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首页> 美国卫生研究院文献>AIDS Research and Human Retroviruses >Isoosmolar Enemas Demonstrate Preferential Gastrointestinal Distribution Safety and Acceptability Compared with Hyperosmolar and Hypoosmolar Enemas as a Potential Delivery Vehicle for Rectal Microbicides
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Isoosmolar Enemas Demonstrate Preferential Gastrointestinal Distribution Safety and Acceptability Compared with Hyperosmolar and Hypoosmolar Enemas as a Potential Delivery Vehicle for Rectal Microbicides

机译：与高渗和低渗灌肠相比等渗灌肠具有更好的胃肠道分布安全性和可接受性可作为直肠杀菌剂的潜在递送工具

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Rectally applied antiretroviral microbicides for preexposure prophylaxis (PrEP) of HIV infection are currently in development. Since enemas (rectal douches) are commonly used by men who have sex with men prior to receptive anal intercourse, a microbicide enema could enhance PrEP adherence by fitting seamlessly within the usual sexual practices. We assessed the distribution, safety, and acceptability of three enema types—hyperosmolar (Fleet), hypoosmolar (distilled water), and isoosmolar (Normosol-R)—in a crossover design. Nine men received each enema type in random order. Enemas were radiolabeled [99mTc-diethylene triamine pentaacetic acid (DTPA)] to assess enema distribution in the colon using single photon emission computed tomography/computed tomography (SPECT/CT) imaging. Plasma 99mTc-DTPA indicated mucosal permeability. Sigmoidoscopic colon tissue biopsies were taken to assess injury as well as tissue penetration of the 99mTc-DTPA. Acceptability was assessed after each product use and at the end of the study. SPECT/CT imaging showed that the isoosmolar enema had greater proximal colonic distribution (up to the splenic flexure) and greater luminal and colon tissue concentrations of 99mTc-DTPA when compared to the other enemas (p<0.01). Colon biopsies also showed that only the hyperosmolar enema caused sloughing of the colonic epithelium (p<0.05). In permeability testing, the hypoosmolar enema had higher plasma 99mTc-DTPA 24-h area under the concentration-time curve and peak concentration compared to the hyperosmolar and isoosmolar enemas, respectively. Acceptability was generally good with no clear preferences among the three enema types. The isoosmolar enema was superior or similar to the other enemas in all categories and is a good candidate for further development as a rectal microbicide vehicle.
机译：直肠应用抗逆转录病毒杀微生物剂用于HIV感染的暴露前预防（PrEP）目前正在开发中。由于灌肠（直肠灌肠）通常是在接受肛门性交之前与男性发生性关系的男性使用的，因此杀菌剂灌肠可以通过无缝配合常规性行为来增强PrEP依从性。我们在交叉设计中评估了三种灌肠类型的分布，安全性和可接受性：高渗（Fleet），低渗（蒸馏水）和等渗（Normosol-R）。九名男子随机接受每种灌肠剂。用单光子发射计算机断层扫描/计算机断层扫描（SPECT / CT）成像对灌肠进行放射性标记[ 99m Tc-二亚乙基三胺五乙酸（DTPA）”以评估结肠中的灌肠分布。血浆 99m Tc-DTPA表明粘膜通透性。进行乙状结肠镜活检，以评估 99m Tc-DTPA的损伤和组织穿透。在每次使用产品后和研究结束时评估可接受性。 SPECT / CT成像显示，与其他灌肠相比，等渗性灌肠具有更大的近端结肠分布（直至脾弯曲），并且 99m Tc-DTPA的腔和结肠组织浓度更高（p <0.01 ）。结肠活检还显示，只有高渗灌肠​​才引起结肠上皮脱落（p <0.05）。在渗透性测试中，与高渗灌肠和等渗灌肠相比，低渗灌肠在浓度-时间曲线和峰值浓度下的血浆 99m Tc-DTPA 24-h面积分别更高。三种灌肠剂之间的接受度总体上良好，没有明显的偏好。在所有类别中，等渗灌肠均优于或类似于其他灌肠剂，并且作为直肠杀菌剂媒介物，是进一步发展的良好候选者。

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