比阿培南治疗呼吸和泌尿系统细菌性感染的临床试验

目的评价注射用比阿培南治疗呼吸和泌尿系统细菌性感染的有效性和安全性。方法本研究为多中心、随机、单盲、阳性平行对照、非劣效性检验的临床试验,符合入选标准的呼吸和泌尿系统细菌性感染患者分别按中心分层随机分为比阿培南组(静脉滴注,每次0.3 g,每日2次)和美罗培南组(静脉滴注,每次0.5 g,每日3次)。两组疗程7~14 d。观察两组临床疗效、细菌清除率和不良事件。结果本研究全分析集病例285例,其中比阿培南组组143例,美罗培南组142例;安全性数据集288例,两组各144例。比阿培南组和美罗培南组总临床治愈率分别为93.7%(134/143)和92.3%(131/142),呼吸系统临床治愈率分别为90%(65/72)和94%(66/70),泌尿系统分别为97%(69/71)和90%(65/72)。两组总细菌清除率分别为88%(66/75)和93%(63/68),呼吸系统细菌清除率分别为83%(30/36)和91%(29/32),泌尿系统分别为92%(36/39)和94%(34/36)。两组不良事件发生率分别为3.5%(5/144)和9.0%(13/144),不良反应发生率分别为4.2%(6/144)和6.9%(10/144)。经统计学分析两组临床治愈率、细菌清除率和不良反应发生率组间比较均无显著差异(P>0.05)。结论比阿培南治疗呼吸和泌尿系统细菌性感染临床疗效确切,安全性好,其临床和细菌学疗效以及安全性均与美罗培南相当。     

注射用法罗培南钠治疗急性尿路感染多中心随机对照临床研究

目的 评价注射用法罗培南钠(碳青霉烯素抗生素)治疗急性尿路感染的有效性和安全性.方法 采用多中心、随机、平行对照试验设计,共入选病例144例,进入PPS(符合方案集)分析131例,其中试验组(法罗培南钠组)66例,法罗培南每次0.3 g,每日2次静脉滴注;对照组(亚胺培南/西司他丁钠组)65例,每次亚胺培南0.5 g,每日2次静脉滴注;一般疗程均为7-14天,最短疗程不少于5天.结果 试验组与对照组:临床痊愈率分别为66.67%和61.54%;总有效率分别为95.45%和95.38%;细菌清除率分别为96.23%和92.31%;药物不良反应发生率分别为14.08%和11.11%.结论 注射用法罗培南钠治疗急性尿路感染安全、有效.     

美罗培南与亚胺培南/西司他丁随机对照治疗急性细菌性感染

目的:研究国产美罗培南治疗急性细菌性感染的临床疗效和安全性.方法:选择中、重度急性细菌性感染患者.治疗组30例,给予美罗培南0.5 g,tid,静脉滴注;对照组26例,给予亚胺培南/西司他丁(泰能)1.0 g,tid,静脉滴注.两药疗程均为7～10 d.结果:美罗培南组和泰能组的临床痊愈率分别为63.3%和65.4%;临床有效率分别为93.3%和96.2%;细菌清除率分别为88.0%和85.7%;不良反应发生率分别为10.0%和7.7%.以上指标差异均无显著性(P>0.05).结论:国产美罗培南治疗急性细菌性感染是有效和安全的,与泰能相比差异无显著性.     

比阿培南治疗急性细菌性感染的多中心随机对照临床试验

目的评价比阿培南(β内酰胺类抗生素)治疗急性细菌感染的有效性和安全性。方法用多中心随机开放平行对照研究方法,共入选有效病例272例,其中试验组(比阿培南)135例,给药剂量:比阿培南每次300mg,每日2次静脉滴注;对照组(亚胺培南/西司他丁钠)137例,每次亚胺培南500mg,每日3次静脉滴注。一般疗程均为7～14天,最短不少于5天。结果试验组与对照组临床痊愈率分别为62.79%和55.64%;总有效率分别为93.8%和88.72%;细菌清除率分别为90.41%和88.33%;药物不良反应发生率分别为10.37%和11.03%。结论比阿培南治疗临床常见急性细菌性感染安全、有效。     

国产美罗培南治疗急性细菌性感染的临床试验

目的:研究国产美罗培南用于抗感染治疗的临床疗效和安全性.方法:将30例中、重度急性细菌性感染患者按随机对照平行法分成2组,治疗组14例,给予美罗培南0.5g,q8h,静脉滴注;对照组16例,给予泰能(亚胺培南/西司他丁)1.0g,q8h,静脉滴注.两药疗程均为7～10d.结果:两组的临床痊愈率均为50%;临床有效率治疗组和对照组分别为85.7%和87.5%;细菌清除率分别为84.6%和85.7%;不良反应发生率分别为14.3%和18.8%.以上指标两组差异均无显著性(P>0.05).结论:国产新药美罗培南用于抗感染治疗安全有效.     

美罗培南和亚胺培南/西司他丁治疗新生儿重度呼吸道感染的疗效观察

目的:与亚胺培南/西司他丁对比,观察美罗培南对新生儿重度呼吸道感染的临床疗效。方法:将66例重度呼吸道感染的新生儿随机分为试验组和对照组,试验组用美罗培南治疗,对照组用亚胺培南/西司他丁治疗。结果:试验组和对照组的治疗有效率分别为81.82%和78.79%,细菌清除率分别为88.46%和85.71%,不良反应发生率分别为3.03%和6.06%,两组间无明显差异(P>0.05)。结论:美罗培南治疗新生儿重度呼吸道感染的效果与亚胺培南/西司他丁相当,是一种有效、安全的抗菌药物。     

美罗培南治疗呼吸系统细菌性感染的随机对照临床研究

目的 评价美罗培南治疗呼吸系统细菌感染性疾病的疗效和安全性.方法 采用随机对照临床试验方法,以头孢地秦作为对照.共入选有效病例232例,其中试验组118例,对照组114例.试验组予美罗培南静脉推注,每次500 mg,每8 h 1次;对照组予头孢地秦静脉推注,每次2 g,每12 h 1次,疗程均为7～14 d.比较2组临床疗效及不良反应.结果 试验组与对照组临床痊愈率分别为83.9%和79.8%,有效率分别为95.8%和95.6%,2组临床疗效比较无显著差异(P>0.05).细菌清除率均为99.2%,组间无显著差异(P>0.05).药物不良反应发生率分别为7.4%和6.8%,组间差异无显著意义(P>0.05). 结论美罗培南治疗临床呼吸系统常见急性细菌感染性疾病与头孢地秦一样有效、安全.     

法罗培南治疗细菌性呼吸道感染的临床研究

目的评价国产法罗培南治疗细菌性呼吸道感染的疗效和安全性。方法将64例细菌性呼吸道感染患者随机分为试验组和对照组各32例。试验组予以法罗培南钠口服治疗,对照组予以头孢呋辛酯口服治疗,疗程均为6～14d。比较2组临床疗效、细菌学疗效及不良反应发生率。结果试验组和对照组痊愈率分别为78.1%和81.3%,总有效率分别为96.9%和93.7%;细菌清除率分别为92.8%和88.9%;不良反应发生率分别为6.3%和6.3%,差异均无统计学意义(P>0.05)。结论国产法罗培南治疗细菌性呼吸道感染安全、有效,与头孢呋辛酯相仿。     

法罗培南钠治疗急性细菌性呼吸道感染疗效观察

目的 评价国产法罗培南钠片治疗急性细菌呼吸道感染的临床疗效和安全性.方法 采用多中心、随机对照试验,选择急性细菌呼吸道感染患者120例,试验组用法罗培南钠治疗,对照组采用头孢克洛治疗.结果 试验组和对照组的痊愈率分别为44.07%和28.57%;有效率分别为89183%和83.33%;试验组和对照组的细菌清除率分别为96.08%和91.00%,两组差异无统计学意义(均P>0.05);试验组和对照组的不良反应发生率分别为1.69%和3.36%,两组差异无统计学意义(P>0.05).结论 法罗培南钠片是一种安全有效的治疗细菌性呼吸道感染的口服抗生素.     

比阿培南治疗急性细菌性感染的疗效及对患者血清IL-6和hs-CRP的影响

目的:考察比阿培南治疗急性细菌性感染的临床疗效、细菌学疗效及对患者血清白细胞介素6(IL-6)、超敏C反应蛋白(hs-CRP)的影响。方法:选择2015年4月-2016年4月我院收治的呼吸系统和泌尿系统急性细菌性感染患者241例,按照随机数字表法分为对照组(119例)和观察组(122例)。对照组患者给予注射用美罗培南0.5 g加入100 mL 0.9%氯化钠注射液中静脉滴注,tid;观察组患者给予注射用比阿培南0.3 g加入100 mL 0.9%氯化钠注射液中静脉滴注,bid。两组患者疗程均为7~14 d。比较两组患者的临床疗效、细菌学疗效、血清IL-6和hs-CRP水平,以及不良反应发生情况。结果:对照组患者的总有效率、细菌培养阳性率、细菌清除率和不良反应发生率分别为88.24%、56.30%、87.14%和13.45%,观察组患者分别为93.44%、55.74%、93.06%和10.66%,两组比较差异均无统计学意义(P>0.05)。治疗前,两组患者血清IL-6和hs-CRP水平比较,差异均无统计学意义(P>0.05);治疗后,两组患者血清IL-6和hs-CRP水平均较治疗前显著降低,差异均有统计学意义(P<0.05),但组间比较差异无统计学意义(P>0.05)。结论:比阿培南治疗呼吸系统和泌尿系统急性细菌性感染的临床疗效和细菌学疗效均较好,能够明显降低机体炎症因子水平,且安全性较好。其有效性与安全性与美罗培南相当,应根据患者具体情况选择用药。     

Cranberry and urinary tract infection

Around 60% of women experience at least one urinary tract infection (UTI) during their lifetime, of whom up to 20% will experience recurrence. UTIs are also common in older people, children and in those with neurological abnormalities such as spina bifida. Patients are increasinglyasking healthcare professionals about the value of taking products containing cranberry (Vaccinium macrocarpon), either as juice or a supplement, for the prevention or treatment of UTIs. What advice should they be given?     

Cannabinoids and the digestive tract

In the digestive tract there is evidence for the presence of high levels of endocannabinoids (anandamide and 2-arachidonoylglycerol) and enzymes involved in the synthesis and metabolism of endocannabinoids. Immunohistochemical studies have shown the presence of CB1 receptors on myenteric and submucosal nerve plexuses along the alimentary tract. Pharmacological studies have shown that activation of CB1 receptors produces relaxation of the lower oesophageal sphincter, inhibition of gastric motility and acid secretion, as well as intestinal motility and secretion. In general, CB1-induced inhibition of intestinal motility and secretion is due to reduced acetylcholine release from enteric nerves. Conversely, endocannabinoids stimulate intestinal primary sensory neurons via the vanilloid VR1 receptor, resulting in enteritis and enhanced motility. The endogenous cannabinoid system has been found to be involved in the physiological control of colonic motility and in some pathophysiological states, including paralytic ileus, intestinal inflammation and cholera toxin-induced diarrhoea. Cannabinoids also possess antiemetic effects mediated by activation of central and peripheral CB1 receptors. Pharmacological modulation of the endogenous cannabinoid system could provide a new therapeutic target for the treatment of a number of gastrointestinal diseases, including nausea and vomiting, gastric ulcers, secretory diarrhoea, paralytic ileus, inflammatory bowel disease, colon cancer and gastro-oesophageal reflux conditions.     

Mucoadhesion and the gastrointestinal tract

The concept of mucoadhesion is one that has the potential to improve the highly variable residence times experienced by drugs and dosage forms at various sites in the gastrointestinal tract, and consequently, to reduce variability and improve efficacy. Intimate contact with the mucosa should enhance absorption or improve topical therapy. A variety of approaches have been investigated for mucoadhesion in the gastrointestinal tract, particularly for the stomach and small intestine. Despite interesting results in these sites, mucoadhesive approaches have not yet shown success in humans. The potential of the lower gut for these applications has been largely neglected, although the large intestine in particular may benefit, and the colon has several factors that suggest mucoadhesion could be successful there, including lower motility and the possibility of a lower mucus turnover and thicker mucus layer. In vitro studies on colonic mucoadhesion show promise, and rectal administration has shown some positive results in vivo. This review considers the background to mucoadhesion with respect to the physiological conditions of the gastrointestinal tract as well as the principles that underlie this concept. Mucoadhesive approaches to gastrointestinal drug delivery will be examined, with particular attention given to the lower gut.     

胃肠道微生态及微生态制剂在治疗胃肠道疾病中的应用

目的对胃肠道微生态及微生态制剂在治疗胃肠道疾病中的应用进行综述,提示临床医师注意微生态制剂的临床应用。方法采用文献查阅法,对有关胃肠道微生态及有关微生态制剂在治疗胃肠道疾病中的应用的文献进行综合、整理。结果胃肠道内环境微生态正常情况处于动态平衡状态,微生态制剂可以纠正胃肠道微生态失调,治疗胃肠道疾病。结论微生态制剂在治疗胃肠道疾病中具有一定作用。     

Clinical studies of ceftizoxime suppositories in respiratory tract infections and urinary tract infections in children

A fundamental and clinical study of ceftizoxime (CZX) suppositories was performed in pre-school and school-age children. The average time courses of CZX serum and urinary concentrations after administration of CZX suppository 250 mg (i.e. per kg body weight doses of 8.3-10.9 mg) to 4 school-age children were as follows. Serum concentrations: 6.1 micrograms/ml at 15 minutes, 6.3 micrograms/ml at 30 minutes, 3.8 micrograms/ml at 1 hour, 1.7 microgram/ml at 2 hours, 0.5 microgram/ml at 4 hours and 0.2 microgram/ml at 6 hours with a biological half-life of 1.43 hours. Urinary concentrations: 885 micrograms/ml for 0-2 hours, 209 micrograms/ml for 2-4 hours and 112 micrograms/ml for 4-6 hours with an average 6-hour urinary recovery rate of 25.6%. The clinical and biological effectiveness and adverse reactions were studied in 11 infants and school-age children afflicted with various infections (acute purulent tonsillitis, 1; acute bronchitis, 3; acute pneumonia, 4; and UTI, 3). The clinical responsiveness was "excellent" in 8, "good" in 2, and "failure" was recorded in 1, with an overall efficacy of 90.9% inclusive of "excellent" and "good". The microbiological effectiveness of CZX suppositories on presumed pathogenic organisms comprising 4 strains of H. influenzae, 1 strain of H. parainfluenzae, and 3 strains of E. coli was satisfactory, as evidenced by the substantially high eradication rate of 87.5%. The only organism that survived CZX suppository treatment was 1 strain of H. influenzae which however was greatly decreased. The only side effect was diarrhea in 1 patient, which however did not necessitate withdrawal of the drug. The only laboratory test abnormality was GOT and GPT elevation in 1 patient which was normalized within 8 days. In conclusion, CZX suppositories were found to be efficacious and safe for treatment of bacterial infections in children.     

胆道疾病对左旋氧氟沙星的胆药浓度的影响

目的:观察左旋氧氟沙星(LVFX)在胆道手术后患者的胆药浓度及其影响因素。方法:13例施行胆道手术并行T-管引流的患者poLVFX200mg,q8h,连服5d,用HPLC法测定LVFX在血浆、胆汁中的药物浓度。结果:胆囊结石降低胆汁中药物浓度;胆道梗阻程度与胆汁药物浓度有密切相关性,梗阻程度愈高,药物浓度愈低。结论:胆道疾病(特别是结石性胆道疾病)所造成的胆道梗阻状态在很大程度上影响LVFX在胆道的浓度,梗阻状态下低胆汁药物浓度将不利于感染的治疗。