关键词: 生半夏, 肿瘤, 中药毒性, 临床用药特征, 中药用药安全

Abstract: Background　Raw Pinelliae Rhizoma (a toxic TCM decoction piece) has demonstrated confirmed therapeutic efficacy in malignant tumor treatment. However, due to its inherent toxicity characteristics, substantial controversies persist regarding its safe dosage range and standardized administration protocols, posing significant clinical challenges in balancing toxicity and efficacy. Objective　This study aimed to investigate the clinical medication characteristics and safety of raw Pinelliae Rhizoma in the outpatient service of the Department of Oncology, Dongfang Hospital, Beijing University of Chinese Medicine, from 2012 to 2023, thereby providing evidence-based references for the standardized application of raw Pinelliae Rhizoma in medical institutions. Methods　A retrospective collection of data from tumor patients who were prescribed formulations containing raw Pinelliae Rhizoma between 2012 and 2023 was conducted. The dataset included demographic characteristics, clinical visit records, prescription details, and liver and kidney function test results. Data integration, statistical analysis, and graphical processing were performed using Microsoft Excel, IBM SPSS Statistics 30.0, R 4.3.2, and Origin Pro 2025b. Results　A total of 44,066 prescriptions were included, involving 11,971 tumor patients (51.91% male, 48.09% female), predominantly elderly (69.87%, 8,364/11,971). The core syndrome types included Intermingled Phlegm and Blood Stasis Syndrome, Qi-Yin Deficiency Syndrome, and Qi Stagnation-Blood Stasis Syndrome. Out of the prescriptions, 35,349 (80.22%) used a single-dosage range of 10-15 g, exceeding the recommended dosage in the Chinese Pharmacopoeia (3-9 g); meanwhile, 63.09% of patients (7,553 cases) had a treatment course of ≤ 30 days.The number of prescriptions containing raw Pinelliae Rhizoma showed a decreasing trend over the past decade(r=-0.964, P<0.001).Lung cancer, colorectal cancer, and breast cancer were the primary tumor types for which raw Pinelliae Rhizoma was prescribed. Taking lung cancer as the reference, esophageal cancer, liver cancer, uterine cancer, ovarian cancer, and pancreatic cancer were identified as influencing factors for the dosage of raw Pinelliae Rhizoma (esophageal cancer: B=-145.195, 95%CI=-280.686 to -9.705; liver cancer: B=-253.363, 95%CI=-400.976 to -105.751; uterine cancer: B=-866.593, 95%CI=-1023.046 to -710.140; ovarian cancer: B=-847.736, 95%CI=-1008.190 to -687.281; pancreatic cancer: B=-236.043, 95%CI=-423.324 to -48.762, P<0.05). Age and gender were not found to be significant factors affecting the dosage of raw Pinellia (P>0.05).Safety analysis showed that all prescriptions strictly followed the operational standard of 30-minute pre-decoction; 86 prescriptions(0.20%) had incompatibility with Aconitum species, 3,476 prescriptions(7.89%) were combined with ginger-family herbs (fresh ginger/dried ginger) for toxicity reduction, and 15,214 prescriptions(34.53%) were compatible with licorice for detoxification.Statistical analysis of liver and kidney function indicators showed no significant differences before and after treatment in the Chinese medicine monotherapy group (n=71) (P>0.05). In the combined Chinese medicine with chemotherapy/ targeted therapy group (n=7), a statistically significant difference was observed in albumin(ALB) (P<0.05). In the Chinese medicine monotherapy group, there was no statistically significant difference between the dose subgroups of ≤ 9 g (n=21) and 10-15 g (n=48) before and after treatment (P>0.05).After excluding 754 patients who received combined chemotherapy during the treatment period, among 11,217 patients, 289 (2.58%) experienced grade 1 gastrointestinal adverse events. The incidence was 3.22% (60/1,861) in the ≤ 9 g group and 2.47% (229/9 255) in the 10-15 g group, with no statistically significant difference between the two groups (χ2 =3.439, P>0.05). A total of 78 patients (0.70%) reported transient palpitations after medication, with an incidence of 0.75% (14/1 861) in the ≤ 9 g group and 0.67% (62/9,255) in the 10-15 g group. The difference between the two groups was not statistically significant (χ2 =0.155, P>0.05).Conclusion　In the Department of Oncology of this hospital,raw Pinelliae Rhizoma is commonly used for syndromes complicated by phlegm pathogens, with a typical dosage range of 10-15 g. The administered amount is adjusted based on the severity of phlegm pathogens across different cancer types. Standardized clinical administration, including strict decoction procedures (pre-decocted for 30 minutes) and rational combination with detoxifying agents (such as ginger and licorice), ensures medication safety. In this study, no significant correlation was observed between excessive use of raw Pinelliae Rhizoma or combined medication and definitive organ function impairment.The available data support that, under standardized operations, raw Pinelliae Rhizoma within the dosage range of 10-15 g has reliable safety in tumor patients, providing empirical references for its rational clinical application.

Key words: Raw Pinelliae Rhizoma, Neoplasms, Toxicity of Chinese medicine, Clinical medication characteristics, Chinese medicine safety