Abstract: Background　Erectile dysfunction（ED）has a high incidence and causes significant harm. The Miao medicine Zhuzhi medicinal moxibustion therapy belongs to the traditional "moxibustion with medication interposed". It is commonly used in clinical practice for the treatment of ED. But it lacks clinical evidence. Objective　To explore the clinical efficacy of the Miao medicine Zhuzhi medicinal moxibustion therapy in the treatment of erectile dysfunction（ED）. Methods　Sixty patients with ED from the outpatient department of the Acupuncture and Department of moxibustion and the urology，first affiliated hospital of Guizhou university of traditional Chinese medicine from December 2021 to March 2024 were selected as the research objects. They were randomly divided into the Sildenafil group and the Miao medicine Zhuzhi medicinal moxibustion group. Each group had 30 cases. In the Sildenafil group，50 mg of sildenafil citrate tablets were taken orally 1 hour before sexual activity. In the Miao medicine Zhuzhi medicinal moxibustion group，the indirect moxibustion method was adopted. The acupoints selected were CV 6（Qi Hai），CV 4（Guan Yuan），CV 3（Zhong Ji），KI 12（Da He），and CV 2（Qu Gu）；BL 23 （Shen Shu），BL 32（Ci Liao），BL 30（Bai Huan Shu），BL 34（Xia Liao），and BL 54（Zhi Bian）. The two groups of acupoints were used alternately. The treatment was done once every other day. Each treatment lasted for 40 minutes. Both groups were treated for 30 days. After treatment，the efficacy of the two groups was evaluated. The changes in serum testosterone（T） levels before and after treatment in both groups were compared. The scores of the International Index of Erectile Function（IIEF），Self-Rating Anxiety Scale（SAS），Self-Rating Depression Scale（SDS），and TCM clinical syndrome scores before and after treatment and during the follow-up period（2 weeks after treatment）were also compared between the two groups.Results　The total effective rate in the Miao medicine Zhuzhi medicinal moxibustion group was 85.71%（24/28）. The total effective rate in the Sildenafil group was 86.67%（26/30）. There was no statistically significant difference between the two groups（χ2 =3.291，P=0.385）. Intra-group comparison：there was no statistically significant difference in T before and after treatment in the Miao medicine Zhuzhi medicinal moxibustion group（P>0.05），while T increased after treatment in the Sildenafil group compared to before treatment（P<0.05）. The IIEF scores in both groups increased after treatment and during the follow-up period compared with those before treatment（P<0.05）. There was no statistically significant difference in the IIEF scores during the follow-up period compared with those after treatment in the Miao medicine Zhuzhi medicinal moxibustion group（P>0.05）. The IIEF scores during the follow-up period in the Sildenafil group were lower than those after treatment（P<0.05）. The SAS，SDS，and TCM syndrome scores in the Miao medicine Zhuzhi medicinal moxibustion group decreased after treatment and during the followup period compared with those before treatment（P<0.05）. There was no statistically significant difference in the SAS，SDS，and TCM syndrome scores before and after treatment and during the follow-up period in the Sildenafil group（P>0.05）. The SAS，SDS，and TCM syndrome scores in the Miao medicine Zhuzhi medicinal moxibustion group during the follow-up period were lower than those after treatment（P<0.05）. Inter-group comparison：After treatment，the T value and IIEF scores in the Sildenafil group were higher than those in the Miao medicine Zhuzhi medicinal moxibustion group（P<0.05）. After treatment，the SAS，SDS，and TCM syndrome scores in the Miao medicine Zhuzhi medicinal moxibustion group were lower than those in the Sildenafil group（P<0.05）. During the follow-up period，the SAS，SDS，and TCM syndrome scores in the Miao medicine Zhuzhi medicinal moxibustion group were lower than those in the Sildenafil group（P<0.05）. There was no statistically significant difference in the IIEF scores between the two groups of subjects during the follow-up period（P>0.05）. During the treatment process，2 cases in the Sildenafil group experienced symptoms such as dry mouth，headache，and facial flushing. These symptoms could be relieved by rest. No serious adverse events occurred in either the Sildenafil group or the Miao medicine Zhuzhi medicinal moxibustion group. Conclusion　The efficacy of the Miao medicine Zhuzhi medicinal moxibustion therapy is equivalent to that of sildenafil in the treatment of ED. The Miao medicine Zhuzhi medicinal moxibustion therapy has more advantages than sildenafil in improving the short-term and long-term anxiety and depression symptoms and TCM syndrome scores of patients with ED. Sildenafil is superior to the Miao medicine Zhuzhi medicinal moxibustion therapy in improving the T value and short-term erectile function of patients with ED.

Key words: Erectile dysfunction, Miao medicine Zhuzhi medicinal moxibustion, Sildenafil, Comparative effectiveness research

摘要： 背景　勃起功能障碍（ED）发病率高且危害大，苗药竹技药灸疗法属于传统“隔药物灸”，临床常用于治疗ED，但缺乏临床证据。目的　探究苗药竹技药灸疗法治疗ED的临床疗效。方法　选取2021年12月—2024年3月贵州中医药大学第一附属医院针灸科门诊及泌尿外科接诊的60例ED患者为研究对象。随机分为西地那非组和苗药竹技药灸组，每组各30例。西地那非组于性活动前1 h口服50 mg枸橼酸西地那非片；苗药竹技药灸组予隔物灸法，穴取气海、关元、中极、大赫、曲骨穴；肾俞、次髎、白环俞、下髎、秩边穴，两组穴位交替治疗，隔日1次，40 min/次。两组均治疗30 d。治疗后评价两组疗效，并比较两组受试者治疗前后血清睾酮（T）及两组治疗前后及随访期（治疗后2周）勃起功能国际问卷（IIEF）评分、焦虑自评量表（SAS）评分、抑郁自评量表（SDS）评分、中医临床证候积分变化。结果　苗药竹技药灸组总有效率为85.71%（24/28），与西地那非组的86.67%（26/30）比较，差异无统计学意义（χ2=3.291，P=0.385）。组内比较：苗药竹技药灸组治疗前后T比较，差异无统计学意义（P>0.05），西地那非组治疗后T较治疗前升高（P<0.05）。两组治疗后、随访期IIEF评分较治疗前增高（P<0.05）；苗药竹技药灸组随访期IIEF评分较治疗后比较，差异无统计学意义（P>0.05），西地那非组随访期IIEF评分较治疗后降低（P<0.05），苗药竹技药灸组治疗后、随访期SAS、SDS、中医证候评分较治疗前降低（P<0.05），西地那非组治疗后、随访期SAS、SDS、中医证候评分较治疗前比较，差异无统计学意义（P>0.05），苗药竹技药灸组随访期SAS、SDS、中医证候评分较治疗后降低（P<0.05）。组间比较：治疗后西地那非组T、IIEF评分高于苗药竹技药灸组（P<0.05），治疗后苗药竹技药灸组SAS、SDS、中医证候评分较西地那非组降低（P<0.05）；随访期苗药竹技药灸组SAS、SDS、中医证候评分较西地那非组降低（P<0.05），随访期两组受试者IIEF评分差异无统计学意义（P>0.05）。治疗过程中西地那非组2例出现口干、头痛、面部潮红症状，休息可缓解。西地那非组及苗药竹技药灸组均未发生严重不良事件。结论　苗药竹技药灸与西地那非治疗ED疗效相当，苗药竹技药灸在改善ED患者远近期焦虑、抑郁症状及中医证候评分方面较西地那非更有优势，西地那非在改善ED患者T及近期勃起功能方面优于苗药竹技药灸。

关键词: 勃起功能障碍, 苗药竹技药灸, 西地那非, 疗效比较研究