目的系统评价复方血栓通胶囊治疗青光眼的临床疗效及安全性。方法全面检索中国知网、万方数据库、维普中文科技期刊全文数据库、中国生物医学文献服务系统数据库,以及PubMed、the Cochrane Library、Web of Science外文数据库,检索时间...目的系统评价复方血栓通胶囊治疗青光眼的临床疗效及安全性。方法全面检索中国知网、万方数据库、维普中文科技期刊全文数据库、中国生物医学文献服务系统数据库,以及PubMed、the Cochrane Library、Web of Science外文数据库,检索时间段均为从各数据库建立至2021年5月8日。纳入使用复方血栓通胶囊治疗青光眼的随机对照试验。使用Cochrane手册评估研究的内容是否存在偏倚风险,使用RevMan 5.3软件对包括总有效率、总灰度值、眼血流动力学指标(收缩期峰值流速、舒张末期血流速度、搏动指数、阻力指数)、光敏度、缺损度等结局指标进行Meta分析,并同时评价安全性。结果共纳入16项研究,涉及研究对象1482例。纳入的研究总体方法学质量偏低。Meta分析结果显示,与对照组相比,治疗组可显著提高青光眼患者的临床治愈率[RR=1.23,95%CI(1.18,1.29),P<0.01],降低灰度值范围[MD=-63.99,95%CI(-66.49,-61.48),P<0.01],提高眼部血管收缩期峰值流速[MD=2.29,95%CI(2.10,2.47),P<0.01]、舒张末期血流速度[MD=1.79,95%CI(1.43,2.16),P<0.01],降低眼部血管的搏动指数[MD=-0.27,95%CI(-0.34,-0.21),P<0.01]和阻力指数[MD=-0.18,95%CI(-0.20,-0.15),P<0.01],增加光敏度[MD=5.36,95%CI(4.47,6.24),P<0.01]和减少缺损度[MD=3.04,95%CI(2.78,3.30),P<0.01]。仅有4项研究报道了不良事件发生情况。结论复方血栓通胶囊联合常规干预或复方血栓通单独治疗青光眼可一定程度上提高临床总有效率,改善血流动力学指标,提高患者视野水平,且未见严重不良反应事件。展开更多
Fufang Xueshuantong （FXT） is a well-known Chinese herbal formula which has been used to treat car- diovascular and ophthalmic diseases, especially diabetic retinopathy. Panax notoginseng （Burkill） F.H. Chen （PN）...Fufang Xueshuantong （FXT） is a well-known Chinese herbal formula which has been used to treat car- diovascular and ophthalmic diseases, especially diabetic retinopathy. Panax notoginseng （Burkill） F.H. Chen （PN） is the main herb of FXT, whose major bioactive constituents are ginsenosides. However, the scientific basis of the compatibility of FXT is still ambiguous. The present study investigated the scientific basis of the compatibility of FXT by comparing the pharmacokinetics of marker compounds after oral administrations of PN and FXT. A high performance liquid chromatography-electrospray ionization tandem mass spectrometry （HPLC-ESI-MS/MS） method was devel- oped for simultaneous detection of notoginsenoside R1 （NR1）, ginsenoside Rgl （GRgl）, and ginsenoside Rbl （GRbl） in rat plasma. The pharmacokinetic studies of FXT and PN were performed using the established method with the pharmacokinetic parameters being determined by non-compartmental analysis. The results showed that the phar- macokinetic parameters （maximum concentration, area under the curve （AUC0-t）, clearance, and mean residence time） of NR1, GRgl, and GRbl were significantly different after oral administration of FXT （P〈0.05） compared with PN. The AUO0-t values of GRgl and GRbl were 1.7- and 3.4-fold greater, respectively, in FXT than in PN. The compatible herbs of FXT could prolong the retention time and increase the systemic exposure of NR1, GRgl, and GRbl compared with PN in vivo, providing some scientific basis for the compatibility and clinical use of FXT.展开更多
基金supported by the Ministry of Science and Technology of China(No.2011ZX09201-201-22)
文摘Fufang Xueshuantong （FXT） is a well-known Chinese herbal formula which has been used to treat car- diovascular and ophthalmic diseases, especially diabetic retinopathy. Panax notoginseng （Burkill） F.H. Chen （PN） is the main herb of FXT, whose major bioactive constituents are ginsenosides. However, the scientific basis of the compatibility of FXT is still ambiguous. The present study investigated the scientific basis of the compatibility of FXT by comparing the pharmacokinetics of marker compounds after oral administrations of PN and FXT. A high performance liquid chromatography-electrospray ionization tandem mass spectrometry （HPLC-ESI-MS/MS） method was devel- oped for simultaneous detection of notoginsenoside R1 （NR1）, ginsenoside Rgl （GRgl）, and ginsenoside Rbl （GRbl） in rat plasma. The pharmacokinetic studies of FXT and PN were performed using the established method with the pharmacokinetic parameters being determined by non-compartmental analysis. The results showed that the phar- macokinetic parameters （maximum concentration, area under the curve （AUC0-t）, clearance, and mean residence time） of NR1, GRgl, and GRbl were significantly different after oral administration of FXT （P〈0.05） compared with PN. The AUO0-t values of GRgl and GRbl were 1.7- and 3.4-fold greater, respectively, in FXT than in PN. The compatible herbs of FXT could prolong the retention time and increase the systemic exposure of NR1, GRgl, and GRbl compared with PN in vivo, providing some scientific basis for the compatibility and clinical use of FXT.
