普鲁卡因青霉素G阻断梅毒母婴垂直传播的等效性和非劣效性评价  

EQUIVALENCE AND NON-INFERIORITY EVALUATION OF EFFECT OF PROCAINE PENICILLIN G ON BLOCKING MOTHER TO CHILD SYPHILIS TRANSMISSION.

作　　者：徐继建[1] 文立章[1] 赖永珲[1] 林丽君[1] 

机构地区：[1]深圳市慢性病防治院,深圳518020

出　　处：《现代预防医学》2006年第8期1333-1335,1341,共4页Modern Preventive Medicine

基　　金：深圳市科技基金项目(200404004)

摘　　要：目的:对普鲁卡因青霉素G治疗妊娠梅毒,阻断梅毒垂直传播及改善妊娠结局等临床疗效进行等效性和非劣效性评价,为临床提供指导。方法:严格按纳入和排除标准,纳入研究对象145例,随机分组,完成临床观察者共129例,其中普鲁卡因青霉素G组61例,苄星青霉素G组68例。采用随机对照设计,以苄星青霉素G为阳性对照药物,观察普鲁卡因青霉素G治疗妊娠梅毒的有效性并进行等效性和非劣效性检验。结果:非劣效性界值δ取对照组各率的20%,进行单侧u检验;以梅毒垂直传播有效阻断率为评价指标时,u=2.5794,u>δ且P=0.0049,有统计学意义;以正常出生率为评价指标时,u=1.7793,u>δ且P=0.0376,有统计学意义。等效性界值δ取对照组各率的20%,进行双单侧u检验(two one-side u test);以梅毒垂直传播有效阻断率为评价指标时,u1=3.1031,u2=2.5794,即u1和u2均大于δ,且P1=0.0010,P2=0.0049,有统计学意义。以正常出生率为评价指标时,u1=2.4866,u2=1.7793,即u1和u2均大于δ,且P1=0.0064,P2=0.0376,P2>0.025,无统计学意义。结论:本研究表明,以梅毒垂直传播有效阻断率为评价指标,普鲁卡因青霉素G治疗妊娠梅毒与苄星青霉素G等效。以正常出生率为评价指标时,普鲁卡因青霉素G治疗妊娠梅毒非劣效于苄星青霉素G,但是,尚不能认为普鲁卡因青霉素G与苄星青霉素G等效。Objective： To carry out Equivalence and non- inferiotity evaluation of the effect of procaine penicillin G treatment in pregnant syphilis on blocking vertical transmission for improving pregnancy outcome and other clinical treatment results, and to provide guidance for clinical practice. Methods. According to rigourous selection criteria, 145 research subjects were enrolled randomly. 129 of them completed clinical observation; 61 received procaine penicillin G treatment, 68 received benzathine penicillin treatment. A randomized control trial was practise, with benzathine penicillin as a control medicine. The effectiveness of procaine penicillin G treatment in pregnant syphilis was observed and Equivalence and non- inferiority test were carried out. Results： Non - inferiority margin δ is define as 20% of the sample rate of control group, a one- side u test was carried out; when the effectiveness rate of blocking vertical syphilis transmission is used as the indicator, u = 2.5794, u 〉δ, P = 0.0049, it is statistical significant; when normal birth rate is as the indicator, u = 1.7793, u 〉 δ,P = 0. 0376, it is statistical significant. Equivalence margin δ is define as 20 % of the sample rate of control group, a two one- side u test was carried out; when the effectiveness rate of blocking vertical syphilis transmission is used as the indicator, u1 = 3.1031, u2 = 2.5794, u1 〉δ and u2 〉δP1 = 0.0010, P2 = 0.0049, it is statistical significant; when normal birth rate is as the indicator, u 1 = 2.4866, u2 = 1.7793, u 1 〉 δand u2 〉 δ, P1 = 0.0064, P2=0.0376, P2〉0.025, it is not statistical significance. Conclusion： This study shows that when the blocking rate of vertical syphilis transmission is used as the indicator, both procaine penicillin G and benzylpenecillin are equivalent. Using normal birth rate as the indicator, procaine penicillin G treatment of pregnant syphilis is not less effective than benzylpenecillin; however, It cannot be concluded that the effectiveness of procaine penicillin G

关 键 词：普鲁卡因青霉素G 妊娠梅毒 垂直传播 等效性检验 非劣效性检验 

分 类 号：R759.1[医药卫生—皮肤病学与性病学]