【Abstract】ObjectiveTo investigate the anatomic feature and special clinical manifestations of variant right intrahepatic bile duct draining into left hepatic bile duct near the umbilical portion. MethodsVariant right intrahepatic bile ducts joining into left hepatic bile ducts near the umbilical portions were identified through cholangiograms in 52 patients, who were included in this study. Their history, clinical process and operations were reviewed. ResultsThere were total 38 cases of intrahepatic gallstone in this group. High incidence of intrahepatic calculi was found in variant right intrahepatic bile ducts （23/38 cases, 60.52%） and left hepatic ducts （33/38 cases, 86.84%）. Most of these cases were accompanied with dilatation and stricture of bile ducts in these area. The gallstones in the variant right intrahepatic bile ducts were not detected in 8 cases (8/23) and the rate of residual gallstone was as high as 86.95%(20/23). Injury of variant right intrahepatic bile duct took place when left hepatectomy was performed in one case. ConclusionGallstone is very likely to be formed in the variant right intrahepatic bile duct due to derangement of bile hydrokinetics and compression of blood vessel. Special attention should be paid to the diagnosis and operation of this abnormity.
Objective To evaluate the clinical efficacy and safety of domestic sparfloxacin in the treatment of acute bacterial infections. Methods A multicenter randomized controlled clinical trial was conducted. 117 patients were treated with domestic sparfloxacin 200-300 mg qd for 5-14 days and 114 patients were treated with domestic lomefloxacin 300 mg bid for 5-14 days. Results The cure rates and the efficacy rates in each group were 84.62%, 74.56% and 94.87%, 92.98%, respectively. The bacterial clearance rates were 94.28% and 92.02%, respectively. Adverse drug reactions rates were 7.69% and 11.40%, most of them were mild. There were no significant differences of above results between the two groups (Pgt;0.05). Conclusions The results suggest that sparfloxacin with wide antibacterial spectrum, satisfactory activity, is an effective and safe antibacterial agent in treatment of mild to moderate acute bacterial infections.
Objective To evaluate the efficacy and safety of amoxicillin/sulbactam (AMX/SBT) in the treatment of acute bacterial infections. Method A multicentre randomized controlled clinical trial was conducted. Ampicillin/sulbactam (AMP/SBT) was chosen as the control drug. 113 patients were enrolled in the study (58 cases in test group and 55 cases in control group). AMX/SUL and AMP/SUL were administered 4.5-6.0 g and 4.5-12.0 g every day respectively. Both drugs were given intravenously for 7-14 days. Results The cure rates and the efficacy rates of the two groups were 75.86%, 80.0% and 94.83%, 98.18% respectively. The β-lactamase producing rates were 67.35% , 69.57% and the bacterial clearance rates were 93.88%, 95.65%.There were no significant differences of the above results between the two groups (Pgt;0.05). There was no serious adverse drug reaction in AMX/SBT groups. Conclusion This study suggests that AMX/SBT is an effective and safe drug for treating acute bacterial infections.
改革教學模式，激發學習興趣，提高教學質量是教師的責任，也是教師孜孜不倦的追求。針對醫學免疫學教學中存在的問題，交替采用比喻法、探究法、討論法、設問引導法、案例法等多種教學方法和形式，改進教學效果，增強學生的學習興趣和學習積極性，使教學質量顯著提高，并受到廣大學生的一致肯定和好評。
目的 評價LB-SDS2.0型酸性氧化電位水生成機生成的酸性氧化電位水對皮膚（手）消毒的有效性和安全性。 方法 2006年2月－8月將90例健康志愿受試者隨機分為3組，各組30例。A組用LB-SDS2.0型酸性氧化電位水生成機生成的酸性氧化電位水（試驗產品）消毒2 min，B組用試驗產品消毒4 min，C組（對照組）用聚維酮碘溶液擦拭3 min。檢測消毒后菌落總數和致病菌，以及受試者不良反應情況。 結果 按照Ⅲ類區域工作人員洗手消毒標準，A、C組合格率均為100%，B組為96.7%；按照Ⅰ、Ⅱ類區域工作人員洗手消毒標準，A組合格率為86.7%；B組合格率為93.3%，C組合格率為100%。各組受試者試驗后生命體征均無臨床意義的改變，未出現任何不良反應。 結論 試驗產品消毒手是安全有效的，可推薦用在Ⅲ類區域工作人員中使用，并進一步觀察其安全性和有效性。建議擴大樣本含量進一步評價其試驗產品是否適用于Ⅰ、Ⅱ類區域工作人員洗手消毒。
Objective To evaluate the clinical efficacy and safety of pazufloxacin for the treatment of moderate and severe acute bacterial respiratory infections.Methods A multicenter randomized controlled trial was conducted to compare the efficacy and safety of pazufloxacin versus levofloxacin. Patients in the pazufloxacin group were treated with pazufloxacin (500 mg twice daily for 7 to 10 days), and patients in the levofloxacin group were treated with levofloxacin (300 mg twice daily for 7 to 10 days). Results A total of 134 patients were enrolled in the study, 68 cases in pazufloxacin group and 66 cases in levofloxacin group were assessable for clinical efficacy by full analysis set(FAS). At the end of the treatment, in FAS analysis the total cure rates and effective rates were 52.9% and 86.7% in pazufloxacin group, 57.6% and 87.9% in levofloxacin group, in PPS analysis the total cure rats and effective rates were 57.1% and 93.7% in pazufloxacin group respectively, 61.3% and 93.6% in levofloxacin group. The bacterial clearance rates were 92.5% and 94.3% respectively. There were no statistically significant differences between the two groups. Adverse reactions were observed in 16.2% of patients in the pazufloxacin group and in 16.7% of patients in the levofloxacin group. These reactions were mainly local stimulation, nausea and diarrhea. No serious adverse event was reported in either group. Conclusion Pazufloxacin is as effective and safe as levofloxacin for the treatment of moderate to severe acute respiratory infections.
Objective To evaluate the safety and tolerance of pegfilgrastin (PEG-G-CSF) in Chinese healthy volunteers. Methods Thirty healthy volunteers were randomly divided into five single-dose groups to receive PEG-G-CSF 15, 30, 50, 60 or 75μg/kg by hypodermic injection. The safety profile and tolerability were evaluated by observing symptoms, vital signs, laboratory tests and electro cardiogram. Results No serious adverse event was reported for any volunteer. Transient dizziness occurred in one person in the 50 μg/kg dose group, and mild dizziness and ostalgia was found in all six people in the 75μg/kg dose group, of whom one experienced transient fever and two experienced mild diarrhea. No clinically significant changes in laboratory tests and electrocardiogram were found during the follow-up period. Conclusions The maximum tolerated dose of PEG-G-CSF injection in Chinese healthy volunteers is 60 μg/kg. Doses below 60μg/kg can be well tolerated. The recommended dose for phase II clinical trials is 60 μg/kgone, one dose for each cycle of chemotherapy.
目的 采用高效液相色譜-質譜聯用法（HPLC-MS/MS）研究普羅布考片的人體藥物代謝動力學變化規律。 方法 2010年10月－11月，24例健康男性受試者單次口服普羅布考片0.5 g，采用HPLC-MS/MS法測定給藥后不同時間點血漿中普羅布考的經時血藥濃度，采用DAS 2.0軟件進行藥動學參數計算。 結果 受試者單次口服普羅布考片，達峰時間為（11.50 ± 6.66）h，峰濃度為（2 894.72 ± 1 320.53）ng/mL，藥-時曲線下面積（AUC）0-t為（238 876.96 ± 131 873.67） ng/mL· h，AUC0-∞為（259 989.08 ± 146 112.88）ng/mL· h，半衰期為（278.52 ± 164.72） h。結論 普羅布考片體內過程符合二室模型，單次口服具有較好的安全性。
Objective To assess the tolerability and safety of Yinhuang injection in Chinese healthy volunteers. Methods Thirty-two healthy subjects were enrolled in the single-dose study. Each subject was administered one of the seven doses of 40, 120, 240, 320, 400, 480, and 560 mg, respectively, by intravenous injection. The sample sizes were 2, 4, 6, 6, 6, 4 and 4, respectively, for each dose group. Twelve healthy subjects were enrolled in the multi-dose study. The subjects in the lower dose group were administered 240 mg and the subjects in the higher dose group were administered 400 mg Yinhuang by intravenous injection once a day for consecutive 7 days. The sample sizes for both groups were 6. The safety was evaluated based on clinical symptoms, vital signs, physical examinations, electrocardiogram (ECG), laboratory tests and adverse events. All analyses were performed by using the software package SAS version 9.1. T-test and analysis of variance were used for continuous variables. Chi-square test and Fisher’s exact test were used for categorical variables.Results A total of 44 healthy volunteers completed the tolerance test. No serious adverse event and clinically significant changes in vital signs, ECG and laboratory tests were found in both single-dose groups and multi-dose groups. Among two mild adverse events, dizziness occurred in one subject in 480 mg dose group in the single-dose trial, which was probably related to the experimental drug. Conclusion Yinhuang injection is safe and well-tolerated in Chinese healthy subjects after administration of single-doses (40-560 mg) and multi-doses (240-400 mg once a day for consecutive 7 days). The maximum-tolerated dose of Yinhuang injection is at 560 mg in the single-dose trial. The dose regimen of 240-400 mg a day is recommended for phase II study.
【摘要】 目的 評價麻敏維C緩釋膠囊（每粒含鹽酸偽麻黃堿90 mg和馬來酸氯苯那敏4 mg）在人體的生物等效性。 方法 于2006年6月采用隨機交叉自身前后對照試驗設計，26例受試者分別單次和多次空腹口服麻敏維C緩釋膠囊（試驗制劑）和復方鹽酸偽麻黃堿緩釋膠囊（參比制劑），與不同時間點取血樣，采用液-質聯用（HPLC/MS）法測定人血漿中鹽酸偽麻黃堿和馬來酸氯苯那敏的濃度，以DAS軟件計算藥物代謝動力學參數，并進行生物等效性評價。 結果 單次給藥后，兩組分的主要藥物代謝動力學參數無統計學意義（Pgt;0.05）。試驗制劑中馬來酸氯苯那敏和鹽酸偽麻黃堿生物利用度分別為104.31%和109.19%。多次給藥后，兩組分的主要藥物代謝動力學參數無統計學意義（Pgt;0.05）。試驗制劑的馬來酸氯苯那敏和鹽酸偽麻黃堿的生物利用度分別為103.58%和99.37%。 結論 麻敏維C緩釋膠囊和復方鹽酸偽麻黃堿緩釋膠囊具有生物等效性。【Abstract】 Objective To investigate the bioequivalence of delayed-release capsule of ephedrine-chlorphenamine-vitamin C. Methods In June 2006, 26 healthy volunteers were administrated with delayed-release capsule of ephedrine-chlorphenamine-vitamin C or delayed-release capsule of ephedrine-chlorphenamine in a randomized and two-way crossover design with single or multiple dosage. The plasma concentrations were determined by HPLC/MS method. The pharmacokinetic parameters and bioequivalence were calculated by DAS software. Results After single dose administration, no significant differences were found in tmax, Cmax, t1/2, and AUC0-t between the two preparations. The relative bioavailability of the test preparation was 104.31% in chlorphenamine and 109.19% in ephedrine, respectively. After multiple dose administration, no significant differences were found in tmax, Cmax, t1/2, and AUC0-t between the two preparations. The relative bioavailability of the test preparation was 103.58% in chlorphenamine and 99.37% in ephedrine, respectively. Conclusion Delayed-release capsule of ephedrine-chlophenamine-vitamin C is equivalent to the reference preparation.