| Objective:To observe the clinical efficacy of Jianpi Qiwei Decoction for the treatment of impotence with spleen deficiency syndrome,explore its mechanism of action and safety.Furthermore,preliminary discussion of its mechanism of action.Methods s All the 126 patients meeting the eligibility criteria were randomly assigned,using random number table based on the temporary order of clinic visit,to the treatment group or control group each including 63 patients.The treatment group was treated with Jianpi Qiwei Decoction,the control group was treatment with Jianpi Pills,both groups were treated for 4 weeks.Defining the day of initial clinic visit as the start date of patient treatment and observation,the TCM syndromes score,IIEF-5 score,and PFI parameters(mean penile arterial flow velocity,RABFV).etc.,were recorded for both groups pre-treatment and at 4 weeks of treatment,so as to compare and evaluate the therapeutic effects and clinical efficacy in both groups.Results:(1)In the treatment group,among the 60 patients excluding the 3 dropouts,10 achieved recovery,16 were markedly effective,23 were effective,and 11 were ineffective;in the control group,among the 58 patients excluding the 5 dropouts,3 achieved recovery,8 were markedly effective,21 were effective,and 26 were ineffective,with statistically significant differences between the two groups(Z=-3.088,p=0.002<0.05.The treatment group was superior over the control group in total effective rate(81.67%vs.55.17%),with statistically significant difference between the two groups(χ2=9.618,P=0.002<0.05).(2)There were post-treatment decreases in TCM syndromes score in both groups,between the two groups and before treatment,P<0.05;the treatment group was superior in post-treatment TCM syndromes score(t=-3.279,P= 0.002).(3)There were post-treatment increases in IIEF-5 score in both groups,between the two groups and before treatment,P<0.05;the treatment group was superior in post-treatment IIEF-5 score(t=5.983,P = 0.000).(4)There were post-treatment increases in mean penile arterial flow velocity in both groups,between the two groups and before treatment,P<0.05;the treatment group was superior in post-treatment mean penile arterial flow velocity(t= 4.106,P =0.000).(5)There were post-treatment increases in RABFA in both groups,between the two groups and before treatment,P<0.05;the treatment group was superior in post-treatment RABFA(t=2.624,P= 0.011).(6)No significant effects on ECG or hepatic/renal function,etc.,were observed in either the treatment or control group.Conclusion:Jianpi Qiwei Decoction could effectively improve the patient’ erectile function.It has certain clinical significance for improving patients’ IIEF-5 score and adjusting PFI action.In addition,this study indicated that Jianpi Qiwei Decoction might act against impotence by regulating mean penile arterial flow velocity and RABFV,and no adverse reactions were observed throughout the treatment course,indicating its favorable safety profile.It is an effective prescription for the treatment of spleen deficiency syndrome in impotence. |
