OBJECTIVE: To investigate the clinical effect and adverse reactions of dapoxetine hydrochloride versus paroxetine in the treatment of primary premature ejaculation by cross-comparison. METHODS: Based on the clinic-visit time, we equally randomized 148 patients with primary premature ejaculation into groups A and B for a cross-comparison test, the former treated with paroxetine at 20 mg once nightly and the latter with dapoxetine hydrochloride at 30 mg on demand, both for 6 successive weeks, during which we observed the therapeutic effects and adverse reactions. Following 4 weeks of drug discontinuance, we administered dapoxetine hydrochloride at 30 mg on demand for group A and paroxetine at 20 mg once nightly for group B, both for another 6 successive weeks, followed by observation and comparison of the therapeutic effects and adverse reactions. RESULTS: There were no statistically significant differences in the initial characteristics of the two groups of patients (P > 0.05). Compared with the baseline, the mean intra-vaginal ejaculation latency time (IELT) was dramatically improved after treatment in both groups A (4.43 min) and B (7.12 min), increased by 3.99% and 6.72%, respectively (P<0.001). The patients treated with paroxetine showed significantly longer IELT than those taking dapoxetine hydrochloride in both groups (P<0.001). Findings of the Premature Ejaculation Profile (PEP) and spouses' conditions indicated significant improvement after treatment in the average scores of the four indicators of PEP, that is, perceived control over ejaculation, ejaculation-related personal distress, satisfaction with sexual intercourse and ejaculation-related interpersonal difficulty, as well as in the overall experience and partner's satisfaction and orgasm frequency. Adverse reactions to medication were found in 20.8% of the cases in group A and 9.7% in group B, but none was serious. Preference survey following drug withdrawal revealed a preference for paroxetine (61.9%) over dapoxetine (26.8%), and that only a few of the patients thought of the two drugs as comparable or both ineffective. CONCLUSION In term of overall effectiveness, paroxetine was superior to dapoxetine in the treatment of primary premature ejaculation. And the patients obviously preferred the former to the latter, which might be partly attributed to the higher price of dapoxetine.
Humans ; Benzylamines/therapeutic use* ; Male ; Premature Ejaculation/drug therapy* ; Naphthalenes/therapeutic use* ; Paroxetine/therapeutic use* ; Adult ; Treatment Outcome ; Middle Aged ; Young Adult ; Selective Serotonin Reuptake Inhibitors/therapeutic use*

OBJECTIVE: To investigate the clinical efficacy of Zhuangdan Yanshi Decoction combined with dapoxetine hydrochloride in the treatment of premature ejaculation with cholestasis and phlegm disturbance. METHODS: A total of 120 patients diagnosed with premature ejaculation and treated in the Andrology Outpatient Department of Shaanxi Provincial Hospital of Traditional Chinese Medicine from March to December in 2022 were selected and randomly divided into treatment group and control group, with 60 cases in each group. The incubation period of intravaginal ejaculation (IELT), the Diagnostic Scale of Premature Ejaculation (PEDT), the Premature Ejaculation Assessment Scale (PEP), the 5-item Sexual Function Evaluation of Chinese Premature Ejaculation Patients (CIPE-5) and the improvement of traditional Chinese medicine symptom scores were compared before and after the treatment. And the adverse reactions were recorded as well. RESULTS: A total of 105 cases were ultimately included, with 55 cases in the treatment group and 50 cases in the control group. Measurable improvements in IELT, PEDT scores, PEP scores, CIPE scores and TCM symptom scores had been found after treatment in both of two groups (P<0.05). Moreover, the improvement in the treatment group was superior to that in the control group (P<0.05). The total effective rate in the treatment group was 89.1%, which was higher than that(84%) in the control group, with no statistically significant difference between the two groups (P>0.05). The incidence of adverse reactions in the treatment group was 9.1%, which was 24% in the control group. There was significantly difference between two groups (P<0.05). CONCLUSION The combination therapy with Zhuangdan Yanshi Decoction and dapoxetine hydrochloride for premature ejaculation associated with cholestasis and phlegm disturbance syndrome is definite, and it can reduce the side effects of drugs, which is better than oral dapoxetine hydrochloride alone.
Humans ; Premature Ejaculation/drug therapy* ; Benzylamines/therapeutic use* ; Drugs, Chinese Herbal/therapeutic use* ; Male ; Naphthalenes/therapeutic use* ; Cholestasis/complications* ; Adult ; Benzyl Compounds/therapeutic use* ; Medicine, Chinese Traditional ; Treatment Outcome

ObjectiveTo evaluate the effect and safety of Yimusake Tablets combined with dapoxetine hydrochloride and either of them used alone in the treatment of premature ejaculation (PE).

METHODSWe randomly assigned 180 PE patients to oral medication of Yimusake Tablets at 1.5 g per night (group A), dapoxetine hydrochloride at 30 mg at 1－3 hours before anticipated sexual activity (group B), the Yimusake Tablets plus dapoxetine hydrochloride simultaneously (group C), all for 8 weeks. After 4 and 8 weeks of medication, we recorded and compared the changes in the intravaginal ejaculation latency time (IELT), measures of the PE profile (PEP), and adverse events among the three groups of patients.

RESULTSThe treatment was accomplished and complete data obtained from 154 of the patients, 56 in group A, 52 in group B, and 46 in group C. After 4 and 8 weeks of medication, the mean IELT was dramatically prolonged in all the three groups as compared with the baseline (P<0.01), most significantly at 8 weeks in group C (［2.08±0.68］ min), followed by B (［1.76±0.52］ min) and A (［1.47±0.44］ min), with statistically significant differences among the three groups (P<0.01). The PEP measures were remarkably improved in group A at 8 weeks (P<0.05), and both in B and C at 4 and 8 weeks (P<0.05), most significantly at 8 weeks in group C (P<0.05), in which the patients scored 1.96±0.77 in perception of control over ejaculation, 2.62±0.98 in satisfaction with sexual intercourse, 3.04±0.62 in PE-related distress, and 3.57±0.80 in PE-induced difficult relationship with their partners, all markedly improved as compared with groups A and B (P<0.05). Adverse reactions were observed in 2 cases (3.6%) in group A, 6 cases (9.6%) in B, and 5 cases (10.9%) in C. No severe adverse events occurred in any of the patients during the study.

CONCLUSIONSCombined medication of Yimusake Tablets and dapoxetine hydrochloride, with its advantages of effectiveness and safety, deserves to be recommended for the treatment of PE.

Administration, Oral ; Adult ; Benzylamines ; therapeutic use ; Coitus ; psychology ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Ejaculation ; Humans ; Male ; Naphthalenes ; therapeutic use ; Personal Satisfaction ; Premature Ejaculation ; drug therapy ; Sexual Behavior ; Tablets ; Time Factors ; Treatment Outcome

OBJECTIVETo evaluate the clinical effect and safety of dapoxetine in the treatment of premature ejaculation (PE).

METHODSWe randomly assigned 116 PE patients to receive dapoxetine on demand at 30 mg qd (dapoxetine group, n = 60, aged 23-49 years) or oral tamsulosin at 20 mg qd (control group, n = 56, aged 24-46 years). After 4 weeks of medication, we compared the clinical global impression of change (CGIC) , PE profile (PEP) scores, intravaginal ejaculation latency time (IELT) , and adverse reactions between the two groups of patients.

RESULTSCompared with the baseline, the IELT was remarkably prolonged after treatment both in the dapoxetine group ([0.86 ± 0.17] vs [4.32 ± 2.23] min, P < 0.05) and the control ([0.88 ± 0.15] vs [4.17 ± 2.26] min, P < 0.05), with no statistically significant difference between the two groups (P > 0. 05). The post-treatment rate of CGIC in the dapoxetine group had no statistically significant difference from that in the control (85.00% vs 82.14%, P > 0.05). In comparison with pre-treatment, the patients of both the dapoxetine and control groups showed dramatically improved scores after medication in perceived control over ejaculation (0.85 ± 0.23 vs 2.13 ± 0.97 and 0.88 ± 0.21 vs 2.06 ± 0.34, both P < 0.05), ejaculation-related personal distress (1.15 ± 0.64 vs 2.89 ± 0.26 and 1.19 ± 0.53 vs 2.82 ± 0.69, both P < 0.05), satisfaction with sexual intercourse (0.81 ± 0.33 vs 2.58 ± 0.37 and 0.79 ± 0.28 vs 2.45 ± 0.32, both P < 0.05), and ejaculation-related interpersonal difficulty (2.05 ± 0.61 vs 3.24 ± 0.35 and 2.03 ± 0.65 vs 3.18 ± 0.76, both P < 0.05), with no significant differences between the two groups (P > 0.05). The incidence of adverse reactions was significantly lower in the dapoxetine than in the control group (3.33% vs 30.36%, P < 0.05).

CONCLUSIONDapoxetine is effective for the treatment of PE, with its advantages of prolonging the intravaginal ejaculation latency time, improving the quality of sexual life, and low incidence of adverse reactions.

Adult ; Benzylamines ; administration & dosage ; therapeutic use ; Coitus ; Double-Blind Method ; Ejaculation ; Humans ; Male ; Middle Aged ; Naphthalenes ; administration & dosage ; therapeutic use ; Patient Satisfaction ; Premature Ejaculation ; drug therapy ; Serotonin Uptake Inhibitors ; administration & dosage ; therapeutic use ; Sexual Behavior ; Sulfonamides ; administration & dosage ; therapeutic use ; Treatment Outcome ; Young Adult

Premature ejaculation (PE) is a most common sexual dysfunction, for which dapoxetine, a novel selective serotonin (5-HT) re-uptake inhibitor (SSRI), is the only licensed oral medicine at present. With the advantages of fast absorption, rapid action, on-demand medication, and short half-life time, dapoxetine has been proved by clinical trials to be effective in prolonging the intravaginal ejaculation latency time (IELT) and improving the overall condition of PE patients in various areas and populations. Compared with the traditional SSRIs, dapoxetine has a better safety and tolerability. The most frequently reported dapoxetine-related adverse events include nausea, diarrhea, headache and dizziness, but with very few severe or serious cases.
Benzylamines ; therapeutic use ; Biomedical Research ; Ejaculation ; drug effects ; Humans ; Male ; Naphthalenes ; therapeutic use ; Premature Ejaculation ; drug therapy ; Reaction Time ; drug effects ; Serotonin Uptake Inhibitors ; therapeutic use ; Treatment Outcome

OBJECTIVETo investigate the efficacy and adverse effects of dapoxetine in the treatment of premature ejaculation.

METHODSWe randomly assigned outpatients with premature ejaculation in the proportion of 2:1 to receive 30 mg dapoxetine on demand (n =78) or 50 mg sertraline qd for one month (n = 39). Follow-up was accomplished in 95 cases, 63 in the dapoxetine group and 32 in the sertraline group. We recorded the intravaginal ejaculatory latency time (IELT), clinical global impression of change (CGIC) score, and adverse reactions of the patients and compared them between the two groups.

RESULTSIELT was significantly increased in both the dapoxetine (from [0.87 ± 0.31] to [2.84 ± 0.68] min, P < 0.05) and the sertraline group (from [0.84 ± 0.28] to [2.71 ± 0.92] min, P < 0.05) after medication. Based on the CGIC scores in premature ejaculation, the rate of excellence or effectiveness was 36.5% in the dapoxetine and 37. 5% in the sertraline group, and the rate of improvement was 63.5% in the former and 71.9% in the latter. The incidence rates of dizziness, nausea, headache, and diarrhea were slightly higher (P > 0.05) while those of fatigue, somnolence, and dry mouth significantly higher (P < 0.05) in the sertraline than in the dapoxetine group.

CONCLUSIONOn-demand oral medication of dapoxetine is effective and well-tolerated for the treatment of premature ejaculation.

Benzylamines ; adverse effects ; therapeutic use ; Double-Blind Method ; Ejaculation ; drug effects ; physiology ; Humans ; Male ; Naphthalenes ; adverse effects ; therapeutic use ; Outpatients ; Premature Ejaculation ; drug therapy ; Reaction Time ; drug effects ; physiology ; Serotonin Uptake Inhibitors ; adverse effects ; therapeutic use ; Sertraline ; administration & dosage ; adverse effects ; Time Factors ; Treatment Outcome

PURPOSE: Cinacalcet is effective for treating refractory secondary hyperparathyroidism (SHPT), but little is known about the response rates and clinical factors influencing the response. MATERIALS AND METHODS: A prospective, single-arm, multi-center study was performed for 24 weeks. Cinacalcet was administered to patients with intact parathyroid hormone (iPTH) level greater than 300 pg/mL. Cinacalcet was started at a dose of 25 mg daily and titrated until 100 mg to achieve a serum iPTH level <300 pg/mL (primary end point). Early response to cinacalcet was defined as a decrease of iPTH more than 50% within one month. RESULTS: Fifty-seven patients were examined. Based on the magnitude of iPTH decrease, patients were divided into responder (n=47, 82.5%) and non-responder (n=10, 17.5%) groups. Among the responders, 38 achieved the primary end point, whereas 9 patients showed a reduction in serum iPTH of 30% or more, but did not reach the primary end point. Compared to non-responders, responders were significantly older (p=0.026), female (p=0.041), and diabetics (p<0.001). Additionally, early response was observed more frequently in the responders (30/47, 63.8%), of whom the majority (27/30, 90.0%) achieved the primary end point. Multivariate analysis showed that lower baseline iPTH levels [odds ratio (OR) 0.96, 95% confidence interval (CI) 0.93-0.99], the presence of diabetes (OR 46.45, CI 1.92-1125.6) and early response (OR 21.54, CI 2.94-157.7) were significant clinical factors affecting achievement of iPTH target. CONCLUSION: Cinacalcet was effective in most hemodialysis patients with refractory SHPT. The presence of an early response was closely associated with the achievement of target levels of iPTH.
Adult ; Aged ; Biomarkers, Pharmacological/blood ; Calcium/blood ; Female ; Humans ; Hyperparathyroidism, Secondary/*drug therapy ; Male ; Middle Aged ; Naphthalenes/adverse effects/*therapeutic use ; Parathyroid Hormone/*blood ; *Renal Dialysis ; Treatment Outcome

OBJECTIVETo assess the efficacy of dapoxetine on demand for premature ejaculation and provide evidence for clinical decision-making.

METHODSWe searched PubMed, Embase, BIOSIS Previews, Cochrane Library, CNKI Database and Wanfang Database for literature on dapoxetine on demand for premature ejaculation. We performed meta-analysis on the identified publications and evaluated its therapeutic efficacy based on the intravaginal ejaculatory latency time (IELT), patient-reported global impression of change (PGI), and composite PRO criteria for clinical benefit (CCCB).

RESULTSFour relevant studies were included involving 6 081 cases of premature ejaculation. Compared with the placebo controls, the patients treated with dapoxetine on demand showed significant improvement in IELT (WMD = 1.39, 95% CI [1.23, 1.55], P < 0.000 01), PGI (OR = 2.59, 95% CI [2.21, 3.04], P < 0. 000 01), and CCCB (OR = 2.59, 95% CI [1.98, 3.39], P < 0.000 01). There were significant differences between the 60 mg and 30 mg dapoxetine groups in IELT (WMD = 0.46, 95% CI [0.19, 0.74], P = 0.001 0) and PGI (OR = 1.32, 95% CI [1.06, 1.64], P = 0.01), but not in CCCB (OR = 1.39, 95% CI [0.90, 2.15], P = 0.13).

CONCLUSIONDapoxetine on demand can prolong IELT and improve PGI and CCCB, either at the dose of 60 mg or 30 mg, and has an even better efficacy in prolonging IELT and improving PGI at 60 mg.

Benzylamines ; therapeutic use ; Ejaculation ; Humans ; Male ; Naphthalenes ; therapeutic use ; Premature Ejaculation ; drug therapy ; Treatment Outcome

BACKGROUNDFungal keratitis is a rare but serious corneal disease that may result in loss of vision. The poor prognosis might be due to limited treatment option. This study aimed to evaluate the clinical efficacy of 0.25% terbinafine eye drops comparing with 5% natamycin suspension on fungal keratitis.

METHODSA retrospective clinical trial was performed on 90 patients presenting with direct smear and/or culture positive fungal keratitis at Beijing Tongren Hospital, Beijing, China from January 2006 to May 2008. Corneal ulcers were categorized as mild or severe. Forty-five patients were treated with topical terbinafine and the next 45 cases received topical natamycin hourly.

RESULTSFilamentous fungi were found in corneal scrapings among all 90 cases. Fungal cultures were positive in 64 patients (71%). Species of Fusarium and Aspergillus were the principal isolates. Forty (89%) patients showed favorable response to terbinafine, while forty-two (93%) patients exhibited favorable response to natamycin (P > 0.05). The mean course of treatment was significantly showed in the terbinafine treatment group than natamycin group ((26.5 +/- 11.2) days versus (19.3 +/- 6.4) days; P < 0.05). In terbinafine group, twenty patients with ulcers smaller than 4 mm had favorable outcome, while 20 of 25 patients with ulcers more than 4 mm in diameter had favorable response (P < 0.05). Twenty-seven patients with depth of infiltration less than half of stroma thickness had favorable response to terbinafine, while 13 of 18 patients with depth of infiltration more than half of stroma responded to terbinafine. This difference was statistically significant (P < 0.05).

CONCLUSIONSOur findings suggest that topical terbinafine is an effective antifungal drug for the management of filamentous mycotic keratitis, particularly in cases with smaller and shallower ulcers. Its mean duration of treatment was longer than natamycin.

Antifungal Agents ; therapeutic use ; Aspergillus ; isolation & purification ; physiology ; Fusarium ; isolation & purification ; physiology ; Humans ; Keratitis ; drug therapy ; microbiology ; Naphthalenes ; therapeutic use ; Natamycin ; therapeutic use ; Retrospective Studies ; Treatment Outcome

OBJECTIVETo assess the effectiveness and safety of the alphala/d blocker naftopidil in the treatment of benign prostatic hyperplasia (BPH) patients with overactive bladder (OAB) symptoms.

METHODSFifty BPH patients with OAB symptoms were treated with naftopidil at the dose of 25 mg/d for 6 weeks. A self-controlled clinical trial was conducted. The effectiveness and safety of the drug were observed by comparing the International Prostate Symptom Scores (IPSS), quality of life indexes (QOL), maximum urinary flow rates (Qmax) , average urinary flow rates (Qave), voiding volumes (VV), blood pressures (BP) and heart rates (HR) obtained before and after the treatment.

RESULTSAfter 6 weeks' medication, the 46 assessable cases showed an average decrease of 9.75 in IPSS (P < 0.01), 3.97 in voiding symptom score (P < 0.01), 5.78 in urinary storage symptom score (P < 0.01) and 1.95 in QOL (P < 0.01), and a mean increase of 4.29 ml/s in Qmax (P < 0.01), 3.75 ml/s in Qave (P < 0.01) and 55.12 ml/s in VV (P < 0.05). But no significant changes were observed in BP and HR. Only 1 patient (4.35%) experienced the adverse event of dizziness.

CONCLUSIONThe alphalA/D blocker naftopidil is both effective and safe in the treatment of BPH patients with OAB symptoms.

Adrenergic alpha-Antagonists ; therapeutic use ; Aged ; Humans ; Male ; Middle Aged ; Naphthalenes ; therapeutic use ; Piperazines ; therapeutic use ; Prostatic Hyperplasia ; complications ; drug therapy ; Urinary Bladder, Overactive ; complications ; drug therapy