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.
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.
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DOI：
10.1186/s13167-015-0048-9
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发表时间：
2015
期刊：
影响因子：
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通讯作者：
Andrianova E
中科院分区：
文献类型：
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作者：
Ashrafian L;Sukhikh G;Kiselev V;Paltsev M;Drukh V;Kuznetsov I;Muyzhnek E;Apolikhina I;Andrianova E
本文介绍了一种新型药物组合物的有效性和安全性的临床试验的结果，在宫颈上皮内瘤样病变（CIN）I-II保守治疗的过程中，阴道栓剂的形式含有二吲哚甲烷。它提供了一种有吸引力的药物治疗，用于更个性化的宫颈癌预防。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，通过宫颈活检组织学评价确定疗效。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 mg/天）的疗效显著高于安慰剂组。高剂量组、低剂量组和安慰剂组的有效性分别为100.0%（置信区间（CI）95%：82.35- 100.00%）、90.5%（CI 95%：69.62- 98.83%）和61.1%（CI 95%：35.75- 82.70%）。22%的患者报告了安慰剂组的不良事件（CI 95%：7.5- 43.7%）;第一治疗组（100 mg/天），40.0%的患者报告了不良事件（CI 95%：21.1- 61.3%）;在第二个治疗组（200 mg/天）中，42.0%的患者报告了不良事件（CI 95%：22.1- 63.4%）。活性药物和安慰剂治疗组之间的副作用差异具有统计学意义。任何组均未报告严重不良事件。因此，阴道内栓剂形式的二吲哚基甲烷的使用在CIN I-II患者中是有效的，并且不伴有临床上显著的副作用。这种方法可能是CIN I-II年轻女性的更好选择，因为它需要注意他们的生殖计划。ID：ChiCTR-INR-15007497（2015年12月2日）
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. 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). 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. 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. ID: ChiCTR-INR-15007497 (2 December 2015)