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重组结核杆菌融合蛋白的临床综合评价
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| 篇名： | 重组结核杆菌融合蛋白的临床综合评价 |
| TITLE： | Clinical comprehensive evaluation of recombinant Mycobacterium tuberculosis fusion protein |
| 摘要： | 目的 评价重组结核杆菌融合蛋白（EC）的有效性、安全性、经济性、创新性、适宜性和可及性，为遴选结核杆菌感染诊断和结核病辅助诊断的皮肤检测药品提供证据。方法采用系统评价法分析EC与结核菌素纯蛋白衍生物（TB-PPD）的有效性和安全性；以最小成本分析、成本-效果分析、成本-效用分析评价EC与TB-PPD的短期经济性，采用成本-效用分析评价两者的长期经济性；采用系统评价法、改良德尔菲专家咨询法确定创新性、适宜性和可及性评价的指标，通过各指标的权重计算EC和TB-PPD的各维度的综合评分。结果EC的有效性、安全性、经济性、创新性、适宜性评分均高于TB-PPD；两药的可负担性评分一致，EC的可获得性评分低于TB-PPD。考虑维度和指标权重后，EC的有效性、安全性、经济性、创新性、适宜性、可及性评分及其综合评分均高于TB-PPD。结论相较于TB-PPD，EC的有效性、安全性、经济性、创新性、适宜性和可及性均表现更优；但在可及性维度下，EC的可获得性应进一步改善。 |
| ABSTRACT： | OBJECTIVE To evaluate the effectiveness， safety， economy， innovation， suitability and accessibility of recombinant Mycobacterium tuberculosis fusion protein （EC）， and to provide evidence for selecting skin detection methods for tuberculosis infection diagnosis and auxiliary diagnosis of tuberculosis. METHODS The effectiveness and safety of EC compared with purified protein derivative of tuberculin （TB-PPD） were analyzed by the method of systematic review. Cost minimization analysis， cost-effectiveness analysis and cost-utility analysis were used to evaluate the short-term economy of EC compared with TB-PPD， and cost-utility analysis was used to evaluate the long-term economy. The evaluation dimensions of innovation， suitability and accessibility were determined by systematic review and improved Delphi expert consultation， and the comprehensive score of EC and TB-PPD in each dimension were calculated by the weight of each indicator. RESULTS The scores of effectiveness， safety， economy， innovation and suitability of EC were all higher than those of TB-PPD. The affordability scores of the two drugs were consistent， while the availability score of EC was lower than those of TB-PPD. After considering dimensions and index weight， the scores of effectiveness， safety， economy， innovation， suitability， accessibility and the comprehensive score of EC were all higher than those of TB-PPD. CONCLUSIONS Compared with TB-PPD， EC performs better in all dimensions of effectiveness， safety， economy， innovation， suitability and accessibility. However， it is worth noting that EC should further improve its availability in the dimension of accessibility. |
| 期刊： | 2023年第34卷第04期 |
| 作者： | 倪晓凤；刁莎；何思颐；焦雪峰；程晓；陈哲；刘峥；曾力楠；康德英；吴斌；万朝敏；应斌武；张慧；赵荣生；缪丽燕；王卓；李晓宇；刘茂柏；蔡本志；邱峰；孙峰；初乃惠；林明贵；沙巍；张伶俐 |
| AUTHORS： | NI Xiaofeng，DIAO Sha， HE Siyi，JIAO Xuefeng，CHENG Xiao，CHEN Zhe，LIU Zheng，ZENG Linan，KANG Deying，WU Bin， WAN Chaomin，YING Binwu，ZHANG Hui，ZHAO Rongsheng，MIAO Liyan，WANG Zhuo，LI Xiaoyu， LIU Maobai，CAI Benzhi，QIU Feng，SUN Feng，CHU Naihui，LIN Minggui，SHA Wei， |
| 关键字： | 重组结核杆菌融合蛋白；结核菌素纯蛋白衍生物；结核病；诊断药品；临床综合评价 |
| KEYWORDS： | recombinant Mycobacterium tuberculosis fusion protein； purified protein derivative of tuberculin； tuberculosis； |
| 阅读数： | 783 次 |
| 本月下载数： | 20 次 |
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