中华普通外科杂志
中華普通外科雜誌
중화보통외과잡지
CHINESE JOURNAL OF GENERAL SURGERY
2012年
4期
295-298
,共4页
钟林%裘正军%陈国庆%徐军明%孙星%邢同海%王兆文%樊军为%王书云%黄力%张金彦%彭志海
鐘林%裘正軍%陳國慶%徐軍明%孫星%邢同海%王兆文%樊軍為%王書雲%黃力%張金彥%彭誌海
종림%구정군%진국경%서군명%손성%형동해%왕조문%번군위%왕서운%황력%장금언%팽지해
头孢美唑%抗生素预防%细菌感染%治疗效果
頭孢美唑%抗生素預防%細菌感染%治療效果
두포미서%항생소예방%세균감염%치료효과
Cefmetazole%Antibiotic prophylaxis%Bacterial infections%Treatment outcome
目的 评估注射用头孢美唑钠预防术后感染及治疗普外科感染的安全性与有效性.方法 采用多中心、前瞻性、开放性临床研究.清洁污染手术患者入组1700例进行预防性研究,术前半小时给予注射用头孢美唑钠1 g(静注或静滴),术后给药1 g、2次/d,连续3d,根据症状体征及病原菌检查结果进行疗效判定；治疗性研究中,门急诊或住院诊断为腹膜炎、胆囊炎及胆管炎的患者897例,根据感染的程度,给予注射用头孢美唑钠2 g,2次/d(静注或静滴),总疗程7～14d.治疗结束后进行临床症状和细菌学疗效评价.结果 预防研究入选的1700例患者中,有251例由于不符合入选标准等原因不能进行临床疗效分析,最终符合方案的临床疗效可评价病例为1449例,100％的患者预防有效.治疗性研究入选的897例患者中,有110例由于不符合入选标准等原因不能进行临床疗效分析,最终符合方案的临床疗效可评价病例为787例,90.7％ (714/787)的患者临床治疗有效；治疗前在50例患者的血液中检出各种细菌,治疗后46例(92.0％)细菌完全消失.预防性研究中有22例(1.3％,22/1700)、治疗性研究中有11例(1.2％,11/897)患者发生不良反应,主要是轻度恶心、呕吐等.结论 注射用头孢美唑钠预防术后感染及治疗普外科感染有效率高,而且是安全的.
目的 評估註射用頭孢美唑鈉預防術後感染及治療普外科感染的安全性與有效性.方法 採用多中心、前瞻性、開放性臨床研究.清潔汙染手術患者入組1700例進行預防性研究,術前半小時給予註射用頭孢美唑鈉1 g(靜註或靜滴),術後給藥1 g、2次/d,連續3d,根據癥狀體徵及病原菌檢查結果進行療效判定；治療性研究中,門急診或住院診斷為腹膜炎、膽囊炎及膽管炎的患者897例,根據感染的程度,給予註射用頭孢美唑鈉2 g,2次/d(靜註或靜滴),總療程7～14d.治療結束後進行臨床癥狀和細菌學療效評價.結果 預防研究入選的1700例患者中,有251例由于不符閤入選標準等原因不能進行臨床療效分析,最終符閤方案的臨床療效可評價病例為1449例,100％的患者預防有效.治療性研究入選的897例患者中,有110例由于不符閤入選標準等原因不能進行臨床療效分析,最終符閤方案的臨床療效可評價病例為787例,90.7％ (714/787)的患者臨床治療有效；治療前在50例患者的血液中檢齣各種細菌,治療後46例(92.0％)細菌完全消失.預防性研究中有22例(1.3％,22/1700)、治療性研究中有11例(1.2％,11/897)患者髮生不良反應,主要是輕度噁心、嘔吐等.結論 註射用頭孢美唑鈉預防術後感染及治療普外科感染有效率高,而且是安全的.
목적 평고주사용두포미서납예방술후감염급치료보외과감염적안전성여유효성.방법 채용다중심、전첨성、개방성림상연구.청길오염수술환자입조1700례진행예방성연구,술전반소시급여주사용두포미서납1 g(정주혹정적),술후급약1 g、2차/d,련속3d,근거증상체정급병원균검사결과진행료효판정；치료성연구중,문급진혹주원진단위복막염、담낭염급담관염적환자897례,근거감염적정도,급여주사용두포미서납2 g,2차/d(정주혹정적),총료정7～14d.치료결속후진행림상증상화세균학료효평개.결과 예방연구입선적1700례환자중,유251례유우불부합입선표준등원인불능진행림상료효분석,최종부합방안적림상료효가평개병례위1449례,100％적환자예방유효.치료성연구입선적897례환자중,유110례유우불부합입선표준등원인불능진행림상료효분석,최종부합방안적림상료효가평개병례위787례,90.7％ (714/787)적환자림상치료유효；치료전재50례환자적혈액중검출각충세균,치료후46례(92.0％)세균완전소실.예방성연구중유22례(1.3％,22/1700)、치료성연구중유11례(1.2％,11/897)환자발생불량반응,주요시경도악심、구토등.결론 주사용두포미서납예방술후감염급치료보외과감염유효솔고,이차시안전적.
Objective To evaluate the clinical efficiency and safety of cefmetazon in the prevention Department of General Surgery,First People's Hospital,Shanghai Jiaotong University,Shanghai 200080,Chinaand or treatment of infections in general surgery. Methods A multicenter,prospective and open-labeled trial was conducted. In the prevention group,1700 patients were enrolled in clean-infection surgery,cefmetazon was given 1 g iv half an hour before the surgery started,and 1 g iv twice daily after the surgery for 3 days.Clinical response was evaluated in terms of both cure ( disappearance of pre treatment symptoms)and pathogen. In the treatment group,897 patients were diagnosed as peritonitis, cholecystitis and cholangitis,the patients were given cefmetazon 2 g iv twice a day for 7 - 14 days,clinical response and microbiological efficacy were assessed. Results In prophylactic group,1449 patients were finally included.The clinical efficacy was 100％ (1449/1449).In the treatment group,a total of 897 patients were enrolled,and 110 patients failed for assessment of clinical efficacy,787 patients were included in the PPS population,the clinical efficacy was 90.7％ (714/787); Bacterial eradication rate was 92％ (46/50).Adverse reaction rates in prevention group and treatment group were 1.3％ (22/1700) and 1.2％ (11/897),including mild nausea and vomitting. Conclusions Cefmetazon is effective and safe in prevention and treatment of Postoperative infections in general surgery.
