目的 观察单用帕罗西汀、调肝益肾汤及帕罗西汀联合调肝益肾汤治疗早泄的临床疗效。方法 将96例早泄患者随机分为帕罗西汀组、调肝益肾汤组、中西医结合组，每组32例。帕罗西汀组予以帕罗西汀，每次20 mg，口服，每晚1次；调肝益肾汤组予以中药调肝益肾汤口服，每日1剂，早晚分服；中西医结合组联合服用帕罗西汀与中药调肝益肾汤。3组疗程均为8周，比较3组患者治疗前后及停药10周末阴道内射精潜伏时间（intravaginal ejaculatory latency time，IELT）、中国早泄患者性功能指数（Chinese index of sexual function for premature ejaculation，CIPE）及不良反应。结果 治疗后及停药10周末，3组患者IELT均较治疗前明显延长（P＜0.05），CIPE评分及各条目评分均较治疗前明显升高（P＜0.05）；与帕罗西汀组、调肝益肾汤组比较，治疗后及停药10周末中西医结合组患者IELT明显延长（P＜0.05），CIPE评分及各条目评分明显升高（P＜0.05）。停药10周末，调肝益肾汤IELT显著大于帕罗西汀组（P＜0.05），而CIPE评分及各条目评分与帕罗西汀组比较，差异均无统计学意义（P＞0.05）。3组不良反应发生率比较，差异无统计学差异（P＞0.05）。结论 调肝益肾汤联合帕罗西汀治疗早泄的短期疗效和长期疗效较好，不良反应少。单用调肝益肾汤因其较好的安全性及长期疗效，亦有一定的临床应用价值。
Objective To investigate the clinical effect of paroxetine and Tiaogan Yishen Decoction used alone or in combination in the treatment of premature ejaculation. Methods A total of 96 patients with premature ejaculation were randomly divided into paroxetine group, Tiaogan Yishen Decoction group, and paroxetine+Tiaogan Yishen Decoction group, with 32 patients in each group. The patients in the paroxetine group were given oral administration of paroxetine (20 mg) once every night, those in the Tiaogan Yishen Decoction group were given oral administration of the traditional Chinese medicine Tiaogan Yishen Decoction 1 dose per day (divided into two portions and taken in the morning and evening), and those in the paroxetine+Tiaogan Yishen Decoction group were given oral administration of paroxetine and Tiaogan Yishen Decoction. The course of treatment was 8 weeks for all groups, and the three groups were compared in terms of intravaginal ejaculatory latency time (IELT), Chinese Index of Sexual Function for Premature Ejaculation (CIPE), and adverse events before and after treatment and at week 10 after drug withdrawal. Results After treatment and at week 10 after drug withdrawal, all three groups had significant increases in IELT and the total score and the scores of each item of CIPE (P<0.05). Compared with the paroxetine group and the Tiaogan Yishen Decoction group, the paroxetine+Tiaogan Yishen Decoction group had a significant increase in IELT after treatment and at week 10 after drug withdrawal (P<0.05). At week 10 after drug withdrawal, the Tiaogan Yishen Decoction group had a significantly longer IELT than the paroxetine group (P<0.05), while there were no significant differences in the total score and the scores of each item of CIPE between the two groups (P>0.05). There was no significant difference in the incidence rate of adverse events between the three groups (P>0.05). Conclusion Tiaogan Yishen Decoction combined with paroxetine has good short- and long-term effects and few adverse effects in the treatment of premature ejaculation. The traditional Chinese medicine Tiaogan Yishen Decoction also has a certain application value in clinical practice because of its good safety and long-term effect.