中华内科杂志
中華內科雜誌
중화내과잡지
CHINESE JOURNAL OF INTERNAL MEDICINE
2011年
3期
225-229
,共5页
肖永红%崔洪%薛峰%黄文祥%修清玉%李德天%陈萍%贾正平%文爱东%阳国平%冒国光
肖永紅%崔洪%薛峰%黃文祥%脩清玉%李德天%陳萍%賈正平%文愛東%暘國平%冒國光
초영홍%최홍%설봉%황문상%수청옥%리덕천%진평%가정평%문애동%양국평%모국광
随机对照试验%细菌感染%安妥沙星%左氧氟沙星
隨機對照試驗%細菌感染%安妥沙星%左氧氟沙星
수궤대조시험%세균감염%안타사성%좌양불사성
Randomized controlled clinical trials%Bacterial infections%Antofloxacin%Levofloxacin
目的 评价盐酸安妥沙星片治疗呼吸道、泌尿道和皮肤软组织感染的安全性和有效性.方法 采用区组随机化、双盲双模拟、多中心、平行对照的临床试验设计方法,选用左氧氟沙星片为对照药物,疗程7～14 d.结果 719例患者入选,其中安妥沙星组359例,左氧氟沙星组360例,分别有330与337例完成研究,进入符合方案集(PPS)分析人群;安妥沙星组和左氧氟沙星组PPS人群治疗结束后第1天临床痊愈率分别为79.7%与77.4%,有效率分别为95.2%和96.7%,细菌清除率分别为96.7%与97.5%.呼吸道、泌尿道、皮肤软组织感染患者分别为239、240与240例,两组临床疗效差异没有统计学意义.左氧氟沙星组与盐酸安妥沙星组分别有357例和356例进行了安全性评价,不良事件发生率均为10.1%,不良反应发生率分别为7.8%和7.9%,主要以轻度消化道反应为主.没有发现心电图QTc延长患者,两组各有1例患者治疗结束时血糖轻度增加,随访均恢复正常;两组临床、细菌学疗效以及不良反应发生情况差异无统计学意义(P＞0.05).结论 盐酸安妥沙星片治疗急性细菌性呼吸道、泌尿道和皮肤软组织感染疗效确切,安全性良好.
目的 評價鹽痠安妥沙星片治療呼吸道、泌尿道和皮膚軟組織感染的安全性和有效性.方法 採用區組隨機化、雙盲雙模擬、多中心、平行對照的臨床試驗設計方法,選用左氧氟沙星片為對照藥物,療程7～14 d.結果 719例患者入選,其中安妥沙星組359例,左氧氟沙星組360例,分彆有330與337例完成研究,進入符閤方案集(PPS)分析人群;安妥沙星組和左氧氟沙星組PPS人群治療結束後第1天臨床痊愈率分彆為79.7%與77.4%,有效率分彆為95.2%和96.7%,細菌清除率分彆為96.7%與97.5%.呼吸道、泌尿道、皮膚軟組織感染患者分彆為239、240與240例,兩組臨床療效差異沒有統計學意義.左氧氟沙星組與鹽痠安妥沙星組分彆有357例和356例進行瞭安全性評價,不良事件髮生率均為10.1%,不良反應髮生率分彆為7.8%和7.9%,主要以輕度消化道反應為主.沒有髮現心電圖QTc延長患者,兩組各有1例患者治療結束時血糖輕度增加,隨訪均恢複正常;兩組臨床、細菌學療效以及不良反應髮生情況差異無統計學意義(P＞0.05).結論 鹽痠安妥沙星片治療急性細菌性呼吸道、泌尿道和皮膚軟組織感染療效確切,安全性良好.
목적 평개염산안타사성편치료호흡도、비뇨도화피부연조직감염적안전성화유효성.방법 채용구조수궤화、쌍맹쌍모의、다중심、평행대조적림상시험설계방법,선용좌양불사성편위대조약물,료정7～14 d.결과 719례환자입선,기중안타사성조359례,좌양불사성조360례,분별유330여337례완성연구,진입부합방안집(PPS)분석인군;안타사성조화좌양불사성조PPS인군치료결속후제1천림상전유솔분별위79.7%여77.4%,유효솔분별위95.2%화96.7%,세균청제솔분별위96.7%여97.5%.호흡도、비뇨도、피부연조직감염환자분별위239、240여240례,량조림상료효차이몰유통계학의의.좌양불사성조여염산안타사성조분별유357례화356례진행료안전성평개,불량사건발생솔균위10.1%,불량반응발생솔분별위7.8%화7.9%,주요이경도소화도반응위주.몰유발현심전도QTc연장환자,량조각유1례환자치료결속시혈당경도증가,수방균회복정상;량조림상、세균학료효이급불량반응발생정황차이무통계학의의(P＞0.05).결론 염산안타사성편치료급성세균성호흡도、비뇨도화피부연조직감염료효학절,안전성량호.
Objective To evaluate the clinical efficacy and safety of antofloxacin hydrochloride tablet for the treatment of acute bacterial infections. Methods A multi-center randomized control, double blind and double dummy clinical trial was conducted; levofloxacin tablet was chosed as controlled drug. The duration of treatment was 7-14 days in both groups. Results A total of 719 patients were enrolled in the study, in which 359 patients treated with antofloxacin and 360 patients treated with levofloxacin were included. Three hundred and thirty and 337 patients completed the study and met with all the criteria for perprotocol analysis, respectively. By the end of chemotherapy, the cured rates in per protocol set (PPS)population were 79.7% and 77.4%, the effective rates were 95.2% and 96. 7%, and the bacterial clearance were 96. 7% and 97. 5% for the treating and control group, respectively. The clinical and bacterial efficacy of antofloxacin and levofloxacin was comparable by the analysis of infectious sites. Three hundred and fifty-seven and 356 patients in antofloxacin and levofloxacin groups were evaluated the safety.The drug adverse events occurred both in 10. 1%, and drug adverse reactions accurred in 7. 8% and 7.9%patients in the two groups. The most common drug adverse reactions were mild gastroenteric symptoms. No QTc prologation was detected in all the patients. One patient in each group had mild blood glucose increase at the end of therapy, but the glucose returned to normal level without any intervention. No statistic significant difference between the two groups in clinical efficacy and safety was detected (P＞0.05).Conclusions Antofloxacin hydrochloride tablet was effective and safe for the treatment of acute bacterial infections.
