BIOEQUIVALENCE BETWEEN rhGH FOR RECONSTITUTION AND READY-TO-USE rhGH IN TWO LIQUID FORMULATIONS

Objective To evaluate the bioequivalence between recombinant human growth hormone （rhGH） for reconstitution, and two dosages of liquid formulation of rhGH [ （151U） 5mg or （301U） lOmg per 3ml ]. Methods The study drugs were tested in a randomized, single-blind and three-period crossover studies in 24 healthy male subjects. The three drugs were administered by subcutaneous injection at a dose of O. 21U/kg body weight. A continuous somatostatin infusion was given in order to suppress the secretion of endogenous GH. The ve- nous blood samples were drawn at different time points to test the serum concentration of GH. The pharmacokinetic parameters were analyzed by statistical methods. Results 90% confidence intervals （CI） of AUC0-24h among three products were all within 80% - 125% interval （ 103. 4% - 116. 5%, 105. 7% - 119. 6% and 91.9% - 103. 7%, respectively）, and the Cls of C,~ among three products were all within 70% - 143% interval （91.9% - 114. 0%, 103. 7% -127. 2% and 81.6% -97. 4%, respectively）. There was no statisitical difference of tmax among all the three products. Conclusion These data demonstrate that there is bioequivalence between rhGH for reconstitution and two liquid formulations of rhGH.     

克罗米芬兴奋试验预测卵巢储备功能的价值

目的探讨克罗米芬兴奋试验（CCT）在不孕妇女中预测卵巢储备功能的作用。方法对2001年1月至2005年2月就诊于广东省妇幼保健院的666例不孕症患者作为研究对象，分为A组（≥35岁）461例为高龄组，B组（〈35岁）205例为低龄组，另取156例年龄〈35岁、非女方不孕原因者作为对照组，对三组受试者进行CCT。结果CCT异常发生率A组、B组及对照组分别为27．76％、34．14％、2．56％，A组及B组与对照组比较差异均有非常显著性意义（P〈0．01）。基础卵泡刺激素（FSH）〈10IU／L、雌二醇（E2）〈180pmot／L的不孕患者CCT异常发生率分剐为17．46％、24．19％，均明显低于FSH≥10IU／L、E2≥180pmol／L患者的64．19％及39．4％（P〈0．01）。结论CCT预测卵巢储备功能较基础FSH更敏感，CCT可作为常规了解卵巢储备功能的一项检测方法。     

Risk analysis in resection of squamous cell carcinoma of the esophagus

A study of risk factors that affect morbidity and mortality in 523 patients with squamous cell cancer of the esophagus who had one-stage resection was undertaken. The 30-day and hospital mortality rates were 5.0% and 15.5%, respectively. Pulmonary complications, malignant cachexia, and surgical complications accounted for 42%, 25%, and 21% of hospital deaths, respectively. Major pulmonary complications occurred in 23% of patients. Multivariate analysis identified six factors that predicted major pulmonary complications: age, mid-arm circumference, percent of predicted FEV₁, abnormal chest radiograph, amount of blood loss, and palliative resection. Three risk groups of pulmonary complications were identified: low, median, and high risk group with complications in 3%, 17%, and 43% of patients, respectively. Significantly, patients with curative resection had a lower hospital mortality rate (9%) than those with palliative resection (20%), p=0.001. Patients with stage I, IIa, or IIb disease had a lower hospital mortality rate (9%) than those with stage III or IV disease (18%), p=0.026. Multivariate analysis identified six factors that predicted hospital death: age, mid-arm circumference, history of smoking, incentive spirometry, number of stairs climbed, and amount of blood loss. Three risk groups of hospital death were identified: low, median, and high risk groups with death in 7%, 30%, and 38%, respectively. Anastomotic leakage rate was 4%. Technical faults were identified in 53% of patients with leakage. Together with other surgical complications, a presumed or apparent technical error was noted in 63% of patients. The identification of high-risk patients and prevention of technical faults can help improve surgical outcome.

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Resumen Se emprendió un estudio sobre los factores de riesgo que afectaron la mortalidad en 523 pacientes con carcinoma escamocelular del esófago sometidos a resección en una etapa en nuestra institución.Las tasas de mortalidad a 30 días y de mortalidad hospitalaria fueron 5% y 15%. Las complicaciones pulmonares, caquexia maligna y quirúrgica representaron 42%, 25% y 21% de las muertes hospitalarias, respectivamente. Complicaciones pulmonares mayores fueron registradas en 23% de los pacientes.El análisis multivariado identificó seis factores que predicen complicaciones pulmonares mayores: edad, circunferencia del brazo, porcentaje del FEV1 predecible, radiografía de tórax anormal, pérdida de sangre durante la operación y resección de tipo paliativo. Se identificaron tres grupos de riesgo de desarrollar complicaciones pulmonares: bajo, medio y alto, con tasas de 3%, 17% y 43% de los pacientes, respectivamente. Los pacientes que recibieron resección curative exhibieron una significativamente menor tasa de mortalidad hospitalaria (9%) en comparación con los que recibieron resección paliativa (20%), p=0.001. Los pacientes con enfermedad en estados I, IIa, IIb exhibieron menor mortalidad hospitalaria (9%) en comparación con los estados III o IV (18%), p=0.026. El análisis multivariado identificó seis factores que predicen mortalidad hospitalaria: edad, circunferencia del brazo, historia de tabaquismo, espirometría de incentivo, número de escalones que puede ascender y pérdida de sangre durante la operación. Se identificaron tres grupos de riesgo de mortalidad hospitalaria: bajo, medio y alto, con tasas de 7%, 30% y 38% respectivamente.La tasa de fuga anastomótica fue 4% y se identificaron defectos técnicos en 53% de los pacientes. Junto con otras complicaciones quirúrgicas, se observó un error técnico presumible o aparente en 63% de los pacientes.La identificación de los pacientes de alto riesgo y la prevención de los errores técnicos pueden ayudar a mejorar el pronóstico.

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Résumé Dans cette étude, on a étudié les facteurs de risque influençant la morbidité et la mortalité chez 523 patients ayant un cancer épidermoïde de l'oesophage et ayant eu une résection en un seul temps. La mortalité à 30 jours et la mortalité hospitalière ont été respectivement de 5% et de 15.5%. Les complications pulmonaires, la cachexie maligne et les complications chirurgicales ont été responsable respectivement de 42%, 25% et 21% des décès hospitaliers. Une analyse multifactorielle a permis d'identifier six facteurs prédictifs des complications pulmonaires: l'âge, la circonférence brachiale, la prévision du volume expiratoire forcé en une seconde, les anomalies de la radiographie thoracique, la quantité de sang perdu, et le caractère palliatif de la résection. Trois groupes, dont le risque de complications pulmonaires a été classé faible, moyen et élevé, ont été identifiés. Le taux de complications dans ces groupes ont été respectivement de 3%, 17% et 43%. Les patients ayant eu une résection à visée curative avaient une mortalité hospitalière significativement plus basse (9%) comparée à celle des patients ayant eu une résection à visée palliative (20%) (p=0.001). Les patients ayant des maladies de stades I, IIa, IIb avaient une mortalité plus basse (9%) que ceux qui avaient des stades III ou IV (18%), (p=0.026). L'analyse multifactorielle a permis d'identifier six facteurs prédictifs de la mortalité hospitalière: l'âge, la circonférence brachial, des antécédents de consommation excessive du tabac, la spirométrie, le nombre d'escaliers que le patient peut monter, et la quantité de sang perdu. Trois groupes de patients, dont le risque de mortalité hospitalière a été classé faible, moyen, et élevé, ont eu des décès dans respectivement 7%, 30% et 38% des cas. Le taux de fistule a été de 4%. Une faute technique a été identifiée chez 53% des patients ayant eu une fistule. Une faute technique apparente ou présumée a été identifie chez 63% des patients ayant eu soit une fistule soit une complication chirurgicale. L'identification des patients à haut risque et la prévention des fautes techniques peuvent contribuer à améliorer le pronostic après chirurgie.

     

人PD-L2基因克隆及其在大肠杆菌中的表达

目的 克隆人PD-L2基因并构建PD-L2胞外区的原核表达载体，在大肠杆菌中进行表达。方法 以RT-PCR方法从活化的人外周血单个核细胞总RNA中克隆PD-L2基因的cDNA，构建PD-L2胞外区的原核表达载体，在大肠杆菌BL21(ED3)中进行表达并鉴定。结果 克隆到PD-L2基因cDNA编码区全长序列，经DNA测序证明其与已报道的序列一致。进而构建了PD-L2胞外区的原核表达载体，并在大肠杆菌表达，免疫印迹分析表明在IPTG诱导后表达PD-L2胞外区蛋白，相对分子质量Mr为22000，与理论值大小相符。结论 成功克隆PD-L2基因，其胞外区蛋白在大肠杆菌中获得表达，为进一步研究PD-L2功能提供了条件。     

Panfacial fractures: analysis of 33 cases treated late.

PURPOSE: The aim of this retrospective study was to analyze the characteristics of delayed panfacial fractures and evaluate treatment results. PATIENTS AND METHODS: Thirty-three patients with delayed panfacial fractures were treated in the Maxillofacial Trauma Center of Peking University, School and Hospital of Stomatology between 1998 and 2004. Each patient was examined by computed tomography (CT) scans before operation. For those who had no severe opening restriction, dental impressions were taken to fabricate dental casts. For those with severely comminuted fractures, 3-dimensional (3D) models of the facial skeleton were used. Re-establishing the continuity of the mandible was the first step and then used as a platform to reconstruct the maxillary fractures via maxillomandibular fixation after Le Fort I osteotomy. The third step was to restore the mid- and upper-facial width and projection by coronal approach to expose the zygomatic complex and frontal bone/sinus and/or naso-orbito-ethmoid (NOE) fractures. RESULTS: There were 3 types of mandibular fractures that affected the treatment plan: 1) type I, mandibular body/symphysis fracture(s) (17/33, 51.52%); 2) type II, mandibular angle and/or condylar fracture(s) (6/33, 18.18%); and 3) type III, both mandibular body/symphysis and angle/condylar fractures (10/33, 30.30%). Fourteen cases were associated with NOE fractures (42.42%) and 3 cases had frontal sinus fractures (9.1%). Twelve cases had enophthalmos (36.36%) and 3 lost 1 eyeball. The order of treatment was dependent on the mandibular fracture type. For type I fractures, reconstructing the mandibular arch was the first step. For type II fractures, repairing the angle, ascending rami, and condylar areas was the first step. For type III fractures, when both mandibular height and arch were disrupted, freeing the malunited angle or condyle was the first step before restoring the mandibular arch form. Reconstruction of the mandibular height and projection was then carried out. For all 3 types, the second step was to restore the mid- and upper facial width and projection by reducing the zygomatic complex and frontal bone/sinus or NOE fractures. Maxillary fixation across the Le Fort I level was the last step. Le Fort I osteotomy was used for all 33 cases. Bone grafts and soft tissue suspension also were used. Twenty-one cases (63.64%) had good results, 7 (21.21%) cases were acceptable, and 5 (15.15%) were not good. There were 7 cases (21.21%) that still had soft tissue problems that needed secondary operations. CONCLUSIONS: Reconstruction of the mandible first with Le Fort I osteotomy is a good way to treat delayed panfacial fractures. Computed tomography and 3D CT, model surgery, and occasionally 3D models are necessary aids for diagnosis and treatment. Soft tissue problems, including lacerations and asymmetries, were often the factors that caused an unfavorable outcome.     

小剂量异丙酚加喉上神经阻滞用于纤支镜检查

目的：观察异丙酚加喉上神经阻滞用于纤支镜检查期间，患对操作刺激反应、耐受程度以及对心血管反应和遗忘程度。方法：选40例拟诊肺癌患行ASAⅡ～Ⅲ纤支镜检查，喉上神经阻滞成功后推注0．5～1mg／kg异丙酚，患意识消失后，进行纤支镜操作。结果：所有病人都能耐受检查。术中收缩压、舒张压、心率、血氧饱和度等无明显影响，无恶心、呕吐等并发症，大大减轻了检查对病人带来的痛苦。结论：异丙酚加喉上神经阻滞用于纤支镜检查，对呼吸、循环影响小，能减轻病人痛苦，术后具有遗忘作用，值得推广。     

老年认知功能障碍与脑结构CT测量的相关性研究

目的探讨脑萎缩与老年认知功能障碍之间的相关性。方法对开滦集团公司1063名离退休职工进行健康查体,用简易精神状态量表(MMSE)评定认知功能,按分界值将本次研究对象分为认知功能障碍组和认知功能正常组,同时用CT线性测量脑的相关部位以诊断脑萎缩情况,并对各型脑萎缩与认知功能的相关系数及提示老年认知功能障碍的敏感度、特异度、准确度进行分析。结果1063名观察对象中符合入选标准并资料完整者共计511名,其中108名有认知功能障碍,髓质脑萎缩55名、皮质萎缩5名、混合型萎缩30名;认知功能正常者403名,髓质脑萎缩214名、皮质萎缩13名、混合型萎缩62名。认知功能障碍组脑萎缩的发病率高于认知功能正常组,差异具有统计学意义(P<0.005);2组间颞叶海马钩回间距(26.86mm±3.73mmvs25.95mm±3.80mm)及海马钩回间距/大脑左右径的比值(0.21±0.02vs0.20±0.02)差异具有统计学意义(P<0.05);海马钩回间距、皮质脑萎缩、混合型脑萎缩与认知功能障碍呈负相关(分别为r=-0.094,P=0.034,r=-0.156,P≈0.000,r=-0.147,P≈0.000),以海马钩回间距20mm提示老年认知功能障碍的敏感度最高(98.14%),混合型脑萎缩的特异度(84.86%)、准确度最高(72.80%)。结论CT测量相关脑结构,判断脑萎缩类型可以为老年认知功能障碍的诊断提供有价值的信息。     

Characteristics of teenage mothers and predictors of breastfeeding initiation in the Michigan WIC Program in 1995. Women, Infants, and Children.

Although breast milk is recommended as the optimal source of infant nutrition, breastfeeding initiation is below recommended levels, especially among teenage mothers. Breastfeeding initiation rates among Michigan (US) teenage mothers (12-19 y) were compared by demographics and health behaviors. Multivariate analyses determined which factors were significant independent predictors of breastfeeding initiation among teenage mothers enrolled prenatally in the Michigan Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program in 1995. Significant predictors independently associated with breastfeeding initiation were race/ethnicity, education, marital status, postpartum anemia status, parity, prenatal trimester of WIC enrollment, and smoking. The strongest predictor of breastfeeding initiation differed for white mothers (positive predictor: education beyond high school [OR = 3.13]) and black mothers (negative predictor: multiparous [OR = 0.25]). Initiation rates for this population of teenage mothers fall below the national average for mothers of all ages and the US Healthy People 2010 goals. Research is needed concerning how breastfeeding support and education can be improved to reach the US national health goals.     

单甲氧聚乙二醇化学修饰药物酶的研究进展

用单甲氧基聚乙二醉(1)化学修饰药物酶是生化药物研究开发的重要手段之一。本文综述了1化学修饰药物酶的一般方法及修饰后酶在生物和理化性质方面的变化，同时对1研究前景进行展望，并指出了尚待解决的问题。