ABSTRACT
Objective@#To observe the clinical effect and safety of Shanhaidan Granules (SHDG) combined with tadalafil tablets (TT) in the treatment of ED.@*METHODS@#In this open multi-center case-control clinical trial, we enrolled 247 ED patients according to the designed criteria, and treated them orally with SHDG at 10 g per time tid (n = 74), TT at 5 mg per time bid (n = 52), or SHDG + TT at the above doses (n = 121), all for 8 weeks. Before and after medication, we recorded the IIEF-6, erection hardness scores (EHS), traditional Chinese medicine syndromes (TCMS) scores, penile cavernous blood flow parameters and adverse reactions, and compared them between the 3 groups of patients.@*RESULTS@#After 8 weeks of treatment, all the patients showed significantly increased IIEF-6, EHS and TCMS scores in comparison with the baseline (P < 0.05). The total effectiveness rates in the SHDG, TT and SHDG + TT groups were 60.8%, 67.3% and 69.4% respectively based on the IIEF-6 scores, remarkably higher in the TT and SHDG + TT groups than in the SHDG group (P < 0.05), and 40.5%, 32.7% and 63.6% respectively according to the TCMS scores, markedly higher in the SHDG and SHDG + TT groups than in the TT group (P < 0.05). Single-center data manifested significantly increased peak systolic velocity (PSV) of the penile artery in the SHDG + TT and TT groups (P < 0.05). The improvement values of relevant parameters were remarkably higher in the SHDG + TT group than in the TT and SHDG groups, so were IIEF-6 scores in the TT than in the SHDG group, and TCM syndromes in the SHDG than in the TT group. No medication-related adverse events were found in any of patients after treatment, except for some mild side effects including muscle soreness and gastrointestinal reactions in a few cases, all soon relieved, none with abnormalities in blood and urine routine tests or hepatic and renal function indicators.@*CONCLUSIONS@#Shanhaidan Granules combined with tadalafil can significantly improve the erectile function and reduce TCM syndromes in ED patients, and therefore can be applied effectively and safely in clinical practice./.
Subject(s)
Humans , Male , Erectile Dysfunction/drug therapy , Medicine, Chinese Traditional , Penile Erection , Syndrome , Tadalafil/therapeutic useABSTRACT
Objective: To investigate the association between polymorphisms in methylenetetrahydrofolate reductase (MTHFR), serum homocysteine (HCY) concentration and outcome of assistant reproductive technology (ART). Methods: A retrospective study was conducted in 285 infertile couples who underwent ART. Sperm quality, serum HCY concentration and MTHFR genotype of the males in these couples were collected. According to the results of MTHFR C677T and serum HCY of males, they were divided into four groups, i. e, TT+high HCY, TT+normal HCY, NOT TT+high HCY, and NOT TT+normal HCY (as control). Results: There was no significant difference in the frequency distribution of oligoasthenozoospermia of four groups (P>0.05). The fertilization rates were significantly lower in patients with high plasma HCY levels (P0.05). Conclusion: High serum HCY of males may affect outcome of ART. The detection of MTHFR gene polymorphisms helps to remind supplement folic acid in time.