乳酸左氧氟沙星与头孢呋辛3日疗法随机对照治疗尿路感染76例临床评价

以乳酸左氧氟沙星片为试验药与头孢呋辛随机对照,用3 日疗法治疗急性尿路感染76 例。乳酸左氧氟沙星200m g,每日2 次口服;头孢呋辛250m g,每日2 次口服,疗程均为3d。结果试验药组与对照药组总有效率分别为94.7% 和89.5% 。细菌清除率分别为93.3% 和88.5% ,药物不良反应率分别为7.9% 和13% 。结果证明乳酸左氧氟沙星3 日疗法治疗急性尿路感染是安全、有效的药物之一。     

乳酸左氧氟沙星与头孢哌酮/舒巴坦对照治疗老年人下呼吸道感染的临床研究

乳酸左氧氟沙星(LVLXL)与头孢哌酮(CPZ)/舒巴坦(SB)随机对照治疗老年人呼吸道感染各40 例,对其临床疗效和细菌学效果及安全性作出评价,用法为LVLXL 0.2g,每日2 次;CPZ/SB 2g,每日2次,疗程均为7～14d。结果显示:LVLXL组与CPZ/SB组的临床有效率分别是92.5% 和92.5% ,痊愈率分别是75% 和77.5% ,细菌清除率分别是84.4% 和83.5% (无统计学差异),不良反应发生率为7.5% 和7.5%(无统计学差异),不良反应轻微,不需任何处理。     

乳酸左氧氟沙星注射液治疗急性胆囊炎的临床分析

目的分析乳酸左氧氟沙星注射液治疗急性胆囊炎的临床疗效。方法 76例急性胆囊炎患者,按照随机数字表法分为治疗组和对照组,各38例。治疗组给予乳酸左氧氟沙星注射液治疗,对照组给予头孢曲松钠治疗,对比两组患者恢复情况。结果治疗组总有效率(97.4%)与对照组(94.7%)相比,差异无统计学意义(P>0.05);治疗组各症状缓解时间较对照组短,差异有统计学意义(P<0.05);两组患者不良反应对比,差异无统计学意义(P>0.05)。结论乳酸左氧氟沙星注射液治疗急性胆囊炎取得显著效果,安全性高,可在临床推广应用。     

盐酸加替沙星片剂与乳酸左氧氟沙星片剂随机双盲对照治疗急性细菌性感染临床研究

目的评价国产盐酸加替沙星片剂治疗急性细菌性呼吸道感染与泌尿道感染的有效性和安全性。方法采用区组随机化、双盲、平行对照临床试验设计，试验药盐酸加替沙星与对照药乳酸左氧氟沙星片剂用法均为每次200mg。一日2次。疗程均为7～14d。结果本试验共入选74例，因各种原因淘汰12例，最终列入疗效评价的病例数为62例，盐酸加替沙星组32例，乳酸左氧氟沙星组30例。治疗结束后盐酸加替沙星与乳酸左氧氟沙星痊愈率分别为75．0％与73．3％。有效率分别为93．8％与90．0%，细菌清除率分别为86．7％与88．5％；在试验期间，盐酸加替沙星组有1例发生皮疹，乳酸左氧氟沙星组有2例发生不良反应（1例转氨酶升高，1例恶心、食欲差）；上述结果经统计学检验无显著性差异。结论盐酸加替沙星与乳酸左氧氟沙星片剂治疗临床常见细菌性呼吸道、泌尿道感染均有效、安全。     

乳酸左氧氟沙星与头孢呋辛3日疗法随机对照治疗疗尿路感染 …

以乳酸左氧氟沙星片为试验药与头孢呋辛随机对照,用３日疗法治疗急性尿路感染７６例。乳酸左氧氟沙星２００ｍｇ,每日２次口服;头孢呋辛２５０ｍｇ,每日２次口服,疗效均为３d。结果试验药组与对照药组总有效率分别为９４．７％和８９．５％。细菌清除率分７．９％和１３％。结果证明乳酸左氧氟沙星３日疗法治疗急性尿路感染是安全、有效的药物之一。     

加替沙星与左氧氟沙星注射液治疗重症呼吸道感染随机双盲对照临床研究

目的 评价加替沙星注射液治疗重症呼吸道感染的临床疗效与安全性.方法 随机选择急性细菌感染患者186例,采用多中心双盲随机对照试验设计,随机分为对照组（药用左氧氟沙星注射液）与试验组（药用加替沙星注射液）,每组93例.2组均每日给药2次,每次200 mg,疗程7-12 d.结果 2组在疗程结束时痊愈率和总有效率分别为54.65%和84.88%与56.82%和87.50%.2组细菌清除率分别为97.33%与98.70%.疗程结束后7 d,细菌清除率分别为96.88%与100%.以上结果2组比较差异均无统计学意义（P〉0.05）.2组不良反应发生率分别为23.26%与20.45%,不良反应均为轻、中度,2组比较差异无统计学意义（P〉0.05）.结论 加替沙星注射液治疗重症呼吸道感染临床疗效确切,安全性可靠.     

乳酸左氧氟沙星治疗社区获得性肺炎疗效观察

目的：观察乳酸左氧氟沙星治疗社区获得性肺炎的疗效。方法：将30例社区获得性肺炎患者随机分为两组,均给予止咳化痰药物,其中治疗组15例应用乳酸左氧氟沙星0.4 g静脉滴注,1次/d,对照组15例采用头孢西丁2.0 g加入0.9%氯化钠溶液中静脉滴注,2次/d,治疗7 d。结果：治疗组总有效率为93.3%,对照组总有效率为86.6%,两组疗效比较,差异无统计学意义（P〉0.05）。结论：乳酸左氧氟沙星治疗社区获得性肺炎效果显著,安全性好。     

盐酸左氧氟沙星治疗呼吸系统细菌感染临床比较研究

目的评价盐酸左氧氟沙星针粉剂治疗呼吸系统细菌感染的安全有效性.方法以乳酸左氧氟沙星注射液为对照组,进行随机对照临床研究.选择呼吸系统细菌感染60例,随机分为治疗组30例,予以盐酸左氧氟沙星针粉剂治疗;对照组30例,予以乳酸左氧氟沙星治疗.结果临床有效率治疗组为73.3%,对照组为66.7%;各种致病菌清除率治疗组为76.7%,对照组为59.3%;药物不良反应率治疗组为3.3%,对照组为6.7%,两组比较无统计学差异.结论盐酸左氧氟沙星针粉剂治疗呼吸系统细菌感染安全有效,与乳酸左氧氟沙星注射液生物等效.     

左氧氟沙星片联合三金片治疗妇女更年期尿路感染的临床观察

目的观察左氧氟沙星片联合三金片治疗妇女更年期尿路感染的临床疗效。方法对56例尿路感染患者随机分为两组,即口服左氧氟沙星片组（A组）和口服左氧氟沙星片联合三金片组（B组）,治疗1~2周,对其疗效进行评价。结果两组药物48h显效时间比较：B组比A组显效快,有效率分别为83%、30%,差异有显著性（P〈0.05）。不良反映发生率分别为6.7%、8%,差异无显著性（P〉0.05）。结论左氧氟沙星片联合三金片可迅速缓解尿频、尿急、尿痛等症状,是治疗妇女更年期尿路感染方便,有效的药物。     

左氧氟沙星联合头孢曲松治疗肺水肿并发下呼吸道感染的疗效观察

目的观察左氧氟沙星联合头孢曲松与单独应用左氧氟沙星治疗急性肺水肿并发下呼吸道感染的疗效差异。方法对照组21例给予左氧氟沙星治疗,观察组32例给予左氧氟沙星联合头孢曲松治疗。比较两组治疗总有效率、平均给药天数。结果总有效率对照组为85．7％,观察组为96．9％,差异无统计学意义（X2=0．95,P〉0．05）;平均给药天数对照组为（6．1±2．6）d,观察组为（5．7±2．1）d,差异无统计学意义（t=0．62,P〉0．05）。结论单独应用左氧氟沙星与其联合头孢曲松治疗急性肺水肿并发下呼吸道感染疗效无显著差异,因此应尽量避免联合用药。     

乳酸左氧氟沙星治疗老年人下呼吸道感染的临床评价

本文报告乳酸左氧氟沙星治疗老年人下呼吸道感染６０例的临床疗效。下呼吸道感染分别为急性支气管炎,慢性支气管炎发作,肺炎,支气管扩张继发感染和支气哮喘继发感染。每日４００ｇｍ,分２次静脉滴注,疗程７－１４ｄ。痊愈率５５．６％,有效率８８．９％,细菌清除率９０％,不良反应发生率８．２％。提示乳酸左氧氟沙星对老年人下呼吸道感染疗效肯定,特别对系统对难治感染有较好的抗菌效果,不良反应轻,安全性好。     

利福昔明治疗急性感染性腹泻111例临床疗效及安全性

目的:评价利福昔明治疗急性感染性腹泻的临床疗效及安全性。方法:采用多中心、随机、双盲双模拟、阳性药物平行对照研究。入选急性感染性腹泻240例,完成227例,其中利福昔明组111例,男性52例,女性49例,年龄(30±s11)a,入组d1,服用利福昔明300mg和左氧氟沙星安慰剂1片,po,tid,d2~5,利福昔明400mg和左氧氟沙星安慰剂1片,po,bid;左氧氟沙星组116例,男性57例,女性59例,年龄(30±11)a,入组d1,服用左氧氟沙星100mg和利福昔明安慰剂3片,po,tid,d2~5,左氧氟沙星100mg和利福昔明安慰剂4片,po,bid。2组疗程均为3~5d。观察2组疗效和不良反应。结果:利福昔明组痊愈率和有效率分别为84.7%和100%,左氧氟沙星组痊愈率和有效率分别为77.6%和100%。2组疗效无统计学差异(P>0.05)。利福昔明组和左氧氟沙星组细菌清除率分别为100%和99%,2组无统计学差异(P>0.05)。2组均未出现不良反应。结论:利福昔明治疗急性感染性腹泻具有明显疗效,未见不良反应。     

左氧氟沙星联合头孢曲松治疗老年呼吸道感染的临床效果

目的观察左氧氟沙星联合头孢曲松治疗老年呼吸道感染的临床效果。方法选取2017年12月-2019年12月湖南省湘潭市雨湖区万楼街道社区卫生服务中心接收的老年呼吸道感染患者60例,根据电脑随机数字表法分为观察组和对照组各30例。对照组患者给予头孢曲松治疗,观察组患者给予左氧氟沙星联合头孢曲松治疗。比较2组患者的临床疗效、临床症状改善时间、治疗前后生存质量改善情况及不良反应。结果观察组患者的治疗总有效率为96.7%,高于对照组患者的80.0%(χ²=4.043,P=0.044);观察组患者咳嗽、呼吸困难、发热及肺部啰音改善时间均短于对照组(P<0.05);治疗后2组患者生存质量评分高于治疗前,且观察组高于对照组(P<0.01);治疗期间2组不良反应总发生率比较无显著差异(χ²=0.218,P=0.640)。结论左氧氟沙星联合头孢曲松治疗老年呼吸道感染患者的疗效好,可尽早改善患者的临床症状,帮助患者尽早恢复健康,提高患者生存质量,且临床安全性较高。     

Pharmacokinetics and tolerability of buspirone during oral administration to children and adolescents with anxiety disorder and normal healthy adults.

A 21-day, open-label, multisite, dose escalation study comprising three demographic groups (children, adolescents, and adults) was performed to determine the pharmacokinetics and tolerability of orally administered buspirone. Thirteen children and 12 adolescents with anxiety disorder and 14 normal healthy adults were escalated from 5 to 30 mg buspirone bid over the 3-week study. Pharmacokinetic analysis revealed that buspirone was rapidly absorbed in all study groups, reaching peak levels at about 1 hour after administration. Peak plasma buspirone concentrations (Cmax) were highest in children and lowest in adults at all three dose levels (7.5, 15, 30 mg bid). However, 1-pyrimidinylpiperazine (1-PP), the primary metabolite of buspirone, exhibited a different plasma concentration-time profile; Cmax was significantly higher in children than in either adolescents or adults at all concentrations. In addition, TAUC0-T for 1-PP was significantly higher in the children cohort relative to adolescents and adults. Buspirone was generally safe and well tolerated at doses up to 30 mg bid in adolescents and adults and most of the children. The most frequently reported adverse events in children and adolescents were lightheadedness (68%), headache (48%), and dyspepsia (20%); 2 children withdrewfrom the study at the higher doses (15 mg and 30 mg bid) due to adverse effects. In adults, the most common adverse effect was somnolence (21.4%); lightheadedness, nausea, vomiting, and diarrhea were also reported, although these were mild in intensity.     

帕珠沙星治疗急性细菌感染性疾病的Ⅱ期临床试验

目的:评价帕珠沙星对急性细菌感染病人的有效性和安全性。方法:采用多中心随机单盲对照试验设计。选择细菌性感染病人240例,试验组(A组)120例,年龄(44±s 12)a,男性46例,女性74例;对照组(B组)120例,年龄(42±13)a,男性50例,女性70例。A组用帕珠沙星0．5 g,加入氯化钠注射液100 mL,iv,gtt,30 min～1 h,bid;B组用左氧氟沙星0．3 g,加入氯化钠注射液100 mL, iv,gtt,30 min～1 h,bid。疗程均为7～10 d。结果:A组120例,痊愈率为77．5％,总有效率98．3％; B组120例,痊愈率为74．2％,总有效率为96．7％,A组痊愈率和总有效率95％可信区间分别为70％～85％和96％～100％;B组痊愈率和总有效率95％可信区间分别为66％～82％和93％～100％,2组无显著差异。A组和B组的细菌清除率分别为97．1％和96％,2组比较无显著差异(P＞0．05),A组不良反应发生率为4．2％,B组为3．3％,差异无显著意义(P＞0．05)。结论:帕珠沙星治疗由敏感病原体引起的呼吸道感染、泌尿道感染,疗效与左氧氟沙星相近,不良反应较低。     

莫西沙星治疗皮肤细菌感染随机双盲对照临床研究

目的：比较每日po1次莫西沙星400mg与每日po2次左旋氧氟沙星200mg，治疗轻中度急性无合并症皮肤细菌感染(包括蜂窝织炎、脓疱病，疖、单纯脓肿和伤口感染)的安全性和有效性。方法：用随机、双盲、平行研究，共入选88例患者，试验组和对照组各44例。疗程7～14天，主要疗效参数为治疗结束后第1，第7天的临床疗效。结果：在治疗结束后第1天，莫西沙星组与左旋氧氟沙星组临床有效率分别为84．6％(33／39)，85．0％(34／40)；细菌学清除率分别为93．8％(30／32)，93．9％(31／33)。在治疗结束后第7天莫西沙星组与左旋氧氟沙星组临床有效率分别为85.3％(29／34．)，90．0％(36，40)；细菌学清除率分别为92．9％(26／28)，93．9％(31／33)。莫西沙星组药物不良反应发生率为27．3％(12／44)，左旋氧氟沙星组为ll.4％(5／44)。两组差异均无统计学意义。结论：莫西沙星治疗轻中度急性无合并症皮肤细菌感染有效安全。     

含左氧氟沙星和铋剂的四联疗法根除幽门螺杆菌的疗效研究

目的评价含左氧氟沙星和铋剂的四联10d疗法作为一线方案根除治疗幽门螺杆菌感染的有效性和安全性。方法将150例幽门螺杆菌感染的初治患者,随机分配至三联组和四联组,三联组给予埃索美拉唑20mg(2次/d)+克拉霉素500mg,2次/d+阿莫西林1.0g(2次/d)治疗7d,四联组给予埃索美拉唑20mg(2次/d)+胶体果胶铋200mg(2次/d)+左氧氟沙星500mg(1次/d)+阿莫西林1.0g(2次/d)治疗10d。疗程结束6周后行13C-尿素呼气试验检查,判断幽门螺杆菌根除情况,同时观察治疗过程中的不良反应。结果三联组按意向治疗(ITT)分析和按方案(PP)分析H.pylori的根除率分别为73.3%和75.3%,四联组按ITT分析和按PP分析根除率分别为93.3%和95.9%,四联组的按ITT分析和按PP分析H.pylori的根除率均明显高于三联组(P<0.01)。两组不良反应发生率相似,无严重不良反应事件发生。结论含左氧氟沙星和铋剂的四联10d疗法用于幽门螺杆菌感染的初治,疗效高于标准三联7d疗法,是一种可供选择的一线治疗方案。     

五水头孢唑林钠(新泰林)治疗下呼吸道急性细菌性感染的临床研究

目的 评价五水头孢唑林钠（抗生素）治疗轻、中度急性下呼吸道细菌性感染的疗效与安全性.方法 用多中心单盲随机对照试验设计,随机分为3组：五水头孢唑林钠组34例,头孢唑林钠组33例,头孢曲松钠组36例,3组的用量、用法、疗程相同,每日2次,每次静滴2 g,疗程7～14天.结果 疗程结束时,五水头孢唑林钠与头孢唑林钠、头孢曲松钠痊愈率和有效率分别为76.47%,66.66%,30.56%与97.06%,87.88%,52.78%;药物不良反应发生率分别为2.86%,2.94%,5.56%.结论 五水头孢唑林钠治疗轻、中度急性下呼吸道细菌性感染,疗效确切,安全性较好.     

High-dose levofloxacin in community-acquired pneumonia: a randomized, open-label study

Background: The conventional treatment for community-acquired pneumonia (CAP) involves combination therapy consisting of a β-lactam penicillin or a cephalosporin with a macrolide. Alternatively, high-dose levofloxacin treatment has been used as single-agent therapy for treating CAP, covering atypical pathogens. Objective: This study compared the clinical efficacy and safety of high-dose levofloxacin with combined ceftriaxone and azithromycin for the treatment of CAP. Patients and Methods: This phase IV, prospective, randomized, open-label trial enrolled patients admitted to a tertiary referral hospital for CAP treatment from 2010 to 2011. Hospital admission was decided based on clinical judgement and the pneumonia severity index. Forty subjects were enrolled and assigned to two treatment arms using a random numbers table. The 20 subjects in the experimental group were given levofloxacin 750?mg intravenously once daily, followed by the same dose of oral levofloxacin at discharge when clinically improved and the 20 subjects in the control group were given ceftriaxone 2.0?g intravenously once daily plus oral azithromycin 500?mg for 3 consecutive days, followed by oral cefpodoxime 200?mg per day at discharge after clinical improvement. The primary outcome was the clinical success rate. Secondary outcomes were the microbiological success rate and adverse events during the study. Results: Of the 40 subjects enrolled, 36 completed the study: 17 in the experimental group and 19 in the control group. The groups did not differ in terms of demographic factors or clinical findings at baseline. The clinical success rate (cured?+?improved) was 94% in the experimental (levofloxacin) group and 84% in the control group (p?>?0.05). The microbiological success rate and overall adverse events were also similar in both groups. Conclusion: Single-agent, high-dose levofloxacin treatment exhibited excellent clinical and microbiological efficacy with a safety profile comparable to that of ceftriaxone plus azithromycin therapy. Large-scale clinical trials are required to verify these results. Clinical Trial Registration: WHO International Clinical Trials Registry: KCT0000374; Daiichi-Sankyo Korea study code: T11-13-V1.     

Safety and pharmacokinetics of sorafenib combined with capecitabine in patients with advanced solid tumors: results of a phase 1 trial

Sorafenib (twice daily [bid]) plus capecitabine (2 weeks on schedule/1 week off schedule) safety and pharmacokinetics were investigated in patients with advanced solid tumors (N = 35). Cohort 1 (n = 13) included sorafenib 200 mg bid and capecitabine 1050 mg/m(2) bid; cohort 2 (n = 4), sorafenib 400 mg bid and capecitabine 1050 mg/m(2) bid; cohort 3 (n = 6), sorafenib 200 mg bid and capecitabine 1050 mg/m(2) bid (cycles 1 and 2), then 400 mg bid and capecitabine 1050 mg/m(2) bid (cycle 3 onwards); and cohort 4 (n = 12), sorafenib 400 mg bid and capecitabine 850 mg/m(2) bid. The combination of sorafenib and capecitabine was generally well tolerated. Most frequent drug-related adverse events were hand-foot skin reaction (HFSR, 89%), diarrhea (71%), and fatigue (69%). The HFSR was dose-limiting toxicities in 6 patients. Sorafenib exposure (C(max) and AUC(0-12)) was unaffected by concomitant capecitabine. Concomitant sorafenib moderately increased capecitabine and 5-fluorouracil (metabolite) exposure when the capecitabine dose was 1050 mg/m(2) bid. Simultaneous administration of 400 mg bid sorafenib and 850 mg/m(2) bid capecitabine, however, had only minor effects on the exposure to capecitabine and 5-fluorouracil. Based on the overall toxicity profile and pharmacokinetic parameters, the recommended phase 2 doses were therefore sorafenib 400 mg bid and capecitabine 850 mg/m(2) bid, as scheduled above.