Clinical Study Of Different Doses And Frequencies Of Sildenafil In The Treatment Of Erectile Dysfunction

Objective: In this study,we analyzed the patients with erectile dysfunction who received different doses of sildenafil in our hospital,and compared the differences in treatment effect and safety between different groups.Meantime,combined with relevent literature,we explore more optimal medication regimens,so as to provide a reference for the treatment of erectile dysfunction.Methods: A total of 120 ED patients who were admitted to our hospital from January 2018 to November 2018 were recruited.All patients met the inclusion criteria and exclusion criteria.All patients were randomly assigned to the following sildenafil citrate treatment group.group A: on time(25mg / day),group B: as needed(50mg,taken irregularly half an hour before each sex life),group C: regular 1 group(25mg /day,as needed 50 mg before sex),group D: regular 2 groups(100 mg / time).All patients received 8-week treatment with their respective regimens.The patients were followed up at the beginning(t1),the 8th week(t2)and the 16 th week(t3).The follow-up indexes were the five-item International Index of Erectile Function(IIEF-5),Erection Hardness Scale(EHS)and Sexual encounter profile(SEP2/3).During the trial,the adverse was observed and recorded in detail.Result: A total of 120 ED patients were enrolled in this study.A total of 111 patients were followed up(9 were lost to follow-up).IIEF-5 score: Group A patients’ IIEF-5 scores at t1,t2 and t3 were 9.73 ± 5.25,15.19 ± 5.14,and 12.42 ± 5.27,respectively;At t1,t2 and t3 Group B patients’ IIEF-5 scores were 10.79 ± 4.54,15.25± 4.92,12.29 ± 4.85,respectively;Group C patients’ IIEF-5 scores at the same time were 8.76 ± 4.06,16.62 ± 4.92,13.07 ± 4.77,respectively;Group D patients’ IIEF-5scores were 10.29 ± 4.54,17.71 ± 5.83,14.50 ± 5.51,respectively.There was significant difference in the scores before and after treatment in the same group.Improvement of IIEF-5 score compared with baseline: The score at t2 was significantly different between group B and group C(4.0 vs 8.0,adjusted P = 0.003),and between group B and group D(4.0 vs 7.0,adjusted P = 0.01).At t3 The score wassignificantly different between group B and group C(1.0 vs 5.0,adjusted P < 0.001),and between group B and group D(1.0 vs 3.5,adjusted P < 0.001).The effective rate:At t3,it was found that there was significant difference between group B and group C(10.7% vs 62.1%,P < 0.05),between group B and group D(10.7% vs 62.1%,P <0.05).EHS(1/2/3/4): The EHS grade of group A was 11/9/6/0,0/6/8/12 and 3/11/10/2at t1,t2 and t3,respectively;The EHS grade of group B was 6/16/6/0,1/8/11/8 and3/15/7/3 at t1,t2 and t3,respectively;The EHS grade of group C at t1,t2 and t3 was14/9/6/0,0/3/11/15 and 2/9/11/7;The EHS grade of group D at t1,t2 and t3 was8/10/0,0/4/5/19 and 0/9/10/9,respectively.The same group had significant differences in EHS grade before and after treatment.At the same time,the difference between group B and D was significant at t2(P = 0.025);The difference between group B and group D was significant at t3(P = 0.036).SEP-2: Compared with the baseline,the change of SEP-2 positive response rate in group A was statistically significant at t2(76.9% vs 42.3%,P < 0.05).The changes of SEP-2 positive response rate in group C and group D at t2 and t3 were statistically significant(86.2%/69.0% vs44.8%;78.6%/60.7% vs 39.3%,P < 0.05).SEP-3: Compared with the baseline,the change of SEP-3 positive response rate in group A and group B was statistically significant at t2(76.9% vs 42.3%;57.1% vs10.7%,P < 0.05).The changes of SEP-3positive response rate in group C and group D at t2 and t3 were all statistically significant(72.4%/44.8% vs 6.9%;67.9%/53.6% vs 28.6%,P < 0.05).There was significant difference at t3 between group B and group D(53.6% vs 17.9%,P < 0.05).Adverse: During the trial,patients in groups A,B,C and D had transient adverse effect such as headache,blurred vision,nasal congestion and back pain,which did not affect the treatment.Conclusion: All four regimens of oral sildenafil have good clinical effects during the period of treatment.Oral sildenafil 100 mg twice a week,25 mg per day +50 mg as needed could maintain clinical efficacy after a period of withdrawal and all of them were superior to 50 mg as needed.Oral sildenafil 25 mg per day + 50 mg as needed can be used as a new safe and effective treatment regimen.