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目的了解宫瘤消对子宫肌瘤患者的临床疗效及其安全性。方法根据标准选取子宫肌瘤患者进行多中心试验,入选患者101例,应用宫瘤消胶囊治疗,观察其疗效及安全性。结果 101例患者中9例临床痊愈、18例显效、41例有效,总有效率为67.3%。患者治疗前后症状评分分别为(7.0±0.3)分和(3.9±0.2)分,治疗前后肌瘤瘤体大小平均(2.3±0.8)cm和(2.1±1.1)cm,差异均有统计学意义(P<0.001)。在对不同年龄和病情轻重的患者治疗中,宫瘤消的疗效无显著差异(P>0.05)。出现不良反应6例,其中2级不良反应4例、4级2例,为轻度腹痛或腹胀,不良反应均于停药后消失。结论宫瘤消胶囊对子宫肌瘤有一定疗效,不良反应较小,特别适于肌瘤较小的患者。
Objective To understand the clinical efficacy and safety of Gong’s tumor in patients with uterine fibroids. Methods According to the criteria of multi-center trial of patients with uterine fibroids, 101 patients were enrolled in the study, and Gongyouxiao capsule was used to treat them. The curative effect and safety were observed. Results Of the 101 patients, 9 were clinically cured, 18 were markedly effective, 41 were effective, and the total effective rate was 67.3%. The scores of symptoms before and after treatment were (7.0 ± 0.3) and (3.9 ± 0.2) points, respectively. The average size of fibroids was (2.3 ± 0.8) cm and (2.1 ± 1.1) cm before and after treatment, respectively P <0.001). In the treatment of patients of different ages and severity, there is no significant difference (P> 0.05). There were 6 cases of adverse reactions, including 2 cases of adverse reactions in 4 cases, 4 cases in 2 cases, mild abdominal pain or bloating, adverse reactions disappeared after withdrawal. Conclusion Palace tumor Xiao capsule on uterine fibroids have a certain effect, adverse reactions smaller, especially for patients with small fibroids.