomized controlled trials (RCTs) on CMI for treating HF after AMI. Two reviewers independently screened literature, extracted data, and evaluated the bias risk of included studies. Network meta-analysis was then performed by ADDIS1.16.6 software and Stata 16.0 software.Results:A total of 55 studies were included involving 4 760 patients with HF after AMI and 3 types of CMIs, including Shenmai, Shenfu, Xinmailong injections. The results of network meta-analysis showed that Xinmailong injection was superior to Shenmai injection and Shenfu injection in improving the total effective rate and reducing left ventricular end diastolic diameter (LVEDD); Shenmai injection was superior to Xinmailong injection and Shenfu injection in reducing B-type natriuretic peptide (BNP); Shenfu injection was superior to Shenmai injection and Xinmailong injection in increasing left ventricular ejection fraction (LVEF) and reducing heart rate (HR).Conclusions:The combined 3 types of CMIs for treating HF after AMI can improve the clinical efficacy when compared with conventional Western medicine treatment. Among them, Xinmailong injection is better in improving the total effective rate and reducing LVEDD, Shenmai injection is more advantageous in reducing BNP, and Shenfu injection has the best efficacy in improving LVEF and reducing HR.
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OBJECTIVE To study the chemical constituents in S henfu injection and the anti-inflammatory activities of its polyacetylene compounds. METHODS Shenfu injection was separated and purified by macroporous adsorption resin ，medium pressure liquid chromatography ，preparative thin layer chromatography and reversed-phase semi-preparative high-performance liquid chromatography，and the compound structure was identified according to the physicochemical properties and spectral data. RAW 264.7 cell inflammation model was used to evaluate the anti-inflammatory activities of polyacetylene compounds . The effects of active polyacetylene compounds on the expressions of cyclooxygenase- 2（COX-2）protein were evaluated by Western blot assay. RESULTS Twelves compounds were isolated and identified from Shenfu injection ，including 8 ginsenoside compounds ，i.e. ginsenoside Rg 1（1），ginsenoside Re （2），ginsenoside Rb 1（3），ginsenoside Rk 1（4），20（R）-ginsenoside Rh 1（5），20（S）-ginsenoside Rg3 （6），notoginsenoside R 1（7），panaxatriol（8）；4 polyacetylene compounds ，i.e.（3R，9R，10R）-panaxytriol（9），panaxydol（10）， heptadeca-1，8-dien-4，6-diyne-3，10-diol（11）and panaxynol （12）. Among 4 polyacetylene compounds ，only compound 10 had anti-inflammatory activity. Compound 10 was not toxic to normal RAW 264.7 cells；when the concentration of compound 10 ranged 12.5-50.0 μmol/L，it could significantly reverse the lipopolysaccharide-induced NO content increase in cell supernatant （P＜0.05 or P＜0.01）；when the concentration of co mpound 10 was 50.0 μmol/L，it could significantly reverse the lipopolysaccharide-induced protein expression increase of COX- 2 in cells （P＜0.05）. CONCLUSIONS Compounds 4，7，10-12 are identified and reported in Shenfu injection for the first time ，and panaxydol possesses a certain anti-inflammatory effect.
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OBJECTIVE@#To investigate whether Shenfu Injection (SFI, ) can alleviate post-resuscitation myocardial dysfunction by inhibiting the inflammatory response.@*METHODS@#After 8 min of ventricular fibrillation and 2 min of basic life support, 24 pigs were randomly divided into 3 groups (n=8), which were given intravenous bolus injections of SFI (1.0 mL/kg), epinephrine (EP, 0.02 mg/kg) and normal saline (SA), respectively. The animals were sacrificed at 24 h after restoration of spontaneous circulation (ROSC), and serum interleuking-6 (IL-6) and tumor necrosis factor-α (TNF-α) levels were measured by enzyme-linked immunosorbent assay (ELISA); expressions of Toll-like receptor 4 (TLR4)/nuclear factor kappa B (NF-κB) mRNAs and proteins were determined by RT-PCR and Western blot, respectively.@*RESULTS@#Compared with the EP and the SA groups, the ultrastructure of myocardial cells were slightly damaged and the systolic function of the left ventricle was markedly improved in the SFI group at 24 h after ROSC (P<0.05). In addition, compared with the EP and SA groups, the SFI group also showed significantly reduced levels of serum IL-6 and TNF-α, protein and mRNA levels of myocardial NF- κB and TLR4 (P<0.05).@*CONCLUSIONS@#Activation of TLR4/NF-κB signaling pathway may be involved in the pathological mechanisms of post-resuscitation myocardial dysfunction. SFI may block NF-κB-mediated inflammatory response by reducing the activity of NF- κB and the level of TNF-α, thus playing a protective role in post-resuscitation myocardial dysfunction.
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OBJECTIVE：To investigate the intervention effect of Shenfu i njection（SFI）on the nuclear translocation of high mobility group box 1（HMGB1） in lipopolysaccharide （LPS）-induced RAW 264.7 cells. METHODS ： Using LPS-induced RAW264.7 cells as objects ，the histone deacetylase inhibitor RGFP 966 as positive control ，CCK-8 assay was used to screen drug dosage，and the effects of low ，medium and high doses （3，6，12 μL/mL）of SFI on HMGB 1 nuclear translocation in RAW 264.7 cells were observed by immunofluorescence method ；mRNA expression of HMGB 1 in RAW 264.7 cells were detected by real time fluorescent PCR. Western blotting assay was used to determine protein expression of HMGB 1 and Toll-like receptor 4（TLR4）；the expression of HMGB 1 were compared between nucleus and cytoplasm. The levels of HMGB 1，IL-1β and TNF-α in supernatant of cells were detected by ELISA. RESULTS ：In blank control group ，HMGB1 was mainly located in the nucleus ；after LPS induction， HMGB1 migrated from nucleus to cytoplasm. Compared with blank control group ， mRNA and protein （No.81760738） expression of HMGB 1， protein expression of TLR 4 in RAW264.7 cells as well as the levels of HMGB 1，IL-1β and TNF-α in supernatant of cells were increased significantly in LPS group （P＜0.01）. The protein expression of HMGB 1 was decreased significantly in nucleus while was in creased significantly in cytoplasm （P＜0.01）. After SFI treatment ，the nuclear translocation and secretion of HMGB 1 were inhibited in different degrees ；compared with LPS group ，mRNA and protein expression of HMGB 1 in administration groups ，protein expression of TLR 4 in RAW 264.7 cells of positive control group ，SFI medium- and high-dose groups as well as the levels of HMGB 1，IL-1β and TNF-α in supernatant of cells in administration groups were decreased significantly （P＜0.01）. In positive control group ，SFI medium- and high-dose groups ，the protein expressions of HMGB1 in nucleus were increased significantly ，while protein expressions of HMGB 1 in cytoplasm were decreased significantly （P＜0.01）. CONCLUSIONS ：SFI may inhibit the nuclear translocation and secretion of HMGB 1 in RAW 264.7 cells，thus avoiding the activation of inflammatory pathways and the production of inflammatory factors ，so as to reduce the inflammatory response induced by LPS.
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Objective@#To investigate the protective effects of pretreatment with a Shenfu(SF)injection on arrhythmias induced by myocardial ischemia-reperfusion(IR)injury in aged mice.@*Methods@#Thirty 18-month-old C57BL/6J mice were randomly divided into 3 groups(n=10, each group): the sham treatment group(receiving sham operation without thoracotomy), the IR group(undergoing the ligation of the left anterior descending coronary artery with ischemia for 30 min and reperfusion for 2 h)and the SF group(receiving SF intraperitoneal injection of 10 ml/kg 30 min before thoracotomy and the same treatment as the IR group). Arrhythmias were monitored, and serum levels of creatine kinase-isoenzyme(CK-MB), troponin(cTnI)and tumor necrosis factor α(TNFα), and the ratio of myocardial connexin 43(Cx43)phosphorylation(ser368)to total protein(p-Cx43/t-Cx43)were detected in the three groups.@*Results@#Ventricular arrhythmias occurred in the IR and SF groups.Compared with the IR group, ventricular arrhythmias in the SF group were alleviated, the frequency of ventricular premature systolic episodes was reduced(36.6±13.5 times vs. 48.4±22.1 times), the frequency of ventricular tachycardia/fibrillation decreased(3.4±1.8 times vs. 7.6±3.5 times), and the total duration of ventricular tachycardia/fibrillation episodes was shortened(8.9±4.5 times vs. 17.7±5.1 times)in the SF group(P<0.05), but there was no significant difference in arrhythmia scores(1.8±1.2 points vs. 1.9±1.7 points, P>0.05)between the two groups.Compared with the sham treatment group, serum levels of CK-MB, cTnI and myocardial TNF(increased in the IR and SF groups(P<0.05), and their levels were lower in the SF group than in the IR group(P<0.05). Compared with the sham treatment group, the ratio of Cx43 ser368/total protein was lower in the IR and SF groups, but was higher in the SF group than in the IR group(P<0.05).@*Conclusions@#SF pretreatment can significantly reduce IR-induced arrhythmias in aged mice possibly by reducing TNF(and up-regulating the phosphorylation activity of Cx43.
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Objective@#To observe the effect of different doses of Shenfu injection on prognosis and quality of life for patients with vasovagal syncope (VVS).@*Methods@#A total of 126 patients were randomly divided into 3 groups. The control group (n=38) were treated by western medicine comprehensive therapy with tilting training. The low and high dose Shenfu injection groups were treated by Shenfu injection 40 ml/d (n=44) and 120 ml/d (n=44) on the treatment basis of control group. All the groups were treated for 14 days. The patients were followed up for 1 year after discharge. The relapse rate of syncope, quality of life social support rating scale (SSRS), effective rate of treatment, time of stable blood pressure, time of stable heart rate, recovery time of autonomic nervous disorder and adverse reactions were observed in each groups.@*Results@#The total effective rate was 47.4% (18/38) in the control group, 72.7% (32/44) in the low dose group, and 90.9% (40/44) in the high dose group. The difference between the three groups was statistically significant (χ2=18.997, P<0.01), and the total effective rate of Shenfu injection high-dose group was significantly higher than that of low-dose group (P<0.05). After treatment, there were significant differences in the recovery time of blood pressure, heart rate and autonomic nervous disorder among the three groups (F=19.165, 158.428, 33.405, P<0.01). The above indicators in the high dose group of Shenfu injection were significantly higher than the low dose group (t=-4.020, -5.180, -5.307, P<0.05). After 1 year of follow-up, the recurrence rate of the control group was 61.1% (11/18), the low-dose group was 18.8% (6/32), and the high-dose group was 5% (2/40), where there was significant difference among all the groups (χ2=20.886, P<0.01). The quality of life scores were compared for 1 year among the 3 groups, and the difference was statistically significant (F=23.025, P<0.01).@*Conclusions@#The Shenfu injection combined with Western medicine comprehensive therapy can improve the prognosis and quality of life of patients with VVS, and the improvement of each indicator of daily dosage of 120 ml is better than the daily dosage of 40 ml Shenfu injection.
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Objective To investigate the protective effects of pretreatment with a Shenfu(SF) injection on arrhythmias induced by myocardial ischemia-reperfusion(IR)injury in aged mice.Methods Thirty 18-month-old C57BL/6J mice were randomly divided into 3 groups (n=10,each group):the sham treatment group(receiving sham operation without thoracotomy),the IR group (undergoing the ligation of the left anterior descending coronary artery with ischemia for 30 min and reperfusion for 2 h)and the SF group(receiving SF intraperitoneal injection of 10 ml/kg 30 min before thoracotomy and the same treatment as the IR group).Arrhythmias were monitored,and serum levels of creatine kinase-isoenzyme (CK-MB),troponin (cTnI) and tumor necrosis factor α (TNFα),and the ratio of myocardial connexin 43 (Cx43) phosphorylation (ser368) to total protein (p-Cx43/t-Cx43) were detected in the three groups.Results Ventricular arrhythmias occurred in the IR and SF groups.Compared with the IR group,ventricular arrhythmias in the SF group were alleviated,the frequency of ventricular premature systolic episodes was reduced(36.6 ± 13.5 times vs.48.4 ± 22.1 times),the frequency of ventricular tachycardia/fibrillation decreased(3.4 ± 1.8 times vs.7.6 ± 3.5 times),and the total duration of ventricular tachycardia/fibrillation episodes was shortened(8.9± 4.5 times vs.17.7± 5.1 times)in the SF group(P＜0.05),but there was no significant difference in arrhythmia scores(1.8± 1.2 points vs.1.9 ± 1.7 points,P ＞0.05) between the two groups.Compared with the sham treatment group,serum levels of CK-MB,cTnI and myocardial TNF(increased in the IR and SF groups (P ＜ 0.05),and their levels were lower in the SF group than in the IR group (P＜0.05).Compared with the sham treatment group,the ratio of Cx43 ser368/total protein was lower in the IR and SF groups,but was higher in the SF group than in the IR group(P＜0.05).Conclusions SF pretreatment can significantly reduce IR-induced arrhythmias in aged mice possibly by reducing TNF(and up-regulating the phosphorylation activity of Cx43.
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Objective To investigate the effect of Shenfu Injection on acute renal injury (AKI) in children with congenital heart disease after operation. Methods Sixty-two children with atrial or ventricular septal defect, treated in Affiliated Hospital of Southwest Medical University from August 2016 to December 2018, were divided into two groups according to different treatment methods, such as conventional Western medicine treatment group and Shenfu Injection group, with 31 cases in each group. The children in Shenfu Injection group were given 20 mL Shenfu Injection from the beginning of anesthesia induction to the end of cardiopulmonary bypass, the children in Western medicine conventional treatment group were pumped with the same volume of normal saline. The anesthesia time, total operation time, cardiopalmonary bypass time, aortic clamping time, and the use of milrinone, dopamine, epinephrine, sodium nitroprusside and other drugs in the two groups were observed. The serum creatinine (SCr) level was measured by chemiluminescence method before operation (T0), at the beginning of operation (T1), at the beginning of cardiopulmonary bypass (T2), at the end of cardiopulmonary bypass (T3) and at the end of operation (T4), and the glomerular filtration rate (eGFR) was calculated. The mean arterial pressure (MAP), heart rate (HR), central venous pressure (CVP), adrenaline (E) and noradrenaline (NE) in two groups were recorded at each time point. Results There was no significant difference in anesthesia time, total operation time, cardiopalmonary bypass time, aortic clamping time and the use of milrinone, dopamine, E and sodium nitroprusside between the Shenfu Injection group and Western medicine conventional treatment group (all P > 0.05). There was no significant difference in HR and CVP between the two groups at T0-T4 (all P > 0.05). There was no significant difference in MAP level between the two groups at T0 and T1( both P > 0.05), with the time prolonging, the MAP level of Western medicine conventional treatment group was significantly lower than that of T0, while MAP level of Shenfu Injection group was significantly higher than that of T0. At T2, the MAP level of Shenfu Injection group was significantly higher than that of the Western medicine conventional treatment group [mmHg (1 mmHg = 0.133 kPa): 66.6±6.5 vs. 53.1±6.7, P < 0.05]. There was no significant difference in E and NE between the two groups at T0 and T1 (P > 0.05), with the time prolonging, both E and NE decreased compared with those at T0 (both P < 0.05), but there was no significant difference at the same time point (all P > 0.05). At T0, there was no significant difference in SCr and eGFRs between the two groups (both P > 0.05), at T1, the SCr levels of two groups were significantly higher than those at T0, but the SCr level of Shenfu Injection group was significantly lower than that of Western medicine conventional treatment group (μmol/L: 42.43±15.91 vs. 56.58±16.80, all P < 0.05). From T2, the SCr levels of two groups began to gradually reduce, but it was still significantly higher than those at T0, the two groups reached the lowest level at T4, and the level of SCr in Shenfu Injection group was significantly lower than that of Western medicine conventional treatment group (μmol/L: 36.24±9.72 vs. 46.85±15.91, P < 0.05). Compared with T0, the eGFRs levels of the two groups were significantly lower at T1-T4, but gradually increased with time, reached the highest level at T4, and the eGFRs level of Shenfu Injection group was significantly higher than that of Western medicine conventional treatment group (mL·min-1·1.73 m-2: 113.7±12.1 vs. 79.6±12.5, P < 0.05). The incidence of AKI in Shenfu Injection group was significantly lower than that in Western medicine conventional treatment group [22.58% (7/31) vs. 64.52% (20/31), P < 0.05]. Conclusion Shenfu Injection can reduce the incidence of AKI in children with congenital heart disease after operation.
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OBJECTIVE： To study the improvement and anti-inflammation mechanism of Shenfu injection on lung tissue of endotoxin shock model rats. METHODS： Totally 48 rats were randomized into control group，model group，dexamethasone group （positive control，1 mg/kg） and Shenfu injection low-dose，medium-dose and high-dose groups （5，10，15 mL/kg），with 8 rats in each group. Except for normal group， other groups were given intraperitoneal injection of lipopolysaccharide （LPS） to induce endotoxin shock model. After modeling， each group was given relevant medicine once intraperitoneally. 24 h after medication， HE staining was used to observe pathological changes of lung tissue in rats and pathological scoring was conducted. RT-PCR was used to determine mRNA levels of P65 and P50 proteins related to NF-κB signaling pathway. Western blot assay was used to determine the expression levels of P65 and P50 proteins in lung tissue， and the expression levels of P65 protein in nucleus and cytoplasm of lung tissue were also determined. The level of TNF-α in plasma in rats were determined by ELISA. RESULTS： Compared with control group， alveolar septum became thicker， obvious vascular engorgement was found， and a large number of neutrophils infiltrated the interstitium in model group. Histopathological score， mRNA and protein expression levels of P65 and P50 in lung tissues were increased significantly （P＜0.01 or P＜0.001）； the protein expression of levels P65 in nucleus and cytoplasm and level of TNF-α in plasma were increased significantly （P＜0.001）. Compared with model group， alveolar structure of rats in dexamethasone group and Shenfu injection medium-dose and high-dose groups was complete， no obvious bleeding was observed， and the degree of inflammatory cell infiltration was improved significantly. Histopathological score， mRNA and protein expression levels of P65 and P50 in lung tissue and level of TNF-α in plasma were decreased significantly （P＜0.05 or P＜0.01 or P＜0.001）. The protein expression level of P65 in nucleus and cytoplasm of lung tissue were decreased significantly in dexamethasone group and Shenfu injection low-dose and medium-dose groups were decreased significantly （P＜0.05 or P＜0.01 or P＜0.001）. CONCLUSIONS： Shenfu injection can decrease mRNA and protein expression levels of P65 and P50 in lung tissue， level of TNF-α in plasma， and protect lung tissue of endotoxin shock rats.
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Objective To evaluate an effective and feasible quantitative evaluation table of traditional Chinese medicine (TCM) syndrome differentiation, and to observe the effect of combination of TCM syndrome differentiation and standard bundle therapy in patients with septic shock. Methods A prospective randomized controlled trial was conducted. The septic shock patients with acute deficiency syndrome admitted to department of critical care medicine of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine from January 1st, 2016 to December 31st, 2017 were enrolled. The patients were randomly divided into control group and Shenfu group. The patients in both groups received early application of standardized bundle therapy; those in Shenfu group received 60 mL Shenfu injection infusion in addition for 7 days. The TCM syndrome score was evaluated by classification and scoring method of TCM symptoms. The circulation and tissue perfusion, severity of disease, organ function, inflammation response, adjuvant treatment and 28-day mortality were compared between the two groups. Results A total of 50 patients with septic shock were enrolled in the analysis, 25 in control group and 25 in Shenfu group. The markedly effective rate of TCM symptoms score in Shenfu group was significantly higher than that in control group [60.0% (15/25) vs. 16.0% (4/25), P < 0.01]. There was no significant difference in all parameters before treatment between the two groups. After treatment, the observation indexes of both groups were improved. Compared with control group, the mean arterial pressure (MAP) in Shenfu group increased more significantly [mmHg (1 mmHg = 0.133 kPa): 13.0 (2.5, 28.5) vs. 6.0 (0, 13.5)], the lactate (Lac) and procalcitonin (PCT) decreased more significantly [Lac (mmol/L): 0.8 (0.1, 3.7) vs. 0.5 (-0.6, 1.7), PCT (μg/L): 2.0 (0.7, 32.3) vs. 0 (-1.8, 3.8)], activated partial thromboplastin time (APTT) was shortened more significantly [s: 8.5 (0, 12.9) vs. 0 (-7.2, 10.0)], and interleukins (IL-2 receptor and IL-6) levels decreased more significantly [IL-2 receptor (ng/L):1 031.0 (533.0, 1 840.0) vs. 525.5 (186.0, 1 166.8), IL-6 (ng/L): 153.1 (21.4, 406.8) vs. 35.1 (16.3, 110.1)] with significant differences (all P < 0.05). There was no significant difference in the use time of vasoactive drugs, duration of mechanical ventilation, severity of the disease or 28-day mortality between the two groups. However, the use time of vasoactive drugs in Shenfu group was shorter than that in control group (days: 5.48±4.81 vs. 8.28±7.83), and the 28-day mortality was decreased [8.0% (2/25) vs. 20.0% (5/25)]. Conclusions TCM syndrome score is helpful to evaluate the effect of TCM syndrome differentiation and treatment, and it is effective and feasible in clinical application. Septic shock patients treated with TCM syndrome differentiation and treatment combined with standard bundle therapy were significantly improved in circulation, tissue perfusion, coagulation function and inflammation reaction.
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Objective: To evaluate the clinical efficacy and molecular mechanism of Shenfu combined with azithromycin on infantile mycoplasma pneumonia. Methods: Totally 80 children with mycoplasma pneumonia treated in Children's Hospital Affiliated to Soochow University from June 2016 to June 2017 were selected and randomly divided into two groups with 40 in each. Azithromycin was provided in both groups. Shenfu was administered in the observation group. The clinical efficacy, immunological functions and miR-181a level, and related molecular markers of all the subjects were observed. Lentivirus was used to transfer miR-181a into human T lymphocytes to observe its effects on lymphocyte proliferation, cytokine secretion level and related signaling pathways. Results: Compared with the normal group after treatment, the clinical efficacy, T lymphocyte subset proportion and inflammation cytokines were significantly increased (P<0.05), and the time of clinical symptoms remission was significantly decreased in the observation group after treatment (P<0.05). In addition, the content of miR-181a (9.3±5.3) in lymphocytes of the observation group after treatment was significantly lower than that (12.2±4.5) of the control group after treatment (P<0.05). In vitro assay revealed that miR-181a was significantly decreased lymphocyte proliferation and the ability of secretory cytokine. Luciferase reporter assay demonstrated that miR-181a could inhibit KRAS, NRAS and MAPK1 expressions, thus down-regulating P-AKT and P-MEK phosphorylation. Conclusion: Shenfu combined with azithromycin can effectively improve immunity functions and its mechanism might be related to the level of miR-181a in lymphocytes.
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Objective To observe the effect of different doses of Shenfu injection on prognosis and quality of life for patients with vasovagal syncope (VVS). Methods A total of 126 patients were randomly divided into 3 groups. The control group (n=38) were treated by western medicine comprehensive therapy with tilting training. The low and high dose Shenfu injection groups were treated by Shenfu injection 40 ml/d (n=44) and 120 ml/d (n=44) on the treatment basis of control group. All the groups were treated for 14 days. The patients were followed up for 1 year after discharge. The relapse rate of syncope, quality of life social support rating scale (SSRS), effective rate of treatment, time of stable blood pressure, time of stable heart rate, recovery time of autonomic nervous disorder and adverse reactions were observed in each groups. Results The total effective rate was 47.4% (18/38) in the control group, 72.7% (32/44) in the low dose group, and 90.9% (40/44) in the high dose group. The difference between the three groups was statistically significant (χ2=18.997, P<0.01), and the total effective rate of Shenfu injection high-dose group was significantly higher than that of low-dose group (P<0.05). After treatment, there were significant differences in the recovery time of blood pressure, heart rate and autonomic nervous disorder among the three groups (F=19.165, 158.428, 33.405, P<0.01). The above indicators in the high dose group of Shenfu injection were significantly higher than the low dose group (t=-4.020, -5.180, -5.307, P<0.05). After 1 year of follow-up, the recurrence rate of the control group was 61.1% (11/18), the low-dose group was 18.8% (6/32), and the high-dose group was 5% (2/40), where there was significant difference among all the groups (χ2=20.886, P<0.01). The quality of life scores were compared for 1 year among the 3 groups, and the difference was statistically significant (F=23.025, P<0.01). Conclusions The Shenfu injection combined with Western medicine comprehensive therapy can improve the prognosis and quality of life of patients with VVS, and the improvement of each indicator of daily dosage of 120 ml is better than the daily dosage of 40 ml Shenfu injection.
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Objective To evaluate the methodological quality of the systematic evaluation literature of Shenfu injection in the treatment of heart failure with AMSTAR 2 statement.Methods Searching includes Chongqing VIP Database,China Knowledge Network Database,China Biomedical Literature Database.Wanfang Database,PubMed Database,Cochrane library database,search time limit from database construction to Dec 31 st,2017.Two evaluators independently screened the literature based on inclusion and exclusion criteria,and applied the AMSTAR 2 statement list to evaluate all the systematic review literatures included.Results A total of 9 articles were included in the study,and the average reporting rate is 43.75％.The low-reporting domains focused on the review protocols prior to the research,the types of the included studies,the list of excluded documents,the evaluation and causes of bias of risks and heterogeneity,and reports on funds and conflicts of interest.Conclusions The average reporting rate is low overall,indicating that the current reports of the systematic review has defects,which affects the credibility of the systematic review and the use of evidence.For the determination of clinical decision-making,it is recommended that researchers should follow the AMSTAR 2 statement to improve the methodological or reporting quality.
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Objective To investigate the effects of Shenfu injection on early post-operative cognitive dysfunction (POCD) and brain derived neurotrophic factor (BDNF) in patients with burns. Methods Fifty-six patients with burns and ready to receive surgical treatment of scars admitted to Affiliated Hospital of Southwest Medical University from July 2015 to January 2017 were enrolled, and they were divided into a control group and a Shenfu group by random number table, 28 cases in each group. The regimen of anesthesia induction before operation and anesthesia maintenance in the operation in two groups was the same, and the patients in Shenfu group received intravenous drip of Shenfu injection 40 mL at 0.5 hour before surgery. The Mini-mental State Examination Scale (MMSE) was used to evaluate the cognitive function after surgery, and MMSE score reduction of > 2 scores was recognized as cognitive impairment after operation;patient's pain degree was evaluated by using visual analogue scale (VAS); the levels of serum BDNF were detected by the enzyme-linked immunosorbent assay (ELISA) at 0.5 hour before operation, immediately after operation, and 12 hours, 1 day, 3 days after operation. Results The MMSE scores were significantly decreased in the two groups after surgery, but decreasing degree of the MMSE scores in Shenfu group were significantly slower than those of the control group (1 day after surgery was 22.8±2.9 vs. 20.5±3.2, 3 days after surgery was 25.6±3.1 vs. 23.2±3.0, both P < 0.05). The incidence of POCD in the Shenfu group was significantly lower than that of the control group [7.1% (2/28) vs. 42.9% (12/28), P < 0.05]. The VAS scores were significantly higher in the two groups after surgery, but there was no significant difference between the two groups at each time point (all P > 0.05). The serum BDNF levels were significantly increased in two groups at immediate post-operation and 12 hours after surgery compared with those 1 day before operation, in addition, the BDNF level in Shenfu group was obviously higher than that in the control group (mg/L: 13.5±4.2 vs. 9.9±3.3, 11.4±3.5 vs. 9.1±3.2, both P < 0.05), the serum BDNF levels in two groups returned to their preoperative levels on 1 day and 3 days after surgery (all P > 0.05). Conclusion The Shenfu injection can reduce the incidence of early POCD in patients with large area burns and its mechanism may be related to the increase of BNDF expression.
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Objective To investigate the changes of serum procalcitonin ( PCT ) , lactate and lactic acid clearance in severe pneumonia and its clinical significance .Methods Seventy patients with severe pneumonia were enrolled,including 16 cases with hospitalized pneumonia and 54 cases with community acquired pneumonia .All patients were exsanguinated early morning venous blood on day 1,4,7 after treatment,and transferred-out or before death.PCT and arterial lactic acid were measured and 24 -hour lactate clearance was calculated .According to the outcome , the patients were divided into survival group and death group .At different time points , the PCT and Lac levels were observed in the two groups .The patients were divided into high lactic acid clearance group and low lactic acid clearance group according to the 24h lactic acid clearance rate .The initial Lac and mortality were observed . Results All patients had 25 cases of deaths and 45 cases of survive.There were no statistically significant differences in PCT and Lac levels at the 1st day of treatment between the two groups (F=0.87,P=0.19;F=0.03,P=0.40). The PCT levels[(19.5 ±11.1)ng/L,(7.9 ±3.2)ng/L,(3.6 ±1.4)ng/L]and Lac values[(2.8 ±1.6)mmol/L, (2.2 ±1.1)mmol/L,(1.7 ±0.8)mmol/L]at the 4th,7th day of treatment and transferred -out in the survival group were significantly lower than those in the death group [PCT:(39.6 ±24.8) ng/L,(40.4 ±21.9) ng/L,(41.6 ± 38.3)ng/L,Lac:(6.8 ±3.2)mmol/L,(6.2 ±2.1)mmol/L,(7.7 ±2.8)mmol/L,F=3.84,P=0.003;F=7.38, P=0.00;F=4.95,P=0.00;F=5.86,P=0.00;F=6.05,P=0.00;F=10.48,P=0.00].In death group,the serum PCT value and lactic acid value were not significantly decreased with the treatment , and remained in the higher state at the 4th,7th day of treatment and before death ,and even higher than the first day of treatment .The mortality of the high lactic acid clearance group was 15.79％,which was significantly lower than 59.38％ in the low lactic acid clearance group (χ2 =14.37,P=0.00).The initial Lac and PCT of the two groups had no statistically significant differences ( t =0.17, P =0.43;t =0.41, P =0.34 ).Conclusion For the patients with severe pneumonia ,the detection of serum PCT and lactic acid levels and dynamic observation is helpful to judge the severity of the disease.The early lactic acid clearance rate may be of positive significance to the prognosis of patients .
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Objective:To explore therapeutic effect of Shenfu injection combined recombinant human brain natriuret-ic peptide(rhBNP)on patients with acute left heart failure(ALHF).Methods:A total of 92 ALHF patients treated in our hospital were selected.They were divided into rhBNP group(n=46)and combined treatment group(n=46, received Shenfu injection combined rhBNP),both groups were treated for two weeks.Cardiac function,kidney function and blood gas analysis indexes before and after treatment,and therapeutic effect after treatment were re-corded and compared between two groups.Results:Compared with before treatment,there were significant im-provements in cardiac function,kidney function and blood gas indexes in both groups after treatment,P<0.01 all. Compared with rhBNP group,there were significant rise in left ventricular ejection fraction[(51.21 ± 4.23)% vs. (56.02 ± 5.02)%],left ventricular fractional shortening[(28.02 ± 4.78)% vs.(32.78 ± 4.02)%]and partial pres-sure of oxygen in artery[(62.45 ± 6.02)mmHg vs.(75.56 ± 5.78)mmHg],and significant reductions in left ven-tricular end-diastolic dimension[(49.56 ± 5.02)mm vs.(45.12 ± 6.02)mm],arterial partial pressure of carbon dioxide[(41.78 ± 5.89)mmHg vs.(35.78 ± 6.02)mmHg],serum creatinine[(92.02 ± 5.78)μmol/L vs.(86.45 ± 8.12)μmol/L]and blood urea nitrogen[(5.99 ± 1.12)mmol/L vs.(4.56 ± 1.02)mmol/L]in combined treat-ment group,P<0.01 all.After treatment,total effective rate of combined treatment group was significantly higher than that of rhBNP group(95.56% vs.76.08%,P<0.007).Conclusion:Shenfu injection combined rhBNP treat-ment can significantly improve cardiac function,kidney function and blood gas indexes with significant therapeutic effect in ALHF patients,which is worth extending.
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AIM To investigate the effect of Shenfu Injection on atherosclerosis (AS) models of high-fat apolipoprotein E-deficient (ApoE-/-) mice,and to explore its anti-atherosclerosis mechanism through the observation of oxidative stress (OS) variation.METHODS C57 mice were used as controls.ApoE-/-mice fed with 20-week high fat diet were randomly divided into model group,Shenfu group for subsequent 4-week continuous corresponding intervention,after which the mice had their blood lipid levels measured,their levels of MPO and NOX4 identified by ELISA,and their T-SOD activity determined by hydroxylamine method,their MDA level detected by TBA,their plaque formation observation achieved by HE staining of aortic gross and red O of all the aorta,and their Nrf2 mRNA expression detected by real time qPCR method.RESULTS Compared with the control group,the model group manifested with increased contents of TG,TC,LDL,decreased HLD;decreased activity of SOD,increased contents of MPO,NOX4 and MDA,and down-regulated expression of aortic Nrf2 and Keap1 mRNA.Compared with the model group,Shenfu Injection group was observed with no obvious blood lipid level change,but a reduction of plaque area,and an effective inhibition on OS as revealed by improved levels of Nrf2 and Keap1 mRNA.CONCLUSION Shenfu Injection can activate Nrf2 and interfer the relevant enzymes,thus prevents the atherosclerosis progression through OS reduction.