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目的观察生血灵系列制剂治疗激素抵抗型原发免疫性血小板减少症(ITP)的临床疗效。方法将激素抵抗型ITP患者60例随机分为治疗组30例(给予生血灵系列辨证联合小剂量糖皮质激素治疗)和对照组30例(给予环孢素联合小剂量激素治疗)。两组均以3个月为1个疗程,治疗2个疗程后观察两组治疗前后血小板计数(PLT)、出血评分,并评价西医临床疗效、中医证候疗效及不良反应。结果两组治疗后较治疗前比较,PLT升高、中医证候积分及出血评分降低(P<0.01),且治疗组治疗后PLT较对照组升高明显、中医证候积分降低明显(P<0.01)。治疗组西医临床疗效总有效率80.0%,对照组总有效率43.3%,治疗组明显高于对照组(P<0.01)。治疗组中医证候疗效总有效率86.67%,对照组为50.00%,治疗组优于对照组(P<0.01)。结论生血灵系列制剂治疗激素抵抗型ITP疗效优于环孢素软胶囊,可明显改善患者的出血症状,与环孢素作用相似,而不良反应明显低于环孢素。
Objective To observe the clinical efficacy of Shengxueling series in the treatment of steroid-resistant primary immune thrombocytopenia (ITP). Methods Sixty patients with steroid-resistant ITP were randomly divided into treatment group (30 cases treated with Sheng Xue Ling Syndrome combined with low-dose glucocorticoid therapy) and control group (given cyclosporine combined with low-dose steroid treatment). Both groups were treated with 3 months as a course of treatment. After 2 courses of treatment, the platelet count (PLT) and bleeding score of the two groups were observed before and after treatment. The clinical efficacy of Western medicine, the efficacy of traditional Chinese medicine and adverse reactions were evaluated. Results After treatment, PLT increased, TCM syndrome score and bleeding score decreased (P <0.01), and PLT in treatment group increased significantly after treatment compared with control group, while TCM syndrome score decreased significantly (P < 0.01). The total effective rate of western medicine in treatment group was 80.0%, while the total effective rate in control group was 43.3%. The treatment group was significantly higher than that of control group (P <0.01). The total effective rate of TCM syndromes in the treatment group was 86.67%, while that in the control group was 50.00%. The treatment group was superior to the control group (P <0.01). Conclusion Shengyuling series of preparations of hormone-refractory ITP better than cyclosporine soft capsules, can significantly improve the patient’s bleeding symptoms, similar to cyclosporine, and adverse reactions was significantly lower than cyclosporine.