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比较派特灵中药和 CO2 激光治疗高危型 HPV 相关低度鳞状上皮内病变(CIN1)的疗效。

Comparative analysis of Paiteling a traditional Chinese medicine (TCM) and CO2 laser therapy for high-risk HPV-associated with LSIL (CIN1) lesions.

机构信息

Department of Gynecology, The First Affiliated Hospital of Wenzhou Medical, University, Ouhai, Zhejiang 325003, China.

Department of Gynecology, The First Affiliated Hospital of Wenzhou Medical, University, Ouhai, Zhejiang 325003, China.

出版信息

Eur J Obstet Gynecol Reprod Biol. 2024 Nov;302:81-86. doi: 10.1016/j.ejogrb.2024.08.042. Epub 2024 Aug 30.

DOI:10.1016/j.ejogrb.2024.08.042
PMID:39236645
Abstract

OBJECTIVES

This study aims to evaluate the therapeutic outcomes of Paiteling and CO2 laser therapy on high-risk human papillomavirus.

METHODS

We retrospectively analyzed the data of 558 patients with HR-HPV low-grade squamous intraepithelial neoplasia (CIN1) from 2021 to 2023. Patients were selected and put into two groups: Paiteling and CO2 laser. Out of the 558 patients who were included in our final study, 239 (42.8 %) were treated with Paiteling, and 319 (57.2 %) were treated with CO2 laser vaporization. The mean age was 49.55 ± 12.10 years old. We observed that 27 (4.83 %) were younger than 30 years and 531 (95.1 %) were older than 30 years. We reviewed the patient's results at intervals of 3 months, 6 months, 12 months, and 24 months after each therapy. The results of the recurrence rate, effective viral clearance rate, and the effectiveness of both therapies on low-grade cervical lesions were determined using multivariate and univariate cox-regression analysis. The Kaplan-Meier curve was used to determine the HR-HPV conversion rate of each therapy.

RESULTS

The median time for HR-HPV clearance was 6.00 months (95 % CI: 4.26-6.89) in the Paiteling group and 9.00 months (95 % CI: 15.92-22.67) in the CO2 laser group. There was a significant difference between the two groups (χ2 = 25.118, p-Value = 0.000). The HR-HPV clearance rate during 6-12 months for Paiteling and CO2 laser was 100 (55.6 %) and 80 (44.4 %), respectively. The clearance rate for both therapies from 6 to 18 months was statistically significant (6-12 months: p < 0.010, 12-18 months: p < 0.011). The Paiteling HR-HPV negative rate over 24 months 214 (89.5 %) is higher than CO2 laser 176 (55.2 %). Paiteling has a 5.4 % re-infection rate, which is marginally lower than the 5.6 % rate for CO2 lasers. The clearance rate for both therapies from 12 to 18 months [Paiteling: 20 (4.7 %) to 10 (3.6 %) and CO2 laser: 22 (8.4 %) to 15 (4.2 %)] was also significant (p < 0.011). The percentage of persistent Hr-HPV clearance rate for Paiteling patients was higher than carbon dioxide laser vaporization. No severe side effects were reported by the Paiteling patients compared to laser vaporization. This is due to the fact that Paiteling, as a traditional Chinese medicine, is a topical, non-invasive medicine, thus preserving the integrity of the cervix.

CONCLUSIONS

Paiteling is an effective noninvasive therapy that can clear persistent HR-HPV associated with cervical low-grade squamous lesions in a relatively shorter period of time compared to CO2 laser ablation.

摘要

目的

本研究旨在评估派特灵与二氧化碳(CO2)激光治疗高危型人乳头瘤病毒(HR-HPV)的疗效。

方法

我们回顾性分析了 2021 年至 2023 年期间 558 例 HR-HPV 低度鳞状上皮内病变(CIN1)患者的数据。患者被分为派特灵组和 CO2 激光组。在最终纳入研究的 558 例患者中,239 例(42.8%)接受了派特灵治疗,319 例(57.2%)接受了 CO2 激光汽化治疗。患者的平均年龄为 49.55±12.10 岁。我们观察到,27 例(4.83%)患者年龄小于 30 岁,531 例(95.1%)患者年龄大于 30 岁。我们在每次治疗后每隔 3、6、12 和 24 个月对患者的复发率、有效病毒清除率以及两种疗法对低度宫颈病变的疗效进行了评估。采用多变量和单变量 Cox 回归分析来确定复发率、有效病毒清除率以及两种疗法对低度宫颈病变的疗效。采用 Kaplan-Meier 曲线来确定两种疗法的 HR-HPV 转化率。

结果

派特灵组 HR-HPV 清除的中位时间为 6.00 个月(95%CI:4.26-6.89),CO2 激光组为 9.00 个月(95%CI:15.92-22.67)。两组之间存在显著差异(χ2=25.118,p 值=0.000)。派特灵和 CO2 激光在 6-12 个月的 HR-HPV 清除率分别为 100(55.6%)和 80(44.4%)。两种疗法在 6-18 个月的清除率均具有统计学意义(6-12 个月:p<0.010,12-18 个月:p<0.011)。派特灵组 24 个月的 HR-HPV 阴性率为 214(89.5%),高于 CO2 激光组的 176(55.2%)。派特灵的再感染率为 5.4%,略低于 CO2 激光的 5.6%。两种疗法在 12-18 个月的清除率[派特灵:20(4.7%)至 10(3.6%)和 CO2 激光:22(8.4%)至 15(4.2%)]也具有统计学意义(p<0.011)。派特灵组持续清除 HR-HPV 的比例高于 CO2 激光组。与激光汽化相比,派特灵组患者没有报告严重的副作用。这是因为派特灵作为一种中药,是一种局部、非侵入性的药物,因此能够保持宫颈的完整性。

结论

与 CO2 激光消融相比,派特灵是一种有效的非侵入性治疗方法,可在相对较短的时间内清除与宫颈低度鳞状病变相关的持续性 HR-HPV。

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引用本文的文献

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Clinical efficacy analysis of the Chinese medicine Paiteling applied to human papillomavirus infection: A retrospective study.中药派特灵治疗人乳头瘤病毒感染的临床疗效分析:一项回顾性研究。
PLoS One. 2024 Dec 10;19(12):e0315376. doi: 10.1371/journal.pone.0315376. eCollection 2024.