裸花紫珠片治疗热(瘀)毒证的证病结合临床研究

目的:研究裸花紫珠片治疗热(瘀)毒型上呼吸道感染、慢性盆腔炎、痔疮出血的证、病疗效及其相关性,探索以证的疗效指标为主、证病结合的中药新药临床评价模式。方法:选择符合热(瘀)毒证并分别符合上呼吸道感染、慢性盆腔炎、痔疮出血的病例,采用分层随机分组、阳性药物平行对照、双盲双模拟观察方案,疗程结束后评价证、病疗效及其相关性。结果:1)裸花紫珠片对热(瘀)毒证及上呼吸道感染、慢性盆腔炎、痔疮出血证、病疗效与对照组比较,差异均无统计学意义(P0.05)。该药能明显改善咽/喉疼痛,下腹胀/刺痛、腰骶疼痛,症状便血、肛门肿胀积分,差异有统计学意义(P0.05)。2)裸花紫珠片治疗热(瘀)毒型上呼吸道感染、慢性盆腔炎、痔疮出血的证、病疗效,观察组疗前血WBC异常的热(瘀)毒型的上呼吸道感染受试者的证候积分及主要症状咽/喉疼痛与血WBC计数,慢性盆腔炎受试者的证候积分与血WBC计数,痔疮出血受试者的证候疗效与便血疗效的Spearman相关,差异有统计学意义(P0.05),且疾病疗效与便血疗效的Spearman相关均有统计学意义(P0.05)。结论:1)裸花紫珠片对热(瘀)毒型上呼吸道感染、慢性盆腔炎、痔疮出血具有较好的临床疗效。2)中医证候疗效与疾病综合疗效及能反应西医疾病特征的相关指标疗效具有显著相关性;中医证候积分及中医证候的主要症状评分与能反应疾病本质特征的实验室指标或主要症状具有显著相关性。

Clinical Study on Syndrome and Disease Combination of Luohua Zizhu Tablet to Treat Syndrome of Heat (Blood Stasis)

To study the syndrome curative effect, disease curative effect and their correlation of Luohua Zizhu Tablet in treating upper respiratory tract infection, chronic pelvic inflammatory disease and bleeding hemorrhoids with syndrome of heat (blood stasis), and to explore clinical evaluation model of new traditional Chinese medicine by combining syndrome and disease with syndrome curative effective as main index. Methods:Patients with upper respiratory tract infection, chronic pelvic inflammatory disease and bleeding hemorrhoids with syndrome of heat (blood stasis) were selected to observe syndrome curative effect, disease curative effect and their correlation according to random stratified grouping, parallel-controlled, double-blind and double-simulation trials. Results:1)There were no statistical significance (P>0.05) between Luohua Zizhu Tablet and control drugs to treat syndrome of heat (blood stasis) and to treat diseases of upper respiratory tract infection, chronic pelvic inflammatory disease and bleeding hemorrhoids. Luohua Zizhu Tablet could reduce the integrals of sore throat, lower abdominal pain, lumbar and sacral pain, hematochezia and anal swelling (P<0.05). 2) There are relative statistical significance (P<0.05) between syndrome curative effect and disease curative effect of Luohua Zizhu Tablet to treat upper respiratory tract infection, chronic pelvic inflammatory disease and bleeding hemorrhoids with syndrome of heat (blood stasis). The syndrome integrals and sore throat integrals of upper respiratory tract infection patients with high WBC integrals had significant correlation to WBC. The syndrome integrals of chronic pelvic inflammatory disease patients with high WBC integrals had significant correlation to WBC. There were relative statistical significance (P<0.05) between disease curative effect and hematochezia curative effect. Conclusion:1) Luohua Zizhu Tablet can effectively treat upper respiratory tract infection, chronic pelvic inflammatory disease and bleeding hemorrhoids. 2) There are relative statistical significance (P<0.05) between syndrome curative effect and disease curative effect and curative effect of index responding to the characteristics of the disease characteristics of Western Medicine. There are relative statistical significance (P<0.05) between syndrome integrals, main symptom integrals and index responding to the characteristics of the disease characteristics of western medicine or main symptom.