1.Clinical Observation of Leuprorelin Acetate in the Treatment of Endometriosis
Yufang ZHANG ; Yao LIN ; Xiuying LU ; Zhishan CAI
China Pharmacy 2016;27(26):3675-3677
OBJECTIVE:To discuss clinical efficacy and safety of leuprolide acetate in the treatment of endometriosis. METH-ODS:66 endometriosis patients were divided into observation group(37 cases)and control group(29 cases)according to random number table method. Observation group was treated with Leuprolide acetate microsphere for injection,3.75 mg/time,on the upper arm,abdomen or buttocks since the first-fifth day of menstrual cycle(administration time was available at hysterectomized patients disposal),and then every 4 weeks;one administration was recognized as a treatment course. Control group was treated with Ethi-nyl estradiol cyproterone tablet orally,1 tablets per day for 3 weeks,one week drug withdrawal,as a treatment course. 2 groups were given 3-5 courses of treatment according to their tolerance or the improvement of clinical symptoms. The improvement of clini-cal symptoms were compared between 2 groups,and the levels of FSH,LH and E2 were compared before and after treatment;the occurrence of ADR and the time of the return of menses were recorded. RESULTS:2 patients in observation group and 1 patient in control group withdrew from the test. After treatment,total effective rate was 97.14% in observation group,which was significant-ly higher than 75.00% in control group,with statistical significance (P<0.05). Before treatment,there was no statistical signifi-cance in the levels of FSH,LH and E2 between 2 groups (P>0.05). After treatment,the levels of FSH,LH and E2 were de-creased significantly,and the observation group was more significant than the control group,with statistical significance (P<0.05). Total incidence of ADR was 20.00% in observation group,compared to control group (21.42%),there was no statistical significance (P>0.05). The time of the return of menses in observation group was (89.75 ± 3.34) d after drug withdrawal,com-pared to control group [(88.46±2.94)d],there was no statistical significance(P>0.05). CONCLUSIONS:Leuprolide acetate can effectively improve clinical symptoms of patients with endometriosis,and reduce the levels of FSH,LH and E2 with slight ADR, and it doesn’t influence the time of the return of menses.
2.Clinical study on the treatment of spleen deficiency and phlegm stasis syndrome in alcoholic cirrhosis with Qinggan Huashi Huoxue Decoction and conventional western medicine
Shuxian LI ; Shuanhu LIU ; Zhishan YAO ; Yuxiang MAO
International Journal of Traditional Chinese Medicine 2023;45(9):1086-1090
Objective:To evaluate the efficacy of Qinggan Huashi Huoxue Decoction combined with conventional Western medicine in the treatment of alcoholic cirrhosis with spleen deficiency and phlegm stasis syndrome.Methods:Randomized controlled trial. A total of 110 patients from Tangshan Fengrun District Hospital of Traditional Chinese Medicine from March 2020 to March 2022 were selected as observation objects and divided into 2 groups with 55 patients in each group by computer random drawing method. The control group was treated with conventional Western medicine, while the observation group was treated with Qinggan Huashi Huoxue Decoction on the basis of the control group treatment. Both groups were treated for 3 months. The traditional Chinese medicine syndrome score was performed before and after treatment, and the levels of proline peptidase (PLD), type Ⅳ collagen (Ⅳ-C) and type Ⅰ procollagen aminopeptidase (PINP) were detected by phthalaldehyde contrast colorimetry, and the levels of pentamylin 3 (PTX3), protein kinase B (Akt) and B cell activating factor receptor (BAFF-R) were determined by ELISA. Adverse events were recorded and clinical efficacy was evaluated.Results:The total effective rate in the observation group was 92.73% (51/55), while that in the control group was 76.36% (42/55), the difference between the two groups was statistically significant ( χ2=5.64, P=0.018). After treatment, the score and total score of costal pain and fullness, swelling and firmness, anorexia, white and greasy tongue coating in the observation group were significantly lower than those in the control group ( t values were 11.02, 7.36, 7.47, 6.38, 9.37, respectively, P<0.01). After treatment, the levels of serum PLD[(143.28±16.38)U/L vs. (160.69±18.35)U/L, t=5.25], Ⅳ-C[(71.93±8.33)μg/L vs. (83.12±9.91)μg/L, t=6.41], and PINP[(32.36±5.32)ng/L vs. (39.02±5.61)ng/L, t=6.39] in the observation group were significantly lower than those in the control group ( P<0.01); The levels of PTX3[(36.82±4.96)ng/L vs. (42.14±5.83)ng/L, t=5.15], Akt[(69.22±7.94)ng/L vs. (77.24±8.63)ng/L, t=5.07], and BAFF-R[(15.29±3.64)ng/L vs. (19.92±4.15)ng/L, t=6.22] in the observation group were significantly lower than those in the control group ( P<0.01). During the treatment period, the incidence of adverse reactions was 12.73% (7/55) in the observation group and 9.09% (5/55) in the control group, with no statistically significant difference between the two groups ( χ2=0.37, P=0.541). Conclusion:Qinggan Huashi Huoxue Decoction combined with conventional Western medicine therapy can improve the Traditional Chinese Medicine syndrome and the degree of liver fibrosis damage in patients with alcoholic cirrhosis with spleen deficiency and phlegm stasis syndrome, inhibit the expression of serum inflammatory factors, and improve clinical efficacy.