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1.
China Journal of Chinese Materia Medica ; (24): 3712-3721, 2021.
Article in Chinese | WPRIM | ID: wpr-888025

ABSTRACT

This study aimed to analyze the methodological quality of systematic reviews of Shuxuening Injection and evaluate the efficacy and adverse reactions of Shuxuening Injection in the treatment of different diseases,in order to provide supportive evidence for clinical practice. Three Chinese databases and three English databases were retrieved to identify systematic reviews and Meta-analysis on the efficacy and safety of Shuxuening Injection in the treatment of diseases. The AMSTAR 2( a measurement tool to assess systematic reviews 2) tool was used to evaluate the methodological quality of the included systematic reviews,and tables were created to present the results of Meta-analyses. Twenty-four systematic reviews were included,all with very low methodological quality. Among the 16 AMSTAR-2 items,only 5 items had a compliance rate greater than 60. 0%,and 8 items had a compliance rate less than 50. 0%. For patients with cerebral infarction,Shuxuening Injection combined with conventional treatment was more effective than conventional treatment alone in terms of clinical efficiency and neurological deficit improvement. For patients with angina pectoris,Shuxuening Injection was superior to Danshen/Compound Danshen Injection in terms of the total effective rate of angina pectoris and total effective rate of ECG. The efficacy of Shuxuening Injection combined with conventional treatment is significantly better than conventional treatment.Shuxuening Injection( alone or combined with conventional treatments) was better than conventional treatments for cerebral hemorrhage,ischemic cerebrovascular disease,chronic pulmonary heart disease,vertigo and sudden deafness. Shuxuening Injection had better efficacy and lower incidence of adverse reactions,but the methodological quality of included systematic reviews was low. The results of this study still need to be verified by high-quality systematic reviews.


Subject(s)
Humans , Angina Pectoris/drug therapy , Drugs, Chinese Herbal , Injections , Salvia miltiorrhiza , Systematic Reviews as Topic
2.
Acta Pharmaceutica Sinica ; (12): 231-243, 2021.
Article in Chinese | WPRIM | ID: wpr-872616

ABSTRACT

As a Ginkgo biloba extract preparation, shuxuening injection has a unique advantage in the prevention and treatment of acute and subacute stroke, but its main active ingredient is still unclear. Using a subacute model of stroke in mice constructed earlier, we further explored the contribution and mechanism of the two main components of total ginkgo flavonol glycosides and total ginkgolides in facilitating the neurofunctional recovery in stroke-induced mice. The pharmacodynamics was mainly evaluated by neurobehavioral changes, cerebral infarction volume, blood-brain barrier permeability and brain edema. The pathway and targets were predicted by transcriptome and network pharmacology. Finally, the mechanism was verified at the mRNA and protein levels. The results showed that the beneficial effect of total ginkgolides was greater than that of total ginkgo flavonol glycosides in both the pharmacodynamics and the regulatory mechanism of granulocyte adhesion and diapedesis involving granulocyte colony-stimulating factor (G-CSF), macrophage-1 antigen (MAC-1) and E-selectin. These findings suggest that shuxuening injection may improve the prognosis for mice with subacute stroke by down-regulating G-CSF-mediated granulocyte adhesion and diapedesis pathway mainly through the total ginkgolide components. This finding is expected to provide reference for optimizing prescription and searching for natural drugs for targeting the treatment of ischemic stroke prognosis. The animal experiments in this study followed the regulations of Animal Ethics Committee of Tianjin University of Traditional Chinese Medicine.

3.
Journal of Jilin University(Medicine Edition) ; (6): 557-562, 2020.
Article in Chinese | WPRIM | ID: wpr-841556

ABSTRACT

Objective: To investigate the|protective effect of Shuxuening Injection on the brain tissue of the rats with acute cerebral infarction, and to elucidate its mechanism. Methods: Fifty rats were randomly divided into control group, sham operation group, model group, nimodipine group and Shuxuening Injection group ( n=10). The rat models of acute cerebral infarction were made by internal carotid artery suture method in model group, nimodipine group and Shuxuening Injection group. The common carotid arteries, the external carotid arteries and the internal carotid arteries of the rats in sham operation group were separated∗ and only the external carotid arteries were ligated; the rats in control group were not treated with operation; the rats in Shuxuening Injection group were given Shuxuening Injection, the rats in nimodipine group were given nimodipine∗ and the rats in control group, model group and sham operation group were given normal saline at the same volume. The score of neurological impairment, water contents in brain tissue and relative cerebral infarction areas of the rats in various groups were measured. HE staining was used to observe the morphology of brain tissue of the rats in various groups, and immumohistochemical staining was used to detect the expression levels of growth differentiation factor-15 (GDF-15) and C-reactive protein (CRP) in brain tissue of the rats in various groups. EL ISA method was used to detect the levels of tumor necrosis factor-a (TNF-a), interleukin-6 (IL-6) and interleukin-1(3 (1L-1|3) in brain tissue of the rats in various groups. Results: The cortical structures of cortex of the rats in control group and sham operation group were complete and the cells were arranged neatly; the cytoplasm and nucleus of the nerve cells of the rats in model group were wrinkled, and the interstitium between nerve cells and capillaries were loose; the swelling degrees of cerebral cortical nerve cells and glial cells and the loose degrees of stroma of the rats in Shuxuening Injection group were reduced, and the histopathological manifestations were similar to those in nimodipine group. Compared with control group and sham operation group∗ the water content in brain tissue of the rats in model group was significantly increased ( P 0.05). Conclusion: Shuxuening Injection can protect the acute cerebral infarction by up-regulating the expression of GDF-15 and inhibiting the expression of CRP in brain tissue of the rats with acute cerebral infarction, reducing the levels of inflammatory cytokines and improving the neurological function.

4.
The Journal of Practical Medicine ; (24): 461-466, 2019.
Article in Chinese | WPRIM | ID: wpr-743755

ABSTRACT

Objective To observe the clinical efficacy of Shuxuening injection combined with compound coenzyme in the treatment of chronic allograft nephropathy (CAN). Methods A retrospective analysis of 108 patients with chronic allograft nephropathy (CAN) admitted to our hospital from June 2014 to May 2018 were divided into two groups according to different treatments. The 43 cases in the experimental group were given Shuxuening injection combined with compound coenzyme, and the 65 cases in control group were given non-Shu Xuening + compound coenzyme. The original immunization protocol was maintained in both groups. After 4 weeks of treatment, the changes of hemodynamic parameters, clinical efficacy, biochemical parameters, coagulation function and adverse reactions were observed before and after treatment. Results There was no significant difference in baseline data between the two groups before treatment (P> 0.05). After treatment, the peak systolic velocity of the intersegmental artery and cortical arteriole in the experimental group were significantly higher than that the control group (P < 0.05) , and the resistance index was lower than that in the control group (P < 0.05). After treatment, serum creatinine, 24 h urine protein quantitation, urinary microalbumin, total cholesterol and triglycerides were lower than that before treatment (P < 0.05) , and estimated glomerular filtration rate (eGFR) and serum. Albumin increased significantly (P < 0.05) , but the 24 h urine protein quantitation and urinary albumin decreased significantly in the experimental group compared with the control group (P < 0.05). After treatment, the total amount of cholesterol, triglycerides showed no significant difference (P> 0.05). After treatment, the platelet count, fibrinogen and D-dimer of the experimental group were significantly lower than those before treatment (P < 0.05) , and the activated partial thrombin time (APT) was significantly higher than that before treatment (P < 0.05). Significant difference in platelet count, fibrinogen, D-dimer and APTT was found after treatment (P < 0.05). After 4 weeks of treatment, the values of urea nitrogen and serum creatinine were significantly lower than those of the control group (P < 0.05). The recovery of transplanted kidney function in the experimental group was higher than that in the control group (P < 0.05). The experimental group reported 2 cases of fatigue complain and 1 case of dizziness, but no special treatment was given to them and their condition improved after symptomatic treatment; 1 case of mild phlebitis which was cured after given slowed drip rate and local hot compress therapy. The incidence of adverse events was 9.3% (4/43). The control group reported 2 cases of fatigue complain, 1 case of nausea, 1 case of facial flushing, and all cured with no special treatment was given; 1 case of mild phlebitis, and cured after slowed the i.v. drip rate and ocal hot compress; The adverse events rate was 7.7% (5/65). No serious adverse reactions occurred during the entire clinical trial. There was no significant difference in the incidence of adverse events between the experimental group and the control group (χ2=0.054, P=0.732). Conclusion Combined with Shuxuening injection and compound coenzyme can improve blood flow of transplanted kidney, reduce proteinuria, reduce blood urea nitrogen and creatinine in patients with CAN after renal transplantation and effectively improve patient's hemodynamic parameters and safety.

5.
Chinese Journal of Primary Medicine and Pharmacy ; (12): 2351-2355, 2019.
Article in Chinese | WPRIM | ID: wpr-753794

ABSTRACT

To investigate the effects of Shuxuening injection combined with edaravone on neuro -logical function,serum vascular endothelial growth factor ( VEGF) and soluble vascular cell adhesion molecule -1 (sVCAM-1) in patients with cerebral infarction.Methods A total of 112 patients with cerebral infarction admitted to Zhejiang Provincial Armed Police Hospital from August 2016 to August 2018 were enrolled in the study.They were divided into observation group and control group according to the digital table ,with 56 patients in each group.The two groups were given routine symptomatic treatment.On the basis of this, the control group was given edaravone treatment,and the observation group was given Shuxuening injection combined with edaravone .The changes of NIHSS, GCS score,serum NSE,NGF,NTF,VEGF and sVCAM -1 levels before and after treatment were compared between the two groups,and the clinical efficacy was compared.Results After treatment,the effective rate of the observation group was 92.86%(52/56),which was higher than that of the control group 73.21%(41/56),the difference was statistically significant (χ2 =7.669,P<0.05).After treatment,the NIHSS score,NSE,sVCAM-1 of the two groups were decreased,which of the observation group were lower than those of the control group [(3.27 ±1.16)points vs. (6.32 ±2.12)points,(13.15 ±1.14)μg/L vs.(17.64 ±1.89)μg/L,(648.56 ±134.67)ng/mL vs.(1 078.36 ± 131.23 ) ng/mL], while the GCS score, NGF, NTF, VEGF levels of the two groups were elevated , which of the observation group were higher than those of the control group [(13.64 ±3.86) points vs.(11.89 ±3.41) points, (76.13 ±8.72) μg/L vs.( 68.24 ±7.25 ) μg/L, ( 5.14 ±0.36 ) μg/L vs.(3.74 ±0.29) μg/L, (831.51 ± 91.67)ng/L vs.(752.83 ±91.24) ng/L],the differences were statistically significant (t=9.414,2.543,15.223, 5.205,22.663,4.552,15.672,all P <0.05).Conclusion Shuxuening injection combined with edaravone can improve the curative effect of patients with cerebral infarction ,improve neurological function,effectively improve serum VEGF level and decrease sVCAM -1 level.It is worthy of clinical application.

6.
Chinese Journal of Primary Medicine and Pharmacy ; (12): 2351-2355, 2019.
Article in Chinese | WPRIM | ID: wpr-803044

ABSTRACT

Objective@#To investigate the effects of Shuxuening injection combined with edaravone on neurological function, serum vascular endothelial growth factor (VEGF) and soluble vascular cell adhesion molecule-1 (sVCAM-1) in patients with cerebral infarction.@*Methods@#A total of 112 patients with cerebral infarction admitted to Zhejiang Provincial Armed Police Hospital from August 2016 to August 2018 were enrolled in the study.They were divided into observation group and control group according to the digital table, with 56 patients in each group.The two groups were given routine symptomatic treatment.On the basis of this, the control group was given edaravone treatment, and the observation group was given Shuxuening injection combined with edaravone.The changes of NIHSS, GCS score, serum NSE, NGF, NTF, VEGF and sVCAM-1 levels before and after treatment were compared between the two groups, and the clinical efficacy was compared.@*Results@#After treatment, the effective rate of the observation group was 92.86%(52/56), which was higher than that of the control group 73.21%(41/56), the difference was statistically significant (χ2=7.669, P<0.05). After treatment, the NIHSS score, NSE, sVCAM-1 of the two groups were decreased, which of the observation group were lower than those of the control group[(3.27±1.16)points vs.(6.32±2.12)points, (13.15±1.14)μg/L vs.(17.64±1.89)μg/L, (648.56±134.67)ng/mL vs.(1 078.36±131.23)ng/mL], while the GCS score, NGF, NTF, VEGF levels of the two groups were elevated, which of the observation group were higher than those of the control group[(13.64±3.86)points vs.(11.89±3.41)points, (76.13±8.72)μg/L vs.(68.24±7.25)μg/L, (5.14±0.36)μg/L vs.(3.74±0.29)μg/L, (831.51±91.67)ng/L vs.(752.83±91.24)ng/L], the differences were statistically significant (t=9.414, 2.543, 15.223, 5.205, 22.663, 4.552, 15.672, all P<0.05).@*Conclusion@#Shuxuening injection combined with edaravone can improve the curative effect of patients with cerebral infarction, improve neurological function, effectively improve serum VEGF level and decrease sVCAM-1 level.It is worthy of clinical application.

7.
World Science and Technology-Modernization of Traditional Chinese Medicine ; (12): 1754-1760, 2018.
Article in Chinese | WPRIM | ID: wpr-752116

ABSTRACT

Objective: To summarize the clinical effects of Shuxuening Injection on diseases and evaluate the quality of evidence to provide reference for the clinical application of Shuxuening Injection. Methods: Journal articles and conference papers were retrieved from the databases CNKI, Wanfang, VIP, CBM, EMbase, Pubmed and Cochrane with thematic word"Shuxuening"in Chinese and English, then all forms of clinical studies were screened and the disease types and frequency were analyzed, the dominant disease types of Shuxuening Injection were identified. Futhermore, RCT was extracted, and the literature quality was graded using the cochrane manual recommendation method, and its effectiveness and safety were evaluated. Results: All clinical research results show that Shuxuening Injection to treat disease with as many as 74 kinds of varieties, mainly circulation system disease and neural system disease, followed by endocrine disease, respiratory disease, scattered remaining research in ten other system diseases. These researches appeared with the highest frequency of the three diseases were cerebral infarction and its aftermath, angina pectoris and coronary heart disease, diabetes mellitus and its complication. A total of 337 RCT articles were included, all of which were of poor quality. In general, the efficiency of Shuxuening Injection treatment group was significantly higher than that of the control group, with a total efficiency of 84.48%. There were 21.96% references to adverse reactions, but all of them were minor adverse reactions, such as pruritus, which generally got better by itself or after treatment. Conclusion:Shuxuening Injection has a wide range of clinical application and remarkable effect, especially for the ischemic diseases of cardiovascular and cerebrovascular diseases with good efficacy, less adverse reactions and safety. However, the quality of evidence is generally poor, which needs further study.

8.
Chinese Journal of Primary Medicine and Pharmacy ; (12): 2628-2631, 2018.
Article in Chinese | WPRIM | ID: wpr-702142

ABSTRACT

Objective To evaluate the clinical efficacy of Shuxuening injection combined with puerarin in the treatment of coronary heart disease patients with unstable angina pectoris .Methods From January 2014 to June 2014,200 patients with coronary heart disease in the People 's Hospital of Huairen County were selected in the research.The patients were randomly divided into two groups according to the digital table ,with 100 cases in each group.The control group was given Shuxuening injection , the observation group received Shuxuening injection combined with puerarin treatment.The treatment time was 15d.The total effective rate,hospitalization time,frequency of angina pectoris,cost of treatment,the incidence of adverse reactions were compared between the two groups .Results After treatment,in the observation group,90 cases were cured,5 cases were effective,5 cases were invalid,the total effective rate was 95%,there was statistically significant difference compared with that in the control group ( χ2=8.302,P<0.05).The hospitalization time,times of angina pectoris,cost of treatment in the observation group were (10.15 ±1.20) d,(1.10 ±0.23),(3 458.15 ±210.27) CNY,respectively,which were better than those in the control group (t =15.044,12.262,29.177,all P <0.05).In the observation group,1 case of fever,1 case of vomiting,the incidence rate of adverse reaction was 2%,there was statistically significant difference compared with that in the control group (χ2=6.663,P<0.05).Conclusion Shuxuening combined with puerarin in the treatment of coronary heart disease patients with unstable angina pectoris has significant effect , can improve the indicators , reduce adverse reactions,it is worthy of promotion and application .

9.
Herald of Medicine ; (12): 120-122, 2018.
Article in Chinese | WPRIM | ID: wpr-665151

ABSTRACT

Objective To survey the correlation among ADR performances of Shuxuening injection(SXN injection ) based on ADR reports and literature data by rough set theory(RST). Methods By collecting 468 ADR reports of SXN injection,data attribute reduction were processed by Rossata software,and the generated rules and each indicator were analyzed. Results 9 main indicators,which mainly belongs to medication information,had a strong relationship with ADR.There was a correlation among ADR performances.Relationship could also found between performances and medication information. Conclusion The results of the study provide reference for clinical reasonable application of SXN injection,and enrich the research method of ADR.

10.
Academic Journal of Second Military Medical University ; (12): 804-809, 2017.
Article in Chinese | WPRIM | ID: wpr-838425

ABSTRACT

Objective To explore the effect of Shuxuening on early myocardial injury markers and oxidative stress in severe sepsis patients with myocardial injury. Methods A total of 102 severe sepsis patients with myocardial injury, who received therapy in our hospital from Mar. 2013 to Jun. 2016, were randomly divided into two groups; control group (51 cases) and therapy group (51 cases). The patients in the control group received routine treatments and the therapy group were given Shuxuening based on routine treatment. We detected the levels of plasma N-terminal pio-brain natriuretic peptide (NT-proBNP), heart-type fatty acid binding protein (hFABP), cardiac troponin I (cTnl), malondialdehyde (MDA), superoxicle dismutase (SOD) and gluiaihione peroxidase (GSH-Px) of patients before treatment (at admission), after treatment for 6 h and 72 h (after admission), and analyzed the change of left ventricular ejection fraction (LVEF), acute physiology, chronic health evaluation (APACHE) || score, length of ICU slay and 28-day mortality of the patients. Results At admission, there was no difference in the levels of plasma NT-proBNP, hFABP, cTnl. MDA. SOD. GSH-Px, APACHE || score or LVEF between the two groups (P>0.05). After treatment for 6 h, the levels of plasma NT-proBNP, hFABP, cTnl and MDA in the therapy group were significantly lower and the activities of plasma SOD and GSH-Px were significantly higher than those in the control group (P0. 05). APACHE II scores after treatment were significantly lower than that before treatment in the two groups (P0. 05). The therapy group had a significantly lower 28-day mortality than the control group (0. 05). The therapy group had a significantly lower mortality than the control group (P<0. 05). Conclusion Therapeutic effect of Shuxuening on the severe sepsis patients with myocardial injury is superior to the routine treatment. Shuxuening can decrease the levels of NT-proBNP. hFABP. cTnl, and MDA and APACHE || score, and can increase the activities of SOD and GSH-Px.

11.
Chinese Traditional Patent Medicine ; (12): 1361-1365, 2017.
Article in Chinese | WPRIM | ID: wpr-616366

ABSTRACT

AIM To investigate the effects of Shuxuening Injection (Ginkgo biloba extract) combined with ganglioside on cerebral oxygen utilization coefficient (O2UCc) and lactate clearance rate (LCR) in patients with acute severe carbon monoxide poisoning (ASCOP).METHODS Two hundred and sixty-two patients with ASCOP treated in emergency department of Harrison International Peace Hospital Affiliated to Hebei Medical University from Mar 2011 to Mar 2016 were randomly divided into control group,Shuxuening Injection group,ganglioside group and Shuxuening Injection combined with ganglioside (combined medication) group.The changes were detected in oxygen saturations of carotid blood and jugular blood,arterial blood lactic acid,O2UCc and LCR in all patients before and 6,24 hours,3 days after the treatment.The clinical symptoms,and the mortality and morbidity of delayed encephalopathy after acute carbon monoxide poisoning after two weeks were observed.RESULTS Total effective rate of the combined medication group was higher than that of the other groups.O2 Ucc at 6,24 hours after the treatment in the combined medication group were significantly lower than those in the other groups,so did the mortality and morbidity of delayed encephalopathy after acute carbon monoxide poisoning,but LCR was significantly higher than that in the other groups.All the differences had statistical significances.CONCLUSION The efficacy of combined medication of Shuxuening Injection and ganglioside in ASCOP patients is better than that of applying single administration separately.

12.
Chinese Journal of Biochemical Pharmaceutics ; (6): 84-85,88, 2017.
Article in Chinese | WPRIM | ID: wpr-615814

ABSTRACT

Objective To evaluate the clinical efficacy of shuxuening injection in the adjuvant treatment of cerebral infarction (CI) and its clinical nursing. Methods A total of 114 patients with CI were randomly divided into two groups: The control group (n=57) were received conventional treatment and nursing, the observation group (n=57) were received shuxuening injection on the basis of control group. The efficacy and incidence of complications were compared between the two groups, the NIHSS and MMSE scores were evaluated before and after treatment. Results The total effective rate in the observation group was significantly higher than that in the control group (96.49% vs 82.46%)( P<0.05), while the complication rate in the observation group was significantly lower than that in the control group(7.02% vs 21.05%)( P<0.05). After treatment, the NIHSS score in the observation group was significantly lower than that in the control group, while the MMSE score was significantly higher than that in the control group(P<0.05). Conclusion Shuxuening injection is effective in the treatment of CI, which can reduce the complications, promote the rehabilitation of neurological function and protect the cognitive function, proper nursing intervention can promote the rehabilitation.

13.
Chinese Journal of Information on Traditional Chinese Medicine ; (12): 118-120, 2017.
Article in Chinese | WPRIM | ID: wpr-613698

ABSTRACT

Objective To investigate the usage of Shuxuening Injection in Chuzhou Hospital of Traditional Chinese and Western Medicine (hereinafter referred to as our hospital); To promote clinical rational usage of Shuxuening Injection. Methods A retrospective study was conducted to 297 cases of using Shuxuening Injection in our hospital from January 2016 to June 2016. Results In the 297 cases, 58.9% patients were over 60 years old, and indication coincidence rate of Shuxuening Injection was 52.2%. 91.2% single dose met the instructions and 6.7%solvent use met instructions. Shuxuening Injection in the joint medication also had irrational usage phenomenon. Conclusion There is irrational usage of Shuxuening Injection in our hospital, especially in indication and solvent.

14.
Chinese Journal of Biochemical Pharmaceutics ; (6): 310-311,314, 2017.
Article in Chinese | WPRIM | ID: wpr-612875

ABSTRACT

Objective To explore the clinical application effect of Shuxuening combined with ozagrel sodium in the treatment of cerebral infarction patients with psychological intervention.Methods120 patients with cerebral infarction were randomly divided into observation group and control group from January 2015 to June 2016.The control group was treated with intravenous ozagrel sodium and psychological intervention.The observation group was treated with control group based on the use of Shuxuening.ResultsThe clinical efficacy in the observation group was significantly higher than in the control group (P<0.05).The incidence of complications in the observation group was significantly lower than that in the control group (P<0.05).ConclusionThe combination of Shuxuening combined with ozagrel sodium and psychological intervention in the treatment of cerebral infarction, can effectively improve the patient's treatment efficiency, improve the physiological and psychological status of patients, and effectively reduce the treatment of patients with complications.

15.
China Pharmacy ; (12): 3643-3646, 2017.
Article in Chinese | WPRIM | ID: wpr-607175

ABSTRACT

OBJECTIVE:To investigate the occurrence of ADR induced by Shuxuening injection in Beijing area,and to pro-vide reference for rational drug use in clinic. METHODS:ADR induced by Shuxuening injection in Beijing area during 2003-2013 was classified statistically in respects of population,organs/systems involved in ADR,clinical manifestations,occurrence time, drug combination and prognosis. RESULTS:Of 1648 ADR cases,the incidence of ADR in the elderly patients was higher than young patients,and that of female patients (60.92%) was higher than that of male patients (39.14%). Multiple organs/systems were involved in Shuxuening injection-induced ADR,and top 3 were nervous system (422 cases,21.33%),skin and its appen-dants (411 cases,20.78%) and others (305 cases,15.42%). Clinical manifestations were skin rash,itching,dizziness and ner-vousness,palpitation,arrhythmia,etc. ADR mostly occurred within 5-30 min after medication. In ADR reports,there were a vari-ety of drugs combined with Shuxuening injection. Shuxuening injection combined with Alprostadil injection was most common(61 cases,accounting for 23.46% of drug combination). Among 1648 ADR cases,there were 622 cured cases and 1039 cases im-proved,4 cases were not improved,3 cases had sequelae and 1 case died. CONCLUSIONS:Clinical application of Shuxuening in-jection should strictly follow the indications of drug package inserts;differentiation of symptoms and signs is based on specific dos-age,solvent,route of administration,etc. It is necessary to strengthen the prescription check,and strengthen the observation after medication especially for the elderly and other special groups so as to reduce and avoid ADR.

16.
World Science and Technology-Modernization of Traditional Chinese Medicine ; (12): 851-857, 2017.
Article in Chinese | WPRIM | ID: wpr-606886

ABSTRACT

Shu-Xue-Ning (SXN) injection was used as study subject in order to explore the feasibility of pharmacodynamics experiment of Phase 0 clinical trial in Chinese materia medica (CMM).This paper tried to establish key-technique standards which fit to the evaluation on CMM phase 0 (early) clinical evaluations.According to the established research methods,this research selected volunteers and assured low dose SXN injection inside their body.And then,serum before and after medication were collected for the HAEC in vitro experiment.Blood sample of the clinical dosage was used as control to verify the tendency consistency of pharmacodynamics in low dose and clinical dose.The results showed that in the H2O2 inducing HAEC damage experiment,low dose SXN injection can affect the cell proliferation,protect the shape of cells,reduce the release of ion owing to cell damages and influence the secretion in cells.Complete-sequence RNA gave differential multiterm expression before and after the low dose.It was concluded that compared with the clinical group,low dose medication had similar metabolic tendency.The pharmacodynamics experiment of phase 0 CMM clinical trial is feasible.

17.
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care ; (6): 158-161, 2017.
Article in Chinese | WPRIM | ID: wpr-505705

ABSTRACT

Objective To observe the effect of monosialoteterahexosyl ganglioside (GM1) combined with Shuxuening injection on nerve function in patients with acute cerebral infarction (ACI) and its mechanism.Methods A total of 94 patients with ACI admitted to the Department of Neurology in Xiangyang First Peoples' Hospital Affiliated to Hubei Medical College from January 2013 to June 2016 were enrolled,and they were divided into two groups by random number table,each group 47 cases.The patients in two groups were all given conventional western medicine treatment;The patients in one group (single group) were treated by intravenous (Ⅳ) drip of GM1,100 mg once a day;and the patients in another group (combined group),by above GM1 Ⅳ drip combined with Shuxuening intramuscular injection,once 2 mL,twice a day;the therapeutic course in two groups was 14 days.Before and after treatment,the changes of China stroke clinical neurological impairment score (CSS score),glasgow coma score (GCS),nerve factor,oxidative stress index and hemodynamics index of two groups were observed.Results Compared with those before treatment,after treatment the CSS score,the levels of neuron specific enolase (NSE),and malondialdehyde (MDA) were significantly lower,while the GCS score,the levels of nerve growth factor (NGF),neurotrophic factor (NTF),maximum blood flow velocity (Vmax),minimum blood flow velocity (Vmin),mean blood flow velocity (Vmean),mean blood flow quantity (Qmean),glutathione peroxidase (GSH-Px),catalase (CAT) and superoxide dismutase (SOD) were all significantly higher in the combined group (all P < 0.05).After treatment,the CSS score,levels of NSE and MDA in the combined group were significantly lower than those of the single group [CSS:11.20 ± 1.78 vs.16.24 ± 1.95,NSE (μg/L):13.17± 1.00 vs.17.68 ± 1.84,MDA (μmol/L):4.14±0.49 vs.5.61 ±0.50,all P < 0.05],GCS score,NGF,NTF,GSH-Px,CAT,SOD,Vmax,Vmin,Vmean and Qmean of the combined group were all significantly higher than those of the single group [GCS:13.68± 1.85 vs.12.01±1.76,NGF (ng/L):88.10±8.83 vs.68.13±7.16,NTF (pg/L):5.13±0.38 vs.3.71±0.30,GSH-Px (U/L):128.13±8.07 vs.103.90±6.58,CAT (U/L):25.74±2.15 vs.19.43± 1.84,SOD (μU/L):94.36±8.00 vs.77.29±7.34,Vmax (cm/min):48.23±3.36 vs.43.17±2.88,Vmin (cm/'min):8.11±0.76 vs.6.85 ± 0.64,Vmean (cm/min):18.69 ± 1.37 vs.15.60 ± 1.24,Qmean (mL/min):9.10 ± 0.74 vs.7.79 ± 0.66,all P < 0.05].Conclusions GM1 combined with Shuxuening injection can improve nerve function in patients with ACI by improving brain blood flow,secreting neurotrophic related factors and inhibiting oxidative stress reaction,thus it has important clinical significance for repairing the damaged nerve function.

18.
China Journal of Chinese Materia Medica ; (24): 2883-2888, 2017.
Article in Chinese | WPRIM | ID: wpr-256019

ABSTRACT

In order to obtain the characteristics and incidence of adverse reactions of Shuxuening injection (Xingxue), the design method of a multi-center, large sample intensive monitoring in the hospitals was adopted. The hospitalized patients with use of Shuxuening injection from 27 medical institutions were enrolled as the research subjects to monitor their entire process of treatment cycle. The main content of monitoring included the patients' general information, diagnostic information, medication information, and adverse event information. A total of 30 209 patients with Shuxuening injection were enrolled; adverse reactions occurred in 34 cases, with an incidence of 0.113%, which belonged to the rare adverse reactions. Adverse reactions were characterized by headache, dizziness, pruritus, palpitations, nausea, et al. All the above results showed that Xingxue Shuxuening injection had high safety in clinical application.

19.
Drug Evaluation Research ; (6): 1488-1494, 2017.
Article in Chinese | WPRIM | ID: wpr-664822

ABSTRACT

Objective Using Ginkgo biloba extract injection as control drug,to systematically review the efficacy and safety of Shuxuetong Injection in the treatment of acute cerebral infarction.Methods Database including PubMed,Medline,CNKI,VIP and WanFang Data were searched to collect randomized controlled trials (RCTs) about Shuxuetong Injection versus G.biloba extract injection in the treatment of acute cerebral infarction from database setup time to July of 2016.Two reviewers independently screened literature,extracted data and assessed the risk of bias of included studies.The meta-analysis was conducted by RevMan 5.2 software.Results Total of 11 RCTs,1 338 patients were included.Meta-analysis showed that Shuxuetong Injection was significantly better than G.biloba extract injection in clinical total effective rate [RR =1.17,95%CI(1.11,1.23),P < 0.01],reducing neurological deficit score [MD =-4.46,95%CI (-6.07,-3.25),P < 0.01] and improving life ability score [MD =13.98,95%CI (11.30,16.65),P < 0.01],there was no serious adverse reaction in both groups.Conclusion Current evidence shows that Shuxuetong Injection is effective and safe in the treatment of acute cerebral infarction better than G.biloba extract injection.

20.
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care ; (6): 586-589, 2017.
Article in Chinese | WPRIM | ID: wpr-663635

ABSTRACT

Objective To investigate the effects of butylphthalide combined with shuxuening on cognitive function and activity of daily living (ADL) of patients with vascular dementia (VD).Methods A prospective research method was conducted, one hundred and one light and moderate VD patients admitted to Harrison International Peace Hospital from July 2014 to November 2016 were enrolled, and they were divided into a control group (49 cases) and an observation group (52 cases) according to random number tables. The two groups were given routine basic treatment, the control group received Shuxuening injection once a day for 2 courses (2 weeks as a course), while the observation group was additionally treated by butylphthalide capsule 0.2 g on the basis of the control group treatment. Before the treatment and 1 and 2 courses after treatment, the cognitive function was evaluated by mini-mental state examination (MMSE) and Hastgawa Dementia Scale (HDS), ADL was evaluated by ADL scale; the efficacy and adverse reactions were observed.Results The MMSE, HDS and ADL scores were increased gradually after treatment in the two groups, reached the highest degree after 2 courses of treatment, and the degrees of increase in the above indicators in observation group were more significant than those in the control group (MMSE score: 27.92±3.51 vs. 23.88±3.31, HDS score: 20.13±2.33 vs. 17.68±2.42, ADL score: 82.14±6.68 vs. 68.17±5.79, allP < 0.05). The total effective rate of observation group was significantly higher than that in the control group [86.5% (45/52) vs. 75.5% (37/49), P < 0.05], and the incidence of adverse reactions was lower than that in the control group [1.9% (1/52) vs. 4.1% (2/49)], being no significant difference between the two groups in adverse reaction (P > 0.05).Conclusions Polybutylene phthalate capsule combined with shuxuening injection can significantly improve the cognitive function and quality of life of patients with vascular dementia,and the clinical efficacy is safe and reliable.

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