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中成药治疗慢性乙型肝炎的临床综合评价
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| 篇名： | 中成药治疗慢性乙型肝炎的临床综合评价 |
| TITLE： | Clinical comprehensive evaluation of Chinese patent medicine for the treatment of chronic hepatitis B |
| 摘要： | 目的 比较15种治疗慢性乙型肝炎中成药的临床综合价值，以期为临床合理用药提供参考。方法根据《药品临床综合评价管理指南（2021年版试行）》，采用系统文献综述、Meta分析及其他相关数据资料分析方法，对15种中成药的安全性、有效性、经济性、适宜性、可及性、创新性进行定性、定量分析。结果在安全性方面，大部分乙型肝炎中成药上市前的不良反应为尚未观察到或尚不明确；上市后安全性以核苷类似物为中间桥梁进行Meta分析，结果除扶正化瘀胶囊、复方益肝灵胶囊联用方案对比九味肝泰胶囊联用方案差异有统计学意义（P＜0.05）外，各中成药联用化药方案之间不良反应发生率结果差异无统计学意义（P＞0.05）。在有效性方面，网状Meta分析结果显示，绝大多数中成药如扶正化瘀胶囊联用方案等在有效率、乙型肝炎病毒e抗原转阴率、乙型肝炎病毒脱氧核糖核酸转阴率方面差异均无统计学意义（P＞0.05），但在降低肝脏弹性硬度值方面，当飞利肝宁片（胶囊）联用方案优于其余各联用方案（P＜0.05）。在经济性方面，成本最高的为舒肝宁注射液，最低的为乙肝清热解毒颗粒。在适宜性方面，大部分药品为胶囊剂、片剂和颗粒剂，仅需要密封保存，口服或开水冲服，相较于注射剂及一些需要严格控制储藏温度的同类型产品而言适宜性更优。在可及性方面，从药品价格及可负担性来看，舒肝宁注射液日均费用最高，需要日均工资负担天数最多，复方益肝灵片日均费用最低，需要日均工资负担天数最少；从可获得性来看，复方鳖甲软肝片、当飞利肝宁胶囊、五酯颗粒较易获得。在创新性方面，纳入研究的15种中成药均为国产药品，具有较为长期的中医药理论基础和人用药经验，产业创新性良好。其中，扶正化瘀片（胶囊）和安络化纤丸为中药保护品种；专利数较多的为扶正化瘀片（胶囊），有6项有效专利，且均为发明专利。结论五酯胶囊、垂盆草颗粒、复方益肝灵片、大黄䗪虫丸、当飞利肝宁胶囊具有较高的临床综合价值。 |
| ABSTRACT： | OBJECTIVE To compare the clinical comprehensive value of 15 Chinese patent medicines for the treatment of chronic hepatitis B， in order to provide reference for clinical rational drug use. METHODS According to the Management Guidelines for Clinical Comprehensive Evaluation of Pharmaceuticals （2021 Version for Trial Implementation）， systematic literature review， meta-analysis and other related data analysis methods were used to perform qualitative and quantitative analysis for the safety， efficacy， economy， suitability， accessibility and innovation of 15 Chinese patent medicines. RESULTS In terms of safety， most of the adverse drug reactions of chronic hepatitis B Chinese patent medicines before the market were unobserved or unclear； post-marketing safety took nucleoside analogs as the intermediate bridge for meta-analysis， there was no significant difference in the incidence of adverse drug reactions among the combined regimens of Chinese patent medicines （P＞0.05）， except that the combination regimen of Fuzheng huayu capsule， Compound yiganling capsules versus combination regimen of Jiuwei gantai capsules showed statistically significant differences （P＜0.05）. In terms of effectiveness， the results of network meta-analysis showed that most Chinese patent medicines， such as Fuzheng huayu capsules combined regimens， had no significant differences in effective rate， HBeAg negative conversion rate and HBV-DNA negative conversion rate （P＞0.05）； however， in reducing the liver elastic hardness value， the combined regimen of Dangfei liganning tablet （capsule） was better than the other combined regimens （P＜0.05）. In terms of economy， the highest cost was the Shuganning injection， and the lowest was Hepatitis B qingre jiedu granules. In terms of suitability， most of the medicines were capsules， tablets and granules， which only needed to be sealed to store and taken orally or taken with boiling water. Compared with injections and some similar products that required strict control of storage temperature， its suitability was better. In terms of accessibility， from the perspective of drug price and affordability， Shuganning injection had the highest average daily cost， the number of days that needed to be borne by the average daily wage was the highest； the average daily cost of Compound yiganling tablets was the lowest， and the number of days required to be borne by the average daily wage was the lowest. From the perspective of availability， Compound biejia ruangan tablets， Dangfei liganning capsules and Wuzhi granules were easier to obtain. In terms of innovation， the 15 Chinese patent medicines included in the study were all domestically produced medicines with a relatively long-term theoretical basis of traditional Chinese medicine and experience in human medicine， and had good industrial innovation. Among them， Compound huayu tablets （capsules） and Anluo huaxian pills were protected varieties of traditional Chinese medicine； Fuzheng huayu tablets （capsules） with more patents had 6 valid patents， all of which were patents for invention. CONCLUSIONS Wuzhi capsule， Sedum sarmentosum granules， Compound yiganling tablets， Rhubarb buchong pills and Dangfei liganning capsules have high clinical comprehensive value. |
| 期刊： | 2023年第34卷第05期 |
| 作者： | 睢淑莹；周一康；杨男；胡明 |
| AUTHORS： | SUI Shuying，ZHOU Yikang，YANG Nan，HU Ming |
| 关键字： | 慢性乙型肝炎；中成药；临床综合评价；合理用药 |
| KEYWORDS： | chronic hepatitis B； Chinese patent medicine； clinical comprehensive evaluation； rational drug use |
| 阅读数： | 637 次 |
| 本月下载数： | 10 次 |
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