中药膏方外治法治疗乳腺增生用药规律与作用机制的系统回顾与临床疗效Meta-分析

Systematic review on medication rule and mechanism of action and meta-analysis on clinical efficacy of TCM ointment prescriptions in external treatment for mammary gland hyperplasia

目的:总结中药膏方外治法及其联合治疗方案的用药规律与作用机制,比较不同中药膏方外治疗法与常规西医或口服疗法的临床疗效及安全性差异。方法:在数据库中检索近5年基于中药外治法治疗乳腺增生的文献,系统综述中药膏方外治法治疗乳腺增生的用药规律与作用机制。收集有关中药膏方外治法与其他外治法治疗乳腺增生疾病的随机对照试验(RCTs),提取相关数据并应用RevMan 5.3软件进行Meta-分析。结果:中药膏方外治法中常应用疏肝理气、清热凉血的药物。Meta-分析共纳入38项RCTs,分析了7种不同中药外治法治疗乳腺增生的有效率与安全性,结果显示:①中药膏方外敷联合西药口服的有效率(OR=7.44,95%CI=4.29~12.91,P<0.00001)相对于单用西药有明显改善;中药膏方外治联合中药复方内服的有效性(OR=4.30,95%CI=2.96~6.26,P<0.00001)高于单用中药内服;中药贴剂的有效率:(OR=2.55,95%CI=1.51~4.31,P=0.0005)优于常规口服疗法。②中药膏方外敷联合常规西药内服的分析数据存在明显的统计学差异(P=0.03),其余3种联合治疗方案的数据不存在统计学差异(P>0.05)。结论:中药膏方外治法治疗乳腺增生是一种具有前景的治疗方案,系统综述与Meta-分析结果表明,中药外治法相比内治法有效性普遍更高,同时安全性良好。

Objective:To summarize the medication rule and mechanism of action of external treatment of traditional Chinese medicine(TCM)ointment prescriptions and their combined treatment,and compare the efficacy and safety between the external treatment of different TCM ointment prescriptions and routine Western medicine or oral therapy.Method:The literature of external treatment for mammary gland hyperplasia by TCM in the past 5 years were retrieved through the databases,and the medication rule and mechanism of action of the external treatment for mammary gland hyperplasia by TCM ointment prescriptions were systematically reviewed.Randomized controlled trials(RCTs)on external treatment of TCM ointment prescriptions and other external treatments for mammary gland hyperplasia were collected,and relevant data were extracted to use RevMan 5.3 software for meta-analysis.Result:Medicines with the function of relieving the liver,regulating qi,clearing heat and cooling blood were frequently applied in the external treatment of TCM ointment prescriptions.A total of 38 RCTs were included in the metaanalysis,and the efficiency and safety of 7 kinds of external treatments of TCM for mammary gland hyperplasia were analyzed.The results were shown as follow:①The effectiveness(OR=7.44,95%CI=4.29~12.91,P<0.00001)of oral administration of Western medicine combined with external treatment of TCM ointment prescriptions was significantly improved compared with its single application.The effectiveness(OR=4.30,95%CI=2.96~6.26,P<0.00001)of internal administration of TCM compounds combined with external treatment of TCM ointment prescriptions was higher than its single application.The effectiveness(OR=2.55,95%CI=1.51~4.31,P=0.0005)of TCM patch was better than routine oral therapy.②There was a statistically significant difference(P=0.03)in the analysis data of external treatment of TCM ointment prescriptions combined with routine oral administration of Western medicine,while there was no statistically significant difference(P>0.05)in the data of the other three combined treatments.Conclusion:External treatment of TCM ointment prescriptions is a promising treatment for mammary gland hyperplasia.The results of systematic review and meta-analysis show that external treatment of TCM is generally more effective than the internal treatment,and had good safety.