[关键词]
[摘要]
目的 系统评价夏枯草口服液治疗甲状腺功能亢进症的临床疗效与安全性。方法 计算机检索中文学术期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、万方数据库(Wanfang Data)、维普中文期刊全文数据库(VIP)、PubMed、Medline、Embase和Cochrane Library等数据库,纳入夏枯草口服液治疗甲状腺功能亢进症的临床随机对照试验(RCT),检索时限均从建库至2021年4月30日,运用RevMan 5.3软件进行统计分析。结果 共纳入8篇RCTs,共计800例患者。Meta分析结果显示:与常规西药治疗(对照组)相比,夏枯草口服药联合常规治疗(试验组)在改善临床有效率方面更为明显[OR=0.13,95% CI=(0.07,0.18),P<0.001],并可以有效降低血清游离三碘甲状腺原氨酸(FT3)[SMD=-0.50,95% CI=(-0.97,-0.03),P=0.04]、血清游离甲状腺素(FT4)[SMD=-0.46,95% CI=(-0.90,-0.02),P=0.04]和促甲状腺素受体抗体(TRAb)水平[SMD=-1.59,95% CI=(-2.19,-0.99),P<0.001],提高血清促甲状腺激素(TSH)水平[SMD=0.82,95% CI(0.12,1.52),P=0.02],缩小甲状腺体积[MD=-0.30,95% CI=(-0.53,-0.06),P=0.01]。安全性评价方面,两组比较差异无统计学意义[OR=0.48,95% CI=(0.19,1.22),P=0.12]。结论 夏枯草口服液可以提高甲状腺功能亢进症的临床有效率,能有效降低FT3、FT4及TRAb水平、缩小甲状腺肿大体积、提高TSH水平。但是受到纳入研究数量和质量的限制,上述结论需要更多的临床RCTs加以验证。
[Key word]
[Abstract]
Objective Systematic evaluation of the clinical efficacy and safety of Prunella vulgaris Oral Liquid in the treatment of hyperthyroidism. Methods A computer search of Chinese academic Journal full-text Database (CNKI), China Biomedical Literature Database (CBM), Wanfang Database (Wanfang Data), VIP Chinese Journal full-text Database (VIP), PubMed, Medline, Embase and CochraneLibrary was conducted to include the clinical randomized controlled trial (RCT) of Prunella vulgaris Oral Liquid in the treatment of hyperthyroidism. The search time limit was from the establishment of the database to April 30, 2021. Statistical analysis was carried out by using RevMan 5.3 software. Results A total of eight randomized controlled trials including 800 subjects were included. Meta-analysis results show that as compared with conventional treatment alone, Prunella vulgaris Oral Liquid combined with conventional treatment is more effective in improving clinical efficiency [OR = 0.13, 95%CI = (0.07, 0.18), P < 0.001], and can effectively reduce serum free triiodo thyroprotinin (FT3) levels [SMD =-0.50, 95%CI = (-0.97,-0.03), P = 0.04], serum free thyroxine (FT4) levels [SMD = -0.46, 95%CI = (-0.90, -0.02), P = 0.04], and thyrotropin receptor antibody (TRAb) levels [SMD =-1.59, 95%CI = (-2.19, -0.99), P < 0.001]; increase serum thyroid stimulating hormone (TSH) levels [SMD = 0.82, 95%CI = (0.12, 1.52), P = 0.02], reduce thyroid volume [MD = -0.30, 95%CI = (-0.53, -0.06), P = 0.01]. 3 studies involved adverse reaction, there was no significant difference between the two groups [OR = 0.48, 95%CI = (0.19, 1.22), P = 0.12]. Conclusion Prunella vulgaris Oral Liquidcan improve the clinical effectiveness of hyperthyroidism, reduce FT3, FT4 and TRAb levels and thyroid volume, and increase the level of TSH. Due to the limitations of quality and quantity of the included studies, this conclusion needs to be verified by high quality research.
[中图分类号]
R286.7
[基金项目]
国家自然科学基金青年科学基金资助项目(81603585,81804070);国家中医药管理局重大疑难疾病中西医临床协作试点项目(2018)