中医药优化方案治疗湿热痹阻型类风湿关节炎的不良反应观察

摘要

Objective:To observe the adverse reaction in the treatment of dampness-heat-blockage-type rheumatoid arthritis with optimized scheme of traditional Chinese medicine to probe the impact of changes of sex hormones on patient’s condition.Methods:60 cases with rheumatoid arthritis were randomly divided into a treatment group and a control group,30 cases in each.The control group were given methotrexate,lelfunomide,and the combination of modiifed Xuanbi Decoction and Ermiao San;while the treatment group,based on the treatment of the control group,were given Tripterygium Wilfordii Mixture combined with joint exercise.Two groups were treated for 1 course(3 months).Comparisons were made on the aspects of blood routine,liver and kidney functions,sex hormone levels and adverse reaction of the two groups before and 4,8,12 weeks after the treatment. Results:After 12 weeks,comparing the blood cell count(WBC),alanine transarninase(ALT),and sex hormone (including follicle stimulating hormone,luteinizing hormone,estradiol,testosterone,prolactin level) of the two groups with those before the treatment,the differences were statistically significant (P < 0.05);the difference of serum creatinine (SCr) before and after the treatment was not significant(P > 0.05);the difference between the levels of WBC,ALT,SCr and sex hormone between the two groups had no significant difference(P > 0.05).There are mild adverse reactions of the two groups,returning to normal after proper treatment and having no effects on the treatment.In the treatment group, 2 cases had leukopenia,2 cases had gastrointestinal reaction,1 case had liver function damage,and the menstrual blood volume reduced in 1 case,the incidence rate of adverse reaction being 20%;while in the control group, 1 case had leukopenia,1 case had gastrointestinal reaction,2 cases had liver function damage,and 1 case had skin allergy,the rate of adverse reaction being 16.66%.The difference between the two groups was not significant (P > 0.05).Conclusion:There were no serious adverse reactions in the treatment of dampness-heat-blockagetype rheumatoid arthritis with optimized scheme of traditional Chinese medicine,safe in clinical application.%目的：观察中医药优化方案治疗湿热痹阻型活动期类风湿关节炎出现的不良反应及性激素变化对病情的影响。方法：将60例类风湿关节炎患者随机分为优化方案组（治疗组）和对照组，每组30例。对照组给予西药甲氨蝶呤+来氟米特，中药宣痹汤合二妙散加减；治疗组在对照组治疗的基础上给予雷公藤合剂，并配合关节操。两组均以3个月为1个疗程。比较两组治疗前及治疗4，8，12周血常规、肝肾功能、性激素水平及不良反应的差异。结果：两组白细胞计数（WBC）、谷丙转氨酶（ALT）、性激素（包括促卵泡生成素、促黄体生成素、雌二醇、睾酮、垂体泌乳素）水平与治疗前比较，差异有统计学意义（P<0.05）；血肌酐（SCr）与治疗前比较，差异无统计学意义（P>0.05）；两组间WBC、ALT、SCr、性激素水平比较，差异无统计学意义（P>0.05）。两组均有轻微的不良反应，对症处理后恢复正常，不影响治疗。治疗组WBC下降2例，消化道反应2例，肝功能损害1例，月经量减少1例，不良反应发生率为20.00%；对照组WBC下降1例，消化道反应1例，肝功能损害2例，皮肤过敏1例，不良反应发生率为16.66%。两组比较，差异无统计学意义（P>0.05）。结论：中医药优化方案治疗湿热痹阻型活动期类风湿关节炎未出现严重不良反应，临床应用安全性好。