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Taurodeoxycholic acid in the treatment of cholelithiasis: health technology assessment of effectiveness, safety and economics
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Hui-bo LI1, 2, Shuang LIU1, 2, You-fa QIN3, Suo-di ZHAI1, 2
Chinese Journal of New Drugs | 2021, 30(1) : 80 - 86
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Chinese Journal of New Drugs | 2021, 30(1): 80-86
Taurodeoxycholic acid in the treatment of cholelithiasis: health technology assessment of effectiveness, safety and economics
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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
Published: 2021-01-15
Outline
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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.

tauroursodeoxycholic acid  /  cholelithiasis  /  health technology assessment  /  rational drug use
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 .
Year 2021 volume 30 Issue 1
25
7
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  • Online Date:2026-10-29
  • Published:2021-01-15
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  • Accepted:2020-04-21
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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
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表12种不同金属材料的力学参数
科
Family
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Number of
genus
种数
Number of
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Number of
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Percentage of total
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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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