目的 评价不同剂量参蒲颗粒治疗盆腔炎性疾病后遗症-慢性盆腔痛（湿热瘀阻证）的有效性及安全性。方法 采用多中心、随机、双盲、安慰剂平行对照试验方法，计划纳入160例盆腔炎性疾病后遗症-慢性盆腔痛（湿热瘀阻证）患者，按照1∶ 1∶ 1∶ 1比例随机分为参蒲颗粒高、中、低剂量（用量分别为每次3、2、1袋，每日3次）组及安慰剂组，每组40例。疗程12周，随访4周。以腹部/腰骶疼痛VAS评分、McCormack量表评分、中医证候评分有效率为疗效评价指标。结果 腹部/腰骶疼痛VAS评分方面，参蒲颗粒高、中剂量组可显著降低腹部/腰骶疼痛VAS评分，疗效均显著优于低剂量组和安慰剂组，差异有统计学意义（P＜0.05）。第3月经周期亚组分析，基线腹部/腰骶疼痛VAS评分≥40患者，参蒲颗粒高、中、低剂量组腹部/腰骶疼痛VAS评分较基线的下降值均优于安慰剂组，且中剂量组缓解疼痛疗效显著优于低剂量组和安慰剂组，差异有统计学意义（P＜0.05）；基线腹部/腰骶疼痛VAS评分＜40患者，参蒲颗粒高、中、低剂量组及安慰剂组腹部/腰骶疼痛VAS评分较基线的下降值组间比较差异无统计学意义（P＞0.05）。McCormack量表评分方面，参蒲颗粒高、中剂量组可显著降低McCormack量表评分，疗效均显著优于低剂量组和安慰剂组，差异有统计学意义（P＜0.05）。中医证候评分有效率方面，参蒲颗粒高、中剂量组可显著提高中医证候评分有效率，疗效均显著优于安慰剂组，差异有统计学意义（P＜0.05）。试验期间，参蒲颗粒高、中、低剂量组和安慰剂组的不良事件和不良反应发生率均无明显差异，参蒲颗粒总体耐受性及安全性良好。结论 参蒲颗粒高、中剂量组均可显著减轻盆腔炎性疾病后遗症-慢性盆腔痛（湿热瘀阻证）患者腹部/腰骶疼痛，且对基线腹部/腰骶疼痛VAS评分≥40的患者疗效更加显著，可显著减轻子宫附件压痛及反跳痛，改善临床症状，提高患者生活质量，且整体安全性良好。基于药物有效性及安全性考虑，推荐纳入腹部/腰骶疼痛VAS评分≥40的患者，以及中剂量参蒲颗粒进行后续临床试验。

Objective To evaluate the efficacy and safety of different doses of Shenpu Granules in treatment of chronic pelvic pain after pelvic inflammatory disease (with dampness-heat and blood stasis syndrome). Methods A multi-center, randomized, double-blind, placebo-parallel controlled trial was conducted. A total of 160 patients with chronic pelvic pain after pelvic inflammatory disease (with dampness-heat and blood stasis syndrome) were planned for enrollment. Participants were randomly assigned in a 1∶ 1∶ 1∶ 1 ratio to high-dose, medium-dose, low-dose, and placebo groups (n = 40 per group). The treatment duration was 12 weeks, followed by a four-week follow-up period. The efficacy evaluation indicators include the VAS score for abdominal/lumbar pain, the McCormack scale score, the effective rate of TCM syndrome scoring. Results In terms of the VAS score for abdominal/lumbar pain, Both the high-dose and medium-dose groups could significantly reduce the VAS score for abdominal/lumbar pain, and the therapeutic effects were significantly better than that of the low-dose group and the placebo group. The differences were statistically significant (P<0.05). In the subgroup analysis of the third menstrual cycle, for patients with a baseline VAS score of abdominal/lumbar pain ≥ 40, the decrease in abdominal/lumbar pain VAS scores from baseline in the high, medium, and low dose groups was better than that in the placebo group. The pain relief efficacy of the medium dose group was significantly better than that of the low-dose group and the placebo group, and the difference was statistically significant (P<0.05). For patients with baseline abdominal/lumbar pain VAS score<40, there was no statistically significant difference in the decrease in abdominal/lumbar pain VAS score from baseline among the high, medium, low dose groups and the placebo group (P>0.05). In terms of the McCormack scale scores, Both the high-dose and medium-dose groups could significantly reduce the McCormack scale scores, and the therapeutic effects were significantly better than those of the low-dose group and the placebo group. The differences were statistically significant (P<0.05). In terms of the effective rate of TCM syndrome scoring, Both the high-dose and medium-dose groups could significantly increase the effective rate of TCM syndrome scoring, and the therapeutic effects were significantly better than those of the placebo group. The differences were statistically significant (P<0.05). During the trial, there were no significant differences in the incidence of adverse events and adverse reactions among the high-dose, medium-dose, low-dose groups and the placebo group. The overall tolerability and safety of Shenpu Granules were good. Conclusion The high-dose and medium-dose groups of Shenpu Granules can significantly alleviate abdominal/lumbar pain in patients with chronic pelvic pain after pelvic inflammatory disease (with dampness-heat and blood stasis syndrome). The therapeutic effect is more significant for patients with a baseline VAS score for abdominal/lumbar pain of ≥ 40. Shenpu Granules can significantly reduce uterine appendage tenderness and rebound tenderness, improve clinical symptoms, enhance the quality of life of patients, and have good overall safety. Considering the effectiveness and safety of the medicine, it is recommended to include patients with a VAS score for abdominal/lumbar pain of ≥ 40 and the medium-dose Shenpu Granules for subsequent clinical research.

R287.4

“重大新药创制”科技重大专项（2017ZX09301035）；连云港市科技成果转化专项（CZ202303）