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河南省中医院,郑州 450002
展俊平,博士,主治医师,从事中西医结合治疗自身免疫性疾病研究,Tel:0371-53312126,E-mail:zjp123sun@126.com
杜旭召,硕士,主治医师,从事中医治疗风湿病研究,Tel:0371-59915379,E-mail:gouqi66669999@163.com
收稿日期:2018-06-07,
网络出版日期:2018-09-28,
纸质出版日期:2019-01-05
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展俊平, 谷慧敏, 孟庆良, 等. 虎潜丸加减治疗类风湿关节炎肝肾阴虚证的临床观察[J]. 中国实验方剂学杂志, 2019,25(1):107-113.
Jun-ping ZHAN, Hui-min GU, Qing-liang MENG, et al. Clinical Observation on Modified Huqianwan in Treatment of Rheumatoid Arthritis Liver-kidney Yin Deficiency Syndrome[J]. Chinese journal of experimental traditional medical formulae, 2019, 25(1): 107-113.
展俊平, 谷慧敏, 孟庆良, 等. 虎潜丸加减治疗类风湿关节炎肝肾阴虚证的临床观察[J]. 中国实验方剂学杂志, 2019,25(1):107-113. DOI: 10.13422/j.cnki.syfjx.20182424.
Jun-ping ZHAN, Hui-min GU, Qing-liang MENG, et al. Clinical Observation on Modified Huqianwan in Treatment of Rheumatoid Arthritis Liver-kidney Yin Deficiency Syndrome[J]. Chinese journal of experimental traditional medical formulae, 2019, 25(1): 107-113. DOI: 10.13422/j.cnki.syfjx.20182424.
目的:
2
观察虎潜丸加减治疗类风湿关节炎(RA)肝肾阴虚证的临床疗效及安全性。
方法:
2
将符合条件的184例肝肾阴虚型RA患者按照数字表法随机分为中药组(62例),西药组(57例)和中西药组(65例)。中药组给予虎潜丸加减治疗,西药组给予甲氨蝶呤片联合来氟米特片治疗,中西药组同时给予虎潜丸加减、甲氨蝶呤片及来氟米特片,疗程均为12周。比较各组治疗前后疼痛视觉模拟评分(VAS),28个关节的肿胀和压痛评分(DAS28),双手平均握力,晨僵时间和中医辨证肝肾阴虚证评分;测定各组治疗前后血沉(ESR),C反应蛋白(CRP),免疫球蛋白(Ig)G,肿瘤坏死因子-
α
(TNF-
α
)和类风湿因子(RF)等理化指标的变化;比较各组临床疗效及给药后的胃肠反应、肝损伤情况、白细胞减少、血清谷氨酸草酰乙酸氨基转移酶(GOT)及血小板(PLT)变化等不良反应情况,以考察各组药物的有效性和安全性。
结果:
2
治疗12周后,中药组、西药组、中西药组的临床疗效总有效率分别为79.0%,80.7%,92.3%,中西药组显著优于中药组及西药组(
P
<
0.01),中药组和西药组无明显差异;各治疗组均能有效改善RA患者的肝肾阴虚证(
P
<
0.05),其中中西药组优于中药组(
P
<
0.05),中药组优于西药组(
P
<
0.05);不良反应的发生率中药组(1.61%,1/62)
<
中西药组(7.69%,5/65)
<
西药组(22.81%,13/57)。
结论:
2
虎潜丸加减治疗RA肝肾阴虚证的疗效与西药甲氨蝶呤片及来氟米特片联合用药的疗效无显著差异,且具有不良反应少的优点。虎潜丸加减结合西药甲氨蝶呤片及来氟米特片联合用药治疗RA肝肾阴虚证疗效优于西药甲氨蝶呤片及来氟米特。
Objective:
2
To explore the clinical efficacy and safety of modified Huqianwan in treatment of rheumatoid arthritis (RA) liver-kidney Yin deficiency syndrome
and investigate its possible mechanism.
Method:
2
A total of 184 patients with RA liver-kidney Yin deficiency syndrome were randomly divided into Chinese medicine group (62 cases)
western medicine group (57 cases) and integrated Chinese and western medicine group (65 cases) according to the digital table method. The patients in Chinese medicine group were treated with Huqianwan; the patients in western medicine group were treated with methotrexate tablets and leflunomide tablets; and the patients in integrated Chinese and western medicine group received Huqianwan+ methotrexate tablets and leflunomide tablets
with a treatment course of 12 weeks in all groups. The pain visual analog scale (VAS)
swelling and tenderness scores of 28 joints (DAS28)
average hands grip strength
morning stiffness time and liver-kidney Yin deficiency syndrome differentiation of traditional Chinese medicine (TCM) syndrome score were compared between groups before and after treatment. The changes of erythrocyte sedimentation rate (ESR)
C reactive protein (CRP)
immunoglobulin (Ig)G
tumor necrosis factor-alpha (TNF-
α
) and rheumatoid factor (RF) were detected in all groups after treatment. Clinical efficacy
and incidence of adverse reactions such as gastrointestinal response
liver injury
leukopenia
serum glutamate oxaloacetic aminotransferase (GOT) and platelet (PLT) level changes were compared between the groups
so as to investigate the efficiency and safety of the different medicines.
Result:
2
After 12 weeks of treatment
the total clinical effective rate was 79.0%
80.7%
and 92.3% respectively in Chinese medicine group
western medicine group
and integrated Chinese and western medicine group; the integrated Chinese and western medicine group was significantly better than the Chinese medicine group and western medicine group (
P
<
0.01)
but there was no difference between the Chinese medicine group and western medicine group. Every treatment group can effectively improve liver and kidney Yin deficiency syndrome in RA patients (
P
<
0.05)
and the effect in integrated Chinese and western medicine group was superior to that in Chinese medicine group (
P
<
0.05); the effect in Chinese medicine group was superior to that in western medicine group (
P
<
0.05). The incidence of adverse reactions was Chinese medicine group (1.61%
1/62)
<
integrated Chinese and western medicine group (7.69%
5/65)
<
western medicine group (22.81%
13/57).
Conclusion:
2
The efficacy in treating RA liver and kidney Yin deficiency syndrome shows no significant difference between modified Huqianwan and methotrexate tablets+ leflunomide tablets. In the treatment of RA liver and kidney Yin deficiency syndrome
Huqianwan has fewer adverse reactions. Huqianwan combined with methotrexate tablets+ leflunomide tablets is superior to that in methotrexate tablets+ leflunomide tablets in treatment of RA liver-kidney Yin deficiency syndrome.
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