Objective: To make a real-world study on the efficacy and safety of traditional Chinese medicine (TCM) combined with sildenafil in the treatment of erectile dysfunction (ED) that failed to respond to TCM medication.
Methods: This study included 1 038 ED patients with the International Index of Erectile Function-5 (IIEF-5) scores ≤21 and improvement <30% after 4 weeks of TCM medication, differentially diagnosed with kidney-yang or kidney-yin deficiency syndrome. We administered TCM combined with sildenafil (Viagra, Pfizer Pharmaceutical Co., Ltd) at 100 mg 1 hour before sexual intercourse. After 2 and 4 weeks of medication, we recorded the scores in IIEF-5, erection hardness, Sexual Encounter Profile question 2 (SEP-2: whether vaginal penetration is successful), SEP-3 (whether sexual intercourse is successful), and TCM Syndromes Scale as well as the indexes of routine blood, urine, liver function, and renal function of the patients, and compared them with those obtained before treatment.
Results: No serious adverse reactions were observed in any of the patients. Compared with the baseline, the patients achieved significantly increased IIEF-5 scores after 2 and 4 weeks of medication (15.01 ± 2.25 vs 16.96 ± 2.55 and 19.41 ± 2.82, P <0.05), penileelectionhardness remarkably improved at 4 weeks (3.36% vs 44.58%, P<0.05), and the positive answers to SEP-2 and SEP-3 both markedly increased at 2 (38.11% vs 90.49%, P<0.05; 22.01% vs 63.77% , P<0.05) and 4 weeks (38.11% vs 96.95% , P<0.05; 22.01% vs 89.73%, P<0.05).
Conclusions: TCM combined with sildenafil is safe and effective in the treatment of ED in Chinese men, which can significantly improve the IIEF-5 score and erection hardness of the patients.
目的: 观察真实世界中药联合西地那非治疗中药无效型勃起功能障碍（ED）疗效及安全性。方法: 选取1038例中药治疗无效（服用4周中药，治疗后IIEF-5评分改善率<30%且≤21分）的ED患者，重新辨证为肾阳虚证、肾阴虚证，中药同时联合西地那非100 mg性生活前1 h服用，在2、4周后观察患者IIEF-5、勃起硬度分级（EHS）、性生活日志问题2（SEP2）、性生活日志问题3（SEP3）、中医证候评分及血常规、尿常规、肝功能( ALT) 、肾功能( BUN、Cr)等指标，并与治疗前对比。结果: 所有患者未发现严重的不良反应。治疗2、4周后IIEF-5评分［(16.96±2.55)分、(19.41±2.82)分］均有不同程度提高，差异有统计学意义(P<0.05)；治疗4周后EHS4比例（44.58%）上升，与治疗前EHS4（3.36%）相比有统计学差异（P<0.05）；治疗2、4周后，SEP2肯定回答的比例分别为90.49%,96.95%，与治疗前（38.11%）比较，均有统计学差异（P<0.05）。治疗2、4周后，SEP3肯定回答的比例分别为63.77%、89.73%，与治疗前（22.01%）比较，均有统计学差异（P<0.05）。结论: 真实世界研究发现中药联合西地那非治疗ED是安全、有效的，能有效提高ED患者IIEF5评分，提高勃起硬度。.
Keywords: erectile dysfunction; safety; therapeutic effect evaluation; real-world study.