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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2024, Vol. 29 ›› Issue (5): 527-534.doi: 10.12092/j.issn.1009-2501.2024.05.007

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Comparison of clinical effectiveness and safety between generic and branded dienogest tablets in the treatment of endometriosis

LIU Qian, ZHANG Jianing, ZHANG Shuang, LIU Qinglan, ZHANG Baoyin, SUN Nan   

  1. Department of Pharmacy, Third Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, Henan, China
  • Received:2023-11-06 Revised:2023-11-28 Online:2024-05-26 Published:2024-04-16

Abstract:

AIM: To evaluate the clinical effectiveness and safety of generic and branded dienogest in the treatment of endometriosis. so as to provide the basis for clinical use of dienogest. MEHTODS: The data of patients admitted to Third Affiliated Hospital of Zhengzhou University from August 2022 to August 2023 who received dienogest (2 mg/d, orally, for 6 months) for treatment of endometriosis were collected. The clinical efficacy and adverse reactions of generic drugs and original drugs in the treatment of endometriosis-related pain were compared through follow-up surveys of the two groups of patients at 3 months and 6 months respectively. RESULTS: There was highly significant reduction in pelvic pain in both groups with mean of similar in generic group (34.0±3.0) mm and branded group (34.5±3.9) mm. The most frequent drug-related adverse effects in generic dienogest was vaginal bleeding (93%) which was no statistical difference with branded dienogest (90%). CONCLUSION: The generic and branded dienogest have the same clinical effectiveness and similar safety.

Key words: dienogest, generic drugs, branded drugs,  endometriosis

CLC Number: