金英胶囊治疗盆腔炎性疾病的有效性及安全性的系统评价与Meta分析

The systematic assessment and Meta-analysis of the effectiveness and security of the Jinying capsules in the treatment of pelvic inflammatory diseases

目的:系统评价金英胶囊治疗盆腔炎性疾病(Pelvic Inflammatory Diseases,PID)的有效性及安全性。方法:检索中国知网、万方数据库、Wed of Science、Cochrane Library等8个中、英文数据库,获得关于金英胶囊治疗PID的随机对照研究,检索时段从建库至2022年9月。筛选所得文献,提取所需资料,评价纳入文献的质量,并使用RevMan 5.4进行Meta分析。结果:共纳入13项研究,共2 154例PID患者。Meta分析的结果显示:单用金英胶囊治疗PID的有效率与单用妇炎净胶囊治疗PID的有效率的差异无统计学意义(P> 0.05);金英胶囊联合康妇消炎栓治疗PID的有效率高于妇科千金片联合康妇消炎栓(P=0.047);金英胶囊联合抗生素治疗PID有效率高于单用抗生素治疗PID的有效率,且金英胶囊联合抗生素治疗PID在缩短患者下腹腰骶疼痛消失时间、发热消失时间、白带增多消失时间,降低PID患者体内炎症指标肿瘤坏死因子-α、白细胞介素-1β水平等方面均优于单用抗生素(P <0.05)。安全性方面:1篇文献报道了试验组发生了药物相关不良反应,其不良反应的发生率与对照组的差异无统计学意义(P> 0.05)。结论:金英胶囊治疗PID具有一定的有效性,安全性较好。受纳入文献质量及数量的限制,上述结论仍需开展更多的临床试验加以证实。

Objective:To evaluate the effectiveness and security of the Jinying capsules( 金英胶囊) in the treatment of pelvic inflammatory disease(PID) systematically.Methods:Eight Chinese or English databases including CNKI,Wanfang,Wed of Science,Cochrane library and so on were retrieved to collect randomized controlled trials of treating PID with the Jinying capsules.The retrieval time limit was from the establishment of each database to December 2022.The obtained literature was selected to extract the required data and evaluate the quality of the included literature.RevMan 5.4 was used to do the data analysis.Results:A total of 13 studies with a total of 2 154 patients with PID were analyzed in this research.The results of the Meta-analysis showed that there was no statistical difference in the efficiency between the Jinying capsules and Fuyanjing capsules( 妇炎净胶囊) alone in the treatment of PID(P>0.05).The efficiency of the Jinying capsules plus Kangfu Xiaoyan Shuan( 康妇消炎栓) on PID was higher than Fuke Qianjin Pian( 妇科千金片) plus Kangfu Xiaoyan Shuan(P=0.047).The efficiency of the Jinying capsules plus antibiotics on PID was higher than that of antibiotics alone.And the Jinying capsules plus antibiotics in the treatment of PID was superior to antibiotics alone in shortening the disappearance time of lower abdominal lumbosacral pain,fever,and leucorrhea,and reducing the inflammatory indicator levels of TNF-αand IL-1β in PID patients.In terms of safety,one study reported the occurrence of drug-related adverse reaction in the test group,and the incidence of adverse reactions was not statistically different from that in the control group(P>0.05).Conclusion:The Jinying capsules are effective and safe in the treatment of PID.Due to the limitation of the quality and number of included studies,the above results still need to be confirmed by conducting more clinical trials.