■慢性盆腔疼痛(CPP)是盆腔炎(PID)的主要后遗症,没有既定的治疗。ZY5301片,从AjugadecumbensThunb中提取的有效部分制剂。(jingucao),正在测试作为对PID引起的CPP的治疗。
■评估ZY5301片剂对于患有PID的女性CPP治疗是否有效和安全。
■这种安慰剂对照的双盲,剂量平行,在中国9家医院进行了2期随机临床试验.PID后CPP的女性参与者在2020年10月16日至2021年8月31日之间注册。数据分析在2021年12月至2022年3月之间进行。
■参与者被随机分为1:1:1,接受ZY5301300mg/d,ZY5301600mg/d,或安慰剂每天口服3次,持续12周。
■视觉模拟量表(VAS)评分是用于评估ZY5301降低CPP功效的主要指标。VAS评分的评估终点包括每周平均VAS评分相对于基线的变化,VAS分数-时间曲线下的面积,疼痛缓解(VAS评分为0和1)率,和疼痛缓解的中位时间。通过治疗紧急和治疗相关不良事件的发生来评估安全性。
■总共,180名妇女被随机分配,177人被纳入疗效分析;因此,完整的分析集包括ZY5301mg/d组的60名参与者(平均[SD]年龄,37.4[8.1]年),ZY5301600mg/d组58岁(平均[SD]年龄,37.1[7.9]年),安慰剂组59岁(平均[SD]年龄,38.9[7.3]年)。基线时的参与者特征在组间相似。治疗12周后,VAS评分相对于基线的平均(SD)变化为-2.1(1.7)分,-3.5(1.5)分,安慰剂中的-3.8(1.7)分,ZY5301300mg/d,和ZY5301600mg/d组,分别(P<.001)。ZY5301300mg/d和ZY5301600mg/d组12周疼痛缓解率分别为43.3%和53.5%,分别,与安慰剂组相比有显著差异(11.9%;P<.001)。所有其他终点都显示出类似的改善。ZY5301600mg/d组疗效优于ZY5301300mg/d组,但差异不显著。安全性分析显示各组间无显著差异。
■这些发现表明ZY5301片剂对于缓解CPP是有效的,具有可接受的耐受性。
■ClinicalTrials.gov标识符:NCT05460546。
UNASSIGNED: 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.
UNASSIGNED: To evaluate whether ZY5301 tablets are effective and safe for CPP treatment in women with PID.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: These findings show that ZY5301 tablet is efficacious for the relief of CPP with acceptable tolerability.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT05460546.