[The efficacy and safety of domestic luteinizing hormone-releasing hormone analogue and low-dose norethindrone "add-back" therapy in the treatment of endometriosis].

OBJECTIVE: To study the efficacy and safety of combining domestic luteinizing hormone-releasing hormone analogue(LHRH-a) with low-dose norethindrone in the treatment of endometriosis. METHODS: Seventy-seven women with endometriosis were randomized into one of the following two groups. Group A (n = 36) were treated with LHRH-a (150 micrograms/d, i.m.) plus norethindrone (2.5 mg/d, p.o.) and group B (n = 41) received only LHRH-a (150 micrograms/d, i.m.) for 3 to 6 months. Symptoms and signs were recorded before and after the treatment. Liver and renal functions, lipid and bone metabolism and speed of sound (SOS) in the tibia were also examined at the same time. All data were analyzed using paired and grouped Student's t-tests. RESULTS: Total subjective symptom scores of group A showed 82% decrease at 3 months and 94% at 6 months of treatment (P < 0.01). Reductions in endometriotic foci were 34% and 61% at 3 and 6 months, respectively (P < 0.01). Of group B, there were 77% and 90% decreases in total subjective symptom scores at 3 and 6 months of treatment (P < 0.01). Reductions of 37% and 38% in endometriotic foci were observed at 3 and 6 months, respectively (P < 0.01). Liver and renal functions and fast blood sugar of both groups were all in normal range. Triglyceride (TG), apolipoproteinA (ApoA), serum calcium, phosphorus and alkaline phosphatase levels of group B increased significantly after treatment. And significant differences between the two groups were observed. There's no change of SOS in the tibia within or between the two groups before and after treatment. The percentages of hemorrhage in the group A and B were 18% and 38%, respectively. The percentages of hot flush and the other vasomotor symptoms were 14% and 41%, respectively (P < 0.01). CONCLUSIONS: Domestic LHRH-a combined with low-dose norethindrone was effective in the treatment of endometriosis. It could also improve the symptom of hypoestrogenemia, decrease hemorrhage rete and bone turn-over.