格列齐特胶囊人体生物等效性研究

目的 :采用高效液相色谱法测定格列齐特的血药浓度 ,进行两种格列齐特胶囊人体生物等效性比较研究。方法 :12位健康男性受试者采用自身交叉给药方案 ,分别单剂量口服 80mg试验品或对照品。结果 :试验品的主要药代动力学参数分别为AUC0～ 36=(10 0 .19± 10 .34) μg/ (ml·h) ,Cmax=(6 .5 9± 0 .5 9) μg/ml,Tpeak=(4 .33± 1.0 7)h ;对照品的参数分别为AUC0～ 36=(10 3 .41± 9.2 5 ) μg/ (ml·h) ,Cmax=(6 .75± 0 .6 0 ) μg/ml,Tpeak=(4 .5 8± 1.0 8)h ,两制剂的AUC0～ 36、Cmax及Tpeak均无显著性差异。试验品相对于对照品的生物利用度为 (96 .99± 6 .6 2 ) %。结论 :两制剂体内过程相仿 ,具有生物等效性     

国产与进口降糖药瑞格列奈片的生物等效性研究

目的 :评价国产与进口降糖药瑞格列奈片的生物等效性。 方法 :2 2名男性健康志愿者双周期随机交叉单剂量口服国产与进口瑞格列奈片 4m g,服药间隔为 1周 ,高效液相色谱法测定血浆中瑞格列奈浓度。 结果 :国产与进口片 t1 / 2 分别为(0 .86± 0 .2 4)和 (0 .83± 0 .31) h;tmax分别为 (0 .79± 0 .37)和 (0 .75± 0 .41) h;cmax分别为 (5 2 .43± 2 0 .92 )和 (5 3.32±2 4.94) μg/ L;AU C0 - t分别为 (79.87± 36 .48)和 (74.95± 30 .5 7) μg· h· L- 1。单剂量口服国产瑞格列奈片的相对生物利用度为 (10 6 .5 5± 16 .15 ) %。 结论 :方差分析和双向单侧 t检验结果表明两种制剂具有生物等效性。     

吉非罗齐胶囊在健康人体内的相对生物利用度

目的 :研究吉非罗齐胶囊在健康人体内的相对生物利用度。方法 :采用高效液相色谱 (HPLC)法测定 18名男性健康受试者单剂量交叉口服 90 0mg 2种吉非罗齐胶囊后不同时间血浆中的药物浓度。结果 :二者药 时曲线均符合一房室模型 ,Cmax分别为 (45 .2 4± 10 .15 )mg·L-1和 (43.38± 9.84 )mg·L-1;Tmax分别为 (2 .4 7± 0 .93)h和 (2 .2 5±0 .75 )h ;T1/ 2 分别 (1.5 9± 0 .19)h和 (1.75± 0 .2 9)h ;AUC分别为 (16 5 .79± 37.79)mg·h·L-1和 (15 6 .39± 32 .2 8)mg·h·L-1。被试制剂的相对生物利用度为 (95 .5 5± 11.4 5 ) % (77.0 3%～ 119.4 5 % )。结论 :2种制剂具有生物等效性。     

尼莫地平在健康人体内的药动学和相对生物利用度

目的 :研究尼莫地平在健康人体内的药动学和相对生物利用度。方法 :8名健康受试者单剂量随机交叉口服尼莫地平标准参比制剂和待测制剂 1 2 0mg,采用HPLC法测定用药后不同时间的血药浓度。结果 :2种制剂的体内过程均符合一房室开放模型 ,AUC分别为 (1 4 3.1± 9.9) μg·h·L-1 和 (1 37.0± 7.3) μg·h·L-1 ,Cmax分别为 (83.1±7.4 ) μg·L-1 和 (80 .8± 4 .6 ) μg·L-1 ,Tmax分别为 (1 .0 0± 0 .0 0 )h和 (1 .0 6± 0 .1 7)h。待测制剂的相对生物利用度为 (96 .0± 5 .9) %。经双向单侧t检验证明 ,2种制剂的AUC、Cmax相比 ,差异均无统计学意义。结论 :2种制剂具有生物等效性。     

格列吡嗪片健康人体生物等效性研究

目的　研究格列吡嗪片在健康人体内的生物等效性。方法　 9名健康受试者单剂量随机交叉口服格列吡嗪片参比制剂和被试制剂 5mg,采用HPLC法测定用药后不同时间的血药浓度。结果　二制剂健康人体的体内过程均符合一房室开放模型 ,Tmax分别为 (3 0± 0 )h和 (3 0± 0 )h ,Cmax分别为 (30 5± 2 2 ) μg·L-1和 (2 99± 13) μg·L-1;T1/2 分别 (3 2 4± 0 37)h和 (3 2 2± 0 4 0 )h ;AUC分别为 (14 90± 70 ) μg·h·L-1和 (14 90± 70 ) μg·h·L-1。被试制剂的相对生物利用度为 (10 0 4± 7 8) %。结论　方差分析和单双侧t检验证明 ,两种制剂具有生物等效性     

头孢克肟胶囊在健康人体内的相对生物等效性

目的 :比较国产和进口头孢克肟胶囊在健康人体内的药代动力学及相对生物等效性 ,确保临床用药质量 .方法 :采用标准二阶段交叉设计自身对照试验法 ,12名男性健康志愿受试者分别口服单剂量两种头孢克肟胶囊 ,用RP HPLC法测定血清中头孢克肟的浓度 ,以双向单侧检验统计法比较 2种头孢克肟胶囊之间的差异 .结果 :国产和进口头孢克肟胶囊在健康志愿者体内的药时曲线均符合血管外给药一室开放模型 ,其主要的药代动力学参数Tmax分别为 (3 .3 9± 0 .5 0 )和(3 .3 3± 0 .4 8)h ,ρmax、AUC( 0～ 2 4h) 分别为 :(2 .97± 0 .5 4 )和 (2 .83±0 .5 5 )mg·L-1;(2 5 .88± 3 .75 )和 (2 4 .67± 4 .3 0 ) (mg·h-1·L-1) ,药动学参数间均无统计学差异 (P >0 .0 5 ) ,国产胶囊对进口胶囊的相对生物利用度为 10 4 .9% .结论 :两种头孢克肟胶囊在健康志愿者体内具有生物等效性     

格列齐特片健康人体药物动力学及相对生物利用度

目的　研究格列齐特片的健康人体药物动力学及相对生物利用度。方法　 8例健康受试者单剂量交叉口服格列齐特片标准参比制剂和被试制剂 80mg后 ,用高效液色谱法测定血浆中格列齐特片浓度。结果　两药体内过程均符合一房室开放模型 ,Tmax分别为 (5 5 0± 0 5 3)h和 (5 0 0± 0 5 3)h ,Cmax为 (2 95± 0 4 1)mg·L-1和 (3 0 2± 0 31)mg·L-1,AUC为 (45 79± 5 99)mg·h·L-1和 (42 99± 6 93)mg·h·L-1,被试制剂的相对生物利用度为 (10 2 9± 8 2 ) %。两种制剂的药动学参数无显著性差异。结论　两种制剂具有生物等效性。     

格列吡嗪片在健康人体内的药物动力学及相对生物利用度

目的 :研究格列吡嗪片在健康人体的药物动力学及相对生物利用度。方法 :9名健康受试者单剂量随机交叉口服格列吡嗪片参比制剂和被试制剂 5mg ,采用HPLC法测定用药后不同时间的血药浓度。 结果 :2种制剂的体内过程均符合一房室开放模型 ,Tmax分别为 (3 .67± 0 .50 )h和 (3 .33± 0 .50 )h。Cmax分别为 (391± 37) μg·L- 1和 (40 0± 35) μg·L- 1 ,AUC分别为 (2 .46± 0 .39) μg·h·L- 1 和 (2 .2 3± 0 .88) μg·h·L- 1 ,被试制剂的相对生物利用度为 (1 0 2 .9± 1 5 .7) %。结论 :用NDST软件对两种制剂的AUC、Cmax、Tmax进行双单侧t检验 ,证明两种制剂具有生物等效性。     

阿奇霉素颗粒剂的健康人体药物动力学和相对生物利用度

目的 :研究阿奇霉素颗粒剂的健康人体相对生物利用度及生物等效性。方法 :8名健康受试者单剂量交叉口服阿奇霉素颗粒剂和胶囊 10 0 0mg后 ,采用微生物法测定用药后不同时间血清和尿中药物质量浓度。结果 :二者体内过程符合二房室模型 ,AUC分别为 (16 .6 9± 3.2 0 )mg·h·L-1和 (16 .95± 3.0 9)mg·h·L-1,Cmax为 (1.77±0 .42 )mg·L-1和 (1.78± 0 .6 3)mg·L-1,Tmax为 (1.88± 0 .6 4)h和 (1.88± 0 .35 )h ,2种制剂药物动力学参数及 192h尿中总排泄率差异均无显著性 (P >0 .0 5 )。阿奇霉素颗粒剂的相对生物利用度为 (10 1.97± 10 .46 ) %。结论 :2种制剂具有生物等效性     

吉非罗齐胶囊的人体相对生物等效性

目的　考察吉非罗齐在正常人体内的药代动力学过程 ,评价两种胶囊制剂的人体相对生物等效性 .方法　采用标准二阶段交叉设计自身对照试验方法 ,10例健康受试者单剂量口服两种吉非罗齐胶囊后 ,以 HPL C法测定吉非罗齐的血浆浓度 .结果　吉非罗齐的体内过程符合血管外一室开放模型 .吉非罗齐胶囊 A与 B的主要药动学参数 Tmax,Cmax,AUC(0～ 12 h)分别为 :(1.5± 0 .3)和 (1.6± 0 .4) h;(33.2±5 .5 )和 (34 .6± 5 .3) mg· L- 1 ;(134 .5± 11.2 )和 (131.7±17.0 ) m g· h· L- 1 ,经统计学处理 ,两者间无显著性差异 .结论　吉非罗齐胶囊 A相对胶囊 B的平均生物利用度为(10 3.5± 15 .3) % ,两种制剂具有生物等效性     

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…     

Dr.Zhang Ren''''s Experience in the Acupuncture Treatment of Different Diseases with the Same Therapeutic Principle

Dr.Zhang Ren,the chief physician,is the chairman of Shanghai Acupuncture and Moxibustion Association.Having been engaged in medicine for about 40 years,he is experienced in treating various intractable diseases.In his long years of clinical practice,he advocates taking the TCM differentiation as the basis to seek for the acupuncture method for treatment of modern intractable diseases.The author of this essay had the fortune to follow Dr.Zhang in study.The following is a summary of Dr.Zhang's experience in the acupuncture treatment for different intractable diseases with the same therapeutic principle.     

Luo Lingjie''''s Experience in Treating Chronic Nephropathy

In treating chronic nephropathy,Luo Lingjie,a chief physician,pays attention to regulating the balance between yin and yang,treating infection if present,and removing pathogenic factors.He prescribes gentle drugs and uses carefully strongly warming-tonifying ones,emphasizes the importance of persuading the patient to persist in treatment with medication and nurse one's health for recuperation,and is good at combined use of TCM and western medicine therapy and brings the merits of various therapies into full play,with obvious theraoeutic effects.     

Acupuncture Combined with Spinal Tui Na for Treatment of Primary Dysmenorrhea in 30 Cases

Objective: To observe the therapeutic effects in acupunture treatment of primary dysmenorrhea combined with spinal Tui Na, and study its mechanism. Methods: Thirty cases of the treatment group were treated by acupuncture combined with spinal Tui Na, and thirty cases in the control group were treated by routine acupuncture. Results: The total effective rate was 93.3% in the treatment group, and 73.3% in the control group, with a significant difference between the two groups (P<0.05). Conclusions: Acupuncture combined with spinal Tui Na has good prospects for treatment of primary dysmenorrhea.     

猪肺磷脂注射液联合经鼻持续气道正压通气对呼吸衰竭早产儿的临床疗效及肌酸激酶同工酶活性的影响

目的 探讨猪肺磷脂注射液联合经鼻持续气道正压通气(NCPAP)对呼吸衰竭早产儿的临床疗效及肌酸激酶同工酶活性(CK-MB)的影响.方法 选取呼吸衰竭早产儿80例,分为观察组和对照组各40例.对照组采用NCPAP给氧治疗,观察组给予NCPAP给氧联合猪肺磷脂气管内给药.观察两组患儿治疗前及治疗12h、24 h后PaO2、PaCO2、血氧饱和度(SaO2)、pH的变化情况,检测治疗前及治疗5d后血清CK-MB水平;评估两组患儿的临床治疗效果.结果 两组患儿PaO2、PaCO2、SaO2、pH比较,差异均有统计学意义(P＜0.05),其中观察组治疗后的PaO2、SaO2、pH均高于对照组,PaCO2则低于对照组.两组的PaO2、SaO2、pH均随观察时间延长而升高(P＜0.05),PaCO2均随观察时间的延长而降低(P＜0.05).观察组治疗有效率为87.5％,显著高于对照组的70.0％ (P ＜0.05).治疗5d后两组患儿血清CK-MB水平均较前降低(P＜0.05),且观察组明显低于对照组(P＜0.05).结论 猪肺磷脂注射液气管内给药联合NCPAP可以显著降低呼吸衰竭早产儿CK-MB的含量,提高治疗有效率,起到很好的呼吸循环支持作用.     

Survey and practice of reporting quality of randomized controlled clinical trials on traditional Chinese medicine

Evidence obtained from randomized controlled trials （RCTs） has been generally accepted as the gold standard in the evaluation of clinical effectiveness. Readers need to understand the trial design, implementation, results, analysis and interpretation, so as to fully Jnderstand the results of RCTs. Thus, the investigators of RCTs have to report these items in a complete, accurate and clear manner. Since 1998, we have conducted several evaluations on the reporting quality of RCTs published in Chinese journals on traditional Chinese medicine （TCM） and results have shown that there is an urgent need for higher quality RCTs on TCM.     

TCM Treatment of Ankylosing Spondylitis by Tonifying the Kidney and Strengthening the Governor Vessel

Ankylosing spondylitis is a chronic and progressive disorder with inflammation mainly involving the central axis joints. It mainly affects the cervical spine and the lumbosacral area, with the pathogenesis closely related to the kidney and the Governor Vessel (GV). TCM holds that the syndrome is deficiency in origin and excess in superficiality, which is due to insufficiency of the kidney, deficiency of GV, and blocking of the channels with the invasion of exogenous evil, leading to poor circulation of qi and blood and malnutrition of the bones, muscles and joints. The TCM method of tonifying the kidney and strengthening GV to regulate circulation of qi and blood and check the arthralgia pain should be adopted, with the Kidney-Tonifying and GV Strengthening Decoction (益肾强督汤) prescribed.     

IMPROVING P-gp EXPRESSION IN HUMAN MONONUCLEAR CELLS IN VITRO TRANSFECTED BY MULTIDRUG RESISTANCE-1 mRNA

CHEMOTHERAPY playsa greatrolein the treat- ment of malignanttumors,especiallyingynecolo- gicalones.But inanticancerchemotherapy,leuko-cytopeniaisfrequentlytheprimarydose-limitingsideeffect factor.Moreover,cancersarefrequentlychemoresistantbe-causeof overexpressionof P-glycoprotein(P-gp), which isencodedby multidrugresistancegene (MDR1 ) and detectableinup to50% ofhuman cancersand renderscellsresistancetoanticancerdrugs.The safetyand potentialtherapeuticbenefitof mdr1 gene transferredto h…