Objective  To observe the clinical efficacy of Penyan pill combined with thunder fire moxibustion (TFM) in patients with sequelae of pelvic inflammatory disease (SPID).

Methods  This study was conducted at the department of gynecology, the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine from May 2023 to May 2024. Patients with SPID were recruited and randomly and equally divided into group A (treated with ornidazole), group B (treated with ornidazole combined with Penyan pill), and group C (treated with ornidazole combined with Penyan pill and TFM). The primary outcome was the treatment effective rate, the secondary indicators were the Traditional Chinese Medicine Syndrome Integral (TCMSI), Visual Analogue Scale (VAS) score, short-form 36 health survey (SF-36) score, Self-rating Anxiety Scale (SAS) score, inflammatory factors [interleukin-6 (IL-6), tumor necrosis factor (TNF-α), and C-reactive protein (CRP)], and the incidence of adverse drug reactions. All observation indicators were evaluated before treatment and 12 weeks after treatment.

Results  A total of 195 patients with SPID were included, and 16 patients failed to complete the study due to poor compliance. Therefore, the final number of cases was 59 in group A, 60 in group B, and 60 in group C. The treatment effective rate in group C was 95.00%, which was significantly higher than that in group B (80.00%) and group A (71.19%) (P<0.017). However, there was no significant difference in the effective rates between group A and group B (P>0.017). After treatment, the TCMSI total score, VAS score, SF-36 score, SAS score, and the levels of serum IL-6, TNF-α, and CRP in the three groups were significantly improved compared with those at enrollment (P<0.05). In addition, all the indicators in group C were significantly better than those in group B and group A (P<0.05). No adverse reactions were observed in the three groups.

Conclusion  Penyan pill combined with TFM can improve the pain degree, quality of life and anxiety state in SPID patients, which may be related to the regulation of inflammatory factor expression.

1.张艳, 刘恒炼, 姚瑶, 等. 妇科止痛颗粒治疗盆腔炎性疾病后遗症的疗效及对患者IL-6、IL-8、TNF-α和PGE2水平的影响[J]. 临床合理用药杂志, 2022, 15(19): 25-28. [Zhang Y, Liu HL, Yao Y, et al. Effect of Fukezhitong granule in the treatment of pelvic inflammatory disease sequelae and influence on IL-6, IL-8, TNF-α and PGE2[J]. Chinese Journal of Clinical Rational Drug Use, 2022, 15(19): 25-28.] DOI: 10.15887/j.cnki.13-1389/r.2022.19.008.

2.徐珊, 张小菜, 裴巧丽, 等. 通络盆腔炎方口服联合灌肠治疗慢性盆腔炎疗效及对血清hs-CRP、补体C3的影响 [J]. 现代中西医结合杂志, 2020, 29(29): 3271-3274. [Xu S, Zhang XC, Pei QL, et al. Efficacy of oral combination enema for chronic pelvic inflammation and its effect on serum hs-CRP and complement C3[J]. Modern Journal of Integrated Traditional Chinese and Western Medicine, 2020, 29(29): 3271-3274.] DOI: 10.3969/j.issn.1008-8849.2020.29.019.

3.《中成药治疗优势病种临床应用指南》标准化项目组. 中成药治疗盆腔炎性疾病后遗症临床应用指南（2020年） [J]. 中国中西医结合杂志, 2021, 41(3): 286-299. DOI: 10.7661/j.cjim. 20210130.006.

4.张兵, 刘鹏飞, 王丽, 等. 中医药干预盆腔炎性疾病后遗症作用机制研究概况[J]. 山东中医药大学学报, 2024, 48(1): 128-133. [Zhang B, Liu PF, Wang L, et al. Research review of mechanism of traditional Chinese medicine intervention in sequelae of pelvic inflammatory diseases[J]. Journal of Shandong University of Traditional Chinese Medicine, 2024, 48(1): 128-133.] DOI: 10.16294/j.cnki.1007-659x.2024.01.021.

5.任娇, 许彩凤, 彭凤娣, 等. 盆腔炎性疾病后遗症中医治疗进展[J]. 中国中医药图书情报杂志, 2023, 47(3): 169-172. [Ren J, Xu CF, Peng FD, et al. Research progress in TCM treatment of sequelae of pelvic inflammatory diseases[J]. Chinese Journal of Library and Information Science for Traditional Chinese Medicine, 2023, 47(3): 169-172.] DOI: 10.3969/j.issn.2095-5707. 202208045.

6.魏绍斌. 中医药防治盆腔炎性疾病及其后遗症的思路、方法及长期管理策略[J]. 北京中医药大学学报, 2023, 46(9): 1204-1212. [Wei SB. Thoughts, methods, and long-term management strategies of traditional Chinese medicine in preventing and treating pelvic inflammatory diseases and their sequelae[J]. Journal of Beijing University of Traditional Chinese Medicine, 2023, 46(9): 1204-1212.] DOI: 10.3969/j.issn.1006-2157.2023.09.003.

7.韩叶芬. 酉时雷火灸在盆腔炎性疾病后遗症（肾虚血瘀证）患者中的应用研究[D]. 南宁: 广西中医药大学, 2022. DOI: 10.27879/d.cnki.ggxzy.2022.000326.

8.王碧云, 秦琴. 雷火灸治疗盆腔炎性疾病后遗症疗效及对血清Caspase-3、sFas影响[J]. 天津中医药大学学报, 2021, 40(5): 587-590. [Wang BY, Qin Q. Thunder fire moxibustion for sequelae of pelvic inflammatory disease: clinical efficacy and influence on serum Caspase-3 and sFas[J]. Journal of Tianjin University of Traditional Chinese Medicine, 2021, 40(5): 587-590.] DOI: 10.11656/j.issn.1673-9043.2021.05.11.

9.余阳祺.盆炎丸对盆腔炎性疾病后遗症大鼠GPX4、NF-κB、TGF-β1及SMAD7的表达影响[D]. 长沙: 湖南中医药大学, 2023. DOI: 10.27138/d.cnki.ghuzc.2023.000108.

10.冯睿. 基于Nrf2/HO-1通路研究盆炎丸治疗盆腔炎性疾病后遗症模型大鼠的作用机制[D]. 长沙: 湖南中医药大学, 2023. DOI: 10.27138/d.cnki.ghuzc.2023.000427.

11.中华医学会妇产科学分会感染性疾病协作组. 盆腔炎症性疾病诊治规范（2019修订版）[J]. 中华妇产科杂志, 2019, 54(7): 433-437. [Infectious Diseases Cooperative Group of Obstetrics and Gynecology Branch of Chinese Medical Association. Code for diagnosis and treatment of pelvic inflammatory diseases (2019 revision)[J]. Chinese Journal of Obstetrics and Gynecology, 2019, 54(7): 433-437.] DOI: 10.3760/cma.j.issn.0529-567x.2019. 07.001.

12.郑筱萸, 主编. 中药新药临床研究指导原则（试行）[M]. 北京: 中国医药科技出版社, 2002: 242-253.

13.赵时碧, 主编. 中国雷火灸疗法[M]. 上海: 上海远东出版社, 2008: 170-171.

14.赵珊.芳香疗法结合雷火灸对气滞血瘀型盆腔炎性疾病后遗症的应用研究[D]. 南宁: 广西中医药大学, 2020. DOI: 10.27879/d.cnki.ggxzy.2020.000018.

15.万丽, 赵晴, 陈军, 等. 疼痛评估量表应用的中国专家共识（2020版）[J]. 中华疼痛学杂志, 2020, 16(3): 177-187. [Wan L, Zhao Q, Chen J, et al. The Chinese expert consensus on the application of the pain assessment scale (2020 edition)[J]. Chinese Journal of Pain, 2020, 16(3): 177-187.] DOI: 10.3760/cma.j.cn101379-20190915-00075.

16.伍勇, 胡伟汉, 刘国龙, 等. SF-36中文版健康状况调查表评价鼻咽癌疗后长期存活者适用性研究[J]. 中华放射肿瘤学杂志, 2010, 19(3): 201-204. [Wu Y, Hu WH, Liu GL, et al. SF-36 Chinese version of long-term survivors after NPC treatment[J]. Chinese Journal of Radiation Oncology, 2010, 19(3): 201-204.] DOI: 10.3760/cma.j.issn.1004-4221.2010.03.007.

17.王昕旭, 陈晗晖, 王宇昊, 等. Zung焦虑自评量表在社区居民中的信效度检验[J]. 临床精神医学杂志, 2024, 34(5): 397-401. [Wang XX, Chen HH, Wang YH, et al. Confidence validity test of the Zung Anxiety Self-rating Scale in community residents[J]. Journal of Clinical Psychiatry, 2024, 34(5): 397-401.] DOI: 10.3969/j.issn.1005-3220.2024.05.016.

18.程力, 唐潇冉, 何成瑶, 等. 中药治疗盆腔炎性疾病后遗症作用机制研究进展[J]. 世界科学技术-中医药现代化, 2024, 26(4): 988-1000. [Cheng L, Tang XR, He CY, et al. Research progress on the mechanism of traditional Chinese medicine in treating sequelae of pelvic inflammatory diseases[J]. Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology, 2024, 26(4): 988-1000.] DOI: 10.11842/wst.20230504005.

19.殷凯铃, 张月群. 子午流注灵龟八法联合中药封包治疗对缓解盆腔炎性疾病患者下腹疼痛的临床价值观察[J]. 中国实用医药, 2022, 17(1): 176-179. [Yin KL, Zhang YQ. The clinical value of eight methods and traditional Chinese medicine to relieve lower abdominal pain in patients with pelvic inflammatory diseases[J]. China Practical Medicine, 2022, 17(1): 176-179.] DOI: 10.14163/j.cnki.11-5547/r.2022.01.067.

20.朱娇芳, 王华, 王赛莉, 等. 雷火灸治疗盆腔炎性疾病后遗症的临床疗效观察[J]. 实用妇科内分泌电子杂志, 2017, 4(33): 8-9. [Zhu JF, Wang H, Wang SL, et al. Clinical observation on the treatment of sequelae of pelvic inflammatory disease by thunder and fire moxibustion[J]. Electronic Journal of Practical Gynecological Endocrinology, 2017, 4(33): 8-9.] DOI: 10.3969/j.issn.2095-8803.2017.33.004.

21.王适, 胡立志, 左姿, 等. 化瘀止痛贴膏调节IL-6/STAT3信号通路对急性软组织损伤大鼠炎症反应的影响[J]. 西部医学, 2024, 36(6): 820-825. [Wang S, Hu LZ, Zuo Z, et al. Effect of Huayu Zhitong plaster on inflammatory response in rats with acute soft tissue injury by regulating IL-6/STAT3 signal pathway[J]. Medical Journal of West China, 2024, 36(6): 820-825.] DOI: 10.3969/j.issn.1672-3511.2024.06.007.

22.卢芳. 骨科内置物术后感染性发热患者ESR、TNF-α、hs-CRP水平分析[J]. 数理医药学杂志, 2022, 35(4): 521-523. [Lu F. Analysis of levels of ESR, TNF-α and hs-CRP in patients with infectious fever after orthopedic implant surgery[J]. Journal of Mathematical Medicine, 2022, 35(4): 521-523.] DOI: 10.3969/j.issn.1004-4337.2022.04.016.

23.巫林芝, 潘学会, 陈小凤. 白细胞介素在青光眼中的作用研究进展[J]. 医学新知, 2024, 34(7): 817-824. [Wu NZ, Pan XH, Chen XF. Recent research progress on the role of interleukin in glaucoma[J]. Yixue Xinzhi Zazhi, 2024, 34(7): 817-824.] DOI: 10.12173/j.issn.1004-5511.202312058.

24.李亚梅, 张凯强, 彭壮, 等. 大叶千斤拔对慢性盆腔炎大鼠的抗炎作用及机制研究[J]. 中国药学杂志, 2019, 54(11): 874-880. [Li YM, Zhang KQ, Peng Z, et al. Anti-inflammatory effect and mechanisms of Flemingia macrophylla Merr. for chronic pelvic inflammatory disease in rats[J]. Chinese Pharmaceutical Journal, 2019, 54(11): 874-880. DOI: 10.11669/cpj.2019.11.004.

25.王冰玉, 黄巧玲, 傅金英, 等. 祛瘀通络方联合灌汤1号对盆腔炎性疾病后遗症患者炎症因子的影响[J]. 中华中医药学刊, 2024, 42(2): 224-227. [Wang BY, Huang QL, Fu JY, et al. Effect of Quyu Tongluo prescription combined with Enema No.1 on inflammatory factors in patients with sequelae of pelvic inflammatory disease[J]. Chinese Archives of Traditional Chinese Medicine, 2024, 42(2): 224-227.] DOI: 10.13193/j.issn.1673- 7717.2024.02.042.

26.邵美华, 蒋珊珊, 张敏. 自拟清热逐秽饮保留灌肠联合抗生素治疗盆腔炎性疾病后遗症疗效研究[J]. 辽宁中医杂志, 2024, 51(1): 133-136. [Shao MH, Jiang SS, and Zhang M. Efficacy of Qingrei Zhuhui Yin for retention enema combined with antibiotics in treatment of sequelae of pelvic inflammatory disease[J]. Liaoning Journal of Traditional Chinese Medicine, 2024, 51(1): 133-136.] DOI: 10.13192/j.issn.1000-1719.2024.01.035.