Joshi Smita N, Katti Usha, Godbole Sheela, Bharucha Kapila, B Kishore Kumar, Kulkarni Sangeeta, Risbud Arun, Mehendale Sanjay
National AIDS Research Institute, Epidemiology Department, MIDC, Bhosari, Pune, Maharashtra, India.
Trans R Soc Trop Med Hyg. 2005 Oct;99(10):769-74. doi: 10.1016/j.trstmh.2005.01.007.
Praneem polyherbal formulations containing purified extracts of Azadirachta indica (neem tree) have shown activity against HIV and sexually transmitted disease pathogens in studies in vitro. The product also has contraceptive properties. This has prompted its development as a possible microbicide. We evaluated the safety of Praneem polyherbal tablet use among HIV-uninfected women. Twenty eligible women were enrolled in a Phase I open-label study requiring 14 days of consecutive intravaginal use of Praneem polyherbal tablets. Nine (45%) participants experienced 17 episodes of genital irritation. Transient genital itching was reported by eight (40%) participants, burning micturation by two (10%) and lower abdominal pain, genital burning and intermenstrual spotting by one (5%) each. On colposcopy, petechial haemorrhage was observed in two participants, one on day 7 and the other on day 14, and both were resolved without any treatment. There were no serious adverse events. Praneem polyherbal tablets were found to be safe for once daily intravaginal use for 14 consecutive days in sexually active HIV-uninfected women and a Phase II study may be taken up as a priority.
含有印度楝（印楝树）纯化提取物的Praneem多草药配方在体外研究中已显示出对艾滋病毒和性传播疾病病原体的活性。该产品还具有避孕特性。这促使其作为一种可能的杀微生物剂进行开发。我们评估了未感染艾滋病毒的女性使用Praneem多草药片的安全性。20名符合条件的女性参加了一项I期开放标签研究，该研究要求连续14天阴道内使用Praneem多草药片。9名（45%）参与者经历了17次生殖器刺激事件。8名（40%）参与者报告有短暂的生殖器瘙痒，2名（10%）报告有排尿烧灼感，各有1名（5%）报告有下腹部疼痛、生殖器烧灼感和月经间期点滴出血。在阴道镜检查中，2名参与者观察到瘀点性出血，1名在第7天，另1名在第14天，两者均未经任何治疗而消退。没有严重不良事件。在性活跃的未感染艾滋病毒的女性中，发现Praneem多草药片连续14天每天一次阴道内使用是安全的，可优先开展II期研究。
