益气养阴方治疗系统性红斑狼疮有效性和安全性的meta分析

张强; 邓伟哲; 伊世华; 邵英子; 王振宇; 路秀云

doi:10.16766/j.cnki.issn.1674-4152.003608

益气养阴方治疗系统性红斑狼疮有效性和安全性的meta分析

doi: 10.16766/j.cnki.issn.1674-4152.003608

1.
中国人民解放军联勤保障部队第九六二医院中医风湿科，黑龙江哈尔滨 150048
2.
黑龙江省中医药科学院肾病三科，黑龙江哈尔滨 150036
3.
黑龙江省中医药科学院检验科
4.
哈尔滨医科大学附属第二医院中医科，黑龙江哈尔滨 150086

基金项目:

黑龙江省卫生健康委科研课题 20222121011102

黑龙江省医学发展基金会项目 2023QY003

详细信息

通讯作者:
伊世华，E-mail：50742758@qq.com

中图分类号: R593.241 R256
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出版历程
- 收稿日期: 2024-01-09
- 网络出版日期: 2024-09-05

Efficacy and safety of Yiqi Yangyin Decoction in treating systemic lupus erythematosus: a meta-analysis

1.
Rheumatology and Traditional Chinese Medicine Department, the 962nd Hospital of the PLA, Harbin, Heilongjiang 150048, China

摘要

摘要: 目的中医经典方在风湿性疾病的应用是近年研究的热点，系统性红斑狼疮(SLE)在我国拥有庞大的患者基数，中西医结合治疗SLE的疗效存在争议。本研究通过荟萃分析的方法探讨益气养阴方治疗系统性红斑狼疮有效性和安全性。方法检索PubMed、Medline、EMbase、Cochrane Library、Web of science、CBM、Wangfang、CNKI和VIP，检索时间为从建库至2023年11月26日。纳入益气养阴方治疗SLE的随机对照试验研究，试验组接受益气养阴方联合西药治疗，对照组接受西药治疗。应用EndNote 20.0进行筛选和管理文献。提取数据后应用RevMan 5.4进行质量评价和分析。应用Stata 15.0进行敏感性和发表偏倚分析。结果纳入24项研究，共1 991例患者，其中试验组1 051例，对照组940例。试验组的总有效率(OR=4.35，95% CI：3.11~6.11)高于对照组，不良反应发生率(OR=0.17，95% CI：0.11~0.26)低于对照组，差异均有统计学意义(P＜0.05)。试验组的中医证候积分、系统性红斑狼疮活动指数(SLEDAI)、ds-DNA转阴率、C3水平、24小时尿蛋白定量、糖皮质激素维持量均优于对照组，差异均有统计学意义(P＜0.05)，试验组的ANA转阴率略高于对照组，但差异无统计学意义(P＞0.05)。结论应用益气养阴方治疗SLE可提高临床总有效率，降低不良反应发生率，在各项转归均有良好的效果。
- 益气养阴方 /
- 系统性红斑狼疮 /
- 中西医结合治疗 /
- Meta分析
Abstract: Objective The application of classic Chinese medicine in rheumatic diseases has been a prominent research focus. Systemic lupus erythematosus (SLE) has a significant patient population in China. The efficacy of integrated Chinese and Western medicine in the treatment of SLE remains controversial. This study explores the effectiveness and safety of the Yiqi Yangyin Decoction in the treatment of systemic lupus erythematosus through meta-analysis. Methods A comprehensive search was conducted on multiple databases including PubMed, Medline, EMbase, Cochrane Library, Web of Science, CBM, Wangfang, CNKI, and VIP from the establishment of the database to November 26, 2023. The scope of the search was limited to randomized controlled trial studying the efficacy of Yiqi Yangyin Decoction in the treatment of SLE. The experimental group received Yiqi Yangyin Decoction in combination with Western medicine, while the control group received only Western medicine. The retrieved literature was filtered and managed using EndNote 20.0. Data extraction and quality evaluation were performed using RevMan 5.4. Sensitivity analysis and publication bias analysis were conducted using Stata 15.0. Results A total of 24 studies were conducted, including 1 051 patients in the experimental group and 940 patients in the control group. The experimental group showed a higher total effective rate compared to the control group (OR=4.35, 95% CI: 3.11-6.11). Additionally, the experimental group had a lower incidence of adverse reactions compared to the control group (OR=0.17, 95% CI: 0.11-0.26). These differences were statistically significant (P < 0.05). The experimental group showed better scores in traditional Chinese medicine syndrome, systemic lupus erythematosus disease activity index, ds-DNA negative conversion rate, complement3, 24 hour urinary protein quantity, and glucocorticoid maintenance dosage compared to the control group, with all differences being statistically significant (P < 0.05). The ANA negative conversion rate was slightly higher in the experimental group, but the difference was not statistically significant (P > 0.05). Conclusion The application of Yiqi Yangyin Decoction in the treatment of SLE can enhance clinical effectiveness, reduce the occurrence of adverse reactions, and yield positive outcomes across multiple aspects.
- Yiqi Yangyin Decoction /
- Systemic lupus erythematosus /
- Chinese-Western medicine treatment /
- Meta-analysis

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图 1 文献检索流程图

Figure 1. Flowchart of literature search process

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图 2 风险偏倚评价图

Figure 2. Risk bias assessment chart

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图 3 总有效率森林图

Figure 3. Forest plot of total effective

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图 4 TCMs森林图

Figure 4. Forest plot of TCM score

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图 5 SLEDAI积分森林图

Figure 5. Forest plot of SLEDAI score

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图 6 ANA和ds-DNA转阴率森林图

Figure 6. Forest plot of ANA and ds-DNA negative conversion rate

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图 7 C3水平森林图

Figure 7. Forest plot of C3 levels

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图 8 24hUPro森林图

Figure 8. Forest plot of 24hUPro

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图 9 GCs维持量森林图

Figure 9. Forest plot of glucocorticoid maintenance

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图 10 不良反应发生率森林图

Figure 10. Forest plot of adverse reaction incidence

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图 11 总有效率漏斗图

Figure 11. Forest plot of total effectiveness

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图 12 TCMs漏斗图

Figure 12. Funnel plot of TCM score

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表 1 纳入文献基本信息表

Table 1. Basic information of included literature

作者/序号	年份	地域	诊断	分组	例数(试验/对照)	干预(试验/对照)	疗程(月)	疗效判定	结局指标
郭竹秀^[10]	2002	江西	1982	R	30/10	A/B	6	C	①⑥⑧
郭竹秀^[11]	2006	江西	1982	R	30/20	A/B	6	临床症状	①⑥⑧
王志祥^[12]	2007	云南	1982	R	40/20	A/B	12	C	①②④⑤⑥⑦
陈翠莉^[13]	2008	广东	1982	R	40/40	A/B	3	C	①②③④⑤⑥⑦⑧
黄咏菁^[14]	2008	广东	1997	R	44/43	A/B	3	-	②⑧
宋树斌^[15]	2008	福建	1982	-	20/18	A/B	3	C	①④⑤⑥⑦
温蝶梅^[16]	2010	广东	1997	R	29/24	A/B	3	-	②③⑧
李群燕^[17]	2010	天津	1997	R	50/30	A/B	6	C	①②④⑤⑥⑧⑨
张璐芸^[18]	2010	上海	2002	R	30/30	A/B	6	C	①②③⑤⑥
钱程亮^[19]	2011	江苏	1997	-	150/150	A/B	12	-	③⑥⑦
陈宇^[20]	2012	云南	1997	R	30/30	A/B	2	C	①②④⑨
平晓芳^[21]	2013	天津	1997	R	57/28	A/B	6	C	①③⑤⑥⑦⑧⑨
郑虹^[22]	2014	湖北	1997	R	90/90	A/B	6	-	⑥⑨
胡晓琳^[23]	2015	天津	1997	R	30/30	A/B	3	-	⑥
廖圣榕^[24]	2015	广东	1997	R	43/43	A/B	3	C	①②⑥⑨
赖瑞^[25]	2015	云南	2009	R	30/30	A/B	2	C	①②③⑥⑦⑧⑨
田昱平^[26]	2017	陕西	1997	R	45/45	A/B	3	SLEDAI	①③⑨
熊斯璐^[27]	2018	江西	1997	R	30/30	A/B	2	C	①②⑥⑦⑨
张靖^[28]	2018	湖北	1997	R	50/50	A/B	2	C	①⑨
杨晔颖^[29]	2018	上海	1997	R	29/26	A/B	3	-	②③⑥⑦⑧⑨
张龙飞^[30]	2019	陕西	2009	R	25/25	A/B	3	C	①②③⑤⑥⑦
朱英^[31]	2019	江苏	2009	-	53/54	A/B	3	C	①②
陶素莹^[32]	2022	浙江	2012	R	16/14	A/B	3	C	①②③⑥⑦⑨
王慧娟^[33]	2023	河南	1997	R	60/60	A/B	3	C	①②⑥⑦
注：“-”为未描述随机规则或疗效判定标准；①为有效性，②为TCMs，③为SLEDAI，④为ANA，⑤为ds-DNA，⑥为C3，⑦为24hUPro，⑧为GCs，⑨为安全性；A为益气养阴方加减+西药方案，B为西药方案，C为中药新药指导原则；SLEDAI为系统性红斑狼疮活动指数；R为随机分配。

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表 2 Egger检验表

Table 2. Checklists of Egger

项目	数量	t值	P＞\|t\|
有效性	18	0.821	0.422
TCMs	15	-0.953	0.360
C3水平	18	0.862	0.404
24hUPro	11	-1.789	0.107
安全性	11	0.824	0.431
注：当P＜0.05时存在发表偏倚。

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