雷公藤多苷片联合硫酸羟氯喹及戈利木单抗方案治疗老年类风湿关节炎的疗效观察

杨永清; 王丽萍

doi:10.16766/j.cnki.issn.1674-4152.004365

雷公藤多苷片联合硫酸羟氯喹及戈利木单抗方案治疗老年类风湿关节炎的疗效观察

doi: 10.16766/j.cnki.issn.1674-4152.004365

杨永清¹,
王丽萍^2, ,

1.
兰州大学第二临床医学院，甘肃兰州 730030
2.
兰州大学第二医院风湿免疫科，甘肃兰州 730030

基金项目:

甘肃省自然科学基金项目 18JR3RA319

兰州大学第二医院“萃英学子科研培育”计划 CYXZ2023-51

详细信息

通讯作者:
王丽萍，E-mail：191700146@qq.com

中图分类号: R593.22
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出版历程
- 收稿日期: 2025-01-13
- 网络出版日期: 2026-04-11

Efficacy of Tripterygium Wilfordii Polyglycoside Tablets combined Hydroxychloroquine Sulfate and Golimumab in the treatment of elderly-onset rheumatoid arthritis

YANG Yongqing¹,
WANG Liping^{2
, ,}

1.
The Second Clinical College of Lanzhou University, Lanzhou, Gansu 730030, China

摘要

摘要: 目的探讨雷公藤多苷片联合硫酸羟氯喹及戈利木单抗治疗老年类风湿关节炎(EORA)的药效与不良反应。方法纳入2018年6月—2022年12月就诊于兰州大学第二医院且年龄≥60岁的77例RA患者，采用简单随机分组分为实验组(40例)和对照组(37例)。应用雷公藤多苷片+硫酸羟氯喹(实验组)或者艾拉莫德(对照组)联合戈利木单抗治疗24周。记录类风湿关节炎(RA)的主要疗效指标：ACR疗效标准达到20%改善(ACR20)、50%改善(ACR50)、70%改善(ACR70)、类风湿关节炎疾病活动性评分(DAS28)缓解率，并全程监测不良反应。结果治疗第24周实验组分别有97.44%(38/39)、84.62%(33/39)、69.23%(27/39)和87.18%(34/39)的患者达到ACR20、ACR50、ACR70和DAS28；对照组分别有97.06%(33/34)、88.24%(30/34)、70.59%(24/34)和76.47%(26/34)的患者达到ACR20、ACR50、ACR70和DAS28。其中1例实验组患者失访，1例对照组患者失访，2例对照组患者因出现腕关节和踝关节肿胀改用其他方案治疗。结论雷公藤多苷片联用硫酸羟氯喹及戈利木单抗治疗RA能有效控制疾病进展，缓解临床症状，不良反应少，安全性良好，患者在治疗24周后整体评价高于对照组，其疗效不劣于艾拉莫德联合戈利木单抗，且经济费用优于对照组，是值得推广的一种治疗方式。
- 类风湿关节炎 /
- 雷公藤多苷片 /
- 硫酸羟氯喹 /
- 戈利木单抗 /
- 老年
Abstract: Objective To evaluate the efficacy and safety of Tripterygium Wilfordii Polyglycoside Tablets combined Hydroxychloroquine Sulfate and Golimumab therapy in patients with elderly-onset rheumatoid arthritis (EORA). Methods A total of 77 patients diagnosed with EORA at Lanzhou University Second Hospital from June 2018 to December 2022 were enrolled. They were randomly divided into the observation group (40 cases) and the control group (37 cases). Patients were treated for 24 weeks with either Tripterygium glycosides tablets and Hydroxychloroquine Sulfate or Iguratimod combined with golimumab. The primary efficacy endpoints were the American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) response rates. The secondary efficacy endpoint was the 28-joint Disease Activity Score (DAS28) remission rate. Adverse effects were assessed throughout the treatment period. Results At week 24, the proportions of ACR20, ACR50, ACR70, and DAS28 in the observation group was 97.44% (38/39), 84.62% (33/39), 69.23% (27/39), and 87.18% (34/39), respectively. In the control group, the proportion of ACR20, ACR50, ACR70, and DAS28 was 97.06% (33/34), 88.24% (30/34), 70.59% (24/34), and 76.47% (26/34), respectively. One patient in the observation group was lost to follow-up. In the control group, one patient was lost to follow-up and 2 patients withdrew from the treatment. Conclusion Tripterygium glycosides tablets or Iguratimod combined with Hydroxychloroquine Sulfate and Golimumab can effectively relieve clinical symptoms in patients with EORA with acceptable safety profiles. The treatment regimen in the observation group was more cost-effective. Therefore, Tripterygium glycosides tablets combined with Hydroxychloroquine Sulfate and Golimumab represents a therapeutic strategy worthy of broader clinical application.
- Rheumatoid arthritis /
- Tripterygium wilfordii polyglycosides tablets /
- Hydroxychloroquine sulfate /
- Golimumab /
- Elderly

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表 1 2组EORA患者一般资料比较

Table 1. Comparison of general data of EORA patients between two groups

组别	例数	性别(男性/女性，例)	年龄(x±s，岁)	病程(x±s，年)	缺乏社会支持[例(%)]	财务状况(差/尚可, 例)	较少锻炼[例(%)]	吸烟[例(%)]	饮酒[例(%)]	COVID-19+[例(%)]	COVID-19+对病情影响严重[例(%)]
实验组	40	15/25	68.64±7.09	5.09±3.41	38(95.00)	35/5	35(87.50)	16(40.00)	10(25.00)	33(82.50)	5(15.15)
对照组	37	12/25	67.45±5.50	5.56±3.61	34(91.89)	33/4	32(86.49)	15(40.54)	12(32.43)	31(83.78)	9(29.03)
统计量		0.217^a	0.780^b	0.580^b	0.333^a	0.016^a	0.043^a	0.002^a	0.520^a	0.023^a	1.806^a
P值		0.642	0.438	0.565	0.564	0.901	0.836	0.961	0.471	0.881	0.179
注：^a为χ²值，^b为t值。

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表 2 2组EORA患者用药后有效率比较[例(%)]

Table 2. Comparison of the effective rate of medication in two groups of EORA patients [cases (%)]

组别	例数	ACR20						ACR50
组别	例数	4周	8周	12周	16周	20周	24周	4周	8周	12周	16周	20周	24周
实验组	39	7(17.94)	13(33.33)	24(61.54)^a	38(97.44)	38(97.44)	38(97.44)	0	1(2.56)^d	13(33.33)^ad	20(51.28)	29(74.36)	33(84.62)
对照组	34	9(26.47)	15(44.12)	21(61.76)^b	31(91.18)	32(94.12)^c	33(97.06)	0	7(20.59)	20(58.82)^b	25(73.53)	26(76.47)^c	30(88.24)

组别	例数	ACR70						DAS28＜3.2
组别	例数	4周	8周	12周	16周	20周	24周	4周	8周	12周	16周	20周	24周
实验组	39	0	0	13(33.33)^a	17(43.59)	22(56.41)	27(69.23)	0	2(5.13)	15(38.46)^a	22(56.41)	28(71.79)	34(87.18)
对照组	34	0	1(2.94)	7(20.59)^b	15(44.12)	20(58.82)^c	24(70.59)	0	3(8.82)	20(58.82)^b	22(64.71)	26(76.47)^c	26(76.47)
注：与同组用药前比较，^aP＜0.05；与同组用药8周比较，^bP < 0.05；与同组用药16周比较，^cP < 0.05；与对照组同时间点比较，^dP < 0.05。

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表 3 2组EORA患者治疗前后临床指标比较[M(P₂₅, P₇₅)]

Table 3. Comparison of clinical indicators before and after treatment in 2 groups of EORA patients [M(P₂₅, P₇₅)]

组别	例数	项目	0周	4周	8周	12周	16周	20周	24周
实验组	39	CRP(mg/L)	46.80(21.02, 89.70)^a	30.00(6.92, 48.00)^ab	14.20(7.50, 26.00)^abc	9.40(7.00, 17.50)^bd	6.00(5.00, 12.00)^be	4.00(1.95, 7.30)^bf	3.00(1.00, 4.62)^bg
		ESR(mg/L)	37.00(22.50, 57.50)	21.00(7.00, 33.00)^b	18.00(13.00, 28.50)^b	16.00(11.00, 20.00)^b	10.00(4.50, 16.00)^be	7.00(1.00, 12.00)^bf	4.00(0.00, 8.00)^bg
		HAQ(分)	3.50(2.38, 5.13)	2.25(1.50, 3.00)^b	2.00(1.13, 2.63)^ab	1.00(0.75, 2.00)^abd	1.00(0.50, 1.63)^abe	1.00(0.00, 1.00)^ab	0.00(0.00, 0.00)^abg
		VAS(分)	7.00(5.50, 10.00)	5.00(3.00, 6.00)^b	3.00(2.00, 4.50)^bc	2.00(1.00, 3.00)^bd	1.00(1.00, 2.00)^be	1.00(0.00, 1.00)^bf	0.00(0.00, 0.00)^abg
		PtGA(分)	7.00(5.00, 10.00)	5.00(3.00, 6.00)^b	3.00(2.00, 4.50)^bc	2.00(1.00)3.00)^bd	1.00(0.50, 2.00)^be	1.00(0.00, 1.00)^bf	0.00(0.00, 0.00)^abg
		DAS28(分)	4.56(2.52, 6.21)	3.00(1.56, 3.89)^b	2.01(1.12, 2.89)^bc	1.54(1.01, 2.06)^bd	1.07(0.50, 1.58)^be	0.73(0.50, 1.05)^bf	0.14(0.00, 0.52)^bg
对照组	34	CRP(mg/L)	24.35(14.83, 37.56)	5.99(0.73, 17.45)^b	4.89(0.37, 12.68)^b	4.89(1.00, 15.13)^b	1.55(0.46, 14.83)	4.00(1.93, 5.80)^b	3.85(0.09, 6.73)^b
		ESR(mg/L)	54.00(25.00, 68.25)	19.50(6.25, 63.00)^b	20.50(10.00, 61.50)^b	16.00(4.00, 48.50)^b	13.00(5.00, 28.00)^b	4.50(0.00, 23.25)^b	8.50(1.25, 20.00)^b
		HAQ(分)	5.00(2.63, 6.19)	3.38(2.00, 4.81)^b	2.25(2.00, 4.63)^b	2.25(1.00, 3.81)^b	2.00(1.00, 3.75)^b	1.13(1.00, 2.75)^b	1.00(0.25, 2.75)^b
		VAS(分)	6.00(5.00, 8.75)	4.00(3.00, 5.75)^b	3.00(2.00, 5.00)^b	2.00(1.00, 5.00)^b	2.00(0.00, 3.75)^b	1.00(0.00, 2.75)^b	1.00(0.00, 2.00)^b
		PtGA(分)	7.00(5.00, 8.00)	3.50(2.00, 5.75)^b	2.50(2.00, 4.75)^b	2.00(1.00, 4.75)^b	2.00(0.00, 3.00)^b	0.50(0.00, 2.75)^b	0.50(0.00, 1.75)^b
		DAS28(分)	5.55(3.52, 6.76)	2.19(1.33, 3.52)^b	1.52(1.18, 3.21)^b	1.22(0.71, 2.58)^b	1.29(0.57, 2.30)^b	0.66(0.12, 1.68)^bf	0.22(0.12, 1.04)
注：Waldχ_交互(CRP)²=20.589，P_交互(CRP)＜0.05，Waldχ_交互(ESR)²=3.621，P_交互(ESR)＞0.05，Waldχ_交互(HAQ)²=9.509, P_交互(HAQ)＞0.05，Waldχ_交互(VAS)²=21.366, P_交互(VAS)＜0.05, Waldχ_交互(PtGA)²=10.496，P_交互(PtGA)＞0.05, Waldχ_{交互(DAS28)}²=9.594，P_{交互(DAS28)}＞0.05；Waldχ_组间(CRP)²=10.257，P_组间(CRP)＜0.05，Waldχ_组间(ESR)²=1.663，P_组间(ESR)＞0.05，Waldχ_组间(HAQ)²=8.050, P_组间(HAQ)＜0.05, Waldχ_组间(VAS)²=0.301, P_组间(VAS)＜0.001, Waldχ_组间(PtGA)²=0.037, P_组间(PtGA)＞0.05, Waldχ_{组间(DAS28)}²=0.127, P_{组间(DAS28)}＞0.05；Waldχ_周期(CRP)²=130.573, P_周期(CRP)＜0.001, Waldχ_周期(ESR)²=87.015，P_周期(ESR)＜0.001, Waldχ_周期(HAQ)²=159.141, P_周期(HAQ)＜0.001, Waldχ_周期(VAS)²=866.027, P_周期(VAS)＜0.001, Waldχ_周期(PtGA)²=364.116, P_周期(PtGA)＜0.001, Waldχ_{周期(DAS28)}²=306.747, P_{周期(DAS28)}＜0.001。与对照组同时间点比较，^aP＜0.05；与同组治疗0周比较，^bP＜0.05；与同组治疗4周比较，^cP < 0.05；与同组治疗8周比较，^dP < 0.05；与同组治疗12周比较，^eP < 0.05；与同组治疗16周比较，fP < 0.05；与同组治疗20周比较，^gP < 0.05。

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