TABLE 1.
The basic information of the 42 included articles (sorted by the first letter of author’s name).
| Studies | Sample size (T/C) | Sex M/F | Age, Mean ± SD (year) | Intervention | Course of treatment | Diagnostic criteria | Outcomes | ||
|---|---|---|---|---|---|---|---|---|---|
| T | TXLC dosage | C | |||||||
| Cai and Li (2010) | 120 (61/59) | 73/47 | NR | TXLC + CT | 4 capsules, Tid | CT (isosorbide dinitrate, diltiazem hydrochloride tables, metoprolartrate tables, sublingual nitroglycerin if angina attach, no details) | 4 weeks | 2000 CMA recommendations for diagnosis and treatment of UA | (6) (8) (9) |
| Chang et al. (2018) | 108 (54/54) | 53/55 | T | TXLC + CT | 3 capsules, Tid | CT (aspirin 100 mg Qd, atorvastatin 20 mg Qd, isosorbide mononitrate 40 mg Qd, subcutaneous injection of enoxaparine 0.6 mg Q12h if necessary) | 30 days | 2007 CMA Guidelines for the diagnosis and management of UA and non-ST-segment elevation myocardial infarction | (11) (12) |
| 57.2 ± 2.8 | (13) (14) | ||||||||
| C | (15) (17) | ||||||||
| 57.7 ± 2.4 | |||||||||
| Chang and Zhao (2004) | 114 (68/46) | NR | T 65 ± 4 C 64 ± 6 | TXLC + CT | 3 capsules, Tid | CT (isosorbide dinitrate, aspirin, calcium antagonists, β-blocker, no details) | 6 weeks | WHO Diagnostic criteria for UA | (10) |
| Chen and Li (2009) | 118 (60/58) | 79/39 | NR | TXLC + CT | 4 capsules, Tid | CT (aspirin 100 mg, Qd; simvastatin 10 mg, Qd; subcutaneous injection of LMWH 5000U, Q12h; metoprolol) | 4 weeks | 2000 CMA recommendations for diagnosis and treatment of UA (except for variantangina vectoris) | (6) (10) |
| Cui (2008) | 144 (76/68) | 82/62 | T:55 ± 2 | TXLC + CT | 3 capsules, Tid | CT (β-blocker, calcium antagonists, aspirin, etc.; nitroglycerin, ivgtt; LMWH Calcium Injection, iH, 5–7 d) | 1 month | 1979 WHO nomenclature and diagnostic criteria of IHD | (6) (10) |
| C:55 ± 3 | |||||||||
| Ding et al. (2013) | 120 (60/60) | 77/43 | NR | TXLC + CT | 4 capsules, Tid | CT (aspirin, 100 mg, Qd; metoprolol 12.5 mg, Bid; nitroglycerin for angina attack 0.5–1 sublingual; simvastatin 10 mg, Qd; LMWH 5000U, iH, Q12h) | 4 weeks | 2000 WHO Diagnostic criteria for UA | (10) (11) |
| Du (2016) | 100 (50/50) | 51/49 | T | TXLC + CT | 4 capsules, Tid | CT (ACEI; nitrates; lipid-altering drugs; β-blocker; aspirin, 100 mg, Qd) | 4 weeks | 2000 WHO Diagnostic criteria for UA | (6) (10) (11) |
| 63.3 ± 5.4 | |||||||||
| C | |||||||||
| 62.9 ± 5.1 | |||||||||
| Gao et al. (2002) | 100 (60/40) | 63/37 | NR | TXLC + CT | 2–4 capsules, Tid | CT (nitroglycerin, metoprolol, aspirin, etc., no details) | 4 weeks | WHO Nomenclature and diagnostic criteria of IHD and the clinical research guidelines for new traditional Chinese medicines for the treatment of chest pain formulated by the Ministry of Health in 1993 | (10) |
| Hao (2015) | 110 (55/55) | 53/57 | T | TXLC + CT | 4 capsules, Tid | CT (aspirin, nitrates, metoprolol, simvastatin, etc., no details) | 2 months | Diagnostic criteria of UA in “Internal medicine” | (10) |
| 48.1 ± 3.8 | |||||||||
| C | |||||||||
| 49.3 ± 3.3 | |||||||||
| Hui et al. (2018) | 100 (50/50) | 55/45 | T | TXLC + CT | 3 capsules, Tid | CT (aspirin, β-blocker, statins, nitrates, atients with diabetes were also given hypoglycemic therapy, isosorbide mononitrate for angina attack) | 2 weeks | Diagnostic criteria for UA | (11) |
| 56.20 ± 6.75 | |||||||||
| C | |||||||||
| 56.56 ± 6.32 | |||||||||
| Jiang et al. (2019) | 160 (80/80) | 90/70 | T | TXLC + CT | 4 capsules, Tid | CT (antiplatelet aggregation, calcium antagonist and anticoagulant therapy. astatin tablets 20 mg/times, Qd, daily bedtime oral) | 3 months | Relevant standards formulated by the South China International Cardiovascular Symposium | (16) |
| 58.5 ± 6.4 | |||||||||
| C | |||||||||
| 59.1 ± 6.2 | |||||||||
| Li Q. et al. (2018) | 128 (64/64) | 74/54 | T:68.11 ± 7.29 | TXLC + CT | 2 capsules, Tid | CT (conventional treatment and a torvastatin calcium tablets 20 mg, Qd) | 2 months | 2009 edition of “Coronary Heart Disease with Integrated Traditional Chinese and Western Medicine” | (16) |
| C:68.11 ± 7.29 | |||||||||
| Li (2013) | 110 (55/55) | 81/29 | T:55.4 ± 9.6 | TXLC + CT | 2 capsules,Tid | CT (atorvastatin, 20 mg, Qd; oral nitrates, β-receptor blockers, calcium antagonists, anti-platelet aggregation drugs and LMWH, etc.) | 8 weeks | Diagnostic criteria for UA in the 1979 WHO standards and the standards of the National Symposium on the Diagnosis and Treatment of UA in August 2000 | (11) |
| C:57.0 ± 9.2 | |||||||||
| Liu and An (2016) | 160 (80/80) | 101/59 | 51.1 ± 1.4 | TXLC + CT | 4 capsules, Tid | CT (sublingual nitroglycerin; aspirin antiplatelet therapy; heparin anticoagulation therapy; thrombolysis; β-blockers (propranolol) and ACEI (angiotensin II), attovastatin calcium tablets, 20 mg, Qd) | 3 months | The relevant diagnostic criteria for coronary heart disease and angina pectoris formulated by the WHO; all are diagnosed as UA of coronary heart disease through clinical symptoms, laboratory examinations, and imaging data | (6) |
| Liu (2011) | 102 (51/51) | 47/54 | NR | TXLC + CT | 4 capsules, Bid | CT (conventional treatment and LMWH 5000U, iH, Q12h, continuous use of 5–7 d) | 4 weeks | The diagnostic criteria for unstable myocardial infarction in the “Guidelines for the Diagnosis and Treatment of Elevated Myocardial Infarction” formulated by the Cardiovascular Branch of the CMA in 2007 | (8) (9) |
| Luo (2013) | 120 (60/60) | 63/57 | T:58.88 ± 14.37 | TXLC + CT | 2–4 capsules, Tid | CT [rest, oxygen inhalation, low-fat diet, give nitrate vinegar drugs, aspirin, lipid-lowering drugs, calcium antagonists, LMWH, metoprolol tartrate (start from the minimum dose of 6 t 25 mg, Bid, every 1–2 weeks to gradually increase, and finally increase to the target value of 50–150 mg, Qd, for 14 consecutive days)] | 3 months | “Naming and Diagnostic Standards for Coronary Heart Disease” developed by WHO | (11) |
| C:59.12 ± 15.01 | |||||||||
| Ma et al. (2011) | 318 (159/159) | 194/124 | 60.6 ± 12.8 | TXLC + CT | 3–4 capsules, Tid | CT (aspirin, nitroglycerin, heparin, calcium antagonists, β-blockers, no details) | NR | Diagnosis based on the characteristics of angina pectoris and the dynamic evolution of the S-T segment of the ECG at the onset (s-T segment downward shift ≥0.1 mv) | (1) (2) (3) (4) (5) (6) |
| Ren et al. (2018) | 100 (50/50) | NR | NR | TXLC + CT | 4 capsules, Tid | CT (nitrate drugs, β-blockers, aspirin orally, 100 mg, Qd) | 4 weeks | Evidence for the diagnosis of UA | (6) (11) |
| Shi (2013) | 112 (56/56) | 45/67 | 65.38 ± 10.57 | TXLC + CT | 4 capsules, Tid | CT (rest on bed, low-salt diet, low-flow oxygen inhalation, etc. nifedipine tablets, 10 mg, Tid; aspirin enteric-coated tablets 112 mg, Qd; angiotensin converting enzyme inhibitor benazepril 5 mg, Qd; trimetazidine, 20 mg, Tid; isosorbide dinitrate tablets 10 mg, Tid; take isosorbide dinitrate tablets when angina pectoris attacks, 10 mg/time) | 14 days | Diagnostic criteria for UA developed by experts from the ACC and the American Association of Cardiology (AHA) | (6) (10) (11) |
| Song et al. (2008) | 176 (106/70) | NR | NR | TXLC + CT | 2 capsules, Bid | CT (nitroglycerin 5mg, added to 5% glucose injection 250 ml intravenous infusion, first start at 10 μg/min, increase by 5–10 μg every 15 min, maintain the systolic blood pressure at about 100 mmHg) | 2 weeks | Standards established by WHO in 1979 | (6) (10) (11) |
| Sun et al. (2011) | 128 (66/62) | 62/66 | 68.26 ± 10.17 | TXLC + CT | 4 capsules, Tid | CT (aspirin 100 mg, Qd; atorvastatin 20 mg, Qn; isosorbide mononitrate 20 mg, Bid; oral ACEI and calcium antagonists, β-blockers. intravenous nitrates and subcutaneous injection of LMWH if necessary) | 4 weeks | WHO recommended diagnostic criteria for UA | (16) |
| Tian and Xu (2005) | 118 (77/41) | 82/36 | NR | TXLC + CT | TXLC group 1: 45 cases, 2 capsules, Tid; TXLC group 2: 32 cases, 4 capsules, Tid | CT (isosorbide 10 mg, tid; enteric-coated aspirin 0.1 g, Qd; captopril 6.25–25 mg, Tid; and add β-blockers or calcium antagonists, statins lipid-lowering drugs, intravenous nitrates and subcutaneous injection of LMWH if necessary) | 8 weeks | 1997 WHO Diagnostic criteria for IHD | (5) (6) |
| Tian et al. (2007) | 120 (60/60) | 69/51 | 57.4 ± 4.7 | TXLC + CT | 4 capsules, Tid | CT (Conventional coronary artery dilation, anticoagulation, and oxygen consumption reduction therapy) | 4 weeks | WHO standard for UA | (6) |
| Wang and Li (2007) | 180 (90/90) | 124/56 | T:56 ± 6 | TXLC + CT | 4 capsules, Tid | CT [enteric-coated aspirin (changed to 100 mg/d after 300 mg/d, 3 days), nitrate, β-blockers, LMWH sodium (5000 IU subcutaneous injection, Q12h) (LMWH for 1 week)] | 8 weeks | Selection criteria: 1. initial exertional angina pectoris; 2. deteriorating exertional angina pectoris; 3. resting angina pectoris; 4. angina after infarction. At the same time: 1.96 h of sudden exacerbation of angina, activity tolerance decreased significantly; 2. spontaneous angina attack at least once within 24 h; 3. ST-segment moved down more than 1 mm at the time of the attack, and it recovered significantly after the attack was relieved | (6) (11) |
| C:56 ± 7 | |||||||||
| Wang (2017) | 120 (60/60) | 62/58 | T:63.1 ± 5.2 C:62.8 ± 4.3 | TXLC + CT | 4 capsules, Tid | CT (nitrate drugs, ACEI, β-blockers, aspirin, 100 mg/time) | 4 weeks | All patients meet the clinical diagnostic criteria for UA established by the Cardiovascular Branch of the CMA in 2000; | (6) (11) |
| ASA Cardiac Function Classification I∼II | |||||||||
| Wang et al. (2013) | 150 (100/50) | 85/65 | T:74.28 ± 5.14 | TXLC + CT | 4 capsules, Tid | CT (antiplatelet aggregation and anticoagulant drugs, antiangina drugs; in special circumstances, quick-acting anti-angina pectoris can be added temporarily) | 4 weeks | The diagnostic criteria for UA in the 2007 “Guidelines for the Diagnosis and Treatment of UA and Non-ST Segment Elevation Myocardial Infarction”. The angina pectoris classification adopts the angina pectoris classification of the CCS | (4) (10) (11) (12) (13) (14) (15) |
| C:72.80 ± 4.98 | |||||||||
| Wang et al., 2010 | 110 (56/54) | 74/36 | 63.3 ± 7.2 | TXLC + CT | 3 capsules, Tid | CT (aspirin + simvastatin + nitrate) | 12 weeks | UA risk stratification of Brauwald in 1989 | (11) |
| Wang (2015) | 100 (50/50) | 62/38 | T:75.3 ± 2.7 | TXLC + CT | 4 capsules, Tid | CT (antiangina drugs, antiplatelet aggregation drugs and anticoagulant drugs) | 1 month | clinical diagnostic criteria for UA | (11) |
| C:74.8 ± 3.1 | |||||||||
| Wang et al. (2009) | 126 (66/60) | 88/38 | T:54.3 | TXLC + CT | 4 capsules, Tid | CT (isosorbide, 10 mg, Tid) | 2 months | The naming and diagnostic criteria of IHD developed by WHO | (6) (11) |
| C:53.8 | |||||||||
| Wang et al. (2012) | 144 (72/72) | 80/64 | T:68.6 ± 8 | TXLC + CT | 4 capsules, Tid | CT (nitrates, lipid-lowering drugs, β-receptor blockers, enteric-coated aspirin, calcium channel blockers, ACEI, angiotensin receptor inhibitors) | 8 weeks | The “Nomenclature and Diagnostic Criteria for IHD” recommended by WHO and the diagnostic criteria in “Recommendations for the Diagnosis and Treatment of UA” issued by the Cardiovascular Branch of the CMA in 2000 | (6) (10) (11) |
| C:67.6 ± 10 | |||||||||
| Wu (2011) | 109 (59/50) | 75/34 | T:66.6 ± 11.35 | TXLC + CT | 2 or 4 capsules, Tid | CT (clopidogrel 75 mg, Qn; LMWH calcium 5000 U, iH, Q12h, 7 days; isosorbide mononitrate, 20 mg, Bid; betaloc 12.5 mg, Bid: simvastatin, 20 mg, Qn; enalapril, 5 mg, Bid, as long as hypotension does not occur; calciumion antagonists, etc. Patients with arrhythmia, hypertension, and diabetes are given symptomatic treatments such as antihypertensive, hypoglycemic, and antiarrhythmic treatment at the same time) | 10 months | “Acc/A—HA2007 UA/Non-ST-segment Elevation Myocardial Infarction Treatment Guidelines Diagnostic Criteria” | (6) |
| C:63.8 ± 10.57 | |||||||||
| Wu S. J. et al. (2006) | 180 (120/60) | NR | NR | TXLC + CT | TXLC low dose group 2 capsules, Tid; TXLC high dose group 4 capsules, Tid | CT (antithrombotic, nitrate vinegar drugs, β-blockers, ACEI) | 4 weeks | UA diagnostic criteria in the guidelines and recommendations for the treatment of cardiovascular diseases | (6) |
| Wu et al. (2010) | 110 (57/53) | 63/47 | T:71.4 ± 4.5 | TXLC + CT | 4 capsules, Tid | CT (routinely give clopidogrel 75 mg/d and aspirin 100 mg/d for at least 7 days before PCI; routine treatment after PCI (such as aspirin, clopidogrel, β-blockers, nitrates, angiotensin conversion) enzyme inhibitors, LMWH, etc.) | 6 months | Guidelines for the diagnosis and treatment of UA and non-ST-segment elevation myocardial infarction formulated by the Cardiovascular Branch of the CMA in 2007 | (3) (4) (7) |
| C:69.8 ± 4.3 | |||||||||
| Xin et al. (2008) | 128 (66/62) | 73/55 | T:64 ± 10 | TXLC + CT | 4 capsules, Tid | CT (enteric-coated aspirin, nitrate esters, β-blocker, containing nitroglycerin at the time of disease) | 4 weeks | The naming and diagnostic criteria for IHD recommended by the International Society of Cardiology and WHO | (6) (8) (9) |
| C:63 ± 8 | |||||||||
| Xing (2013) | 120 (60/60) | 71/29 | NR | TXLC + CT | 4 capsules, Tid | CT (Low-fat diet, recorde resting ECG once a day; isosorbide, 10 mg, Tid; enteric-coated aspirin, 100 mg, qd; oxygen inhalation, sublingual nitroglycerin for angina pectoris, intravenous nitroglycerin, subcutaneous injection of tid LMWH, etc. if necessary) | 4 weeks | WHO diagnosis and classification criteria of coronary heart disease and angina pectoris in 1979 | (9) |
| Yang (2008) | 100 (50/50) | 49/51 | T:62.4 ± 10.9 | TXLC + CT | 3 capsules, Tid | CT (nitrates, calcium antagonists, β-receptor blockers, ACEI, enteric-coated aspirin, statins) | 1 month | In line with the WHO diagnosis of UA patients | (11) (17) |
| C:58.2 ± 12.0 | |||||||||
| Yang et al. (2019) | 100 (50/50) | 61/39 | T:66.2 ± 4.8 | TXLC + CT | 4 capsules, Bid | CT (5-isosorbate mononitrate, 40 mg, Bid; aspirin,100 mg, Qn, before bedtime; betaloc, 25 mg, Bid) | 3 months | According to the WHO diagnostic criteria for angina pectoris of coronary heart disease: typical symptoms of angina pectoris; ECG showed obvious changes of myocardial ischemia | (6) (10) (11) |
| C:66.6 ± 4.7 | |||||||||
| Yu and Chen (2015) | 122 (68/54) | 69/53 | T:56.6 ± 3.5 C:57.2 ± 2.9 | TXLC + CT | 2 capsules, Tid | CT (aspirin, clopidogrel, ACEI, β-blockers, statins, nitrates, and subcutaneous injection of LMWH and other drugs) | 1 year | On the basis of typical clinical manifestations, dynamic changes of ECG ST-segment elevation and depression, myocardial enzyme spectrum during angina pectoris attack, troponin was clearly diagnosed as UA patient | (3) (7) |
| Yu and Hu (2012) | 120 (60/60) | 66/54 | T:55.3 ± 6.5 | TXLC + CT | 2 capsules, Tid | CT (betalox 50 mg, Bid; antiplatelet aggregation drugs, ACEI and lipid lowering drugs) | NR | According to the Braunwald grade, there were 46 cases in grade I, 40 cases in grade II and 34 cases in grade III. | (2) (5) (6) |
| C:54.7 ± 6.2 | |||||||||
| Yuan (2019) | 100 (50/50) | 53/47 | T:63.14 ± 5.79 | TXLC + CT | 3 capsules, Qd | CT (adjusting blood glucose and controlling blood pressure; simvastatin 4 tablets/time, Qd) | 4 months | The relevant diagnostic criteria for coronary heart disease UA in the Guidelines for the Diagnosis and Treatment of UA and Non-ST-Segment Elevation Myocardial Infarction formulated by the Chinese Society of Cardiology, etc. | (16) |
| C:62.78 ± 5.42 | |||||||||
| Zhang et al. (2009) | 166 (86/80) | 114/52 | T:55 | TXLC + CT | 4 capsules, Tid | CT (nitrates, aspirin, β-blockers, etc.) | 3 months | International Society of Cardiology and WHO Diagnostic Criteria | (6) (10) |
| C:54 | |||||||||
| Zhou (2013) | 152 (78/74) | 98/54 | T:67 | TXLC + CT | 3 capsules, Tid | CT (rest on bed for 7 days, oxygen inhalation, blood pressure control; isosorbide tablets, 10 mg, Tid; atorvastatin calcium tablets, 20 mg, Qn; enteric-coated aspirin tablets, 150 mg, Qd, change to 100 mg Qd after 3 days) | 1 month | The standard of the middle and high risk group for the risk stratification of UA by the Cardiovascular Branch of the CMA | (6) (10) |
| C:68 | |||||||||
Note: CT, conventional treatment; T, trial; C, control; M, male; F, female; SD, standard deviation; TXLC, Tongxinluo capsule; CMA, Chinese Medical Association; UA, unstable angina; WHO, World Health Organization; IHD, ischemic heart disease; LMWH, low molecular weight heparin; ACEI, angiotension converting enzyme inhibitors; ECG, electrocardiogram; ASC, American Society of Cardiology; AHA, American Heart Association; CCS, Canadian Cardiovascular Society; PCI, percutaneous coronary intervention; Bid, twice a day; Tid, three times a day; Qd, once a day; iH, hypodermic injection; Qn, every night; Q12h, every 12 h. (1) Rate of cardiovascular events; (2) Mortality due to any cardiovascular event; (3) Incidence of acute myocardial infarction (AMI); (4) Revascularization (including percutaneous coronary intervention (PCI), percutaneous transluminal coronary angioplasty (PTCA) and coronary artery bypass grafting (CABG)); (5) All-cause mortality; (6) Adverse effect; (7) Recurrence of angina; (8) NST; (9) ∑ST; (10) ECG Improvement; (11) Clinical efficacy in UA; (12) Chest pain or tightness; (13) Palpitation; (14) Shortness of breath; (15) Asthenia; (16) Hypersensitive C-reactive protein (hs-CRP) Level; (17) Nitric oxide (NO) Level.