Department of Gynecology, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China.
Department of Gynecology, The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, China.
JAMA Netw Open. 2024 Jul 1;7(7):e2423229. doi: 10.1001/jamanetworkopen.2024.23229.
Chronic pelvic pain (CPP) is the main sequela of pelvic inflammatory disease (PID), with no established treatment. ZY5301 tablets, an effective part preparation extracted from Ajuga decumbens Thunb. (jingucao), are being tested as a treatment for CPP caused by PID.
To evaluate whether ZY5301 tablets are effective and safe for CPP treatment in women with PID.
DESIGN, SETTING, AND PARTICIPANTS: This placebo-controlled double-blind, dose-parallel, phase 2 randomized clinical trial was conducted in 9 hospitals in China. Female participants with CPP after PID were enrolled between October 16, 2020, and August 31, 2021. The data analysis was performed between December 2021 and March 2022.
Participants were randomized 1:1:1 to receive ZY5301 300 mg/d, ZY5301 600 mg/d, or placebo orally 3 times a day for 12 weeks.
Visual analog scale (VAS) scores were the main measure used to evaluate the efficacy of ZY5301 in reducing CPP. The evaluation end points for VAS score included changes in mean weekly VAS score from baseline, area under the VAS score-time curve, pain remission (VAS score of 0 and 1) rate, and median time to pain remission. Safety was evaluated by the occurrence of treatment-emergent and treatment-related adverse events.
In total, 180 women were randomly assigned, and 177 were included in the efficacy analysis; thus, the full analysis set included 60 participants in the ZY5301 mg/d group (mean [SD] age, 37.4 [8.1] years), 58 in the ZY5301 600 mg/d group (mean [SD] age, 37.1 [7.9] years), and 59 in the placebo group (mean [SD] age, 38.9 [7.3] years). Participant characteristics at baseline were similar among the groups. After 12 weeks of treatment, the mean (SD) change in VAS score from the baseline was -2.1 (1.7) points, -3.5 (1.5) points, and -3.8 (1.7) points in the placebo, ZY5301 300 mg/d, and ZY5301 600 mg/d groups, respectively (P < .001). The pain remission rates at week 12 were 43.3% and 53.5% in the ZY5301 300 mg/d and ZY5301 600 mg/d groups, respectively, a significant difference compared with the placebo group (11.9%; P < .001). All the other end points showed similar improvements. The ZY5301 600 mg/d group had better efficacy than the ZY5301 300 mg/d group, but the difference was not significant. The safety analysis revealed no significant differences among groups.
These findings show that ZY5301 tablet is efficacious for the relief of CPP with acceptable tolerability.
ClinicalTrials.gov Identifier: NCT05460546.
慢性盆腔痛（CPP）是盆腔炎（PID）的主要后遗症，目前尚无既定的治疗方法。ZY5301 片剂是从筋骨草（Ajuga decumbens Thunb.）中提取的有效部位制剂，目前正在作为治疗 PID 引起的 CPP 的药物进行测试。
评估 ZY5301 片剂对 PID 引起的 CPP 治疗的有效性和安全性。
设计、设置和参与者：这是一项在中国 9 家医院进行的安慰剂对照、双盲、剂量平行、2 期随机临床试验。2020 年 10 月 16 日至 2021 年 8 月 31 日期间，招募 PID 后出现 CPP 的女性参与者。2021 年 12 月至 2022 年 3 月进行数据分析。
参与者按 1:1:1 的比例随机接受 ZY5301 300mg/d、ZY5301 600mg/d 或安慰剂，每日口服 3 次，共 12 周。
视觉模拟量表（VAS）评分是评估 ZY5301 降低 CPP 疗效的主要指标。VAS 评分的评估终点包括从基线开始每周 VAS 评分的变化、VAS 评分时间曲线下面积、疼痛缓解（VAS 评分为 0 和 1）率以及疼痛缓解的中位数时间。通过治疗出现的和与治疗相关的不良事件评估安全性。
共有 180 名女性被随机分配，177 名被纳入疗效分析；因此，全分析集包括 ZY5301 100mg/d 组 60 名参与者（平均[标准差]年龄，37.4[8.1]岁）、ZY5301 600mg/d 组 58 名参与者（平均[标准差]年龄，37.1[7.9]岁）和安慰剂组 59 名参与者（平均[标准差]年龄，38.9[7.3]岁）。各组基线特征相似。治疗 12 周后，安慰剂、ZY5301 300mg/d 和 ZY5301 600mg/d 组的 VAS 评分从基线的平均（标准差）变化分别为-2.1（1.7）点、-3.5（1.5）点和-3.8（1.7）点（P<0.001）。ZY5301 300mg/d 和 ZY5301 600mg/d 组在第 12 周的疼痛缓解率分别为 43.3%和 53.5%，与安慰剂组（11.9%）相比差异有统计学意义（P<0.001）。所有其他终点均显示出相似的改善。与 ZY5301 300mg/d 组相比，ZY5301 600mg/d 组疗效更好，但差异无统计学意义。安全性分析显示各组之间无显著差异。
这些发现表明 ZY5301 片剂对 CPP 的缓解有效，且耐受性良好。
ClinicalTrials.gov 标识符：NCT05460546。
