Assessment of bioequivalence after subcutaneous and intramuscular administration of urinary gonadotrophins

The objective was to demonstrate bioequivalence between s.c. and i.m. administration of Humegon (FSH/LH ratio 1:1) and Normegon (FSH/LH ratio 3:1). In two randomized, single-centre, cross-over studies, 18 healthy volunteers on each formulation were assigned to one of the two administration sequences. Subjects were given single doses of one of the above gonadotrophins after endogenous gonadotrophin production had first been suppressed using high-dose oral contraceptive. Subsequently, rate (Cmax, tmax) and extent (AUC) of absorption of follicle stimulating hormone (FSH) and luteinizing hormone (LH) were determined for 14 days. For Cmax and AUC, analysis of variance (ANOVA) was performed on log-transformed data and for tmax ANOVA was performed on ranks. Intramuscular and s.c. injections of Humegon were bioequivalent with respect to the main pharmacokinetic parameters, being AUC and Cmax of FSH absorption. Intramuscular and s.c. injections of Normegon were bioequivalent with respect to the AUC of FSH and not bioequivalent with respect to the Cmax of FSH. For tmax of FSH as well as for most LH variables of both preparations, bioequivalence could not be proven due to the high intra- and interindividual variability and/or concentrations being close to the detection limit. Thus, the main pharmacokinetic FSH variables after i.m. and s.c. administration of Humegon and Normegon were bioequivalent.      

传染性肺结核患者家庭中儿童结核感染发病及预防的研究

目的　分析传染性肺结核患者家庭中的儿童结核感染和发病情况 ,探讨预防儿童发病的有效方案。方法　对与传染性肺结核患者密切接触的儿童进行X线胸透和做结核菌素试验 ;对结核菌素强阳性者给予预防性治疗。结果　与传染性肺结核患者密切接触的儿童感染率为 88 2 %。规则预防治疗组、不规则预防治疗组和不接受预防治疗组的患病率分别为 :8 3%、4 7 6 %、5 8 8%。结论　与传染性肺结核患者密切接触的儿童属于高危人群 ,给予预防性治疗可减少发病。     

Neoadjuvant chemotherapy with gemcitabine/cisplatin vs. methotrexate/vinblastine/doxorubicin/cisplatin for muscle-invasive urothelial carcinoma of the bladder: A retrospective analysis from the University of Southern California

ObjectivesWe evaluated pathologic and survival outcomes of GC (gemcitabine/cisplatin) and methotrexate/vinblastine/doxorubicin/cisplatin (M-VAC) neoadjuvant chemotherapy (NAC) in patients with muscle-invasive bladder cancer (MIBC).Materials and methodsA retrospective analysis of prospectively collected data on 116 patients who received NAC (GC: n = 58; M-VAC: n = 58) before radical cystectomy and superextended pelvic lymph node dissection for clinical stage T2-4N0M0 bladder cancer was performed. The outcomes were complete response rate (CRR; pT0N0), partial response rate (PRR; pT0N0, pTaN0, pT1N0, or pTisN0), overall mortality (OM), and recurrence. The Kaplan-Meier method and multivariable Cox regression analysis were used to analyze OM. The cumulative incidence method and Fine and Gray's competing risk regression analysis were used to analyze recurrence.ResultsThe median follow-up duration was 2.1 years for the GC group and 7.4 years for the M-VAC group (P < 0.001). There were no statistically significant differences between the GC and M-VAC groups with regard to CRR (27.3% vs. 17.1%, P = 0.419) or PRR (45.5% vs. 37.1%, P = 0.498). The predicted 5-year freedom from OM rate (P = 0.634) and cumulative incidence of recurrence rate (P = 0.891) did not differ between the GC and M-VAC groups. Multivariable analysis showed that there was no independent association between type of NAC and OM (P = 0.721) or recurrence (P = 0.065).ConclusionsPathologic and survival outcomes did not differ in patients who received GC and M-VAC NAC. These data support the use of the GC regimen in the neoadjuvant setting.     

延边地区肺结核病人归口转诊模式的探讨

目的　分析延边地区建立肺结核归口转诊模式对肺结核病人的转诊到位率的影响,探讨提高转诊到位率的方法。方法 对全州8个县(市)医院、中医医院、中心卫生院、大型厂矿企事业单位职工医院的执法检查考核资料进行评价。结果 1.建立归口转诊模式前期转诊率为48.3%,转诊到位率为29.0%,后期转诊率为89.0%,转诊到位率为72.4%,有明显提高;2.前期年平均涂阳病人新登记率为13.36/10万,后期为17.86/10万,实施归口转诊模式前期与实施后期的指标有显著性差异(P<0.01)。结论 延边地区实施的肺结核病人归口转诊模式,对提高肺结核病的转诊到位率十分有效,应不断完善并深入推广。     

复治肺结核病人的成因分析

目的　探讨复治肺结核病人形成原因。方法　使用调查表的方法 ,对前来诊治的复治涂阳肺结核病人的首次诊疗 ,管理情况进行问卷调查。结果　综合医院仍然为大多数患者的首次诊疗单位 ,因此部分肺结核患者未能得到正确的诊断、治疗和化疗管理。导致 67.2 %病人“中断”或“间断”治疗 ;另外结核病健康教育宣传做得不够 ,60 .3 %的患者诊断前未接受过防痨宣教 ,3 4.5 %的患者接受初次化疗时仍未得到宣教。这些均在导致复治病人的产生中起了重要作用。结论　加大DOTS覆盖面 ,加强归口管理力度 ,做好防治结核病教育工作是防止复治肺结核病人产生的重要环节。