A fast, simple and sensitive high performance liquid chromatographic (HPLC) method has been developed for determination of 10a-methoxy-6-methyl ergoline-8b-methanol (MDL, a main metabolite of nicergoline) in human pla...A fast, simple and sensitive high performance liquid chromatographic (HPLC) method has been developed for determination of 10a-methoxy-6-methyl ergoline-8b-methanol (MDL, a main metabolite of nicergoline) in human plasma. One-step liquid–liquid extraction (LLE) with diethyl ether was employed as the sample preparation method. Tizanidine hydrochloride was selected as the internal standard (IS). Analysis was carried out on a Diamonsil ODS column (150 mm 4.6 mm, 5 mm) using acetonitrile–ammonium acetate (0.1 mol/L) (15/85, v/v) as mobile phase at detection wavelength of 224 nm. The calibration curves were linear over the range of 2.288–73.2 ng/mL with a lower limit of quantitation (LLOQ) of 2.288 ng/mL. The intra-and inter-day precision values were below 13% and the recoveries were from 74.47% to 83.20% at three quality control levels. The method herein described was successfully applied in a randomized crossover bioequivalence study of two different nicergoline preparations after administration of 30 mg in 20 healthy volunteers.展开更多
目的探讨血栓通注射液联合奥拉西坦对老年缺血性脑卒中(ischemic stroke,IS)的作用。方法选取106例老年IS患者作为研究对象,随机分为观察组和对照组,每组53例。对照组用奥拉西坦治疗,观察组在对照组治疗的基础上联合血栓通注射液治疗,比...目的探讨血栓通注射液联合奥拉西坦对老年缺血性脑卒中(ischemic stroke,IS)的作用。方法选取106例老年IS患者作为研究对象,随机分为观察组和对照组,每组53例。对照组用奥拉西坦治疗,观察组在对照组治疗的基础上联合血栓通注射液治疗,比较2组的临床疗效、神经功能[用美国国立卫生研究院卒中量表评分(national institute of health stroke scale,NIHSS)评估]、运动功能(用日常生活活动能力(activities of daily living,ADL)量表评估)、颈动脉狭窄程度(颈动脉内中膜厚度和狭窄率)、血流动力学(全血黏度、血流速度和血流阻力)、神经损伤因子[神经胶质原纤维酸性蛋白(glial fibrillary acidic protein,GFAP)、神经元特异性烯醇化酶(neuron-specific enolase,NSE)和脑源性神经生长因子(brain-derived neurotrophic factor,BDNF)]和氧化应激指标[丙二醛(malondialdehyde,MDA)和超氧化物歧化酶(superoxide dismutase,SOD)]水平。结果观察组的总有效率为98.11%,高于对照组的86.79%(P<0.05);治疗后,观察组的NIHSS评分为(10.14±1.91)分,低于对照组的(12.43±2.12)分,P<0.05;观察组的ADL评分为(64.49±8.30)分,高于对照组的(58.37±7.26)分,P<0.05;观察组颈动脉内中膜厚度和狭窄率分别为(1.27±0.11)mm、(74.84%±5.14%),低于对照组[(1.33±0.13)mm、(78.92%±5.95%)],P<0.05;观察组(高切和低切)全血黏度和血流阻力分别为(4.72±0.91)mPa·s、(10.99±2.25)mPa·s、(1.52±0.24)Pa·s·L^(-1),低于对照组[(5.86±1.17)mPa·s、(13.40±2.77)mPa·s、(1.64±0.27)Pa·s·L^(-1)],血流速度为(18.33±3.85)cm·s^(-1),高于对照组[(16.51±3.61)cm·s^(-1)],P<0.05;观察组的GFAP和NSE分别为(5.62±1.11)、(23.88±4.25)ng·mL^(-1),低于对照组[(6.57±1.30)、(27.17±4.76)ng·mL^(-1)],BDNF为(3.06±0.77)ng·mL^(-1),高于对照组[(2.38±0.52)ng·mL^(-1)],P<0.05;观察组的MDA为(3.62±0.63)μmol·L^(-1),低于对照组[(4.05±0.78)μmol·L^(-1)],SOD为(105.20±15.63)U·mL^(-1),高于对照组[(93.42±13.27)U·mL^(-1)],P<0.05。结论血栓通注射液联合奥拉西坦对老年IS患者疗效显著,可通过调节神经损伤因子和氧化应激因子水平及改善血流动力学,提高患者的神经功能和运动功能,改善颈动脉狭窄。展开更多
Aim To study the pharmacokinetics of oxiracetam after single and multipleintravenous administrations in healthy volunteers. Method A HPLC method was used to determine theserum concentration of oxiracetam after intrave...Aim To study the pharmacokinetics of oxiracetam after single and multipleintravenous administrations in healthy volunteers. Method A HPLC method was used to determine theserum concentration of oxiracetam after intravenous single dose and daily dose of 2 000 mg for 7 din ten Chinese healthy volunteers. Pharmacokinetic analysis was carried out using Drug And Statisticsoftware. Results The AUC_(0-12), AUC_(0-∞), K_e, t_(1/2), MRT after a single dose of 2 000 mgoxiracetam were 256.26 ± 16.84 μg·mL^(-1)·h, 276.74 ±18.11 μg·mL^(-1)·h, 0.18 ±0.03 h^(-1),3.84±0.64 h, and 4.39 10.39 h, and after multiple doses of oxiracetam were 259.36 ±25.43μg·mL^(-1)·h, 285.59 ±27.38 μg·mL^(-1)·h, 0.17 ±0.04 h^(-1), 4.14 ± 0.82 h, and 4.87 ±0.69 h, respectively. Conclusion The pharmacokinetic parameters of oxiracetam do not differremarkably after single and multiple intravenous administration and there is accumulation in serumafter 2 000 mg multiple intravenous administration once a day fof 7 d.展开更多
目的探讨奥拉西坦联合丁苯酞对非痴呆型血管性认知障碍(vascular cognitive impairment of non-dementia,VCIND)患者的临床疗效。方法将64例VCIND患者随机分为对照组与联合组,每组32例。2组均接受常规治疗,对照组给予奥拉西坦治疗,联合...目的探讨奥拉西坦联合丁苯酞对非痴呆型血管性认知障碍(vascular cognitive impairment of non-dementia,VCIND)患者的临床疗效。方法将64例VCIND患者随机分为对照组与联合组,每组32例。2组均接受常规治疗,对照组给予奥拉西坦治疗,联合组给予奥拉西坦联合丁苯酞治疗,疗程为3个月。比较2组患者治疗前后蒙特利尔认知评估量表(Montreal cognitive assessment scale,MoCA)评分、简易精神状态评价量表(mini mental state evaluation scale,MMSE)、美国国立卫生院卒中量表(national institutes of health stroke scale,NIHSS)评分和日常生活活动能力量表(activity of daily living scale,ADL)评分,检测血清转化生长因子-β(transforming growth factor-β,TGF-β)、基质金属蛋白酶-9(matrix metalloproteinase-9,MMP-9)、抗凋亡因子(anti-apoptotic factor,Livin)、神经元特异性烯醇化酶(neuron-specific enolase,NSE)和神经生长因子(nerve growth factor,NGF)水平的变化,检测脑血管平均血流速度(mean velocity,V_(m))、动脉搏动指数(pulsatility index,PI)与阻力指数(resistance index,RI)。结果治疗后,2组MoCA、MMSE和ADL评分均升高,NIHSS评分均降低,且联合组MoCA、MMSE和ADL评分显著高于对照组(P<0.05)。2组脑血管V_(m)均升高,PI和RI均降低,且联合组显著优于对照组(P<0.05);2组血清MMP-9NSE均降低,TGF-β、Livin和NGF水平均升高,且联合组显著优于对照组(P<0.05)。结论奥拉西坦联合丁苯酞治疗VCIND可有效改善患者的脑血管功能,保护神经功能及认知功能,其机制可能与纠正血清TGF-β、MMP-9、Livin、NSE及NGF水平有关。展开更多
目的研究尼麦角林与吲哚布芬联合应用治疗急性脑梗死的效果。方法选择南京医科大学附属淮安第一医院收治的急性脑梗死患者122例,以随机数字表法分成研究组(n=61)与对照组(n=61)。2组均接受基础治疗,对照组在此基础上给予吲哚布芬治疗,...目的研究尼麦角林与吲哚布芬联合应用治疗急性脑梗死的效果。方法选择南京医科大学附属淮安第一医院收治的急性脑梗死患者122例,以随机数字表法分成研究组(n=61)与对照组(n=61)。2组均接受基础治疗,对照组在此基础上给予吲哚布芬治疗,研究组在对照组的基础上给予尼麦角林治疗。2组均治疗14 d。比较2组美国国立卫生研究所卒中量表(National Institute of Health Stroke Scale,NIHSS)评分、改良Rankin量表(Modified Rankin Scale,mRS)评分、临床疗效、血清心型脂肪酸结合蛋白(heart-type fatty acid-binding protein,H-FABP)、β-肌动蛋白(β-actin)、胰岛素样生长因子1(insulin like growth factor-1,IGF-1)水平、血浆比黏度、全血比高切黏度、血浆纤维蛋白原、全血比低切黏度及安全性。结果治疗后,2组NIHSS评分、mRS评分均降低,研究组低于对照组(P<0.05)。研究组总有效率(91.80%)比对照组(77.05%)高(P<0.05)。治疗后,2组血清H-FABP、β-actin水平均降低,研究组低于对照组(P<0.05);治疗后,2组血清IGF-1水平均升高,研究组高于对照组(P<0.05)。治疗后,2组血浆比黏度、全血比高切黏度、血浆纤维蛋白原及全血比低切黏度均降低,研究组低于对照组(P<0.05)。2组不良反应总发生率比较差异无统计学意义(P>0.05)。结论尼麦角林与吲哚布芬联合应用治疗急性脑梗死效果确切,可改善患者神经功能、血清生化指标及血液流变学,且不良反应少。展开更多
目的探讨健脑醒聪汤联合针康法治疗缺血性脑卒中后认知障碍患者的临床疗效。方法前瞻性选取2021年1月—2022年12月期间广东省中西医结合医院收治的135例缺血性脑卒中后认知障碍患者作为研究对象,采用随机数字表法分为对照A组、对照B组...目的探讨健脑醒聪汤联合针康法治疗缺血性脑卒中后认知障碍患者的临床疗效。方法前瞻性选取2021年1月—2022年12月期间广东省中西医结合医院收治的135例缺血性脑卒中后认知障碍患者作为研究对象,采用随机数字表法分为对照A组、对照B组和治疗组,每组各45例。对照A组给予奥拉西坦,对照B组给予奥拉西坦+针康法,治疗组给予奥拉西坦+针康法+健脑醒聪汤。均持续治疗4周。观察比较3组患者临床疗效,治疗前后中医证候积分、美国国立卫生研究院卒中(National institute of health stroke scale,NIHSS)评分、Barthel指数(Barthel index,BI)、神经递质[脑源性神经营养因子(Brain-derived neurotrophic factor,BDNF)、胶质纤维酸性蛋白(Glial fibrillary acidic protein,GFAP)]水平。结果治疗后治疗组中医疗效总有效率88.89%(40/45)明显高于对照A组47.73%(21/44)、对照B组70.45%(31/44),差异有统计学意义(P<0.05)。治疗后治疗组西医疗效总有效率91.11%(41/45)高于对照A组52.27%(23/44)、对照B组72.73%(32/44),差异有统计学意义(P<0.05)。治疗4周后3组患者中医证候头痛如刺、智能减退、神情默默、寡言少语评分均较治疗前降低,差异有统计学意义(P<0.05);且治疗组中医证候头痛如刺、智能减退、神情默默、寡言少语评分均明显低于对照A、B组,差异有统计学意义(P<0.05)。治疗4周后3组患者BI评分均较治疗前升高,NIHSS评分均较治疗前降低,差异有统计学意义(P<0.05);且治疗组BI评分明显高于对照A、B组,NIHSS评分明显低于对照A、B组,差异有统计学意义(P<0.05)。治疗4周后3组患血清BDNF水平均较治疗前升高,GFAP水平均较治疗前降低,差异有统计学意义(P<0.05);且治疗组血清BDNF水平明显高于对照A、B组,GFAP水平明显低于对照A、B组,差异有统计学意义(P<0.05)。治疗期间,3组患者血常规、尿常规、心电图、肝肾功能、便常规、血压等安全性指标均无异常改变。结论针康法联合健脑醒聪汤能有效改善缺血性脑卒中后认知障碍患者神经功能,缓解临床症状,提高日常生活能力,增强疗效,机制可能与调节BDNF、GFAP水平有关。展开更多
文摘A fast, simple and sensitive high performance liquid chromatographic (HPLC) method has been developed for determination of 10a-methoxy-6-methyl ergoline-8b-methanol (MDL, a main metabolite of nicergoline) in human plasma. One-step liquid–liquid extraction (LLE) with diethyl ether was employed as the sample preparation method. Tizanidine hydrochloride was selected as the internal standard (IS). Analysis was carried out on a Diamonsil ODS column (150 mm 4.6 mm, 5 mm) using acetonitrile–ammonium acetate (0.1 mol/L) (15/85, v/v) as mobile phase at detection wavelength of 224 nm. The calibration curves were linear over the range of 2.288–73.2 ng/mL with a lower limit of quantitation (LLOQ) of 2.288 ng/mL. The intra-and inter-day precision values were below 13% and the recoveries were from 74.47% to 83.20% at three quality control levels. The method herein described was successfully applied in a randomized crossover bioequivalence study of two different nicergoline preparations after administration of 30 mg in 20 healthy volunteers.
文摘目的探讨血栓通注射液联合奥拉西坦对老年缺血性脑卒中(ischemic stroke,IS)的作用。方法选取106例老年IS患者作为研究对象,随机分为观察组和对照组,每组53例。对照组用奥拉西坦治疗,观察组在对照组治疗的基础上联合血栓通注射液治疗,比较2组的临床疗效、神经功能[用美国国立卫生研究院卒中量表评分(national institute of health stroke scale,NIHSS)评估]、运动功能(用日常生活活动能力(activities of daily living,ADL)量表评估)、颈动脉狭窄程度(颈动脉内中膜厚度和狭窄率)、血流动力学(全血黏度、血流速度和血流阻力)、神经损伤因子[神经胶质原纤维酸性蛋白(glial fibrillary acidic protein,GFAP)、神经元特异性烯醇化酶(neuron-specific enolase,NSE)和脑源性神经生长因子(brain-derived neurotrophic factor,BDNF)]和氧化应激指标[丙二醛(malondialdehyde,MDA)和超氧化物歧化酶(superoxide dismutase,SOD)]水平。结果观察组的总有效率为98.11%,高于对照组的86.79%(P<0.05);治疗后,观察组的NIHSS评分为(10.14±1.91)分,低于对照组的(12.43±2.12)分,P<0.05;观察组的ADL评分为(64.49±8.30)分,高于对照组的(58.37±7.26)分,P<0.05;观察组颈动脉内中膜厚度和狭窄率分别为(1.27±0.11)mm、(74.84%±5.14%),低于对照组[(1.33±0.13)mm、(78.92%±5.95%)],P<0.05;观察组(高切和低切)全血黏度和血流阻力分别为(4.72±0.91)mPa·s、(10.99±2.25)mPa·s、(1.52±0.24)Pa·s·L^(-1),低于对照组[(5.86±1.17)mPa·s、(13.40±2.77)mPa·s、(1.64±0.27)Pa·s·L^(-1)],血流速度为(18.33±3.85)cm·s^(-1),高于对照组[(16.51±3.61)cm·s^(-1)],P<0.05;观察组的GFAP和NSE分别为(5.62±1.11)、(23.88±4.25)ng·mL^(-1),低于对照组[(6.57±1.30)、(27.17±4.76)ng·mL^(-1)],BDNF为(3.06±0.77)ng·mL^(-1),高于对照组[(2.38±0.52)ng·mL^(-1)],P<0.05;观察组的MDA为(3.62±0.63)μmol·L^(-1),低于对照组[(4.05±0.78)μmol·L^(-1)],SOD为(105.20±15.63)U·mL^(-1),高于对照组[(93.42±13.27)U·mL^(-1)],P<0.05。结论血栓通注射液联合奥拉西坦对老年IS患者疗效显著,可通过调节神经损伤因子和氧化应激因子水平及改善血流动力学,提高患者的神经功能和运动功能,改善颈动脉狭窄。
文摘Aim To study the pharmacokinetics of oxiracetam after single and multipleintravenous administrations in healthy volunteers. Method A HPLC method was used to determine theserum concentration of oxiracetam after intravenous single dose and daily dose of 2 000 mg for 7 din ten Chinese healthy volunteers. Pharmacokinetic analysis was carried out using Drug And Statisticsoftware. Results The AUC_(0-12), AUC_(0-∞), K_e, t_(1/2), MRT after a single dose of 2 000 mgoxiracetam were 256.26 ± 16.84 μg·mL^(-1)·h, 276.74 ±18.11 μg·mL^(-1)·h, 0.18 ±0.03 h^(-1),3.84±0.64 h, and 4.39 10.39 h, and after multiple doses of oxiracetam were 259.36 ±25.43μg·mL^(-1)·h, 285.59 ±27.38 μg·mL^(-1)·h, 0.17 ±0.04 h^(-1), 4.14 ± 0.82 h, and 4.87 ±0.69 h, respectively. Conclusion The pharmacokinetic parameters of oxiracetam do not differremarkably after single and multiple intravenous administration and there is accumulation in serumafter 2 000 mg multiple intravenous administration once a day fof 7 d.
文摘目的研究尼麦角林与吲哚布芬联合应用治疗急性脑梗死的效果。方法选择南京医科大学附属淮安第一医院收治的急性脑梗死患者122例,以随机数字表法分成研究组(n=61)与对照组(n=61)。2组均接受基础治疗,对照组在此基础上给予吲哚布芬治疗,研究组在对照组的基础上给予尼麦角林治疗。2组均治疗14 d。比较2组美国国立卫生研究所卒中量表(National Institute of Health Stroke Scale,NIHSS)评分、改良Rankin量表(Modified Rankin Scale,mRS)评分、临床疗效、血清心型脂肪酸结合蛋白(heart-type fatty acid-binding protein,H-FABP)、β-肌动蛋白(β-actin)、胰岛素样生长因子1(insulin like growth factor-1,IGF-1)水平、血浆比黏度、全血比高切黏度、血浆纤维蛋白原、全血比低切黏度及安全性。结果治疗后,2组NIHSS评分、mRS评分均降低,研究组低于对照组(P<0.05)。研究组总有效率(91.80%)比对照组(77.05%)高(P<0.05)。治疗后,2组血清H-FABP、β-actin水平均降低,研究组低于对照组(P<0.05);治疗后,2组血清IGF-1水平均升高,研究组高于对照组(P<0.05)。治疗后,2组血浆比黏度、全血比高切黏度、血浆纤维蛋白原及全血比低切黏度均降低,研究组低于对照组(P<0.05)。2组不良反应总发生率比较差异无统计学意义(P>0.05)。结论尼麦角林与吲哚布芬联合应用治疗急性脑梗死效果确切,可改善患者神经功能、血清生化指标及血液流变学,且不良反应少。
文摘目的探讨健脑醒聪汤联合针康法治疗缺血性脑卒中后认知障碍患者的临床疗效。方法前瞻性选取2021年1月—2022年12月期间广东省中西医结合医院收治的135例缺血性脑卒中后认知障碍患者作为研究对象,采用随机数字表法分为对照A组、对照B组和治疗组,每组各45例。对照A组给予奥拉西坦,对照B组给予奥拉西坦+针康法,治疗组给予奥拉西坦+针康法+健脑醒聪汤。均持续治疗4周。观察比较3组患者临床疗效,治疗前后中医证候积分、美国国立卫生研究院卒中(National institute of health stroke scale,NIHSS)评分、Barthel指数(Barthel index,BI)、神经递质[脑源性神经营养因子(Brain-derived neurotrophic factor,BDNF)、胶质纤维酸性蛋白(Glial fibrillary acidic protein,GFAP)]水平。结果治疗后治疗组中医疗效总有效率88.89%(40/45)明显高于对照A组47.73%(21/44)、对照B组70.45%(31/44),差异有统计学意义(P<0.05)。治疗后治疗组西医疗效总有效率91.11%(41/45)高于对照A组52.27%(23/44)、对照B组72.73%(32/44),差异有统计学意义(P<0.05)。治疗4周后3组患者中医证候头痛如刺、智能减退、神情默默、寡言少语评分均较治疗前降低,差异有统计学意义(P<0.05);且治疗组中医证候头痛如刺、智能减退、神情默默、寡言少语评分均明显低于对照A、B组,差异有统计学意义(P<0.05)。治疗4周后3组患者BI评分均较治疗前升高,NIHSS评分均较治疗前降低,差异有统计学意义(P<0.05);且治疗组BI评分明显高于对照A、B组,NIHSS评分明显低于对照A、B组,差异有统计学意义(P<0.05)。治疗4周后3组患血清BDNF水平均较治疗前升高,GFAP水平均较治疗前降低,差异有统计学意义(P<0.05);且治疗组血清BDNF水平明显高于对照A、B组,GFAP水平明显低于对照A、B组,差异有统计学意义(P<0.05)。治疗期间,3组患者血常规、尿常规、心电图、肝肾功能、便常规、血压等安全性指标均无异常改变。结论针康法联合健脑醒聪汤能有效改善缺血性脑卒中后认知障碍患者神经功能,缓解临床症状,提高日常生活能力,增强疗效,机制可能与调节BDNF、GFAP水平有关。
