普卢利沙星片与盐酸左氧氟沙星片治疗急性细菌性感染对比研究

摘要

OBJECTIVE:To evaluate the clinical efficacy and safety of prulifloxacin tablet vs.levofloxacin hydrochloride tablet for acute respiratory tract or urinary tract infection.METHODS: By a randomized controlled clinical trial, the patients with acute bacterial infection were randomly assigned to either trial group administered orally with Prulifloxacin tablets ( at a dosage of 0.2 g twice daily for 7 to 14 days) or control group administered orally with levofloxacin hydrochloride tablet ( at a dosage of 0.2 g twice daily for 7 to 14 days) .RESULTS:A total of 223 patients were enrolled, of whom, 210 patients were assigned to either trial group ( n=104) or control group ( n=106) ( the others were lost follow-up or excluded from our study) .At treatment completion, the cure rate and response rate were 70.19%and 91.35% in trial group, as compared with 71.70% and 89.62% in the control group; the bacterial clearance rates in the trial group and the control group were 86.27%and 88.68%, respectively, with all of the above results showing no statistical differences between the two groups ( P >0.05 ) .Adverse drug reactions including diarrhea, skin rash and stomachache were noted in both groups, which occurred in 4.81% of the trial group vs. 6.60%of the control group, showing statistical difference between the two groups ( P >0.05 ) .CONCLUSION:Prulifloxacin tablet is similar to levofloxacin hydrochloride tablet in that both have remarkable antibacterial activity, and which was safe and effective in the treatment of acute bacterial infection of respiratory or urinary tract, furthermore it is cost-effective in the treatment of acute bacterial infection.%目的：评价普卢利沙星片与盐酸左氧氟沙星片随机对照治疗急性泌尿道及呼吸道感染的安全性和临床疗效。方法：采用随机对照的临床试验设计，急性细菌性感染患者随机分为试验组和对照组，试验组患者给予普卢利沙星片200 mg 口服2／日，疗程7～14 d；对照组患者给予盐酸左氧氟沙星片200 mg 口服2／日，疗程7～14 d。结果：本研究共纳入223例患者，除去脱落和剔除患者，入组共210例，其中试验组104例，对照组106例。治疗结束后，试验组的临床总痊愈率和总有效率分别为70．19％与91．35％，对照组的临床总痊愈率和总有效率分别为71．70％与89．62％；2组细菌清除率分别为86．27％和88．68％，以上结果经统计学检验差异均无统计学意义（ P＞0．05）。2组均有不良反应发生，主要表现为腹泻、皮疹、胃痛等，不良反应发生率分别为4．81％和6．60％，2组不良反应发生率比较差异无统计学意义（ P＞0．05）。结论：普卢利沙星片与盐酸左氧氟沙星片相似，具有较好的抗菌活性，对治疗泌尿道及呼吸道感染临床疗效显著且安全性高，同时治疗急性细菌性感染疾病的经济性较佳。