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.     

高血压合并阻塞性睡眠呼吸暂停的短期血压变异性研究

目的 比较高血压合并阻塞性睡眠呼吸暂停患者的短期血压变异性。方法 将155例分为对照组、高血压组、高血压合并轻度或中重度阻塞性睡眠呼吸暂停组，EE较患者不同活动状态的短期血压变异性。结果 高血压合并中重度阻塞性睡眠呼吸暂停组患者睡眠期间和早晨血压变异系数分别为：收缩压18．69、21．32；舒张压19．41、23．61，明显高于其他各组。结论 夜间睡眠期间和早晨短期血压变异性增加，是高血压合并中重度阻塞性睡眠呼吸暂停患者夜间和早晨心血管事件发生率增加的重要危险因素。     

联合应用口服水剂和水灌肠肠道充盈法的MSCT研究

目的：评价口服水剂、水灌肠及两者联合应用充盈肠道后,使用MSCT显示成人正常肠道的能力。材料和方法：将43名非肠道病变志愿者分别采用口服水剂法(21例)、水灌肠法(12例)、双重法(口服水剂和水灌肠联合应用,10例)充盈肠道,然后行MSCT平扫和增强扫描并进行图像重建,对小肠和大肠各肠段充盈状态进行评价。结果：口服水剂法回肠充盈良好,水灌肠法大肠充盈良好,双重法回肠及大肠均充盈良好。口服水剂法小肠充盈优于水灌肠法,与双重法无显著差异,大肠充盈状态水灌肠法明显优于口服水剂法,与双重法无显著差异。结论：口服水剂和水灌肠联合应用可以在MSCT同时较好地充盈显示小肠和大肠,而两种方法单独使用则仅能分别充盈显示小肠和大肠,需要根据显示目的选择相应的充盈方法。     

癌症患者放疗期情绪障碍的评估及干预

目的:探讨和研究恶性肿瘤患者放疗期的情绪状态、变化规律及应对措施.方法:采用抑郁自评量表(SDS)和焦虑自评量表(SAS)对220例恶性肿瘤患者进行自评测查.结果:220例恶性肿瘤患者的抑郁严重程度指数超过0.5者200人,占被调查者90.9%.放疗前1周,放疗前夜和放后1周抑郁分别为90.9%、93.72%、85.4%,以轻度抑郁为主,焦虑情绪评分在放疗前夜达到高峰.结论:应重视恶性肿瘤患者放疗期的情绪变化,避免中、重度抑郁和焦虑的出现,有利于患者放疗后顺利康复提高生活质量,减少患者轻生想法导致的严重后果.     

原发性甲状腺鳞状细胞癌3例报告

笔者报告3例原发性甲状腺鳞状细胞癌临床资料。3例均行手术切除，并经病理检查确诊。1例术后0.5年死于肺部转移;1例1年后出现骨、胸膜转移后失访;1例生存3年，情况良好。提示：该肿瘤恶性程度高，预后差，应予重视。     

The adverse effect of treatment prolongation in cervical cancer by high-dose-rate intracavitary brachytherapy.

BACKGROUND AND PURPOSE: The potential risk of prolongation of treatment time in cervical cancer has been reported for many low-dose rate (LDR) studies, with an estimated loss of local control ranging from 0.3 to 1.6% per day of treatment prolongation. Since the treatment schedule for fractionated high-dose rate intracavitary brachytherapy (HDRICB) is not directly comparable with that for low-dose rate studies, this report aims to evaluate the adverse effect of treatment prolongation specifically for cervical cancer treated with HDRICB. MATERIAL AND METHODS: From September 1992 to December 1997, 257 patients diagnosed with uterine cervical cancer (35 Ib, 26 IIa, 122 IIb, 10 IIIa, 57 IIIb, 7 IVa), who underwent external radiotherapy combined with between two and four courses of HDRICB and a minimum of 3 years of follow-up (median 57 months), were analyzed. Treatment consisted of irradiation of the whole pelvis with 44-45 Gy consisting of 22-25 fractions by 5 weeks, with the dose boosted to 54-58 Gy (with central shielding) for patients diagnosed as FIGO stage IIb-IVa bilateral parametrial disease. HDRICB was performed using an Ir-192 remote afterloading technique at 1-week intervals. The standard prescribed dose for each course of HDRICB was 7.2 Gy to point A for three insertions (before July 1995), or 6.0 Gy to point A for four insertions (after July 1995). Total prescribed point A doses (external beam radiotherapy+HDRICB) ranged from 58 to 71.6 Gy (median, 65.6 Gy) for stage IB-IIA, while analogous dosage for larger lesions (stage IIb-IVa) ranged from 59 to 75.6 Gy (median, 65.6 Gy). Kaplan-Meier and multivariate analyses were used to test the effect of treatment time on pelvic control rate (PCR) and cause-specific survival (CSS) at 5 years. RESULTS: Median treatment time was 63 days. For all stages of disease, the 5-year CSS and PCR were significantly different comparing treatment times of less than and greater than or equal to 63 days [83% and 65% (P=0.004], 93% and 83% (P=0.02), respectively]. These associations were also significant for stage Ib/IIa [97% and 79% (P=0.01), and 100% and 87% (P=0.02), respectively), but not for stage IIb [75% and 72% (P=0.79), and 93% and 87% (P=0.83), respectively] or stage III [66% and 49% (P=0.2), and 83% and 72% (P=0.21), respectively]. Multivariate analysis identified three prognostic factors for CSS, stage (P<0.001), tumor response to external RT (P=0.001), and overall treatment time (OTT; P=0.006). Prognostic factors for pelvic failure were stage (P<0.001), tumor response to external RT (P=0.001), and OTT (P=0.03). Prolongation of treatment time resulted in a daily decrease in pelvic control rate of 0.67% overall, and 0.43% for stage Ib-IIa, 0.57% for stage IIb, and 0.73% for stage III patients. CONCLUSION: Analysis of the data from the current study demonstrates that the adverse effect of treatment prolongation was observed later in the treatment course for the high-dose rate (HDR) series compared to the LDR analog, however, treatment-time prolongation still negatively influenced the cause-specific survival and pelvic control rate for both dosage groups.     

健身宝对衰老模型小鼠血清SOD和MDA的影响

目的　研究健身宝补脾益肾、延缓衰老的作用机制。方法　将 60只小鼠随机分为 6组 ,除正常对照组外均每日注射对D -半乳糖造成衰老模型 ,同时给予不同剂量的健身宝和金匮肾气丸。 6周后检测小鼠血清中SOD活性、MDA含量。结果　衰老模型组与正常对照组比较 ,小鼠血清中SOD活性显著降低 ,MDA含量显著升高 (P <0 .0 1 ) ;而健身宝大、中剂量组与正常对照组相比较 ,小鼠血清中SOD活性显著升高 ,MDA含量显著降低 ,与衰老模型组相比较有显著性差异 (P <0 .0 5 )。结论　健身宝明显提升D -半乳糖拟衰小鼠血清中SOD活性 ,降低MDA含量 ,可从调节自由基代谢和提高抗氧化能力方面发挥延缓衰老的作用。     

NGF对小脑皮质细胞凋亡影响的实验研究

目的　探讨神经生长因子 (NGF)对小脑皮质神经细胞凋亡的影响 ,为临床治疗小脑变性疾病提供新的措施。方法　以原代培养的新生SD乳鼠小脑皮质细胞建立谷氨酸诱导的神经细胞凋亡模型。为观察NGF对受损细胞的保护作用 ,应用MTT法测定细胞的存活率和细胞代谢情况 ;利用光学显微镜技术观察细胞凋亡的形态学改变。结果　Glu (5 0 0 μmol/L)作用 5min可诱导小脑神经细胞凋亡。MTT法计数结果显示 ,NGF高剂量治疗组细胞存活率显著高于模型组 (P <0 0 1) ,光学显微镜观察发现受损细胞的形态学变化也得到明显改善。结论　外源性NGF能够减轻大鼠小脑皮质神经细胞凋亡。     

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。