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1.
目的观察匹伐他汀钙治疗高胆固醇血症的安全性和有效性。方法采用随机、双盲、阳性药物平行对照方法,将入选的高胆固醇血症48例经4周停用降血脂药物处理后,随机接受A药(匹伐他汀钙每日1 mg,A组)、B药(匹伐他汀钙每日2 mg,B组)和C药(辛伐他汀胶囊每日20 mg,C组)治疗,疗程8周。分别于治疗前、治疗4周及8周末检测计算血清低密度脂蛋白胆固醇(LDL-C)、总胆固醇(TC)、甘油三酯(TG)、高密度脂蛋白胆固醇(HDL-C)改变百分数,并记录血常规、尿常规、心电图、血生化检测结果及不良反应发生情况,分析降脂效果和安全性,并对3组进行比较。结果治疗前3组年龄、性别、身高、体重、收缩压、舒张压、心率以及LDL-C、TC、TG水平比较差异均无统计学意义(P>0.05);HDL-C水平比较差异有统计学意义(P<0.05),行Kruskal-Wallis检验,发现B组与C组比较差异有统计学意义(P<0.05)。与治疗前比较,治疗4周和8周末3组LDL-C、TG、TC水平均下降,差异有统计学意义(P<0.05)。3组血脂改变百分数比较差异均无统计学意义(P>0.05)。3组均未出现严重不良反应及紧急破盲事件,且无未预知的不良反应发生。结论临床使用匹伐他汀钙每日1~2 mg治疗高胆固醇血症,能有效降低LDL-C、TC、TG水平,效果确切、安全。  相似文献   

2.
《Clinical therapeutics》2022,44(10):1310-1325
PurposePitavastatin is a unique lipophilic statin with moderate efficacy in lowering LDL-C levels by 30% to 50% with a tolerable safety profile. However, the efficacy of adding ezetimibe to pitavastatin in patients with dyslipidemia has not been well investigated. Therefore, the objective of this double-blind, multicenter, randomized, Phase III study was to compare the efficacy and safety of pitavastatin and ezetimibe combination therapy with those of pitavastatin monotherapy in Korean patients with primary hypercholesterolemia.MethodsKorean men and women aged >19 and <80 years with primary hypercholesterolemia requiring medical treatment were included in this study. During the 8-week screening period, all patients were instructed to make therapeutic lifestyle changes. The screening period consisted of a 4-week washout period and a placebo run-in period (4–8 weeks). During treatment period I, patients were randomly assigned to receive 1 of 4 treatments: pitavastatin 2 mg plus ezetimibe 10 mg, pitavastatin 2 mg, pitavastatin 4 mg plus ezetimibe 10 mg, or pitavastatin 4 mg. The 8-week double-blind treatment period then commenced. Adverse events (AEs), clinical laboratory data, and vital signs were assessed in all patients.FindingsThe percentages in LDL-C from baseline after 8 weeks of double-blind treatment decreased significantly in the pooled pitavastatin/ezetimibe (–52.8% [11.2%]) and pooled pitavastatin (–37.1% [14.1%]) groups. Treatment with pitavastatin/ezetimibe resulted in a significantly greater LDL-C–lowering effect than that with pitavastatin (difference, –15.8 mg/dL; 95% CI, –18.7 to –12.9; P < 0.001). The precentages of achieving LDL-C goal in pooled pitavastatin/ezetimibe and pooled pitavastatin groups were 94.2% and 69.1%, respectively (P < 0.001). There were no significant differences in the incidence of overall AEs and adverse drug reactions. Serious AEs were comparable between the groups.ImplicationsPitavastatin and ezetimibe combinations effectively and safely decreased LDL-C levels by >50% in patients with dyslipidemia. The safety and tolerability of pitavastatin and ezetimibe combination therapy were comparable with those of pitavastatin monotherapy. ClinicalTrials.gov identifier: NCT04584736.  相似文献   

3.
目的探讨缓释型氟伐他汀和速释胶囊型氟伐他汀对高脂血症患者动脉僵硬度的影响。方法将139例混合型高脂血症患者按随机数字表法分为速释胶囊型氟伐他汀组(68例)和缓释型氟伐他汀组(71例)。速释胶囊型氟伐他汀组给予氟伐他汀40mg,口服,2次·d^-1,治疗12周;缓释型氟伐他汀组给予缓释型氟伐他汀80mg,口服,1次·d^-1,治疗12周。用SphygmoCor动脉脉搏波分析仪测定2组患者脉搏波传导速度(PWV)及增强指数(AIx)值,观察其数值的变化。结果缓释型氟伐他汀组治疗后,AIx及PWV数值均较速释胶囊型氟伐他汀组明显降低(均P〈0.05)。结论与速释胶囊型氟伐他汀相比,缓释型氟伐他汀更有效地降低动脉僵硬度。选择使用缓释型氟伐他汀治疗混合型高脂血症患者是较为合适的治疗方案。  相似文献   

4.
目的:观察依折麦布联合阿托伐他汀钙对严重高脂血症患者降脂的疗效与安全性。方法选择原发性高胆固醇血症患者88例,随机分为两组。阿托伐他汀钙组予以阿托伐他汀钙,20mg/d;联合治疗组予以阿托伐他汀钙,20mg/d,并加用依折麦布,10mg/d,两组均治疗10w。比较两组患者治疗后的血脂参数变化率、血脂达标率及不良反应发生率。结果治疗10w后,两组的TC、LDL-C、TG的变化率具有差异性差异,有统计学意义(P<0.01);联合用药组疗效明显优于阿托伐他汀钙组。不良反应发生率两组间差异无统计学意义(P>0.05)。结论依折麦布联合阿托伐他汀钙具有较好的调节胆固醇代谢作用,优于单药使用,其安全性和耐受性均较好。  相似文献   

5.
The purpose of the study was to evaluate the efficacy and safety of a new formulation of colestipol provided in table form. This was a randomized, double-blind, placebo-controlled, multicenter, dose-ranging study. A total of 196 patients with primary hypercholesterolemia who were following a low-fat, low-cholesterol diet (NCEP Step I diet), and having mean low-density lipoprotein cholesterol (LDL-C) levels greater-than-or-equal4.14 mmol L(minus sign1) (160 mg dl(minus sign1)) and less-than-or-equal6.46 mmol L(minus sign1) (250 mg dl(minus sign1)) were studied. Study medication was taken twice daily, with breakfast and supper, for 8 weeks. The five parallel treatment groups consisted of colestipol tablets 1, 2, 4, and 8 g BID, and matching placebo tablets BID. The main outcome measures were absolute change and percent change from baseline in selected lipid, lipoprotein, and apolipoprotein measurements; LDL-C was considered primary. Statistically significant (p less-than-or-equal 0.05) dose-dependent reductions in LDL-C from 5.2% to 25.8% and in total cholesterol from 2.8% to 16.8% were observed. Colestipol tablet treatment also resulted in statistically significant dose-dependent increases in LpAl levels reaching 25.8% at 16 g day(minus sign1). The treatment was well tolerated, and no serious adverse events were reported. Colestipol administered in tablet form was efficacious in lowering LDL-C and total cholesterol and was well tolerated in patients with primary hypercholesterolemia.  相似文献   

6.

Background

Pitavastatin, a fully synthetic β-hydroxy-β-methylglutaryl–coenzyme A reductase inhibitor, is potent for the treatment of primary hyperlipidemia and mixed dyslipidemia. Recently, the original product and some generic products of pitavastatin calcium have become available in China. However, the intrasubject variability and interchangeability of this newly developed generic product and the branded innovator product have rarely been investigated in the Chinese population.

Purpose

The aim of this study is to develop and compare the scaled-average, population, and individual bioequivalence (BE) of pitavastatin calcium tablets in healthy Chinese volunteers. This study will be used to allow for the interchangeability (switchability and prescribability) of the 2 products in clinical medication in China.

Methods

A single-dose, reference-replicated, 3-period crossover BE study was conducted in 36 healthy male volunteers. Plasma samples were collected before and after oral administration of 2-mg test or reference tablets. A LC-MS/MS method was used to determine the concentration of pitavastatin calcium. A noncompartmental method was used to investigate the pharmacokinetic parameters. The ANOVA and 90% CIs of ln(AUC0–t) and ln(Cmax) were used for statistical analysis of scaled-average BE. A nonparametric test (Wilcoxon signed rank test) was performed to Tmax. The analyses of population BE and individual BE were used to assess the switchability and prescribability of the 2 products.

Findings

Thirty-six volunteers were enrolled in this clinical research; 33 volunteers completed the 3 treatment periods. The mean (SD) relative bioavailability calculated from the ratios (T/R) of AUC0–t was 101.3% (19.7%). The mean ln(AUC0–t) and ln(Cmax) were 98.64 (90% CI, 93.44–104.13) and 98.68 (90% CI, 91.88–105.99) within previously stipulated ranges recommended by the US Food and Drug Administration and the China Food and Drug Administration (CFDA). The intrasubject %CVs of AUC0–t and Cmax were 12.0% and 18.0% for the reference tablet and 13.0% and 17.0% for the test tablet. No significant differences were found among Tmax (0.742 ± 0.276, 0.674 ± 0.202, and 0.689 ± 0.226, respectively) for reference tablet 1, reference Supplemental Table II in the online version at 10.1016/j.clinthera.2014.06.21, and test tablet by a Wilcoxon test (P > 0.05). For ln(AUC0–t) and ln(Cmax), the statistical test-reference ratios were 99.13% and 98.95%, respectively. After inspecting the results for reference and mixed scaling, all the upper confidence limits were <0; therefore, population and individual BE were given.

Implications

In the healthy Chinese males, the generic and branded name tablets of pitavastatin calcium are bioequivalent at the rate and extent of absorption after a comparison of scaled-average, population, and individual BE and thus may be used interchangeably. Both the formulations are generally well tolerated. Chinese Clinical Trial identifier: ChiCTR-TTRCC-13003973.  相似文献   

7.
《Clinical therapeutics》2020,42(10):2021-2035.e3
PurposeDyslipidemia is an important risk factor for cardiovascular disease (CVD). Statins are known to effectively reduce not only low-density lipoprotein cholesterol (LDL-C) level but also death and nonfatal myocardial infarction due to coronary heart disease. The risk for CVD from atherogenic dyslipidemia persists when elevated triglyceride (TG) and reduced high-density lipoprotein cholesterol (HDL-C) levels are not controlled with statin therapy. Therefore, statin/fenofibrate combination therapy is more effective in reducing CVD risk. Here, we assessed the efficacy and tolerability of pitavastatin/fenofibrate combination therapy in patients with mixed dyslipidemia and a high risk for CVD.MethodsThis multicenter, randomized, double-blind, parallel-group, therapeutic-confirmatory clinical trial evaluated the efficacy and tolerability of fixed-dose combination therapy with pitavastatin/fenofibrate 2/160 mg in Korean patients with a high risk for CVD and a controlled LDL-C level (<100 mg/dL) and a TG level of 150–500 mg/dL after a run-in period with pitavastatin 2 mg alone. In the 8-week main study, 347 eligible patients were randomly assigned to receive pitavastatin 2 mg with or without fenofibrate 160 mg after a run-in period. In the extension study, patients with controlled LDL-C and non–HDL-C (<130 mg/dL) levels were included after the completion of the main study. All participants in the extension study received the pitavastatin/fenofibrate combination therapy for 16 weeks for the assessment of the tolerability of long-term treatment.FindingsThe difference in the mean percentage change in non–HDL-C from baseline to week 8 between the combination therapy and monotherapy groups was −12.45% (95% CI, −17.18 to −7.72), and the combination therapy was associated with a greater reduction in non-HDL-C. The changes in lipid profile, including apolipoproteins, fibrinogen, and high-sensitivity C-reactive protein from baseline to weeks 4 and 8 were statistically significant with combination therapy compared to monotherapy at all time points. Furthermore, the rates of achievement of non–HDL-C and apolipoprotein B targets at week 8 in the combination therapy and monotherapy groups were 88.30% versus 77.98% (P = 0.0110) and 78.94% versus 68.45% (P = 0.0021), respectively. The combination therapy was well tolerated, with a safety profile similar to that of statin monotherapy.ImplicationsIn these Korean patients with mixed dyslipidemia and a high risk for CVD, combination therapy with pitavastatin/fenofibrate was associated with a greater reduction in non–HDL-C compared with that with pitavastatin monotherapy, and a significantly improvement in other lipid levels. Moreover, the combination therapy was well tolerated, with a safety profile similar to that of statin monotherapy. Therefore, pitavastatin/fenofibrate combination therapy could be effective and well tolerated in patients with mixed dyslipidemia. ClinicalTrials.gov identifier: NCT03618797.  相似文献   

8.
目的:观察奥氮平治疗脑外伤后精神障碍的疗效和安全性。方法:脑外伤后精神障碍患者68例,给予奥氮平治疗,分别于治疗前及治疗2、4、8周后,采用简明精神病评定量表(BPRS)、临床疗效总评量表(CGI)及治疗副反应量表(TESS)评定疗效及副反应。结果:完成治疗及评定患者60例,奥氮平治疗2、4、8周后,患者的BPRS及CGI评分均较治疗前下降(P<0.05),总有效率95%。仅2例出现恶心、体重增加、血糖轻度增高等副反应。结论:奥氮平能较好控制脑外伤后精神症状,且副反应低。  相似文献   

9.
《Clinical therapeutics》2022,44(10):1272-1281
PurposeThis study aimed to show that the efficacy of 1PC111 is superior to that of either ezetimibe or pitavastatin alone (monotherapy) for the treatment of hypercholesterolemia.MethodsThis was a multicenter, randomized, double-blind, Phase III study. Patients with hypercholesterolemia or mixed dyslipidemia were randomized to receive 1PC111 (which was a fixed-dose combination of pitavastatin 2 mg and ezetimibe 10 mg), pitavastatin 2 mg, or ezetimibe 10 mg daily for 12 weeks. The primary end point was the difference in the percent change in LDL-C from baseline to week 12 between the 1PC111 and each monotherapy group. The secondary end points were the percent change in other lipid profiles from baseline to each visit. All patients were assessed for adverse events until end of study.FindingsA total of 388 patients were randomly assigned to the 1PC111 (n = 128), pitavastatin (n = 132), or ezetimibe (n = 128) group. Generally, baseline characteristics were similar among the 3 groups. A statistically significant decrease in the LDL-C level at week 12 was observed in the 1PC111 group (–50.50% [14.9%]) compared with either the pitavastatin (–36.11% [11.4%]; P < 0.001) or ezetimibe (–19.85% [12.4%]; P < 0.001) group. Also, there was a statistically significant difference between 1PC111 and each monotherapy group in the reduction in total cholesterol, non–HDL-C, and apolipoprotein B levels. Moreover, there was a trend toward more efficient lowering of LDL-C levels in elderly patients (age ≥65 years) than in younger patients (age <65 years) by 1PC111 treatment. In patients given a class I recommendation for atherosclerotic cardiovascular disease prevention, the percentage of patients achieving the LDL-C target of <100 mg/dL at week 12 was significantly higher in the 1PC111 group than in both monotherapy groups (P < 0.001). Overall, the incidence of adverse events was similar among 3 groups.Implications1PC111 was more effective in improving lipid profiles and achieving the LDL-C goal than pitavastatin or ezetimibe alone for hypercholesterolemia treatment. Furthermore, 1PC111 may provide more benefit in treating elderly patients. ClinicalTrials.gov identifier: NCT04643093.  相似文献   

10.
目的探讨临床路径在轮状病毒肠炎患儿护理中的应用效果。方法便利抽样法选取2009年8月至2010年7月嘉兴市第二医院儿科收治的45例轮状病毒肠炎患儿作为对照组,同法选取2010年8月至2011年7月收治的45例轮状病毒肠炎患儿作为观察组。观察组患儿采用临床路径(clinical pathway,CP)进行护理,对照组采用传统护理方法,比较两组患儿平均住院日、人均住院费用、患儿及家属满意度、健康教育知识掌握情况等。结果观察组患儿的平均住院日、人均住院费用均低于对照组,差异有统计学意义(均P<0.01);且患儿及家属的满意度、健康教育知识掌握情况明显优于对照组,差异有统计学意义(均P<0.01)。结论实施临床路径护理能够缩短轮状病毒肠炎患儿的平均住院日,减少医疗费用,提高患儿及其家属对医疗护理工作的满意度。  相似文献   

11.
静脉应用维拉帕米治疗快速型心房颤动的临床观察   总被引:1,自引:0,他引:1  
目的:探讨静脉应用维拉帕米对快速型心房颤动的临床价值。方法:对38例快速型心房颤动患者采用维拉帕米静脉注射,观察用药手5、10、15、20、30min心室率变化情况。结果:用药后30min内心室率明显减慢,呈显效27例、有效11例,总有效率为100%。结论:对快速型心房颤动患者静脉应用维拉帕米治疗安全、有效。  相似文献   

12.
两种呼吸道湿化法对气管切开患者的影响   总被引:1,自引:0,他引:1  
目的比较气管切开患者呼吸道内间断湿化法与输液泵持续湿化法的临床效果。方法选取2008年11月至2009年5月某院行气管切开的患者50例,按住院病例单双号分为两组。实验组25例患者采用输液泵持续湿化,对照组25例患者采用呼吸道内间断湿化。比较两组患者痰痂形成、发生刺激性咳嗽、呼吸道黏膜出血及肺部感染情况。结果实验组痰痂形成、发生刺激性咳嗽、呼吸道黏膜出血的例数明显少于对照组(P<0.01),肺部感染发生率亦低于对照组(P<0.05)。结论输液泵持续呼吸道湿化可以明显减少痰痂形成、刺激性咳嗽、呼吸道黏膜出血及肺部感染的发生。  相似文献   

13.
目的 :观察氟伐他汀对高脂血症患者血小板CD6 2p、CD6 3及纤维蛋白原的影响。方法 :测定 5 0例高胆固醇血症和混合性高脂血症患者 (治疗组 )降脂治疗前和治疗 (氟伐他汀 4 0mg/d) 8周后及 5 0例健康者 (对照组 )的血脂、血小板CD6 2 p、CD6 3及纤维蛋白原 (Fg)。结果 :治疗组患者CD6 2 p、CD6 3、Fg较对照组明显增高 (P <0 .0 1) ,氟伐他汀治疗 8周后CD6 2p、CD6 3及Fg较治疗前明显下降 (P <0 .0 1)。结论 :氟伐他汀治疗高脂血症患者 ,在有效调脂的同时 ,可抑制血小板活性及降低纤维蛋白原  相似文献   

14.
Susan Thys-Jacobs  M.D. 《Headache》1994,34(10):590-592
SYNOPSIS
Two postmenopausal migraineurs who developed frequent and excruciating migraine headaches (one following estrogen replacement therapy and the other following a stroke) were treated with combination vitamin D and calcium. Therapeutic replacement with vitamin D and calcium resulted in a dramatic reduction in the frequency and duration of their migraine headaches.  相似文献   

15.
16.
目的:研究调肠消炎片对三硝基苯磺酸(TNBS)诱导的大鼠溃疡性结肠炎(UC)的治疗作用机制.方法:利用TNBS制造UC大鼠模型,从结肠组织形态学、炎症因子水平、抗氧化损伤作用方面考察调肠消炎片对TNBS诱导的大鼠UC的治疗作用以及作用机制.结果:调肠消炎片可减轻溃疡性大鼠结肠组织病理学变化;显著减轻结肠组织损伤(P<0.05或P<0.01);显著降低血清与结肠组织丙二醛(MDA)含量(P<0.01),显著提高血清与结肠组织超氧化物歧化酶(SOD)水平(P<0.05或P<0.01);显著抑制血清白细胞介素6(IL-6)及肿瘤坏死因子(TNF-α)炎症因子的表达(P<0.05或P<0.01).结论:调肠消炎片对TNBS诱导的大鼠UC有较好的治疗作用.其作用机制可能与促进结肠修复,降低自由基损伤,抗炎修复、调节细胞因子水平有关.  相似文献   

17.
术前提高血钙浓度对剖宫产产后出血的影响   总被引:1,自引:0,他引:1  
目的:探讨术前应用葡萄糖酸钙对剖宫产产后出血的有效性及安全性。方法:对709例患者采用随机对照的方法进行研究。研究组术前30 min静脉滴注10%葡萄糖酸钙10 mL,对照组静脉滴注生理盐水100 mL,分别于术中胎儿娩出时、术后2 h测定血清钙离子的浓度,并用容积法和称重法对两组出血量进行对比观察。结果:胎儿娩出时和术后2 h研究组血清钙高于对照组(P<0.01);研究组平均出血量和产后出血的发生率低于对照组(P<0.01);术前血钙浓度高的产后出血量少(P<0.01);不同剖宫产指征的出血量比较研究组低于对照组(P<0.01);各项指标均具统计学意义。结论:术前提高血钙浓度可减少剖宫产产后出血量,并未见副作用。  相似文献   

18.
目的探讨无抽搐电休克对精神分裂症患者阴性症状的治疗效果及安全性。方法选取2014年12月~2015年11月我院收治的138例精神分裂症患者作为研究对象,按照随机数字表法分为研究组和对照组,每组69例。对照组在使用利培酮治疗的基础上进行传统电休克治疗,观察组在使用利培酮治疗的基础上进行无抽搐电休克治疗。比较两组患者治疗总有效率、治疗前后PANSS评分及不良反应发生率的差异。结果研究组治疗总有效率为75.4%,对照组为56.5%,研究组比对照组高(P〈0.05);治疗后4w、治疗后8w,研究组患者阴性症状、阳性症状、精神病理和PANSS总分等均比对照组低(P〈0.05);两组不良反应发生率比较无统计学差异(P〉0.05)。结论无抽搐电休克对以阴性症状为主的精神分裂症疗效突出,能有效改善患者症状,且不良反应少,值得临床推广使用。  相似文献   

19.
关节镜术后患者局部冰敷的临床效果   总被引:1,自引:0,他引:1  
目的探讨关节镜术后患者局部冰敷与非冰敷的临床效果,以寻求更为有效的实施方法。方法行关节镜手术患者120例,按术后不冰敷(观察组)与冰敷1、6、24h随机分为4组,观察疼痛度、足趾氧饱和度、负压引流量、足背动脉搏动。结果在减轻疼痛方面,观察组和对照组术后1h对比差异有统计学意义(P〈0.05),而术后6、24、48h差异无统计学意义(P〉0.05);负压引流量比较,术后1h和48h对比差异有统计学意义(P〈0.05),而6、24h对比差异无统计学意义(P〉0.05);足趾氧饱和度和足背动脉搏动比较,两组差异均无统计学意义(P〉0.05)。结论关节镜术后局部冰敷1h是恰当的,既能起到减轻疼痛、减少渗出和引流的作用,又不会因为冰敷影响患肢的末梢血液循环。  相似文献   

20.
周美玉  徐娟  徐才刚 《华西医学》2010,25(6):1019-1022
目的总结多发性骨髓瘤(multiple myeloma,MM)的发病特征及临床特征,分析比较不同治疗方案对MM的疗效及不同类型与不同临床特征的MM治疗效果。方法回顾性分析2003年1月2008年1月128例MM患者的发病和临床特征,以及与治疗效果的关系,并对不同治疗方案、不同类型间的疗效进行比较。结果 MM患者发病的中位年龄为59岁,临床上以不明原因的骨痛、贫血、感染和球蛋白增高为主要表现。128例患者中行方案一(马法兰、强的松/地塞米松、反应停)的总有效率为53.3%(32/60);方案二(环磷酰胺、长春新碱、马法兰、强的松、卡氮芥、阿霉素)为44.4%(8/18);方案三(长春新碱、阿霉素/表阿霉素/脂质体阿霉素、地塞米松)为68.5%(24/35),方案四(硼替佐米、地塞米松/反应停)的总有效率为86.6%(13/15)。方案一和方案二间、方案三和方案四间疗效差异无统计学意义(P〉0.05),方案三、方案四的疗效均优于方案一和方案二(P〈0.05)。IgG型总有效率为63.2%(48/76),IgA型为60.9%(14/23),kappa轻链型为42.8%(6/14),lammda轻链型为46.2%(6/13)。IgG型和IgA型间的疗效差异无统计学意义(P〉0.05),但IgG型、IgA型的疗效均优于kappa轻链型和lammda型(P〈0.05)。不同类型及使用不同方案的患者,其中位生存期及3年和5年的生存率差异无统计学意义(P〉0.05)。结论 MM患者发病高峰年龄介于40~70岁,骨痛和贫血是最常见的首发症状。长春新碱、阿霉素/表阿霉素/脂质体阿霉素、地塞米松以及硼替佐米、地塞米松/反应停方案总体疗效相当,但后者完全缓解率高于前者。  相似文献   

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