中药熏洗联合西药治疗系统性硬化症合并肺动脉高压的疗效观察

Efficacy Observation of Chinese Herbal Fumigation Combined W estern Drugs for Treating Systemic Sclerosis Complicated Pulmonary Arterial Hypertension

目的研究中药熏洗联合来氟米特(leflunomide,LEF)及泼尼松(prednisone,Pred)治疗系统性硬化症(systemic sclerosis,SSc)合并早期肺动脉高压(pulmonary arterial hypertension,PAH)的疗效及安全性。方法随机将99例SSc合并早期PAH患者随机分为西药组(49例)、中西医结合组(50例),西药组给予LEF 20mg及Pred 15mg,口服,每日1次。中西医结合组在西药组治疗方案基础上行活血祛瘀中药熏洗治疗。两组治疗各进行6个月。在治疗前及治疗后,分别观察两组雷诺现象(Raynaud′s Phenomenon,RP),比较两组治疗前后RP积分、红细胞沉降率(erythrocyte sedimentation rate,ESR)、C反应蛋白(C reactive protein,CRP)、肺动脉收缩压(pulmonary artery systolic pressure,PASP)及肺功能水平,并评价临床疗效和观察不良反应。结果因各种原因流失13例,共86例完成试验,西药组41例,中西医结合组45例。与本组治疗前比较,两组治疗后RP积分降低,ESR、CRP水平明显降低(P<0.05);与西药组治疗后比较,中西医结合组治疗后RP积分、ESR、CRP水平降低,且ESR、CRP及PASP降低差值更多,而肺总量(total lung capacity,TLC)、一氧化碳弥散量(carbon monoxide diffusing capacity,DLCO)水平升高差值更多(P<0.05)。中西医结合组治疗后总有效率[93.33%(42/45)]明显高于西药组[70.73%(29/41)],差异有统计学意义(P<0.05)。两组总不良反应发生率比较,差异无统计学意义(χ2=0.019,P=0.891)。结论中药熏洗外治联合西药治疗SSc合并PAH,疗效明显,不良反应少,值得临床推广。

Objective To observe the therapeutic efficacy and safety of Chinese herbal fumigation combined with leflunomide （LEF） and prednisone （Pred） in treatment of systemic sclerosis （SSc） complicated pulmonary arterial hypertension （PAH）. Methods Totally 99 SSc patients complicated early PAH were randomly assigned to the Western drugs group （WD, 49 cases） and the integrative medicine group （IM, 50 cases）. Patients in the WD group took LEF （20 mg） and Pred （15 mg）, once per day. In addition to routine WD program, those in the IM group additionally received Chinese herbal fumigation. All treatment lasted for 6 months. Raynaud＇s phenomenon （RP） was observed in each group before and after treatment. RP score, erythrocyte sedimentation rate （ESR）, C reactive protein （CRP）, pulmonary arterial systolic pressure （PASP）, and pulmonary function were compared between the two groups before and after treatment. The clinical efficacy and adverse reactions were evaluated. Results Thirteen cases were lost due to various reasons. A total of 86 patients completed this study, 41 in the WD group and 45 in the IM group. Compared with the same group before treatment, RP score, levels of ESR and CRP all decreased in the two groups after treatment （P 〈0.05）. Compared with the WM group after treatment, RP score, levels of ESR and CRP were obviously lowered in the IM group after treatment （P 〈 0.05）. Besides, lowered differences between post-pre-values of ESR, CRP, and PASP were more obviously higher, while elevated differences between post-pre-values of total lung capacity （TLC） and carbon monoxide diffusing capacity （DLCO） were more obviously higher in the IM group （P 〈0.05）. The total effective rate was 93.33% （42/45） in the IM group, obviously higher than that in the WD group E70.73% （29/41）, P 〈0.051. There was no statistical difference in total adverse reaction rate between the two groups （X2 =0.019, P =0,891 ）, Conclusion Chinese herbal fumigation combined with WD had obvious efficacy with less adverse reactions, so it was worth clinical spread.