甲磺酸加替沙星葡萄糖注射液治疗急性细菌性感染随机对照临床研究

目的：评价甲磺酸加替沙星葡萄糖注射液治疗急性细菌性感染的有效性和安全性。方法：采用区组分层均衡随机单盲试验设计,完成甲磺酸加替沙星葡萄糖注射液21例及盐酸左氧氟沙星注射液19例共40例感染患者的临床试验。结果：试验组对照组病例的一般项目基本相似,甲磺酸加替沙星葡萄糖注射液与左氧氟沙星注射液的临床有效率分别为95．23％和89．47％,细菌学有效率分别为94．74％和87．50％,细菌清除率为100％和93．75％,不良反应发生率分别为4．76％、0,不良反应轻微,无需处理,自行复常。结论：甲磺酸加替沙星葡萄糖注射夜是一种安全有效的广谱抗菌药物,抗菌活性强,可用于治疗多种细菌引起的感染。     

磷霉素氨丁三醇与环丙沙星随机对照治疗急性细菌性泌尿道感染的评价

用磷霉素氨丁三不丙沙星随机对照治疗急性细菌性泌尿道感染,对前者进行安全性及有效性评价。方法：磷霉素氨丁三醇３ｇ,ＱＤ,疗程５天,环丙沙星２５０ｍｇＢｉｄ,疗程５天,结果：共完成４１例,病例包括急性膀胱炎,急性尿道炎、急性肾盂肾炎、慢性肾盂肾炎急性,复杂尿路感染。     

加替沙星注射液治疗急性尿路感染的多中心随机对照临床研究

目的：评价国产加替沙星注射液治疗急性尿路感染的临床疗效与安全性。方法：以左氟沙星注射液为对照,采用多中心随机对照试验设计,两药均为200mg静脉滴注,Q12h,疗程7～10日。结果：加替沙星组与左氟沙星组的痊愈率和总有效率分别为65．79％与83．33％和94．74％与97．62％,细菌清除率分别为87．88％和96．77％,不良反应发生率分别为9．30％和8.89％,以上结果两组间比较差异均无统计学意义。两组不良反应均主要为轻度恶心、呕吐、失眠、局部刺激及肝功转氨酶增高。结论：国产加替沙星注射液治疗急性尿路感染疗效确切,安全性较好。     

加替沙星与洛美沙星随机对照治疗呼吸系统感染临床观察

加替沙星(gatifloxacin)是一种抗菌谱广、抗菌活力强、使用方便的新型氟喹诺酮类抗菌药，适于治疗由需氧菌、厌氧菌及支原体、衣原体、结核杆菌等引起的各种感染。本研究以加替沙星为试验药，以洛美沙星为对照药进行非盲法随机对照临床试验，对加替沙星治疗呼吸系统急性细菌性感染的安全性及有效性予以评价，报告如下。     

加替沙星注射液治疗急性细菌性感染的多中心双盲随机对照研究

目的：评价国产加替沙星注射液治疗中、重度急性细菌性感染的临床疗效与安全性。方法：采用多中心、双盲、随机对照试验设计，以左氧氟沙星注射液为对照药，两组的用量、用法及疗程均为200mg静脉滴注，每12小时1次，疗程7～10d。结果：本研究共纳入255例，加替沙星组和左氧氟沙星组分别为126例和129例，其中加替沙星组进行ITT分析123例，PP分析112例，左氧氟沙星组进行ITT分析120例，PP分析107例。疗程结束时加替沙星组与左氧氟沙星组的总痊愈率和有效率分别为56．25％与55．14％和86．61％与82．24％，两组细菌清除率分别为94．85％和97．75％；治疗结束后7d随访，两组的总痊愈率和有效率分别为67．57％与69．23％和87．39％与90．38％，两组细菌清除率分别为94．79％和97．70％。以上结果两组间比较及疗程结束时与结束后7d比较，差异均无显著性。加替沙星组和左氧氟沙星组的不良反应发生率分别为17．89％和19．17％，均主要表现为轻度恶心、呕吐、头晕、失眠、局部刺激及转氨酶增高等。结论：国产加替沙星注射液治疗中、重度急性细菌性感染疗效确切，安全性较好。     

加替沙星治疗下呼吸道感染临床随机对照研究

目的　采用非盲随机对照法比较加替沙星与左氧氟沙星治疗下呼吸道感染的有效性和安全性。方法　经临床确诊的下呼吸道感染患者84例,其中加替沙星组45例,口服加替沙星0.2 g,每日2次;左氧氟沙星组39例,口服左氧氟沙星0.2 g,每日2 次,疗程均为7 ~ 14 天。结果　加替沙星组和左氧氟沙星组痊愈率分别为80.0%和74.4%,有效率分别为95.6%和92.3%,两组细菌清除率分别为89.7%和88.6%(P>0.05);两组间临床和细菌学疗效差异无统计学意义,两组不良事件发生率分别为6.7%和7.7%。结论　加替沙星能安全有效地治疗下呼吸道感染。     

加替沙星与左氧氟沙星序贯治疗细菌性感染的多中心单盲随机对照研究

目的：评价加替沙星注射液的疗效与安全性。方法：本研究为多中心、单盲、随机、对照试验，下呼吸道及尿路感染患被随机分配接受加替沙星或左氧氟沙星静脉给药继以口服序贯治疗。结果：(1)试验组和对照组临床有效率分别为92．4％(110／119)和91．2％(114／125)，其中下呼吸道感染两组有效率为94．2％(65／69)和90．2％(65／72)，尿路感染两组有效率为90．0％(45／50)和92．5％(42／72)，经统计学分析2组间差异无显性；(2)两组总的细菌清除率分别为94．O％(78／83)和88．0％(8l／92)，其中尿路感染细菌清除率为89．2％(33／37)和92．9％(39／42)，两组间差异无显性；但试验组下呼吸道感染细菌清除率为97．8％(45／46)，高于对照组的84．3％(43／51)，差异有显性；(3)试验组不良反应发生率为29．9％(38／127)，显高于对照组的10．1％(13／129)；两组不良反应均系轻度，患可耐受，无中途停药。两组实验室检查异常分别占24．8％(30／121)和22．1％(27／122)，均系轻度并呈一过性，经统计学分析差异无显性。结论：加替沙星注射荆静脉给药用于全身症状明显感染的初期治疗可使病情早期缓解，继以口服完成疗程，可获良好疗效；加替沙星组临床疗效与对照组相仿，虽不良反应多于对照组，但均属轻度并可为患耐受。     

氧氟沙星注射剂治疗细菌性感染随机对照研究

应用氧氟沙星注射剂治疗各种中、重度急性细菌感染患者３３例，并与环丙沙星注射液相对照。结果显示，试验组与对照组临床痊愈率分别８４８５％与７５７６％，有效率分别为１００％与９６９７％，细菌清除率分别为９３９４％与９４２９％，不良反应发生率分别为３０３％与６０６％。研究结果表明，氧氟沙星注射剂是一安全有效的抗菌药物。     

甲磺酸加替沙星治疗老年人肺炎疗效分析

目的 探讨应用甲磺酸加替沙星治疗老年人肺炎的疗效.方法 对110 例老年人肺炎,随机分为治疗组和对照组,各55 例,治疗组给予甲磺酸加替沙星400mg 静脉滴注,1次/d,对照组给予左氧氟沙星注射液400mg 静脉滴注,1次/d,疗程均2周,观察临床疗效及不良反应.结果 治疗组有效率88.6%,对照组有效率67.5%,治疗组明显高于对照组(P<0.05 ).结论 甲磺酸加替沙星治疗老年人肺炎疗效较好,不良反应少.     

口服加替沙星与左氧氟沙星治疗下呼吸道和尿路感染的前瞻性多中心随机对照研究

目的：评价加替沙星片治疗下呼吸道感染及尿路感染的疗效与安全性。方法：以左氧氟沙星片为对照药，在248例下呼吸道和尿路感染中进行疗效和安全性的多中心随机对照观察。加替沙星组125例，其中下呼吸道感染50例，尿路感染75例；左氧氟沙星组123例，其中下呼吸道感染54例，尿路感染69例。给药方案分别为治疗下呼吸道感染加替沙星片400mg1次／d口服，左氧氟沙星片200mg2次／d口服，疗程均为7—14d；肾盂肾炎、复杂性尿路感染及反复发作性尿路感染加替沙星片400mg1次／d口服，左氧氟沙星200mg2次／d口服，疗程均为7—14dl急性单纯性下尿路感染加替沙星片200mg1次／d口服，左氧氟沙星片100mg2次／d口服，疗程均为5d。结果：加替沙星组125例和左氧氟沙星组123例的临床有效率分别为95．2％(119／125)和91．9％(113／123)，临床痊愈率分别为68．8％(86／125)和63．4％(78／123)；细菌清除率分别为89．3％(100／112)和89．5％(94／105)；不良反应发生率分别为25．3％(40／158)和18．6％(30／161)，实验室检查异常发生率为14．7％(22／150)和15．8％(24／152)。上述结果经统计学处理，差异均无显性。结论：本研究结果显示加替沙星片治疗下呼吸道及尿路感染的疗效和安全性与左氧氟沙星片相仿。     

利奈唑胺和糖肽类抗生素对复杂性皮肤及软组织感染治疗效果的荟萃分析

目的 对现已发表的利奈唑胺和糖肽类抗生素治疗革兰阳性球菌复杂性皮肤及软组织感染的文献进行综合分析,评价利奈唑胺的疗效及安全性是否优于糖肽类抗生素.方法 计算机检索Medline数据库、Embase数据库、Ovid数据库、Cochrane 图书馆及中文生物医学期刊数据库等网络资源,并查阅所有纳入的参考文献,进行荟萃分析....     

Prospective randomized controlled study of ciprofloxacin versus imipenem-cilastatin in severe clinical infections.

In a randomized prospective study, 66 patients with serious bacterial infections--mainly lower respiratory tract infections--were treated with either imipenem plus cilastatin (32 patients) or ciprofloxacin (34 patients); 30 patients in each group were evaluable for efficacy. Substantial underlying disease was present in most of the patients; pathogens isolated prior to treatment (77 isolates) consisted mainly of members of the family Enterobacteriaceae, Pseudomonas aeruginosa, Staphylococcus aureus, Haemophilus influenzae, and streptococci. Of the etiologic bacteria, 67% were eradicated by ciprofloxacin treatment and 79% by imipenem therapy; however, two patients (6.7%) failed in the ciprofloxacin group, and six patients (20%) did not respond to imipenem treatment (P = 0.25). All patients with therapeutic failures suffered from severe fatal underlying diseases, which had substantial impact on the outcome of treatment. Therapeutic drug monitoring in the ciprofloxacin patients revealed higher concentrations in serum at days 4 and 8 in comparison with day 1 of treatment, indicating that steady-state conditions were reached between days 1 and 4. The total number of side effects was relatively high--eight imipenem patients (25%) and six ciprofloxacin patients (18%) had reactions. Treatment had to be discontinued due to adverse reactions for three ciprofloxacin patients and two imipenem patients. Major side effects in both groups were gastrointestinal and central nervous system-related symptoms. In terms of clinical and bacteriological efficacy and safety, there was no statistical difference between the two groups, and both groups gave good to excellent results for bacterial infections that were difficult to treat.     

Linezolid versus vancomycin in treatment of complicated skin and soft tissue infections

Skin and soft tissue infections (SSTIs) are a common cause of morbidity in both the community and the hospital. An SSTI is classified as complicated if the infection has spread to the deeper soft tissues, if surgical intervention is necessary, or if the patient has a comorbid condition hindering treatment response (e.g., diabetes mellitus or human immunodeficiency virus). The purpose of this study was to compare linezolid to vancomycin in the treatment of suspected or proven methicillin-resistant gram-positive complicated SSTIs (CSSTIs) requiring hospitalization. This was a randomized, open-label, comparator-controlled, multicenter, multinational study that included patients with suspected or proven methicillin-resistant Staphylococcus aureus (MRSA) infections that involved substantial areas of skin or deeper soft tissues, such as cellulitis, abscesses, infected ulcers, or burns (<10% of total body surface area). Patients were randomized (1:1) to receive linezolid (600 mg) every 12 h either intravenously (i.v.) or orally or vancomycin (1 g) every 12 h i.v. In the intent-to-treat population, 92.2% and 88.5% of patients treated with linezolid and vancomycin, respectively, were clinically cured at the test-of-cure (TOC) visit (P=0.057). Linezolid outcomes (124/140 patients or 88.6%) were superior to vancomycin outcomes (97/145 patients or 66.9%) at the TOC visit for patients with MRSA infections (P<0.001). Drug-related adverse events were reported in similar numbers in both the linezolid and the vancomycin arms of the trial. The results of this study demonstrate that linezolid therapy is well tolerated, equivalent to vancomycin in treating CSSTIs, and superior to vancomycin in the treatment of CSSTIs due to MRSA.     

Teicoplanin for skin and soft tissue infections: An open study and a randomized, comparative trial versus cefazolin

An open trial and a multicenter, three-group, randomized trial versus cefazolin were performed to study the use of teicoplanin in the treatment of serious skin and soft tissue infections caused by Gram-positive bacteria. A total of 418 patients were entered into the randomized trial, 293 of whom were available for efficacy analysis, and 262 patients were entered in the open trial. The randomized trial had three arms: intramuscular (125 patients) vs intravenous (148 patients) teicoplanin vs cefazolin (145 patients). In both trials teicoplanin was administered once daily, originally as 3 mg/kg per day, with the option of higher doses in the open trial. Cefazolin was given at a dose of 1.5–4 g/day, in three divided doses. In the randomized trial, teicoplanin and cefazolin showed similar overall efficacy. The higher dose of teicoplanin (6 mg/kg) was significantly more effective than the lower dose (3 mg/kg), particularly in patients with diabetes. In the open trial, teicoplanin had a clinical success rate of 93%. There was no significant difference in the incidence of adverse events between the cefazolin and teicoplanin groups. Outpatient ambulatory therapy was shown to be a practical method of administering teicoplanin. Once-daily dosing with teicoplanin may allow physicians to treat skin and soft tissue infections on a totally outpatient basis. Received: September 19, 1997 / Accepted: October 7, 1998     

磷霉素氨丁三醇与环丙沙星随机对照治疗121例泌尿道细菌性感染临床评价

目的 :评价磷霉素氨丁三醇与环丙沙星随机对照治疗泌尿道细菌性感染的疗效和安全性。方法 :以环丙沙星为对照 ,采用随机化开放试验方法 ,观察试验药磷霉素氨丁三醇组 6 1例 ,对照药环丙沙星组 6 0例。结果 :磷霉素氨丁三醇与环丙沙星治疗泌尿系统感染的临床痊愈率分别为 85 .2 %和 83.3% ,有效率分别为 95 .1%和 95 .0 % ,细菌清除率分别为 92 .3%和92 .2 %。经统计学检验 ,上述两组结果差异无显著性 (P >0 .0 5 )。从分离到的 10 3株致病菌药敏试验结果分析发现 ,93株(90 .3% )致病菌对磷霉素氨丁三醇敏感 ,81株 (78.6 % )致病菌对环丙沙星敏感 ,经统计学处理两组的差异有显著性 (P =0 .0 2 1)。两药不良反应发生率分别为 4 .8%与 7.7%。结论 :磷霉素氨丁三醇对多数革兰阳性菌、阴性菌引起的泌尿道感染的治疗是安全有效的     

注射用头孢唑肟钠治疗细菌性感染的多中心随机对照临床研究

目的评价国产注射用头孢唑肟钠治疗呼吸系统及泌尿系统细菌性感染的l临床疗效和安全性。方法采用多中心、随机、盲法、平行对照试验设计，选择呼吸系统和泌尿系统细菌性感染患者，试验组（A组）应用国产注射用头孢唑肟钠，对照组（B组）应用进口注射用头孢唑肟钠（商品名益保世灵），用法均为2．0g，静脉滴注，每12小时1次；下呼吸道感染疗程为7～14d，泌尿系统感染为5～14d。结果本研究共入选病例144例，其中下呼吸道感染和泌尿系统感染各72例。A、B两组基本临床特征差异无统计学意义，资料具有可比性。疗效分析显示．A组与B组的痊愈率分别为81．9％和63．9％，总有效率分别为98．6％和98．6％，两组差异无统计学意义（P〉0．05）。A、B两组细菌清除率分别为100％和98．4％（P〉0．05）。本研究两组不良反应发生率均较低（2．8％与2．8％，P〉0．05），未见严重不良反应。结论国产注射用头孢唑肟钠对临床常见致病菌引起的下呼吸道、泌尿系统感染，临床疗效较好而不良反应发生率低，有较高的临床应用价值。     

左氧氟沙星与头孢曲松联合阿奇霉素治疗社区获得性下呼吸道感染的对照研究

目的比较左氧氟沙星注射液与头孢曲松注射液＋口服阿奇霉素在治疗社区获得性下呼吸道感染中的疗效和安全性。方法采用随机、开放、对照研究，共入选88例患者，其中试验组43例，接受左氧氟沙星治疗，500mg每日1次静脉滴注；对照组45例，接受头孢曲松＋阿奇霉素治疗，头孢曲松2g每日1次静脉滴注，阿奇霉素口服，每日0．25g（首次0．5g）。治疗7～10d后评价临床和细菌学疗效。结果左氧氟沙星组的总有效率为86．0%，头孢曲松＋口服阿奇霉素组为84．4％；试验组细菌清除率为93．3％，对照组为92．9％，差异均无显著性（P〉0．05）。两组患者中发现非典型病原体感染共12例，其中5例为肺炎支原体，4例为肺炎衣原体，3例为嗜肺军团菌。所有12例非典型病原体感染患者均痊愈。患者对左氧氟沙星和头孢曲松＋口服阿奇霉素均有良好的耐受性。结论左氧氟沙星和头孢曲松＋口服阿奇霉素都可以作为治疗社区获得性下呼吸道感染的有效、安全的药物。     

Clinafloxacin versus piperacillin-tazobactam in treatment of patients with severe skin and soft tissue infections

Patients (n = 409) with severe skin and soft tissue infections (SSTIs) were randomized to receive clinafloxacin or piperacillin-tazobactam (plus optional vancomycin for methicillin-resistant cocci), administered intravenously, with the option to switch to oral medication. Most patients had cellulitis, wound infections, or diabetic foot infections. Staphylococcus aureus, Enterococcus faecalis, and Pseudomonas aeruginosa were the most common baseline pathogens. Fewer baseline pathogens were resistant to clinafloxacin (1.8%) than to piperacillin-tazobactam (6.2%) (P = 0.001). The clinafloxacin and piperacillin-tazobactam groups did not differ significantly in clinical cure rates (68.8 and 65.2%, respectively) or microbiologic eradication rates (61.5 and 57.2%). Clinafloxacin yielded higher eradication rates for all three of the most common pathogenic species, although no differences were statistically significant. Within the power of this study, the overall frequency of adverse events was similar (P = 0.577) in the two treatment groups. Drug-associated adverse events (P = 0.050) and treatment discontinuations (P = 0.052) were marginally more frequent in the clinafloxacin group, primarily due to phototoxicity in outpatients receiving clinafloxacin. Although most cases of phototoxicity were mild to moderate, four cases were reported as severe. In summary, clinafloxacin monotherapy was equivalent in effectiveness to therapy with piperacillin-tazobactam plus optional vancomycin in the treatment of hospitalized patients with severe SSTIs.     

A randomized controlled trial of azithromycin versus doxycycline/ciprofloxacin for the syndromic management of sexually transmitted infections in a resource-poor setting

A randomized controlled trial was carried out to assess the effectiveness of azithromycin versus a standard regimen with doxycycline/ciprofloxacin in the treatment of sexually transmitted infections in a resource-poor environment. Infection with Chlamydia trachomatis was cured in 23/24 (95.8%) of women in the azithromycin arm versus 19/21 (90.5%) in the doxycycline arm (P = 0.6), resulting in three treatment failures. Gonorrhoea was cured in 55/56 (98.2%) women, with one treatment failure in a patient with concomitant C. trachomatis infection. These results indicate that a single oral dose of azithromycin may prove to be a more effective and convenient treatment for sexually transmitted infections in women in a resource-poor environment