Shi Xin-de, Li Guo-chun, Qian Zu-xi, Jin Ze-qiu, Song Yan
China Academy of Chinese Medical Sciences, Beijing, China.
Chin J Integr Med. 2008 Mar;14(1):17-22. doi: 10.1007/s11655-007-9001-7.
To investigate the compatibility of a modified prescription of Simiao Pill in the treatment of acute gouty arthritis and to verify the clinical efficacy and safety of the drug through a clinical trial.
A randomized and controlled clinical trial was designed based on clinical epidemiological principles. A total of 107 patients with acute gouty arthritis were enrolled and randomly assigned to four groups. The first group (Group I) included 27 patients taking gout prescription I; the second group (Group II) included 27 patients taking gout prescription II; the third group (Group III) included 28 patients taking gout prescription III; and the fourth group (control group) included 25 patients taking indomethacin and Benzobromarone as a control group. The duration of the treatment in all 4 groups was two weeks. After the treatment, the index of blood uric acid, blood leukocyte count, score of clinical symptoms, etc. were observed and measured.
The total clinical effective rate of the three different modified prescriptions of the Simiao Pill was above 96%, significantly superior to that of the control group (68%, P<0.05). In terms of the improvement of main symptoms, the scores of four symptoms in all TCM treatment and control groups decreased after treatment, with statistically significant differences (P<0.05). Moreover, the scores markedly fell more so in the three Chinese herb groups than in the control group, and especially in Group III (P<0.05). There was a statistically significant difference in blood uric acid values before and after the treatment in the same group but no significant inter-group difference was seen.
The modified prescriptions, based on the clinical research, clinical experience and traditional Chinese medicine theory, did show a better effect than Western medicine in this clinical study. Moreover, the prescriptions were precise, with the herbs inexpensive and readily available. The patients had good compliance with less adverse reactions noted. The modified prescription has a favorable prospect for future development and is worthy of further blind trials with larger samples.
探讨四妙丸加味方治疗急性痛风性关节炎的配伍规律，并通过临床试验验证该药物的临床疗效及安全性。
依据临床流行病学原理设计随机对照临床试验。共纳入107例急性痛风性关节炎患者，随机分为四组。第一组（Ⅰ组）27例，服用痛风方Ⅰ；第二组（Ⅱ组）27例，服用痛风方Ⅱ；第三组（Ⅲ组）28例，服用痛风方Ⅲ；第四组（对照组）25例，服用吲哚美辛和苯溴马隆作为对照组。四组治疗疗程均为两周。治疗后，观察并测量血尿酸、血白细胞计数、临床症状评分等指标。
四妙丸三种不同加味方的总临床有效率均在96%以上，显著优于对照组（68%，P<0.05）。在主要症状改善方面，各中医治疗组和对照组治疗后四项症状评分均下降，差异有统计学意义（P<0.05）。而且，三个中药组的评分下降幅度明显大于对照组，尤其Ⅲ组（P<0.05）。同一组治疗前后血尿酸值差异有统计学意义，但组间差异无统计学意义。
基于临床研究、临床经验和中医理论的加味方在本临床研究中确实比西药显示出更好的疗效。此外，该方剂配伍精准，药材价廉易得。患者依从性好，不良反应较少。加味方具有良好的未来发展前景，值得进一步开展大样本的盲法试验。
