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OBJECTIVE To evaluate the efficacy， safety and economical efficiency of Xuesaitong injection in the treatment of stroke by rapid health technology assessment，so as to provide evidence for clinical rational drug use. METHODS Retrieved from Wanfang database， CBM， CNKI，PubMed，Cochrane Library，Embase， INAHTA and HTAI databases or organization websites， health technology assessment （HTA） reports， meta-analysis/systematic reviews and pharmacoeconomic studies related to Xuesaitong injection in the treatment of stroke were summarized and analyzed. RESULTS A total of 29 pieces of literature were included. Among them， 14 studies were conducted on meta-analysis/systematic reviews，15 studies were conducted on pharmacoeconomics， HTA was not obtained. The results of meta-analysis/systematic reviews showed that Xuesaitong injection had certain advantages for stroke in improving the total effective rate， clinical symptoms and related scale scores compared with blank control group and some drug control groups. Safety studies had shown that the adverse reactions of Xuesaitong injection were mainly allergic-like reactions. The results of pharmacoeconomic evaluation are quite different， which may also be related to the long time span among various studies and the adjustment of some drug prices. CONCLUSIONS Xuesaitong injection in the treatment of stroke is helpful to improve the clinical efficacy and evaluation indexes， but there are some serious adverse reactions， and it is not economically superior to some chemical drugs.
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Aim To explore the feasibility of APTT bioactivity detection for Xuesaitong injection. Methods The APTT values of rabbit plasma of samples/reference were detected by automatic coagulometer, and the data were analyzed by bioassay statistics. Results The results of repeated test of different rabbit plasma, multiple enterprises and various concentrations of Xuesaitong injection were stable. The APTT values of standard ginsenoside Rb1, ginsenoside Rg1, notoginsenoside R1 and Panax notoginseng saponins were compared with that of Xuesaitong injection, and the APTT values of the former three were not correlated with Xuesaitong injection; while the Panax notoginseng saponins were significantly correlated with Xuesaitong injection. The panax notoginseng saponins were used as the reference material, and the results were consistent with those of the physical and chemical analysis. Conclusions The active ingredients in Xuesaitong injection do not represent the effective ingredients, and its medicinal effect is the result of the combined action of various ingredients. Therefore, it is not suitable to simply look for some monomer as the control. This paper suggests using panax notoginseng saponins as the control substance to explore the biological activity study of injections for promoting blood circulation and removing blood stasis.
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Objective To observe the curative effect of clinically equivalent doses of Xuesaitong and ginaton injections on cerebral ischemia reperfusion (I/R) injury of rats.Methods Male rats were randomly divided into five groups:normal control group,sham-operation group,model control group,Xuesaitong group and ginaton group.The cerebral ischemia rat model was established by middle cerebral artery occlusion (MCAO).Rats in the Xuesaitong group were given 20 mg·kg-1 of Xuesaitong injection,and rats in the ginaton group were intravenously injected with 7.5 mg· kg-1of ginaton immediately after I/R injury and once daily for 7 days.Rats in the sham-operation group and model control group were given the same volume of 0.9％ sodium chloride solution.The score of ethology,volume of cerebral infarction,mortality,superoxide dismutase (SOD),malondialdehyde (MDA),xanthine oxidase (XOD),nitrogen oxide (NO) and NO synthase (NOS) in seruu were examined.Results Compared with model control group,Xuesaitong and ginaton effectively reduced behavioral score 96 h (P ＜ 0.05),120 h (P＜0.01),144 h (P＜0.01) and 168 h (P＜0.01) after I/R injury,the volume of cerebral infarction 168 h after I/R injury and NO content (P ＜ 0.05).But they had no effects on NOS,SOD,MDA,and XOD contents.Conclusion Curatively injecting Xuesaitong and ginaton can effectively reduce cerebral I/R injury,but no significant difference in curative efficacy is observed between Xuesaitong and ginaton at clinically equivalent doses.
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OBJECTIVE:To explore the effects of Xuesaitong injection on related indexes of patients with acute ST segment el-evation myocardial infarction(STEMI)before percutaneous coronary intervention(PCI). METHODS:112 STEMI patients under-went PCI were analyzed retrospectively and divided into control group (48 cases) and observation group (64 cases) according to different treatment methods. Control group was given Clopidogrel sulfate tablets 300 mg and Aspirin enteric-coated tablets 300 mg orally before PCI;given conventional treatment according to patients'condition after surgery. Observation group additionally re-ceived intravenous push of Xuesaitong injection 8 mL before surgery,and Xuesaitong injection 8 mL added into Sodium chloride 250 mL intravenously,once a day after surgery,on the basis of control group. Treatment course of 2 groups lasted for 14 d. TIMI level,MPG level,the serum levels of cTnT,CKMB were observed in 2 groups before surgery,24 h after surgery;serum level of PTX-3,hs-CRP were observed before surgery,one week after surgery;LVEF,LVEDD,serum level of BNP were observed before surgery and one month after surgery;the occurrence of ADR was observed to. RESULTS:Before surgery,there was no statistical significance in TIMI level,MPG level,the serum levels of cTnT,CKMB,PTX-3 and hs-CRP,LVEF,LVEDD,serum level of BNP between 2 groups (P>0.05). 24 h after surgery,TIMI level and MPG level of 2 groups were significantly higher than be-fore,and the observation group was significantly higher than the control group;the serum levels of cTnT and CKMB in 2 groups were significantly lower than before,and the observation group was significantly lower than the control group,with statistical sig-nificance(P0.05). CONCLUSIONS:Based on convention-al treatment,Xuesaitong injection can effectively improve myocardial blood supply before PCI,decrease the level of inflammatory factor,relieve myocardial injury,improve cardiac function without increasing the incidence of ADR.
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Objective:To investigate the influence of auxiliary application of Xuesaitong injection on blood coagulation indices and thromboembolic complications in the patients after finger replantation. Methods:Totally 64 patients with finger replantation were cho-sen from March 2012 to March 2014 in our hospital and randomly divided into the control group (32 patients) treated with low molecu-lar weight heparin and Xuesaitong group (32 patients) treated with Xuesaitong injection additionally. The clinical curative effect, sur-vival time of finger replantation, the levels of blood coagulation indices before and after the operation and the incidence of thrombotic complications in both groups were compared. Results: The clinical curative effect of the control group and Xuesaitong group was 68. 75% and 93. 75, respectively, and that of Xuesaitong group was significantly better than that of the control group (P0. 05). Conclusion:Auxiliary application of Xuesaitong injection in the patients after finger replantation can efficiently speed up the replantation survival process and improve blood coagulation indices after the operation, which is helpful to reducing the risk of thrombotic complications.
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Objective To study the effect of the combination of rivaroxaban and Xuesaitong injection on deep venous thrombosis (DVT) of lower extremity after spinal surgery.Methods The clinical data of 90 patients undergoing spinal surgery from May 2013 to May 2015 were retrospective analyzed.The patients were divided into two groups randomly: the treatment group and control group.Forty-five patients in treatment group were treated with rivaroxaban and Xueshuantong injection from 1 st day after surgery to one week after off-bed activity, and forty-five patients in control group were treated with rivaroxaban alone.The vessels of lower extremity were detected by doppler ultrasonography pre-surgery, 7-10d and 3 months post-surgery, then the rates of DVT and pulmonary embolism were statistically analysed.Results The DVT rate in treatment group was 8.89%(4 cases), which was significantly lower than 24.4% (11 cases) in control group (P<0.05).Conclusion The anticogulant effect of the combination of rivaroxaban and Xuesaitong injection is stronger than rivaroxaban alone.
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To establish the uncertainty evaluation for the quantitative analysis on Xuesaitong Injection by near infrared (NIR) spectroscopy based on β-content tolerance interval (β-CTI). The data of NIR calibration and validation sets were obtained by " I × J × K" full factorial experimental design. The NIR quantification model was established through the PLS algorithm. Based on the validation data, the β-CTI was introduced to estimate the quantitative analysys on uncertainty of NIR, which was compared with the regular β-expectation tolerance interval (β-ETI). Among the seven designed concentration levels, the uncertainty values estimated by the β-ETI are smaller than that estimated by the β-CTI, except for the concentration level of 1.485 mg/mL. Then, the relationship between the relative expanded uncertainty (U) and corresponding concentration (Y) was fitted by lnU= a + b lnY model. When the uncertainty acceptance limit (λ) was set to 20% and the decision profile of uncertainty was plotted, the critical concentration for β-ETI and β-CTI with the acceptable uncertainty could be read as 4.867 and 5.686 mg/mL, respectively. This study has proved that β-CTI can be used to adequately estimate the uncertainty of quantitative analysis by NIR, which provides a new potential tool for the assessment of the accuracy and reliability of NIR spectroscopy.
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Objective To study anaphylactoid reactions induced by traditional Chinese medicine injections (TCMI) of Qingkailing (QKL) and Xuesaitong (XST) with RBL-2H3 cells;To provide some reference for improving the screening system of TCMI induced anaphylactoid reactions.Methods The IC50 induced by QKL and XST injections was determined by MTT assay. RBL-2H3 cells were stimulated with TCMI at different concentrations or with C48/80 or culture medium. Thirty minutes later, the supernatant was collected to determine the release of histamine andβ-hexosaminidase. The cell degranulation rate and the ultrastructure changes were observed. The ICR mice were given single injection of TCMI containing Evans Blue through tail vein. The number of the animal with blue ear, the total number of blue ears and the quantity of Evans Blue of extravasation were determined 30 minutes later.Results The IC50 of both QKL injection and XST injection was 12.5μL/mL. These two injections promoted RBL-2H3 cells to release histamine andβ-hexosaminidase at higher concentrations (P<0.05,P<0.01) in a dose dependent manner. Cell morphology showed a decrease of villous on the cell surface and an increase of the internal vacuolated structure. Both injections caused the blue ears of all animal with a rate of 100%. The quantity of Evans Blue of the extravasation was significantly increased (P<0.01). The results in vitro study were in close agreement with that in vivo.Conclusion Both QKL injection and XST injection may potentially cause anaphylactoid reactions. The RBL-2H3 cell model may be valuable to evaluate the anaphylactoid reactions induced by TCMI.
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Objective To evaluate the effect and safety of Xuesaitong injection (XST) in stable angina. Methods The effects on XST and(or) isosorbide mononitrate injection(IM) were compared with that of placebo in 147 cases with stable angina.40 cases were performed XST 10ml per day,65 cases IM 20mg per day and 42 cases both XST and IM. Results XST injection was effective on relieving symptoms,improving curative effect of electrocardiogram, decreasing levels of serum TCLDL and adhesive rate of platelet, union of XST and IM might obtain better curative efect. Conclusion XST is an effective and safe drug in stable angina.
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Objective To study the effects of endothelin (ET) and Xuesaitong injection on hepatic, renal and myocardial tissues after bile duct ligation (BDL) in rabbits. Methods Seventy-two rabbits were randomly divided into three groups: BDL group (24 rabbits), BDL+Xuesaitong injection group (24 rabbits), and sham operation group (24 rabbits). Each group was subdivided into four subgroups of postoperative 3, 6, 9 and 12 d (6 rabbits in each subgroup). Automatic biochemical analysis equipment was used to detect the levels of serum TBIL, ALT, BUN and Crea. The levels of ET in plasma, hepatic, renal and myocardial tissues were measured with radioimmunological method. Results The levels of ET in plasma, hepatic, renal and myocardial tissues in both BDL group and BDL+Xuesaitong injection group were higher than those of sham operation group (P
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OBJECTIVE:To explore the clinical efficacy of Shenfu tongmai capsule in the treatment of cerebral infarction.METHODS:204 patients were equally divided into 3 groups.Group A were given Shenfu tongmai capsule combined with Xuesaitong injection.Group B were treated with 40 mL Xuesaitong injection added into 250 mL 0.9%NaCl (i.v.gtt).Group C were orally administered Shenfu tongmai capsule (0.3 g?7,t.i.d).One treatment course lasted for 3 weeks.Blood rheology and platelet activation markers were detected by L-G-R80A fully automatic blood rheology analysis instrument and Epics XL-4 flow cytometry to analyze the clinical efficacy.All markers were redetected after half year.RESULTS: Group A was better than group B and C in the respect of overall cure rate,total effective rates,platelet activation markers and blood rheology (P0.05).CONCLUSION: Shenfu tongmai capsule combined with Xuesaitong injection might be one of optimal way in the treatment of cerebral infarction.Shenfu tongmai capsule especially suits the lower-income patients with cerebral infarction and rehabilitation.
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AIM:To study the curative effect of Xuesaitong Injection (total notoginsenoside) on cerebral infarction.METHODS: 60 patients are divided into two groups at random. The treatment group was treated with Xuesaitong Injection (10mg in 250mL of 0.9% NS by IV infusion). The control group was treated with Danshen Injection (16mL in 250mL of 0.9% NS by IV infusion). Once a day for 28 days.RESULTS: The total effective rate of Xuesaitong Injection group was 80.0%. There were little bad reaction reported. The total effective rate of Danshen Injection was 66.7%. The curative effect of treatment group is superior to the control group ( P
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OBJECTIVE:To determine the pharmacokinetic parameters of Xuesaitong injection in rabbits.METHODS:Using ginsenoside Rg1 in Xuesaitong injection as a marker,the determination was carried out with HPLC.The detection conditions were:mobile phase,acetonitrile-water(3∶7);chromatgraph column,Hypersil C18(250mm?4.6mm,5?m);detection wavelength,210nm and flow rate,1 ml/min.RESULTS:After intravenous injection,the plasma concentration time data was found to be in accordance with the 2-compartment model in rabbits.The pharmacokinetic parameters were obtained with PKBP-NI.CONCLUSION:The method is simple,accurate and reliable.It could be used to determine the concentration of ginsenoside Rg1 in plasma.