藥物上市前須經過人體試驗，參與藥物臨床試驗的受試者將承擔不同程度的風險，我國GCP明確規定要充分保障受試者的權益，倫理委員會和知情同意書是保障受試者權益的主要措施，但在實際中仍存在不少問題。為此，如何切實保障受試者的權益，是臨床試驗所要解決的一個重要問題。
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 clinical efficacy and safety of sparfioxacin in treatment of the acute respiratory tract infections. Methods A randomized-controlled clinical trial was carried out. Sparfloxaein 200 mg once daily and ofioxacin, as a control drug, 200 mg twice a day, both drugs were given by infusion for 7-14 days. There were 30 cases in each group. Results The clinical cure rates and the clinical efficacy rates of the two groups were 33.33%, 26.67%, and 80.00%, 76.67 % respectively. The bacterial clearance rates were 89.66% and 89.29% respectively. The adverse drug reaction rates were 13.33% and 16.67% respectively. There were no statistical differences between the two groups (Pgt;0.05). Photosensitive reaction was not observed in this study. Conclusion Sparfloxacin was effective in the treatment of the respiratory infections.