TABLE 5.
GRADE evidence profile.
| Table 5A. The clinical efficacy and safety | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Indicators (Trials) | Quality assessment | NSCLC | Clinical efficacy and safety | Quality | ||||||
| Risk of bias | Inconsistency | Indirectness | Imprecision | Publication bias | Aidi injection | GP | Odds ratios (95% CI) | Absolute effects | ||
| Objective response rate (63) | Serious a | No | No | No | None | 1319/2454 (53.7%) | 946/2397 (39.5%) | 1.82 (1.62–2.04) | 148 more per 1000 (from 119 more to 176 more) | ⊕⊕⊕Ο Moderate |
| Disease control rate (61) | Serious a | No | No | No | None b | 2095/2406 (87.1%) | 1766/2355 (75%) | 2.29 (1.97–2.67) | 123 more per 1000 (from 105 more to 139 more) | ⊕⊕⊕Ο Moderate |
| Quality of life (31) | Serious a | No | No | No | None | 706/1267 (55.7%) | 373/1218 (30.6%) | 3.03 (2.55–3.6) | 266 more per 1000 (from 223 more to 308 more) | ⊕⊕⊕Ο Moderate |
| 1-year OS rate (3) | Serious c | No | No | Serious d | None | 84/133 (63.2%) | 73/133 (54.9%) | 1.41 (0.86–2.3) | 83 more per 1000 (from 38 fewer to 188 more) | ⊕⊕ΟΟ Low |
| 2-years OS rate (1) | Serious c | No | No | Serious d | None | 17/49 (34.7%) | 9/52 (17.3%) | 2.54 (1–6.42) | 174 more per 1000 (from 0 more to 400 more) | ⊕⊕ΟΟ Low |
| Myelosuppression (17) | Serious a | No | No | No | None | 218/642 (34%) | 342/632 (54.1%) | 0.36 (0.28–0.47) | 243 fewer per 1000 (from 185 fewer to 293 fewer) | ⊕⊕⊕Ο Moderate |
| Neutropenia (40) | Serious a | No | No | No | None e | 626/1701 (36.8%) | 862/1670 (51.6%) | 0.41 (0.35–0.49) | 212 fewer per 1000 (from 173 fewer to 244 fewer) | ⊕⊕⊕Ο Moderate |
| Thrombocytopenia (28) | Serious a | No | No | No | None | 286/1181 (24.2%) | 409/1156 (35.4%) | 0.48 (0.39–0.59) | 146 fewer per 1000 (from 110 fewer to 178 fewer) | ⊕⊕⊕Ο Moderate |
| Anemia (11) | Very serious f | No | No | No | None | 156/524 (29.8%) | 200/523 (38.2%) | 0.59 (0.43–0.8) | 115 fewer per 1000 (from 51 fewer to 172 fewer) | ⊕⊕ΟΟ Low |
| Gastrointestinal toxicity (49) | Serious a | No | No | No | None | 756/2043 (37%) | 1059/2002 (52.9%) | 0.45 (0.39–0.51) | 193 fewer per 1000 (from 165 fewer to 224 fewer) | ⊕⊕⊕Ο Moderate |
| Liver toxicity (29) | Serious a | No | No | No | None b | 192/1284 (15%) | 285/1257 (22.7%) | 0.58 (0.47–0.72) | 81 fewer per 1000 (from 52 fewer to 106 fewer) | ⊕⊕⊕Ο Moderate |
| Renal toxicity (24) | Serious a | No | No | No | None | 132/1070 (12.3%) | 192/1044 (18.4%) | 0.62 (0.48–0.79) | 61 fewer per 1000 (from 33 fewer to 86 fewer) | ⊕⊕⊕Ο Moderate |
| Alopecia (3) | Very serious f | No g | No | Serious d | None | 41/94 (43.6%) | 57/89 (64%) | 0.27 (0.05–1.37) | 316 fewer per 1000 (from 559 fewer to 69 more) | ⊕ΟΟΟ Very low |
| Neurotoxicity (5) | Serious a | No | No | Serious d | None | 26/208 (12.5%) | 37/208 (17.8%) | 0.63 (0.35–1.12) | 58 fewer per 1000 (from 107 fewer to 17 more) | ⊕⊕⊕Ο Moderate |
| Oral mucositis (3) | Serious a | No | No | Serious d | None | 10/106 (9.4%) | 18/106 (17%) | 0.5 (0.22–1.16) | 77 fewer per 1000 (from 127 fewer to 22 more) | ⊕⊕ΟΟ Low |
| Table 5B. The levels of peripheral blood lymphocytes | ||||||||||
| Indicators (Trials) | Risk of bias | Inconsistency | Indirectness | Imprecision | Publication bias | Aidi injection | GP | Odds ratios (95% CI) | SMD (95% CI) | Quality |
| CD3+ T cell (15) | Serious a | No g | No | No | None b | 700 | 699 | No | 1.04 higher (0.63–1.46 higher) | ⊕⊕⊕Ο Moderate |
| CD3+ CD4+ T cell (16) | Serious a | No g | No | No | None b | 740 | 738 | No | 1.38 higher (1.04–1.72 higher) | ⊕⊕⊕Ο Moderate |
| CD4+/CD8+ T cell ratios (12) | Serious a | No g | No | No | None | 556 | 555 | No | 0.99 higher (0.62–1.35 higher) | ⊕⊕⊕Ο Moderate |
| Natural killer cell (3) | Serious a | No g | No | Serious d | None | 115 | 113 | No | 0.96 higher (0.22–1.71 higher) | ⊕⊕ΟΟ Low |
Note: NSCLC: non-small cell lung cancer; GP: gemcitabine and cisplatin; OS: overall survival; SMD: standardized mean difference; and CI: confidence interval.
Most trials had unclear risk and with high risk, the result of sensitivity analysis was robust, and the evidence was downgraded by only one level
with publication bias, the result was overestimated and robust, and not downgraded
most trials had unclear risk and without high risk, the evidence was downgraded by only one level
the sample size for result <300 cases, and the evidence was downgraded by one level
with publication bias, the result was underestimated and robust, and not downgraded
most trials had unclear risk and with high risk, the result of sensitivity analysis was poorly robust, and the evidence was downgraded by two levels
with heterogeneity, the results was robust, and not downgraded