传统中药饮片汤剂与免煎颗粒剂治疗寻常型银屑病临床对照研究

Comparative study of traditional Chinese herbal pieces decoction and free decocted granule in the treatment of psoriasis vulgaris

目的比较中药单味传统饮片和中药单味免煎颗粒剂制成的退银汤(自拟中药协定方剂)治疗寻常型银屑病的临床疗效,为临床治疗寻常型银屑病提供选择。方法将2016年7月至2017年6月118例寻常型银屑病患者分为观察组和对照组,各59例,观察组给予传统中药饮片煎煮汤剂内服,对照组给予中药免煎颗粒剂冲服,疗程均为12周。在治疗前和治疗后2、4、8、12周记录皮损面积和银屑病严重程度指数(PASI)评分,疗程完成后进行临床疗效和复发率评估,同时进行起效时间比较,并观察不良反应发生情况。结果治疗后,观察组和对照组PASI评分与治疗前比较均明显降低,4、8、12周时,观察组PASI评分显著低于对照组(P<0.05,P<0.01)。观察组痊愈率高于对照组(57.63%vs 38.98%,P<0.05);观察组起效时间短于对照组[(13.2±5.3)d vs(18.4±8.5)d,P<0.01]。观察组总有效率91.53%稍高于对照组84.75%,复发率11.76%稍低于对照组17.39%,不良反应发生率8.47%稍高于对照组6.78%,但差异均无统计学意义(P均>0.05)。结论传统中药饮片煎煮汤剂和中药免煎颗粒剂在治疗寻常型银屑病的某些临床疗效指标上不具有等效性,临床医师应综合分析其优缺点,根据患者实际情况选择用药,实现中药饮片汤剂和中药免煎颗粒剂优势互补。

Objective To compare the clinical efficacy of Tuiyin soup（ self-made prescription for traditional Chinese medicine） made from single-flavor traditional Chinese herbal pieces decoction and Tuiyin soup made from single Chinese herbal free decocted granules in the treatment of psoriasis vulgaris,and to provide clinical options for the treatment of psoriasis vulgaris. Methods A total of 118 patients with psoriasis vulgaris were divided into two groups. The observation group in which traditional Chinese herbal decoction was given orally,and the control group in which free decocted granules was given from July 2016 to June 2017（ n = 59,each）. The course of treatment was 12 weeks for both two groups. Psoriasis area and psoriasis severity index（ PASI） scores were recorded before treatment and at 2-,4-,8-and 12-week after treatment. The clinical efficacy and recurrence rates were evaluated after finishing the course of treatment,the time of taking effect and rate of adverse reactions was compared between two groups. Results Compared with pre-treatment,PASI scores decreased significantly after treatment in both two groups,and at 4-,8-,12-week after treatment,PASI scores were statistically lower in observation group than those in control group（ 11. 98 ± 3. 05 vs 13. 16 ± 3. 21,P〈0. 05; 5. 96 ± 2. 26 vs 7. 19 ± 2. 18,P〈0. 01; 2. 71 ± 1. 43 vs 4. 23 ± 1. 81,P〈0. 01）. The cure rate in observation group was significantly higher than that in control group（ 57. 63% vs 38. 98%,P〈0. 05）,and the time of taking effect in observation group was statistically shorter than that in control group [（ 13. 2 ± 5. 3） d vs（ 18. 4 ± 8. 5） d,P〈0. 01]. Compared with control group,the total effective rate was slightly higher（ 91. 53% vs 84. 75%）,the recurrence rate was slightly lower（ 11. 76% vs17. 39%）,and the adverse reaction rate was slightly highe（ 8. 47% vs 6. 78%） in observation group,but there were no significant differences between two groups（ all P〈0. 05）. Conclusions Traditional Chinese herbal pieces decoction and herbal free decocted granules are not equivalent in the clinical efficacy of psoriasis vulgaris. Clinicians should make a comprehensive analysis of their advantages and disadvantages,select appropriate drugs according to the actual situation of patients,and realize the complementary advantages of Chinese herbal decoction and herbal free decocted granules.