1.天津中医药大学第一附属医院/国家中医针灸临床医学研究中心,天津市西青区昌凌路88号,300380
2.四川省第二中医医院
3.天津中医药大学
4.杭州市中医院
5.杭州市红十字会医院
6.北京市海淀区田村路社区卫生服务中心
7.上海中医药大学
毛静远, E-mail:jymao@126. com
张伯礼, E-mail:zhangbolipr@163. com
收稿:2022-10-02,
修回:2023-02-12,
纸质出版:2023-04-02
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毕颖斐,王贤良,王聪等.中医药辨治稳定性冠心病的病、证、症-疗效-用药规律的真实世界研究[J].中医杂志,2023,64(07):702-709.
BI Yingfei,WANG Xianliang,WANG Cong,et al.A Real-world Study on the Diseases/Syndromes/Symptoms-Curative Effects-Medication Rules of Traditional Chinese Medicine in the Treatment of Stable Coronary Heart Disease[J].Journal of Traditional Chinese Medicine,2023,64(07):702-709.
毕颖斐,王贤良,王聪等.中医药辨治稳定性冠心病的病、证、症-疗效-用药规律的真实世界研究[J].中医杂志,2023,64(07):702-709. DOI: 10.13288/j.11-2166/r.2023.07.010.
BI Yingfei,WANG Xianliang,WANG Cong,et al.A Real-world Study on the Diseases/Syndromes/Symptoms-Curative Effects-Medication Rules of Traditional Chinese Medicine in the Treatment of Stable Coronary Heart Disease[J].Journal of Traditional Chinese Medicine,2023,64(07):702-709. DOI: 10.13288/j.11-2166/r.2023.07.010.
目的
2
基于真实世界探讨中医药辨治稳定性冠心病患者的病-疗效-用药、证-疗效-用药、症-疗效-用药规律。
方法
2
建立中医诊疗信息数据库,在维持原西医治疗不变的基础上,对来自全国不同地域的中医专家辨治稳定性冠心病患者的过程进行1~2周的跟踪和记录。统计治疗前纳入患者的证候要素及证候类型分布,于治疗前后进行中医证候积分评价,并以治疗后中医证候积分改善率≥50%为中医证候积分有效病例。治疗前后采用欧洲五维健康量表[包括五维健康描述系统(EQ-5D)评分、视觉模拟(EQ-VAS)评分]评价患者健康状况,并以治疗后EQ-VAS评分改善率>10%为有效病例。选取冠心病的典型症状胸痛并记录发作情况进行中药联合应用的效应分析。
结果
2
纳入2046例患者,其中2003例患者有明确的证候要素诊断,1998例患者有明确的证候类型诊断,1953例患者有完整中医证候积分数据,1954例患者符合EQ-5D评分分析标准,1906例患者符合EQ-VAS评分分析标准,1826例患者有胸痛发作次数记录。治疗前中医证候要素分布前三位为血瘀(1793例、89.5%)、气虚(1651例、82.4%)、痰浊(1428例、71.3%),中医证候类型分布前三位为气虚血瘀(450例、22.5%)、痰瘀互结(285例、14.3%)、气虚痰瘀(233例、11.7%)。治疗后符合中医证候积分有效标准的患者共672例,在气虚血瘀、痰瘀互结、气虚痰瘀证中有效病例的占比分别为37.5%、30.2%、33.0%。符合EQ-VAS评分有效标准的患者共707例,使用频率前三位中药为丹参(484例,68.5%)、茯苓(420例,59.4%)、川芎(375例,53.0%)。胸痛症状消失的患者共306例,使用频率前三位中药为丹参(207例,67.6%)、茯苓(196例,64.1%)、半夏(162例,52.9%)。有胸痛发作次数记录的患者使用频率较高(>10%)的中药共计34种,合用指数(CI值)前六位中药为丹参(0.306)、茯苓(0.264)、川芎(0.226)、半夏(0.221)、陈皮(0.207)、赤芍(0.205)。34种中药用药频率与胸痛发作次数的相关性分析显示,应用频次越高的单味中药对应病例胸痛发作次数下降率越高;应用多元回归模型显示具有统计学意义(P=0.028),CI值较高的6味中药为胸痛发作次数下降的重要贡献者,且药物间相互效应呈现相加性作用。
结论
2
真实世界不同专家辨治稳定性冠心病有一定的病-疗效-用药、证-疗效-用药、症-疗效-用药规律,其中丹参、茯苓、川芎、半夏、陈皮、赤芍为减少胸痛发作次数的核心用药组群,且组群中药物合用的疗效明显强于任何单用药的疗效。
Objective
2
To explore disease/syndrome/symptoms-curative effects-medication rules of traditional Chinese medicine (TCM) in the treatment of patients with stable coronary heart disease (SCHD) in a real-world study.
Methods
2
An information database for TCM diagnosis and treatment was established, and records for pattern differentiation and treatment of SCHD in addition to maintaining the western medicine by TCM experts from different regions of China were tracked for 1 to 2 weeks. The syndrome elements and syndrome types of the included patients were counted before treatment. The TCM syndrome scores were evaluated before and after treatment, and the patients with an improvement rate equaling or exceeding 50% after treatment were regarded as the effective cases. The European five-dimensional health scale including EuroQol-5D (EQ-5D) score and visual analogue (EQ-VAS) score were used to evaluate the patient's health status, and those with improvement rate of EQ-VAS score after treatment exceeding 10% were taken as the effective cases. Chest pain as a typical symptom of CHD was recorded to analyze the effect of the combined application of Chinese herbal medicine.
Results
2
Of the included 2046 patients, there were 2003 cases with definite syndrome elements and 1998 cases with definite syndrome types regarding the diagnosis. Totally, 1953 cases had complete data in terms of the TCM syndrome score, while 1954 cases and 1906 cases had eligible data for EQ-5D and EQ-VAS analyses, respectively. Occurrence of chest pain was recorded in 1826 cases. Before treatment, the top three syndrome elements were blood stasis (1793 cases, 89.5%),
qi
deficiency (1651 cases, 82.4%), and phlegm turbidity (1428 cases, 71.3%), and the top three syndrome types were
qi
deficiency and blood stasis (450 cases, 22.5%), binding of phlegm and stasis (285 cases, 14.3%), and
qi
deficiency and phlegm stasis (233 cases, 11.7%). Totally, 672 cases met the effective criteria of TCM syndrome score after treatment, and the effective cases accounted for 37.5%, 30.2%, and 33.0% of all the cases with
qi
deficiency and blood stasis syndrome, binding of phlegm and stasis syndrome, and
qi
deficiency and phlegm stasis syndrome, respectively. A total of 707 cases met the effective criteria of the EQ-VAS score, and the top three frequent herbs were Danshen (
Radix et Rhizoma Salviae Miltiorrhizae
, 484 cases, 68.5%), Fuling (
Poria
, 420 cases, 59.4%), and Chuanxiong (
Rhizoma Chuan
-
xiong
, 375 cases, 53.0%). There were 306 patients whose chest pain symptom disappeared, and for them the top three frequently used herbs were Danshen (207 cases, 67.6%), Fuling (196 cases, 64.1%), and Banxia (
Rhizoma Pinelliae
, 162 cases, 52.9%). Thirty-four herbs were frequently used (>10%) by patients with chest pain records, and the top six herbs regarding the CI values were Danshen (0.306), Fuling (0.264), Chuanxiong (0.226), Banxia (0.221), Chenpi (
Pericarpium Citri Reticulatae
, 0.207), and Chishao (
Radix Paeoniae Rubra
, 0.205). The linear correlation graph between the frequency of 34 herbs and the occurrence of chest pain showed that higher frequent herb was associated with more reduction of the occurrence rate of chest pain; multivariate regression model showed statistical significance (
P
= 0.028), and six herbs with higher CI contributed importantly to the decrease of chest pain occurrence, and additive effect was shown among the herbs.
Conclusion
2
This real-world study shows certain disease, syndrome, symptom-curative effect-medication rules of different experts in the pattern differentiation and treatment of SCHD. Danshen, Fuling, Chuanxiong, Banxia, Chenpi and Chishao are the core herbs for decrease the occurrence of chest pain of SCHD patients, and the additive effect between the herbs make it better when combining the herbs than using single herb alone.
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