帕罗西汀联合坦索罗辛治疗原发性早泄的临床研究

发布时间：2018-03-21 11:37

本文选题：原发性早泄　切入点：盐酸帕罗西汀　出处：《第三军医大学》2014年硕士论文　论文类型：学位论文

【摘要】：背景和目的对于原发性早泄的治疗，虽有不少方法，但各种治疗方法的有效性和安全性尚有待进一步证实。在原发性早泄的治疗选择中，心理疗法及行为训练疗法的有效性和依从性欠佳；手术治疗的疗效不确切且可能造成不可逆性损害而并没有得到国内外各类诊治指南的推荐；因而，药物治疗早泄仍是临床上广泛应用的主要方法和国际多种诊治指南所推荐的首选措施。目前全世界范围内仅达泊西汀(dapoxetine)作为早泄治疗的适应症性用药。5－羟色胺再摄取抑制剂(SSRIs)，局部麻醉剂和选择性α-肾上腺素能受体阻断剂等是早泄的治疗常用药物。但由于患者个体差异以及早泄病因的不同，不同患者对同种药物治疗反应效果不一。本研究选择盐酸帕罗西汀和盐酸坦索罗辛两种药物，以探讨其在原发性早泄治疗中，联合用药及单独用药的有效性及安全性；并评价5-HT浓度在原发性早泄的诊断及治疗效果判断中的意义，并对SSRIs的具体作用机制进行探讨。方法根据国际性学会(International Society for Sexual Medicine， ISSM)2008年制定的原发性早泄的诊断标准：“射精往往或总是在插入阴道1min左右发生;大多数或每次插入阴道后，没有延长射精的能力;有消极的后果，例如苦恼、痛苦、沮丧或/和逃避亲密接触等”，筛选本院男科门诊18-65岁原发性早泄患者225例，按照就诊的先后随机分成A、B和C组，每组75例。每组符合筛选要求的原发性早泄患者予以治疗前血样采集并提取血浆冻存。同样方法采集同期就诊于我科，无早泄症状的50例其他疾病患者血样，作为健康男性血样，同法处理及保存。A组单用盐酸帕罗西汀，20mg/d；B组单用盐酸坦索罗辛，0.4mg/d；C组同时服用盐酸帕罗西汀和盐酸坦索罗辛，剂量同A、B组，均连用8周。治疗8周后再次予以血样采集并离心提取血浆冻存。采用美国clound-clone corporation生产的5-HT ELISA试剂盒测定血浆中5-HT浓度并予以比较分析。采用问卷调查形式比较三组治疗8周后与治疗前的平均阴道内射精潜伏时间(IELT)、早泄量表(premature ejaculation profile, PEP)中患者性交满意度，控制射精的能力，早泄相关苦恼以及早泄相关夫妻沟通困难等指标的改变情况，并对治疗期间的所有不良反应进行收集和统计总结。结果共计198例患者获得可靠随访数据， A组IELT的均值由用药前的1.23min增加到8.52min，增加了7.29min；B组IELT的均值由用药前的1.16min增加到2.30min，增加了1.14min，C组IELT的均值由用药前的1.16min增加到9.31min，增加了8.15min；三组平均IELT在治疗后显著高于治疗前均增加(B组：P 0.01，A，C组：P0.001)。联合用药C组治疗后IELT增加了8.02倍。显著高于B组(1.98倍)和A组(6.92倍)(P0.001)。早泄量表中射精控制能力，性交满意度，早泄相关苦恼及早泄相关两性沟通困难四项指标评分显示，在治疗后各组较治疗前均有显著提高(P0.001)；而联合用药组四项指标的均值提高更为显著。A、组有10例(13.3%)患者出现了不良反应,B组有2例(2.6%),C组有9例(12.0%)。 A，B，C组患者在治疗前血浆5-HT浓度均值分别为：61.64ng/mL，62.31ng/mL，，62.77ng/mL，均显著低于对照组的132.21ng/mL(P0.001)，经过治疗后A,C组血浆5-HT浓度较治疗前显著增加,A组增加至113.59ng/mL，C组增加至117.82ng/mL(同治疗前相比，P0.001)，治疗后A,C组血浆5-HT浓度之间无明显差异(P0.05)，B组治疗前后血浆5-HT浓度无明显改变(P0.05)。结论 1.联合应用盐酸帕罗西汀和盐酸坦索罗辛治疗原发性早泄的有效性和安全性均较好，可作为一种原发性早泄药物治疗的优选方案. 2.血浆5-HT浓度可作为原发性早泄的较客观的诊断指标，并对早泄治疗效果的判断有一定的意义。
[Abstract]:Background and purpose
For the treatment of primary premature ejaculation, although there are many methods, but the safety and efficacy of various treatment methods still need to be further confirmed. In the treatment of primary premature ejaculation, effectiveness and compliance of psychological therapy and behavior training is poor; the effect of surgical treatment for imprecise and may cause irreversible the damage has not been recommended guidelines for the diagnosis and treatment of all kinds of domestic; therefore, the preferred drug for the treatment of premature ejaculation is still widely used measures of the main clinical guidelines for the diagnosis and treatment of a variety of methods and international recommended. At present all over the world only Daboxi ting (dapoxetine) as premature ejaculation treatment indications medication.5 serotonin reuptake inhibitors (SSRIs), a local anesthetic and selective alpha adrenergic receptor blockers are commonly used in the treatment of premature ejaculation drugs. But because of individual differences and the different causes of premature ejaculation, different The patients of the same drug reaction results. This research chooses Pa Rossi Dean hydrochloride and tamsulosin hydrochloride two drugs, in order to explore its treatment of primary premature ejaculation, the efficacy and safety of combined therapy and medication alone; and to evaluate the significance of the concentration of 5-HT in diagnosing the primary premature ejaculation diagnosis and treatment effect the discussion and the specific mechanism of SSRIs.
Method
According to the international society (International Society for Sexual Medicine, ISSM) in 2008 to develop primary premature ejaculation diagnostic criteria: "often or always in the vagina ejaculation occurred around 1min; most time is inserted into the vagina, not prolong ejaculation ability; have negative consequences, such as distress, pain, depression and / or avoid close contact", the Academy of andrology clinic screening at the age of 18-65 patients with primary premature ejaculation in 225 cases, according to the treatment were randomly divided into A, B and C group, 75 cases in each group. Each group meets the requirements of the screening of primary premature ejaculation patients treated before blood samples were collected and extracted from the plasma of cryopreservation. The same method selected collection in our department, no premature ejaculation symptoms of 50 patients with other diseases were as healthy male blood samples, with the method of processing and preservation of.A group with Pa Rossi Dean hydrochloride, 20mg/d; group B treated with hydrochloric acid Tanzania Sorosin, 0.4mg/d; group C at the same time Take Pa Rossi Dean and tamsulosin hydrochloride, the same dose of A, B group, both for 8 weeks. After 8 weeks of treatment, blood samples were collected and centrifuged again to extract plasma cryopreservation. Determination of plasma concentration of 5-HT and to compare the analysis by 5-HT ELISA kit clound-clone Corporation production. By questionnaire treatment between the three groups after 8 weeks and the average vagina before treatment in premature ejaculation, premature ejaculation (IELT) scale (premature ejaculation profile, PEP) in patients with sexual satisfaction, ability to control ejaculation, premature ejaculation, premature ejaculation changes related distress related indicators such as communication difficulties, and all adverse reactions during treatment were collected and statistical summary.
Result
A total of 198 patients received reliable follow-up data, the average A group IELT increased from 1.23min to 8.52min before treatment, increased by 7.29min; the average B group IELT increased from 1.16min to 2.30min before treatment, 1.14min increased, the average C group IELT increased from 1.16min to 9.31min before treatment, increased by 8.15min; three the average IELT was significantly higher than that after treatment before treatment were increased (B group: P 0.01, A, C group: P0.001). The combination of C group after treatment, IELT increased 8.02 times. Significantly higher than that of group B (1.98 times) and A group (6.92 times) (P0.001). The ability to control scale, ejaculation in the four indicators of sexual satisfaction of premature ejaculation, premature ejaculation and ejaculation related distress related to gender communication difficulties score showed that after treatment were significantly improved (P0.001); the mean and the combination group of four indexes was more significant.A group had 10 cases (13.3%) patients had adverse reactions, B group There were 2 cases (2.6%), 9 cases in C group (12%). A, B, C groups before treatment, mean plasma concentrations of 5-HT were: 61.64ng/mL, 62.31ng/mL, 62.77ng/mL, 132.21ng/mL were significantly lower than the control group (P0.001), A after treatment, the plasma 5-HT concentration in C group than before treatment significantly with the increase of A group increased to 113.59ng/mL, C group increased to 117.82ng/mL (compared with before treatment, P0.001, A) after treatment, no significant difference between the concentration of plasma 5-HT C (P0.05) group, B group before and after treatment of plasma 5-HT concentration did not change significantly (P0.05).
conclusion
The safety and efficacy of the 1. combined application of Pa Rossi Dean and tamsulosin for the treatment of primary premature ejaculation is good, can be used as the preferred scheme of a primary premature ejaculation treatment.
2. the concentration of plasma 5-HT can be used as an objective diagnostic index for primary premature ejaculation, and it is of certain significance to the judgment of the effect of premature ejaculation.

【学位授予单位】：第三军医大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R698

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