BACKGROUND: Hanshibi granule indicates rheumatism due to blockage of cold and damp.OBJECTIVE: To observe the effects and safety of intervention of hanshibi granule on rheumatism due to blockage of cold and damp and the comparative observation was carried on by taking zhengqingfengtongning as the control drug.DESIGN: Case randomized-controlled observation was designed.SETTING: Luoyang Bone-setting Hospital of Henan Province.PARTICIPANTS: Totally 400 cases of rheumatism due to blockage of cold and damp visited in Luoyang Orthopedic Hospital of Henan Province were volunteered in the observation from May 2000 to February 2002.Hanshibi granule was composed of fuzhi (Radix Aconiti Praeparata),huangqi (Radix Astragali), weilingxian (Radix Clematidis), more than 10 herbs, 10 g each bag. Zhengqing fengtongning tablet is 20 mg each tablet.METHODS: Based on the randomization and sequence of visiting, the cases were divided into observing group and the control at the ratio of 3:1.In the observing group, hanshibi granule was administrated, 1 bag/time,3 times/day, infused with water. In the control, zhengqing fengtongning tablet was administered orally, 2 tablets/time, 3 times/day; 1 week later,if there was no harmful reaction, it was administered 3 tablets/time,3 times/day. For rheumatic arthritis (RA) and ankylosing spondylitis (AS),the drugs were taken for 2 months as 1 course, and for knee osteoarthritis,the drugs were taken for 1 month as 1 course. The changes of ESR, C-reactive protein (CRP) and rheumatic factor (RF) and uric acid (UA) were determined and recorded. Criteria on evaluation: ① Evaluation on therapeutic effects on syndromes: Remarkable effect: the symptoms were improved remarkably after treatment and symptom integral was 0-1 score or decreased by ≥ 2/3. Effect: the symptoms were improved after treatment and the symptom integral was decreased by≥1/3.② Evaluation on therapeutic effects on symptoms: Remarkable effect: The symptom integral was reduced to 0 score or reduced by 2 scores after treatment, such as joint pain, swelling, tender pain, morning stiffness and functional impairment. Effect: the integral was reduced by 1 score after treatment. ③ Evaluation on total therapeutic effects on diseases: Remarkable effect: the symptoms and physical signs disappeared basically, the main laboratory indexes were improved remarkably and reduced by ≥ 50%. Effect: The symptoms and physical signs were alleviated and the main laboratory indexes were improved.MAIN OUTCOME MEASURES:① Total clinical therapeutic effect,therapeutic effect on different symptoms and diseases between two groups.②Safety of hanshibi granule.RESULTS: Totally 400 cases were employed, of which, 300 cases were in observing group and 100 cases in the control. In observing group, 19 cases were dropped out and 281 cases were in the statistics. In the control,6 cases were dropped out and 94 cases were in the statistics.①Comparison of total clinical therapeutic effects between two groups: The total effective rate in the observing group was higher significantly than that in the control (94.31％, 84.04％, P ＜ 0.01). ② Comparison of therapeutic effects on different symptoms between two groups: There was no significant difference in the therapeutic effects on joint pain, swelling,tender pain, functional disturbance and morning stiffness between two groups (P ＞ 0.05). ③ Comparison of therapeutic effects on different diseases between two groups: There was no significant difference in the therapeutic effects on RA, AS and knee osteoarthritis (P ＞ 0.05). ④ Safetyof hanshibi granule: abnormal urine routine for a part of cases before treatment was improved after treatment. ST-T wave alternation in ECG for a part of cases before treatment was not aggravated obviously after medication.CONCLUSION: Both hanshibi granule and zhengqingfengtong tablet, the control drug improves significantly joint pain, swelling, tender pain, functional impairment and morning stiffness in rheumatism due to blockage of cold and damp, in which, the effect of intervention of hanshibi granule is superior to that of the control drug, without obvious harmful reactions;therefore, such drug can be taken as a safe and effective one for rheumatism due to blockage of cold and damp.%背景:寒湿痹颗粒主治寒湿痹阻证风湿病.目的:观察寒湿痹颗粒对寒湿痹阻症风湿病患者的干预效果及安全性,并以正清风痛宁为对照药物,进行对比观察.设计:病例随机对比观察.单位:河南省洛阳正骨医院.对象:选择2000-05/2002-02在河南省洛阳正骨医院就诊的寒湿痹阻型风湿病患者400例,均自愿参加观察.寒湿痹颗粒由附子、制川乌、黄芪、威灵仙等10多种中药组成,每袋10 g;正清风痛宁片规格为每片20 mg.方法:采用随机化原则,根据就诊顺序将病例按观察组:对照组=3:1的比例分配.观察组给予寒湿痹颗粒,1袋/次,3次/d,冲服.对照组给予正清风痛宁片,口服2片/次,3次/d,1周后无不良反应加至3片/次,3次/d.类风湿关节炎和强直性脊柱炎患者服药2个月为1个疗程;膝关节骨关节炎患者服药1个月为1个疗程.检测并记录血沉、C-反应蛋白、类风湿因子、血尿酸等的变化情况.评估标准:①证候疗效评定:显效:治疗后症状明显好转,症状积分0～1分或下降≥2/3;有效:治疗后症状改善,症状积分下降≥1/3.②症状疗效评定:显效为关节疼痛、肿胀、压痛、晨僵和功能障碍等各项症状经治疗症状计分减至0分或减少2分者;有效为经治疗症状计分减少1分者.③疾病总疗效评定:显效:症状、体征基本消失,实验室主要检查指标明显改善,下降度≥50%;有效:症状、体征减轻,实验室主要检查指标有改善.主要观察指标:①两组患者的总临床疗效、不同症状疗效及不同病种疗效.②寒湿痹颗粒的安全检测结果.结果:纳入病例400例,观察组300例,对照组100例.观察组脱落19例,统计病例281例;对照组脱落6例,统计病例94例.①两组患者的总临床疗效比较:观察组总有效率显著高于对照组(94.31%,84.04%,P＜0.01).②两组患者不同症状疗效比较:两组患者在关节疼痛、肿胀、压痛、功能障碍及晨僵等方面的疗效比较,差异均无显著性意义(P＞0.05).③两组患者不同病种疗效比较:两组患者在类风湿关节炎、强直性脊柱炎、膝骨关节炎等不同病种方面进行疗效比较,差异均无显著性意义(P＞0.05).④寒湿痹颗粒的安全检测结果:治疗前有部分患者尿常规异常,经治疗均得改善;部分患者治疗前心电图呈ST-T波改变,服药后无明显加重.结论:寒湿痹颗粒和对照药物正清风痛宁片均可以显著改善寒湿痹阻型风湿病关节疼痛、肿胀、压痛、功能障碍及晨僵等症状,但寒湿痹颗粒的干预效果优于对照药物,且无明显的不良作用,可作为治疗寒湿痹阻型风湿病的一种安全有效的药物.
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