Objective To assess the efficacy and safety of Guizhifuling capsule versus western medicine in the treatment of uterine myoma. Methods Randomized controlled trials (RCTs) involving Guizhifuling capsule versus western medicine in the treatment of uterine myoma were identified from CBM (1978 to 2009), VIP (1989 to 2009), WANFANG Database (1998 to 2009), CNKI (1979 to 2009). We also manually searched relevant journals from Tianjin University of Traditional Chinese Medicine. Data were extracted and evaluated by two reviewers independently with a specially designed extraction form. The Cochrane Collaboration’s RevMan 5.0.22 software was used for data analyses. Results A total of 8 trials involving 798 patients were included. The results of meta-analyses showed that, a) the mean uterine myoma volume in the experimental group was different when compared with the mifepristone group (WMD= 0.64, 95%CI 0.56 to 0.71); b) no difference was found between the experimental group and the mifepristone group in serums hormone level, such as, follicle-stimulating hormone (WMD= 2.40, 95%CI –?3.09 to 7.89), luteinizing hormone (WMD= 1.22, 95%CI –?1.05 to 3.49), estriol (WMD= 11.07, 95%CI –?7.70 to 29.84), and P (WMD= 0.52, 95%CI –?0.33 to 1.37); c) As for clinical symptoms effective rate, significant difference was noted between the experimental group and the mifepristone group, such as, menorrhagia (RR= 0.49, 95%CI 0.25 to 0.94), dysmenorrheal (RR= 0.12, 95%CI 0.04 to 0.38), and bellyache and abdominal distension (RR= 0.28, 95%CI 0.12 to 0.62); d) In terms of the total effective rate, significant differences were noted between the experimental group and the mifepristone group (RR= 1.16, 95%CI 1.02 to 1.32); and e) Four trials reported the long-term follow-up results in which the experimental group was better than that in the control group.Conclusion The treatment of uterine myoma by Guizhifuling capsule plus mifepristone is superior to that by mifepristone alone in reducing uterine myoma volume, clinical symptom, and long-term follow-up results. Singly using Guizhifuling capsule is not inferior to western medicine. Further large-scale trials are required to define the role of Guizhifuling capsule in the treatment of uterine myoma.
【摘要】 目的 探讨左炔诺孕酮宫内释放系统联合桂枝茯苓胶囊治疗子宫腺肌病的疗效。 方法 2006年2月-2010年2月108例子宫腺肌病患者随机分为观察组（n=56）与对照组（n=52），观察组患者宫内放置左炔诺孕酮宫内释放系统，同时口服中成药桂枝茯苓胶囊，3粒/次，3次/d，连服6个月。对照组单放置左炔诺孕酮宫内释放系统进行治疗，观察月经量、痛经程度、子宫体积及血清CA125水平变化。 结果 6个月后，观察组患者痛经明显缓解，月经量显著减少，子宫体积缩小，血清CA125水平明显降低，治疗前后比较，差异均有统计学意义（Plt;0.05）；与对照组比较，痛经评级、子宫体积缩小、血清CA125水平差异均有统计学意义（Plt;0.05）。 结论 左炔诺孕酮宫内释放系统与桂枝茯苓胶囊联合治疗子宫腺肌病安全有效，满意度高，值得临床推广应用。【Abstract】 Objective To evaluate the therapeutic effect of levonorgestrel-releasing intrauterine system (LNG-IUS) combined with Guizhi Fulin capsules treating adenomyosis. Methods A total of 108 patients with adenomyosis diagnosed in our hospital from February 2006 to February 2010 were randomly divided into the observation group (n=56) and the control group (n=52). The patients in the observation group were treated with LNG-IUS and simultaneously administrated orally with the Guizhi Fulin capsules (three capsules per time, three times per day for six continuous months). The patients in the control group were treated with LNG -IUS only. The changes of the menstrual blood volume, severity of dysmenorrhea, uterine volume and the level of serum CA125 were observed and evaluated. Results After six months’ treatment, dysmenorrhea of all the patients was obviously alleviated, the menstrual blood volume reduced significantly, the uterine volume shrank, and the level of serum CA125 decreased significantly; the results after the treatment differed much from that before the treatment (Plt;0.05). Compared with those in the control group, the differences in the grades of the dysmenorrheal, shrinkage of the uterine volume and the level of serum CA125 were statistically significant (Plt;0.05). Conclusion Combined usage of LNG-IUS and Guizhi Fulin capsules is an effective and safe way treating adenomyosis.