白芍总苷辅助治疗系统性硬化症的临床观察

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目的研究白芍总苷(TGP)治疗系统性硬化症(SSc)的临床疗效和安全性。方法将50例SSc患者随机分为TGP联合西药治疗组(简称联合组)和单纯西药对照组(简称对照组),治疗24周。观察患者改良Rodnan积分、关节功能积分、齿距、双手握力、手指温度、IgG水平、24 h尿蛋白、肺弥散功能,并监测药物不良反应。结果联合组的总有效率92.0%(23/25)明显高于对照组68.0%(17/25),两组总有效率比较,差异有统计学意义(χ~2=4.5,P<0.05);联合组患者的齿距、手指温度、Ig G水平、24 h尿蛋白在治疗12周后即较治疗前明显改善(P<0.05,P<0.01),而对照组的上述4个指标在24周后较治疗前有明显改善(P<0.05,P<0.01);在治疗24周后,联合组患者的齿距、手指温度、双手握力明显高于对照组,IgG水平、24 h尿蛋白明显低于对照组(P<0.05,P<0.01)。两组肺弥散功能的改善差异无统计学意义(P>0.05)。联合组无肝功能损害(简称肝损)的发生,明显低于对照组[20%(5/25)]。结论 TGP辅助治疗SSc,较单用西药总有效率高,加快且优化24周后的疗效,降低肝损的发生率。 Objective To study the clinical efficacy and safety of total glucosides of paeony (TGP) in the treatment of systemic sclerosis (SSc). Methods Fifty patients with SSc were randomly divided into two groups: TGP combined with western medicine treatment group (abbreviated as combined group) and western medicine control group (referred to as control group) for 24 weeks. The patients were assessed for Rodnan score, joint function score, tooth pitch, two-handed grip, finger temperature, IgG level, 24 h urinary protein, pulmonary diffuse function, and drug adverse reactions. Results The total effective rate in the combination group was 92.0% (23/25), significantly higher than that in the control group (68.0%, 17/25). There was significant difference between the two groups (χ ~ 2 = 4.5, P <0.05) (P <0.05, P <0.01). In the control group, the indexes of tooth pitch, finger temperature, IgG level and 24 h urine protein were significantly improved after treatment for 12 weeks (P <0.05, P <0.01) (P <0.05, P <0.01). After 24 weeks of treatment, the tooth pitch, finger temperature and two-handed grip strength of the patients in the combined group were significantly higher than those in the control group. The levels of IgG and 24 h urinary protein were significantly increased Lower than the control group (P <0.05, P <0.01). There was no significant difference between the two groups in improvement of pulmonary function (P> 0.05). The incidence of liver dysfunction (referred to as liver damage) in the combined group was significantly lower than that in the control group [20% (5/25)]. Conclusion TGP adjuvant treatment of SSc, compared with the single total effective high Western medicine, accelerate and optimize the effect after 24 weeks, reduce the incidence of liver damage.
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