[Lingze Tablets for BPH with kidney-deficiency, blood stasis and dampness resistance: A phase-Ⅳ open-label single-arm multicenter clinical study and safety evaluation]

Autor: Shao-Ying, Yuan, Xiao-Yong, Gong, Xiao-Jun, Huang, Shao-Bo, Jiang, Chao-Ba, He, Yang, Wang, Li-Guo, Geng, Zhao-Lei, Zhang, Wei-Guang, Wang
Rok vydání: 2021
Předmět:
Zdroj: Zhonghua nan ke xue = National journal of andrology. 27(8)
ISSN: 1009-3591
Popis: To evaluate the efficacy and safety of Lingze Tablets in the treatment of BPH with kidney deficiency, blood stasis and dampness resistance.Totally 235 eligible BPH patients, aged 50-80 years and meeting the inclusion criteria, were enrolled and treated with Lingze Tablets orally, 4 tablets per time, tid. Before and after an 8-week course of medication, IPSS, quality of life (QOL) and TCM syndromes scores were obtained from the patients.Of the total number of patients, 211 completed the whole course of treatment. Compared with the baseline, the IPSS was dramatically reduced after 4 and 8 weeks of medication (18.28 ± 5.29 vs 12.82 ± 4.66 and 9.23 ± 4.21, P0.01), and so were the QOL scores (6.44 ± 1.99 vs 4.95 ± 1.64 and 3.16 ± 1.53, P0.01) and TCM syndromes scores (17.49 ± 5.30 vs 12.45 ± 3.74 and 9.17 ± 3.24, P0.01). The incidence rates of adverse events and drug-related adverse reactions were 15.2% and 1.9%, respectively, and no organ function impairment was observed.Lingze Tablets are definitely effective and safe for the treatment of BPH with kidney deficiency, blood stasis and dampness resistance.
Databáze: OpenAIRE