Zhou Jing, Yang Dong, Zhou Shu-Hong, Wang Jin-Ping, Liu Yue-Shu, Wang Shu-Lan
Department of Immunology and Rheumatology, Gansu Provincial Hospital, Lanzhou, 730000, China.
Department of Traditional Chinese Medicine, Gansu Provincial Hospital, Lanzhou, 730000, China.
Chin J Integr Med. 2018 Mar;24(3):185-192. doi: 10.1007/s11655-017-2954-2. Epub 2017 Feb 15.
To examine the efficacy and safety of bathing therapy with Taohong Siwu Decoction (, TSD) in the treatment of early-stage, mild-moderate diffuse cutaneous systemic sclerosis (dcSSc).
This randomized, placebo-controlled trial enrolled 148 men and women (18-60 years) with dcSSc (disease duration 12 months) and baseline modified Rodnan skin score (MRSS) 10. Patients were randomized into a TSD group (71 cases bathing with TSD plus oral prednisone) or control group (71 cases bathing with placebo plus oral prednisone). Bathing (40 °C, 30 min) of the upper and lower limbs was carried out once daily for 12 consecutive weeks. The primary outcome measure was MRSS; secondary outcomes were Raynaud's phenomenon (RP) score, quality of life (QOL), physician visual analogue scale (VAS), patient VAS, percent predicted diffusing capacity for carbon monoxide (DLCO), percent predicted forced vital capacity (FVC), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) level and overall treatment effect.
The final analysis included 135 patients (control group, 68 cases; TSD group, 67 cases). Primary and secondary outcome measures after 2 weeks of treatment showed no improvement (versus baseline) in both groups, with no differences between groups. At 12 weeks, QOL, physician VAS, patient VAS, ESR and CRP were improved in both groups, but MRSS and RP score were improved only in the TSD group (all P<0.05). MRSS, RP score, QOL, physician VAS, patient VAS, ESR and CRP differed significantly between groups (all P<0.05). Meanwhile, the overall treatment effect was significantly higher in the TSD group than in the control group (P<0.05). Adverse events in the two groups were similar (P>0.05).
Bathing with TSD plus oral prednisone achieves better outcomes than oral prednisone alone in patients with dcSSc and is not associated with serious adverse events.
探讨桃红四物汤药浴疗法治疗早期轻中度弥漫性皮肤型系统性硬化症（dcSSc）的疗效及安全性。
本随机、安慰剂对照试验纳入了148例年龄在18至60岁之间、患有dcSSc（病程≤12个月）且基线改良Rodnan皮肤评分（MRSS）≥10的男性和女性患者。患者被随机分为桃红四物汤组（71例，采用桃红四物汤药浴加口服泼尼松）或对照组（71例，采用安慰剂药浴加口服泼尼松）。上下肢药浴（40℃，30分钟）每天进行1次，连续进行12周。主要结局指标为MRSS；次要结局指标包括雷诺现象（RP）评分、生活质量（QOL）、医生视觉模拟评分（VAS）、患者VAS、一氧化碳弥散量预测值百分比（DLCO）、用力肺活量预测值百分比（FVC）、红细胞沉降率（ESR）、C反应蛋白（CRP）水平及总体治疗效果。
最终分析纳入135例患者（对照组68例；桃红四物汤组67例）。治疗2周后，两组的主要和次要结局指标与基线相比均无改善，且组间无差异。在12周时，两组的QOL、医生VAS、患者VAS、ESR和CRP均有所改善，但仅桃红四物汤组的MRSS和RP评分得到改善（均P<0.05）。两组之间的MRSS、RP评分、QOL、医生VAS、患者VAS、ESR和CRP差异均有统计学意义（均P<0.05）。同时，桃红四物汤组的总体治疗效果显著高于对照组（P<|FunctionCallBegin|>[{"name":"GodelPlugin","parameters":{"input":"N[P<0.05]"}}]<|FunctionCallEnd|><|FunctionCallBegin|>[{"name":"GodelPlugin","parameters":{"input":"0<P<0.05"}}]<|FunctionCallEnd|><|FunctionCallBegin|>[{"name":"GodelPlugin","parameters":{"input":"True"}}]<|FunctionCallEnd|>0.05）。两组的不良事件相似（P>0.05）。
对于dcSSc患者，桃红四物汤药浴加口服泼尼松比单纯口服泼尼松疗效更好且未出现严重不良事件。
