冠心宁注射液安全性再评价研究（II）

目的 为冠心宁注射液安全性再评价工作提供数据参考。方法 采用不同药物浓度,按《中国药典》2010年版一部附录方法进行渗透压摩尔浓度测定和溶血与凝聚检查,同时采用分光光度法对样品及其稀释液进行溶血率的测定;采用显微镜法对样品及其稀释液进行血细胞凝聚检查。结果 各厂家产品的渗透压摩尔浓度均为高渗,原液渗透压摩尔浓度（mOsmol/kg）A厂为400～799,F厂为400～999,B、C、D、E厂为600～1 000,并可达到1 000以上。用5%葡萄糖注射液对样品稀释后再进行测定,结果各厂的产品按使用说明书使用时,基本上都能达到等渗;溶血与凝聚检查结果71批样品均符合规定;用分光光度法测定溶血率,结果各厂家样品原液均有一定的溶血（2批样品因凝聚,测定值偏低）,除B厂家4批样品外,各厂家样品最小不溶血浓度均大于1∶8,B厂家3批样品的最小不溶血浓度为1∶16（相当于常规体外试管法药物浓度）,1批样品的最小不溶血浓度为1∶32;红细胞凝聚检查,各厂家样品原液检查结果有58批样品未见凝聚,占总样品数的81.7%,A厂有3批样品凝聚严重,用5%葡萄糖注射液对样品稀释后,最小不凝聚浓度大于1∶8,D厂家血细胞变形、破损较严重,镜下可见大量细胞碎片。结论 不同厂家生产的冠心宁注射液渗透压摩尔浓度、溶血率及红细胞凝聚存在一定的差异,建议用适当的渗透压摩尔浓度及溶血与凝聚检查方法来控制其质量,以保障临床用药的安全。     

冠心宁注射液安全性再评价研究（I）

目的 为做好冠心宁注射液安全性再评价工作提供数据参考。方法 采用不同给药剂量,按《中国药典》2010年版一部附录方法进行异常毒性检查、过敏反应检查及降压物质检查,根据样品注射后动物反应情况,进行分级评价。结果 异常毒性检查：不同厂家的样品原液异常毒性检查结果差异明显,A、D及F 3个厂家的产品异常毒性较小,均未出现动物死亡,其中A与F两个厂家均只有一批样品得3分;B厂的产品异常毒性变化较大,13批样品中,除一批样品未见明显毒性反应外,有8批样品出现动物死亡,占总数的53.3%;C和E厂的产品表现出较大的异常毒性,得分在2～5分,D厂产品最稳定,13批样品得分集中分布在2～3分,没有出现动物死亡情况;选用样品1︰2的稀释液,71批样品中,仅有1批出现动物死亡;不同来源、不同品种动物反应结果基本一致。降压物质检查：冠心宁注射液有一定的降压作用,注射0.2 mL/kg样品原液,降压幅度大于组胺对照（0.1 μg/kg）组,选用样品1︰3的稀释液,71批样品中,仅B厂有4批样品不合格,经换猫再试,有1批样品仍不合格,3批合格。过敏反应检查：取不同厂家样品24批进行过敏反应检查,结果均未出现明显的过敏反应。结论 不同厂家、同一厂家不同生产批号的冠心宁注射液异常毒性、降压物质检查结果存在差异,可增加异常毒性、降压物质检查来控制其质量。     

氧氟沙星葡萄糖注射液细菌内毒素检查法

目的：探讨氧氟沙星葡萄糖注射液细菌内毒素检查法。方法：对三个不同批号的氧氟沙星葡萄糖注射液进行干扰试验。先对内毒素限值进行确定，在确定干扰试验的起始浓度及浓度范围，在有效范围内进行干扰试验。考察样品液、1倍稀释原液及4倍稀释液条件下，样品对试验的干扰情况。结果：氧氟沙星原液(0．08％)和1倍稀释液(0．04％)对试验均有干扰行为，而4倍稀释液(0．02％)对试验无干扰行为。结论：该氧氟沙星葡萄糖注射液使用灵敏度为0．125Eu／mL的鲎试剂，将样品按1：3稀释后，按细菌内毒素检查法检查是可行的。     

参麦注射液治疗充血性心力衰竭50例

[目的]观察参麦注射液治疗充血性心力衰竭的疗效。[方法]将患者随机分为两组,对照组进行常规治疗,治疗组采用常规治疗加参麦注射液治疗,观察疗效。[结果]充血性心力衰竭应用参麦注射液治疗2周后,患者左室收缩功能得到明显改善,未发现药物不良反应。[结论]参麦注射液治疗充血性心力衰竭安全有效。     

参麦注射液抗氧化活性体外实验研究

[目的] 系统研究参麦注射液体外抗氧化性能。[方法] 采用铁还原抗氧化能力 （FRAP）法、1,1-二苯基-2-三硝基苯肼（DPPH）自由基清除法、一氧化氮（NO）自由基清除法、过氧化氢（H₂O₂）清除法、亚铁（Fe²⁺）离子螯合法分别测试不同稀释倍率参麦注射液的总抗氧化能力、DPPH·清除活性、NO·清除活性、H₂O₂清除活性和Fe²⁺离子螯合活性,并将结果与0.1mg/mL 2,6-二叔丁基对甲酚（BHT）、10 mmol/L水溶性维生素E（Trolox）和10%柠檬酸的结果进行比较。[结果] 参麦注射液具有一定的体外抗氧化能力,总抗氧化能力和对自由基清除活性均呈浓度正依赖性;10倍稀释参麦注射液总抗氧化能力显著低于BHT和Trolox （P<0.01）,但高于柠檬酸（P<0.01）;参麦注射液对不同自由基清除能力存在差异,其强弱顺序为：NO·[（54.4±6.6）%] > Fe²⁺离子螯[（42.6±3.2）%] > DPPH·[（36.2±2.8）%] > H₂O₂[（23.5±1.2）%]。[结论] 参麦注射液体外抗氧化活性研究将为其抗氧化药理学机制提供了实验依据。     

参丹芎注射液的安全性试验研究

目的 观察参丹芎注射液是否具有血管刺激性、溶血和过敏性反应。方法 家兔耳缘iv给予参丹芎注射液8 mL/kg,每天给药1次,连续给药5 d,停药48 h后对注射部位进行病理组织学检查;0.1～0.5 mL参丹芎注射液在4.5～4.9 mL兔红细胞混悬液中放置0.25～3 h,观察对兔红细胞悬液的溶血及有无红细胞凝聚作用;豚鼠隔日ip给予0.5 mL参丹芎注射液,连续注射3次,分别于末次致敏后第14和21天iv给予1.0 mL参丹芎注射液进行激发,观察豚鼠30 min内是否出现过敏反应。结果 参丹芎注射液对家兔耳缘静脉血管内皮没有损伤和刺激作用;兔红细胞溶血和凝聚作用阴性;豚鼠全身主动过敏反应阴性。结论 参丹芎注射液无血管刺激性、体外溶血性和全身主动过敏性反应。     

参麦注射液协同阿托品多巴胺对合并急性右室心肌梗死患者缓慢心律失常及低血压的治疗作用

[目的]探讨参麦注射液对急性心肌梗死合并右室梗死患者缓慢心律失常及低血压的治疗作用。[方法]选择符合急性心肌梗死合并右室梗死诊断标准的住院患者75例,其中合并缓慢心律失常的患者58例,随机分为治疗组(加用参麦注射液)和对照组(未使用参麦注射液),比较两组使用阿托品的平均剂量;其中合并低血压的住院患者41例。随机分为治疗组(多巴胺+参麦注射液)和对照组(多巴胺),比较两组使用多巴胺持续时间及使用的最大浓度。[结果]治疗组与对照组相比,使用参麦注射液可显著提高缓慢心律失常患者心室率并减少了使用阿托品的剂量;在合并低血压患者中,使用参麦注射液可缩短多巴胺的维持时间(P<0.05),并使多巴胺的最大使用浓度减低(P<0.05)。[结论]在急性心肌梗死合并右室梗死患者,出现缓慢心律失常及(或)低血压时配合使用参麦注射液可以达到更好的治疗效果。     

参麦注射液热原检查的适用性研究

目的 对热原检查标准制订时开展适用性研究的必要性进行探讨。方法 选用参麦注射液按《中国药典》2010年版一部附录ⅩⅧ B“中药注射剂安全性检查法应用指导原则”进行热原检查适用性研究。结果 参麦注射液热原检查不干扰给药剂量为3 mL/kg;参麦注射液给药剂量为5 mL/kg时,对细菌内毒素致家兔体温升高有干扰。结论 中药注射剂的热原检查有必要进行适用性研究。     

热毒宁注射液配伍后的渗透压研究

目的?研究热毒宁注射液临床配伍后的渗透压值,以供临床医生参考。方法?采用FM8P全自动冰点渗透压计考察热毒宁注射液与不同稀释溶剂配伍以及与常用抗生素配伍后的渗透压值。结果? 热毒宁注射液与5%葡萄糖注射液及0.9%氯化钠注射液稀释后渗透压值均在人体正常渗透压范围内;而与化学药同时配伍后,渗透压值均低于人体正常渗透压范围。结论?热毒宁注射液可与5%葡萄糖注射液或0.9%氯化钠注射液稀释后使用,不得与抗生素同时配伍使用。      

固相萃取-高效液相色谱法测定青银注射液中蒿酮

目的 建立固相萃取-高效液相色谱法测定青银注射液中蒿酮的分析方法。方法 采用高效液相色谱法测定。色谱柱为Dikma Kromasil C₁₈（250 mm×4.6 mm，5 μm）；流动相：乙腈-水（75∶25）；检测波长：242 nm；柱温：30 ℃；体积流量：0.8 mL/min；进样量：10 μL。供试品溶液的制备采用C₁₈固相萃取小柱（甲醇10 mL活化，水10 mL平衡），用50％甲醇洗脱，弃去洗脱液，再用甲醇洗脱。结果 蒿酮在0.220 5～3.527 2 μg具有良好的线性关系（r＝0.999 9），平均回收率为98.28％，RSD为0.35％。结论 该方法简便、快速、准确，具有良好的重复性和回收率，可作为青银注射液中蒿酮的定量分析方法。     

Value of D-Dimers in patients with acute aortic dissection

Objective: To evaluatel the value of D-dimers in patients with acute aortic dissection (AAD). Methods: This study consisted of 16 patients with AAD and 27 non-AAD patients. Serum D-dimets were measured by Sta-Liatest D-DI immunoturbidimetric assay. Results: D-dimer level was higher (P ＜ 0.001) in patients with AAD(7.91 ± 5.52 μg/ml) than that in non- AAD group(1.57±1.24 μg/ml). D-dimer was positive (＞0.4 μg/ml) in all patients with AAD and in 10 control group patients (37%). Among patients with acute AAD, D-dimers tended to be higher in Stanford A than in Stanford B (8.67 ± 4.31 μg/ml vs. 3.24±1.27 μg/ml, P ＜0.01). D-dimer values tended to be higher in more extended disease(3.84 ± 1.65 μg/ml, 8.57 ± 3.58 μg/ml and 11.87 ± 5.69 μg/ml in thoracic aorta, thoracic and abdominal aorta, thoracic and abdominal aorta and iliacal arteries, respectively, P ＜ 0.05 for both 8.57 ± 3.58 and 11.87 ± 5.69 vs. 3.84 ± 1.65 ). Including the control group into the analysis, we found a sensitivity of 100%, a negative predictive value of 100%, and a specificity of 66% and a positive predictive value of 64% for D-dimer in diagnosis of AAD in our patients with suspected AAD. Conclusion: D-dimer was elevated in patients with AAD. A negative D-dimer test result could be useful in excluding AAD.     

Research of combined liver-kidney transplantation model in rats

Objective： To set up a simple and reliable rat model of combined liver-kidney transplantation. Methods： SD rats served as both donors and recipients. 4℃ sodium lactate Ringer＇s was infused from portal veins to donated livers,and from abdominal aorta to donated kidneys, respectively. Anastomosis of the portal vein and the inferior vena cava （IVC） inferior to the right kidney between the graft and the recipient was performed by a double cuff method, then the superior hepatic vena cava with suture. A patch of donated renal artery was anastomosed to the recipient abdominal aorta. The urethra and bile duct were reconstructed with a simple inside bracket. Results： Among 65 cases of combined liver-kidney transplantation, the success rate in the late 40 cases was 77.5%. The function of the grafted liver and kidney remained normal. Conclusion： This rat model of combined liver-kidney transplantation can be established in common laboratory conditions with high success rate and meet the needs of renal transplantation experiment.     

Development on Adjustable Calibration Marker for Shock Wave Focus

Shock wave lithotripsy （SWL） is a treatment of choice for upper urinary stones. However, this procedure is inappropriate for obese patients because the focus is often unable to reach the target owing to the limited focal distance in shock wave source. Although treating such patients in a blast path may increase the application length of shock wave source, it＇s difficult to find this path on the lithotripter monitor. For this reason, we invented an adjustable calibration marker in order to set an effective focus in the shock wave hath.     

Study on the TCM Pathogenesis of Angiopathic Complications of Type II Diabetes

Excess production of reactive oxygen species(ROS)of mitochondrion mediated by hyperglycemia is the common pathogenesis of angiopathic complications of diabetes.TCM holds that the damp from the dysfunction of spleen.kidney and liver is the causative factor of complications of diabetes.This is similar to the mechanism of Ros resulting in angiopathic complications of diabetes.When the angiopathic complications of type II diabetes mellitus(T2DM)are difierentiated as caused by turbid damp in TCM can be explained as ROS.Since the obstruction of pathogenic damp in channels and collaterals is said to be the main pathogenesis,the treating principle should be dissolving the damp to remove the obstruction.     

Leptin, Ghrelin and TNF-α before and after Hypo-caloric Traditional Chinese Diet and Auricular Acupuncture

INTRODUCTION Obesity is a complex emergent problem, which can be possibly solved not only by the diet but also by the life style and promotion of a constant physical exercise. 1, 2 No doubt careful attentions must be given to the nutritional condition of obese people, the dietary habits, the somatic build (i.e. distribution of fat mass) and the organic functions linked to formation of the fat mass. All the parameters should be constantly monitored before, during and after a diet treatment. 3, 4, 5     

BLOOD PRESSURE CHANGE WITH AGE IN SALT-SENSITIVE TEENAGERS

Objective To observe blood pressure change with age in salt-sensitive teenagers whose salt sensitivity were determined by repeated testing.Methods Salt sensitivity was determined through intravenous infusion of normal saline combined with volume-depletion by oral diuretic furosemide in 55 teenagers. After five years, salt sensitivity was re-examined and subject blood pressure was followed up. Blood pressure changes in salt-sensitive teenagers were compared to that of non-salt sensitive teenagers over five years.Results After 5 years, the repetition rate of salt sensitivity determined by intravenous saline loading is 92.7%. In teenagers with salt sensitivity on the baseline, both the systolic blood pressure increments and increment rates were much higher than non-salt sensitive teenagers (12.7±12.1 mmHg vs. 2.8±5.2 mmHg, P＜ 0.01; 12.2%± 12.0% vs. 2.5% ±4.4%, P＜ 0.001,respectively). There was a similar trend for diastolic blood pressure (8.4 ± 6.4 mmHg vs. 3.7 ± 6.4 mmHg, P = 0.052; 13.2% ±10.6 % vs. 6.8%± 10.1%, P = 0.053, respectively).Conclusions Salt sensitivity determined by intravenous saline loading showed good reproducibility. Blood pressure increments with age were much higher in salt-sensitive teenagers than non-salt sensitive teenagers, especially in terms of systolic blood pressure.     

Relationship between Dysglycemia and Carotid Atherosclerosis in Tibetan Population

People with dysglycemia are at high risk for atherosclerotic diseases. This study aims at investigating the atherosclerotic vascular damage in dysglycemia and its metabolic origin in Tibetan population.     

APPLICATION OF LORNOXICAM TO PATIENT-CONTROLLED ANALGESIA IN PATIENTS UNDERGOING ABDOMINAL SURGERIES

FOR anesthesiologis s ,treatingpostoperativepainhas alwaysbeen a problem.Althoughopioidshave been provedtobe effective,theirsideeffectscouldnotbeignored.With thedevelopmentofscienceand pharmacology,many drugs with aspectsof satisfactoryanalgesicefficacyand couldbe welltoleratedby patientshave been developed.And lornoxicamisone of them, which isa non-steroidalanti-inflammatorydrug (NSAID ), with analgesic, anti-infl-ammatory,andantipyreticproperties.Itseliminationhalf-time(3 to 5 hours) isle…     

安心颗粒对急诊经皮冠状动脉介入术后生活质量影响的研究

目的：评价使用安心颗粒对急诊经皮冠状动脉介入术（PPCI）术后生活质量的影响.方法：将160例接受PPCI的急性ST段抬高型心肌梗死患者随机分为安心颗粒组（术前顿服安心颗粒8.8g,术后安心颗粒4.4 g/次,每日2次）和对照组（仅接受基础药物治疗）.所有患者均服用阿司匹林、氯吡格雷和阿托伐他汀.分别在入院时、出院前1d、出院后180 d时,应用心肌梗死多维度量表（MIDAS）、中文版SF-36评价量表对患者生活质量评分.并观察术后30 d以内的出血并发症、血小板减少症发生情况.结果：入院时和出院前1d,两组患者的心肌梗死MIDAS、SF-36量表评分比较无差异（P＞0.05）;出院后180 d时,与对照组比较,安心颗粒组MIDAS、SF-36评分明显减低（P＜0.05）;组内与入院时比较,两组出院前1d、出院后180 d时,MIDAS、SF-36评分均降低（P＜0.05）.两组患者在随访期间均无大量出血、少量出血、重度和极重度血小板减少症发生,安心颗粒组有4例、对照组有7例发生不明显出血（P＞0.05）.两组发生轻度血小板减少症的患者数比较无差异（P＞0.05）.结论：PPCI使用安心颗粒,能改善急性ST段抬高型心肌梗死患者的生活质量,且不增加出血风险.     

CLINICAL SIGNIFICANCE OF SERUM CYTOKINES IL-1β,sIL-2R,IL-6,TNF-α,AND IFN-v IN ACUTE CORONARY SYNDROME

Objectives To explore serum cytokines levels (including IL-1 β, sIL-2R, IL-6, TNF-α, and IFN-v) and their significance in patients with acute coronary syndrome (ACS) and the subsequent follow-ups, with attempt to estimate the role of various serum inflammatory markers in the diagnosis and assessment of ACS.Methods The study population include 40 patients with acute myocardial infarction (AMI), 40 patients with unstable angina pectoris (UAP), and 40 controls. Among the 80 patients, 60 patients attended a follow up 4 months later. Serum inflammatory markers including IL-1 β, sIL-2R, IL-6, TNF-α, and IFN-v were measured by enzyme linked immunosorbent assay.Results Serum IL- 1 β, sIL-2R, IL-6, TNF-α were significantly higher in AMI group or UAP group compared to the control group and became significantly lower 4 months later in the follow-up patients. Serum levels of IFN-v shows no significant difference between AMI group or UAP group and controls, also showing no significant change when measured in follow up patients. There was no correlation between serum creatine kinase-MB isoenzyme levels and serum inflammatory markers either in UAP or AMI group. Furthermore, when divided into two subgroups using Wagner's QRS scoring system in the AMI group, there is no difference of each serum inflammatory marker between ≤ 6 scores group and ＞ 6 scores group.Conclusion Serum levels of certain inflammatory markers may have some diagnostic value for ACS, and can be a useful marker reflecting disease stability.