中药治疗类风湿关节炎的系统评价
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摘要
背景:类风湿关节炎是一种系统性自身免疫病,易致畸致残,是造成我国人群致残的主要原因之一,严重危害人类的健康。其病因及发病机制尚不清楚。目前西药治疗本病尚无特异的疗法,尽管非甾类抗炎药、改善病情的抗风湿药和糖皮质激素等可以减轻症状,但疗效难以令人满意,且副作用较多。而中药在临床上有广泛的应用,是目前治疗本病的常用手段之一,但其疗效及安全性尚待验证。
目的:对中药治疗类风湿关节炎的疗效及安全性进行客观评价。
检索策略:使用包含所有类型的关节炎结合中药的术语,以“类风湿关节炎”、“关节炎”、“痹证”、“草药”、“中药”、“中医”、“传统医学”为关键词和题名进行检索。搜索了下列文献数据库:中国期刊全文数据库(CNKI)、中国科技期刊全文数据库(Vip)、万方数据库、中国生物医学文献光盘数据库(CBMDISC)(1978—2007.4)、中国生物医学文献期刊数据库(CMCC)、中国生物医学文摘数据库网络版(CBMWEB)、中国药学文献数据库。并依据所收集文献的参考文献,进行补充检索。
纳入标准:我们收集了所有中药与安慰剂、西药、空白对照比较的干预类风湿关节炎的随机对照试验。盲法和非盲法研究均纳入。
排除标准:试验组与对照组干预措施设置不合理者。非平行对照研究。
数据收集和分析:两个评价者独立地进行数据提取并对方法学质量进行评估。
结果:
1.共检索出2675篇文献,最后共纳入110篇中药干预或中药联合西药干预类风湿关节炎的随机对照试验,所获得的文献临床试验的方法学质量普遍较低,其中有5篇高质量研究,其余105篇均为低质量研究。
2.纳入的110篇文献中,有8篇研究的总有效率的比较进入Meta分析,包括2篇白芍总甙+甲氨喋呤与甲氨喋呤比较、2篇雷公藤多苷片与甲氨喋呤比较、2篇痹速清合剂与吲哚美辛比较、2篇风湿仙丹与消炎痛比较。其合并分析结果显示:白芍总甙联合甲氨喋呤与单独使用甲氨喋呤相比,其差异无统计学意义,RR_(合并)=1.05,95%CI为[0.92,1.20],表明白芍总甙联合甲氨喋呤与单独使用甲氨喋呤疗效相当;雷公藤多苷片与甲氨喋呤相比,其差异有统计学意义,RR_(合并)=1.15,95%CI为[1.01,1.30],表明雷公藤多苷片比甲氨喋呤疗效好;风湿仙丹与消炎痛相比,其差异有统计学意义,RR_(合并)=1.21,95%CI为[1.04,1.41】,表明风湿仙丹比消炎痛疗效好;痹速清合剂与吲哚美辛相比,其差异有统计学意义,RR合并=1.35,95%CI为[1.05,1.73】,表明痹速清合剂比吲哚美辛疗效好。其余50篇中药联合西药与西药比较的研究中,有29篇研究提示前者治疗并不比后者效果好,其余21篇研究表明前者并不比后者疗效差。其余52篇中药与单独西药比较的研究中,有27篇研究提示中药并不比西药效果好,其余25篇研究表明前者并不比后者疗效差。由于试验干预措施复杂,有中成药、中药提取物、单味中药、汤剂等,存在明显异质性,故无法进行汇总分析。
3.纳入的110篇文献中,51篇文献详细报道了不良事件情况。其中,有4篇研究的不良反应的比较进入Meta分析,包括2篇白芍总甙+甲氨喋呤与甲氨喋呤的比较、2篇雷公藤与甲氨喋呤的比较,其合并分析结果显示:白芍总甙联合甲氨喋呤与单独使用甲氨喋呤相比,其差异无统计学意义,RR_(合并)=0.80,95%CI为[0.49,1.31】,表明白芍总甙联合甲氨喋呤的不良反应发生率并不比单独使用甲氨喋呤不良反应发生率低;雷公藤多甙片与单独使用甲氨喋呤相比,其差异无统计学意义,RR_(合并)=0.81,95%CI为[0.48,1.38】,表明雷公藤多甙片的不良反应发生率并不比单独使用甲氨喋呤不良反应发生率低。其余23篇中药联合西药与西药比较的研究中,13篇提示前者不良反应发生率并不比后者低,其余10篇提示前者不良反应发生率比后者低。其余24篇中药与西药比较的研究中,12篇文献提示前者不良反应发生率并不比后者低,其余12篇提示前者不良反应发生率低于后者。
4.有5篇高质量研究均报道了总有效率,其中有2篇提示中药联合西药比单纯西药治疗效果好,其余3篇则提示中药(或联合西药)并不比单纯西药效果好。有4篇高质量研究报道了不良反应发生率,其中1篇研究提示中药联合西药的不良反应发生率较单纯中药治疗的低,其余3篇提示中药(或联合西药)的不良反应发生率并不比单纯西药低。
评价者的结论:由于原始报告质量较低,中药治疗类风湿关节炎的临床疗效仍旧不能确定,现有的证据还不足以得出肯定的结论。因此,需要更多大样本多中心的设计良好的随机对照试验,从而为临床决策提供科学依据。
Background: Rheumatoid arthritis (RA) is a kind of systemic autoimmune disease,which may lead to be deformed and disability.That is one of the main reasons lead to disable in our countty.The pathogenesis isn't clear.So far,the effectiveness of western medicine is not satisfactive and adverse reaction is serious, though NSAIDs and GC could control the symptom temporarily. Traditional Chinese medicine have superiority against RA. The curative effect have be admitted by patients and doctors.
Objectives: To assess the effectiveness and safety of traditional Chinese medicine therapies in the treatment of rheumatoid arthritis.
Search Strategy: We developed a search strategy using terms to include all forms of arthritis combined with traditional Chinese medicine. We have searched the following electronic databases: CNKI, Wanfang Data, Vip Information , CBMdisc, CMCC, CBMweb and the Chinese medicine document database. This was supplemented by searching the reference lists from retrieved trials.
Selection criteria: All randomized trials of traditional Chinese medicine interventions in rheumatoid arthritis, compared to placebo or western medicine or no intervention. There were two reviewers independently read and select each potential study according to the criteria.
Exclusion criteria:Except the studies of follow interventions: traditional Chinese medicine fumigate、iontophoresis、intermediate frequency、electromagnetic therapy and so on. The intervention of trial group and control group is unreasonable.Not parallel control study.
Data collection and analysis: Data were extracted independently by two reviewers and an assessment of methodological quality were conducted.
Main results:
1. 110 trials were included.The general methodological quality of all the trials wererelatively poor. 5 trials had high quality as assessed with Jadad scales.The otherswere poor.
2. Eight of the trials were included into Meta analysis about the effective rate,including 2 studies with the intervention of Total Glucosides of Paeony +Methotrexate VS Methotrexate、2 studies of Tripterygium wilfordii VS Methotrexate、2 Studies of Bi Su Qing composition VS Indomethacin、2 Studies of Feng Shi Xian Dan VS Indomethacin .The results of meta-analysis: Total Glucosides of Paeony + Methotrexate VS Methotrexate show no significant differences between them, RR_(total)=1.05, 95%CI [0.92, 1.20], the curative effect of the former was not better than the latter; Tripterygium wilfordii VS Methotrexate show significant differences between them, RR_(total)=1.15, 95%CI [1.01, 1.30]; Feng Shi Xian Dan VS Indomethacin show significant differences between them, RR_(total)=1.21, 95%CI [1.04, 1.41], the former was more effective than the latter;Bi Su Qing composition VS Indomethacin show significant differences between them, RR_(total)=1.35, 95%CI [1.05, 1.73], the former was more effective than the latter. 29 of 50 studies(Chinese traditional medicine integrated western medicine VS western medicine) show Chinese traditional medicine were not better than western medicine;the left 21 studies were opposite. 27 of 52 studies(Chinese traditional medicine VS western medicine) show Chinese traditional medicine were not better than western medicine; the left 25 studies were opposite.Because of the multiformity of the intervention, including Chinese formulated products, extractive, medicinal broth and so on, there were significant heterogeneity, so we cann't pool more data.
3. 51 of 110 studies reported the adverse effect detailly. Four of the trials were included into Meta analysis about the adverse effect rate,including 2 studies with the intervention of Total Glucosides of Paeony +Methotrexate VS Methotrexate、2 studies of Tripterygium wilfordii VS Methotrexate .The results of meta-analysis: Total Glucosides of Paeony + Methotrexate VS Methotrexate show no significant differences between them, RR_(total)=0.80, 95%CI [0.49, 1.31], the adverse effect rate of the former was not lower than the latter; Tripterygium wilfordii VS Methotrexate show no significant differences between them, RR_(total)=0.81, 95%CI[0.48, 1.38], the adverse effect rate of the former was not lower than the latter; 13 of 23 studies(Chinese traditional medicine integrated western medicine VS western medicine) show the adverse effect rate of Chinese traditional medicine were not lower than western medicine;the left 10 studies were opposite. 12 of 24 studies(Chinese traditional medicine VS western medicine) show the adverse effect rate of Chinese traditional medicine were not lower than western medicine; the left 12 studies were opposite.
4. 5 trials with high quality as assessed with Jadad scales reported effective rate:2 of them show Chinese traditional medicine integrated western medicine were better than western medicine.The left 3 trials were opposite.4 of them reported the adverse effect rate:1 trails show the adverse effect rate of Chinese traditional medicine integrated western medicine were lower than western medicine.The other 3 trials were opposite.
Author's conclusions: The clinical effect of traditional Chinese medicine or integrated western medicine against RA didn't be confirmed yet.The quality of the RCTs'reports of traditional Chinese medicine against RA was low.Analysis results of questionnaires to researchers indicated that research of RCTs was a process of low quality too.
目的:对中药治疗类风湿关节炎的疗效及安全性进行客观评价。
检索策略:使用包含所有类型的关节炎结合中药的术语,以“类风湿关节炎”、“关节炎”、“痹证”、“草药”、“中药”、“中医”、“传统医学”为关键词和题名进行检索。搜索了下列文献数据库:中国期刊全文数据库(CNKI)、中国科技期刊全文数据库(Vip)、万方数据库、中国生物医学文献光盘数据库(CBMDISC)(1978—2007.4)、中国生物医学文献期刊数据库(CMCC)、中国生物医学文摘数据库网络版(CBMWEB)、中国药学文献数据库。并依据所收集文献的参考文献,进行补充检索。
纳入标准:我们收集了所有中药与安慰剂、西药、空白对照比较的干预类风湿关节炎的随机对照试验。盲法和非盲法研究均纳入。
排除标准:试验组与对照组干预措施设置不合理者。非平行对照研究。
数据收集和分析:两个评价者独立地进行数据提取并对方法学质量进行评估。
结果:
1.共检索出2675篇文献,最后共纳入110篇中药干预或中药联合西药干预类风湿关节炎的随机对照试验,所获得的文献临床试验的方法学质量普遍较低,其中有5篇高质量研究,其余105篇均为低质量研究。
2.纳入的110篇文献中,有8篇研究的总有效率的比较进入Meta分析,包括2篇白芍总甙+甲氨喋呤与甲氨喋呤比较、2篇雷公藤多苷片与甲氨喋呤比较、2篇痹速清合剂与吲哚美辛比较、2篇风湿仙丹与消炎痛比较。其合并分析结果显示:白芍总甙联合甲氨喋呤与单独使用甲氨喋呤相比,其差异无统计学意义,RR_(合并)=1.05,95%CI为[0.92,1.20],表明白芍总甙联合甲氨喋呤与单独使用甲氨喋呤疗效相当;雷公藤多苷片与甲氨喋呤相比,其差异有统计学意义,RR_(合并)=1.15,95%CI为[1.01,1.30],表明雷公藤多苷片比甲氨喋呤疗效好;风湿仙丹与消炎痛相比,其差异有统计学意义,RR_(合并)=1.21,95%CI为[1.04,1.41】,表明风湿仙丹比消炎痛疗效好;痹速清合剂与吲哚美辛相比,其差异有统计学意义,RR合并=1.35,95%CI为[1.05,1.73】,表明痹速清合剂比吲哚美辛疗效好。其余50篇中药联合西药与西药比较的研究中,有29篇研究提示前者治疗并不比后者效果好,其余21篇研究表明前者并不比后者疗效差。其余52篇中药与单独西药比较的研究中,有27篇研究提示中药并不比西药效果好,其余25篇研究表明前者并不比后者疗效差。由于试验干预措施复杂,有中成药、中药提取物、单味中药、汤剂等,存在明显异质性,故无法进行汇总分析。
3.纳入的110篇文献中,51篇文献详细报道了不良事件情况。其中,有4篇研究的不良反应的比较进入Meta分析,包括2篇白芍总甙+甲氨喋呤与甲氨喋呤的比较、2篇雷公藤与甲氨喋呤的比较,其合并分析结果显示:白芍总甙联合甲氨喋呤与单独使用甲氨喋呤相比,其差异无统计学意义,RR_(合并)=0.80,95%CI为[0.49,1.31】,表明白芍总甙联合甲氨喋呤的不良反应发生率并不比单独使用甲氨喋呤不良反应发生率低;雷公藤多甙片与单独使用甲氨喋呤相比,其差异无统计学意义,RR_(合并)=0.81,95%CI为[0.48,1.38】,表明雷公藤多甙片的不良反应发生率并不比单独使用甲氨喋呤不良反应发生率低。其余23篇中药联合西药与西药比较的研究中,13篇提示前者不良反应发生率并不比后者低,其余10篇提示前者不良反应发生率比后者低。其余24篇中药与西药比较的研究中,12篇文献提示前者不良反应发生率并不比后者低,其余12篇提示前者不良反应发生率低于后者。
4.有5篇高质量研究均报道了总有效率,其中有2篇提示中药联合西药比单纯西药治疗效果好,其余3篇则提示中药(或联合西药)并不比单纯西药效果好。有4篇高质量研究报道了不良反应发生率,其中1篇研究提示中药联合西药的不良反应发生率较单纯中药治疗的低,其余3篇提示中药(或联合西药)的不良反应发生率并不比单纯西药低。
评价者的结论:由于原始报告质量较低,中药治疗类风湿关节炎的临床疗效仍旧不能确定,现有的证据还不足以得出肯定的结论。因此,需要更多大样本多中心的设计良好的随机对照试验,从而为临床决策提供科学依据。
Background: Rheumatoid arthritis (RA) is a kind of systemic autoimmune disease,which may lead to be deformed and disability.That is one of the main reasons lead to disable in our countty.The pathogenesis isn't clear.So far,the effectiveness of western medicine is not satisfactive and adverse reaction is serious, though NSAIDs and GC could control the symptom temporarily. Traditional Chinese medicine have superiority against RA. The curative effect have be admitted by patients and doctors.
Objectives: To assess the effectiveness and safety of traditional Chinese medicine therapies in the treatment of rheumatoid arthritis.
Search Strategy: We developed a search strategy using terms to include all forms of arthritis combined with traditional Chinese medicine. We have searched the following electronic databases: CNKI, Wanfang Data, Vip Information , CBMdisc, CMCC, CBMweb and the Chinese medicine document database. This was supplemented by searching the reference lists from retrieved trials.
Selection criteria: All randomized trials of traditional Chinese medicine interventions in rheumatoid arthritis, compared to placebo or western medicine or no intervention. There were two reviewers independently read and select each potential study according to the criteria.
Exclusion criteria:Except the studies of follow interventions: traditional Chinese medicine fumigate、iontophoresis、intermediate frequency、electromagnetic therapy and so on. The intervention of trial group and control group is unreasonable.Not parallel control study.
Data collection and analysis: Data were extracted independently by two reviewers and an assessment of methodological quality were conducted.
Main results:
1. 110 trials were included.The general methodological quality of all the trials wererelatively poor. 5 trials had high quality as assessed with Jadad scales.The otherswere poor.
2. Eight of the trials were included into Meta analysis about the effective rate,including 2 studies with the intervention of Total Glucosides of Paeony +Methotrexate VS Methotrexate、2 studies of Tripterygium wilfordii VS Methotrexate、2 Studies of Bi Su Qing composition VS Indomethacin、2 Studies of Feng Shi Xian Dan VS Indomethacin .The results of meta-analysis: Total Glucosides of Paeony + Methotrexate VS Methotrexate show no significant differences between them, RR_(total)=1.05, 95%CI [0.92, 1.20], the curative effect of the former was not better than the latter; Tripterygium wilfordii VS Methotrexate show significant differences between them, RR_(total)=1.15, 95%CI [1.01, 1.30]; Feng Shi Xian Dan VS Indomethacin show significant differences between them, RR_(total)=1.21, 95%CI [1.04, 1.41], the former was more effective than the latter;Bi Su Qing composition VS Indomethacin show significant differences between them, RR_(total)=1.35, 95%CI [1.05, 1.73], the former was more effective than the latter. 29 of 50 studies(Chinese traditional medicine integrated western medicine VS western medicine) show Chinese traditional medicine were not better than western medicine;the left 21 studies were opposite. 27 of 52 studies(Chinese traditional medicine VS western medicine) show Chinese traditional medicine were not better than western medicine; the left 25 studies were opposite.Because of the multiformity of the intervention, including Chinese formulated products, extractive, medicinal broth and so on, there were significant heterogeneity, so we cann't pool more data.
3. 51 of 110 studies reported the adverse effect detailly. Four of the trials were included into Meta analysis about the adverse effect rate,including 2 studies with the intervention of Total Glucosides of Paeony +Methotrexate VS Methotrexate、2 studies of Tripterygium wilfordii VS Methotrexate .The results of meta-analysis: Total Glucosides of Paeony + Methotrexate VS Methotrexate show no significant differences between them, RR_(total)=0.80, 95%CI [0.49, 1.31], the adverse effect rate of the former was not lower than the latter; Tripterygium wilfordii VS Methotrexate show no significant differences between them, RR_(total)=0.81, 95%CI[0.48, 1.38], the adverse effect rate of the former was not lower than the latter; 13 of 23 studies(Chinese traditional medicine integrated western medicine VS western medicine) show the adverse effect rate of Chinese traditional medicine were not lower than western medicine;the left 10 studies were opposite. 12 of 24 studies(Chinese traditional medicine VS western medicine) show the adverse effect rate of Chinese traditional medicine were not lower than western medicine; the left 12 studies were opposite.
4. 5 trials with high quality as assessed with Jadad scales reported effective rate:2 of them show Chinese traditional medicine integrated western medicine were better than western medicine.The left 3 trials were opposite.4 of them reported the adverse effect rate:1 trails show the adverse effect rate of Chinese traditional medicine integrated western medicine were lower than western medicine.The other 3 trials were opposite.
Author's conclusions: The clinical effect of traditional Chinese medicine or integrated western medicine against RA didn't be confirmed yet.The quality of the RCTs'reports of traditional Chinese medicine against RA was low.Analysis results of questionnaires to researchers indicated that research of RCTs was a process of low quality too.
引文
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