摘要
目的以肝功能检查指标变化为指征评价首荟通便胶囊用于预防肛肠术后便秘患者的安全性。方法选取2022-11-01-2023-05-30临沂市中医医院肛肠科住院手术后便秘并使用首荟通便胶囊治疗的125例患者作为研究对象,按年龄分为成年组(n=89)和老年组(n=36),基于真实世界研究方法,在不干预临床用药情况下对2组患者术前和术后的谷丙转氨酶(ALT)、谷草转氨酶(AST)、碱性磷酸酶(ALP)和总胆红素(TBIL)4项肝功能进行对比分析。结果应用首荟通便胶囊治疗术后便秘125例患者,未出现有自觉症状的不良反应发生。对用药前后4项肝功能指标检测发现,用药前2组患者ALT、AST、ALP和TBIL水平均在正常范围内。用药后,成年组和老年组ALT水平分别为(34.63±23.76)和(27.67±16.80)U/L,均高于用药前的(21.77±12.13)和(17.52±10.61)U/L,差异有统计学意义,t值分别为4.032和2.340,P值分别为<0.001和0.024;AST水平分别为(24.49±11.89)和(24.86±10.57)U/L,均高于用药前的(23.77±7.05)和(22.86±7.06)U/L,差异无统计学意义,t值分别为0.432和0.296,P值分别为0.666和0.475;ALP水平分别为(66.46±14.35)和(73.71±21.52)U/L,均低于用药前的(68.59±17.18)和(80.57±21.89)U/L,差异无统计学意义,t值分别为-0.778和-1.127,P值分别为0.438和0.312;TBIL水平分别为(8.77±3.95)和(7.42±2.74)μmol/L,均低于用药前的(13.09±5.34)和(12.78±4.54)μmol/L,差异有统计学意义,t值分别为-5.445和-4.626,均P<0.001。125例患者中仅有1例在用药后ALT>3倍正常值,达到肝功能异常判断标准。结论首荟通便胶囊用于治疗肛肠术后便秘患者的安全性较高,ALT异常升高可能与患者个体差异有关,还需大样本多中心的前瞻性研究进一步验证。
Objective To evaluate the safety of Shouhui Tongbian capsule for preventing postoperative constipation in patients with anorectal surgery by the changes of liver function test indicators.Methods A total of 125 patients admitted to the Proctology Department of Linyi Hospital of Traditional Chinese Medicine from November 1,2022 to May 30,2023 who were treated with Shouhui Tongbian capsule after surgery for constipation were selected as the study objects.They were divided into the adult group(n=89)and the elderly group(n=36)according to age.The liver functions of alanine aminotransferase(ALT),aspartate aminotransferase(AST),alkaline phosphatase(ALP)and total bilirubin(TBIL)in 2 groups were compared before and after operation without clinical medication intervention.Results Totally 125patients with postoperative constipation were treated with Shouhui Tongbian capsule,and no adverse reactions with conscious symptoms occurred.ALT,AST,ALP and TBIL levels were all within the normal range before and after treatment.After medication,ALT levels in the adult group and the elderly group were(34.63±23.76)and(27.67±16.80)U/L,respectively,higher than those before medication(21.77±12.13)and(17.52±10.61)U/L,and the difference was statistically significant(t values were 4.032 and 2.340,respectively,and the P values were<0.001 and 0.024,respectively).AST levels were(24.49±11.89)and(24.86±10.57)U/L,respectively,which were higher than those before treatment(23.77±7.05)and(22.86±7.06)U/L,with no statistically significant difference(The t values were 0.432 and 0.296,and the P values were 0.666 and 0.475,respectively).ALP levels were(66.46±14.35)and(73.71±21.52)U/L,respectively,which were lower than those before medication(68.59±17.18)and(80.57±21.89)U/L,with no statistical significance(t values were-0.778 and-1.127,respectively,and the P values were 0.438 and 0.312,respectively).TBIL levels were(8.77±3.95)and(7.42±2.74)μmol/L,respectively,which were lower than those before treatment(13.09±5.34)and(12.78±4.54)μmol/L,wit
作者
邱健珉
赵小燕
徐鹏
耿瑞金
陈亚飞
邢念国
卞瑞祺
刘安昌
QIU Jianmin;ZHAO Xiaoyan;XU Peng;GENG Ruijin;CHEN Yafei;XING Nianguo;BIAN Ruiqi;LIU Anchang(School of Pharmacy,ShandongUniversity,Jinan,Shandong 250012,China;Pharmacovigilance Center of Linyi City,Linyi,Shandong 276715,China;Department of Clinical Pharmacy,Linyi Hospital of Traditional Chinese Medicine,Linyi,Shandong 276037,China;Department of Pharmacy,Qilu Hospital of Shandong University,Jinan,Shandong 250063,China)
出处
《社区医学杂志》
CAS
2023年第24期1301-1304,共4页
Journal Of Community Medicine
基金
山东省药品不良反应监测中心项目(2022SDADRKY22)。
关键词
肛肠疾病
首荟通便胶囊
安全性评价
肝功能
anorectal diseases
Shouhui Tongbian capsule
safety evaluation
liver function
