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Objective:To investigate the effects of different light sources on the stability of cinepazide maleate in sodium chloride solution, providing a theoretical basis for standardizing operation for avoiding light in clinical medication.Methods:First, a standard curve was created and methodological studies were conducted. Then, intravenous drip solutions were prepared using clinically prescribed methods. Then, the absorbance of the solution of cinepazide maleate injection under outdoor light, light emitting diode (LED) light, indoor light, artificial sunlight with a color temperature of 6 500 K (D65), and under a shading condition for 1, 2, 3, and 7 hours were brought into the standard curve to obtain the concentrations, and the change of the concentrations was studied.Results:There was no light decomposition phenomenon of cinepazide maleate injection in the shading group (control group) within 7 hours. In the other four experimental groups, there was no obvious light decomposition phenomenon of cinepazide maleate injection in the LED light group. Compared with the shading group, cinepazide maleate injection in the indoor, outdoor, and D65 groups began to exhibit a light decomposition phenomenon at 1 hour ( F = 44 840.44, P < 0.001). At 2 hours, cinepazide maleate content in the outdoor and D65 groups began to decrease significantly compared with the shading group ( F = 15 459.12, P < 0.001). At 7 hours, cinepazide maleate exhibited significantly greater light decomposition in the outdoor group [(29.84 ± 0.43) L·mol -1·cm -1] and D65 group [(21.01 ± 0.51) L·mol -1·cm -1] than the shading group [(101.65 ± 1.5) L·mol -1·cm -1] ( F = 63 106.32, P < 0.001). There was no significant difference in cinepazide maleate content between LED and shading groups ( P > 0.05). Conclusion:Cinepazide maleate injection is stable under the common LED light source and therefore it is not necessary to take lightproof operation. Cinepazide maleate injection is unstable under indoor, outdoor, and D65 light sources, and it is necessary to take lightproof operation.
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Objective:To investigate the compatibility stability of cinepazide maleate injection and dopamine hydrochloride injection and explore the basis for the combined application of cinnamazide maleate injection and dopamine hydrochloride injection.Methods:A method for determining cinnamazide maleate injection and dopamine hydrochloride injection was established using an ultraviolet-visible spectrophotometer and verified from March 1, 2021 to May 20, 2021. The color and pH value of the solution prepared using the two drugs were determined within 5 hours at room temperature. The content change of the prepared solution was determined using an ultraviolet-visible spectrophotometer.Results:The linear range of the mass concentration of cinnamazide maleate was 4.03 - 32.24 mg/L and the linear range of dopamine hydrochloride was 20 -120 mg/L. At 25 ℃, the color of the prepared solution did not change within 5 hours and the pH value was in the range of 4.43 ± 0.06, indicating that the pH of the prepared solution did not change markedly. The concentrations of cinnamazide maleate and dopamine hydrochloride were (98.23 ± 1.09)% and (99.96 ± 0.41)% respectively, indicating good stability.Conclusion:The prepared solution using cinepazide maleate injection and dopamine hydrochloride injection can be used within 5 hours at 25 ℃.
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Objective:To confirm the efficacy and safety of cinepazide maleate injection in acute ischemic stroke patients with obvious motor function deficit.Methods:This study is a subgroup analysis of multi-center, randomized, double-blind, placebo-controlled phase Ⅳ clinical trial. A total 812 patients of acute ischemic stroke with obvious limb motor deficit [motor function of limbs score in National Institutes of Health Stroke Scale (NIHSS) ≥4] were enrolled in this subgroup analysis. Patients received either cinepazide maleate injection or placebo. The treatment period was 14 days and follow-up was 90 days. The efficacy endpoints included the proportions of patients with a modified Rankin Scale (mRS) score ≤2, mRS score ≤1 and Barthel Index <95 on day 90. Safety was evaluated by recording all adverse events, monitoring vital signs, laboratory parameters and electrocardiogram.Results:A total of 732 patients were involved in the final efficacy analysis (361 in cinepazide maleate group and 371 in control group). The baseline limb motor function score of NIHSS was 5.23±1.43 in the cinepazide maleate group whereas 5.20±1.36 in the control group. Logistic regression analysis showed that following treatment for 90 days, the proportion of patients with a mRS score ≤2 was significantly higher in the cinepazide maleate group than in the control group [56.0% (202/361) vs 44.2% (164/371), OR=0.60, 95% CI 0.44-0.82, P=0.002]. The proportion of patients with a mRS score ≤1 was higher in the cinepazide maleate group than in the control group [43.3% (139/361) vs 35.2% (118/371), OR=0.69, 95% CI 0.50-0.97, P=0.031]. The proportion of patients with a Barthel Index <95 on day 90 was significantly lower in the cinepazide maleate group than in the control group [45.2% (145/361) vs 55.2% (185/371), OR=0.64, 95% CI 0.46-0.88, P=0.007]. During the treatment and follow-up period, the incidence of the most common adverse events in the cinepazide maleate group was 50.4% (199/395). Constipation and abnormal liver function were more common, but there were no statistically significant differences between the two groups. Conclusion:Cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery and safe in patients with acute ischemic stroke with obvious limb motor deficit.
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Objective:To investigate the blood pressure change in patients with acute ischemic stroke (AIS) and hypertension treated with cinepazide maleate injection.Methods:This was a subgroup analysis of post-marketing clinical confirmation study of cinepazide maleate injection for acute ischemic stroke: a randomized, double-blinded, multicenter, placebo-parallel controlled trial, which conducted in China from August 2016 to February 2019. Eligible patients fulfilled the inclusive criteria of acute anterior circulation ischemic stroke with National Institutes of Health Stroke Scale (NIHSS) scores of 7-25. The primary endpoints were mean blood pressure of AIS patients treated with cinepazide maleate or control, which were assessed during the treatment period (14 days), and the proportion of the patients with normal blood pressure was analyzed after the treatment period. Furthermore, a subgroup analysis was performed to investigate a possible effect of the history of hypertension on outcomes.Results:This analysis included 809 patients with hypertension. There was no significant difference in patients blood pressure and the proportion of patients with normal blood pressure (60.5% vs. 59.0%, P>0.05) between cinepazide maleate group and control group. Conclusion:Administration of cinepazide maleate injection does not affect the management of clinical blood pressure in patients with AIS.
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OBJECTIVE: To discuss the effect and mechanism of cinepazide maleate (CM) on myocardial injured rats induced by isoproterenol (Iso). METHODS: Fifty male and female rats were divided into normal group, model group, the low and the high dose group of the CM, and captopril (Cap)positive control group. The rat model of myocardial injury was established by subcutaneous injection of Iso (5 mg·kg-1·d-1)for 7 d, rats in treatment group were given intraperitoneal injection of CM on the second day (1.5, 3 mg·kg-1·d-1), rats in positive control group were given intragastric administration of Cap(10 mg·kg-1·d-1), and rats in normal group and model group were given intraperitoneal injection of normal saline in the same volume, for 14 d. The rats in each group were tested before and after treatment by three times of running endurance test. After stopping drug all rats were anesthetized for measuring the electrocardiogram (ECG), then taken blood for measuring the activities of serum SOD, LDH and CK, and taken hearts for measuring heart weight index (HWI), left ventricular mass index (LHWI), the contents of myocardial hydroxyproline (Hyp)and MDA, and observing the morphological changes of myocardial tissue by HE staining. RESULTS: Compared with rats in normal group, rats in model group showed endurance value decrease, ECG abnormalities (arrhythmia and myocardial ischemia in waveform), increased HWI, LHWI (P<0.01), myocardial Hyp content, myocardial MDA level, and the level of serum LDH and CK, and reduced the serum SOD activity (P<0.05 or P<0.01). Compared with model group, CM could significantly increase endurance value, improve abnormal phenomenon of ECG, lower the HWI, LHWI, myocardial Hyp content, myocardial MDA level, and serum LDH and CK levels were lower, and serum SOD activity increased, especially in high dose group of CM (P<0.01). HE staining showed in the model group rat ventricular remodeling, myocardial rupture, a large number of collagen fibers, in the treatment group, ventricular remodeling and myocardial fibrosis were significantly improved. CONCLUSION: Cinepazide maleate has protective effect on myocardial injury of rats induced by Iso.
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OBJECTIVE:To observe the clinical efficacy and safety of cinepazide maleate combined with oxiracetam in the treat-ment of vascular dementia. METHODS:62 patients with vascular dementia were randomly divided into treatment group and control group,with 31 patients in each group. Patients in control group were treated with Oxiracetam injection 4g/d for 3weeks. Patients in treat-ment group were treated with cinepazide maleate 160 mg/d for 3 weeks on the basis of control group. The patients of 2 groups were exam-ined with Mini-mental State Examination (MMSE)and Activity of Daily Living Scale (ADL)before and after treatment. RESULTS:There was statistically significant difference in MMSE and ADL scores of 2 groups before and after treatment(P<0.05);MMSE score and ADL score of treatment group was better than that of control group,with statistical significance(P<0.05);Obvious ADR was not found in both groups. CONCLUSIONS:Cinepazide maleate combined with oxiracetam can significantly improve ADL and MMSE score in patients with vascular dementia,improve the quality of life,showing significant and good clinical efficacy.
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OBJECTIVE:To observe the effect of cinepazide maleate combined with Xueshuantong injection on the blood sup-ply of subcutaneous artery after flap transplantation. METHODS:68 patients with cross-regional combined with flap transplantation in extremity soft tissue injury were randomly divided into observation group and control group. The roast lamp irradiation in the flap transplantation and ambulation prohibited,alcohol and tobacco prohibited were carried out as rountine treatment. On this basis, control group was treated with cephalosporins,papaverine and low molecular dextran after flap transplantation. Observation group was treated with cinepazide maleate 8 ml adding into 0.9% Sodium chloride injection 250 ml by intravenous infusion,once a day+Xueshuantong injection 5 ml adding into 0.9% Sodium chloride injection 250 ml by intravenous infusion,once a day. The course for both was 14 d. The clinic data was observed,including blood rheological indicators (whole blood high cut,whole blood cut, whole blood low cut,plasma viscosity and RBC aggregation index),and coagulation function indicators [thrombin time(TT),acti-vated partial thromboplastin time(APTT),prothrombin time(PT)and GB normalized ratio(INR)] before and after 1,3 and 7 d of surgery,and the postoperative incidence of arterial vascular crisis within 7 d and adverse reactions. RESULTS:There was no sig-nificant difference in the incidence of arterial vascular crisis in 2 groups after 1 and 2 d of surgery(P>0.05);the incidence of arte-rial vascular crisis in 3,4,5,6 and 7 d in observation group was significantly lower than control group,with significant difference (P0.05). CONCLUSIONS:Cinepa-zide maleate combined with Xueshuantong injection can effectively improve the blood rheological indicators and coagulation func-tion indicators of patients,reduce the incidence of arterial vascular crisis,with good safety.
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Objective To learn the effect of cinepazide maleate combined with Shuxuetong in the treatment of ischemic vertigo.Methods 1 81 cases with ischemic vertigo were randomly divided into the observation group (98 cases)and the control group(83 cases)by random number table method.The observation group was treated with cinepazide maleate combined with Shuxuetong,and the control group was treated with cinepazide maleate.The blood flow velocity of vertebral artery and basilar artery of the two groups were measured before and after a period of treat-ment.The therapeutic effects were evaluated after one course.Results The peak systolic velocity and end diastolic velocity of right vertebral artery,left vertebral artery and basilar artery of the two groups were higher than before treat-ment,the differences were statistically significant(t =1 1 .21 5,1 2.51 0,6.030,6.81 4,7.052,7.730,1 9.884,1 7.774, 1 0.954,1 9.320,1 9.483,1 9.1 98,all P 0.05).Conclusion In the treatment of ischemic vertigo,cinepazide maleate combined with Shuxuetong has better curative effect and low incidence rate of drug adverse reaction.
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Objective To dynamically monitor the effect of Cinepazide maleate (CM) on ischemic region of the brain and to elucidate the neuroprotection of CM on acute cerebral ischemic rat model and related mechanisms.Methods The rat model of acute brain ischemia-reperfusion was established with tighting threads.They were randomly divided into ischemia-reperfusion group and CM treatment group(n=8 in each group).Rats in CM treatment group were given 3 mg / kg CM by caudal intravenous injection immediately after brain ischemia-reperfusion.T2 weighted imaging(T2WI) and proton magnetic resonance spectroscopy (1HMRS) were performed before operation and at 6 hours,24 hours and 3 days after reperfusion.Results At 6 h,24 h and 3 d after operation there was no difference for areas of cerebral ischemia on T2WI between 2 groups.The values of N-acetylaspartate(NAA) (Phosphocreatine(PCr) +Creartine(Cr)) in ischemia-reperfusion group rats were (1.53±0.20),(0.50 ±0.17),(0.44±0.13),(0.40±0.10) before operation and at 6 h,24 h,3 d after operation,respectively.And in CM treatment group the values of NAA/(PCr+Cr) were (1.44±0.22),(0.68±0.13),(0.61±0.10),(0.53±0.09) at the same time points.The values of lactate(Lac)/(PCr+Cr) in ischemia-reperfusion group were (0.03±0.01),(1.10 ±0.28),(1.30± 0.23),(1.23± 0.19) before operation and at 6 h,24 h,3 d after operation,respectively.And in CM treatment group the values of Lac/(PCr+Cr) were (0.02±0.01),(0.85±0.25),(0.99±0.20),(0.90±0.15) at the same time points.The rats in ischemia-reperfusion group had lower value of NAA/(PCr+Cr) (P＜0.01) and higher value of Lac/(PCr+Cr) at all time points after operation than those before operation.Compared with rats in ischemia-reperfusion group,the value of NAA/(PCr+Cr) increased(P＜0.05) and the value of Lac/(PCr+Cr) decreased(P＜0.05) decreased significantly for CM treatment group rats.Conclusion CM treatment can decrease the intracellular accumulation of lactic acid and reduce neuronal necrosis in acute brain ischemia-reperfusion rats.
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Objective Comparing the clinical effect between Cinepazide Maleate and low Molecular weight Dextran,to the one which is more effective,safer and less unhealthy to patients after digital replantation.Methods From April 2010 to April 2012 in our hospital during single finger replantation patients,the observation group 120 cases of postoperative to Cinepazide Maleate injection 320mg/d intravenous drip,the control group of 120 cases treated with low Molecular Dextran 500ml/d IVGTT.Results The effective rate of observe group and control group was 96.67％ and 92.50％,respectively.The difference between the two groups was too small to have statistically significant difference (P ＞ 0.05),but the adverse effect of treatment group was only 5.8％,much lower than 14.17％ in control group however with the statistically significant difference (P ＜0.05).Conclusion Cinepazide Maleate Injection and low Molecular weight Dextran both have apparent effect in patients after digital replantation surgery.Both of them significantly improved microcirculation,enhanced the survival rate of replantation.However Cinepazide Maleate injection has fewer adverse effects,which is one of idea auxiliary medicine and deserved more extensive clinic application in currently microsurgery.
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@#ObjectiveTo investigate the effect of cinepazide maleate combined with venlafaxine on post-stroke depression.Methods60 stroke patients with post-stroke depression were divided into control group (n=30) and observation group (n=30). On the basis treatment, the control group was given venlafaxine, the observation group was given venlafaxine and maleate cinepazide injection. The course was 4 weeks. The two groups were assessed with Hamilton Depression Scale(HAMD) and modified Barthel Index(MBI) before and after treatment.ResultsThe observation group improved better than the control group (P<0 05) even in HAMD and MBI 4 weeks after treatment(P<0.01).ConclusionCinepazide maleate combined with venlafaxine may be more effective on post-stroke depression to improve depressive symptoms, and the activities of daily living.
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Objective To observe the effects of cinepazide maleate and nimodipine in improving the neurological function in patients with hypertensive cerebral hemorrhage after microtraumatic craniopuncture.Methods Seventy-eight patients with hypertensive cerebral hemorrhage were randomly divided into 2 groups,cinepazide maleate group (39 patients)and nimodipine group(39 patients).After 3 days operated with the microtraumatic craniopuncture,cinepazide maleate group used the amount 160mg cinepazide maleate mixed with sodium chloride injection(500ml,concentration 0.9%),and the nimodipine group uesd nimodipine(4mg)mixed with the same injection.Both the patients of the 2 groups were given intravenous drip once a day,then after continuous 14 days,the general information and the improvement of nerve were observeed.Results The total improvement rate and the improvement rate of nervous symptom was 87.2%and 61.5%respectively,in comparison,the nimodipine group was 64.1%and 39.9%.Conclusion Cinepazide maleate was better than nimodipine in improving chnical symptoms and the neurological deficit of the patients with hypertensive cerebral hemorrhage after microtraumatic craniopuncture.
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Objective To investigate the clinical value for treatment of diabetic foot with PTA and PTA combined cinepazide maleate.Methods In 24 cases of diabetic associated vascular disease of lower limb,12 cases were treated with PTA and other 12 cases were treated with PTA combined einepazide maleate,We analysed and compared clinical effects before and after the procedure,together with 3 months follow up.Results In patients treated with PTA,the clinical symptom scores of posttreatment and follow-up decreased;ABI and TcPO_2 increased significantly.The clinical symptom score and ABI of follow-up remained,stable,but TcPO_2 decreased significantly.Control angiography showed improvement in degree of vascular stenosis and peripheral staining of 11 patients after treatment.The vascular patency remained in 12 patients and the peripheral staining decreased in 7 patients on follow-up.In patients treated with VIA combined cinepazide maleate,the clinical symptom score,ABI and TcPO_2 after treatment and on follow-up showed no signifcant changes compared with those in patients treated by PTA.F,Control angiography showed that the degree of vascular stenosis and peripheral staining were improved in 12 patients after treatment.The vascular pateney was maintained and peripheral staining was improved on follow-up.Before and after treatment,there were no significant differences in clinical symptom score.ABI and TcPO_2 between patients treated with PTA and PTA combined cinepazide maleate,however,there were significant differences in clinical symptom score and TcPO_2 on follow-up.Conclusion PTA can significantly improve clinical symptom of diabetic foot and the application of cinepazide maleate is a benefitial and necessary supplement.PTA combined cinepazide maleate can be taken as one of the conventional treatment plans for diabetic foot.(J Intervent Radiol,2007,16:811-815)
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OBJECTIVE:To evaluate the clinical efficacy of cinepazide maleate in combination with magnesium sulfate for traumatic subarachnoid hemorrhage.METHODS:A total of 160 patients with traumatic subarachnoid hemorrhage were randomly assigned to 4 groups:Control group(n=40)received conventional therapy alone(hemostasis,dehydration,hormone and drugs promoting recovery of nervous function;Group Ⅰ(Control group,n=40)received cinepazide maleate plus conventional therapy;Group Ⅱ(n=40)received magnesium sulfate plus conventional therapy,and Group Ⅲ(n=40)received cinepazide maleate in combination with magnesium sulfate in additional to the conventional therapy.All the drugs were given in every 12 h for 14 consecutive days.Transcranial Doppler(TCD)examination was scheduled at 0,3,7,14 days after admission to observe the incidences of cerebral angiospasm(CVS)and patients' prognosis.RESULTS:There were significant differences between Group Ⅲ and the other 3 groups(Control group,Group Ⅰ and Group Ⅱ)in the incidence of CVS,the change of the blood flow rate of the middle cerebral artery and patients' prognosis at 3 and 6 months respectively(P