Deluyker H A, Chester S T, Van Oye S N
Pharmacia & Upjohn, Puurs, Belgium.
J Vet Pharmacol Ther. 1999 Aug;22(4):274-82. doi: 10.1046/j.1365-2885.1999.00205.x.
A study was conducted to compare the efficacy in lactating dairy cows of intramammary infusions in quarters affected with clinical mastitis between a formulation containing 330 mg lincomycin and 100 mg neomycin in a 10-mL aqueous solution (LINCOCIN FORTE S, Pharmacia & Upjohn) and a formulation containing 75 mg ampicillin and 200 mg cloxacillin in an oil suspension (AMPICLOX, Pfizer Animal Health). This study was designed as a multicentre clinical trial involving investigators in France, Germany and Belgium and carried out according to the European Commission guidelines on Good Clinical Practices. Cows in the herds were monitored for clinical mastitis. When evidence of clinical mastitis was detected in a single quarter, a pretherapy milk sample was collected from the affected quarter. After milk sampling, the cow was assigned to one of the two treatment groups at random and treated with an intramammary infusion of one syringe of either LINCOCIN FORTE S or AMPICLOX for three successive milkings in the mastitic quarter. At 4-5, 13-15 and 20-22 days after first infusion, the veterinarian returned to the farm to conduct a clinical examination and collect milk samples from the affected quarter. Milk samples were cultured for the presence of mastitis organisms and somatic cell count (SCC) was measured. Following a 10-month study period, 256 cases were enrolled in the study. A total of 232 and 189 cases were analysed for clinical cure and for clinical-plus-bacteriological cure, respectively. The proportions of cases cured clinically and cured clinically-plus-bacteriologically were compared between the two treatment groups. Somatic cell count differences between treatment groups were also tested. The clinical cure rate for LINCOCIN FORTE S (62.5%) was significantly better than for AMPICLOX (51.8%) (P = 0.035). The clinical-plus-bacteriological cure rate was also significantly better for LINCOCIN FORTE S (38.1%) than for AMPICLOX (21.7%) (P = 0.005). Among bacteriologically cured cases, the SCC declined in both treatment groups but the SCC was significantly higher for the AMPICLOX group than for the LINCOCIN FORTE S group (P = 0.036). In conclusion, clinical cure rate, clinical-plus-bacteriological cure rate, and SCC level were significantly better with LINCOCIN FORTE S than for AMPICLOX.
开展了一项研究,以比较在患有临床型乳腺炎的泌乳奶牛乳房内注入两种制剂的疗效。一种制剂是10毫升水溶液中含330毫克林可霉素和100毫克新霉素的配方(LINCOCIN FORTE S,法玛西亚普强公司),另一种制剂是油悬液中含75毫克氨苄青霉素和200毫克氯唑西林的配方(AMPICLOX,辉瑞动物保健公司)。本研究设计为一项多中心临床试验,涉及法国、德国和比利时的研究人员,并按照欧盟委员会的《药物临床试验质量管理规范》进行。对牛群中的奶牛进行临床型乳腺炎监测。当在单个乳房发现临床型乳腺炎迹象时,从受影响的乳房采集一份治疗前乳样。采乳后,将奶牛随机分配到两个治疗组之一,在患乳腺炎的乳房连续三次挤奶时,通过乳房内注入一注射器LINCOCIN FORTE S或AMPICLOX进行治疗。在首次注入后的第4 - 5天、13 - 15天和20 - 22天,兽医返回农场进行临床检查,并从受影响的乳房采集乳样。对乳样进行培养以检测乳腺炎病原体的存在,并测量体细胞计数(SCC)。经过10个月的研究期,共有256例病例纳入研究。分别对232例和189例病例进行了临床治愈和临床加细菌学治愈分析。比较了两个治疗组之间临床治愈和临床加细菌学治愈的病例比例。还对治疗组之间的体细胞计数差异进行了检测。LINCOCIN FORTE S的临床治愈率(62.5%)显著高于AMPICLOX(51.8%)(P = 0.035)。LINCOCIN FORTE S的临床加细菌学治愈率(38.1%)也显著高于AMPICLOX(21.7%)(P = 0.005)。在细菌学治愈的病例中,两个治疗组的体细胞计数均有所下降,但AMPICLOX组的体细胞计数显著高于LINCOCIN FORTE S组(P = 0.036)。总之,LINCOCIN FORTE S在临床治愈率、临床加细菌学治愈率和体细胞计数水平方面均显著优于AMPICLOX。