目的 观察口服中药从肝论治单纯疱疹性角膜炎(HSK)的临床效果。方法 前瞻性、双盲单模拟随机对照设计。以2012年12月—2014年12月在我院辨治为肝经风热型或肝阴不足型的单纯疱疹性角膜炎患者为研究对象,均纳入单眼发病患者。将两个中医证型的HSK患者随机分为对照组和治疗组。对照组予更昔洛韦眼用凝胶及中药安慰剂,治疗组在应用更昔洛韦眼用凝胶的基础上口服中药,肝经风热证患者予清肝退翳方,肝阴不足证患者予柔肝明目方。治疗周期为4周,随访12个月。观察各组患者的总体疗效、症状体征消失时间、复发情况及不良反应。结果 1.纳入患者情况:共纳入受试者153例,包括肝经风热证患者75例,肝阴不足证78例。肝经风热证者中,对照组35例,完成31例;治疗组40例,完成33例。肝阴不足证者中,对照组38例,完成32例;治疗组40例,完成34例。试验共完成总人数130例,符合样本数要求,纳入统计分析。2.治愈率及总体疗效:(1)肝经风热证,对照组31例,治愈14例(45.16%),显效12例(38.71%),有效5例(16.13%),无效0例(0.00%),总有效率100.00%;治疗组33例,治愈24例(72.73%),显效7例(21.21%),有效2例(6.06%),无效0例(0.00%),总有效率100.00%。(2)肝阴不足证,对照组32例,治愈13例(40.63%),显效13例(40.63%),有效4例(12.50%),无效2例(6.25%),总有效率93.75%;治疗组34例,治愈23例(67.65%),显效9例(26.47%),有效2例(5.88%),无效0例(0.00%),总有效率100.00%。两组总体疗效差异无统计学意义(P〉0.05),治愈率差异有统计学意义(P〈0.05),治疗组好于对照组。3.治愈患者症状、体征消失时间:接受中药治疗患者的症状、体征平均消失时间均短于对照组,差异均有统计学意义(P〈0.05)。4.复发率:两种证型接受中药治疗者至停药12个月为止的总复发率均低于对照组,差异有统
OBJECTIVE To observe the clinical effect of the Chinese formula on herpes simplex keratitis (HSK) by regulating liver. METHODS This was a prospective double-blind, single-dummy and randomized controlled research. From December of 2012 to December of 2014, participants with HSK of single eye in wind-heat invading liver meridian (WHILM) pattern or liver-yin deficiency (LYD) type in our hospital were incorporated and randomly divided into control group and treatment group according to random number table. Control group was treated with ganciclovir ophthalmic gel and TCM placebo, while the treatment group was treated with either Qinggan Tuiyi prescription for WHILM pattern or Rougan Mingmu prescription for LYD pattern on the basis ofganciclovir ophthalmic geL After 4 week treatment and 12 month follow-up, general curative effect, signs and symptoms removal time, relapse and adverse reactions were observed. RESULTS 1. Inclusion: A total WHILM type and 78 were LYD type. Among the 75 WHILM type completed the follow-up; 40 cases were in treatment group, and 33 of 153 patients were included, 75 of them were patients, 35 cases were in control group, and 31 finished the follow-up. Among 78 LYD type patients, 38 cases in control group, and 32 finished foliow-up; 40 cases were in treatment group, and 34 completed the follow-up. A total of 130 cases went through the trial which met the requirements of the sample, and then was statis- tically analyzed. 2. Effects: (~)Type of WHILM: In control group, 14 cases (45.16%) were cured, 12 (38.71%) were markedly improved, 5 (16.13%) were effective, 0 was invalid (0.00%), the total effective rate was 100.00%; In treat- ment group, 24 patients(72.73%) were cured, 7 (21.21%) were markedly improved, 2 (6.06%) were effective, 0 was invalid (0.00%) and the total effective rate was 100.00%. (2)Type of LYD: In control group, 13 cases (40.63%) were cured, 13 (40.63%) were markedly improved, 4 (12.50%) were effective, 2 were