Reversible effect of testosterone undecanoate injection on spermatogenesis in rats

Aim: To study the effect of testosterone undecanoate (TU) injection on spermatogenesis in rats. Methods:Twenty adult SD rats received vehicle or TU (8 mg/kg, 19 mg/kg or 625 mg/kg) injection, im, every 15 days for 60days, and another 38 animals received similar treatments for 130 days with half of them undergoing a recovery phase of120 days (5 rats for each treatment). At the end of the treatment, testes were removed and the diameter of the seminif-erous tubules and the number of late elongated spermatids (steps 15-19) per testis were estimated with stereologicalmethods as a measure of the spermatogenic efficiency. Results: Low dose (8 mg/kg) TU treatment virtually hadno effect on spermatogenesis. A dose of 19 mg/kg slightly suppressed spermatogenesis 60 days after treatment, and se-vere suppression occurred after another 70 days of dosing. Spermatogenesis was completely recovered at the end of therecovery phase. Large dose (625 mg/kg) TU treatment did not significantly affect spermatogenesis and was well toler-ated by animals. Conclusion: TU injection reversibly suppresses spermatogenesis in rats.

More than eight years＇ hands-on experience with the novel long-acting parenteral testosterone undecanoate

Testosterone （T） as a compound for treatment of T deficiency has been available for almost 70 years, but the pharmaceutical formulations have been less than ideal. Traditionally, injectable T esters have been used for treatment, but they generate supranormal T levels shortly after the 2-3 weekly injection interval. T levels then decline very rapidly, becoming subnormal during the days preceding the next injection. The rapid fluctuations in plasma T are subjectively experienced as disagreeable. T undecanoate （TU） is a new injectable T preparation with a considerably better pharmacokinetic profile. After two initial injections separated by a 6-week interval, the following intervals between two injections are generally 12 weeks, eventually amounting to a total of four injections per year. Plasma T levels with this preparation are nearly always in the range of normal men, as are its metabolic products estradiol and dihydrotestosterone （DHT）. It reverses the effects of hypogonadism on bone and muscle and metabolic parameters, and on sex functions. It is suitable for male contraception. Its safety profile is excellent because of the continuous normalcy of plasma T levels. No polycythemia has been observed and no adverse effects on lipid profiles. Prostate safety parameters are well within reference limits. TU is a valuable treatment option of androgen deficiency.

Studies on apoptosis of spermatogenic cells in normal fertile men treated with supraphysiological doses of testosterone undecanoate

Aim: To study the anti-spermatogenic mechanism of supra-physiological doses of testosterone undecanoate (TU).Methods: Twenty fertile adult men received four intramuscular injections of TU at monthly intervals, 1000 mg uponadmission and 500 mg for the subsequent injections. The apoptotic germ cells in the semen were studied under light mi-croscope with tenninal deoxynucleotidyl tmnsferase-mediated dUTP-biotin nick end labeling (TUNEL) and Wright-Giem-sa staining methods. Results: After treatment, the sperm density and the number of spermatogenic cells in the semenwere significantly decreased ( P < 0.01), while the apoptotic ratios of spermatocytes and spermatids increased significantly( P <0.01) as compared with the pretreatment levels. Apoptosis was found to be augmented in the whole series of castoffspennatogenic cells. Conclusion: Besides its suppressive effect on spermatogenesis through a negative feed-backmechanism, TU enhances apoptosis of spermatogenic cells, which may be an additional mechanism of its anti-spermato-genic activity. ( Asian J Androl 1999 Sep; 1: 155 - 158)

Study on Differences in Spermatogenic Suppression between Azoospermic and Oligozoospermic Responders Treated with Levonorgestrel Implant Plus Testosterone Undecanoate Injectable in Chinese Men

Objective To investigate possible causes resulting in the differences in the spermatogenesis suppression on individual treated with levonorgestrel (LNG) implants and testosterone undecanoate (TU) injectableMethods Totally 21 Chinese male volunteers were given treatment with LNG implants (four rods, 75 mg/rod) and intramuscular injection of TU (500 mg,bimonthly for 3 times). According to the effects of treatment, they were divided into two groups, namely, azoospermia group (group A) and oligozoospermia group (group O). Then seminal FSH, LH, T and estradiol (E2) were determined by immunoenzymetric assay, while seminal and serum dihydrotachysterol (DHT) and serum sex hormone binding globulin (SHBG) were by radioimmunoassay, and seminal transferrin (Tf) by scatter turbidimetry assay.Results Seminal FSH, LH and serum DHT, SHBG, FTI (T/SHBG ×100) levels were significantly lower in group A than in group O, while higher seminal concentrations ofE2 were observed in azoospermia group.Conclusion The differences in the spermatogenic suppression in Chinese men might be attributed to different rate of peripheral androgen metabolism, variations in serum SHBG levels, 5á-reductase activity and individual aromatase activity during LNG plus TU administration. In addition, seminal sex hormones might be more sensitive indexes to assess the extent of feedback inhibition on hypothalamus-pituitary-testis with exogenous testosterone plus progestogen in the efficacy hormone male contraceptive trials.

Suppression of androgen receptor gene expression by testosterone undecanoate in rats

The mechanism of antifertility effect of testosterone undecanoate on male rat was investigated. Eight 12-week old rats were injected with 20 mg/kg of testosterone undecanoate at bi--week intervals for 3 months. As compared to that in the 10 control rafs, the sperm density in testis rete fluid of the treatment rats declined by 7%, the motility of sperm from epididymis cauda reduced to 6%. While the testosterone level in serum increased to 255 %, the testosterone level in testis rete fluid decreased to 55%. All of these differences were significant. The androgen receptor gene expression in the testis and epididymis was suppressed in the treatment group. The decrease in output of the sperm and sperm motility of epididymis cauda may be due to the reduced testosterone production by Leydig cells and suppression of androgen receptor gene expression in testis and epididymis.

Inhibitine Effects of Sino-implant Plus Testosterene Undecanoate(TU) on Spermatogenesis in Chinese Men

The purpose of this study was to use a kind of safe,long acting and reversible hormonal regimen for male contraception .The studied regimen was a subdermal insertion of a two rod implant (Sino implant, each rod containing 75 mg levenorgestrel LNG) in each subject's forearm, followed 3 weeks after by monthly injection of TU (Testosterone Undecanoate 250 mg) for 3 months. Eighteen weeks after implantation, the Sino implant was removed. There were altogether 16 male volunteers recruited in the entire research program. Among them 6 cases reached azoospermia; one case reached oligozoospermia (sperm density <3 million/ml); 5 cases' sperm density declined greatly, the lowest to be 5.7±1.3 million/ml; the other four cases' sperm density also declined, but remained within normal range (above 20 million/ml), the lowest to be 24.5±9.0 million/ml. The duration to reach azoospermia was 16.7±0.5 weeks. The duration to resume to normal range of sperm density was 8.2±2.5 weeks in the subjects with azoospermia and oligozoospermia. In the first two weeks after insertion the LNG release of Sino implant's mean serum LNG level was about 0.38 ng/ml, in the rest of the time the LNG levels in blood was rather constant about 0.24 ng/ml. Routine analyses of blood and urine, liver and kidney functions, and blood chemistry including those parameters (TG,TC,HDL C,LDL C) of lipid metabolism didn't change much throughout the research. All the subjects' libido and sex function were well kept. Clinical observation didn't show any other adverse effects during the research.

Testosterone therapy reduces hepatic steatosis in men with type 2 diabetes and low serum testosterone concentrations

BACKGROUND Non-alcoholic fatty liver disease(NAFLD)is highly prevalent in people with diabetes with no available treatment.AIM To explore the effect of testosterone treatment on liver.Testosterone therapy improves insulin resistance and reduces total body fat,but its impact on the liver remains poorly studied.METHODS This secondary analysis of a 40 wk,randomised,double-blinded,placebocontrolled trial of intramuscular testosterone undecanoate in men with type 2 diabetes and lowered serum testosterone concentrations evaluated the change in hepatic steatosis as measured by liver fat fraction on magnetic resonance imaging(MRI).RESULTS Of 88 patients enrolled in the index study,39 had liver MRIs of whom 20 received testosterone therapy and 19 received placebo.All patients had>5%hepatic steatosis at baseline and 38 of 39 patients met diagnostic criteria for NAFLD.Median liver fat at baseline was 15.0%(IQR 11.5%-21.1%)in the testosterone and 18.4%(15.0%-28.9%)in the placebo group.Median ALT was 34units/L(26-38)in the testosterone and 32units/L(25-52)in the placebo group.At week 40,patients receiving testosterone had a median reduction in absolute liver fat of 3.5%(IQR 2.9%-6.4%)compared with an increase of 1.2%in the placebo arm(between-group difference 4.7%P<0.001).After controlling for baseline liver fat,testosterone therapy was associated with a relative reduction in liver fat of 38.3%(95%confidence interval 25.4%-49.0%,P<0.001).CONCLUSION Testosterone therapy was associated with a reduction in hepatic steatosis in men with diabetes and low serum testosterone.Future randomised studies of testosterone therapy in men with NAFLD focusing on liver-related endpoints are therefore justified.

Exploring the efficacy of testosterone undecanoate in male children with 5α-reductase deficiency

Importance:Children with 5-alpha-reductase deficiency(5α-RD)and hypospadias present with micropenis,which makes it difficult to obtain sufficient tissue for urethral reconstruction.Objective:We investigated the therapeutic effects of oral testosterone undecanoate and established a standard androgen treatment protocol for patients with 5α-RD with micropenis.Methods:Patients with 5α-RD were treated with oral testosterone undecanoate for 3 months as a course.All patients were treated with no more than 3 courses.If the penile length(PL)reached 2.5 cm(the minimum criterion for surgery)or greater than or equal to−2.5 standard deviations(SDs)(lower limit of normal),testosterone undecanoate was considered to be effective.Results:The median age of 90 patients with 5α-RD was 1.7 years(0.9,3.1 years).The baseline PL was 1.9±0.6 cm before treatment.At the end of the first course,the PL of 63 patients(70%)reached 2.5 cm,and 49 patients(54%)reached greater than or equal to−2.5 SDs.After two treatment courses,the PL of 81 patients(90%)reached 2.5 cm,and 90 patients(100%)reached greater than or equal to−2.5 SDs.After three courses,the PL of all patients reached 2.5 cm,and all patients reached a PL greater than or equal to−2.5 SDs.No abnormal increase was observed in height-SD score,weight-SD score,or ratio of bone age to chronological age during the 1-3-year follow-up.Interpretation:After 3-9 months of treatment,PL increased to the target length.No severe adverse reactions were observed during follow-up.Testosterone undecanoate was safe and effective in children with 5α-RD with micropenis.

Suppression of spermatogenesis by testosterone undecanoate-loaded injectable in situ-forming implants in adult male rats

We have investigated the feasibility of administration of testosterone undecanoate （TU）-Ioaded injectable in situ-forming implant （ISFI） for contraception in adult male Sprague-Dawley rats. Male rats were treated with vehicle, TU-Ioaded ISFIs （540, 270 and 135 mg TU kg-1） or TU injections （45 mg TU kg-1 every 30 days） for 120 days. Fertility tests served for determining infertility or restoration of fertility in treated rats. Serum testosterone concentration, epididymal sperm count, motility, morphology, and histology of the testis were monitored. The TU-Ioaded ISFIs increased serum testosterone levels in rats steadily without fluctuation over 3 months. One month after TU administration, the epididymal sperm count decreased significantly in all experimental groups. After 3 months, the animals treated with 270 and 135 mg kg-~ TU-Ioaded ISFIs were 100% infertile, and no implantation sites were produced in the mated females. However, some of males treated with 540 mg kg-~ ISFI or TU injections were still fertile but numbers of implantation sites were also significantly lower than control values. TU-Ioaded ISFI at an appropriate dose has potential as a long-acting male contraceptive drug that suppresses spermatogenesis consistently over a period of 3 months.

Testosterone undecanoate supplementation together with human chorionic gonadotropin does not impair spermatogenesis in males with isolated hypogonadotropic hypogonadism:a retrospective study

Gon adotropin therapy is comm only used to in duce virilizati on and spermatoge nesis in male isolated hypog on adotropic hypog on adism (IHH) patients. In clinical practice, 5.6%-15.0% of male IHH patients show poor responses to gonadotropin treatment;therefore, testosterone (T) suppleme ntation can serve as an alter native therapy to no rmalize serum T levels and promote virilization. However, treatment with exogenous T impairs spermatogenesis and suppresses intratesticular T levels. This retrospective study aimed to determine whether oral testosterone undeca noate (TU) suppleme ntation together with human chorionic gonadotropin (hCG) would negatively affect spermatogenesis in IHH patients compared with hCG alone. One hundred and seven IHH patients were included in our study. Fifty-four patients received intramuscular hCG and oral TU, and 53 patients received intramuscular hCG alone. The median follow-up time was 29 (range: 12-72) mon ths in both groups. Compared with the hCG group, the hCG/TU group required a shorter median time to normalize serum T levels (P < 0.001) and achieve Tanner stage (III and V) of pubic hair and genital development (P < 0.05). However, there were no significant differences in the rate of seminal spermatozoa appearance, sperm concentration, or median time to achieve different sperm concentration thresholds between the groups. In addition, there were no significant differences in side effects, such as acne and gynecomastia, observed in both groups. This study indicates that oral TU supplementation together with hCG does not impair spermatogenesis in treated IHH patients compared with hCG alone, and it shortens the time to normalize serum T levels and promote virilization.

Effectiveness of Testosterone Undecanoate Treatment in Men with Asthenospermia

Objective To assess the effectiveness of testosterone undecanoate on sperm motility and pregnancy incidence in men with asthenospermia. Methods A clinical trial was performed. Fifty men with asthenospermia were included to receive placebo （control group, n=9） or T undecanoate 80 mg/d （study group, n=41）. Pregnancy incidence and sperm characteristics after 1, 2 and 3 months of medication and 3 months after the end of the trial were measured. Results Compared with the placebo, T undecanoate treatment produced a satisfactory improvement of seminal motility （F=55.904, P=0.000）. In study group, the incidence of pregnancy was 28.2% while the incidence of pregnancy in control group was 11.1%. In study group, 26patients took T undecanoate for more than 3 months. In the 3 months, semen volume showed no statistical difference （F=1.206, P=0.312） before and after treatment, sperm concentration （F=0.023, P=0.000） and motility a, b, a ＋b （P=0.000） showed statistical differences. Motility grade a showed significantly higher increment in 2 and 3 months after treatment than 1 month and there was no statistical difference between 2 and 3 months. So did grade b. Conclusion The results indicate that T undecanoate increases semjnal motility, leading to a higher incidence of pregnancy in couples with infertility related to asthenoaspermia.

基于报告比值比法对十一酸睾酮不良反应事件警戒信号的挖掘与评价

目的基于报告比值比法对十一酸睾酮不良反应事件进行警戒信号挖掘与评价。方法通过美国食品药品监督管理局公共数据公开项目的药品不良反应数据库,检索2004年1月至2021年7月十一酸睾酮不良反应事件报告情况,采用报告比值比法进行警戒信号挖掘。结果共检索到十一酸睾酮不良反应事件报告19466例,以男性、成年人(18~64岁)、口服给药为主;有32.23%的患者用药适应证不明确,在用药适应证前10位中,有6种用药适应证不属于说明书推荐范畴。共挖掘到十一酸睾酮不良反应事件警戒信号51个,涉及11个系统器官分类,主要系统器官分类为生殖系统疾病、心血管疾病、精神疾病及呼吸道、胸、纵隔疾病等,主要表现为梗死、深静脉血栓形成、睡眠呼吸暂停综合征、急性心肌梗死、肺栓塞。结论通过美国食品药品监督管理局公共数据公开项目的药品不良反应数据库对十一酸睾酮不良反应事件的警戒信号进行全面分析与挖掘,有助于提高医务人员对十一酸睾酮不良反应的认识。建议在临床上使用十一酸睾酮时,尤其是在合并心血管基础疾病的人群中使用该药时,应警惕心血管不良反应事件的发生。

短期口服小剂量十一酸睾酮治疗青春期前46,XY男童阴茎短小自身前后对照研究

目的观察短期口服小剂量十一酸睾酮胶丸治疗46,XY男童阴茎短小的疗效及安全性。方法以前瞻性自身对照研究方法,对2008年8月至2010年8月各类青春期前46,XY阴茎短小男童的连续样本给予十一酸睾酮胶丸(2～3mg.kg-1.d-1,最大剂量120mg.d-1)口服治疗。3个月为1个疗程,最多2个疗程。以Feldman方法观测阴茎牵长(PL),睾丸模型子比较法测量睾丸体积,G-P图谱法评测骨龄,检测治疗期间性激素等生化指标,观察治疗期间的不良反应。结果 50例患儿进入研究,平均年龄3.3岁。经第1疗程治疗后PL从(1.4±0.8)cm增长至(2.9±0.7)cm(P=0.00),PL标准差分值(SDS)的变化(△PL-SDS)为(2.9±1.3)(P=0.00);34/50例PL达标(≥-2.5s)予以停药,1/50例阴茎增长良好达手术标准停药。余15例进入第2疗程治疗,11例完成疗程。第2疗程PL增长量为(0.6±0.4)cm,△PL-SDS为(1.1±0.8)。第2疗程8/11例PL达标,3/11例达手术标准。第1疗程PL增长比第2疗程明显(P<0.05)。起始PL短于-4SDS者第1疗程为24例,第2疗程为15例。所有患儿及家长对治疗效果表示满意。治疗前后身高及血清IGF-1、血常规、血电解质、糖脂代谢指标和甲状腺功能等均在正常范围,未见肝肾功能等异常。治疗前后患儿骨龄/实足年龄的平均值均<1。结论短期口服小剂量十一酸睾酮治疗青春期前46,XY男童阴茎短小能有效促进阴茎生长,第1疗程疗效优于第2疗程。初始阴茎越长,越可能1个疗程结束治疗,治疗不良反应相对较小。药物依从性和家长满意度高。

选择性5α-还原酶抑制剂与十一酸睾酮合用对雄性大鼠生殖功能的影响

目的: 观察 5α 还原酶抑制剂与十一酸睾酮合用对雄性大鼠的生殖功能影响,从而探讨双氢睾酮是否参与生精及精子成熟的激素调节过程。 方法: 设立对照组后,给雄性大鼠经食道喂饲选择性 5α 还原酶抑制剂非那甾胺,并肌肉注射十一酸睾酮。观察大鼠生殖腺重量与组织学变化,血清睾酮、双氢睾酮水平,附睾精子计数和配对雌性大鼠妊娠胎仔数等变化情况。 结果: 与正常对照组相比,①非那甾胺减轻雄性大鼠的前列腺、睾丸和附睾的重量。合用外源性长效睾酮可以拮抗非那甾胺对大鼠前列腺重量的抑制作用。②非那甾胺使大鼠血清睾酮水平上升,而双氢睾酮显著下降。加用十一酸睾酮后的FT组血清睾酮和双氢睾酮水平均明显高于F组。③较大剂量的非那甾胺对大鼠的附睾精子计数,精子活率均有抑制作用,而且使精子畸形率明显升高和配对雌鼠的妊娠胎仔数减少。④非那甾胺与十一酸睾酮合用对大鼠的附睾精子计数与活率的抑制作用并没有得到进一步加强,虽然精子畸形率进一步升高,但配对雌鼠的妊娠胎仔数比T组却显著增加。 结论: 5α 还原酶抑制剂非那甾胺可以通过减少双氢睾酮的生成对大鼠的生殖器官和功能产生抑制作用。非那甾胺加用大剂量外源性雄激素并没有出现更强的抑制效应,反而部分抵消外源性雄激素的抑制生殖效应。

口服十一酸睾酮胶丸联合麒麟丸治疗男性迟发性性腺功能减退症的临床观察

目的:观察口服十一酸睾酮胶丸联合麒麟丸治疗男性迟发性性腺功能减退症(LOH)患者的临床疗效。方法:符合纳入标准的63例LOH患者随机分为对照组和试验组,对照组口服十一酸睾酮胶丸,试验组口服十一酸睾酮胶丸和麒麟丸。十一酸睾酮胶丸用法:80 mg/次,1次/d,连续服用3个月;麒麟丸用法:6 g/次,3次/d,连续服用3个月。比较组内和组间治疗前后的IIEF-5评分、老年男性症状问卷(AMS)评分及血清总睾酮(TT)水平的变化。结果:两组间各项数据无明显差异(P>0.05)。但治疗后试验组IIEF-5评分(21.7±5.8)分和TT值(16.7±2.2)nmol/L均显著高于对照组(15.9±4.7)分和(13.1±2.8)nmol/L(P<0.05);且AMS评分(20.7±5.7)分显著低于对照组(31.3±6.5)分(P<0.05)。结论:麒麟丸联合十一酸睾酮胶丸治疗LOH的疗效比单用十一酸睾酮胶丸治疗效果更显著,且不增加不良反应发生率,有一定的临床应用前景。

雄激素对阿朴吗啡和电刺激诱导的去势大鼠勃起功能的影响

目的 :探讨应用安雄进行雄激素替代对去势大鼠勃起功能的影响。方法 :取40只成年雄性 SD大鼠 ,分为去势、高、低剂量安雄及假手术 4组。治疗 4周后采用阿朴吗啡 ( APO)皮下注射与电刺激海绵体神经诱导大鼠勃起 ,对其勃起功能进行评价。结果 :高、低剂量安雄组与假手术组大鼠 APO诱导的勃起成功率、勃起次数与电刺激诱导的海绵体内压 ( ICP)均较去势组大鼠为高或多 ,统计学处理差异有显著性 ( P<0 .0 1 )。结论 :通过 APO皮下注射和电刺激海绵体神经证实 ,去势导致大鼠勃起功能明显下降 ;采用安雄进行雄激素替代可恢复其勃起功能 ;去势既影响了药物诱发的勃起反应 。

十一酸睾酮胶丸改善糖尿病合并迟发性性腺功能减退患者胰岛素抵抗的临床研究

目的:探讨睾酮替代治疗对糖尿病合并迟发性性腺功能减退患者胰岛素抵抗的作用及其临床疗效。方法:82例糖尿病合并迟发性性腺功能减退患者随机分为睾酮治疗组(n=42)和对照组(n=40),两组患者均维持原有降糖、调脂治疗方案,治疗组在此基础上予十一酸睾酮胶丸口服,共治疗6个月,观察两组治疗前后体重指数、腰围、血糖、血脂谱、胰岛素敏感性、生殖激素以及中老年男性症状问卷(AMS)评估的相关症状评分及IIEF-5评分变化。结果:与治疗前相比,治疗组干预后体重指数(26.71±2.39 vs 25.15±2.28,P<0.05)、腰围(cm)(89.96±9.13 vs 85.03±9.58,P<0.05)、糖化血红蛋白(%)(7.73±1.31 vs 7.01±1.25,P<0.05)、甘油三酯(mmol/L)(1.97±0.83 vs 1.41±0.69,P<0.05)显著下降,总睾酮(μmol/L)(7.16±2.21 vs 14.22±2.63,P<0.05)显著升高,稳态模型评估的胰岛素抵抗指数(3.76±1.18 vs 2.55±1.03,P<0.05)和胰岛素敏感指数(96±51 vs 138±53,P<0.05)显著改善,AMS心理和躯体评分显著改善(P<0.05),但IIEF-5评分(13.28±6.38 vs14.95±6.08,P>0.05)改善不明显。结论:睾酮替代治疗可以改善糖尿病合并迟发性性腺功能减退患者胰岛素抵抗并具有确切临床疗效。

伐地那非、十一酸睾酮合用与单用伐地那非治疗糖尿病患者勃起功能障碍的疗效比较

目的比较联合应用伐地那非和十一酸睾酮与单用伐地那非治疗糖尿病患者勃起功能障碍的疗效及不良反应。方法该院男科门诊患有糖尿病的勃起功能障碍患者58例,随机分成A、B组,每组29例,A组口服伐地那非20mg,性生活前30min服用;B组除了同样服用伐地那非外,每日早晚饭后服用十一酸睾酮40mg,共观察12周。比较两组治疗前后的国际勃起功能指数-5(IIEF-5)问卷中的评分、每周性交频率以及治疗期间的不良反应,并评估在疗程结束时,患者及其配偶对性生活的满意程度。结果 A、B两组患者IIEF-5评分在治疗后均显著增加,而B组较A组增加更显著(P<0.05);治疗后每周性交频率两组均显著增多,两组之间比较B组增加更明显(P<0.05)。治疗结束时,A组患者对性生活感到满意的有15例(51.7%),B组有21例(72.4%),B组满意比例较A组更高(P<0.05)。在不良反应方面,B组患者共有6例(20.7%)发生不良反应,较A组的5例(17.2%)无统计学意义(P>0.05)。结论在对糖尿病患者勃起功能障碍的治疗上,联合应用伐地那非和十一酸睾酮比单用伐地那非治疗糖尿病患者勃起功能障碍疗效要好,同时引起的不良反应却无明显增加。

益肾活血法对肾虚型LOH患者睾酮分泌指数的影响

目的:探讨中医益肾活血法对肾虚型迟发性性腺功能减退症(LOH)患者睾酮分泌指数的影响及治疗机制。方法:采用中国中老年男子健康研究会(CHISAM)认可的《男性更年期自我评定表》进行症状评分,检测血清总睾酮(TT)、黄体生成素(LH)的水平,并依据TT/LH计算出TSI(睾酮分泌指数)值,筛选出60例肾虚型LOH患者入组,按2∶1随机分为中药组和对照组。中药组用男更宁汤剂治疗;对照组用十一酸睾酮口服治疗,疗程均为12周。观察治疗后第4、8、12周两组患者心理学分量表评分、躯体分量表评分、性分量表评分、TT、LH和TSI的变化。结果:①中药组与对照组治疗前LH的水平分别为(5.32±2.08)、(5.36±2.07)IU/L,治疗12周后为(4.89±1.46)、(4.81±1.75)IU/L,两组治疗前后差异具有显著性(P均<0.05);两组治疗前心理学分量表评分分别为(5.2±1.3)、(4.8±2.2)分,治疗12周后分别为(2.7±1.4)、(2.9±1.2)分,两组治疗前后差异均具有显著性(P均<0.05);两组躯体分量表评分分别为(6.9±2.5)、(7.1±2.7)分,治疗12周后分别为(2.9±1.6)、(3.1±1.5)分,两组治疗前后差异具有显著性(P均<0.05);两组性分量表评分分别为(10.2±3.3)、(9.8±3.1)分,治疗12周分别为(4.5±2.9)、(4.8±3.0)分,两组治疗前后差异有显著性(P均<0.05);②两组治疗前TT分别为(11.13±0.69)、(10.99±0.74)nmol/L,治疗12周后分别为(14.55±0.75)、(14.74±0.83)nmol/L,差异有显著性(P均<0.05);两组治疗前TSI分别为(2.14±0.65)、(2.05±0.73)nmol/IU,治疗12周后分别为(2.99±0.72)、(3.11±0.65)nmol/IU,差异有显著性(P均<0.05);③中药组治疗12周后LH、TT、TSI、心理学分量表评分、躯体分量表评分、性分量表评分分别为(4.89±1.46)IU/L、(14.55±0.75)nmol/L、(2.99±0.72)nmol/IU、(2.7±1.4)分、(2.9±1.6)分、(4.5±2.9)分,对照组治疗12周后分别为(4.81±1.75)IU/L、(14.74±0.83)nmol/L、(3.11±0.65)nmol/IU、(2.9±1.2)分、(3.1±1.5)分、(4.8±3.0)分,两组间对比差异无显著性(P均>0.05)。④整个治疗过程,两组均无不良事件发生。结论:益肾活血法治疗肾虚型LOH可显著改善患者临床症状,同时使TT水平、TSI水平升高,疗效与补充雄激素治疗相当;男更宁汤通过下丘脑-垂体-性腺轴发挥作用可能是其治疗LOH的主要机制之一。

复方玄驹胶囊联合十一酸睾酮治疗糖尿病性勃起功能障碍的疗效分析

目的探讨复方玄驹胶囊联合十一酸睾酮治疗糖尿病性勃起功能障碍(DMED)的疗效分析。方法选取在丽水市中心医院泌尿科门诊就诊的84例DMED患者为研究对象,随机将其分为观察组和对照组,每组42例患者。两组患者予以十一酸睾酮软胶囊40mg/次,3次/d,口服;观察组在对照组基础上加用复方玄驹胶囊3粒/次,3次/d,口服。两组疗程均12周。观察治疗前后总睾酮(TT)和游离睾酮(FT)水平的变化,并比较其临床疗效及不良反应。结果治疗12周后,两组血清TT和FT水平较前明显上升(P<0.05或P<0.01),且观察组上升幅度较对照组更显著(P<0.05);同时观察组临床总有效率明显高于对照组(χ~2=4.09,P<0.05);对照组与观察组分别出现不良反应4例(9.52%)和6例(14.29%),两组比较差异无统计意义(χ~2=0.45,P>0.05)。结论复方玄驹胶囊联合十一酸睾酮治疗DMED的疗效较确切,安全性较好,能升高血清TT和FT水平。