S-腺苷蛋氨酸改善妊娠肝内胆汁淤积症患者妊娠结局的评价

Systematic Review of Effects for S-Adenosyl-L-Methionin on Improving the Pregnancy Outcomes of Intrahepatic Cholestasis of Pregnancy

目的 评价S 腺苷蛋氨酸改善妊娠肝内胆汁淤积症患者妊娠结局的作用。方法 计算机检索MED LINE、EMBASE、中国循证医学数据库 /Cochrane中心数据库 (CEBM/CCD)、Cochrane图书馆 (2 0 0 3年 4期 )、中国医院数字图书馆和中国数字化期刊万方数据库 ,手工检索有关S 腺苷蛋氨酸治疗妊娠肝内胆汁淤积症的中英文随机和半随机临床对照试验 ,检索截止时间为 2 0 0 3年 12月。在严格质量评价的基础上 ,利用RevMan 4. 2软件进行Meta分析。结果 共检索到符合纳入标准的文献 8篇 ,包括随机对照试验 2篇 ,半随机对照试验 6篇 ,共有研究对象 4 2 4例。所有纳入研究的方法学质量均不高。Meta分析结果显示 ,S 腺苷蛋氨酸改善妊娠肝内胆汁淤积症患者妊娠结局的作用如下 :①降低剖宫产率 :与安慰剂比较差异无统计学意义 [OR =1 .0 0 ,95 %CI (0. 2 3,4. 33) ,P =1. 0 0 ];与地塞米松组及强力宁比较差异有统计学意义 ,其OR (95 %CI)和P值分别为 0. 4 4 (0. 2 3,0 . 85 ) ,P =0 .0 1;0 .2 8(0 . 10 ,0. 75 ) ,P =0 .0 1)。②延长孕周 :与安慰剂比较差异无统计学意义 [WMD =0. 70 ,95 %CI(=0. 6 9,2 .10 ) ,P=0 . 32 ];而与地塞米松、强力宁、肝益灵相比差异有统计学意义 ,其WMD(95 %CI)值和P值分别为 1. 10

Objective To assess the efficacy and safety of S adenosyl l methionine (SAMe) for outcome improvement of intrahepatic cholestasis of pregnancy Methods Randomized controlled trials (RCT) and quasi randomized controlled trials were identified from MEDLINE (1983 to 2003), The Cochrane Library (Issue 4,2003)、EMBASE (1980 to 2003), China Hospital Digital Library (CHDL) and Wanfang data (1994 to 2003). We also handsearched the relative references Two researchers evaluated the quality of the trials and extracted the data independently RevMan software 4 2 was used for meta analysis Results Eight studies involving 424 pregnant women were included The following data were the results of meta analysis of SAMe for improvements: ① Reducing cesarean section ratio: no significant difference was seen between SAMe and placebo groups with OR 1 00, 95%CI 0 23 to 4 33 and P= 1 00; significant differences were seen SAMe versus dexamethasone and SAMe versus Dianglining with OR 0 44, 95%CI 0 23 to 0 85 and P=0 01; OR 0 28 95%CI 0 10 to 0 75 and P=0 01 respectively。② Prolonging the period of pregnancy: SAMe had no significant difference compared with placebo groups with WMD=0 70, 95%CI -0 69 to 2 10, P=0 32 SAMe was more effective than dexamethasone, Ganyinling and Qianglining on prolonging the period of pregnancy with WMD=1 10,95%CI 0 46 to 1 74, P=0 000 07; WMD=2 50,95%CI 1 86 to 3 14, P≤0 000 01; WMD=2 20,95%CI 1 61 to 2 79, P≤0 000 01 respectively;③ Increasing the weight of the newborn: meta analysis showed that SAMe group had not significant difference compared with placebo group on increasing the weight of the newborn with WMD=26 27,95%CI 338 35 to 285 82, P=0 87 Significant differences were seen between SAMe and dexamethasone, SAMe and Ganyiling, SAMe and Qiangling with WMD=386 86,95%CI 134 41 to 603 31, P=0 002; WMD=410 00,95%CI 321 10 to 498 90, P≤0 000 01 respectively ④ Fetal distress: There was no significant difference compared with dexamethasone and Kuhuang groups on decreasing the fetal distress with OR=0 47, 95%CI 0 14 to 1 16,P=0 23; OR=0 44, 95%CI 0 10 to 1 97, P=0 29 respectively;⑤ Decreasing pollution of amniotic fluid: no significant differences were seen in SAMe versus dexamethasone, SAMe versus ursoddeoxycholic and SAMe versus Kuhuang with OR=0 46, 95%CI 0 21 to 1 02,P=0 06; OR=0 68, 95%CI 0 20 to 2 31,P=0 53; OR=0 82 95%CI 0 24 to 2 81,P=0 75 recpectively ⑥ born stifile: SAMe group had no significant difference compared with dexamethasone and Kuhuang groups on decreasing the born stifile with OR=0 19, 95%CI 0 01 to 4 06,P=0 29;OR=0 31, 95%CI 0 08 to 1 13,P=0 08 respectively Compared with Qianglining group, SAMe group had better effect on reducing ratio of newborn stifile with OR=0 09, 95%CI 0 02 to 0 42, P=0 002 ⑦ Improving Apgar scores: no significant differences were seen between SAMe and placebo, dexamethasone and ursoddeoxycholic with OR=0 25, 95%CI 0 02 to 3 04,P=0 28; OR=2 09, 95%CI 0 70 to 6 27,P=0 19; OR=1 22, 95%CI 0 35 to 4 19,P=0 75 respectively Six RCTs mentioned the side effects of S adenosy l methionine, only one RCT reported mild gastrointestinal irritation Conclusions SAMe is partly effective on improving the pregnancy outcomes of intrahepatic choletasis of pregnancy, such as reducting cesarean section ratio, prolonging the period of pregnancy and increasing the weight of the newborn The specified efficacy and safety of SAMe require rigorously designed, randomized, double blind and placebo controlled trials to offer evidence