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 Newborn stifile: SAMe group had no significant difference compared with dexamethasone and Kuhuang groups on decreasing the Newborn 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.
目的 观察糖皮质激素对胎盘组织促肾上腺皮质激素释放激素（CRH）的分泌水平的影响。 方法 收集2006年1月－3月住院分娩的正常妊娠妇女的胎盘组织与妊娠肝内胆汁淤积症（ICP）患者胎盘及其血清各10例。分3组进行胎盘组织培养，即正常胎盘组、ICP胎盘组，正常胎盘组织加ICP患者血清组，分别用放射免疫法测定各组加与不加地塞米松胎盘组织培养液中CRH的水平。 结果 正常组与正常胎盘加地塞米松组培养24、48、72、96 h其CRH分泌水平分别为：（74.81 ± 27.92）、（63.71 ± 24.72）、（91.87 ± 41.64）、（98.90 ± 42.52） pg/mL；（66.94 ± 29.62）、（77.39 ± 31.84）、（61.89 ± 33.94）、（75.13 ± 36.98） pg/mL，两组比较差异有统计学意义（P＞0.05）。ICP组与ICP加地塞米松组培养上清液中CRH水平在24、48、72、96 h其CRH分泌水平分别为：（48.28 ± 16.56）、（60.20 ± 29.97）、（72.92 ± 31.65）、（69.22 ± 29.33）pg/mL；（41.81 ± 25.00）、（57.36 ± 39.75）、（57.72 ± 23.29）、（61.43 ± 20.77）pg/mL, 两组比较差异有统计学意义（P＞0.05）；正常胎盘加ICP血清培养组与正常胎盘加ICP血清加地塞米松培养组上清液中CRH水平在24、48、72、96 h其CRH分泌水平分别为：（84.9 ± 34.98）、（74.5 ± 29.93）、（71.1 ± 27.26）、（81.0 ± 37.18）pg/mL；（76.29 ± 33.11）、（63.70 ± 24.20）、（64.85 ± 28.39）、（67.65 ± 33.20）pg/mL，两组比较差异有统计学意义（P＞0.05）。3组加入地塞米松培养的胎盘组织，CRH分泌水平并无明显改变。 结论 地塞米松不影响体外培养胎盘组织CRH分泌。
【摘要】 目的 观察妊娠肝内胆汁淤积症（intrahepatic cholestasis of pregnancy，ICP）患者血清对体外培养的胎盘组织促肾上腺皮质激素释放激素（corticotropin-releasing hormone，CRH）的分泌水平的影响。 方法 收集2005年3月-7月在四川大学华西第二医院产科住院分娩的正常妊娠妇女胎盘组织及其血清（对照组）与ICP患者血清（ICP组）各10例。通过胎盘组织培养及放射免疫法测定其培养液中CRH水平。 结果 ICP组胎盘组织CRH分泌水平低于对照组，ICP组24、48、72、96 h分别为（84.95±34.98）、（74.57±29.93）、（71.16±27.26）、（81.07±37.18） pg/mL；对照组分别为（103.74±30.85）、（108.27±23.77） 、（109.20±23.81）、（118.15±26.84） pg/mL。两组比较，48h后差异有统计学意义（Plt;0.05）。 结论 ICP患者血清对体外培养的胎盘组织CRH分泌有抑制作用。【Abstract】 Objective To observe the effect of serum of pregnant patients with intrahepatic cholestasis (ICP) on the excretion level of corticotrophin-releasing hormone in the placental tissue in vitro. Methods Serum from 10 patients with ICP (ICP group) and from the healthy placental tissue of 10 normal people (control group) were collected from March to July, 2005. Cell culture and radioimmunoassay methods were used to investigate the corticotropin-releasing hormone (CRH) levels in placental tissue. Results The level of CRH in human placental tissue treated with sera of ICP was lower than that in the control group. 24, 48, 72, and 96 hours after treated with the serum, the levels of CRH in the ICP group were (84.95±34.98), (74.57±29.93), (71.16±27.26), and (81.07±37.18) pg/mL, respetively;while in the control group were (103.74±30.85), (108.27±23.77), (109.20±23.81), and (118.15±26.84) pg/mL, respectively. There was significant difference in the levels of CRH between ICP group and control group 48 hours after the culture (Plt;0.05). Conclusion The serum from the patients with ICP may inhibit the excretion of CRH in the placental tissue.