丹黄祛瘀胶囊中药保护治疗盆腔炎性疾病后遗症临床研究

目的:评价丹黄祛瘀胶囊治疗盆腔炎性疾病后遗症的安全性及有效性,为中药品种保护注册申请提供依据。方法:采用随机、阳性药平行对照、双盲单模拟、多中心临床试验方法。纳入受试者424例,其中试验组318例,对照组106例。试验组口服丹黄祛瘀胶囊3粒+丹黄祛瘀胶囊模拟剂1粒,3次/d;对照组口服止痛化癥胶囊4粒,3次/d。用药8周,4周访视1次。综合疗效达到临床痊愈的患者在用药结束4周后随访。结果:主要症状消失率及综合疗效痊愈率及愈显率均有统计学差异,试验组优于对照组;中医证候疗效2组患者疗效的痊愈率及愈显率均有统计学差异,试验组优于对照组;局部体征疗效PPS级愈显率试验组优于对照组,差异有统计学意义(P0.05)。结论:丹黄祛瘀胶囊治疗治疗盆腔炎性疾病后遗症-中医证属气虚血瘀、痰湿凝滞者安全有效,其有效性优效于止痛化癥胶囊。

Clinical Research on Danhuang Quyu Capsule in the Treatment of Sequelea of Pelvic Inflammatory Disease for the Protection of Chinese Materia Medica

To evaluate the safety and effectiveness of Danhuang Quyu Capsule in treating sequelea of pelvic inflammatory disease and to provide clinical test evidence for protection, registration and application of corresponding Chinese materia medica species. Methods:Random, positive drug paralleled control, double-blind & single, multicenter trials were designed and organized. The total subjects were 424 cases, including 318 cases of treatment group and 106 cases of control group. Patients in the treatment group were treated with 3 Danhuang Quyu Capsules and a simulation agent of Danhuang Quyu Capsule for oral-taking, 3 times per day. Patients in the control group were treated with 4 Zhitong Huazheng Capsules for 3 times per day. Patients in both groups received 8-week treatment and were visited once a month. Patients who were cured were followed up 4 weeks after the trial. Results:It showed significant difference between the treatment group and the control group on main symptom disappearance rate, curative rate of comprehensive rate and effective rate, and the treatment group was superior to the control group. There was significant difference between the treatment group and the control group in TCM syndrome curative effect, including the curative rate and the effective improvement rate, and the treatment group was better than the control group. For local improvement, the PPS good improvement rate of treatment group was better than that of the control group, with statistically significant difference. Conclusion:It is safe and effective for Danhuang Quyu Capsule to treat sequelea of pelvic inflammatory disease of blood stasis due to qi deficiency syndrome and phlegm-dampness blocking collaterals syndrome. The clinical effect of Danhuang Quyu Capsule is superior to Zhitong Huazheng Capsule.