【摘要】 目的评价金英胶囊治疗盆腔炎性疾病湿热蕴结证的有效性和安全性。方法采用前瞻性、阳性药平行对照、多中心临床研究方法,共纳入328例患者。其中试验组213例,给予金英胶囊口服,0.5 g/粒,每次4粒,每日3次;对照组115例,予康妇炎胶囊口服,0.4 g/粒,每次3粒,每日2次。疗程4周。观察两组治疗前及治疗4周后中医证候评分以评价疗效,并比较两组下腹疼痛视觉模拟评分(visual analogue scale,VAS)及欧洲五维健康量表(European quality of life-five dimension scale,EQ-5D)评分变化。结果试验组完成病例204例,对照组完成109例。试验组中医证候总有效率为89.71%(183/204),明显高于对照组的76.15%(83/109),两组比较,差异有统计学意义(P<0.01)。与本组治疗前比较,治疗后两组EQ-5D评分均升高,下腹疼痛VAS评分降低(均P<0.05)。治疗后试验组EQ-5D评分为(0.857±0.157)分,明显高于对照组(0.753±0.126)分,两组比较,差异有统计学意义(P<0.05)。试验组下腹疼痛VAS评分为(2.14±1.23)分,低于对照组(2.33±1.24)分,两组比较,差异无统计学意义(P>0.05)。两组均未发生不良反应。结论金英胶囊在改善盆腔炎性疾病湿热蕴结证患者中医证候和生活质量方面优于康妇炎胶囊。更多还原

【Abstract】 Objective To evaluate the efficacy and safety of Jinying Capsule( JC) in treating pelvic inflammatory disease patients with accumulated damp-heat syndrome( ADHS). Methods Totally 328 patients were recruited in a prospective,positive drug parallel controlled,and multi-center clinical trial. Of them 213 patients in the treatment group took JC( 0. 5 g per capsule),4 capsules each time,3 times per day,while 115 patients in the control group took Kangfuyan Capsule( KC,0. 4 g per capsule),3 capsules each time,twice per day. The course of treatment was 4 weeks for all. Scores of Chinese medical syndromes,visual analogue scale( VAS) of the lower abdominal pain,and European quality of life- five dimension scale( EQ-5D) were observed before treatment and after 4 weeks of treatment. Results There were 204 patients in the treatment group and 109 in the control group who completed this trial. The total effective rate of Chinese medical syndrome was 89. 71%( 183 /204 cases) in the treatment group and 76. 15%( 83 /109 cases) in the control group(P <0. 01). Compared with before treatment in the same group,EQ-5D scores increased,and VAS scores of the lower abdominal pain decreased in the two groups after treatment. EQ-5D scores was 0. 857 ± 0. 157 in the treatment group,obviously higher than that in the control group( 0. 753 ± 0. 126,P < 0. 05). VAS scores of the lower abdominal pain was 2. 14 ± 1. 23 in the treatment group,lower than that in the control group( 2. 33 ± 1. 24),but with no statistical difference between the two groups(P > 0. 05). No adverse reaction occurred in the two groups. Conclusion JC was superior to KC in improving Chinese medical syndrome and quality of life of pelvic inflammatory disease patients with accumulated damp-heat syndrome.更多还原