Hase J C, Edwardsson S, Rundegren J, Attström R, Kelty E
Department of Clinical Research, Biosurface AB, Malmö, Sweden.
J Clin Periodontol. 1998 Nov;25(11 Pt 1):841-9. doi: 10.1111/j.1600-051x.1998.tb02380.x.
This double-blind, randomised, 6-month clinical trial with parallel group design in 68 subjects with gingivitis was conducted to study the effects on the oral flora of delmopinol hydrochloride 2 mg/ml (0.2% w/v, Decapinol Mouthwash), when used for partly supervised mouthrinsing in comparison with placebo and chlorhexidine digluconate 2 mg/ml (0.2% w/v, Hibitane Dental, ICI Pharmaceuticals, UK). Apart from estimating the total cultivable microbial dental plaque flora and salivary flora, analyses were focused on bacterial groups associated with gingivitis/periodontitis and dental caries. Furthermore, the presence of staphylococci, gram-negative enteric bacteria and yeasts in saliva were evaluated. The minimal inhibitory concentration (MIC) was determined for isolates belonging to the predominating micro-organisms in samples of both dental plaque and saliva. In relation to the findings in the placebo group, the use of delmopinol during the rinsing period did not produce an undesirable shift in the bacterial populations considered to be related to dental caries or periodontal diseases. These groups remained virtually unchanged during the study. In relation to the observations in the placebo group, slight reductions in the total cultivable plaque and salivary flora were observed during the study and no change was found in the ratio total anaerobically/aerobically cultivable microbial flora. Furthermore, no increased growth in staphylococci, enteric bacteria or yeasts was observed in the saliva samples. The pattern of changes taking place in the composition of the plaque and salivary microbial flora in samples from the participants rinsing with chlorhexidine were in most aspects similar to that observed in the delmopinol group. In the delmopinol group, no microbiologically significant changes were observed over time in the MIC-values for the isolates, neither in the plaque nor in the saliva samples, which indicates that no adaptation to delmopinol had taken place during the rinsing period. Similar observations were made for the plaque isolates in samples from the participants in the chlorhexidine group. On the other hand, when gram-positive and catalase-negative cocci from the saliva samples of the latter group were tested against chlorhexidine, 4-6 times higher MIC-values were obtained at 3 and 6 months both when compared to baseline and in comparison with the other two rinsing groups (p<0.01 or p<0.05). Neither delmopinol nor chlorhexidine showed any residual effect on the studied microbial groups in the plaque and the saliva samples 3 months after the end of treatment. In conclusion, delmopinol was accompanied by a composition of the plaque and salivary flora associated with healthy conditions in the oral cavity.
本研究采用双盲、随机、平行组设计，对68名牙龈炎患者进行了为期6个月的临床试验，旨在研究2mg/ml盐酸地莫匹醇（0.2%w/v，Decapinol漱口水）与安慰剂及2mg/ml葡萄糖酸氯己定（0.2%w/v，Hibitane Dental，ICI制药公司，英国）相比，在部分监督下漱口时对口腔菌群的影响。除了估计可培养的口腔菌斑微生物总数和唾液菌群外，分析重点还包括与牙龈炎/牙周炎及龋齿相关的细菌群。此外，还评估了唾液中葡萄球菌、革兰氏阴性肠道细菌和酵母菌的存在情况。测定了牙菌斑和唾液样本中主要微生物分离株的最低抑菌浓度（MIC）。与安慰剂组的结果相比，在漱口期间使用地莫匹醇并未导致被认为与龋齿或牙周疾病相关的细菌种群出现不良变化。在研究期间，这些菌群基本保持不变。与安慰剂组的观察结果相比，研究期间可培养的菌斑和唾液菌群总数略有减少，需氧/厌氧可培养微生物菌群的比例未发生变化。此外，在唾液样本中未观察到葡萄球菌、肠道细菌或酵母菌的生长增加。用氯己定漱口的参与者样本中，菌斑和唾液微生物菌群组成的变化模式在大多数方面与地莫匹醇组观察到的情况相似。在地莫匹醇组中，随着时间的推移，分离株的MIC值在菌斑和唾液样本中均未观察到具有微生物学意义的变化，这表明在漱口期间未出现对盐酸地莫匹醇的适应性变化。氯己定组参与者样本中的菌斑分离株也有类似观察结果。另一方面，当对氯己定组后者唾液样本中的革兰氏阳性和过氧化氢酶阴性球菌进行测试时，在3个月和6个月时获得的MIC值比基线时以及与其他两个漱口组相比均高出4至6倍（p<0.01或p<0.05）。治疗结束3个月后，地莫匹醇和氯己定对菌斑和唾液样本中所研究的微生物群均未显示出任何残留影响。总之，地莫匹醇伴随着与口腔健康状况相关的菌斑和唾液菌群组成。
