中国新药杂志

牛磺熊去氧胆酸治疗胆石症有效性、安全性和经济性的卫生技术评估

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李慧博 ¹^,² , 刘爽 ¹^,² , 秦又发 ³ , 翟所迪 ¹^,²

中国新药杂志 | 药物安全与合理应用 2021,30(1): 80-86

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中国新药杂志 |药物安全与合理应用 2021 , 30 (1) : 80 -86

牛磺熊去氧胆酸治疗胆石症有效性、安全性和经济性的卫生技术评估

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李慧博¹^,², 刘爽¹^,², 秦又发³, 翟所迪¹^,²

作者信息

¹北京大学第三医院药剂科，北京　100191

²北京大学医学部药物评价中心，北京　100191

³东莞市第三人民医院药学部，东莞　523326

通讯作者:

翟所迪，男，主任药师，教授，主要从事循证药物评价工作。联系电话：（010）82266686，E-mail：zhaisuodi@163.com。

作者简介:

李慧博，女，主管药师，主要从事循证药学、个体化药物治疗和治疗药物监测的研究等工作。联系电话：（010）82265740，E-mail：lihuibo@bjmu.edu.cn。

Taurodeoxycholic acid in the treatment of cholelithiasis: health technology assessment of effectiveness, safety and economics

Hui-bo LI¹^,², Shuang LIU¹^,², You-fa QIN³, Suo-di ZHAI¹^,²

Affiliations

¹Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China

²Institute for Drug Evaluation, Peking University Health Science Center, Beijing 100191, China

³Department of Pharmacy, Dongguan Third People's Hospital, Dongguan 523326, China

出版时间: 2021-01-15

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摘要

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目的：

基于卫生技术评估（HTA）方法，系统评价牛磺熊去氧胆酸（TUDCA）治疗胆石症的有效性、安全性和经济性。

方法：

计算机系统检索PubMed，Embase，the Cochrane Library，CNKI和万方数据库，以及检索国内外HTA数据库与官方网站，纳入TUDCA治疗胆石症的HTA报告、系统评价、随机对照试验（RCT）和药物经济学研究，对检索结果进行荟萃分析或描述性分析。

结果：

纳入RCT研究4篇，经济学研究1篇。文献总体质量良好。与熊去氧胆酸（UDCA）或安慰剂相比，TUDCA治疗3~4个月后，显效率高于对照组[RR=3.60，95%CI（1.56~8.29），P=0.003]，有效率高于对照组[RR=5.24，95%CI（2.67~10.26），P<0.000 01]，无效率更低[RR=0.19，95%CI（0.10~0.37），P<0.000 01]。与UDCA相比，TUDCA治疗6个月后，显效率和总有效率稍微高于对照组[RR=1.54，95%CI（0.88~2.72），P=0.13]及[RR=1.66，95%CI（0.93~2.96），P=0.09]，治疗无效率更低[RR=0.60，95%CI（0.34~1.08），P=0.09]。TUDCA安全性良好，无严重不良反应发生。对于非手术胆石症患者，TUDCA费用高（ΔC=3 876.08），但疗效比UDCA更好（ΔE=24.98%），ICER=15 504.32。相比UDCA方案，TUDCA预防保胆取石术后胆结石复发ΔC=-1 742.05和增量产出ΔU=0.22 QALYs，ICER=-7 975.26元·QALD^-1，具有绝对经济性优势。

结论：

TUDCA治疗胆石症具有良好的有效性和安全性，与UDCA相比，TUDCA治疗胆石症具有良好的经济性，在我国的使用具有一定的成本效果。由于只纳入4篇TUDCA与UDCA或安慰剂比较的研究，因样本量较小和研究方法的局限性，本研究结果存在偏倚的风险。

关键词

牛磺熊去氧胆酸 / 胆石症 / 卫生技术评估 / 合理用药

Abstract

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Objective:

To systematically evaluate the effectiveness, safety and economics of taurodeoxycholic acid (TUDCA) in the treatment of cholelithiasis based on the health technology assessment (HTA) method.

Methods:

The HTA reports, systematic reviews, randomized controlled trials and pharmacoeconomic researches were retrieved from PubMed, Embase, Cochrane Library, CNKI and Wanfang databases, as well as the HTA organization databases and websites. A Meta-analysis or descriptive analysis on the search results were performed.

Results:

Four RCT studies and one economic study were included in this study. The literature is generally of good quality. Compared with ursodeoxycholic acid (UDCA) or placebo, after TUDCA treatment for 3 to 4 months, the apparent efficiency rate was higher than the control group [RR=3.60, 95%CI (1.56 to 8.29), P=0.003], and the effective rate was also higher than the control group [RR=5.24, 95%CI (2.67~10.26), P<0.000 01], the inefficiency rate is lower [RR=0.19, 95%CI (0.10~0.37), P<0.000 01]. Compared with UDCA, the apparent and total effective rates were slightly higher than those in the control group after 6 months of treatment with TUDCA [RR=1.54, 95%CI (0.88~2.72), P=0.13] and [RR=1.66, 95%CI (0.93~2.96), P=0.09], the treatment inefficiency was lower [RR=0.60, 95%CI (0.34~1.08), P=0.09]. TUDCA has a good safety without serious adverse reactions occurred during the treatment. For patients with non-surgical cholelithiasis, TUDCA is expensive (ΔC=3 876.08), but more effective than UDCA (ΔE=24.98%, ICER=15 504.32). Compared with the UDCA, TUDCA has an absolute economic advantage in preventing gallstone recurrence (△C=-1 742.05) and incremental output (△U=0.22 QALYs, ICER=-7 975.26 yuan/QALD).

Conclusions:

TUDCA has good efficacy and safety in treating cholelithiasis. Compared with UDCA, TUDCA was relatively more cost-effective in treating cholelithiasis. Since only 4 studies comparing TUDCA with UDCA or placebo were included, the results of this study are at risk of bias due to the small sample size and limitations of the research methods.

Key words

tauroursodeoxycholic acid / cholelithiasis / health technology assessment / rational drug use

引用本文

李慧博, 刘爽, 秦又发, 翟所迪. 牛磺熊去氧胆酸治疗胆石症有效性、安全性和经济性的卫生技术评估. 中国新药杂志, 2021 , 30 (1) : 80 -86 .

Hui-bo LI, Shuang LIU, You-fa QIN, Suo-di ZHAI. Taurodeoxycholic acid in the treatment of cholelithiasis: health technology assessment of effectiveness, safety and economics[J]. Chinese Journal of New Drugs, 2021 , 30 (1) : 80 -86 .

基金

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北京医卫健康公益基金(YWJKJJHKYJJ-B17765)

参考文献

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2021年第30卷第1期

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首发时间：2026-10-29
出版时间：2021-01-15

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录用日期：2020-04-21

基金

北京医卫健康公益基金(YWJKJJHKYJJ-B17765)

作者信息

¹北京大学第三医院药剂科，北京　100191

²北京大学医学部药物评价中心，北京　100191

³东莞市第三人民医院药学部，东莞　523326

通讯作者:

翟所迪，男，主任药师，教授，主要从事循证药物评价工作。联系电话：（010）82266686，E-mail：zhaisuodi@163.com。

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https://castjournals.cast.org.cn/joweb/zgxyzz/CN/1322626711653565358

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2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
鹅膏菌科Amanitaceae	2	11	5.26	鹅膏菌属 Amanita	10	4.78
小菇科 Mycenaceae	2	12	5.74	丝盖伞属 Inocybe	5	2.39
多孔菌科 Polyporaceae	8	14	6.70	蜡蘑属 Laccaria	5	2.39
红菇科 Russulaceae	3	23	11.00	小皮伞属 Marasmius	6	2.87
				小菇属 Mycena	11	5.26
				光柄菇属 Pluteus	5	2.39
				红菇属 Russula	17	8.13
				栓菌属 Trametes	5	2.39

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