ObjectiveTo observe intervention effect of Shenlingcao oral liquid on asymptomatic chronic hepatitis B virus carriers (AsC). MethodsA self control before-after trial was conducted in the First Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine and the Ninth People's Hospital of Nanchang City from November 2011 to May 2012. A total of 64 AsCs were treated by Shenlingcao oral liquid (1 bottle/d, 200 mL, once daily for 6 months). Serum HBV viral load, six specific serum markers of HBV and 11 liver function index were tested and recorded before and at the 1th, 3th, 6th months of the treatment. Analysis of variance of repeated data was conducted. ResultsAfter one month of the treatment, 35/57 (61.40%) AsCs' serum HBV-DNA loads decreased, 1 log decrease was observed in 15 cases, 2 log decrease was observed in 4 cases, and decrease under the detection limit was observed in 12 cases. 41/57 (71.93%) AsCs' serum HBV-DNA loads decreased after 3 months of treatment, 1 log decrease was observed in 21 cases, 2 log decrease was observed in 5 cases, and decrease under the detection limit was observed in 15 cases. 31/49 (63.26%) AsCs' serum HBV-DNA loads decreased after 6 months of the treatment, 1 log decrease was observed in 19 cases, decrease more than 2 log was observed in 7 cases, and decrease under the detection limit was observed in 12 cases. The serum HBV viral loads at different time points of the treatment were significantly different (P<0.001). As medication time went, AsCs' serum HBV viral loads presented a decrease trend after taking Shenlingcao oral liquid, especially obvious at the 3th month. ConclusionShenlingcao oral liquid could help promote AsCs' ability of clearing virus and controlling serum HBVDNA loads.
ObjectiveTo observe the effects of Shenlingcao oral liquid on HIV-RNA load, CD4+ T cells of HIV carriers. MethodsWe included asymptomatic HIV-infection people from February to April 2012, gave them Shenlingcao oral liquid for oral intake (1 bottle/d, 200 mL/bottle) during 6 months, and observed the changes of HIV-RNA load and CD4+ T cell at different time points (before intake, 2 months, 4 months, and 6 months). ResultsA total of 25 cases were included. The results showed that a tendency existed that CD4+ T cells counts gradually increased along with time; HIV-RNA load did not change regularly; and the total effective rate was steady; and the cases in steady status tended to increase. ConclusionShenlingcao oral liquid is beneficial to the improvement of the immunity of asymptomatic HIV-infected people. Because of limited sample size and study design, the above conclusion should be verified by further conducting large-scale high quality randomized controlled trials.
ObjectiveTo estimate the individual treatment effect (ITE) of Shenlingcao oral liquid (SOL) combined with adjuvant chemotherapy in patients with stage Ⅱ-ⅢA non-small cell lung cancer (NSCLC) after complete resection using the Rboost method, and to identify characteristics of the potential high-benefit population, thereby providing a decision-making basis for clinical precision medicine. MethodsBased on data from a previously conducted nationwide, multicenter, pragmatic, open-label randomized controlled trial (n=516), the change in the overall quality of life score from baseline to the 4th chemotherapy cycle, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), was used as the primary outcome. The Rboost method was employed to establish an ITE estimation model. Internal validation was performed using 500 bootstrap resampling iterations. The model's ability to discriminate between beneficiaries was evaluated using the C-for-benefit. Patients were divided into high- and low-benefit groups based on the median ITE. A linear regression model incorporating an interaction term between treatment allocation and benefit group was constructed to verify treatment effect heterogeneity. Differences in baseline characteristics between the two groups were compared. ResultsThe established Rboost model yielded a C-for-benefit of 0.52 (95%CI 0.38 to 0.66). The median individual treatment effect was 5.84 (range: –0.86 to 12.50). The estimated individual treatment effect was 3.79 (95%CI –0.25 to 5.74) in the low-benefit group and 7.89 (95%CI 5.98 to 11.35) in the high-benefit group. After adjusting for covariates including sex, age, and BMI, the heterogeneity of treatment effect was statistically significant (P=0.01). Comparisons between benefit groups revealed that patients who were male, had a smoking history, had higher BMI, had squamous cell carcinoma, were at stage ⅢA, or had higher levels of white blood cells, neutrophils, hemoglobin, total bilirubin, aspartate aminotransferase, or alanine aminotransferase derived greater benefit from treatment with SOL. ConclusionThe Rboost model can effectively identify the advantageous population for SOL. The findings provide evidence-based support for the precise adjuvant use of traditional Chinese medicine during chemotherapy.