Jagelman D G, Fabian T C, Nichols R L, Stone H H, Wilson S E, Zellner S R
Department of Colorectal Surgery, Cleveland Clinic Florida, Fort Lauderdale, 33309.
Am J Surg. 1988 May 31;155(5A):71-6. doi: 10.1016/s0002-9610(88)80217-4.
The safety and effectiveness of a single 2 g preoperative dose of cefotetan to reduce postoperative infectious complications after colorectal surgery was compared with multiple 2 g perioperative doses of cefoxitin in 289 patients enrolled in a multicenter trial; of the 239 evaluable patients, 164 received cefotetan and 75, cefoxitin. No statistically significant difference was detected in the successful clinical response rates for cefotetan and cefoxitin (88 percent and 92 percent, respectively). The difference in median increase in oral body temperature before and after the study (2.5 degrees F for cefotetan and 2 degrees F for cefoxitin) was statistically but not clinically significant (p = 0.03). Although nearly four times as many cefotetan patients as cefoxitin patients had surgery lasting 4 hours or more, the satisfactory bacteriologic response rates for cefotetan and cefoxitin were similar (88 percent and 93 percent, respectively). Nonobese patients and patients whose surgical procedures lasted less than 4 hours treated with either drug had significantly higher success rates (p less than 0.01). The incidence of major wound infection was approximately 8 percent for both treatment groups. Mean concentrations of cefotetan in plasma, specimens of colon, and subcutaneous fat were 128 +/- 61.8 micrograms/ml, 57.2 +/- 40.4 micrograms/g, and 26.8 +/- 19.4 micrograms/g, respectively. The incidence of adverse reactions was 12 percent for each group, and no reaction was considered treatment-related, including changes in results of clinical laboratory tests. A single 2 g preoperative dose of cefotetan was as safe and effective as multiple doses of cefoxitin in the reduction of postoperative wound infections after colorectal surgery.
在一项多中心试验的289例患者中，比较了术前单次给予2克头孢替坦与围手术期多次给予2克头孢西丁预防结直肠手术后感染并发症的安全性和有效性；在239例可评估患者中，164例接受头孢替坦治疗，75例接受头孢西丁治疗。头孢替坦和头孢西丁的临床有效率无统计学显著差异（分别为88%和92%）。研究前后口腔体温升高的中位数差异（头孢替坦为2.5华氏度，头孢西丁为2华氏度）有统计学意义，但无临床意义（p = 0.03）。虽然接受头孢替坦治疗的患者手术时间持续4小时或更长时间的人数几乎是接受头孢西丁治疗患者的四倍，但头孢替坦和头孢西丁的细菌学有效率相似（分别为88%和93%）。接受任何一种药物治疗的非肥胖患者和手术时间持续少于4小时的患者成功率显著更高（p < 0.01）。两个治疗组的主要伤口感染发生率约为8%。头孢替坦在血浆、结肠标本和皮下脂肪中的平均浓度分别为128±61.8微克/毫升、57.2±40.4微克/克和26.8±19.4微克/克。每组的不良反应发生率均为12%，且无反应被认为与治疗相关，包括临床实验室检查结果的变化。术前单次给予2克头孢替坦在降低结直肠手术后伤口感染方面与多次给予头孢西丁一样安全有效。
