【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 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.
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 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.
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 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.
Objective
To assess the efficacy and safety of percutaneous closure of patent ductus arteriosus (PDA) solely under echocardiography guidance.
Methods
We retrospectively analyzed the clinical data of 200 patients who received the percutaneous closure of PDA under echocardiography guidance in Fuwai Hospital from August 2013 to April 2016. According the different approach, they were divided into 2 groups: a femoral artery approach group (n=143) and a femoral vein approach group (n=57). In the femoral artery approach group, there were 42 males and 101 females aged 3.20±5.63 years. In the femoral vein group, there were 10 males and 47 females aged 7.30±11.36 years. All Patients were treated by percutaneous PDA closure solely under echocardiography guidance. The follow-up was performed at one month after the operation by echocardiography, chest radiograph and electrocardiogram.
Results
All 200 patients were successfully treated with percutaneous closure of PDA. The patients’ gender, in-hospital stay, rates of occluder detachment were similar between the two groups (P>0.05). Compared with the femoral vein approach group, the femoral artery approach group had a younger age (3.20±5.63 yearsvs. 7.30±11.36 years, P<0.001), less body weight (14.25±11.54 kgvs. 24.25±19.14 kg, P<0.001) and shorter diameter of PDA (3.06±0.79 mmvs. 5.93±0.68 mm, P<0.001) and PDA occluders (5.43±1.00 mmvs. 12.14±0.54 mm, P<0.001), but had higher hospitalization expenses (32 108.2±3 100.2 yuanvs.25 120.7±3 534.1 yuan, P<0.001). In the femoral vein approach group, one patient was closed under radiation guidance because guide wires could not pass through PDA. One patient in the femoral artery approach group suffered from occluder detachment at one day after operation and was cured by transthoracic minimally invasive PDA occlusion. There were no complications of occluder detachment, residual shunt, pericardial effusion or left pulmonary stenosis during the follow-up.
Conclusion
Echocardiography-guided percutaneous PDA closure is safe and effective, while the proper interventional approach should be chosen by the anatomical features of PDA.
