[Systematic review and Meta-analysis of efficacy and safety of Shuxuetong Injection in treatment of diabetic peripheral neuropathy].

The present study evaluated the efficacy and safety of Shuxuetong Injection in the treatment of diabetic peripheral neuropathy(DPN). PubMed, Cochrane Library, EMbase, CNKI, VIP, SinoMed, and Wanfang were searched for randomized controlled trials(RCTs) of Shuxuetong Injection in the treatment of DPN from database inception to July 18, 2021. Literature screening was carried out according to the inclusion and exclusion criteria, and the required information was extracted. Cochrane risk-of-bias tool was used to evaluate the quality of the included trials, and RevMan 5.3 was used for Meta-analysis. Finally, six articles were included, involving 507 patients. The overall quality of included RCTs was not high. As revealed by Meta-analysis results, in terms of DPN score, one trial showed a significant difference in the experimental group before and after treatment, and the symptom of the experimental group was significantly improved compared with that in the control group after treatment. After treatment, a significant difference in DPN scores of the experimental group and the control group was observed(P<0.05), and the symptom improvement of the experimental group was significantly better than that of the control group. In terms of sensory nerve conduction velocity(SCV), the experimental group was superior to the control group in improving conduction velocities(MD_(median SCV)=4.45, 95%CI[2.79, 6.10], P<0.000 01; MD_(peroneal SCV)=6.70, 95%CI[5.64, 7.75], P<0.000 01; MD_(posterior tibial SCV)=4.03, 95%CI[0.56, 7.49], P=0.02). In terms of motor nerve conduction velocity(MCV), compared with the conditions before treatment, the conduction velocities of median nerve, peroneal nerve, and posterior tibial nerve in both groups increased after treatment(P<0.01). The experimental group was superior to the control group in improving MCV after treatment(P<0.05). In terms of average blood glucose change, there is no statistical significance of the improvement of average blood glucose between experimental group and the control group(MD=-0.15, 95%CI[-0.82, 0.51], P=0.65). In terms of overall response rate, the curative effect of the experimental group in the treatment of DPN was superior to that of the control group(RR=1.23, 95%CI[1.11, 1.37], P=0.000 1). In terms of adverse events, no obvious adverse events were reported in the included RCTs. In light of existing data and indexes, the clinical efficacy of Shuxuetong Injection combined with western medicine in the treatment of DPN may be superior to that of conventional western medicine. It can improve the clinical symptoms, SCV, MCV, and average blood glucose of DPN, with good safety. However, existing clinical trials are few and the quality is low. It is recommended to further verify the above conclusions with internationally recognized outcome indicators.

[Meta-analysis and GRADE evaluation of Shuxuetong Injection in treatment of stroke in progressive].

This study aims to systematically evaluate the efficacy and safety of Shuxuetong Injection in the treatment of stroke in progressive. Randomized controlled trials of Shuxuetong Injection in the treatment of stroke in progressive were searched from CNKI, Wanfang, VIP, CMB, PubMed and EMbase. After strict literature screening, data extraction and quality evaluation, a total of 22 articles were included for analysis by RevMan 5.3. The Meta-analysis showed that Shuxuetong Injection combined with conventional treatment was superior to the conventional treatment alone in the major outcome indicators including effective rate(RR=1.27, 95%CI[1.20, 1.33], Z=9.18, P<0.000 01), deterioration rate(RR=0.38, 95%CI[0.22, 0.68], Z=3.31, P=0.000 9), NIHSS scores(MD=-3.89, 95%CI[-4.34,-3.43], Z=16.83, P<0.000 01), CSS scores(MD=-5.59, 95%CI[-6.42,-4.76], Z=13.20, P<0.000 01) and activity of daily living scores(MD=12.02, 95%CI[10.31, 13.72], Z=13.83, P<0.000 01), mortality during treatment was not increased(RR=0.40, 95%CI[0.13, 1.26], Z=1.56, P=0.12). Moreover, Shuxuetong Injection combined with conventional treatment further reduced the secondary outcome indicators including fibrinogen(MD=-0.35, 95%CI[-0.58,-0.13], Z=3.09, P=0.002), triglyceride(MD=-0.38, 95%CI[-0.67,-0.10], Z=2.65, P=0.008), low density lipoprotein cholesterol(MD=-0.72, 95%CI[-0.83,-0.61], Z=12.64, P<0.000 01), serum hypersensitive C-reactive protein(MD=-4.41, 95%CI[-6.96,-1.86], Z=3.38, P=0.000 7), and interleukin-6(MD=-5.43, 95%CI[-6.91,-3.96], Z=7.22, P<0.000 01). GRADE evaluation results showed that the major outcome indicators had low quality of evidence. Shuxuetong Injection in the treatment of stroke in progressive can improve the clinical effective rate, reduce the deterioration rate, improve the neurological function and activity of daily living, down-regulate the levels of fibrinogen, triglyceride, low density lipoprotein cholesterol and alleviate the inflammatory response. Although most studies have reported no adverse reactions, there are selective reports. The safety of Shuxuetong Injection needs to be further verified by more high-quality randomized controlled trial.

A strategy based on gene sequencing and molecular docking for analysis and prediction of bioactive peptides in Shuxuetong injection.

Peptides are a class of protein fragments with relatively high biological activity and intense specificity, which play crucial role in the treatment of Shuxuetong injection (SXT). However, the extraordinary complexity of Chinese medicinal formulates and the lack of systematic identification methods are primary challenges for study of pharmacodynamic peptides. In addition, infinitesimal peptides contents further hinder the identification and structural characterization of polypeptide by traditional means. In this paper, we described a strategy that LC-MS combined with molecular docking to systematically illustrate the peptide components of SXT. The key to this research was used of gene sequencing to establish a SXT protein database to further achieve the separation and enrichment of chemical methods. Moreover, the ADRA2A, PAR4 and DRD3 were precisely docked with the identified peptides. The result indicated that 12 compounds had stable binding ability and were speculated to be the latent bioactive monomers for the treatment of stroke. Additionally, 12 peptides were verified by cell-based experiment. The results showed that only YLKTT could indeed protect astrocytes from oxygen glucose deprivation/reoxygenation (OGD/R). The YLKTT showed higher activity than the others in vitro. It might be a completely new compound that has never been reported before, providing the basis for further research and a new paradigm for stroke.

Meta-analysis and GRADE evaluation of Shuxuetong Injection in treatment of stroke in progressive / 中国中药杂志

This study aims to systematically evaluate the efficacy and safety of Shuxuetong Injection in the treatment of stroke in progressive. Randomized controlled trials of Shuxuetong Injection in the treatment of stroke in progressive were searched from CNKI, Wanfang, VIP, CMB, PubMed and EMbase. After strict literature screening, data extraction and quality evaluation, a total of 22 articles were included for analysis by RevMan 5.3. The Meta-analysis showed that Shuxuetong Injection combined with conventional treatment was superior to the conventional treatment alone in the major outcome indicators including effective rate(RR=1.27, 95%CI[1.20, 1.33], Z=9.18, P<0.000 01), deterioration rate(RR=0.38, 95%CI[0.22, 0.68], Z=3.31, P=0.000 9), NIHSS scores(MD=-3.89, 95%CI[-4.34,-3.43], Z=16.83, P<0.000 01), CSS scores(MD=-5.59, 95%CI[-6.42,-4.76], Z=13.20, P<0.000 01) and activity of daily living scores(MD=12.02, 95%CI[10.31, 13.72], Z=13.83, P<0.000 01), mortality during treatment was not increased(RR=0.40, 95%CI[0.13, 1.26], Z=1.56, P=0.12). Moreover, Shuxuetong Injection combined with conventional treatment further reduced the secondary outcome indicators including fibrinogen(MD=-0.35, 95%CI[-0.58,-0.13], Z=3.09, P=0.002), triglyceride(MD=-0.38, 95%CI[-0.67,-0.10], Z=2.65, P=0.008), low density lipoprotein cholesterol(MD=-0.72, 95%CI[-0.83,-0.61], Z=12.64, P<0.000 01), serum hypersensitive C-reactive protein(MD=-4.41, 95%CI[-6.96,-1.86], Z=3.38, P=0.000 7), and interleukin-6(MD=-5.43, 95%CI[-6.91,-3.96], Z=7.22, P<0.000 01). GRADE evaluation results showed that the major outcome indicators had low quality of evidence. Shuxuetong Injection in the treatment of stroke in progressive can improve the clinical effective rate, reduce the deterioration rate, improve the neurological function and activity of daily living, down-regulate the levels of fibrinogen, triglyceride, low density lipoprotein cholesterol and alleviate the inflammatory response. Although most studies have reported no adverse reactions, there are selective reports. The safety of Shuxuetong Injection needs to be further verified by more high-quality randomized controlled trial.

Shuxuetong injection protects cerebral microvascular endothelial cells against oxygen-glucose deprivation reperfusion.

Shuxuetong injection composed of leech (Hirudo nipponica Whitman) and earthworm (Pheretima aspergillum) has been used for the clinical treatment of acute stroke for many years in China. However, the precise neuroprotective mechanism of Shuxuetong injection remains poorly understood. Here, cerebral microvascular endothelial cells (bEnd.3) were incubated in glucose-free Dulbecco's modified Eagle's medium containing 95% N2/5% CO2 for 6 hours, followed by high-glucose medium containing 95% O2 and 5% CO2 for 18 hours to establish an oxygen-glucose deprivation/reperfusion model. This in vitro cell model was administered Shuxuetong injection at 1/32, 1/64, and 1/128 concentrations (diluted 32-, 64-, and 128-times). Cell Counting Kit-8 assay was used to evaluate cell viability. A fluorescence method was used to measure lactate dehydrogenase, and a fluorescence microplate reader used to detect intracellular reactive oxygen species. A fluorescent probe was also used to measure mitochondrial superoxide production. A cell resistance meter was used to measure transepithelial resistance and examine integrity of monolayer cells. The fluorescein isothiocyanate-dextran test was performed to examine blood-brain barrier permeability. Real-time reverse transcription polymerase chain reaction was performed to analyze mRNA expression levels of tumor necrosis factor alpha, interleukin-1ß, interleukin-6, and inducible nitric oxide synthase. Western blot assay was performed to analyze expression of caspase-3, intercellular adhesion molecule 1, vascular cell adhesion molecule 1, occludin, vascular endothelial growth factor, cleaved caspase-3, B-cell lymphoma 2, phosphorylated extracellular signal-regulated protein kinase, extracellular signal-regulated protein kinase, nuclear factor-κB p65, I kappa B alpha, phosphorylated I kappa B alpha, I kappa B kinase, phosphorylated I kappa B kinase, claudin-5, and zonula occludens-1. Our results show that Shuxuetong injection increases bEnd.3 cell viability and B-cell lymphoma 2 expression, reduces cleaved caspase-3 expression, inhibits production of reactive oxygen species and mitochondrial superoxide, suppresses expression of tumor necrosis factor alpha, interleukin-1ß, interleukin-6, inducible nitric oxide synthase mRNA, intercellular adhesion molecule-1, and vascular cell adhesion molecule-1, markedly increases transepithelial resistance, decreases blood-brain barrier permeability, upregulates claudin-5, occludin, and zonula occludens-1 expression, reduces nuclear factor-κB p65 and vascular endothelial growth factor expression, and reduces I kappa B alpha, extracellular signal-regulated protein kinase 1/2, and I kappa B kinase phosphorylation levels. Overall, these findings suggest that Shuxuetong injection has protective effects on brain microvascular endothelial cells after oxygen-glucose deprivation/reperfusion. Moreover, its protective effect is associated with reduction of mitochondrial superoxide production, inhibition of the inflammatory response, and inhibition of vascular endothelial growth factor, extracellular signal-regulated protein kinase 1/2, and the nuclear factor-κB p65 signaling pathway.

Formulation of Criterion for Clinical Application of Shuxuetong Injection by Clinical Pharmacists in Our Hospital Based on Evidence Quality Evaluation Method / 中国药房

OBJECTIVE： To provide reference for strengthening clinical application of key monitoring drugs and promoting rational drug use in clinic. METHODS： Based on evidence-based medicine， taking key monitoring drugs Shuxuetong injection as example， clinical evidence of domestic and foreign clinical studies were collected. The included literatures were graded according to the quality of GRADE evidence and recommended strength system. Evidence-based medicine evidence for the indications of Shuxuetong injection were evaluated， and criterion for clinical use of Shuxuetong injection was formulated in Huaihua First People’s Hospital （our hospital）. RESULTS： The main content of criterion for clinical application of Shuxuetong injection formulated by our hospital was that there was A-level evidence support for acute ischemic cerebral infarction， but it was weakly recommended and only used for adjuvant therapy； there was B-level evidence support for anticoagulation （for preventing DVT）， diabetic peripheral nerve lesion， but it was weakly recommended； there was only C-level or D-level evidence support for other indications， it was strongly recommendation against use. CONCLUSIONS： Clinical pharmacists formulate the criterion for clinical application of Shuxuetong injection by evidence quality evaluation method， provide reference for clinical application management of key monitoring drug and play an important effect on rational drug use in clinic.

Clinical Observation of Shuxuetong Injection Combined with Rosuvastatin in the Treatment of Angina Pectoris after Acute Myocardial Infarction / 中国药房

OBJECTIVE:To observe therapeutic efficacy and safety of Shuxuetong injection combined with rosuvastatin in the treatment of angina pectoris after acute myocardial infarction.METHODS:The information of 68 patients with angina pectoris after acute myocardial infarction were collected retrospectively and divided into control group (34 cases) and study group (34 cases).Based on routine treatment,control group was given Rosuvastatin calcium tablet 10 mg orally,once a day.Study group was additionally given Shuxuetong injection 6 mL added into 0.9％ Sodium chloride injection 250 mL intravenously,once a day,on the basis of control group.Both groups were treated for 14 days.Clinical efficacies of 2 groups were observed,and the levels of platelet activation markers (CD62p,CD63,PAC-1,LPA),vascular endothelial growth function indexes (NO,ET-1,VEGF)were observed before and after treatment.The occurrence of ADR was observed.RESULTS:The total response rate of the study group was (94.12％) was significantly higher than that of control group (73.53％),with statistical significance (P＜0.05).After treatment,the levels of platelet activation markers,ET-1 and VEGF of 2 groups were significantly lower than before treatment,the study group was significantly lower than the control group;the levels of NO in 2 groups were significantly higher than before treatment,the study group was significantly higher than the control group,with statistical significance (P＜0.05).There was no statistical significance in the incidence of ADR between 2 groups (P＞0.05).CONCLUSIONS:Based on routine treatment,Shuxuetong injection combined with msuvastatin show significant therapeutic efficacy for angina pectoris after acute myocardial infarction,which can effectively improve vascular endothelial growth function and platelet function,without increasing the occurrence of ADR.

[Effect of Shuxuetong injection on anticoagulant effect of warfarin in rats].

To explore the effect of Shuxuetong injection on the pharmacodynamics and pharmacokinetics of warfarin in rats, and to provide reference for rational drug use. In studies on the single dose of warfarin, Wistar rats were randomly divided into four groups： blank control group(group A), Shuxuetong injection group(group B), warfarin control group(group C), and warfarin+Shuxuetong injection group(group D). In studies on the steady state of warfarin, Wistar rats were randomly divided into warfarin control group(group E) and warfarin+Shuxuetong injection group(group F). To investigate the pharmacodynamic effect of Shuxuetong injection on warfarin, prothrombin time(PT) and activated partial thromboplastin time(APTT) were measured by coagulation analyzer, and international normalized ratio(INR) was calculated. To investigate the pharmacokinetic effect of Shuxuetong injection on warfarin, the blood concentrations of S-warfarin and R-warfarin were determined by UPLC-MS/MS combined with technology of chiral chromatographic column, and the related pharmacokinetic parameters were calculated accordingly. The results on the single dose of warfarin showed that Shuxuetong injection markedly increased PT, INR(P<0.01), and APTT(P<0.05). Meanwhile, when Shuxuetong injection was co-administrated with warfarin, it significantly increased PT, INR(P<0.01), and APTT(P<0.05) as compared with warfarin control group. In addition, increased pharmacokinetic parameters including Cmax, AUC0-t and AUC0-∞, prolonged t1/2, and decreased CL/F were observed for S-warfarin and R-warfarin. The results of the steady state of warfarin suggested that Shuxuetong injection significantly increased PT and INR of warfarin(P<0.01), and elevated the plasma concentrations of S-warfarin and R-warfarin when co-administrated with warfarin. These findings indicated that Shuxuetong injection had anticoagulant effect, and would produce pharmacodynamics synergistic action when it was co-administrated with warfarin. Shuxuetong injection also decelerated the metabolism of warfarin, and resulted in pharmacokinetics interaction. Therefore, Shuxuetong injection could significantly increase anticoagulant effect of warfarin, indicating that the combination use of these two drugs should be refrained in order to avoid the risk of bleeding in clinical application. If they need to be used in combination, special attention should be paid to ensure the safety of patients.

Effect of Shuxuetong injection on anticoagulant effect of warfarin in rats / 中国中药杂志

To explore the effect of Shuxuetong injection on the pharmacodynamics and pharmacokinetics of warfarin in rats, and to provide reference for rational drug use. In studies on the single dose of warfarin, Wistar rats were randomly divided into four groups： blank control group(group A), Shuxuetong injection group(group B), warfarin control group(group C), and warfarin+Shuxuetong injection group(group D). In studies on the steady state of warfarin, Wistar rats were randomly divided into warfarin control group(group E) and warfarin+Shuxuetong injection group(group F). To investigate the pharmacodynamic effect of Shuxuetong injection on warfarin, prothrombin time(PT) and activated partial thromboplastin time(APTT) were measured by coagulation analyzer, and international normalized ratio(INR) was calculated. To investigate the pharmacokinetic effect of Shuxuetong injection on warfarin, the blood concentrations of S-warfarin and R-warfarin were determined by UPLC-MS/MS combined with technology of chiral chromatographic column, and the related pharmacokinetic parameters were calculated accordingly. The results on the single dose of warfarin showed that Shuxuetong injection markedly increased PT, INR(P<0.01), and APTT(P<0.05). Meanwhile, when Shuxuetong injection was co-administrated with warfarin, it significantly increased PT, INR(P<0.01), and APTT(P<0.05) as compared with warfarin control group. In addition, increased pharmacokinetic parameters including Cmax, AUC0-t and AUC0-∞, prolonged t1/2, and decreased CL/F were observed for S-warfarin and R-warfarin. The results of the steady state of warfarin suggested that Shuxuetong injection significantly increased PT and INR of warfarin(P<0.01), and elevated the plasma concentrations of S-warfarin and R-warfarin when co-administrated with warfarin. These findings indicated that Shuxuetong injection had anticoagulant effect, and would produce pharmacodynamics synergistic action when it was co-administrated with warfarin. Shuxuetong injection also decelerated the metabolism of warfarin, and resulted in pharmacokinetics interaction. Therefore, Shuxuetong injection could significantly increase anticoagulant effect of warfarin, indicating that the combination use of these two drugs should be refrained in order to avoid the risk of bleeding in clinical application. If they need to be used in combination, special attention should be paid to ensure the safety of patients.

Shuxuetong injection combined with intravitreal injection of Ranibizumab and laser photocoagulation in the treatment of BRVO with macular edema / 国际眼科杂志(Guoji Yanke Zazhi)

AIM:To investigate the curative effect of Shuxuetong injection combined with intravitreal injection of ranibizumab and laser photocoagulation in the treatment of macular edema (ME) secondary to branch retinal vein occlusion (BRVO).METHODS:Totally 70 patients (70 affected eyes) with ME secondary to BRVO treated from January 2015 to December 2016 were randomly divided into the control group and the observation group by random number table method,35 patients (35 affected eyes) in each group.The control group were treated by intravitreal injection of ranibizumab and laser photocoagulation,and on the basis,the observation group were treated with Shuxuetong injection.The clinical curative effect and complications were compared between the two groups.At 1wk,1 and 3mo after treatment,the best corrected visual acuity (BCVA) and central retinal thickness (CRT)were checked again.RESULTS:The total effective rate of treatment in the observation group was slightly higher than that in the control group (91％ vs 80％;P＞0.05) while the markedly effective rate in the observation group was higher than that in the control group (43％ vs20％;P＜0.05).At 1wk,1 and 3mo after treatment,BCVA and CMT in the two groups decreased (P＜0.05),and they were lower in the observation group than the control group at the same time point (P＜0.05).There was no significant difference in the incidence of complications between the two groups (P＞0.05).CONCLUSION:The treatment of ME secondary to BRVO with Shuxuetong injection combined with intravitreal injection of ranibizumab and laser photocoagulation can effectively reduce CRT and improve visual acuity,with high safety.

A system review on efficacy and safety of Shuxuetong Injection in treatment of acute cerebral infarction / 药物评价研究

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.

Effect of shuxuetong injection combined with oxiracetam on hemorheology and serum Hcy levels in patients with cerebral infarction / 中国生化药物杂志

Objective To investigate the effects of oxiracetam combined with Shuxuetong injection on hemorheology and serum Hcy levels in patients with cerebral infarction. Methods 60 patients with cerebral infarction were randomly divided into 2 groups, 30 cases in the observation group and were treated with oxiracetam combined with Shuxuetong injection. 30 cases in the control group were treated with Shuxuetong injection. The hemorheology and serum Hcy levels in the two groups were compared. Results After treatment, the hemorheological indexes and serum Hcy levels in the observation group were lower than those in the control group (P<0.05). The treatment effect of the observation group was better than that of the control group (P<0.05). The scores of neurological deficits in the observation group were significantly better than those in the control group (P<0.05). The number of complications in the observation group was 2 cases, the incidence of complications was 6.7%, which were significantly lower than 9(30.0%) in the control group, the differences between the two groups was statistically significant (P<0.05). Conclusion The application of oxiracetam combined with Shuxuetong injection in patients with cerebral infarction can effectively improve the hemorheology and reduce the serum Hcy level.

Effects of Shuxuetong Injection on Related Indexes of Patients with Acute Myocardial Infarction / 中国药房

OBJECTIVE:To investigate the effects of Shuxuetong injection on related indexes of patients with acute myocardial infarction (AMI).METHODS:The data of 156 AMI patients were analyzed retrospectively,and then divided into control group (65 cases) and observation group (91 cases) according to therapy plan.Control group received routine treatment.Observation group was additionally given Shuxuetong injection 6 mL added into 5％ Glucose injection 250 mL intravenously,once a day,on the basis of control group.Both groups were given treatment for 5 d.The incidence of vascular recanalization,recanalization time,the incidence of reocclusion as well as LVEF,APTT,PT,FIB,the occurrence of adverse cardiovascular events before and after treatment as well as the occurrence of ADR were observed in 2 groups.RESULTS:The incidence of reocclusion and adverse cardiovascular events in observation group was significantly lower than control group,with statistical significance (P＜0.05).There was no statistical significance in the incidence of vascular recanalization,recanalization time or the incidence of ADR between 2 groups (P＞0.05).After treatment,the levels of LVEF,APTT and PT in 2 groups were significantly higher than before treatment,and the observation group was significantly higher than the control group.The levels of FIB in 2 groups were significantly lower than before treatment,and the observation group was significantly lower than the control group,with statistical significance (P＜0.05).CONCLUSIONS:Based on routine treatment,Shuxuetong injection can reduce the incidence of reocclusion,improve cardiac function and reduce the incidence of adverse cardiovascular events without increasing the occurrence of ADR.

Clinical Observation of Shuxuetong Injection Combined with Alprostadil in the Treatment of Acute Cere-bral Infarction / 中国药房

OBJECTIVE:To observe clinical efficacy and safety of Shuxuetong injection combined with alprostadil in the treat-ment of acute cerebral infraction(ACI). METHODS:A total of 123 ACI patients selected from our hospital during Mar. 2014-Sept. 2016 selected as research subjects were divided into observation group (62 cases) and control group (61 cases) according to ran-dom number table. Control group was additionally given Alprostadil injection 2 mL+0.9% Sodium chloride injection 100 mL, ivgtt,qd,on the basis of routine treatment. Observation group was additionally given Shuxuetong injection 6 mL+0.9% Sodium chloride injection 250 mL,ivgtt,qd,on the basis of control group. Both groups were treated for 2 weeks. MPV,FIB content, hemorheology indexes,neurologic impairment degree score before and after treatment as well as clinical efficacy,the occurrence of ADR were compared between 2 groups. RESULTS:Before treatment,there was no statistical significance in MPV,FIB content, hemorheology indexes or neurologic impairment score between 2 groups (P>0.05). Compared with before treatment,MPV,FIB content,hemorheology indexes and modified Rankin scale of 2 groups were all decreased significantly;Barthel index and NIHSS scores were increased significantly,and each aspect of observation group was better than that of control group,with statistical sig-nificance(P<0.05). Total response rate of observation group was 95.16%,which was significantly higher than 85.25% of control group,with statistical significance(P<0.05). No severe ADR was found in 2 groups. CONCLUSIONS:Shuxuetong injection com-bined with alprostadil can significantly improve the neurological function of ACI patients,improve hypercoagulable state by reduc-ing MPV and FIB content,and have good therapeutic efficacy and safety.

[32 546 intensive hospital monitoring cases of Shuxuetong injection].

This study adopted multi-center and large sample design to understand the incidence, characteristics and other information about adverse reaction of Shuxuetong injection. In 54 medical institutions, use of Shuxuetong injection of entire treatment period was monitored, including patients' general information, diagnostic information, medication, adverse reaction/event information, etc. Sixty four cases of adverse reactions in 32 546 patients was monitored, adverse rate was 0.197%, mainly characterized by skin itching, rash, flu-like, dyspnea, palpitations, headache, chest tightness and other allergic reactions. Adverse reaction occurred mainly in elderly patients and medication was consistent with the instruction. Based on these results, safety of Shuxuetong injection in clinical application is excellent.

Clinical Observation of Shuxuetong Injection in the Treatment of Acute Cerebral Infarction / 中国药房

OBJECTIVE:To observe the efficacy and safety of Shuxuetong injection in the treatment of acute cerebral infarc-tion (ACI). METHODS:110 patients with ACI were randomly divided into control group and observation group. Control group was given mannitol,aspirin,atorvastatin,antidiabetic drugs and other conventional treatment;observation group was additionally given Shuxuetong injection 6 ml adding into 0.9% Sodium chloride solution 250 ml by intravenous infusion,3 times a day. The ef-ficacy in 2 groups was evaluated after 15 d,and the National Institute of Health Stroke Scale(NIHSS)score,neuron specific eno-lase(NSE),high-sensitivity C-reactive protein(hs-CRP)and tumor necrosis factor-α(TNF-α)levels before and after treatment and the incidence of adverse reactions in 2 groups were recorded. RESULTS:After treatment,NIHSS score,NSE,hs-CRP and TNF-αin 2 groups were significantly lower than before,and observation group was lower than control group,the differences were statisti-cally significant(P<0.05);total effective rate in observation group was significantly higher than control group,the difference was statistically significant(P<0.05). There was no obvious adverse reactions in 2 groups during treatment. CONCLUSIONS:Based on the conventional treatment,Shuxuetong injection has good efficacy and safety in the treatment of ACI.

Comparison study of determination methods of free amino acid in Shuxuetong injection by HPTLC, pre-column derivation-UPLC, and ion chromatography / 药学学报

Free amino acids play a great role in traditional Chinese medicine in injections of animal products, as they may take part in peptide synthesis and exhibit a bioactivity in vivo. However, most of the national standards for drugs and peer-reviewed papers only focus on the total amount of amino acids after peptide hydrolysis. We compare the advantage and disadvantage among high performance thin layer chromatography (HPTLC), pre-column derivatization ultra performance liquid chromatography (UPLC) and ion chromatography. As a result, the HPTLC and pre-column derivatization UPLC are suitable for quality analysis, while there is high matrix influence for ion chromatography analysis. The verified pre-column derivatization UPLC method is utilized in quantitative analysis. 24 kinds of amino acid were detected by this method, and 8 of them were reported for the first time from the injection. The system has high repeatability and accuracy with LOD on the level of pmol·mL-1.

32 546 intensive hospital monitoring cases of Shuxuetong injection / 中国中药杂志

This study adopted multi-center and large sample design to understand the incidence, characteristics and other information about adverse reaction of Shuxuetong injection. In 54 medical institutions, use of Shuxuetong injection of entire treatment period was monitored, including patients' general information, diagnostic information, medication, adverse reaction/event information, etc. Sixty four cases of adverse reactions in 32 546 patients was monitored, adverse rate was 0.197%, mainly characterized by skin itching, rash, flu-like, dyspnea, palpitations, headache, chest tightness and other allergic reactions. Adverse reaction occurred mainly in elderly patients and medication was consistent with the instruction. Based on these results, safety of Shuxuetong injection in clinical application is excellent.

Effect of Shuxuetong injection on microcirculation of patients with septic shock / 中国中西医结合急救杂志

Objective To analyze the effect of Shuxuetong injection on microcirculation in patients with septic shock and its therapeutic effect. Methods A prospective study was conducted. Eighty patients with septic shock treated in Department of Critical Care Medicine of Hebei Provincial Traditional Chinese Medical Hospital were randomly divided into a Shuxuetong group and a conventional therapy group according to random number table, 40 cases in each group. The conventional treatment in the two groups was energetically carried out in accord to the sepsis shock guidelines, such as positive fluid resuscitation, anti-infection, etc. In the Shuxuetong group, additionally Shuxuetong injection 6 mL in 5% glucose injection 250 mL intravenous drip was given once a day for 7 days. The levels of urine output, lactic acid (Lac), blood urea nitrogen (BUN), creatinine (Cr), aspartate aminotransferase (AST), alanine aminotransferase (ALT), left ventricular ejection fraction (LVEF), and cardiac index (CI) in the two groups were observed before and after treatment; the total dosages of dopamine, dobutamine, noradrenaline, etc. vascoactive agent used for the patients and 28-day mortality in the two groups were also recorded. Results The comparisons of levels of urine output, Lac, BUN, Cr, AST, ALT, LVEF, and CI before treatment between the two groups were of no statistical significant differences (all P>0.05). After treatment in the two groups, the urine output, LVEF, and CI were increased compared with those before treatment, whereas the Lac, BUN, Cr, AST, and ALT were significantly decreased, and the changes were more obvious in Shuxuetong group [urine output (mL/h):112.1±39.8 vs. 73.3±28.5, LVEF:0.49±0.15 vs. 0.44±0.14, CI (mL·s-1·m-2):66.2±5.7 vs. 54.2±6.2, Lac (mmol/L):3.83±1.65 vs. 4.72±2.25, BUN (mmol/L):7.1±2.7 vs. 9.3±3.5, Cr (μmol/L): 73.9±16.2 vs. 95.7±15.8, AST (U/L): 39.8±9.5 vs. 45.8±12.7, ALT (U/L):34.3±9.7 vs. 41.7±11.3, all P<0.05]. The total dosages of all kinds of vascoactive agent of Shuxuetong group were remarkably less than those in the conventional therapy group [dopamine (mg): 993.1±261.7 vs. 1 340.9±356.4, dobutamine (mg):776.2±281.0 vs. 1 049.2±364.3, noradrenaline (mg):56.4±34.6 vs. 107.6±51.3, all P<0.05]. The 28-day mortality of Shuxuetong group was obviously lower than that of conventional therapy group [40.0%(16/40) vs. 60.0%(24/40), P<0.05]. Conclusion Shuxuetong injection can improve the microcirculation perfusion in patients with septic shock and reduce their mortality.

Curative efficacy of shuxuetong injection and its effects on oxidative stress in patients with type 2 diabetic nephropathy / 中国综合临床

Objective To investigate the clinical effect of shuxuetong injection and its effects on oxidative stress in patients with type 2 diabetic nephropathy (DN).Methods One hundred and twenty cases with type 2 DN meeting the inclusion criteria were divided into two groups equally according to therapeutic scheme.Besides conventional treatments patients in the control group were treated with acarbose,while patients in the observation group were treated with shuxuetong injection and acarbose.The curative efficacy,renal function,superoxide dismutase (SOD),malonaldehyde (MDA) and advanced oxidation protein products (AOPPs) were recorded or detected.Results Therapeutic efficiency ratio (TER) in observation group was 93.3％,significantly higher than that in control group (80.0％;x2 =4.62,P =0.03).The levels of blood urea nitrogen (BUN),serum creatinine (Scr),urine total protein in observation group were (7.9 ± 2.3) mmol/L,(110.7±19.9) μumol/L and (2.2±0.5) g/24,lower than those in control group and the differences were significant ((11.5±2.7) mmol/L,(163.4±20.8) μmol/L and (2.9±0.5) g/24 h;t =7.86,14.48,7.67;P =＞0.000).Regarding of oxidative stress indices,MDA,AOPPs and SOD levels in observation were (3.5±0.4) μmol/L,(50.7±4.8) mmol/L and (56.7±3.8) kU/L,significant different from those in control group((6.7±0.3)μmol/L,(89.5 ± 5.6) mmo]/L and (35.4 ± 4.0) kU/L;t =49.57,40.75,29.90;P =0.00).During the treatment,there was no severe case with adverse reactions and the incidence of adverse reactions in the two groups (10.0％ vs 11.7％;x2 =0.09,P =0.77).Conclusion The method scheme of shuxuetong injection and acarbose on type 2 DN is effective with increasing the therapeutic efficiency ratio,improving renal function and alleviating oxidative stress with minor adverse reactions.