思美泰联合熊去氧胆酸治疗重度妊娠期肝内胆汁淤积症的临床疗效研究

Efficacy of Transmetil Combined with Ursodeoxycholic Acid in the Treatment of Severe Intrahepatic Cholestasis of Pregnancy

目的比较单用思美泰与联合熊去氧胆酸治疗重度妊娠期肝内胆汁淤积症(ICP)的临床疗效。方法选取2005年1月—2009年6月在我院住院治疗的重度ICP患者32例,根据随机数字表法随机分为A、B两组。A组15例,采用思美泰1 000 mg静脉滴注,1次/d,联合口服熊去氧胆酸300 mg,2次/d;B组17例,采用思美泰1 000mg静脉滴注,1次/d。两组均同时给予ICP的常规治疗及监护。比较两组受试者治疗前及治疗后3 d、7 d各项生化指标〔总胆汁酸(TBA)、血清总胆红素(TB)、直接胆红素(DB)、血清丙氨酸氨基转移酶(ALT)、门冬氨酸氨基转移酶(AST)〕水平、皮肤瘙痒情况、妊娠结局及围产儿情况。采用的统计分析方法有t检验、χ2检验。检验水准为α=0.05。结果 A、B两组瘙痒评分、TBA、TB、DB、ALT、AST治疗7 d后与治疗前比较,差异均有统计学意义(P<0.05)。B组瘙痒评分治疗3 d、7 d后与治疗前差值的比较,差异无统计学意义(t=1.793,P=0.068),余五项指标及A组的各项指标变化差异均有统计学意义(P<0.05)。在治疗3 d后两组间比较,差异无统计学意义(P>0.05)。治疗7 d后与治疗前瘙痒评分、TBA、ALT、AST差值两组间比较,差异有统计学意义(P<0.05)。妊娠结局中两组的分娩孕周及新生儿体质量比较,差异有统计学意义(P<0.05)。结论单用思美泰治疗重度ICP有一定疗效,但与联合熊去氧胆酸治疗相比,后者更安全有效。

Objective To compare the efficacy of Transmetil（ademetionine） alone and Transmetil combined with ursodeoxycholic acid（UDCA） in the treatment of severe intrahepatic cholestasis of pregnancy（ICP）.Methods A total of 32 patients who were admitted to our hospital for severe ICP between January 2005 and June 2009 were randomly divided into two groups using random number table.Patients in group A（n=15） were given intravenous injection of 1 000 mg Transmetil once a day plus oral admission of 300 mg UDCA twice a day.Patients in Group B（n=17） were only given intravenous injection of 1 000 mg Transmetil once a day.Conventional treatment and care for ICP were given to both groups.Biochemical index（TBA,TB,DB,ALT,and AST） level,pruritus,pregnancy outcome,and perinatal infant conditions of the two groups were recorded and compared at day 0,day 3 and day 7.T test and chi-square test were used.P0.05 was considered statistically significant.Results The differences of pruritus score,levels of TBA,TB,DB,ALT,and AST were significant at day 7 compared to day 0 in both groups（P0.05）.The pruritus score,levels of TBA,TB,DB,ALT,and AST at day 3 and day 7 showed significant difference in both groups（P0.05） except for the pruritus score change in group B（t=1.793,P=0.068）.No significant difference of pruritus score and biomedical index levels was observed between the two groups at day 3（P0.05）.Pregnant week and newborn body weight were significantly different between the two groups（P0.05）.Conclusion Transmetil combined with UDCA is safer and more effective than Transmetil alone in the treatment of severe ICP.