【作者】 王璐；

【导师】 徐键；

【作者基本信息】 浙江大学 ， 妇产科， 2016， 硕士

【摘要】 目的本课题主要目的是通过前瞻性随机对照试验,评价康妇炎胶囊对于湿热瘀结型盆腔炎性疾病的治疗效果、用药安全性,并系统分析其结果,为临床运用该药物治疗湿热瘀结型盆腔炎性疾病提供数据支持和科学依据。方法选取门诊确诊为湿热瘀结型盆腔炎性疾病的患者共83例,前瞻性随机对照临床试验设计,按照随机双盲表分为中西医联合用药组和西药组,中西医联合用药组42例：康妇炎胶囊+阿奇霉素片+甲硝唑片,西药组41例：阿奇霉素片+甲硝唑片。观察各组患者临床症状体征变化评分、中医证候疗效评分、实验室评分及不良反应发生率等。结果中西医联合用药组和西药组比较,两组治疗前症状体征如下腹坠胀、子宫附件压痛、超声检查盆腔积液等临床症状体征的出现率,经统计学分析无差异(p>0.5)；治疗后,上述两组的症状体征均明显好转(p<0.05),且中西医联合用药组治疗后下腹坠痛、子宫附件压痛、盆腔积液发生率显著低于西药组(p<0.05)；两组实验室评分较治疗前明显降低(p<0.05),两组总体不良反应发生率无统计学差异(p>0.05)。结论康妇炎胶囊联合抗生素能够有效缓解患者临床症状体征,提高治疗有效率,其安全性高、不增加药物不良反应,值得临床推广应用。更多还原

【Abstract】 Objective:The main intention of this study is to evaluation the efficacy and safety of Kang Fu yan capsule in the treatment of damp heat stasis pelvic inflammatory disease by prospective randomized trials,and make a systematic analysis to provide data support and scientific basis for the clinical use of the Kang Fu yan capsule in the treatment of pelvic inflammatory disease.Methods:By prospective randomized trials,the damp heat stasis pelvic inflammatory disease patients in outpatient departments were randomly divided into two groups as follows:Kang fu yan capsule+oral antibiotics group(Azithromycin plus Metronidazole),only treated with oral antibiotics group.The efficacies of two type of treatments were compared through scoreing the severity based on symptoms, sings,Chinese medicine symptom efficacy scores and laboratory paramenters before and after treatment,also the incidence of adverse drug reactions between the two groups.Results:There were no statistically significant differences in these parameter between the groups (p>0.5). The clinical symptoms and signs of the two groups were significantly improved after treatment (p<0.05), laboratory paramenters scores of the two groups were significantly lower than those before treatment, there was no statistically significant differences in the incidence of adverse reactions between the two groups.Conclusion:Kang fu yan capsule combined with antibiotics has obvious advantages in the treatment of PID,it can effectively relieve the clinical symptoms and signs, improve the efficiency.The safety of the Kang fu yan capsule has be proved, and it does not increase the incidence of adverse drug reactions, the Kang fu yan capsule is worthy of clinical application.更多还原