Department of Obstetrics and Gynecology, Urmia University of Medical Sciences, Urmia, Iran.
Mahzad Hospital, Urmia University of Medical Sciences, Urmia, Iran.
Asian Pac J Cancer Prev. 2022 Mar 1;23(3):947-952. doi: 10.31557/APJCP.2022.23.3.947.
To compare the efficacy and safety of up to two-time administration of 85% TCA, as a promising alternative therapy to conservative and surgical management of grade one to three CINs.
In this two-armed randomized clinical trial, a total of 53 patients with biopsy-proven CIN lesions were allocated to two groups of TCA treatment. The first group (n=26) received a single dose of local therapy with 85% TCA while the second group (n=27) was treated on two separate occasions with a two-week interval. Two participants (one in each group) were lost to follow-up. At the two-month follow-up after TCA application, a colposcopy-guided biopsy was performed for all patients and the pathological specimens were studied by a single experienced pathologist to determine the post-intervention grading of CIN.
Two groups were comparable in terms of age and base-line lesion grading, as CIN 1 lesions comprised the majority of cases (54%), followed by CIN 2(37%). While our sample was a poor representative of CIN3 lesions (7%), no significant difference was noticed between the single and twice TCA treated groups with a response rate of 52% and 54% respectively (either complete remission to normal histology or regression to any low-grade lesion). Either separate analysis (with respect to the base-line grading within each treatment group) or combined analysis (regardless of CIN sub-group) could not generate any statistical significance. The second dose of TCA did not increase the frequency of reported adverse events.
The second dose of topical 85% TCA does not seem to increase the CIN response rate more so than its single dose. However, further controlled clinical trials with larger samples are warranted to verify current findings. The use of TCA was not limited by any major side effect, therefore, the potential to achieve an increased efficacy with more frequent TCA applications is appealing.
比较 85%三氯乙酸（TCA）最多两次给药的疗效和安全性，作为治疗 1 级至 3 级宫颈上皮内瘤变（CIN）的保守和手术治疗的一种有前途的替代疗法。
在这项双臂随机临床试验中，共有 53 名经活检证实为 CIN 病变的患者被分配到 TCA 治疗两组。第一组（n=26）接受单次局部 85%TCA 治疗，第二组（n=27）在两周的间隔内分两次治疗。两组各有两名患者（各一名）失访。在 TCA 应用后两个月的随访中，对所有患者进行阴道镜引导下活检，并由一位经验丰富的病理学家研究病理标本，以确定 CIN 的干预后分级。
两组在年龄和基线病变分级方面具有可比性，因为 CIN 1 病变占大多数（54%），其次是 CIN 2（37%）。虽然我们的样本中 CIN3 病变的代表性较差（7%），但单次和两次 TCA 治疗组之间没有发现显著差异，其缓解率分别为 52%和 54%（要么完全缓解至正常组织学，要么消退至任何低级别病变）。无论是单独分析（考虑每个治疗组的基线分级）还是联合分析（无论 CIN 亚组如何）都无法产生任何统计学意义。第二剂 TCA 并未增加报告的不良事件的频率。
与单次剂量相比，第二次局部使用 85%TCA 似乎不会增加 CIN 的缓解率。然而，需要进一步进行更大样本的对照临床试验来验证当前的发现。TCA 的使用不受任何主要副作用的限制，因此，通过更频繁地应用 TCA 来提高疗效的潜力是吸引人的。
