Solomkin J S, Wilson S E, Christou N V, Rotstein O D, Dellinger E P, Bennion R S, Pak R, Tack K
Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio 45267-0558, USA.
Ann Surg. 2001 Jan;233(1):79-87. doi: 10.1097/00000658-200101000-00013.
Clinafloxacin is a novel quinolone with wide activity against the plethora of microorganisms encountered in intraabdominal infections. This trial was performed to examine its clinical efficacy.
Clinafloxacin is representative of a new class of quinolones with considerable antimicrobial activity resulting from their mechanisms of action and pharmacodynamics. There is, however, concern about specific potential toxicities, including photosensitivity.
This prospective, randomized, double-blind trial was conducted to compare clinafloxacin with imipenem/cilastatin as adjuncts in the management of complicated intraabdominal infections.
Five hundred twenty-nine patients were included in the intent-to-treat population, with 312 meeting all criteria for the valid population. Patients with a wide range of infections were enrolled; perforated or abscessed appendicitis was the most common (approximately 50%). One hundred twenty-three of the 150 valid patients treated with clinafloxacin (82%) had successful outcomes, as did 130 of the 162 (80%) treated with imipenem. For the intent-to-treat groups, 219 of 259 patients treated with clinafloxacin (85%) had successful outcomes, as did 219 of 270 patients treated with imipenem/cilastatin (81%). Treatment failure occurred in 39 patients who underwent drainage. There were substantially more gram-negative organisms recovered from the patients with treatment failure who were initially treated with imipenem/cilastatin.
The results of this study clearly demonstrate the safety and efficacy of clinafloxacin in the treatment of a range of intraabdominal infections, and in patients with a broad range of physiologic disturbances.
克林沙星是一种新型喹诺酮类药物，对腹腔内感染中遇到的多种微生物具有广泛活性。本试验旨在检验其临床疗效。
克林沙星是一类新型喹诺酮类药物的代表，因其作用机制和药效学具有相当的抗菌活性。然而，人们对其特定的潜在毒性，包括光敏性存在担忧。
本前瞻性、随机、双盲试验旨在比较克林沙星与亚胺培南/西司他丁作为辅助药物治疗复杂性腹腔内感染的效果。
意向性治疗人群纳入了529例患者，其中312例符合有效人群的所有标准。纳入了各种感染的患者；穿孔性或脓肿性阑尾炎最为常见（约50%）。150例接受克林沙星治疗的有效患者中有123例（82%）取得成功结果，162例接受亚胺培南治疗的患者中有130例（80%）取得成功结果。在意向性治疗组中，259例接受克林沙星治疗的患者中有219例（85%）取得成功结果，270例接受亚胺培南/西司他丁治疗的患者中有219例（81%）取得成功结果。39例接受引流的患者治疗失败。最初接受亚胺培南/西司他丁治疗的治疗失败患者中分离出的革兰氏阴性菌明显更多。
本研究结果清楚地证明了克林沙星在治疗一系列腹腔内感染以及生理紊乱范围广泛的患者中的安全性和有效性。
