Gynecology Private Practice, Perpignan, France.
Carémeau University Hospital, Nimes, France.
BMC Womens Health. 2021 Aug 28;21(1):322. doi: 10.1186/s12905-021-01435-w.
Vulvo-vaginal atrophy (VVA) is one of the common consequences of estrogen deficiency especially after the menopause. Several studies have assessed the effects of Hyaluronic acid (HA) on physical and sexual symptoms associated with VVA with promising results. However, most of these studies have focused on subjective assessment of symptom response to topically administered preparations. Nonetheless, HA is an endogenous molecule and it is logical that its effects are best realized if injected in the superficial epithelial layers. Desirial® is the first crosslinked HA that is administered by injection in the vaginal mucosa. The aim of this study was to explore the effect of multipoint vaginal intra-mucosal injections of specific cross-linked hyaluronic acid (DESIRIAL®, Laboratoires VIVACY) on several clinical and patient reported core outcomes.
A cohort bi-centric pilot study. The chosen outcomes included change in vaginal mucosa thickness, biological markers for collagen formation, vaginal flora, vaginal pH, vaginal health index, vulvo-vaginal atrophy symptoms and sexual function 8 weeks post Desirial® injection. Patients' satisfaction was also assessed using the patient global impression of improvement (PGI-I) scale.
A total of 20 participants were recruited between 19/06/2017 and 05/07/2018. At the end of the study, there was no difference in the median total thickness of the vaginal mucosa or in procollagen I, III or Ki67 fluorescence. However, there was a statistically significant increase in COL1A1 and COL3A1 gene expression (p = 0.0002 and p = 0.0010 respectively). There was also a significant reduction in reported dyspareunia, vaginal dryness, vulvar pruritus, vaginal chafing and significant improvement in all female sexual function index dimensions. Based on PGI-I, 19 patients (95%) reported varying degrees of improvement where, 4 (20%) felt slightly better; 7 (35%) better and 8 (40%) much better.
Multi-point vaginal intra-mucosal injections, of Desirial® (a crosslinked HA) was significantly associated with the expression of CoL1A1 and CoL3A1 suggesting stimulation of collagen formation. Furthermore, there was a significant reduction in VVA symptomatology and a significant improvement in patient satisfaction and sexual function scores. However, there was no demonstrable change in the total vaginal mucosal thickness. Study registration ID-RCB: 2016-A00124-47, Protocol code number: LOCAL/2016/PM-001.
外阴阴道萎缩（VVA）是雌激素缺乏的常见后果之一，尤其是绝经后。几项研究评估了透明质酸（HA）对与 VVA 相关的身体和性症状的影响，结果有一定前景。然而，这些研究大多集中于对外用制剂治疗反应的主观评估。尽管如此，HA 是一种内源性分子，如果将其注射到浅层上皮层，其效果应该是最佳的。Desirial®是第一个通过阴道黏膜注射给药的交联透明质酸。本研究旨在探讨多点阴道内黏膜注射特定交联透明质酸（DESIRIAL®，Laboratoires VIVACY）对几项临床和患者报告的核心结局的影响。
这是一项两中心队列研究的试点研究。选择的结局包括阴道黏膜厚度变化、胶原蛋白形成的生物标志物、阴道菌群、阴道 pH 值、阴道健康指数、外阴阴道萎缩症状和性功能，在注射 Desirial®后 8 周进行评估。还使用患者总体印象改善（PGI-I）量表评估患者满意度。
2017 年 6 月 19 日至 7 月 5 日期间共招募了 20 名参与者。研究结束时，阴道黏膜总厚度或前胶原 I、III 或 Ki67 荧光无差异。然而，COL1A1 和 COL3A1 基因表达有统计学显著增加（p=0.0002 和 p=0.0010）。报告的性交痛、阴道干燥、外阴瘙痒、阴道摩擦显著减少，所有女性性功能指数维度均显著改善。根据 PGI-I，19 名患者（95%）报告了不同程度的改善，其中 4 名（20%）感觉稍有改善，7 名（35%）改善较好，8 名（40%）改善明显。
多点阴道内黏膜注射 Desirial®（交联透明质酸）与 CoL1A1 和 CoL3A1 的表达显著相关，提示胶原蛋白形成的刺激。此外，VVA 症状显著减轻，患者满意度和性功能评分显著改善。然而，阴道黏膜总厚度无明显变化。研究注册号-RCB：2016-A00124-47，方案编号：LOCAL/2016/PM-001。
