摘要
研究目的 急性痛风性关节炎是骨科常见病、疑难病之一。近年来,随着我国人民生活水平的提高及饮食结构的改变,痛风性关节炎在我国的发病率有明显的上升趋势,发病率在3‰左右,相当于癌的发病率,且严重地影响着人们的身体健康和生活质量。在本病的治疗上,西医多采用消炎、止痛、抑制血尿酸形成或(和)促进血尿酸排泄及对症治疗,但因其有明显的毒副作用,且停用后易复发,故在一定程度上限制了它们的应用。四黄水蜜由广东省中医院研制生产,在治疗湿热型病症所致疼痛方面,有良好疗效。而四妙散乃治疗痛风的基础方,临床疗效显著。本研究旨在探讨四黄水蜜外敷合加味四妙散内服的方法治疗急性痛风性关节炎的临床疗效,从而为急性痛风性关节炎的治疗开辟一条安全有效的新途径。
研究方法 本研究将65例符合纳入标准的患者随机分为两组,治疗组予以加味四妙散内服及四黄水蜜外敷,对照组予以秋水仙碱口服。参照《中药新药临床研究指导原则》对急性痛风性关节炎患者的症状、体征进行分级,并制定急性痛风性关节炎观察表,一周后按观察表计分做统计学处理,进行治疗前后比较及组间比较。对纳入本研究的急性痛风性关节炎患者进行体温(T)、血尿酸(UA)、白细胞计数(WBC)、关节疼痛、关节压痛、关节功能、综合疗效、不良反应等方面的评估。
结果 研究结果表明两组疗效相当:治疗组总有效率为90.9%,对照组总有效率为90.6%,经Ridit检验(P>0.05),差异无统计学意义。两组患者治疗前后症状和体征积分及实验室指标的比较,除对照组的血尿酸治疗前后比较(P>0.05)外,其余指标治疗前后比较(P<0.01),治疗后结果明显优于治疗前。组间血尿酸水平比较(P<0.05),治疗组疗效优于对照组,其余指标组间比较(P>0.05),两组无显著性差异。整个研究过程,治疗组无一例出现不良反应;对照组有5例患者出现不良反应:其中胃脘部不适者2例,安全级别为3级,经对症处理后可继续给药;肾功能异常者3例,安全性分级均为2级,无需处理后好转,可继续给药。
结论 本研究结果表明,通过应用四黄水蜜外敷合加味四妙散内服治疗急性痛风性关节炎,确实能起到降体温、消肿止痛、改善关节功能、降低血尿酸的作用,且未发现有明显的临床毒副作用,故值得临床推广。
ObjeciveAcute gouty arthritis is a common disease and stubborn disease in orthopedics. Along with the elevation of living standard and the changing of food and drink structure, the morbility of acute gouty arthritis increases year by year. In the recent years the morbility of acute gouty arthritis is about 3%o and corresponds to the cancerous incidence. Acute gouty arthritis has impacted human healthy and quality of life severely. In the treatment of this disease, the medical doctors used to apply dephlogisticate or alliviate and symptomatic treatment, but for their apparente poison and side effect and also for the recurrence of this disease after drug withdraw. So in some degree, the application of these drugs is limited. The Sihuangshuimi is manufactured and produced by the Guangdong hospital of Chines Tradictional Medicine. It has a good curative effect in the therapy of humid heat type disease. Simiaosan is an empirical formula in the treatment of acute gouty arthritis. It is aplplied to treat acute gouty arthritis frequently and got significant clinical curative effect. The research objective is to investigate the clinical curative effect about the oral administration of Simiaosan jiawei combined with the external application of Sihuangshuimi in the treatment of acute gouty arthritis and to seek for a safe and valid program for it. MethodsAll the 65 patients of acute gouty arthritis were choosen from the patients from out-patients' clinic or in-patient of the Guangdong Hospital of TCM. And all the patients consistent with the internalize standard were randomly divided into two groups. The treament group was treated by simiaosan jiawei and combined with the external apllication of Sihuanhuimi. The control group
was treated by Qiushuixianjian. Then reference to the ((New Traditional Chinese Medicine Clinical Study Direction Principle )) made a observation table according to patients' grade of acute gouty arthritis symptoms and physical sign. After a week, all the acquired data were done statistical treatment, and carried out prior treatment and post-treatment comparision and group comparison. To evaluate the blood uric acid (BUA), the temperature (T), the lencocyte count (WBC), the joint function, the comprehensive curative effect, and side effects etc of these patients. ResultsThe therapies of two groups are equivalence. The total effective rate of treament group is 90.9%, the control group is 90.6%. After been examined by Ridit analysis (P>0. 05), the difference between two groups has not statistical significant. Comparing the symptoms and physical sign' integral of patients before treatment and post treatment, except for the BUA of control group has not statistical significant (P>0. 05) , all the other indexs have statistical significant (P<0. 01) , the results of before treatment are better than that of post treatment obviously. The comparison between two groups, except for BUA of the treament group has an advantage to the control group (P<0. 05) , the other indexs have not statistical significant between two groups (P> 0. 05) . There are no cases to appear side effect in treament group. The control group has 5 patients to show up side effect. Among them, there are 2 patients not well with their stomaches, safety rating for 3 Class, and they can keep on this research after treated according to their symptoms. Besides of it the other 3 patients appear kidney function abnormality, safety rating for 2 Class, but their kiney funtion can change to nomal level without any special treatment, and all of them can keep on this research. Cone I us i onThe effect of using sihuangshuimi combined with simiaosan jiawei to cure acute gouty arthritis is not only to improve joint fuction and cut down BUA leval obviously, but also to decline the body temperature^ decrease swelling and to relieve pain. Moreover it has no any side effect. It is a safe and effective therapeutic regiment for gout.
引文
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