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目的评价国产盐酸米诺环素粉针治疗急性细菌性感染的有效性和安全性。方法采用多中心、单盲、随机对照研究方法,试验组114例,给予盐酸米诺环素100mg静脉滴注,bid;对照组122例,给予盐酸左氧氟沙星注射液200mg静脉滴注,bid。两药疗程均为7~14d。结果试验组总痊愈率和有效率分别为49.12%和86.84%;对照组分别为51.64%和84.43%。试验组和对照组细菌清除率分别为94.92%和93.85%,两组比较差异均无显著意义(P>0.05)。试验组不良反应发生率为21.95%,对照组为9.60%,两组比较差异有显著意义(χ2=7.1076,P=0.0077)。结论盐酸米诺环素治疗急性细菌性感染临床疗效确切,不良反应能够耐受。
Objective To evaluate the efficacy and safety of domestic minocycline hydrochloride injection in the treatment of acute bacterial infections. Methods A multicenter, single-blind and randomized controlled study was conducted in 114 patients in the experimental group, 100 mg minocycline hydrochloride was given intravenously and once a day. In the control group, 122 patients were given 200 mg levofloxacin injection intravenously. Two courses of treatment are 7 ~ 14d. Results The total cure rate and effective rate of the experimental group were 49.12% and 86.84%, respectively; the control group were 51.64% and 84.43% respectively. The bacterial clearance rates of the experimental group and the control group were 94.92% and 93.85%, respectively, with no significant difference between the two groups (P> 0.05). The incidence of adverse reactions was 21.95% in the experimental group and 9.60% in the control group, with significant difference between the two groups (χ2 = 7.1076, P = 0.0077). Conclusion Minocycline hydrochloride is effective in the treatment of acute bacterial infections and the adverse reactions are tolerable.