Sanjie Milk The Addiction Tiegao Treatment Of Mammary Glands (qi Stagnation) Safety And Effectiveness Of Random Single-blind Multi-center Phase Ii Clinical Trial Report,

Objective : To study the clinical efficacy ,security and side effect of sanjierupi ointment in the treatment of hyperplasia of mammary glandMethods : This was a single blind,randomized /controlled ,multicenter trial. 240 cases were included.there were 235 cases in intention-to treat(ITT) and 232 cases in per-protocol popolation.the study group (ITT:n=117, PP:n=115) received sanjierupi ointment and the controll group(ITT:n=118, PP:n=117) were given sanjiezhitong plaster.the data of demology and state of illness in two groups had no statistical difference.Results : the value of synthesis curative effecy : In ITT ,the total effective percentage in the study group was 91.38% and 81.20% in the control group. In PP ,the numbers were 92.17% and 81.20% , they showed obvious statistical difference(ITT : X2=2.944 P=0.0032; PP : X2=3.066 P=0.0022) ; In ITT ,the percentage of recovery and obvious effect was 60.34% in the study group and 44.44% in the controll group.in PP, the numbers were 60.87% and 44.44% , there was statistical difference (ITT : CMH = 6.77 P = 0.0067 ;PP : CMH = 7.35 P = 0.0093) . the value of abolishing the bump of brest: In ITT ,the total effective rate of abolishing the bump of brest was 91.38% in the study group and 82.91 % in the controll group .In PP, the numbers were 92.17% and 82.91% , there was statistical difference (X2=2.887 P=0.0039 ; X2=3.013 P=0.0026 ) ; In ITT ,the rate of recovery andobvious effect was 68.10% in the study group and 52.99% in the controll group .In pp , the numbers were 68.70% and 52.99% , there wes statistical difference (CMH = 5.87 P = 0.0154; CMH = 6.48 P = 0.0109 ) . the value of abolishing the traditional medicinal certificate: In ITT ,the total effective rate of abolishing the traditional medicinal certificate was 90.52% in the study group and 82.91% in the controlled group. In PP , the numbers were 91.30% and 82.91% .there was no statistical difference ( ITT:X2=7.005 P=0.0717 ;PP:X2=7.713 P=0.0523) ; In ITT,the rate of recovery and obvious effect was 22.41% in the study group and 12.82% in the controll group .In pp , the numbers were 22.61% and 12.82% , there was statistical difference (CMH = 3.89 P=0.0485 CMH =4.07 P = 0.0436 ) . The analysis of securitycthe frequency of side effects in two groups had no statistical difference.Conclusion : Sanjierupi ointment is effective and safety in the treament of hyperplasia of mammary gland,the conclusion is awaiting to be confirmed by the third period clinical trail.