丹黄祛瘀胶囊治疗慢性盆腔炎的系统评价与Meta分析

doi:10.19803/j.1672-8629.2022.09.15

摘要/Abstract

摘要： 目的系统评价丹黄祛瘀胶囊治疗慢性盆腔炎的有效性及安全性。方法检索中文电子数据库中国知网、维普网、万方数据、中国生物医学文献数据库,英文电子数据库PubMed、EMbase、Cochrane Library、Web of Science,自建库至2021年8月16日丹黄祛瘀胶囊治疗慢性盆腔炎的临床随机对照试验（randomized controlled trial, RCT）。采取改良Jadad评分对文献质量进行评价,另根据Cochrane Handbook 5.3设立的评价标准和RevMan 5.4 软件对最终纳入的研究进行分析。结果共纳入10篇RCT文献,总样本量为1 411例（试验组813,对照组598）。纳入文献的干预措施为丹黄祛瘀胶囊+常规抗生素治疗vs常规抗生素治疗、丹黄祛瘀胶囊vs常规中成药治疗、丹黄祛瘀胶囊联合常规中成药治疗vs常规中成药治疗。Meta分析结果显示丹黄祛瘀胶囊治疗慢性盆腔炎在临床症状体征消失率（RR=1.40, 95%CI [1.13, 1.75] , P=0.003）、盆腔包块消失率（RR=1.55, 95%CI [1.19, 2.03] , P=0.001）、盆腔包块大小(MD=-1.03, 95%CI [-1.29, -0.77], P<0.000 01)、下腹压痛消失率（RR=1.56, 95%CI[1.18, 2.07] , P=0.002）的改善明显优于对照组,对于降低血清C反应蛋白(MD=-3.84, 95%CI [-6.46, -1.23], P=0.004)、血清TNF-α含量(MD=-29.11, 95%CI [-36.33, -21.89], P<0.000 01)方面优于对照组。而丹黄祛瘀胶囊联合常规抗生素治疗在降低1月内复发率方面与单纯抗生素治疗差异无统计学意义(RR=1.26, 95%CI [0.95, 1.65] , P=0.10)。安全性方面,试验组与对照组不良反应发生率差异无统计学意义。结论丹黄祛瘀胶囊单用或联合对照组治疗慢性盆腔炎在消除临床症状体征、消除盆腔包块、减小盆腔包块大小、消除下腹压痛等方面明显优于对照组,临床疗效明确,且未明显增加不良反应,可为临床用药提供一定的参考。受纳入文献质量和数量的限制,上述研究结果需高质量RCT研究加以验证。

关键词: 丹黄祛瘀胶囊, 慢性盆腔炎, Meta分析, 有效性, 安全性

Abstract: Objective To evaluate the efficacy and safety of Danhuang Quyu capsules in the treatment of chronic pelvic inflammatory disease. Methods Eight electronic databases (the Cochrane Library, PubMed, EMBASE, Web of Science, China Biomedical Database Web, China National Knowledge Infrastructure Databases, Chinese Scientific Journal Database, and Wanfang database) were searched for related articles published from inception to August 16, 2021 to retrieve RCTs related to Danhuang Quyu capsules in the treatment of chronic pelvic inflammatory disease. The improved Jadad score was used to assess the quality of literature. The criteria established by Cochrane Handbook 5.3 and RevMan 5.4 software were used for meta-analysis. Results 10 RCTs were included, with a total sample size of 1 411 cases (813 in the experimental group and 598 in the control group). Measures of intervention described in the literature were Danhuang Quyu capsules + conventional antibiotic treatment vs conventional antibiotic treatment, Danhuang Quyu capsules vs proprietary Chinese medicine treatment, and Danhuang Quyu capsules combined with proprietary Chinese medicine treatment vs proprietary Chinese medicine treatment. Meta-analysis showed that the therapeutic effect of Danhuang Quyu capsules was significantly better than in the control group as was evidenced by the disappearance rate of symptoms and signs (RR=1.40, 95%CI [1.13, 1.75], P=0.003), that of pelvic mass (RR=1.55, 95%CI [1.19, 2.03], P=0.001), pelvic mass size (MD=-1.03, 95%CI[-1.29, -0.77], P < 0.000 01) and that of lower abdominal tenderness (RR=1.56, 95%CI[1.18, 2.07], P=0.002) . However, there was no statistically significant difference between Danhuang Quyu capsules combined with conventional antibiotic treatment and treatment with antibiotics alone in the effect of reducing the recurrence rate within one month (RR=1.26, 95%CI [0.95, 1.65],P=0.10). There was no significant difference in the incidence of adverse reactions between the experimental group and the control group. Conclusion Danhuang Quyu capsules alone or combined with the control group are much more effective in mitigating chronic pelvic inflammation than in the control group. Due to the limited amount of the literature, the results of the above research need to be verified by high-quality RCT studies.

Key words: Danhuang Quyu capsule, chronic pelvic inflammation, Meta-analysis, effectiveness, safety

中图分类号:

R978.1

赵晓晓, 刘福梅, 席俊羽, 史卜文, 谢雁鸣, 王连心. 丹黄祛瘀胶囊治疗慢性盆腔炎的系统评价与Meta分析[J]. 中国药物警戒, 2022, 19(9): 1002-1008.

ZHAO Xiaoxiao, LIU Fumei, XI Junyu, SHI Buwen, XIE Yanming, WANG Lianxin. Systematic evaluation and Meta-analysis of Danhuang Quyu capsules in the treatment of chronic pelvic inflammatory disease[J]. Chinese Journal of Pharmacovigilance, 2022, 19(9): 1002-1008.

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