二吲哚甲烷治疗宫颈上皮内瘤变的疗效与安全性双盲随机安慰剂对照多中心临床试验（IIa期）：对宫颈癌预防的意义
Double-blind randomized placebo-controlled multicenter clinical trial (phase IIa) on diindolylmethane's efficacy and safety in the treatment of CIN: implications for cervical cancer prevention.
作者信息
Ashrafian Levon, Sukhikh Gennady, Kiselev Vsevolod, Paltsev Mikhail, Drukh Vadim, Kuznetsov Igor, Muyzhnek Ekaterina, Apolikhina Inna, Andrianova Evgeniya
机构信息
Russian Scientific Center of Roentgenoradiology of the Ministry of Health of the Russian Federation, Moscow, 86, Profsouznaya Str., Moscow, 117837 Russia.
Federal State Budget Institution "Research Center for Obstetrics, Gynecology and Perinatology" of the Ministry of Health of Russian Federation, 4, Akademika Oparina Str., Moscow, 117198 Russia.
出版信息
EPMA J. 2015 Dec 21;6:25. doi: 10.1186/s13167-015-0048-9. eCollection 2015.
BACKGROUND
The article presents the results of a clinical trial on the efficacy and safety of a novel pharmaceutical composition in the form of vaginal suppositories containing diindolylmethane in the course of cervical intraepithelial neoplasia (CIN) I-II conservative treatment. It offers an attractive drug therapy for more personalized prevention of cervical cancer.
METHODS
A total of 78 women of reproductive age were included. This was a multicenter, randomized, placebo-controlled, double-blind, parallel-group trial with efficacy determined by histological evaluation of cervical biopsies. The efficacy of active drug treatment (100 and 200 mg/day) in both treatment groups was significantly higher in comparison with the placebo group, according to the primary efficacy end point (proportion of patients with complete CIN regression after 90-180 days of the study drug treatment).
RESULTS
The efficacies were 100.0 % (confidence interval (CI) 95 %: 82.35-100.00 %), 90.5 % (CI 95 %: 69.62-98.83 %), and 61.1 % (CI 95 %: 35.75-82.70 %), for the high dose, low does, and placebo, respectively. Adverse events in the placebo group were reported in 22 % of patients (CI 95 %: 7.5-43.7 %); in the first treatment group (100 mg/day), adverse events were reported in 40.0 % of patients (CI 95 %: 21.1-61.3 %); in the second treatment group (200 mg/day), adverse events were reported in 42.0 % of patients (CI 95 %: 22.1-63.4 %). The differences in side effects between treatment groups treated with the active drug and placebo were statistically significant. No serious adverse events were reported in any of the groups.
CONCLUSIONS
Thus, the use of diindolylmethane in the form of intravaginal suppositories can be effective in patients with CIN I-II and is not accompanied by clinically significant side effects. This approach could be a better option for young women with CIN I-II as it takes in attention their reproductive plans.
TRIAL REGISTRATION
ID: ChiCTR-INR-15007497 (2 December 2015).
背景
本文介绍了一项关于新型药物组合物（含二吲哚甲烷的阴道栓剂）在宫颈上皮内瘤变（CIN）I-II期保守治疗中的疗效和安全性的临床试验结果。它为更个性化的宫颈癌预防提供了一种有吸引力的药物治疗方法。
方法
共纳入78名育龄妇女。这是一项多中心、随机、安慰剂对照、双盲、平行组试验，疗效通过宫颈活检的组织学评估来确定。根据主要疗效终点（研究药物治疗90 - 180天后CIN完全消退的患者比例），两个治疗组中活性药物治疗（100和200毫克/天）的疗效均显著高于安慰剂组。
结果
高剂量组、低剂量组和安慰剂组的有效率分别为100.0%（95%置信区间：82.35 - 100.00%）、90.5%（95%置信区间：69.62 - 98.83%）和61.1%（95%置信区间：35.75 - 82.70%）。安慰剂组22%的患者报告有不良事件（95%置信区间：7.5 - 43.7%）；第一个治疗组（100毫克/天）40.0%的患者报告有不良事件（95%置信区间：21.1 - 61.3%）；第二个治疗组（200毫克/天）42.0%的患者报告有不良事件（95%置信区间：22.1 - 63.4%）。活性药物治疗组与安慰剂组之间的副作用差异具有统计学意义。所有组均未报告严重不良事件。
结论
因此，阴道栓剂形式的二吲哚甲烷对CIN I-II期患者可能有效，且无临床显著副作用。这种方法对于患有CIN I-II期的年轻女性可能是一个更好的选择，因为它考虑到了她们的生育计划。
试验注册
编号：ChiCTR-INR-15007497（2015年12月2日）。
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