克拉霉素胶囊的人体相对生物利用度研究

目的：研究健康中国青年志愿者单剂量口服克拉霉素后的药代动力学和相对生物利用度。方法：采用微生物法测定,血药浓度—时间数据用３Ｐ９７ 程序拟合计算药动学参数与生物利用度。结果：国产克拉霉素胶囊试验品与进口克拉霉素片剂对照品的Ｔｍ ａｘ分别为（１．２６±０．３６） ｈ 和（１．３２±０．３５） ｈ,Ｃｍａｘ分别为（２．４５６±０．４３０） ｍ ｇ／Ｌ和（２．２４６±０．３３８） ｍ ｇ／Ｌ,ＡＵＣ０－ ２４ｈ分别为（１５．１８９±２．７１８） ｍ ｇ／（Ｌ·ｈ）和（１５．６５１±２．５５７） ｍ ｇ／（Ｌ·ｈ）。经配对ｔ检验、方差分析检验差异无显著性（Ｐ＞ ０．０５）。结论：国产克拉霉素胶囊和进口克拉霉素片剂具有生物等效性。     

罗红霉素颗粒剂人体生物利用度研究

１０名健康男性志愿者交叉口服３００ｍｇ国产罗红霉素颗粒剂和进口片剂，进行国产制剂生物利用度研究，采用微生物法测定不同时间的血药浓度。结果罗红霉素颗粒剂和进口片剂两种制剂的血药浓度曲线均符合二室模型。Ｃｍａｘ分别为８．２８±０．５６ｍｇ／Ｌ和８．４２±０．７８ｍｇ／Ｌ，达峰时间分别为１．５１±０．２２ｈ和１．４２±０．１８ｈ，Ｔ１／２β分别为１２．２０±０．８５ｈ和１２．５８±０．９３ｈ，ＡＵＣ分别为１２０．５８±１２．９５ｍｇ／Ｌ·ｈ－１，和１１７．８０±１３．６８ｍｇ／Ｌ·ｈ－１两种制剂的药代动力学参数统计学检查无显著性差异。国产罗红霉素颗粒剂相对于进口片剂的生物利用度为１０２．７９±８．６８％，两种制剂生物等效。     

头孢克洛分散片在健康人体的药物动力学及相对生物利用度研究

研究头孢克洛分散片在健康人体内的药物动力学及相对生物利用度。采用高效液相色谱法测定８ 名志愿者单剂量口服５００ ｍ ｇ 头孢克洛分散片和胶囊后的血液浓度。药动学参数经３Ｐ８７ 软件处理计算。头孢克洛分散片的主要药动学参数：Ｃｍ ａｘ（１５３２±２４２） ｍ ｇ／Ｌ,Ｔｐｅａｋ（０５７±０１５） ｈ,Ｔ１／２ｋｅ（０７６±０２５） ｈ,ＡＵＣ（２４０７±４４７） ｍ ｇ／（ｈ·Ｌ）;头孢克洛胶囊的主要药动学参数：Ｃｍ ａｘ（１５．６３±２．３２） ｍ ｇ／Ｌ,Ｔｐｅａｋ（０．６０±０．１３） ｈ,Ｔ１／２ｋｅ（０６７±０１８） ｈ,ＡＵＣ（２３１３±３３７）ｍ ｇ／（ｈ·Ｌ）。经统计学处理,两种剂型的药动学参数之间差异均无显著性（Ｐ＞ ００５）。头孢克洛分散片的相对生物利用度为（１０３７５±１１３６）％ ,双单测ｔ检验（ＮＤＳＴ程序）的结果表明,两种制剂生物等效。     

阿奇霉素分散片人体生物利用度及生物等效性对比研究

以藤黄八迭球菌为指示菌,采用微生物法测定 １０ 名志愿者阿奇霉素分散片（实验制剂）和胶囊（参比制剂）经时血药浓度。最低检测限度 ０００５μｇ／ｍ ｌ,线性范围 ００１～０４μｇ／ｍ ｌ。实验采用双交叉单剂口服给药设计,数据经 ３ Ｐ９７ 药代动力学程序处理,阿奇霉素实验制剂和参比制剂主要药物动力学参数 ｋａ为０７２１９±０．０７５５ｈ－ １ 和 ０．７５５２±０．０５９３ｈ－ １,ｔ１／２（α）为 ２．３１８８±０．２４３８ｈ 和 ２．３５１８±０．３８１１ｈ,ｔ１／２ （β）为４１．５８１０ ±２． ２２８５ｈ 和 ４４．１２８３±９．８６４３ｈ, Ｃｍ ａｘ 为 ０．２４５８ ±０．００５８μｇ／ｍ ｌ 和 ０．２３８３±０．００６１μｇ／ｍ ｌ, Ａ Ｕ Ｃ０～１２０为 ０．４１７０±０．０８７４μｇ／（ｍ ｌ·ｈ ）和 ０．３８７７±０．０９６２μｇ／（ｍ ｌ·ｈ ）,实验制剂相对生物利用度为１０７．０５６６％ 。经双单侧ｔ检验和（１２α）置信区间法分析,两种制剂主要药代动力学参数剂型间、阶段间和个体间差异均无显著性（ Ｐ＞ ０．０５）,证实二者具有生物等效性。     

国产盐酸特拉唑嗪胶囊剂的人体相对生物利用度和生物等效性评价

目的：研究国产特拉唑嗪胶囊剂的人体相对生物利用度和生物等效性。方法：９ 名男性健康志愿者口服国产盐酸特拉唑嗪胶囊剂和进口片剂,用高效液相色谱法测定血浆中特拉唑嗪（质量） 浓度,按照随机、交叉试验设计给药。在取血同时测量血压和心率。结果：口服国产胶囊剂和进口片剂的药时曲线均符合二室模型,ρｍａｘ 分别为（４１±１１）、（４４ ±１０） μｇ·Ｌ－ １ ,ｔｍａｘ（０ ．８±０．４）和（０ ．７±０．５） ｈ;ｔ１／２（１２±４） 和（９．０ ±１．６） ｈ;ＡＵＣо∝（４０５±１０６） 和（３９８ ±９０） μｇ·ｈ·Ｌ－ １ , 经统计学处理两种制剂的药代动力学参数差异无显著性（ Ｐ＞ ０．０５） 。国产特拉唑嗪胶囊剂的相对生物利用度为１０４ ．４３ ％ 。双单侧检验表明：两种制剂生物等效。药效学提示血药（ 质量） 浓度达高峰时,血压稍降但不明显,心率无明显变化,两制剂间差异无显著性。结论：（１） 两制剂的药代动力学参数差异无显著性（Ｐ＞ ０ ．０５） ,国产胶囊剂生物利用度１０４．４３％ ;（２） 特拉唑嗪国产胶囊剂和进口片剂生物等效;（３）正常人单次口服２ｍｇ 特拉唑嗪胶囊剂或片剂对血压、心率无明显影响。     

人体内三氮唑核苷的药物动力学及其生物利用度

用ＨＰＬＣ法研究三氮唑核苷在９名健康受试者体内药物动力学和生物利用度。ｉｖ给药后，血药浓度－时间数据用三房室模型拟合，ｔ（１／２）γ为１７．０２±２．１９ｈ；ｐｏ给药后用二房室拟合，ｔ（１／２）β、ｔ（ｍａｘ）和Ｃ（ｍａｘ）分别为（１６．４０±３．８４）ｈ，（１．９４±０．３３）ｈ和（１．４６±０．７４）μｇ／ｍｌ。ｐｏ给药制剂绝对生物利用度为０．４０４±０．０９９。     

克拉霉素胶囊人体相对生物利用度实验研究

１２名健康志愿者随机自身交叉口服单剂量５００ｍｇ国产克拉霉素胶囊或进口片剂进行生物利用度研究,用微生物杯碟法测定血清中克拉霉素浓度。结果表明克拉霉素胶囊和片剂两种制剂的体内药时数据符合二室模型,Ｃｍａｘ分别为２．４４和２．７８μｇ／ｍｌ;ｔｐ为２．２９和２．０７ｈ;为６．８１和７．３９ｈ;ＡＵＣ为２３．６８和２４．０５ｍｇ·ｈ·Ｌ－１。克拉霉素胶囊相对生物利用度为９９．８６±１９．２８％,表明国产克拉霉素胶囊与进口片剂具有生物等效性。关键词     

盐酸二甲双胍胶囊的药动学与相对生物利用度研究

目的　研究盐酸二甲双胍胶囊在正常人体内的药物动力学和相对生物利用度。方法　１０ 例健康男性志愿者,随机分为两组,分别交叉口服盐酸二甲双胍胶囊和片剂采用通过反相 Ｈ Ｐ Ｌ Ｃ 法测定盐酸二甲双胍在体内的药物浓度。结果　口服１ ０００ ｍｇ 盐酸二甲双胍胶囊片剂的达峰时间（ Ｔｍａｘ） 分别为１８３ ｈ ±０５６ ｈ 和１８３ ｈ ±０５０ ｈ ;峰浓度（ Ｃｍａｘ） 分别为２２５ ｍｇ· Ｌ－ １ ±０４９ ｍｇ· Ｌ－ １ 和２２４ ｍｇ· Ｌ－ １±０５０ ｍｇ· Ｌ－ １ ;消除半衰期（ Ｔ１／２β） 分别为２４０ ｈ ±０２３ ｈ和２４０ ｈ ±０２８ ｈ ;药时曲线下面积（ Ａ Ｕ Ｃ） 分别为１３４１ ｍｇ·ｈ － １· Ｌ－ １ ±３５５ ｍｇ·ｈ － １· Ｌ－ １ 和１２９９ ｍｇ·ｈ － １· Ｌ－ １ ±３３９ｍｇ·ｈ － １· Ｌ－ １ ,经ｔ 检验,两种剂型的药代动力学参数无显著性差异;口服盐酸二甲双胍胶囊对其片剂的相对生物利用度为１０３２４ ％ 。结论　两种制剂具有生物等效性。     

甲状腺功能亢进症的骨代谢和骨密度改变

目的　研究甲亢病人的钙磷代谢、骨代谢和骨密度改变及机理。方法　对３８ 例甲亢病人治疗前后用单能 Ｃ Ｔ（ Ｓ Ｅ Ｑ Ｃ Ｔ） 测定骨密度（ Ｂ Ｍ Ｄ） 变化,用双抗体法测定血Ⅰ型胶原羧基端前肽（ Ｃ Ｉ Ｃ Ｐ） ,骨钙素（ Ｂ Ｇ Ｐ） 和尿脱氧吡啶酚（ Ｄ Ｐ Ｄ） 排泄率的变化。结果　治疗前 Ｂ Ｍ Ｄ 明显降低［ 男（１２０±８） ｍｇ／ｃｍ ３ Ｈ Ａ,女（１１４ ±７ ．２） ｍ ｇ／ｃｍ ３ Ｈ Ａ］ 治疗后都恢复正常。血 Ｂ Ｇ Ｐ 男性从（１５ ．２ ±７ ．９）μｇ／ Ｌ 下降到（７ ．５ ±２ ．８）μｇ／ Ｌ（ Ｐ＜ ０ ．０５） ,女性从（１６ ．４ ±７ ．１）μｇ／ Ｌ 下降到（６ ．８ ±２ ．１） μｇ／ Ｌ（ Ｐ＜ ０ ．０１） 。血 Ｃ Ｉ Ｃ Ｐ 男性从（１８５ ±２３ ．５）ｎｇ／ ｍｌ 下降到（７０ ±１０ ．４）ｎｇ／ ｍｌ（ Ｐ＜ ０ ．０５） ,女性从（１６４ ±１６ ．２）ｎｇ／ ｍｌ 下降到（６９ ±９ ．２）ｎｇ／ ｍｌ（ Ｐ＜ ０ ．０５） 。尿 Ｄ． Ｐ． Ｄ 男性从（１３ ．７ ±２ ．５）ｎ Ｍ／ ｍ Ｍ 下降到（３ ．４ ±１ ．０） ｎ Ｍ／ ｍ Ｍ（ Ｐ＜ ０ ．０１） ,女性从（１４ ．６ ±２ ．３）ｎ Ｍ／ ｍ Ｍ 下降到（４ ．５ ±１ ．２     

人血浆中盐酸氟桂嗪HPLC测定及其药代动力学

建立了盐酸氟桂嗪的ＨＰＬＣ测定法。血浆样品碱化后用正已烷提取，以ＭｉｃｒｏＰａｃＭＣＨ－５为固定相，６５％甲醇，３５％水（含０．０２ｍｏｌ／Ｌ四丁基溴化铵，ｐＨ３．０）为流动相，紫外检测波长２５４ｎｍ。最低检出浓度为５．０ｎｇ／ｍｌ，线性范围１０．０～２００．０ｎｇ／ｍｌ（ｒ＝０．９９９８，ｎ＝６），平均回收率为（９７．５５±２．６８）％（ＲＳＤ２．１３％。用本法测定了８名健康男性志愿者分别服用杨森产盐酸氟桂嗪胶囊和新昌产盐酸氟桂嗪片剂的血药浓度。结果表明，其血药浓度－时间曲线均符合一房室模型。新昌产盐酸氟桂嗪片的主要药代动力学参数Ｔ１／２Ｋａ＝（０．７７±０．１１）ｈ，Ｔ１／２Ｋｅ＝（５．０７±０．５２）ｈ，Ｔｍａｘ＝（２．７９±０．２４）ｈ，Ｃｍａｘ＝（９５．００±４．５２）ｎｇ／ｍｌ，ＡＵＣ＝（９９７．６±６２．５）ｎｇ·ｈ／ｍｌ，相对生物利用度为９６．４％。     

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.     

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…     

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.     

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.     

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.     

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.     

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.     

The comparative studies of the influences of Urapidil and Nicardipine on sino-atrial node function, atrio-ventricular node function and hemodynamics

Objective:To investigate the influences of urapidil and nicardipine on rabbit sinus function,atrio-ventricular node function and hemodynamics.Methods:Thirty-two Angora's rabbits were selected and randomly divided into four groups.U1 group:urapidil 0.25 mg/kg;U2 group:urapidil 0.5 mg/kg;N1 group:nicardipine 10 μg/kg;N2 group:nicardipine 20 μg/kg.All these medicine were administrated within 30 seconds.Measurements were taken before and after the administration of urapidil or nicardipine for the following data:mean blood pressure(MAP),heart rate(HR),sino-atrial conduction time(SACT),maximal sinoatrial recovery time(SNRTmax)corrected sinus node recovery time(CSNRT),index of sinus node recovery time(SNRTI),Wenckebach A-V conduction frequency (WB),and P-R interval.Results:Significant MAP and HR changes were identified in all of the four groups before and after administration of both urapidil and nicardipine.No significant changes could be found in the rest of the parameters.Intergroup analysis showed that SACT and CSNRT of N1 and N2 groups were shorter than those of the U2 group(P＜0.01);the MAP decreased(P＜0.01)and the HR increased drastically(P＜0.01).Conclusions:Neither urapidil(0.25 mg/kg,0.5 mg/kg)nor nicardipine(10μg/kg,20μg/kg)has any significant influence on rabbit sinus function or rabbit atrio-ventricular node function.Nicardipine could be a better choice than urapidil for parafunctional sinus node patients.