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舍曲林与利福平治疗胆汁淤积性瘙痒的比较:一项随机临床试验。

Comparison of Sertraline with Rifampin in the treatment of Cholestatic Pruritus: A Randomized Clinical Trial.

作者信息

Ataei Sara, Kord Leila, Larki Amir, Yasrebifar Fatemeh, Mehrpooya Maryam, Seyedtabib Maryam, Hasanzarrini Maryam

机构信息

Department of Clinical Pharmacy, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan, Iran.

Department of Pharmacology and Toxicology, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan, Iran.

出版信息

Rev Recent Clin Trials. 2019;14(3):217-223. doi: 10.2174/1574887114666190328130720.

Abstract

BACKGROUND

Pruritus is one of the most common and disabling symptoms of liver disease such as Primary Sclerosing Cholangitis and Primary Biliary Cholangitis. Cholestyramine, rifampin, opioid antagonists, antihistaminic agents and SSRIs are used for the management of pruritus. Due to rifampin drug interactions as well as its serious side effects such as hepatotoxicity, clinicians are endeavoruing to find a safer and a more effective substitution.

OBJECTIVE

The purpose of this study was to compare the efficacy and safety of sertraline with rifampin in the management of cholestatic pruritus.

METHODS

In a single-blinded randomized clinical trial a total of 36 patients of PSC and PBC were divided into two equal groups, one group received 100 mg/day sertraline and the other group received rifampin 300 mg/day for 4 weeks. Visual analog scale was used to record pruritus severity at baseline and 4 weeks after drug intervention, also, ALT, AST, ALP and total bilirubin of all patients were measured at three different time points.

RESULTS

Over the follow-up period, pruritus had relieved in both groups, but there was no significant differences between sertraline and rifampin in pruritus management (pvalue=0.740), also there was no significant difference between the two intervention strategies (A versus B) in total bilirubin level (pvalue=0.106). Moreover, the ALT, AST and ALP levels were found to be significantly different between the two groups (Pvalue˂0.01).

CONCLUSION

There is no difference between sertraline and rifampin in pruritus improvement, but sertraline has less adverse effects on hepatobiliary enzyme levels, so it seems to be safer than rifampin.

摘要

背景

瘙痒是原发性硬化性胆管炎和原发性胆汁性胆管炎等肝病最常见且使人丧失能力的症状之一。考来烯胺、利福平、阿片类拮抗剂、抗组胺药和选择性5-羟色胺再摄取抑制剂(SSRI)用于治疗瘙痒。由于利福平存在药物相互作用及其严重副作用,如肝毒性,临床医生正努力寻找更安全、更有效的替代药物。

目的

本研究旨在比较舍曲林和利福平治疗胆汁淤积性瘙痒的疗效和安全性。

方法

在一项单盲随机临床试验中,共36例原发性硬化性胆管炎和原发性胆汁性胆管炎患者被分为两组,每组人数相等,一组接受每日100毫克舍曲林治疗,另一组接受每日300毫克利福平治疗,为期4周。采用视觉模拟量表记录药物干预前及干预4周后的瘙痒严重程度,同时在三个不同时间点测量所有患者的谷丙转氨酶(ALT)、谷草转氨酶(AST)、碱性磷酸酶(ALP)和总胆红素水平。

结果

在随访期间,两组瘙痒均有缓解,但舍曲林和利福平在瘙痒治疗方面无显著差异(p值=0.740),两种干预策略(A与B)在总胆红素水平上也无显著差异(p值=0.106)。此外,发现两组之间的谷丙转氨酶、谷草转氨酶和碱性磷酸酶水平存在显著差异(P值˂0.01)。

结论

舍曲林和利福平在改善瘙痒方面无差异,但舍曲林对肝胆酶水平的不良影响较小,因此似乎比利福平更安全。

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