Clinical Study On The Effectiveness Of DNG in Treating Endometriosis
DNG was first reported to be used in the treatment of endometriosis patients in 1987. Köhler et al. selected 57 patients with endometriosis and administered DNG 2 mg orally every day for 6 months. Secondary exploration was performed on 51 patients. The results showed that 67 The lesions disappeared in 100% of the patients, and the symptoms of 84% of the patients improved; the main side effects were spotting and decreased libido, and no patient terminated the treatment due to side effects. However, at the time, this research was not taken seriously. It was not until 1998, when Katsuki et al. confirmed the effectiveness of DNG in treating endometriosis through animal experiments and explored the mechanism of action, that DNG began to be paid attention to. Subsequently, Japanese and European scholars conducted in-depth research on DNG through clinical trials such as dose control, placebo control, other drug control, and long-term drug treatment, and found that DNG is highly effective in controlling pain and inhibiting the development of lesions. At the same time, side effects The incidence rate of the drug is very low, and the patient's tolerance is high. It is a promising new drug for the treatment of endometriosis.
Köhler et al. conducted a 24-week randomized open study in Europe. 68 patients with endometriosis diagnosed by laparoscopy were randomly divided into 3 groups, and the doses of oral DNG in the 3 groups were 1 mg once a day and 2 mg a day. 1 time, 4mg once a day, the 1mg group terminated the test early due to irregular vaginal bleeding, the patients in the 2mg group and 4mg group had significant improvement in dyspareunia, dysmenorrhea and diffuse pelvic pain; the main side effect was irregular vaginal bleeding, but with The medication time is prolonged, the side effects are relieved, and can be tolerated by patients.
Momoeda and Taketani found through a randomized double-blind multi-center parallel study that 2 mg and 4 mg had similar curative effects on endometriosis; at the end of treatment, the serum estradiol levels of patients in the 1 mg, 2 mg and 4 mg groups were 309.27, 136.88 and 95.89, respectively. pmol/L. Considering that when the estrogen level is 109.8-183.0 pmol/L (30-50 pg/ml), it can inhibit the growth of the endometrium and at the same time minimize the side effects of low estrogen such as bone loss, etc., the dose of 2 mg is more recommended. Most studies believe that a dose of 2-3mg/d can effectively treat endometriosis, and at the same time have few side effects and high tolerance, and can be used for long-term drug treatment of endometriosis.
GnRH-a has been widely used all over the world as the "standard therapy" for the treatment of endometriosis. How does DNG compare to it? Strowitzki et al used a randomized controlled study to compare the effects of DNG and GnRH-a, and treated 252 patients with endometriosis with DNG (2mg/d orally) and leuprolide (3.75mg, every 28 days, deep intramuscular injection) , the treatment time was 24 weeks, and the visual analogue scale (VAS) was used to score the pain. The VAS score of the DNG group was reduced by 4.75 points, and the leuprolide group was reduced by 4.60 points. There was no significant difference in the score and the Health Survey Short Form (SF-36) score; however, the incidence of low-estrogen side effects such as hot flashes, irregular vaginal bleeding, and bone loss were significantly reduced in the DNG group, and the tolerance was higher. Harada et al. used DNG (2 mg/d orally) and buserelin (300 μg 3 times a day, intranasally) to treat endometriosis through a multicenter double-blind randomized controlled trial and achieved similar results.
DNG has shown good clinical efficacy in relieving endometriosis pain. In a 65-week placebo-controlled study in Europe with 168 patients, it was found that the degree of pelvic pain in patients taking DNG was significantly reduced. At the end of the study, the VAS score of the placebo group dropped to 3.41 points, while The VAS score of the DNG group dropped to 1.15 points. The study also followed up the patients for 24 weeks after the end of the study, and found that the disease in the DNG group had no significant progression, suggesting that its therapeutic effect can still be maintained for a period of time after the drug is stopped.
