中国新药杂志

柴胡疏肝散配方颗粒与饮片治疗慢性乙肝疗效比较

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梅雪 ¹ , 唐兴 ² , 徐兴培 ³ , 段定山 ⁴ , 余葱葱 ⁵^,^*

中国新药杂志 | 临床研究 2026,35(13): 1403-1408

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中国新药杂志 |临床研究 2026 , 35 (13) : 1403 -1408

柴胡疏肝散配方颗粒与饮片治疗慢性乙肝疗效比较

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梅雪¹, 唐兴², 徐兴培³, 段定山⁴, 余葱葱⁵^,^*

作者信息

¹四川省林业中心医院，成都 610081

²四川省中医药转化医学中心，成都 610041

³剑阁县中医医院，广元 628300

⁴青白江区中医医院，成都 610300

⁵四川省中西医结合医院，成都 610041

通讯作者:

^* 余葱葱，男，主任中药师，主要从事中西医结合干预亚健康、临床药学与药品研究。E-mail: ycc71@163.com。

作者简介:

梅雪，女，主管药师，主要从事临床药学评价研究。E-mail: 165595942@QQ.com。

Comparative efficacy of Chaihu Shugan San formula granules and traditional decoction pieces in treating chronic hepatitis B: a randomized controlled trial

Xue MEI¹, Xing TANG², Xing-pei XU³, Ding-shan DUAN⁴, Cong-cong YU⁵^,^*

Affiliations

¹Sichuan Forestry Central Hospital, Chengdu 610081, China

²Sichuan Center for Translational Medicine in Traditional Chinese Medicine, Chengdu 610041, China

³Jiange County Hospital of Traditional Chinese Medicine, Guangyuan 628300, China

⁴Qingbaijiang District Hospital of Traditional Chinese Medicine, Chengdu 610300, China

⁵Sichuan Provincial Hospital of Integrative Medicine, Chengdu 610041, China

出版时间: 2026-07-15 doi: 10.20251/j.cnki.1003-3734.2026.13.009

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摘要

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目的：

评价柴胡疏肝散配方颗粒与传统饮片治疗慢性乙型肝炎（chronic hepatitis B, CHB）免疫清除期肝郁气滞证的临床疗效与安全性的一致性，为临床剂型选择提供循证依据。

方法：

采用多中心、随机、单盲、阳性对照临床试验设计，纳入133例CHB免疫清除期肝郁气滞证患者，按随机数字表法分为受试组（配方颗粒）和对照组（传统饮片）。两组均饭前口服，tid，14 d为1个疗程，疗程间隔1 d，连续治疗2个疗程。以治疗应答率、乙型肝炎病毒脱氧核糖核酸（hepatitis B virus DNA, HBV-DNA）定量、肝功能指标［谷草转氨酶（aspartate aminotransferase, AST）、谷丙转氨酶（alanine aminotransferase, ALT）］、中医证候评分及不良反应为评价指标，采用一致性检验方法分析两组疗效与安全性的一致性。

结果：

两组治疗应答率一致性较强（κ=0.645），受试组完全应答率（8.0%）高于对照组；两组肝功能AST、ALT改善情况一致性均较强[相关系数（ICC）=0.689、0.791]，且受试组治疗后AST、ALT均值均低于对照组；两组中医证候评分改善一致性较强（ICC=0.637），受试组治疗后证候评分低于对照组；两组HBV-DNA转阴率一致性一般（κ=0.332），受试组转阴率（42.7%）高于对照组（30.0%）；受试组不良反应发生率为5.0%，对照组无不良反应发生。

结论：

柴胡疏肝散配方颗粒与传统饮片在整体应答率及肝功能改善方面一致性较强；配方颗粒在中医证候改善、HBV-DNA转阴率及完全应答率方面优于传统饮片，但轻度不良反应发生率较高，提示临床选方配药时应考虑安全风险。

关键词

柴胡疏肝散 / 中药配方颗粒 / 慢性乙型肝炎 / 免疫清除期 / 肝郁气滞证 / 疗效一致性

Abstract

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Objective:

To evaluate the consistency of clinical efficacy and safety between Chaihu Shugan San formula granules and traditional decoction pieces in the treatment of chronic hepatitis B (CHB) in the immune clearance phase with liver depression and qi stagnation syndrome, and to provide an evidence-based basis for clinical dosage form selection.

Methods:

A multicenter, randomized, single-blind, positive-controlled clinical trial design was adopted. A total of 133 patients with CHB in the immune clearance phase with liver depression and qi stagnation syndrome were enrolled and randomly divided into a test group (formula granules) and a control group (traditional decoction pieces) using a random number table. Both groups received oral administration before meals, three times a day, with 14 days as one course of treatment, an interval of 1 day between courses, and a total of 2 consecutive courses. The treatment response rate, hepatitis B virus DNA (HBV-DNA) quantification, liver function indexes [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)], TCM syndrome score and adverse reactions were used as evaluation indicators, and a consistency test was employed to analyze the consistency of efficacy and safety between the two groups.

Results:

The consistency of treatment response rate between the two groups was strong (κ=0.645); the complete response rate in the test group (8.0%) was higher than that in the control group. The consistency of improvement of AST and ALT between the two groups was strong [intraclass correlation coefficient (ICC)=0.689, 0.791], and the mean AST and ALT after treatment in the test group were lower than those in the control group. The consistency of the improvement in TCM syndrome scores between the two groups was strong (ICC=0.637), and the post treatment syndrome score in the test group was lower than that in the control group. The consistency of HBV-DNA negative conversion rate between the two groups was moderate (κ=0.332), and the negative conversion rate in the test group (42.7%) was higher than that in the control group (30.0%). The incidence of adverse reactions in the test group was 5.0%, and no adverse reactions occurred in the control group.

Conclusion:

Chaihu Shugan San formula granules and traditional decoction pieces show strong consistency in overall response rate and liver function improvement. Formula granules demonstrate advantages in TCM syndrome improvement, HBV-DNA negative conversion rate, and complete response rate; however, they are associated with a higher incidence of adverse reactions. Therefore, the benefits and risks should be carefully weighed when selecting the dosage form in clinical practice.

Key words

Chaihu Shugan Powder / traditional Chinese medicine formula granules / chronic hepatitis B / immune clearance phase / liver depression and qi stagnation syndrome / efficacy consistency

引用本文

梅雪, 唐兴, 徐兴培, 段定山, 余葱葱. 柴胡疏肝散配方颗粒与饮片治疗慢性乙肝疗效比较. 中国新药杂志, 2026 , 35 (13) : 1403 -1408 . DOI: 10.20251/j.cnki.1003-3734.2026.13.009

Xue MEI, Xing TANG, Xing-pei XU, Ding-shan DUAN, Cong-cong YU. Comparative efficacy of Chaihu Shugan San formula granules and traditional decoction pieces in treating chronic hepatitis B: a randomized controlled trial[J]. Chinese Journal of New Drugs, 2026 , 35 (13) : 1403 -1408 . DOI: 10.20251/j.cnki.1003-3734.2026.13.009

基金

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四川省中医药发展专项资金资助项目(T000011947436)

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2026年第35卷第13期

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文章信息

doi: 10.20251/j.cnki.1003-3734.2026.13.009

首发时间：2026-10-26
出版时间：2026-07-15

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录用日期：2026-05-08

基金

四川省中医药发展专项资金资助项目(T000011947436)

作者信息

¹四川省林业中心医院，成都 610081

²四川省中医药转化医学中心，成都 610041

³剑阁县中医医院，广元 628300

⁴青白江区中医医院，成都 610300

⁵四川省中西医结合医院，成都 610041

通讯作者:

^* 余葱葱，男，主任中药师，主要从事中西医结合干预亚健康、临床药学与药品研究。E-mail: ycc71@163.com。

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https://castjournals.cast.org.cn/joweb/zgxyzz/CN/10.20251/j.cnki.1003-3734.2026.13.009

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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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