清热除湿汤治疗带状疱疹肝经郁热证的随机对照试验

Qingre Chushi Decoction(清热除湿汤)in the Treatment of Herpes Zoster with Liver Channel Heat Constraint Syndrome:A Randomized Controlled Trial

目的观察清热除湿汤治疗带状疱疹肝经郁热证的临床疗效与安全性。方法选取带状疱疹肝经郁热证患者56例,随机分为治疗组29例和对照组27例。治疗组给予中药清热除湿汤口服,每日1剂;对照组予盐酸伐昔洛韦片(每次0.3 g,每日2次)、甲钴胺片(每次0.5 mg,每日3次)、维生素B1(每次10 mg,每日3次)口服,两组疗程均为7天。于治疗前、治疗后记录症状或体征积分,治疗后判定临床疗效;于治疗前、治疗后、30天随访时、90天随访时记录疼痛视觉模拟法(VAS)评分,并记录两组患者水疱停止出现时间、全部结痂时间、全部脱痂时间、疼痛减轻时间、疼痛消失时间;观察并记录试验过程的不良事件发生情况,并检测肝功能、肾功能、血常规、尿常规。结果治疗组临床疗效总有效率(82.76%)高于对照组(54.17%),差异有统计学意义(P<0.05)。两组患者VAS评分治疗前后差值、30天随访时与治疗前差值、90天随访时与治疗前差值比较差异均有统计学意义(P<0.05),治疗组优于对照组。30天随访时治疗组后遗神经痛发生率为0,对照组为20.83%(5/24,P<0.05),90天随访时治疗组后遗神经痛发生率为0,与对照组的4.17%(1/24)比较差异无统计学意义(P>0.05)。两组患者水疱停止出现时间、全部结痂时间、全部脱痂时间比较差异无统计学意义(P>0.05)。两组患者疼痛减轻时间、疼痛消失时间比较,治疗组短于对照组(P<0.05)。治疗期间两组均未出现严重不良反应,肝功能、肾功能及血常规、尿常规均未见异常。结论清热除湿汤口服治疗带状疱疹肝经郁热证可明显减轻疼痛、促进皮疹愈合、缩短病程、减少后遗神经痛的发生,且安全性良好。

Objective To observe the clinical effectiveness and safety of Qingre Chushi Decoction(清热除湿汤,QCD)in the treatment of herpes zoster with liver channel heat constraint syndrome.Methods Fifty-six cases of herpes zoster with liver channel heat constraint syndrome were randomly divided into treatment group(29 cases)and control group(27 cases).The treatment group was given oral QCD,one dose daily,while the control group was given oral valaciclovir hydrochloride tablets(0.3 g per time,twice daily),methylcobalamin tablets(0.5 mg per time,three times daiy)and vitamin B1(10 mg per time,three times daily).The course of treatment for both groups was 7 days.The score of symptoms and signs before and after treatment was recorded,and the effective rate was calculated after treatment.Pain visual analog score(VAS),blister stopping time,scab forming time,scab removal time,pain relief time,and pain disappearance time were assessed before and after treatment,and at 30-and 90-day follow-up.The occurrence of adverse events during the trial was recorded,and the liver function,kidney function,blood routine,and urine routine indicators were detected.Results The total effective rate in the treatment group(82.76%)was significantly higher than 54.17%in the control group(P<0.05).VAS differences before and after treatment,30-day follow-up vs before and 90-day follow-up vs before treatment in both groups were significant(P<0.05),while the treatment group was superior to the control(P<0.05).At 30-day follow-up,the incidence of postherpetic neuralgia was 0 in the treatment group,significantly lower than 20.83%(5/24)of the control group(P<0.05).At 90-day follow-up,the incidence of postherpetic neuralgia was 0 as well in the treatment group,while that was 4.17%(1/24)in the control group(P>0.05).There was no significant difference in blister stopping time,scab forming time,and scab removal time between the two groups(P>0.05).The mean time of pain relief and pain disappearance were significantly shorter in the treatment group(P<0.05).During the trial,there were no serious adverse reactions in both groups,and no abnormalities were found of the liver function,kidney function,blood routine and urine routine indicators.Conclusion Oral QCD is safe and effective in the treatment of herpes zoster with liver channel heat constraint syndrome by significantly relieving pain,promoting skin rash healing,shortening the course of disease and reducing the occurrence of postherpetic neuralgia.