利福昔明片治疗急性感染性腹泻的多中心临床研究

目的评价利福昔明片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。227例急性感染性腹泻患者被随机分成试验组(111例)和对照组(116例)。试验组给利福昔明片第1天为0.3g Po,tid,第2天起改为0.3g,Po,bid。对照组给氧氟沙星片,第1天为0.3g Po,tid,第2天起改为0.3g,Po,bid。疗程3~5d。观察两组疗效和不良反应。结果利福昔明组痊愈率和有效率分别为84.7%和100%,氧氟沙星组痊愈率和有效率分为77.6%和100%;两组疗效无统计学差异(P>0.05)。利福昔明组和氧氟沙星组细菌清除率分别为100%和99%,两组均未出现不良反应。结论利福昔明片是治疗急性感染性腹泻具有明显疗效且安全的口服制剂。     

利福昔明治疗急性细菌感染性腹泻94例的随机双盲多中心临床试验

目的:评价国产新药利福昔明胶囊治疗细菌感染性腹泻的有效性与安全性。方法:采用多中心随机双盲对照试验设计,分成2组。试验组(n=94)给利福昔明400 mg,对照组(n=109)给环丙沙星200 mg,均po,d 1,tid,d 2~5,bid。疗程均3~5d。结果:利福昔明与环丙沙星在症状及体征复常率、止泻率、止泻时间、粪便常规、粪便性状复常率和细菌清除率均无显著性差异;试验组与对照组总痊愈率分别为79%和88.1%(P>0.05),总有效率分别为94%和94.5%(P>0.05);试验组不良反应发生率为1.8%,对照组为5.0%(P>0.05),未发生严重不良反应。2组疗效与安全性的差异均无显著意义。结论:国产利福昔明胶囊治疗急性细菌感染性腹泻安全、有效,与环丙沙星胶囊相似。     

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。     

利福昔明治疗急性细菌性肠道感染临床试验

目的:评价利福昔明治疗急性肠道细菌感染性痰病的疗效和安全性。方法:采用多中心随机双盲双模拟阳性药物平行对照试验。急性细菌性肠道感染患者237例,随机分为:①治疗组118例,给予利福昔明0.2g,po,q6h,同时给予盐酸环丙沙星模拟片1片,bid,疗程5d,②对照组119例,给予环丙沙星0.25g,po,bid,同时给予利福昔明模拟片2片,po,q6h,疗程5d。结果:治疗组肠道感染的治愈率和显效率分别是79.49%,17.09%,总有效率96.58%;对照组分别是79.49%,16.24%,总有效率95.73%,两组差异无统计学意义。利福昔明和环丙沙星的细菌清除率分别是96.55%,100%。经确认与药物有关的不良反应发生率为2.54%和3.36%。各项结果的差异无统计学意义(P>0.05)。结论:利福昔明治疗肠道感染具有较好的疗效,该药有疗效高、起效快、疗程短、不良反应发生率低等优点,是临床治疗急性肠道细茵感染的一种安全有效的抗菌药。     

利福昔明治疗急性细菌性肠道感染107例

目的　评价利福昔明治疗急性细菌性肠道感染疾病的疗效和安全性。方法　采用多中心随机双盲双模拟平行对照试验。急性细菌性肠道感染患者 211例,随机分为两组,治疗组 107例,每次给予利福昔明 0. 2g,po,q6h,同时给予环丙沙星模拟安慰药片 1片,bid,疗程 5d;对照组 104例每次给予环丙沙星 0 .25g,po,bid,同时给予利福昔明模拟安慰药片 2片,po,q6h,疗程 5d。评价两药的疗效及不良反应。结果　治疗组肠道感染的治愈率和显效率分别是 75 7%和 18 .7%,总有效率为 94 .4%;对照组分别是 84 .6%和 13 .5%,总有效率为 98 .1%。利福昔明和环丙沙星的细菌清除率分别是 96. 2%和 96 3%,不良反应发生率为 2. 8%和 2. 9%。各项结果的差异均无显著性 (P>0 .05)。结论　利福昔明治疗急性细菌性肠道感染具有较好的疗效,不良反应发生率低,与环丙沙星的疗效相仿。     

利福昔明胶囊治疗急性细菌感染性腹泻的临床疗效观察

目的:评价利福昔明胶囊治疗急性细菌感染性腹泻的疗效和安全性。方法:采用随机双盲平行对照研究。利福昔明胶囊组,每次口服利福昔明胶囊0.4 g,首日t.i.d,以后b.i.d;对照环丙沙星胶囊组,每次口服环丙沙星0.2 g,首日t.i.d,以后b.i.d,疗程均为3-5 d。治疗前后查血、尿、大便常规、肝肾功能、心电图用于安全性评价。结果:利福昔明胶囊组治疗感染性腹泻16例,有效率93.8%,对照环丙沙星胶囊组治疗感染性腹泻19例,有效率89.5%,两组间疗效差异无显著性(P >0.05)。35例中有11例治疗前粪便细菌培养阳性,阳性率31.4%,治疗后细菌清除率为100%。利福昔明胶囊组未观察到不良反应和严重不良事件发生。结论:对治疗急性细菌感染性腹泻利福昔明胶囊具有与环丙沙星胶囊同等的疗效和安全性。     

国产利福昔明治疗急性细菌感染性腹泻115例

目的评价国产利福昔明治疗急性细菌感染性腹泻的疗效与安全性。方法急性细菌感染性腹泻患者224例，随机分为治疗组和对照组，治疗组115例给予国产利福昔明片口服，第1天3次，每次0.4 g，第2天起每天两次，每次0.4 g;对照组109例给予左氧氟沙星片口服，第1天3次，每次0.2 g，第2天起每天2次，每次0.2 g。疗程均为3～5 d。结果治疗组与对照组临床有效率分别为93.9%和90.8%，细菌清除率分别为97.62%和100.00%，不良反应发生率分别为2.61%和1.83%，两组各对应指标均差异无显著性(均P＞0.05)。结论国产利福昔明片治疗急性细菌感染性腹泻安全、有效。     

利福昔明治疗感染性腹泻50例的随机双盲对照试验

目的 :评价利福昔明治疗感染性腹泻的疗效及安全性。方法 :采用随机、双盲对照临床试验设计 ,选用 18～ 6 5a病人共 12 6例 ,分为A ,B两组。分别用利福昔明与环丙沙星 2种药物治疗 ,用法一致 ,d 1,2粒 ,tid ,以后 2粒 ,bid ,疗程皆为 3～ 5d。结果 :利福昔明与环丙沙星临床疗效评价病例数分别为 5 0例和 5 7例 ,有效率分别为 94 %与 95 % ,细菌阳性率分别为 4 4%与 4 6 % ,细菌清除率分别为95 %与 92 % ,不良反应发生率分别为 2 %与 5 % (均P >0 .0 5 )。结论 :利福昔明是治疗成人肠道细菌感染的有效和安全的药物 ,与环丙沙星相当     

两种药物治疗急性感染性腹泻的临床研究

目的评估利福昔明片治疗急性感染性腹泻的临床疗效及安全性。方法采用随机、双盲双模拟、阳性药物平行对照的方法,入选120例患者,实验组60例服用利福昔明片,第1天300mg,3次/d;第2~5天400mg,2次/d;对照组60例服用左氧氟沙星片,第1天100mg,3次/d;第2~5天100mg,2次/d,疗程为3~5d。结果实验组治疗3~5d后,腹痛、腹泻及大便检查恢复正常或明显好转,痊愈率84.68%,显效率15.31%,总有效率为100.00%,细菌清除率为100.00%,与对照组比较P>0.05,两组均未见严重不良反应(P>0.05)。结论利福昔明片是治疗急性感染性腹泻安全有效的药物。     

桃花止泻颗粒联合环丙沙星治疗感染性腹泻38例

目的观察桃花止泻颗粒治疗感染性腹泻的临床疗效,并评价其安全性。方法将38例住院患者作为治疗组,30例同期入院的患者为对照组。治疗组给予桃花止泻颗粒冲服,每次6 g,tid;合用环丙沙星口服,每次0.4 g,tid;对照组用双八面体蒙脱石散,po,tid;合用环丙沙星,每次0.4 g,po,tid;均5～7 d为1个疗程并观察疗效。结果治疗组总有效率97.37%,对照组总有效率96.67%,两组疗效差异无显著性（P＞ 0.05）。结论桃花止泻颗粒联合环丙沙星治疗感染性腹泻的临床疗效与双八面体蒙脱石散相当,是治疗腹泻安全、有效的中药制剂。     

Oral zolmitriptan in the short-term prevention of menstrual migraine: a randomized, placebo-controlled study

OBJECTIVE: To evaluate the efficacy and tolerability of oral zolmitriptan as a short-term preventative therapy for menstrual migraine. METHODS: This was a randomized, double-blind, parallel group, placebo-controlled, multicentre, two-phase study. The results of the second phase are reported here (the first phase evaluated zolmitriptan in the acute treatment of menstrual migraine and is reported elsewhere). Women who successfully completed phase I (with either a positive or negative outcome, and who still fulfilled the inclusion criteria) were randomized to zolmitriptan 2.5 mg oral tablet three times daily, zolmitriptan 2.5 mg twice daily or placebo three times daily. Patients were treated for three consecutive menstrual cycles, starting 2 days prior to the expected onset of menses, for 7 days in total. RESULTS: Two hundred and fifty-three patients completed phase I and were eligible for phase II. The intention-to-treat population comprised 244 patients (zolmitriptan three times daily [n = 83]; zolmitriptan twice daily [n = 80]; placebo [n = 81]). Both zolmitriptan regimens demonstrated superior efficacy versus placebo, as measured by the proportion of patients with a >/=50% reduction in the frequency of menstrual migraine attacks (zolmitriptan three times daily [58.6%], p = 0.0007 vs placebo; zolmitriptan twice daily [54.7%], p = 0.002 vs placebo; placebo three times daily [37.8%]). The mean frequency of breakthrough migraine attacks per menstrual cycle was reduced accordingly. Fewer breakthrough attacks were treated with escape medication in the zolmitriptan three times daily (61.6% of attacks; p = 0.0004 vs placebo) and twice daily (60.7%; p = 0.0055 vs placebo) treatment groups than in the placebo group (74.4%). Short-term preventative therapy with zolmitriptan was well tolerated. CONCLUSION: Zolmitriptan 2.5 mg oral tablet is effective and well tolerated as a short-term preventative therapy for menstrual migraine attacks.     

利福昔明胶囊对急性感染性腹泻的疗效和安全性及其血药浓度测定

目的评价利福昔明胶囊（抗结核病药）治疗急性感染性腹泻的疗效、安全性及口服后吸收情况。方法用随机对照前瞻性试验方法，共入选病例70例，利福昔明胶囊（试验组33例）每次200mg，每6h1次；左氧氟沙星胶囊（对照组35例）每次200mg，每12h1次，疗程均3天。试验组有10例患者接受了血药浓度分析。结果从开始服药至最后1次排不成型便的时间，试验组和对照组平均分别为33．56，31．13h，2组相比无明显差异（P〉0．05）；2者的临床疗效比较也无明显差异（P〉0．05）；利福昔明口服后血药浓度极低或测不出。结论利福昔明口服后基本不吸收，是治疗急性感染性腹泻的安全有效药物。     

The effect of multiple-dose, oral rifaximin on the pharmacokinetics of intravenous and oral midazolam in healthy volunteers

STUDY OBJECTIVE: To evaluate the potential of rifaximin, an oral nonabsorbed (< 0.4%) structural analog of rifampin, to induce human hepatic and/or intestinal cytochrome P450 (CYP) 3A enzymes, with use of a known CYP3A probe, midazolam. DESIGN: Prospective, randomized, open-label, two-period, crossover study. SETTING: Clinical research center. SUBJECTS: Twenty-seven healthy adult volunteers. INTERVENTION: During the first treatment period, subjects received a single dose of either intravenous midazolam 2 mg over 30 minutes or oral midazolam 6 mg on day 0. From days 3-10, they received rifaximin 200 mg every 8 hours. On days 6 (after the 9th dose of rifaximin) and 10 (after the 21st dose of rifaximin), subjects received a concomitant single dose of intravenous or oral midazolam. After a 15-day washout period, subjects were crossed over to the other formulation of midazolam, and the treatment schedule was repeated, with the second treatment period starting on day 26 and single-dose administration of midazolam on days 26, 32, and 36. Serial plasma samples were collected for pharmacokinetic analyses. MEASUREMENTS AND MAIN RESULTS: The pharmacokinetic parameters of single-dose intravenous or oral midazolam were determined alone and after coadministration of rifaximin for 3 and 7 days. Rifaximin coadministration did not alter the measured pharmacokinetic parameters for midazolam or its major metabolite, 1'-hydroxymidazolam. The 90% confidence intervals for the maximum concentration and area under the concentration-time curve from time zero extrapolated to infinity (bioavailability) were all within 80-125% for intravenous and oral midazolam. Therefore, no drug interaction was observed between rifaximin and midazolam. Coadministration of midazolam and rifaximin was well tolerated. CONCLUSION: Overall, 3-7 days of rifaximin 200 mg 3 times/day did not alter single-dose midazolam pharmacokinetics. Rifaximin also does not appear to induce intestinal or hepatic CYP3A activity.     

思密达联合左氧氟沙星治疗成人急性感染性腹泻60例临床观察

目的：观察恩密达联合左氧氟沙星治疗成人急性感染性腹泻的疗效。方法：所选病例分成A组(60例)、B组(27例)和C组(30例)。给予A组患者恩密达每次1袋(3g)，每日3次，左氧氟沙星每次0.2g，每日2次；给予B组患者恩密达每次一袋(3g)，每日3次；给予C组患者左氧氟沙星，每次0.2g，每日2次。3组疗程均为3天。结果：A组显效51例，有效8例，总有效率达98．30％；B组显效19例，有效3例，总有效率达81．48％；C组显效20例，有效5例，总有效率达86．66％。结论：思密达联合左氧氟沙星治疗成人急性腹泻，疗效高，安全，且不影响抗生素吸收。     

Rifaximin treatment of pathogen-negative travelers' diarrhea

BACKGROUND: Antibacterial drugs appear to be effective in shortening the illness of a majority of cases of travelers' diarrhea. METHODS: This was a subanalysis from two randomized, double-blind, placebo-controlled trials in adult travelers with acute diarrhea treated with rifaximin 200 mg three times a day or placebo for 3 days. Efficacy was assessed by the interval beginning with the first dose of medication and ending with the last unformed stool passed after becoming well [time to last unformed stool (TLUS)]; number of unformed stools passed; percent with clinical improvement; and incidence of wellness achieved. RESULTS: Stool pathogens were not identified in pretreatment samples in 122 of 322 (38%) patients and 106 of 230 (46%) randomized to rifaximin and placebo, respectively. Among pathogen-negative patients, rifaximin was more effective than placebo for median TLUS (33 vs 68 h, p < 0.005), mean number of unformed stools passed (6.5 vs 8.6, p < 0.0001), and clinical wellness (77% vs 61%, p = 0.01). The adverse-event profiles between rifaximin and placebo were similar. CONCLUSIONS: More than one third of patients with travelers' diarrhea had pathogen-negative illness. Rifaximin was effective in treating the illness without associated side effects. These results are consistent with the hypothesis that undetected bacterial pathogens are the most likely cause of travelers' diarrhea without definable cause.     

琥珀酸美托洛尔缓释片和酒石酸美托洛尔片对急性心肌梗死患者心率的影响

目的比较琥珀酸美托洛尔缓释片和酒石酸美托洛尔片对急性心肌梗死患者心率的影响。方法选择急性心肌梗死患者76例,在除外应用美托洛尔禁忌后,按1∶2比例随机分配到琥珀酸美托洛尔缓释片组25例和酒石酸美托洛尔片组51例。前者给予琥珀酸美托洛尔23.75 mg,日1次口服,后者给予酒石酸美托洛尔12.5 mg,日2次口服。在此基础上,两组均常规予阿司匹林、氯吡格雷、ACEI及他汀类药物治疗,分别记录用药前和用药后24、48、72 h静息状态的心率,比较用药后心率下降的程度和趋势。结果琥珀酸美托洛尔缓释片组在用药后24、48、72 h 3个时间点的心率分别下降了0、1%、9%,次数下降了0.5次/min、1.6次/min、7.6次/min,酒石酸美托洛尔片组心率分别下降了3%、5%、6%,次数下降了3.5次/min、4.1次/min、5.7次/min。P均<0.05,认为不同时间点上患者心率的差异有统计学意义;而因素心率和剂型的交互作用的P值均>0.05,尚不能认为剂型和心率有交互作用。两组患者服药后72 h内,心率变化的趋势无统计学意义,P均>0.05。结论急性心肌梗死患者应用琥珀酸美托洛尔缓释片或酒石酸美托洛尔片,72 h内心率降低的差异有统计学意义,但两组服药后72 h内,心率的降低程度差异无统计学意义,而且72 h内两组心率下降的趋势,差异也无统计学意义。     

消旋卡多曲治疗成人急性腹泻的临床疗效

目的观察消旋卡多曲(抗腹泻药)治疗成人急性腹泻的临床疗效及安全性。方法将109例急性腹泻患者随机分为消旋卡多曲治疗组(55例)和对照组(54例)。对照组用WHO标准化口服补液治疗,纠正电解质和酸碱失衡;治疗组在此基础上,加用消旋卡多曲每次100 mg,每天3次。观察2组临床疗效及不良反应发生情况。结果治疗组大便次数及性质恢复时间较对照组缩短,分别为(33.3±23.96)h vs(64.3±27.32)h;(47.8±10.46)h vs(70.8±12.82)h;脱水、电解质紊乱纠正时间也较对照组明显缩短,分别为(30.7±14.51)h vs(56.0±16.58)h;消旋卡多曲治疗总病程短于对照组,分别为(56.8±20.51)hvs(90.9±21.35)h;治疗72 h后,治疗组总有效率(90.90%)高于对照组(72.22%),差异有统计学意义(P<0.05)。结论常规治疗基础上配合消旋卡多曲治疗,可较快缓解急性腹泻的病情,缩短病程,且安全。