A型肉毒素球海绵体肌注射治疗原发性早泄的初步临床观察

Injection of botulinum-A toxin into bulbospongiosus muscle for primary premature ejaculation:A preliminary clinical study

目的:初步评估A型肉毒素球海绵体肌注射治疗原发性早泄的有效性及安全性。方法:自2017年9~12月就诊的原发性早泄患者中按照纳入标准筛选入组70例,随机分成两组,试验组35例给予双侧球海绵体肌注射A型肉毒素100U,对照组35例给予双侧球海绵体肌注射等量生理盐水。于注射后第4周随访并比较治疗前后阴道内射精潜伏期(IELT)及早泄相关量表各项指标的改变,同时记录发生的不良反应。结果:70例入组受试者中最终按要求完成观察并获得完整信息69例(试验组34例、对照组35例)。试验组有效率为47.06%(16/34),对照组症状无改善。试验组4周后IELT由治疗前(0.74±0.27)min增加至(2.35±1.83)min,且与对照组治疗后IELT(0.79±0.21)min相比明显增加,差异有统计学意义(P<0.01)。试验组早泄谱量表评价中射精控制力、性生活满意程度、早泄相关痛苦程度、早泄相关配偶沟通困难程度均有改善,评分分别为(1.21±1.04)、(1.32±1.01)、(2.12±1.01)、(1.38±0.70),与本组治疗前、对照组治疗后相比差异均有统计学意义(P<0.05)。试验组配偶性生活满意度有改善,评分为(1.18±1.00),与本组治疗前、对照组治疗后相比差异均有统计学意义(P<0.05)。两组治疗前后射精功能评分、焦虑及抑郁评分均无统计学差异。试验组发生不良反应6例(17.65%),分别为自觉勃起硬度降低4例(11.76%),排尿不尽感2例(5.88%),均于注射后3~4 d起出现,勃起硬度降低者可完成性生活,均未给予其他治疗,症状于3周内自行缓解。结论:球海绵体肌注射A型肉毒素可作为一种治疗原发性早泄的方式,具有一定的研究及应用前景,但其临床应用优势有待大样本研究进一步探索验证。

Objective： To evaluate the efficacy and safety of injection of botulinum-A toxin into the bulbospongiosus muscle in the treatment of primary premature ejaculation （PPE）. Methods： According to the inclusion criteria, we randomly assigned 70 out- patients with PPE to a trial and a control group of equal number, the former injected with 100 U botulinum-A toxin at 10 U/ml and the latter with the same volume of saline into the bulbospongiosus muscle. Then, we obtained the intravaginal ejaculatory latency time （IELT）, scores of the Premature Ejaculation Profile （PEP）, Male Sexual Health Questionnaire-Ejaculatory Dysfunction （MSHQ- EjD）, and Hospital Anxiety and Depression Scale （HADS）, and the incidence of adverse reactions between the two groups before and 4 weeks after treatment. Results： Complete data were obtained from 69 of the patients, 34 in the trial and 35 in the control group. The effectiveness rate was 47.06% （16/34） in the former but 0 in the latter. At 4 weeks after treatment, the patients of the trial group showed a significantly longer IELT than the controls and the baseline （ [ 2.35±1.83 ] vs [ 0.79 ± 0.21 ] and [ 0.74 ± 0.27 ] min, P 〈 0.01 ） and the controls. The patients in the trial group, in comparison with those in the saline control group and the base- line, also exhibited significant improvement in the scores of PEP-ejaculation control （ 1.21 ± 1.04 vs 0. 49 ± 0.56 and 0.47± 0.51, P 〈 0.05） , PEP-sexual satisfaction （ 1.32 ±1.01 vs 0. 71 ± 0.57 and 0.79 ± 0. 48, P 〈 0.05）, PEP-PE-related distress （2.12 ±1.01 vs 2.80±0.68 and 2.76±1.26, P 〈 0.05）, and PEP-PE-induced difficult relationship with the partners （ 1.38 ±0.70 vs 2.37±0.55 and 2.12 ±1.49, P 〈 0.05）. The sexual satisfaction score of the female partners after treatment was markedly improved in the trial group as compared with the control group and the baseline （ 1.18±1.00 vs 0. 57± 0. 50 and 0.62±0.60, P 〈 0.05）. There were no statistically significant differences in MSHQ-EjD and HADS scores between the two groups before and after treatment. Adverse reactions were observed in 6 cases （17.65%） in the trial group, including 4 cases of decreased erectile hardness （11.76%） and 2 cases of incomplete urination （5.88%）, which occurred from the 3 to 4 days after injection, and those with decreased erectile hardness could complete sexual intercourse without any other treatment and recovered after 3 weeks. Conclu- sion ： Injection of botulinum-A toxin into the bulbospongiosus muscle can be used as an option for the treatment of PPE. Its clinical ap- plication value, however, needs to be verified by further studies with further samples.