1.首都医科大学附属北京中医医院,北京市东城区美术馆后街23号,100010
2.中国人民解放军空军特色医学中心
3.北京中医医院顺义医院
4.北京中医医院怀柔医院
5.北京中医医院延庆医院
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收稿:2025-08-31,
修回:2026-02-10,
录用:2026-02-03,
纸质出版:2026-04-17
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刘志勇,秦万里,马腾飞等.清热除湿汤治疗带状疱疹肝经郁热证的多中心、随机对照试验[J].中医杂志,2026,67(08):855-861.
LIU Zhiyong,QIN Wanli,MA Tengfei,et al.Qingre Chushi Decoction (清热除湿汤) in Treating Herpes Zoster with Constraint Heat in the Liver Channel Syndrome:A Multicenter, Randomized Controlled Trial[J].Journal of Traditional Chinese Medicine,2026,67(08):855-861.
刘志勇,秦万里,马腾飞等.清热除湿汤治疗带状疱疹肝经郁热证的多中心、随机对照试验[J].中医杂志,2026,67(08):855-861. DOI: 10.13288/j.11-2166/r.2026.08.009.
LIU Zhiyong,QIN Wanli,MA Tengfei,et al.Qingre Chushi Decoction (清热除湿汤) in Treating Herpes Zoster with Constraint Heat in the Liver Channel Syndrome:A Multicenter, Randomized Controlled Trial[J].Journal of Traditional Chinese Medicine,2026,67(08):855-861. DOI: 10.13288/j.11-2166/r.2026.08.009.
目的
2
观察清热除湿汤治疗带状疱疹肝经郁热证的疗效和安全性。
方法
2
采用前瞻性、多中心、单盲、随机对照试验方法,将114例带状疱疹肝经郁热证患者随机分为治疗组和对照组各57例。对照组采用西药治疗(包括伐昔洛韦片、甲钴胺片和维生素B1片);治疗组给予口服清热除湿汤,每日1剂。两组疗程均为7天,疗程结束后观察两组患者临床疗效,如果患者疼痛不缓解,治疗组经医师诊断仍为肝经郁热证,则继续给予清热除湿汤加减口服,对照组继续给予甲钴胺片、维生素B1片口服直至疼痛缓解。记录两组患者治疗前、治疗7天以及研究第14天、21天、30天、90天随访时疼痛视觉模拟量表(VAS)评分;记录研究第30天、90天随访时带状疱疹后神经痛(PHN)发生情况;记录各组患者水疱停止时间(止疱时间)、皮疹完全结痂的时间(结痂时间)、脱痂时间以及疼痛减轻时间;并进行安全性评价。再以不同年龄(<50岁、≥50岁)、性别、病程(发病0~3天、4~7天)分层,对治疗前后不同时间疼痛VAS评分、30天及90天随访时PHN发生情况进行亚组分析。
结果
2
最终治疗组51例、对照组49例纳入统计分析。治疗组临床疗效总有效率72.55%(37/51)、对照组51.02%(25/49),治疗组显著高于对照组(
P
<0.05)。治疗组疼痛VAS评分在治疗7天及研究第14天、21天、30天、90天随访时均低于对照组(
P
<0.05)。治疗组止疱时间、结痂时间、脱痂时间、疼痛减轻时间均短于对照组(
P
<0.05),在研究第30天和90天随访时PHN发生率低于对照组(
P
<0.05)。两组发生轻微不良事件各3例,患者治疗前后血常规、尿常规、肝肾功能指标均在正常范围内。亚组分析显示,在年龄≥50岁、女性及病程4~7天的患者中,清热除湿汤在缓解疼痛和降低PHN方面显示出更明显的优势。
结论
2
清热除湿汤治疗带状疱疹肝经郁热证的临床疗效肯定,可明显减轻疼痛,促进皮疹愈合,缩短病程,降低PHN发生率,且安全性好。
Objective
2
To explore the efficacy and safety of
Qingre Chushi Decoction
(清热除湿汤, QCD) in the treatment of herpes zoster with constraint heat in the liver channel syndrome.
Methods
2
A prospective, multicenter, single-blind, randomized controlled trial was designed. A total of 114 herpes zoster participants with constraint heat in the liver channel syndrome were randomly assigned to a treatment group and a control group, with 57 cases in each group. The control group was treated with valacyclovir tablets, mecobalamin tablets, and vitamin B1, while the treatment group was given oral QCD, one dose per day. Both groups received treatment for 7 days. After the treatment course, the clinical efficacy of both groups was observed. If the patient's pain did not alleviate, and the patients in the treatment group were still diagnosed by the physician as having constraint heat in the liver channel syndrome, QCD was continued with modifications; the control group continued with oral mecobalamin tablets and vitamin B1 until pain relief was achieved. The visual analog scale (VAS) scores for pain were recorded for two groups before treatment, after 7 days of treatment, and at 14-, 21-, 30-, and 90-day follow-up. The occurrence of postherpetic neuralgia (PHN) was recorded at 30- and 90-day follow-up. The blister cessation time, time to full scab formation, time to shed scabs, and time for pain relief were recorded, and safety was evaluated. A subgroup analysis was performed based on different age groups (<50 years, ≥50 years), gender, and disease duration (0-3 days, 4-7 days) to evaluate the pain VAS scores at different time points before and after treatment, as well as the occurrence of PHN at the 30-day and 90-day follow-up.
Results
2
A total of 51 patients in the treatment group and 49 patients in the control group were included in the statistical analysis. The overall clinical efficacy rate in the treatment group (72.55%, 37/51) was significantly higher than that in the control group (51.02%, 25/49), with a statistically significant difference (
P
<0.05). The pain VAS scores in the treatment group were significantly lower than those in the control group at 14-, 21-, 30- and 90-day follow-up (
P
<0.05). The treatment group had shorter blister cessation time, time to full scab formation, time to shed scabs, and time for pain relief than the control group (
P
<0.05). At the 30- and 90-day follow-up, the treatment group had lower occurrence of PHN than the control group (
P
<0.05). There were 3 cases of mild adverse events in either groups. The patients' blood routine, urine routine, and liver and kidney function indicators were all within the normal range before and after treatment. Subgroup analysis revealed that in patients aged ≥50 years, females, and those with a disease duration of 4 to 7 days, QCD demonstrated more pronounced advantages in alleviating pain and reducing the occurrence of PHN.
Conclusion
2
The clinical efficacy of QCD in the treatment of herpes zoster with constraint heat in the liver channel syndrome is positive, which can significantly reduce pain, promote rash healing, shorten the course of the disease and reduce the occurrence of PHN, and has good safety.
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