中华内科杂志
中華內科雜誌
중화내과잡지
CHINESE JOURNAL OF INTERNAL MEDICINE
2013年
11期
956-960
,共5页
段明辉%朱铁楠%韩冰%李剑%周道斌
段明輝%硃鐵楠%韓冰%李劍%週道斌
단명휘%주철남%한빙%리검%주도빈
外周血干细胞移植%随机对照试验%前瞻性研究%头孢他啶%感染
外週血榦細胞移植%隨機對照試驗%前瞻性研究%頭孢他啶%感染
외주혈간세포이식%수궤대조시험%전첨성연구%두포타정%감염
Peripheral blood stem cell transplantation%Randomized controlled trial%Prespective studies%Ceftazidime%Infection
目的 评估自体外周血干细胞移植(APBSCT)患者中性粒细胞缺乏(粒缺)期应用头孢他啶预防早期细菌感染的效果和安全性.方法 前瞻性选取APBSCT患者,随机分为治疗组和对照组,治疗组在粒缺期加用静脉点滴头孢他啶预防早期细菌感染,观察早期感染情况；对照组不给予抗生素预防.结果 2010年3月至2013年1月间,共有70例APBSCT患者入选本研究.随机分为治疗组36例,对照组34例.总计29例(41.4％)患者发生早期感染,其中治疗组9例(25.0％),明显低于对照组20例(58.8％,P=0.004)；对照组中位无感染生存时间(IFS)为8d,而治疗组未达到(P=0.005);无论采用单次大剂量马法兰预处理还是其他方案,治疗组感染率均低于对照组,感染时间均较对照组延迟.治疗组与对照组人均抗生素使用时间分别为(8.08±2.03)d与(3.68±3.56)d(P＜0.001),然而,人均经验性使用碳青霉烯类抗生素时间分别为(1.67±3.03)d与(3.68±3.56)d(P=0.013),因此,人均抗生素费用两组差异无统计学意义(P =0.320).治疗组4例患者出现血清肌酐一过性升高,而对照组未出现(P=0.045).两组均无感染相关死亡.结论 头孢他啶预防APBSCT患者粒缺期早期细菌感染有效,不良反应和抗生素费用可控,但没有影响感染相关死亡.因此,不建议APBSCT患者进行抗生素预防.
目的 評估自體外週血榦細胞移植(APBSCT)患者中性粒細胞缺乏(粒缺)期應用頭孢他啶預防早期細菌感染的效果和安全性.方法 前瞻性選取APBSCT患者,隨機分為治療組和對照組,治療組在粒缺期加用靜脈點滴頭孢他啶預防早期細菌感染,觀察早期感染情況；對照組不給予抗生素預防.結果 2010年3月至2013年1月間,共有70例APBSCT患者入選本研究.隨機分為治療組36例,對照組34例.總計29例(41.4％)患者髮生早期感染,其中治療組9例(25.0％),明顯低于對照組20例(58.8％,P=0.004)；對照組中位無感染生存時間(IFS)為8d,而治療組未達到(P=0.005);無論採用單次大劑量馬法蘭預處理還是其他方案,治療組感染率均低于對照組,感染時間均較對照組延遲.治療組與對照組人均抗生素使用時間分彆為(8.08±2.03)d與(3.68±3.56)d(P＜0.001),然而,人均經驗性使用碳青黴烯類抗生素時間分彆為(1.67±3.03)d與(3.68±3.56)d(P=0.013),因此,人均抗生素費用兩組差異無統計學意義(P =0.320).治療組4例患者齣現血清肌酐一過性升高,而對照組未齣現(P=0.045).兩組均無感染相關死亡.結論 頭孢他啶預防APBSCT患者粒缺期早期細菌感染有效,不良反應和抗生素費用可控,但沒有影響感染相關死亡.因此,不建議APBSCT患者進行抗生素預防.
목적 평고자체외주혈간세포이식(APBSCT)환자중성립세포결핍(립결)기응용두포타정예방조기세균감염적효과화안전성.방법 전첨성선취APBSCT환자,수궤분위치료조화대조조,치료조재립결기가용정맥점적두포타정예방조기세균감염,관찰조기감염정황；대조조불급여항생소예방.결과 2010년3월지2013년1월간,공유70례APBSCT환자입선본연구.수궤분위치료조36례,대조조34례.총계29례(41.4％)환자발생조기감염,기중치료조9례(25.0％),명현저우대조조20례(58.8％,P=0.004)；대조조중위무감염생존시간(IFS)위8d,이치료조미체도(P=0.005);무론채용단차대제량마법란예처리환시기타방안,치료조감염솔균저우대조조,감염시간균교대조조연지.치료조여대조조인균항생소사용시간분별위(8.08±2.03)d여(3.68±3.56)d(P＜0.001),연이,인균경험성사용탄청매희류항생소시간분별위(1.67±3.03)d여(3.68±3.56)d(P=0.013),인차,인균항생소비용량조차이무통계학의의(P =0.320).치료조4례환자출현혈청기항일과성승고,이대조조미출현(P=0.045).량조균무감염상관사망.결론 두포타정예방APBSCT환자립결기조기세균감염유효,불량반응화항생소비용가공,단몰유영향감염상관사망.인차,불건의APBSCT환자진행항생소예방.
Objective To evaluate the efficacy and safety of prophylactic cefiazidime on early bacterial infection in APBSCT recipients during neutropenia.Methods APBSCT recipients were prospectively randomly assigned to intravenous ceftazidime treatment group and control group (no prophylaxis of antibiotics).The treatment started from the first day until resolution of neutropenia or the appearance of early bacterial infection.Results From March 2010 to January 2013,70 APBSCT recipients were enrolled in the study with 36 in treatment and 34 in control group.Overall,29 (41.4％) patients developed early bacterial infection,among which,9(25.0％) in the treatment group and 20(58.8％) in the control group (P =0.004).The median infection free survival (IFS) was not reached in the treatment group and was 8 days in the control group (P =0.005).Despite whether patients received single high dose melphalan or other conditioning regimes,the early bacterial infection rate was lower in the treatment group than in the control group,and the median IFS was longer in the treatment group than that in the control group.The mean courses of antibiotic administration were (8.08 ± 2.03) days and (3.68 ± 3.56) days respectively in the treatment and control groups (P ＜ 0.001).However,the duration of empirical carbapenems were (1.67 ±3.03) days and (3.68 ±3.56) days respectively (P =0.013).There was no significant difference of antibiotics cost per patient between the two groups.Four patients in the treatment group had a transient elevated serum creatinine.Overall,no infection related mortality was observed in either group.Conclusions Prophylaxis of intravenous ceftazidime for APBSCT recipients is effective in preventing early bacterial infection with an acceptable toxicity and cost profile.However,it doesn't have effect on infection related mortality.Therefore,our results do not support the use of antibiotic prophylaxis for patients undergoing APBSCT.
