Efficacy of Lactobacillus vaginal suppositories for the prevention of recurrent cystitis: A phase II clinical trial
Efficacy of Lactobacillus vaginal suppositories for the prevention of recurrent cystitis: A phase II clinical trial
复制标题
DOI：
10.1111/iju.14636
复制
发表时间：
2021-07-13
影响因子：
2.6
通讯作者：
Ishii, Ayano
中科院分区：
文献类型：
--
作者：
Sadahira, Takuya;Wada, Koichiro;Ishii, Ayano
目的 前瞻性评估乳酸菌阴道栓剂预防复发性膀胱炎的有效性和安全性。方法 在这项单臂、开放标签、II 期临床试验中，参与者使用含有卷曲乳杆菌 GAI 98322 菌株的阴道栓剂，为期 1 年，每 2 天或每周 3 次。主要终点是缓解率，通过给药当年复发性膀胱炎的发作次数来评估。次要终点是缓解率，通过给药期结束后 1 年内复发性膀胱炎的发作情况进行评估；给药前、给药期间和给药后复发性膀胱炎发作的总数；不良事件；以及尿液细菌和阴道微生物群的变化。结果 共有 28 名女性入组，其中 21 名完成了研究。共有 18 名患者在给药期间取得有效缓解（86%）。乳酸菌阴道栓剂对膀胱炎发作的抑制作用可持续至最后一次栓剂使用后一年。在使用乳酸菌阴道栓剂期间和之后，膀胱炎的平均发作次数显着减少。没有观察到与治疗相关的不良事件。阴道微生物组的扩增子测序分析表明，在膀胱炎不发作期间，乳酸菌在阴道中定殖。结论 含有卷曲乳杆菌 GAI 98322 菌株的阴道栓剂在给药期间和给药后至少 1 年内可有效预防复发性膀胱炎的发作。
Objectives To prospectively assess the efficacy and safety of Lactobacillus vaginal suppositories for the prevention of recurrent cystitis. Methods In this single-arm, open-label, phase II clinical trial, participants used vaginal suppositories containing the GAI 98322 strain of Lactobacillus crispatus for 1 year either every 2 days or three times per week. The primary end-point was the response rate, as assessed by the number of episodes of recurrent cystitis during the year of administration. The secondary end-points were the response rate, as assessed by episodes of recurrent cystitis during the 1 year after completion of the administration period; the total number of episodes of recurrent cystitis before, during and after administration; adverse events; and changes in urine bacteria and the vaginal microbiome. Results A total of 28 women were enrolled, and 21 completed the study. A total of 18 patients achieved an effective response (86%) during administration. The suppressive effects of Lactobacillus vaginal suppositories on episodes of cystitis continued up to 1 year after the last suppository was administered. There was a significant reduction in the mean number of episodes of cystitis, both during and after administration of Lactobacillus vaginal suppositories. No treatment-related adverse events were observed. Amplicon sequencing analysis of the vaginal microbiome showed that Lactobacillus species colonized the vagina during the periods when episodes of cystitis were absent. Conclusions Vaginal suppositories containing the GAI 98322 strain of Lactobacillus crispatus effectively prevent episodes of recurrent cystitis, both during administration and for at least 1 year after administration.