国产注射用喷昔洛韦粉针剂改善带状疱疹患者皮损及后遗神经痛症状的随机双盲对照试验

Domestic penciclovir powder through injection for improving cutaneous deficiency and residual neuralgia in patients with herpes zoster:A randomized, double-blind and controlled trial

目的:评价国产注射用喷昔洛韦粉针剂改善带状疱疹患者皮损及后遗神经痛症状的疗效和安全性,并与阳性对照药国产注射用阿昔洛韦粉针剂比较。方法:选择2002-07/2003-06于四川大学华西医院皮肤性病科接受住院治疗的带状疱疹患者48例。采用随机双盲、平行对照的临床试验方法,对48例带状疱疹患者随机分为国产注射用喷昔洛韦粉针剂组24例(0.25g/次,每12小时静脉滴注1次)和国产注射用阿昔洛韦粉针剂组24例(0.5g/次,每12小时静脉滴注1次)进行治疗和比较,共用药7d,随访3周。疗效标准:①基本痊愈:皮损基本消退,症状消失,改善率≥90%。②显效:症状和体征改善率≥60%,<90%。③好转:症状和体征改善率≥20%,<60%。④无效:症状和体征改善率<20%。有效率=(显效例数+基本痊愈例数)/全部病例数×100%。结果:共有47例完成了试验,其中喷昔洛韦组23例,1例不符合纳入标准。阿昔洛韦组24例。①随访28d,喷昔洛韦组水疱停止出现时间,水疱消退时间,开始结痂时间,全部结痂时间,开始脱痂时间,全部脱痂时间,疼痛减轻时间,疼痛消失时间,与阿昔洛韦组较接近(P>0.05)。②后遗神经痛的发生率:喷昔洛韦组为13%(3/23),阿昔洛韦组为8.33%(2/24),(P>0.05)。③客观指标(丘疹、水疱、血疱、糜烂、结痂)疗效:治疗7d时总有效率喷昔洛韦组与阿昔洛韦组分别为91%(21/23)和96%(23/24),治疗14d和28d时两组总有效率均为100%;主观指标(疼痛)疗效:治疗7d时总有效率喷昔洛韦组与阿昔洛韦组分别为78%(18/23)和83%(20/24),14d时总有效率分别为87%(20/23)和96%(23/24),28d时总有效率分别为96%(22/23)和100%(24/24)。两组客观指标和主观指标有效率比较,P>0.05。④药物用量:喷昔洛韦组用量0.25g/d,阿昔洛韦组0.5g/d,前者的每日用量明显减少。⑤安全性评估:阿昔洛韦组2例用药后出现一过性肝功能异常;1例出现与药物可能有关的不良反应事件,表现为头晕。喷昔洛韦组没有不良反应发生。结论:国产注射用喷昔洛韦粉针剂和注射用阿昔洛韦粉针剂治疗带状疱疹均能有效地控制皮损和后遗神经痛的发生,但喷昔洛韦组用量较少,无严重不良反应发生,有良好的安全性和耐受性。

AIM： To evaluate efficacy and safety of domestic penciclovir powder for injection for improving the cutaneous deficiency and lingering neuralgia in patients with herpes zoster, and compare the above results with those of domestic acyclovir powder for injection. METI-IODS： Forty-eight hospitalized patients with herpes zoster were selected from the Department of Dermatology, Huaxi Hospital, Sichuan University between July 2002 and June 2003. A randomized, doubleblind and parallel clinical trial was conducted. The 48 patients with herpes zoster were randomly divided into trial group （n=24, domestic penciclovir powder for injection, 0.25 g I.V. once every 12 hours） and control group（n=24, domestic acyclovir powder for injection, 0.5 g I.V. once every 12 hours）. The trial was performed for 7 days and the followup was 3 weeks. Criteria of therapeutic efficacy was as follows： ① Basic recovery： Cutaneous deficiency and symptoms disappeared on the whole, and improvement rate was equal to or more than 90%; ② Excellence： improvement rate of signs and symptoms was equal to or more than 60% and less than 90%; ③Improvement： improvement rate of signs and symptoms was equal to or more than 20% and less than 60%; ④ Ineffectiveness： improvement rate of signs and symptoms was less than 20%. Effective rate =[（number of excellence cases ＋number of basic recovery cases）/total cases]×100%. RESULTS： Totally 47 patients finished the trial, 23 in the trial group, among which 1 was not accordant with the inclusion criteria, and 24 in the control group. ①After 28-day follow-up, the trial group was insignificantly different from the control group in time for cessation and extinction of blister, time for onset and whole scab, and time for onset and whole decrustation, time for relief and extinction of pain（P 〉 0.05）. ②Incidence rate of lingering neuralgia was 13%（3/23） and 8.33%（2/24） in trial group and control group respectively （P 〉 0.05）. ③The total effective rate for objective indexes（such as papule, blister, blood blister, erosion and scab） was 91%（21/23） and 96%（23/24） in trial group and control group at 7 days after treatment respectively, and 100% at 14 and 28 days after treatment in both groups. The total effective rate for subjective index （pain） vias 78%（18/23） and 83%（20/24） in the trial group and control group at 7 days after treatment respectively, 87%（20/23） and 96%（23/24） at 14 days, and 96%（22/23） and 100%（24/24） at 28 days respectively. There was no statistically significant difference in the objective and subjective indexes（P 〉 0.05）. ④The dosage of penciclovir was 0.25 g per day in the trial group, and that of acyclovir was 0.5 g per day in the control group, so the dosage of drug was remarkably less in the former group than in the latter group. ⑤In control group, 2 cases had transient liver dysfunction, and 1 case had adverse reaction related to the drug, manifesting as dizziness. However, there was no adverse reaction in the trial group. CONCLUSION： Both domestic penciclovir and domestic acyclovir for injection have similar effect in controlling cutaneous deficiency and lingering neuralgia in herpes zoster, but the former is used at less dosage and doesnot cause seriously adverse reaction,so itis to good in safety and toierance.