Table 1.
Summary of Main Adjuvant Effects of GPs From Clinical Trials
| Country | GPs formulation | Dose and route of administration | Experimental objects | Type of clinical trials | Observation indicators | Outcomes | Adverse reactions | References | |
|---|---|---|---|---|---|---|---|---|---|
| China | GP injection (product of the Pharmaceutical Factory of Shenyang University of Pharmacy, batch number 001001) | 12 mg for intravenous dripping, starting from 3-7 days before RT till ending RT | 131 cases of NPC (RT-GP group, n = 64, aged 25-65 years; control group, n = 67, aged 26-63 years) | randomized, parallel，placebo-controlled | Status of primary carcinoma and cervical lymph node | CR rate of local focus: 96.6% vs.93.3%; | No evident toxic-adverse reaction | [25] | |
| CR rate of cervical metastatic lymph node: 85.7% vs.78.0% | |||||||||
| CR rate shown by CT: 60.3% vs.51.7% | |||||||||
| T-lymphocyte subsets activity (%) | T3: pre-intervention: 53.3 ± 9.2% vs.52.6 ± 10.8%; post-intervention: 60.9 ± 8.7% vs.45.7 ± 8.9% | ||||||||
| T4: pre-intervention: 40.7 ± 7.6% vs.41.3 ± 8.5%; post-intervention: 43.5 ± 6.8% vs.35.6 ± 9.2% | |||||||||
| T8: pre-intervention: 27.3 ± 4.8% vs.27.2 ± 7.3%; post-intervention: 28.7 ± 5.1% vs.28.3 ± 7.8% | |||||||||
| NK cell activity (%) | pre-intervention: 26.8 ± 8.2% vs.28.8 ± 9.8%; post-intervention: 34.6 ± 8.7% vs.24.4 ± 8.8% | ||||||||
| LAK cell activity (%) | pre-intervention: 14.3 ± 6.1% vs.15.2 ± 6.3%; post-intervention: 23.8 ± 8.3% vs.13.3 ± 5.2% | ||||||||
| China | GP injection (bought from Newcrest pharmaceutical Co., Ltd., Jilin, China) | 4ml for intravenous dripping, twice a day for 6-8 weeks | 80 patients diagnosed with NSCLC (Treatment group, n = 40, 59.3 ± 8.1 years old; Control group, n = 40, 60.1 ± 7.5 years old) | randomized, parallel，placebo-controlled | Total effective rate and clinical benefit rate (%) | Total effective rate: 60.0% vs.45.0%; Clinical benefit rate: 85.0% vs.77.5% | Not mentioned | [26] | |
| Incidence of adverse reactions (%) | Leukopenia: 55% vs.80%; Thrombocytopenia: 40% vs.65%; anemia: 50%vs.65%; Intestinal injury:72.5% vs.87.5%; alopecia:57.5% vs.72.5% | ||||||||
| Korea | Y-75(Ginsan) | oral administrated, 3g twice a day for 14weaks | healthy older adults,50-75 years old (Y-75 group, n = 36; placebo control, n = 36) | randomized, placebo-controlled, parallel, double-blind | NK cell activity (%) | Pre-intervention: 38.5 ± 14.11% vs.40.6 ± 13.4%; Post-intervention:52.0 ± 13.7% vs.40.8% ± 14.6% (week 8);53.9 ± 13.0% vs.41.6 ± 15.5% (week 14) | Total numbers: 14 vs.5; Gastrointestinal disease: 3 vs.2; Infection: 3 vs.1; Musculoskeletal and connective disease: 2 vs.1 | [101] | |
| Macrophages phagocytic activity | Pre-intervention:19632.1 ± 5227.1 vs.20150.4 ± 6620.4;Post-intervention:24585.3 ± 7597.2 vs.21615.4 ± 5662.6(week 8);27366.1 ± 7772.3 vs.21913.5 ± 6455.8(week 14) | ||||||||
| Monocyte-derived mediators (pg/ml) | TNF-α: pre-intervention: 2297.8 ± 1551.6 vs.2322.9 ± 1861.9; post-intervention: 3174.8 ± 1694.5 vs.2286.4 ± 1769.3(week 8); 3319.5 ± 1886.8 vs.2360.3 ± 1552.6(week 14); IL-12: not significantly altered | ||||||||
| China | GP injection (bought from Shanxi Pude pharmaceutical Co., Ltd., Shanxi, China) | Injection under the thoracoscope, 0.5 mg/kg, once a week, 4 times for 30 days | 96 patients diagnosed with NSCLC (Treatment group, n = 48, 33-66 years old; Control group, n = 48, 32-65 years old) | randomized, parallel，placebo-controlled | FACT-L scores | significantly altered | No evident toxic-adverse reaction | [27] | |
| Expression of Th1 and Th2 cytokines (%) | Th1: INF-γ: pre-intervention: 32.46 ± 9.65% vs.34.13 ± 9.24%; post-intervention: 75.35 ± 12.86% vs.65.36 ± 10.21%; IL-2: pre-intervention: 24.12 ± 6.98% vs.25.15 ± 6.14%; post-intervention: 62.42 ± 17.97% vs.51.56 ± 9.48% | ||||||||
| Th2: IL-4: pre-intervention: 47.88 ± 9.67% vs.49.54 ± 9.26%; post-intervention: 32.54 ± 8.32% vs.39.34 ± 9.12%; IL-5: pre-intervention: 61.34 ± 14.29% vs.62.58 ± 12.14%; post-intervention: 43.37 ± 11.32% vs.53.25 ± 12.37% | |||||||||
| China | GP injection (bought from Changchun Boao Biochemical Pharmaceutical Co., Ltd., Changchun, China) | 4ml for intravenous dripping, twice a day for 12 weeks | 130 patients diagnosed with NSCLC (Treatment group, n = 65, 60.8 ± 7.9 years old; Control group, n = 65, 59.4 ± 7.7 years old) | randomized, parallel，placebo-controlled | Total effective rate (%) | 58.5% vs.41.5% | Not mentioned | [28,29] | |
| T-lymphocyte subsets activity (%) | CD3: pre-intervention: 58.7 ± 7.3% vs.58.4 ± 6.9%; post-intervention: 70.1 ± 8.0% vs.62.3 ± 7.5% | ||||||||
| CD4: pre-intervention: 32.5 ± 5.6% vs.31.9 ± 5.3%; post-intervention: 44.2 ± 6.1% vs.35.9 ± 5.9% | |||||||||
| CD8: pre-intervention: 38.7 ± 6.9% vs.38.9 ± 7.0%; post-intervention: 34.2 ± 6.1% vs.36.9 ± 6.5% | |||||||||
| CD4/CD8: pre-intervention: 0.83 ± 0.20 vs.0.81 ± 0.15; post-intervention: 1.21 ± 0.27 vs.0.91 ± 0.19 | |||||||||
| Adverse reactions | Myelosuppression and gastrointestinal reaction significantly decreased | ||||||||
| Quality of life score | Pre-intervention:53.1 ± 10.8 vs.52.7 ± 11.2; Post-intervention: 71.5 ± 12.9 vs.64.2 ± 12.2 | ||||||||
| China | GP injection (bought from Changchun Boao Biochemical Pharmaceutical Co., Ltd., Changchun, China) | 18mg for intravenous dripping, once a day for 60 Days | 108 patients diagnosed with NSCLC (Treatment group, n = 60, 72.4 ± 1.9 years old; Control group, n = 48, 78.2 ± 1.4 years old) | randomized, parallel，placebo-controlled | Total effective rate (%) | 56.7% vs.33.3% | Not mentioned | [28] | |
| T-lymphocyte subsets activity (%) | CD3: pre-intervention: 54 ± 7% vs.52 ± 10%; post-intervention: 65 ± 10% vs.54 ± 10% | ||||||||
| CD4: pre-intervention: 32 ± 7% vs.31 ± 7%; post-intervention: 41 ± 8% vs.35 ± 9% | |||||||||
| CD8: pre-intervention: 36 ± 8% vs.35 ± 9%; post-intervention: 34 ± 8% vs.35 ± 7% | |||||||||
| CD4/CD8: pre-intervention: 0.83 ± 0.12 vs.0.84 ± 0.16; post-intervention: 0.85 ± 0.09 vs.0.83 ± 0.24 | |||||||||
| Serum immunoglobulin (g/ml) | IgA: pre-intervention: 1.26 ± 0.11 vs.1.28 ± 0.10%; post-intervention: 1.39 ± 0.10% vs.1.30 ± 0.12% | ||||||||
| IgG: pre-intervention: 9.3 ± 1.8 vs.9.2 ± 1.9%; post-intervention: 11.2 ± 2.1% vs.10.2 ± 2.0% | |||||||||
| IgM: pre-intervention: 0.91 ± 0.10 vs.0.94 ± 0.19%; post-intervention: 1.72 ± 0.17% vs.1.42 ± 0.17% | |||||||||
| Quality of life score | Pre-intervention: 40 ± 12 vs.40 ± 13; Post-intervention:42 ± 11 vs.45 ± 15 (month 1);35 ± 8 vs.40 ± 12 (month 3) | ||||||||