Objective  To evaluate the safety and efficacy of Relinqing granules in real-world clinical settings and to provide data-based guidance for optimizing clinical dosing regimens and improving rational drug use.

Methods  Open and phase IV clinical trials were conducted in 51 hospitals, with participants suffering from simple or complex urinary tract infections(UTI) caused by dampness and heat in the lower energizer. Patients with simple UTI were given 8 g of Relinqing granules three times a day for 5 days. Patients with complex UTI were given 8 g of Relinqing granules three times a day, in combination with quinolone antibiotics, for a course of 7~14 days. The outcome indicators were clinical efficacy, traditional Chinese medicine syndrome efficacy, bacterial clearance rate, and safety.

Results  A total of 2 009 subjects were included, of which 11 patients were lost to follow-up and dropped out. A total of 1 998 cases were included in the full analysis set, including 1 532 patients with simple UTI and 466 patients with complex UTI. The clinical cure rate was 68.57%, with 74.41% and 49.36% for patients with simple and complex UTI, respectively. The cure rate of traditional Chinese medicine syndrome was 72.22%, with 75.13% and 62.66% for patients with simple and complex UTI, respectively. The bacterial conversion rate of patients with positive bacterial culture and bacterial clearance rate in simple UTI were 57.75% and 58.02%, respectively; The bacterial conversion rate of patients with positive bacterial culture in complex UTI was 45.59%, and the bacterial clearance rate was 43.92%. There were 24 cases of drug-related adverse reactions, including 17 cases of simple UTI and 7 cases of complex UTI.

Conclusion  Relinqing granules have good effectiveness and safety in treating simple UTI, and can also improve the traditional Chinese medicine syndrome of damp heat syndrome in the lower energizer.

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