Objective To evaluate the safety and tolerance of medicinal charcoal enteric-coated tablets in healthy volunteers. Methods A total of 44 healthy volunteers were randomly divided into 6 single-dose groups (0.5 g, 2 g, 4 g, 6 g, 8 g and 10 g) and a multiple-dose group (3 g, 3 times a day, for 14 days). The safety profile and tolerance were evaluated by observing symptoms, vital signs, and laboratory tests. Results No serious adverse event was reported for any volunteer. Abdominal distension occurred in 2 volunteers in the 4 g dose group and the 6 g dose group. One volunteer in the 8 g dose group experienced nausea and vomiting. Transient decrease in white blood cell count was observed in one volunteer in the 10 g dose group. Abdominal distension occurred in 2 volunteers of the multiple-dose group. Conclusion Based on our findings, the maximum tolerated dose of medicinal charcoal enteric-coated tablets in Chinese healthy volunteers is 10 g. The recommended dose for subsequent clinical trials is 3 g, 3 times a day.
目的 总结静脉制剂Ⅰ期临床耐受性试验中的护理要点。方法 2011年10月－12月，采用随机、盲法、安慰剂平行对照试验设计，在健康志愿者中按剂量递增原则，逐组完成8个剂量单次静脉滴注给药耐受性试验。 结果 试验顺利完成。静脉制剂的Ⅰ期耐受性试验中，研究护士在临床试验前需认真学习试验方案，做好试验病房、监护急救设施设备的充分准备，针对可能出现的不良反应制定切实可行的处理预案，试验过程中密切监测，对出现的不良反应做好救治工作。特别针对静脉制剂，须做好受试者的心理疏导，保证静脉穿刺一次成功，减少受试者因情绪紧张、穿刺疼痛等因素干扰对试验药物耐受性的评价。 结论 Ⅰ期临床耐受性试验实施前准备充分，试验过程中为受试者提供良好的试验环境和心理护理，提高静脉穿刺一次成功率，密切监测，可使试验过程顺利，并获得客观、准确的试验结果。
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.