Jing Zhang, Liying Guan, Zhenqing Wang, Hui Zhang, Shuai Liu, Dingqi Sun, Qiang Fu, Keqin Zhang
Department of Nephrology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, Shandong, China.
Physical Examination Center, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, Shandong, China.
Evid Based Complement Alternat Med. 2021 Mar 27;2021:9752592. doi: 10.1155/2021/9752592. eCollection 2021.
To evaluate the efficacy and safety of Ningmitai (NMT) capsules in patients with chronic epididymitis.
This prospective randomized controlled trial included 112 patients diagnosed with chronic epididymitis. The patients were randomized (1 : 1 : 1) to receive levofloxacin (LVX), NMT, or NMT combined with LVX for 4 weeks. The patients were followed up at 2 and 4 weeks after initiation of treatment and were evaluated in terms of Chronic Epididymitis Symptom Index (CESI) scores, epididymal nodules, and safety parameters. The primary endpoints were the CESI scores at the end of 2 and 4 weeks of treatment. The secondary endpoints included the mean epididymal nodule diameter and the clinical efficacy rate. Safety was evaluated by hepatorenal function tests and adverse event reports during the trial.
After 2 weeks of treatment, the CESI score of the NMT group was significantly lower than that of the LVX group ( < 0.05). In addition, the clinical efficacy rate of the NMT group was significantly higher than that of the LVX group (55% vs. 8.33%, < 0.0001), indicating that NMT has a rapid effect on chronic epididymitis. After 4 weeks of treatment, there was no significant difference in CESI scores or clinical efficacy rates between the two monotherapy regimens ( > 0.05); however, the mean diameter of epididymal nodules was significantly smaller in the NMT group than in the LVX group ( < 0.0001). Moreover, after 4 weeks of treatment, the patients in the LVX + NMT group, which had a clinical efficacy rate of 97.22%, had lower CESI scores (both < 0.01) and a smaller epididymal nodule diameter (vs. LVX, < 0.0001; vs. NMT, < 0.05) than those in the other two groups. No adverse events or abnormal hepatorenal function were found during the study.
NMT significantly improved CESI scores and epididymal nodule diameter in patients with chronic epididymitis. The combination of NMT and LVX provides a much better effect than monotherapy, and this treatment regimen was well tolerated.
评估宁泌泰（NMT）胶囊治疗慢性附睾炎患者的疗效和安全性。
这项前瞻性随机对照试验纳入了112例被诊断为慢性附睾炎的患者。患者被随机分为三组（1∶1∶1），分别接受左氧氟沙星（LVX）、NMT或NMT联合LVX治疗4周。在治疗开始后的第2周和第4周对患者进行随访，并根据慢性附睾炎症状指数（CESI）评分、附睾结节及安全性参数进行评估。主要终点为治疗2周和4周结束时的CESI评分。次要终点包括附睾结节平均直径及临床有效率。通过试验期间的肝肾功能检查和不良事件报告评估安全性。
治疗2周后，NMT组的CESI评分显著低于LVX组（<0.05）。此外，NMT组的临床有效率显著高于LVX组（55%对8.33%，<0.0001），表明NMT对慢性附睾炎起效迅速。治疗4周后，两种单药治疗方案的CESI评分或临床有效率无显著差异（>0.05）；然而，NMT组附睾结节的平均直径显著小于LVX组（<0.0001）。此外，治疗4周后，LVX+NMT组的临床有效率为97.22%，其CESI评分低于其他两组（均<0.01），附睾结节直径也更小（与LVX组相比，<0.0001；与NMT组相比，<0.05）。研究期间未发现不良事件或肝肾功能异常。
NMT显著改善了慢性附睾炎患者的CESI评分和附睾结节直径。NMT与LVX联合使用的效果优于单药治疗，且该治疗方案耐受性良好。
