Authentication and distinction of Shenmai injection with HPLC fingerprint analysis assisted by pattern recognition techniques

In this paper, the feasibility and advantages of employing high performance liquid chromatographic （HPLC） fingerprints combined with pattern recognition techniques for quality control of Shenmai injection were investigated and demonstrated. The Similarity Evaluation System was employed to evaluate the similarities of samples of Shenmai injection, and the HPLC generated chromatographic data were analyzed using hierarchical clustering analysis （HCA） and soft independent modeling of class analogy （SIMCA）. Consistent results were obtained to show that the authentic samples and the blended samples were successfully classified by SIMCA, which could be applied to accurate discrimination and quality control of Shenmai injection. Furthermore, samples could also be grouped in accordance with manufacturers. Our results revealed that the developed method has potential perspective for the original discrimination and quality control of Shenmai injection.

Change of Th1/Th2 Cytokine Equilibrium in Rats with Severe Sepsis and Therapeutic Effect of Recombinant Interleukin-12 and Shenmai Injection (参麦注射液)

Objective: To evaluate the dynamic change of Th1/Th2 cytokines in serum, peritoneal lavage fluid (PLF) and splenic macrophages (SM) in rats with severe peritonitis, and to observe the therapeutic effects of recombinant interleukin-12 (rIL-2) and Shenmai injection (SMI, 参麦注射液), a Chinese medicinal preparation.Methods: Severe peritonitis (SP) model was induced by intraperitoneal injection of E. coli and B. frag, and mild peritonitis (MP) model was induced by cecal ligation and punching. Then the following experiments were done: (1) Survival rates of animals after every 6 hrs in the 72 hrs after modeling were recorded, serum and PLF levels of cytokines, including tumor necrosis factor-α (TNF-α), interferon-γ (IFN-γ), and interleukin-10 (IL-10), 6 hrs, 12 hrs, 24 hrs and 48 hrs after modeling were measured. (2) Model rats were treated with rIL-12 or SMI, the survival rate was recorded and serum levels of TNF-α, INF-γ, and IL-10 before and after treatment were measured, and (3) amount of these cytokines produced by SM were determined 6 hrs, 12 hrs and 24 hrs after treatment. The survival rates and levels of cytokines were then compared between the groups (model group treated with rIL-12 or SMI, untreated model group, and blank group).Results: Serum and PLF levels of IFN-γ, TNF-α at all the time points in SP rats were significantly lower than those in MP rats while those of IL-10 6 hrs and 12 hrs after modeling were significantly higher in the former than that in the latter (P<0.05). IFN-γ secretion of SM in SP rats was significantly higher than that in MP rats 6 hrs after modeling (P<0.05). Administration of rlL-12 or SMI given before modeling could improve the survival rate of the model rats (P<0.05) and cause significant increase of the serum level and SM secretion of IFN-γ. Conclusion: Imbalance in promoting/antagonizing inflammatory cytokines and Th2 response dominance appear in SP rats early at the initiating stage, and SM secretion of inflammation promoting factor also reduces. Administration in time of rIL-12 and SMI, may increase the survival rate, and its mechanism may be related with their immuno-stimulating action.

Clinical observation of Shenmai injection in the treatment for adverse reactions of chemotherapy on advanced non-small cell lung cancer

Objective: To observe the efficacy of Shenmai injection in the treatment for adverse reactions of chemotherapy on advanced non-small cell lung cancer (NSCLC). Methods: 45 NSCLC patients with stages IIIb-IV were randomly divided into two groups: the treatment group (treated by chemotherapy combined with Shenmai injection) and the control group (treated by chemotherapy only). The efficacy of the two groups was evaluated after 3 cycles of treatment. Results: There was no significant difference between the two groups in the recent curative effects (P > 0.05), while there were significant differences between them in Karnofsky score and weight (P < 0.05). The treatment group was better than the control group in preventing leucopenia and decreased hemoglobin, and significant differences were found between them (P < 0.05). The incidence of thrombocytopenia, nausea and vomiting, hepatic and renal dysfunction in the treatment group was lower than that in the control group, but no significant differences were found between them (P > 0.05). Conclusion: Shenmai injection would not influence the efficacy of chemotherapy on advanced NSCLC patients, while it could improve the quality of life, increase the body weight of patients, alleviate adverse reactions of chemotherapy as myelosuppression so as to improve the tolerance of organism to chemotherapy.

Identification of bioactive anti-angiogenic constitutes targeting tumor endothelial cells in Shenmai Injection using multidimensional pharmacokinetics

OBJECTIVE To identify the bioactive anti-angiogenic constitutes targeting tumor endothelial cells(TECs)in Shenmai Injection(SMI).METHEODS For pharmacokinetic(PK)studies,Balb/c mice harboring human colorectal cancer(LoVo)xenografts were treated with SMI 10 mL·kg^-1 daily for 1 or 8 d.Multidimensional PK profiles of ginsenosides in plasma,subcutaneous tumors,and TECs were investigated.For PD studies,the tumor-bearing mice Intravital multi-photon imaging and CD31 immunofluorescence staining were used to evaluate the number of microves⁃sels and braches.Double staining of CD31 and α-SMA was performed to evaluate pericytes coverage ratios around vessels.ELISA was performed to determine the concentrations of VEGF and FGF in tumor tissues.For synergistic anti-tumor study,the tumor-bearing mice were treated with SMI 10 mL·kg^-1 daily,Rd 5 mg·kg^-1 daily with or without 5-FU 15 mg·kg^-1 every 3 d for 20 d.HPLC-MS/MS was used to determine the concentrations of 5-FU in plasma and tumor tissues.RESULTS SMI decreased the number of microvessels(P<0.05)and vessel branches(P<0.05)and improved vascular pericytes coverage(P<0.05).PK studies showed that the concentrations of protopanaxadiol-type(PPD)ginsenosides(Rb1,Rb2/Rb3,Rc,and Rd)in both,plasma and tumors,were higher than those of protopanaxatriol-type(Rg1 and Re)and oleanane-type(Ro)ginsenosides.Among PPD ginsenosides,Rd exhibited the greatest concentrations in tumors and TECs after repeated injection.In fact,the proportion of Rd in the detectable components of SMI gradually increased in the following order:SMI formula(2.8%),plasma(16.0%),tumor tissues(34.3%),and TECs(40.3%).In vivo bioactivity results showed that Rd 5 mg·kg^-1 daily significantly decreased the number of microvessels(P<0.05)and vessel branches(P<0.05)and increased pericytes coverage(P<0.05)while Rd 0.5 mg·kg^-1 daily,Rb1 and Rg1 had no significant effect on them.Rd 5 mg·kg^-1 suppressed the expression of VEGF and FGF simultaneously.Rd 5 mg·kg^-1 enhanced the antitumor effect of 5-FU via increasing the distribution of 5-FU in tumor tissues(P<0.05)in xenograft mice.CONCLUSION Ginsenoside Rd may be the major bioactive anti-angiogenic constituent targeting TECs after SMI treatment.

Clinical Study on Effect of Shenmai Injection in Treating Congestive Heart Failure

Objective: To observe the therapeutic effect of Shenmai Injection (SI) in treating congestive heart failure (CHF). Methods: The changes in cAMP, cGMP, serum cardiac troponin T (cTnT, a specific marker reflecting myocardial injury), creatine kinase (CK) and creatine kinase isoenzyme (CK-

Shenmai Injection attenuated doxorubicin-induced cardiac dysfunction via maintaining mitochondrial homeostasis

OBJECTIVE Shenmai Injection(SMI)is widely used in the treatment of cardiovascular diseases,such as heart failure and myocardial ischemia.In clinic,SMI showed protective effects on doxorubicin(Dox)-induced cardiac toxicity.In current study,we investigate the mitochondrial protective mechanisms of SMI on Dox-induced myocardial injury.METHODS C57BL/6 mice were divided into four groups:①control group;②Dox injury group;③SMI+Dox group and dexrazoxane(DRZ)+Dox group.Dex was a positive control.Myocardial injury was evaluated by echocardiography,HE and TUNEL staining,myocardial markers measurement.H9C2 cardiomyocytes pretreatment with SMI for 24 h were exposed to Dox.Cell viability and apoptosis were measured by CCK8,Hoechst33342 staining,and Annexin V/PI staining.MitoSOX,mitochondrial membrane potential,and mitochondrial respiratory function were measured to evaluate mito⁃chondrial function.RESULTS SMI decreased mortality rate of Dox-injected mice,serum CK and CK-MB levels in vivo.SMI significantly prevented Dox-induced cardiac dysfunction and apoptosis and increased expression level of PI3K,p-Akt,and p-GSK-3β.Moreover,SMI significantly inhibited Dox-induced apoptosis,mitochondrial ROS production,and reduction of mitochondrial membrane potential in H9C2 cells.Mechanismly,the cardio-protective effect of SMI was suppressed by PI3K inhibitor LY294002.CONCLUSION SMI prevents Dox-induced cardiotoxicity and mitochondrial damage through activation of PI3K/Akt signaling pathway.

Research on Applications of Shenmai Injection on Hypertensive ICH Combined with Cerebrocardiac Syndromes

Objective: This study is to observe the therapeutic effects of Shenmai injection on patients with hypertensive ICH and cerebrocardiac syndromes as well as its effects on prognosis. Methods: A total of 72 patients with severe hypertensive ICH and cerebrocardiac syndromes were selected and divided into the control group and the experimental group (Shenmai injection group) randomly, 36 patients in each group. The control group was treated by conventional therapy, while the experimental group was administrated by intravenous drip of the mixture of 50 ml Shenmai injection and 250 ml 5% glucose injection based on the treatment of the control group, once everyday, 2 weeks continuously. Results: Myocardial enzyme indexes of two groups at 3d, 7d and 14d were observed (Table 1). Myocardial enzyme index of the experimental group was improved quickly and significantly. Myocardial enzyme data of two groups at 3d, 7d and 14d were P < 0.05. According to the electrocardiographic examinations results, ECG anomalies of the experimental group at 7d and 14d were also improved quickly (P < 0.05). There are no evident anomalies in GCS scores of two groups at 7d, but GCS score of the experimental group at 14d of the medication was significantly higher than that of the control group (P < 0.05). Conclusions: Shenmai injection has some therapeutic effects on cerebral injuries and myocardial damages. It can treat brain and heart simultaneously, realize the goal of addressing both symptoms and root causes, and improve prognosis of patients with severe hypertensive ICH.

Clinical value of sodium ferulate + Shenmai injection in the adjuvant treatment of acute myocardial infarction

Objective: To explore the clinical value of sodium ferulate + Shenmai injection in the adjuvant treatment of acute myocardial infarction (AMI). Methods: A total of 119 patients with AMI who were treated in our hospital between December 2014 and December 2017 were reviewed and divided into the control group (n=60) who received conventional western medicine +Shenmai injection therapy and the sodium ferulate group (n=59) who received conventional western medicine + sodium ferulate + Shenmai injection therapy. The differences in serum levels of myocardial injury markers, inflammatory mediators and ventricular remodeling-related indexes were compared between the two groups before treatment and after 2 weeks of treatment. Results: Before treatment, serum levels of myocardial injury markers, inflammatory mediators and ventricular remodeling-related indexes were not significantly different between the two groups. After 2 weeks of treatment, serum myocardial injury markers GMP-140, cTnT, MYO, NT-proBNP and H-FABP levels of sodium ferulate group were lower than those of control group;serum inflammatory mediators MCP-1, IL-18 and hs-CRP levels were lower than those of control group;serum ventricular remodeling-related indexes GDF-15, MMP-10 and CgA levels were lower than those of control group whereas IGF-1 level was higher than that of control group. Conclusion: Western medicine combined with sodium ferulate+ Shenmai injection therapy can effectively protect the myocardial function and inhibit the systemic inflammatory response and ventricular remodeling in patients with AMI.

Effect of Shenmai injection combined with antiplatelet drugs on the plaque property and inflammatory response in patients with non-ST-segment elevation ACS

Objective: To investigate the effect of Shenmai injection combined with antiplatelet drugs on the plaque property and inflammatory response in patients with non-ST-segment elevation ACS. Methods: A total of 142 patients with non-ST-segment elevation ACS who were treated in the hospital between June 2015 and September 2017 were divided into control group (n=71) and Shenmai injection group (n=71) by random number table method. Control group received antiplatelet drugs based on routine treatment, and Shenmai injection group received Shenmai injection combined with antiplatelet drugs on the basis of routine treatment. The differences in serum contents of plaque property-related indexes and inflammatory factors were compared between the two groups before and after treatment. Results: Before treatment, there was no significant difference in serum contents of metabolism indexes, lipid indexes, cell adhesion molecules and inflammatory factors between the two groups. After 1 week of treatment, serum metabolism indexes Hcy and UA contents of Shenmai injection group were lower than those of control group;serum lipid indexes ox-LDL and Lp-PLA2 contents were lower than those of control group;serum adhesion molecules sVCAM-1 and sICAM-1 contents were lower than those of control group;serum inflammatory factors IL-1β, IL-6, IL-17 and IL-23 contents were lower than those of control group. Conclusion: Adjuvant Shenmai injection therapy can further stabilize the plaques and inhibit the systemic inflammatory response in patients with non-ST-segment elevation ACS.

Clinical Efficacy of Shenmai Injection in the Treatment of Cerebral Vasospasm after Ruptured Aneurysm Surgery

Objective: To investigate the therapeutic effect of Shenmai Injection on postoperative cerebral vasospasm in patients with ruptured aneurysms. Methods: Seventy patients undergoing craniotomy for ruptured aneurysms in our hospital were selected as study subjects and randomly divided into control (n = 33) and research (n = 37) groups, they were treated with nimodipine and nimodipine combined with Shenmai injection after operation. The blood flow velocity in the middle cerebral artery (MCA) before and at 1, 3, 7, 11 and 14 days after surgery and the incidence of cerebral vasospasm during these days were compared, and the GCS scores at 14 days postoperatively and GOS scores at 6 months postoperatively were compared between the two groups. Results: There were no statistically significant differences in the occurrence of cerebral vasospasm, GCS or GOS scores between the two groups (P > 0.05), but the period of postoperative cerebral vasospasm in the study group was significantly shorter than that in the control group. Conclusion: Shenmai injection has the effect of shortening the cycle of occurrence of cerebral vasospasm after the operation of ruptured aneurysms, promoting patients to recover as early as possible and reducing their physical and mental burden.

Effect of Shenmai injection combined with irbesartan on the microinflammatory state and nutritional status of patients with peritoneal dialysis

Objective: To study the effect of Shenmai injection combined with irbesartan on the microinflammatory state and nutritional status of patients with peritoneal dialysis. Methods:A total of 108 patients with end-stage renal disease who received peritoneal dialysis in Guangyuan First People's Hospital between May 2014 and November 2016 were selected and randomly divided into two groups, the combined group received Shenmai injection combined with irbesartan therapy, and the ARB group received irbesartan therapy. The renal function indicators, inflammatory response indicators and nutritional status indicators of the two groups were detected before treatment as well as 3 months and 6 months after treatment. Results: Scr, BUN and RRF of both groups 3 months and 6 months after treatment were not significantly different from those before treatment;serum SAA, CRP, PAPP-A, CHE, TNF-α, IL-6 and IL-8 contents of both groups 3 months and 6 months after treatment were significantly lower than those before treatment, and serum SAA, CRP, PAPP-A, CHE, TNF-α, IL-6 and IL-8 contents of combined group 3 months and 6 months after treatment were significantly lower than those of ARB group;serum Alb, PA and Tf contents as well as mid-arm muscle circumference and mid-arm circumference of combined group 3 months and 6 months after treatment were not significantly different from those before treatment while serum Alb, PA and Tf contents as well as mid-arm muscle circumference and mid-arm circumference of control group 3 months and 6 months after treatment were significantly lower than those before treatment. Conclusion: Shenmai injection combined with irbesartan for peritoneal dialysis can reduce the microinflammatory state and improve the nutritional status.

Effects of Shenmai Injection(参麦注射液)Combined with Meglumine Adenosine Cyclophosphate Injection on Cardiac Function and Peripheral Serum Levels of TNF-α,TGF-β1 and IFN-γ in Patients with Viral Myocarditis

Objective: To explore effects of Shenmai Injection(参麦注射液) combined with Meglumine Adenosine Cyclophosphate Injection on cardiac function and peripheral serum levels of tumor necrosis factor-α(TNF-α), transforming growth factor-β1(TGF-β1) and interferon-γ(IFN-γ) in patients with viral myocarditis.Methods: A total of 70 patients with viral myocarditis admitted in Cardiovascular Medicine Department of our hospital from June 2016 to June 2018 were selected and divided into a control group(treated with Meglumine Adenosine Cyclophosphate Injection) and an observation group(additionally treated with Shenmai Injection(参麦注射液) on the treatment basis of the control group) according to random number method, with 35 cases in each group.Before and after the treatment, cardiac functional indexes like cardiac index(CI), left ventricular ejection fraction(LVEF) and left ventricular shortening fraction(FS), serum levels of TNF-α, TGF-β1 and IFN-γ, clinical efficacy and adverse reactions occurred in the 2 groups were recorded and compared.Results: Therapeutic effective rate in the observation group was 88.57%, higher than 68.57% in the control group(P < 0.05).After the treatment, cardiac functional indexes like CI, LVEF and FS were higher than those in the control group(P < 0.05).After the treatment, the serum expression levels of TNF-α and TGF-β1 were lower than those in the control group(P < 0.05), while the serum expression level of IFN-γ was higher than that in the control group(P < 0.05).There was no statistically significant difference in the adverse reaction rates between the 2 groups(P > 0.05).Conclusion: The treatment of patients with viral myocarditis by Shenmai Injection(参麦注射液) combined with Meglumine Adenosine Cyclophosphate Injection is more effective, reducing inflammation and restoring cardiac function.

Shenmai injection combined with Western medicine in the treatment of acute pancreatitis: a systematic review and meta-analysis

Background:To evaluate the efficacy and safety of the classic ancient prescription Shenmai injection(the classic ancient presciption)combined with Western medicine in the treatment of acute pancreatitis.Method:PubMed,the Cochrane Library,EMBASE,the Web of Science,China National Knowledge Infrastructure,Wanfang database,VIP Database and Chinese BioMedicine Literature Database were searched from database establishment to January 2021.After 2 researchers independently screened the literature,extracted data and evaluated the bias risk included in the study.A meta-analysis of randomized controlled trials of the classic ancient prescription Shenmai injection combined with Western medicine in the treatment of acute pancreatitis was conducted with the Revman 5.0 software.Result:A total of 19 randomized controlled trials were included,including 1,507 patients.The results of meta-analysis showed that the test group had advantage over the control group in total effective rate(RR=1.23,95%CI(1.17,1.34),P<0.00001),serum amylase level(stand mean difference=−2.92,95%CI(−3.75,−2.09),P<0.00001),C-reactive protein level and IL-6 level with statistically significant.Conclusion:The current evidence shows that the classic ancient prescription Shenmai injection combined with Western medicine can achieve better curative effect in the treatment of acute pancreatitis than using Western medicine alone.It has more advantages in terms of the total effective rate,reducing the level of serum amylase level and inflammatory cytokines.

参麦注射液干预对脓毒症新发脏器损伤的影响

目的观察参麦注射液干预对脓毒症的新发脏器损伤的影响。方法选取2017年1月至2021年10月入住首都医科大学附属北京中医医院重症医学科(ICU)的181例成人脓毒症患者作为研究对象。根据患者是否出现新发脏器损伤将脓毒症患者分为新发脏器损伤组(95例)和无新发组(86例)。收集患者基本情况、前期相关实验室指标及干预因素、治疗7 d后实验室相关指标,构建多因素logistic回归模型分析相关发病因素,依据χ^(2)检验探索参麦注射液干预与新发脏器损伤的相关性。结果新发脏器损伤组入院72 h内休克、早期液体平衡量、入ICU及治疗后脓毒症相关性器官功能衰竭评价评分高于无新发组,差异有高度统计学意义(P<0.01)。新发脏器损伤组入院使用参麦注射液干预比例、治疗后血白蛋白水平及血红蛋白水平低于无新发组,差异有统计学意义(P<0.05)。参麦注射液干预(OR=0.261,95%CI:0.109~0.626,P<0.01)、治疗后血红蛋白(OR=0.978,95%CI:0.957~0.998,P<0.05)是新发脏器损伤的独立影响因素。参麦注射液干预后急性肾损伤、急性肺损伤患者少于未使用参麦注射液(P<0.01)。参麦注射液干预后新发急性心功能不全与未使用参麦注射液比较,差异无统计学意义(P>0.05)。结论参麦注射液干预可以降低脓毒症并发急性肺损伤、急性肾损伤等新发脏器损伤风险。

参麦注射液辅助西药治疗中风恢复期临床研究

目的:观察参麦注射液辅助西药治疗中风恢复期的临床疗效。方法:按随机数字表法将90例中风恢复期患者分为治疗组与对照组各45例。对照组给予阿司匹林肠溶片、胞二磷胆碱注射液、甲钴胺片等西药对症治疗,治疗组在对照组基础上给予参麦注射液治疗。治疗4周后,比较2组临床疗效、中医证候评分、美国国立卫生院神经功能缺损评分(NIHSS)、肢体运动功能Fugel-Meyer评定量表(FMA)及血清炎症因子[白细胞介素-1β(IL-1β)、白细胞介素-6(IL-6)、肿瘤细胞因子-α(TNF-α)]水平。结果:治疗后,治疗组总有效率为95.56%,对照组为82.22%,2组比较,差异有统计学意义(P<0.05)。治疗后,2组中医证候评分、NIHSS评分均较治疗前降低(P<0.05),且治疗组2项评分均低于对照组(P<0.05)。治疗后,2组上、下肢的FMA评分均较治疗前升高(P<0.05),且治疗组上、下肢的FMA评分均高于对照组(P<0.05)。治疗后,2组血清IL-1β、IL-6、TNF-ɑ水平均较治疗前降低(P<0.05),且治疗组上述各项指标均低于对照组(P<0.05)。结论:参麦注射液辅助西药治疗中风恢复期患者疗效显著,可有效减轻机体炎症反应,缓解临床症状,改善神经功能及肢体运动功能。

用于病毒性疾病治疗的中药注射液临床应用现状

病毒性疾病一直对人类健康存在一定的威胁,中药注射剂在急性病毒感染的治疗中能快速缓解病情,在临床中发挥了至关重要的作用,其疗效虽迅速,但有效性、安全性等方面仍存在争议,2023年召开的我国国家中药科学监管大会建议推动开展中药注射剂上市后研究、评价,以明确其不良反应发生率,为安全性评价提供科学佐证,有助于全面认识中药注射剂的临床价值。本文对常用治疗病毒性疾病的中药注射剂处方与成分、有效性、安全性及作用机制进行综述,以期为中药注射剂对病毒性疾病的临床治疗以及中药注射剂上市后再评价的未来方向提供参考,全面认识抗病毒中药注射液的临床价值。

参麦注射液治疗慢性阻塞性肺疾病合并呼吸衰竭的Meta分析

目的对参麦注射液应用于慢性阻塞性肺疾病(COPD)伴呼吸衰竭的有效性及安全性进行Meta分析。方法检索中国知网、万方数据库、维普资讯、中国生物医学文献数据库、PubMed、Cochrane Library、Web of Science、Embase医学文献数据库,由2位研究者根据纳入、排除标准独立筛选文献,提取相应研究信息并交叉核对,筛选出参麦注射液治疗COPD伴呼吸衰竭的随机对照试验,使用RevMan5.4软件对纳入研究进行Meta分析,并使用GRADE评价系统对结局指标质量进行分级。结果本研究纳入16项临床研究,共1313例患者,观察组667例,对照组646例;参麦注射液联合西医常规治疗COPD伴呼吸衰竭患者,在临床总有效率[OR=3.10,95%CI(2.05~4.70),P<0.00001]、氧分压[MD=7.98,95%CI(4.97~11.00),P<0.00001]、二氧化碳分压[MD=-8.31,95%CI(-11.11~-5.51),P<0.00001]、C反应蛋白(CRP)[SMD=-1.64,95%CI(-2.37~-0.91),P<0.00001]、第一秒用力呼气容积(FEV1)[MD=0.38,95%CI(0.33~0.42),P<0.00001]方面,相较对照组差异有统计学意义(P<0.01);用力肺活量(FVC)两组间差异无统计学意义(P>0.05)。GRADE证据分级结果提示,总有效率、动脉血气氧分压、动脉血气二氧化碳分压、CRP、FVC、FEV1为极低级质量证据。结论西医常规结合参麦注射液治疗COPD合并呼吸衰竭可以提高临床治疗总有效率,改善低氧血症和(或)二氧化碳潴留,减轻炎症,安全性较好。

参麦注射液对感染性休克患者血流动力学指标影响的研究

目的观察参麦注射液对感染性休克患者血流动力学、炎症指标及组织灌注的影响。方法将感染性休克患者60例,按随机数字表法分为治疗组与对照组各30例。两组均给予基础西医对症治疗,治疗组在西医常规治疗基础上静脉滴注100 mL参麦注射液。观察两组治疗前后血流动力学指标,使用前后不同时间的心率(HR)、平均动脉压(MAP)、心排指数(CI)、全心舒张末期容积指数(GEDVI)、胸腔内血容积指数(ITBVI)、全身血管阻力指数(SVRI)、血管外肺水指数(EVLWI)的影响。观察两组不同时间的心功能指标NT-proBNP、感染指标降钙素原(PCT)水平。观察两组治疗前后不同时间的组织灌注指标变化,如动脉血乳酸(Lac)、APACHEⅡ评分变化。结果治疗后两组之间HR、MAP差异无统计学意义(P>0.05)。CI、GEDVI、ITBVI、SVRI、EVLWI治疗组较对照组有所好转,但差异无统计学意义(P>0.05)。治疗后治疗组心功能指标NT-proB⁃NP、PCT、血乳酸水平低于对照组(P<0.05),两组APACHEⅡ评分好转率差异无统计学意义(P>0.05)。结论参麦注射液在治疗老年人脓毒血症过程中,有一定的改善心功能、降低血管阻力、改善炎症指标的作用,可以在老年人脓毒血症治疗过程中作为辅助用药。但无法作为强心药物来治疗脓毒血症,也无法替代其他免疫调节性药物来改善全身症状。

揿针疗法联合参麦注射液提高晚期子宫颈癌化疗患者免疫功能的临床研究

目的:研究揿针疗法联合参麦注射液提高晚期子宫颈癌化疗患者免疫功能的效果。方法:临床研究对象选择2018年8月—2022年1月在九江市第一人民医院接受治疗的晚期子宫颈癌患者60例,按照随机数字表法将其分为对照组和试验组,每组30例。对照组患者采用参麦注射液进行治疗,试验组在对照组基础上联合使用揿针疗法。观察两组T淋巴细胞亚群情况、卡氏(KPS)评分、肿瘤标志物指标、不良反应及治疗效果。结果:试验组治疗后CD4^(+)和CD4^(+)/CD8^(+)均高于对照组,CD8^(+)低于对照组,差异均有统计学意义(P<0.05)。治疗前试验组KPS评分比较,差异无统计学意义(P>0.05);治疗后试验组的KPS评分显著高于对照组,差异有统计学意义(P<0.05)。治疗前两组糖类抗原125(CA125)、癌胚抗原(CEA)、糖类抗原19-9(CA19-9),差异均无统计学意义(P>0.05);治疗后试验组各项肿瘤标志物指标均较对照组更低,差异均有统计学意义(P<0.05)。试验组不良反应总发生率(10.00%)较对照组(33.33%)更低,差异有统计学意义(P<0.05)。试验组患者总有效率(96.67%)较对照组(76.67%)更高,差异有统计学意义(P<0.05)。结论:采取揿针疗法联合参麦注射液对晚期子宫颈癌化疗患者进行治疗,有利于降低不良反应发生率,提高治疗效果,加强患者免疫功能,改善肿瘤标志物指标水平。

Shenmai Injection Improves Hypertensive Heart Failure by Inhibiting Myocardial Fibrosis via TGF-β1/Smad Pathway Regulation

Objective: To study effects of Shenmai Injection on hypertensive heart failure and its mechanism for inhibiting myocardial fibrosis. Methods: Salt-sensitive(Dahl/SS) rats were fed with normal diet(0.3% Na Cl) and the high-salt diet(8% Na Cl) to observe the changes in blood pressure and heart function, as the control group and the model group. Salt-insensitive rats(SS-13BN) were fed with the high-salt diet(8% Na Cl) as the negative control group. After modeling, the model rats were randomly divided into heart failure(HF) group, Shenmai Injection(SMI) group and pirfenidone(PFD) group by a random number table, with 6 rats in each group. They were given sterilized water, SMI and pirfenidone, respectively. Blood pressure, cardiac function, fibrosis and related molecular expression were detected by sphygmomanometer, echocardiogram, enzyme linked immunosorbent assay(ELISA),hematoxylin-eosin staining, Masson staining, immunofluorescence and qPCR analysis. Results: After high-salt feeding, compared with the control and negative control group, in the model group the blood pressure increased significantly, the left ventricular ejection fraction(LVEF) and left ventricular fraction shortening(LVFS) were significantly reduced, and the serum NT-pro BNP concentration increased significantly(all P<0.05);furthermore,the arrangement of myocardial cells was disordered, the edema was severe, and the degree of myocardial fibrosis was also significantly increased(P<0.05);the protein and m RNA expressions of collagen type Ⅰ(Col Ⅰ) were up-regulated(P<0.05), and the mRNA expressions of transforming growth factor β1(TGF-β1), Smad2 and Smad3 were significantly up-regulated(P<0.05). Compared with HF group, after intervention of Shenmai Injection, LVEF and LVFS increased, myocardial morphology was improved, collagen volume fraction decreased significantly(P<0.05), and the mRNA expressions of Col Ⅰ, TGF-β1, Smad2 and Smad3, as well as Col Ⅰprotein expression, were all significantly down-regulated(all P<0.05). Conclusion: Myocardial fibrosis is the main pathological manifestation of hypertensive heart failure, and Shenmai Injection could inhibit myocardial fibrosis and effectively improve heart failure by regulating TGF-β1/Smad signaling pathway.