从肝论治单纯疱疹性角膜炎的双盲单模拟随机对照研究

发布时间：2018-01-02 22:28

本文关键词：从肝论治单纯疱疹性角膜炎的双盲单模拟随机对照研究　出处：《中国中医眼科杂志》2016年06期 　论文类型：期刊论文

【摘要】：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(P0.05),治愈率差异有统计学意义(P0.05),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(P0.05)。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,差异有统计学意义(P0.05)。5.不良反应:治疗组有4例出现恶心、纳差、腹泻、腹胀等症状,调整剂量均得到控制。对照组中未见不良反应发生。结论口服中药从肝论治HSK在缩短症状、体征消失时间、提高治愈率及降低复发方面好于单纯使用更昔洛韦眼药;尚需优化现有中医治法,并扩大样本做进一步的观察。
[Abstract]:Objective to observe the clinical effect of oral Chinese medicine in treating herpes simplex keratitis (HSK) from liver. Double blind, single simulated randomized controlled design. From December 2012 to December 2014, the patients with herpes simplex keratitis were diagnosed and treated in our hospital as herpes simplex keratitis with wind-heat liver type or deficiency of liver yin type. HSK patients with two TCM syndromes were randomly divided into control group and treatment group. The control group was given ganciclovir eye gel and Chinese medicine placebo. The treatment group was treated with ganciclovir ophthalmic gel on the basis of oral Chinese medicine, the patients with wind and heat syndrome were given Qinggan Tuyi prescription, and the patients with deficiency of liver yin syndrome were treated with Rugan Mingmu recipe. The treatment period was 4 weeks. Follow up for 12 months to observe the overall efficacy, symptoms and signs disappeared time, recurrence and adverse reactions. Results 1.Including the patient situation: a total of 153 patients were included. There were 75 cases of wind-heat syndrome of liver meridian and 78 cases of deficiency of liver yin. Among the patients with wind-heat syndrome of liver meridian, 35 cases were in control group, 31 cases were completed. There were 40 cases in the treatment group and 33 cases in the treatment group. Among the patients with deficiency of liver yin, 38 cases were in the control group and 32 cases in the control group. There were 40 cases in the treatment group and 34 cases in the control group. The total number of patients in the experiment was 130, according to the request of sample number, the curative rate and the total curative effect were analyzed by statistical analysis .2.The cure rate and the total curative effect were: 1) the syndrome of wind and heat in the liver and 31 cases in the control group. 14 cases were cured and 45.16% were cured, 12 cases were significantly effective (38.71%), 5 cases were effective in 16.13 cases, and 0 cases were ineffective. The total effective rate was 100.005%. In the treatment group, 24 cases were cured (72.73), 7 cases were effective (21.21), 2 cases were effective (6.06), and 0 cases were ineffective (0.005%). The total effective rate was 100.00.2.The deficiency of liver yin was found in 32 cases in the control group, 40.63 in 13 cases in the control group, 40.63 in 13 cases in the remarkable effect and 12.50% in 4 cases). Ineffective 2 cases were 6.25%, the total effective rate was 93.75%; In the treatment group, 34 cases were cured, 23 cases were cured 67.65%, 9 cases were effective and 26.47%, 2 cases were effective (5.88%), and 0 cases were ineffective (0.005%). The total effective rate was 100.000.There was no significant difference in the total curative effect between the two groups (P 0.05), but the cure rate was significantly different (P 0.05). Treatment group is better than the control group .3.Cure patients symptoms, physical signs disappear time: the symptoms of patients treated with Chinese medicine, the average disappearance time of signs are shorter than the control group. The recurrence rate of the two syndrome types was lower than that of the control group until 12 months after the treatment. Adverse reactions: in the treatment group, there were 4 cases of nausea, anorexia, diarrhea, abdominal distension and other symptoms. No adverse reactions occurred in the control group. Conclusion Oral Chinese medicine treatment of HSK from the liver can shorten the symptoms and the time of disappearance of signs. It is better to increase the cure rate and reduce the recurrence than to use ganciclovir alone. There is still need to optimize the existing TCM treatment, and expand the sample for further observation.
【作者单位】：山东中医药大学;山东中医药大学附属眼科医院;山东中医药大学第二附属医院;
【基金】：山东省高校中医药抗病毒协同创新中心(XTCX2014A04-04) 国家自然科学基金资助项目(81403438) 山东省自然基金资助项目(ZR2014HP059) 山东省中医药科技发展计划项目(2015-147)
【分类号】：R772.21
【正文快照】： 单纯疱疹性角膜炎(herpes simplex keratitis,HSK)是世界性感染性致盲性眼病,发病率占角膜病的首位[1]。本病一般为单侧发病,少数可双侧同时或先后累及,其临床特点为反复发作,目前尚无有效控制复发的药物,其治疗困难,已成为眼科最棘手的问题之一,至今尚无一种药物能从根本上消

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