1.Clinical research report on Chinese patent medicines and classic traditional Chinese medicine prescriptions (2023)
Xiaolei WU ; Haiyin HU ; Yuetong WANG ; Fauci Alice Josephine ; Yazi ZHANG ; Wenting SONG ; Fengwen YANG ; Boli ZHANG ; Junhua ZHANG ; Zhaochen JI
Digital Chinese Medicine 2025;8(2):123-136
Objective:
Randomized controlled trials (RCTs) of Chinese patent medicines and classic traditional Chinese medicine prescriptions were systematically reviewed from both Chinese and English journals published in 2023. A preliminary summary and evaluation were conducted on the generation and translation of clinical evidence for these treatments. This analysis aims to inform future research on clinical efficacy evaluation and guide the rational application of evidence.
Methods:
RCTs of Chinese patent medicines and classic traditional Chinese prescriptions published in 2023 were comprehensively retrieved from the Artificial Intelligence Clinical Evidence Database for Chinese Patent Medicine (AICED-CPM), with supplementary searches conducted in China National Knowledge Infrastructure (CNKI), Wanfang Data, Chinese Science and Technology Journal Database (VIP), Chinese Biomedical Literature Database (SinoMed), Cochrane Library, PubMed, Embase, and Web of Science. The study characteristics and methodological quality of these RCTs were systematically analyzed and evaluated.
Results:
A total of 1 443 RCTs of Chinese patent medicines were included, comprising 1 399 Chinese articles and 44 English articles. Additionally, 334 RCTs of classic traditional Chinese medicine prescriptions were found, with 331 published in Chinese and 3 in English. 196 567 participants were included, covering 585 types of Chinese patent medicines (487 oral, 61 injectable, and 37 topical) and 179 classic traditional Chinese medicine prescriptions. The involved studies encompassed 22 types of diseases, with research primarily focusing on diseases of the circulatory system, the respiratory system, and the genitourinary system. The sample sizes ranged from 18 to 3 777 participants, and most studies were conducted at a single center. Methodologically, the implementation of allocation concealment and blinding remained insufficiently emphasized.
Conclusion
Overall, compared with 2022, both the number of RCT publications and their methodological quality have improved in 2023, with heightened attention to research on diseases of the genitourinary system. However, quality control and standardized management in the design and implementation processes still require enhancement to produce more high-quality clinical evidence and accelerate the translation and application of this evidence.
2.Effect of Modified Shengjiangsan on Renal Endoplasmic Reticulum Stress and Sirt1/PERK Pathway in Rat Model of Diabetic Nephropathy
Meifang REN ; Zhenhua WU ; Fei GAO ; Guodong YUAN ; Qian ZHANG ; Xiaoling GUO ; Fengwen YANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(14):55-62
ObjectiveTo explore the molecular mechanism of modified Shengjiangsan in alleviating endoplasmic reticulum (ER) stress and reducing urinary protein in the rat model of diabetic nephropathy (DN). MethodSeventy-five SD rats were randomized into normal, model, low-, medium-, and high-dose (4.37, 8.73, 17.46 g·kg-1, respectively) modified Shengjiangsan, and irbesartan (0.014 g·kg-1) groups, with 10 rats in each group. Rats were administrated with corresponding doses of medications or distilled water by gavage, once a day, for 8 consecutive weeks. After the last administration, the levels of glucose (GLU) in the blood, 24-hour urinary protein (24 h-UTP), and superoxide dismutase (SOD), malondialdehyde (MDA), and glutathione peroxidase (GSH-Px) in the renal tissue were measured. Hematoxylin-eosin staining, periodic acid-Schiff staining, and transmission electron microscopy were employed to observe the pathological changes in rat kidneys. Immunohistochemistry was employed to measure the expression levels of nephrin, podocin, glucose-regulated protein 78 (GRP78), C/EBP homologous protein (CHOP), and activating transcription factor 4 (ATF4) in the kidneys of rats. Western blot was employed to measure the protein levels of silent information regulator 1 (Sirt1), phosphorylated (p)-protein kinase RNA-like endoplasmic reticulum kinase (PERK), and p-eukaryotic translation initiation factor 2 alpha (eIF2α) in rat kidneys. ResultCompared with the normal group, the modeling caused pathological damage to the kidneys, elevated the levels of GLU and 24 h-UTP (P<0.05), up-regulated the protein levels of GRP78, CHOP, ATF4, p-PERK, and p-eIF2α (P<0.05), and down-regulated the protein level of Sirt1 (P<0.05) in rat kidneys. Compared with the model group, modified Shengjiangsan and irbesartan lowered the GLU and 24 h-UTP levels (P<0.05), alleviated the pathological damage in the renal tissue, down-regulated the protein levels of GRP78, CHOP, ATF4, p-PERK, and p-eIF2α (P<0.05), and up-regulated the protein level of Sirt1 (P<0.05). ConclusionModified Shengjiangsan up-regulates Sirt1 expression and inhibits phosphorylation of proteins in the PERK/eIF2α pathway to reduce ER stress and oxidative stress in the renal tissue, thus alleviating the pathological damage in the renal tissue and reducing urinary protein in DN rats.
3.Study on the Quantification of Traditional Chinese Medicine Tongue Color Classification Based on Hyperspectral Images
Dong ZHANG ; Wentai PANG ; Keyi WANG ; Fengwen YANG ; Junhua ZHANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2024;26(7):1925-1930
Objective Traditional Chinese medicine tongue diagnosis plays an important role in the clinical diagnosis and treatment of diseases,but the current research results are not applicable to the evaluation of clinical efficacy.This study conducted a hierarchical quantitative study on tongue color based on hyperspectral data of tongue images,making it suitable for clinical efficacy evaluation.Methods Establish inclusion and exclusion criteria,obtain tongue images of different spectral wavelengths within the visible light range of 400-1000 nm,and use traditional Chinese medicine clinical experts to distinguish between red tongue and yellow coating in four different color levels(mild,moderate,severe,and severe).Finally,establish a quantitative prediction model for the grade of red tongue and yellow coating based on machine learning models.Results There were significant differences in hyperspectral curve characteristics between red tongue and yellow coating with different color levels,which could be used as the basis for grade quantification.With the help of principal component analysis+random forest model,85.79%and 88.34%of the red tongue and yellow coating with different color levels could be predicted.Conclusion The use of hyperspectral image data features and machine learning models for predicting different color levels of tongue color has achieved good accuracy.
4.Application of highly selective arterial indocyanine green angiography in the design of anterolateral thigh free flap
Shi WANG ; Shuai DONG ; Yang CAO ; Guiyang WANG ; Chengpeng YANG ; Fengwen SUN ; Yongtao HUANG ; Liping GUO ; Liang YANG ; Rong ZHOU ; Jihui JU
Chinese Journal of Burns 2024;40(10):948-954
Objective:To introduce the application of highly selective arterial indocyanine green angiography (hereinafter referred to as highly selective arterial angiography) in the design of anterolateral thigh free flap.Methods:This study was a retrospective observational study. From November 2023 to April 2024, 29 patients with wounds in extremities which were repaired by anterolateral thigh free flaps designed under the assistance of highly selective arterial angiography and met the inclusion criteria were admitted to the Department of Hand Surgery and Department of Wound Repair Surgery of Suzhou Ruihua Orthopedic Hospital, including 26 males and 3 females, aged 16 to 71 years. The wound area after debridement ranged from 8.0 cm×4.5 cm to 27.0 cm×16.0 cm. During the surgery, highly selective arterial angiography was used to assist in flap design. The fluorescence development range of the source arteries or perforators of flaps was observed. The blood supply range of the source arteries or perforators of flaps was determined based on the fluorescence development of the skin, and the excision position of the flap was adjusted. The flap incision area ranged from 9.0 cm×6.0 cm to 29.0 cm×16.0 cm. During the surgery, the number of highly selective arterial angiography, the type of source artery of perforators for puncture, and changes in the excision position of flaps were observed and recorded. After surgery, the blood supply and survival of flaps, the healing of wounds and the survival of skin grafts in the flap donor sites, and the angiography-related complications were observed.Results:All the 32 flaps of 29 patients were successfully excised. The highly selective arterial angiography was performed 37 times, including 13 cases of puncture of the oblique branch of the lateral circumflex femoral artery, 6 cases of puncture of the descending branch, 8 cases of double puncture of the oblique and descending branches, and 2 cases of puncture of arteries from other branches. During the surgery, the excision position of 28 flaps did not change, the excision position of 3 flaps moved towards proximal extremity of the thigh, and the excision position of 1 flap moved towards distal extremity of the thigh. All the flaps survived successfully after the surgery, and there was no partial necrosis of the flaps at the proximal or distal ends. The wounds in the flap donor sites healed, and all skin grafts survived. No angiography-related complications occurred.Conclusions:Highly selective arterial angiography can be used to determine the blood supply range of the source artery and perforators of the anterolateral thigh free flaps during the surgery. It can evaluate the blood supply of flaps more intuitively and objectively. Its application in assisting flap design can avoid partial flap necrosis caused by unreasonable preoperative design to a certain extent, and it is safe and reliable.
5.Effect of Dahuang Xiezhuo Prescription on Inflammation and SOCS3/TLR4 Pathway in Rats with Chronic Renal Failure
Xin XIN ; Zhenhua WU ; Miao TAN ; Fei GAO ; Fengwen YANG ; Suzhi CHEN ; Qian ZHANG ; Jinchuan TAN
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(7):95-104
ObjectiveTo observe the intervention effect of Dahuang Xiezhuo prescription (DHXZ) on inflammation and suppressor of cytokine signaling 3 (SOCS3)/Toll-like receptor 4 (TLR4) pathway in rats with chronic renal failure (CRF), and to explore its molecular mechanism in alleviating renal inflammatory response. MethodThe 90 male SD rats, 15 were randomly selected as sham group, and the remaining 75 were used as modeling group to replicate CRF rat model by 5/6 nephrectomy. After successful modeling, the rats were randomly divided into model group, DHXZ low-, medium-, high-dose groups (6.825, 13.65, 27.3 g·kg-1) and Niaoduqing Granules group (2.6 g·kg-1). The drug intervention groups received corresponding drugs by gavage for 8 consecutive weeks. After administration, hematoxylin-eosin (HE) staining and Masson staining were used to observe the morphological changes of rat renal tissue, and blood creatinine (SCr), blood urea nitrogen (BUN) and blood uric acid (UA) were tested. Enzyme-linked immunosorbent assay (ELISA) was performed to detect the serum contents of interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α) and C-reactive protein (CRP). The mRNA expressions of SOCS3 and TLR4 in renal tissue were detected by Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR), and the protein expressions of SOCS3, TLR4, nuclear transcription factor (NF-κB) and myeloid differentiation factor (MyD88) were detected by Western blot. Immunohistochemistry was used to determine the protein expressions of NF-κB, MyD88, NOD-like receptor protein 3 (NLRP3) and melanoma deficiency factor 2 (AIM2). ResultCompared with the sham group, the model group had a significant inflammatory response in renal tissue, and an increase in blood SCr, BUN, UTP, IL-6, TNF-α and CRP (P<0.05). The protein and mRNA expressions of SOCS3 in renal tissue of rats in the model group were lower while the protein expressions of TLR4, NF-κB, MyD88, NLRP3 and AIM2 and the mRNA expression of TLR4 were higher than those in the sham group (P<0.05). Compared with the model group, DHXZ and Niaoduqing granules groups presented markedly reduced inflammatory response in renal tissue and decreased blood SCr, BUN, UTP, IL-6, TNF-α and CRP (P<0.05). Additionally, DHXZ and Niaoduqing granules up-regulated the protein and mRNA expressions of SOCS3 in renal tissue while down-regulated the protein expressions of TLR4, NF-κB, MyD88, NLRP3 and AIM2 and the mRNA expression of TLR4 (P<0.05). ConclusionDHXZ can reduce the release and expression of inflammatory factors, inhibit the inflammatory response and improve renal function, and the mechanism may be related to the regulation of SOCS3/TLR4 signaling pathway.
6.Mechanism of Salvianolate in Inducing Autophagy in Podocytes of Rats with Membranous Nephropathy via AMPK/SIRT1/PGC-1α Signaling Pathway
Yao ZHANG ; Fei GAO ; Miao TAN ; Fengwen YANG ; Suzhi CHEN ; Meifang REN ; Guodong YUAN ; Jinchuan TAN
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(8):203-213
ObjectiveTo observe the effect of salvianolate on the protein expressions of adenosine monophosphate (AMP)-activated protein kinase (AMPK), silent information regulator 1 (SIRT1) and peroxisome proliferator-activated receptor-γ coactivator-1α (PGC-1α), autophagy and apoptosis in kidney tissue of rats with membranous nephropathy (MN), and to explore its possible molecular mechanism against MN. MethodEighty male SD rats were randomly divided into normal group, model group, benazepril hydrochloride group (10 mg·kg-1), and salvianolate low-, medium-, and high-dose groups (16.7, 33.3 and 66.7 mg·kg-1). The rats were modeled by injection of cationized bovine serum albumin (C-BSA) into the tail vein. After successful modeling, rats in the administration groups were given corresponding doses of drugs for 4 consecutive weeks, and then 24-hour urine, serum and kidney tissue were collected for the detection of 24-hour urinary protein (UTP), blood urea nitrogen (BUN), serum creatinine (SCr), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), C reactive protein (CRP), glutathione peroxidase (GSH-Px), superoxide dismutase (SOD), and malondialdehyde (MDA). The pathological changes of kidneys were observed by light microscope, electron microscope and immunofluorescence. Western blot was used to detect the protein expressions of phospho-AMPK (p-AMPK), AMPK, phospho-SIRT1 (p-SIRT1), SIRT1 and PGC-1α in rat kidney tissue. The protein expressions of autophagy-specific gene (Beclin-1), microtubule-associated protein 1 light chain 3 (LC3) Ⅱ, ubiquitin-binding protein (p62), B cell lymphoma (Bcl-2), Bcl-2-associated X (Bax), and cysteine aspartic protease-7 (Caspase-7) in rat kidney tissue were determined by immunohistochemistry (IHC). ResultCompared with the conditions in the normal group, the levels of UTP, IL-6, TNF-α, CRP and MDA in the model group were increased (P<0.05) while the levels of SOD and GSH-Px were decreased (P<0.05), and there was no difference in BUN and SCr. Compared with the model group, the administration groups had lowered UTP, IL-6, TNF-α, CRP and MDA (P<0.05) while elevated SOD and GSH-Px (P<0.05). It could be seen from hematoxylin and eosin (HE) staining, Masson staining, immunofluorescence and electron microscopy that the pathological damage of rat kidney tissue in the model group was significant, but after treatment with benazepril hydrochloride and salvianolate, the pathological damage of kidney cells was gradually improved. The expressions of p-AMPK/AMPK, p-SIRT1/SIRT1, PGC-1α, Bcl-2, Beclin-1 and LC3Ⅱ in rat kidney in the model group were lower than those in the normal group (P<0.05) while the expressions of Bax, Caspase-7 and p62 were higher (P<0.05). Compared with the model group, benazepril hydrochloride group and salvianolate groups had an up-regulation in the expressions of p-AMPK/AMPK, p-SIRT1/SIRT1, PGC-1α, Bcl-2, Beclin-1 and LC3Ⅱ in the kidney (P<0.05) while a down-regulation in the expressions of Bax, Caspase-7 and p62 (P<0.05). ConclusionThe protective effect of salvianolate on the kidneys of MN rats may be related to the activation of AMPK/SIRT1/PGC-1α signaling pathway, the up-regulation of autophagy and the reduction of apoptosis.
7.New Explanation of Jichuan Decoction(济川煎)
Ning GAO ; Shujie ZAN ; Zexi ZHANG ; Xinyao JIN ; Fengwen YANG
Journal of Traditional Chinese Medicine 2023;64(20):2150-2152
This paper explores the interpretation of Jichuan Decoction (济川煎) by tracing its name's origin, exa-mining the original texts of herbs in the decoction within Jingyue's Complete Works(《景岳全书》), exploring the debate on the sovereign drug of Danggui (Angelica sinensis [Oliv.] Diels) and Roucongrong (Cistanche deserticola Y.C. Ma), and analyzing the historical discussions on the efficacy of the decoction. It is believed that the original meaning of the name Jichuan Decoction (济川煎) refers to its strategy for treating “deficiency constipation”, which can be described as “increasing water to navigating the boat”. Danggui (Angelica sinensis [Oliv.] Diels) is considered the sovereign herb for nourishing blood and moistening dryness, while Roucongrong (Cistanche deserticola Y.C. Ma) serves as the minister herb for moistening the intestines and promoting bowel movements. It is concluded by the author that Jichuan Decoction (济川煎) does not primarily focus on warming the kidneys and assisting yang, but rather emphasizes nourishing blood, moistening dryness, and promoting bowel movements. Its main indication is constipation due to deficiency of yin and blood, which is supported by evidence from antiquarian materials.
8.Effect of Dahuang Xiezhuo Prescription on Renal Tubular Function in Patients with IgA Nephropathy Complicated with Hyperuricemia
Qian ZHANG ; Fengwen YANG ; Meng SHI ; Jinchang LIU ; Gang WANG ; Meifang REN ; Meijiao ZHAO ; Jingyu MAO ; Jinchuan TAN
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(12):135-141
ObjectiveTo observe the effect of Dahuang Xiezhuo prescription on the clinical symptoms, blood uric acid, and renal tubular function of patients with immunoglobulin A (IgA) nephropathy in stages 1-2 of chronic kidney disease (CKD) complicated with hyperuricemia (HUA). MethodSixty patients with IgA nephropathy in stages 1-2 of CKD complicated with HUA of spleen and kidney deficiency and combined turbidity and blood stasis syndromes were randomly divided into an observation group and a control group, with 30 cases in each group. The patients in the control group received basic treatment, i.e., losartan potassium tablets 50-100 mg/time, once per day, and sodium bicarbonate tablets 0.5 g/time, three times per day by oral administration, combined with low-salt, low-fat, and low-purine diet. The patients in the observation group received Dahuang Xiezhuo prescription on the basis of basic treatment, one dose per day, twice a day in the morning and evening with warm water. Both groups were treated for two months. The total scores of traditional Chinese medicine(TCM)syndrome, blood pressure, 24 h urinary protein (24 h UTP), blood urea nitrogen (BUN), serum creatinine (SCr) [glomerular filtration rate (eGFR) was calculated by CKD-epidemiology collaboration (CKD-EPI) formula], serum uric acid (SUA), and renal tubular function indexes [urinary α1-microglobulin (α1-MG), urinary β2-microglobulin (β2-MG), urinary kidney injury molecule-1 (KIM-1), and neutrophil gelatinase-associated lipocalin (NGAL)] of the two groups before treatment and two months after treatment were recorded. The clinical efficacy of the two groups was evaluated two months after treatment. ResultAfter 2 months of treatment,the total effective rate in the observation group was 81.48%(22/27),higher than 50.00%(14/28) in the control group(χ2 =6.661,P<0.05). The total scores of TCM syndrome, 24 h UTP, and SUA in the observation group and the observation group were lower than those before treatment (P<0.05), and compared with the control group after treatment, the observation group decreased more significantly (P<0.05). After treatment, the blood pressure in the observation group and the observation group was lower than that before treatment (P<0.05), and there was no significant difference in blood pressure between the two groups after treatment. After treatment, the levels of urinary α1-MG, β2-MG, KIM-1, and NGAL in the two groups were lower than those before treatment (P<0.05), and the observation group was lower than the control group after treatment (P<0.05). There were no significant inter-group and intra-group differences in BUN, SCr, and eGFR levels before and after treatment. There were no obvious abnormalities in blood routine, liver function, and electrolytes before and after treatment in the two groups, and no adverse reactions such as allergies occurred. ConclusionDahuang Xiezhuo prescription can effectively improve the clinical symptoms of IgA nephropathy with HUA (CKD1-2) patients with spleen and kidney deficiency and combined turbidity and blood stasis syndromes, reduce blood uric acid level, alleviate renal tubular injury, and protect the kidney. The curative effect is better than that of basic treatment.
9.Application of "ABC" three line perforator locating method for free anterolateral perforator flap of calf
Tao ZHANG ; Lin YANG ; Junnan CHENG ; Shengzhe LIU ; Zhijin LIU ; Yongtao HUANG ; Qinfeng GAO ; Fengwen SUN ; Chengpeng YANG ; Jihui JU
Chinese Journal of Microsurgery 2023;46(1):70-75
Objective:To explore the feasibility of an "ABC" three line perforator locating method in design and harvest of free anterolateral perforator flap of calf.Methods:Between March 2021 and November 2021, 42 patients with 62 wounds on hand and foot were treated in the Department of Hand Surgery, Suzhou Ruihua Orthopaedic Hospital. The "ABC" three line perforator locating method was applied to determine the location and source of perforating branch before operation and to guide the design and harvest of flap during operation in wound reconstruction. Among the 42 patients, 24 had the injury of single digit, 7 had the injuries with 2 digits, 4 with 3 digits, 1 with 4 digits, 1 of the first web, 1 in the wrist, 2 of the great toe, 1 of second toe and 1 in dorsal foot. The sizes of soft tissue defect were 1.5 cm×2.0 cm-3.0 cm×14.0 cm. The sizes of the flaps were 2.0 cm×2.5 cm-3.5 cm×15.0 cm. All donor sites were sutured directly. In the follow-up, sensations of flaps were evaluated following the sensory function evaluation standard of British Medical Research Council(BMRC), and the recovery of the donor and recipient sites was evaluated by the flap comprehensive evaluation scale. Regular follow-up were scheduled at outpatient clinic.Results:A total of 162 perforators were located before operation. There were 95 perforating branches being explored in the operation, of which 5 patients had 1 extra perforating branch than that located before surgery. Seventy-six perforating branches were found consistent with preoperative localisation, with a coincidence rate of 84.4%(76/90). Sixty-four perforating branches were found consistent with the preoperative source with an accuracy rate of 84.2%(64/76). All the 62 flaps survived without a vascular compromise. Follow-up lasted for 6-10(mean 7.1) months. The colour and texture of the flaps were excellent. The flaps were thin and wear-resistant. The sensory function of the flaps was evaluated at S 1-S 3 by BMRC. Comprehensive evaluation scale of flap was excellent in 38 patients and good in 4 patients. Conclusion:"ABC" three line perforator locating method in design of free anterolateral calf flap is a feasible and an ideal auxiliary method in surgical practice. It combines anatomical knowledge, clinical experience and Doppler ultrasound localisation as well as accurately guides the location and source prediction of perforator before surgery.
10.Sorting and Elaborating on the Combination Theory of Herb Pairs
Shujie ZAN ; Kai WANG ; Lin LI ; Fengwen YANG ; Feng JIANG ; Han ZHANG ; Boli ZHANG
Journal of Traditional Chinese Medicine 2023;64(17):1729-1733
As the smallest combination unit of Chinese medicinals, herbal pairs serve as the bridge between medicinals and formulas, whose combination theory reflects the basic characteristics of Chinese medicinals combination and the core essence of prescription composition. Simultaneously, as a key combination of medicinals in clinical treatment of diseases, syndromes, and symptoms, herbal pairs are the main form of clinical medication in traditional Chinese medicine (TCM) as well as the characteristic advantage of treating diseases. This article summarized that “mutual complement of medicinals of same or antagonism flavor and nature” theory is the theoretical origin, and efficacy-enhancement and toxicity-attenuation is the core purpose of the combination of herbal pairs. The property theory of Chinese medicinals and the thought of differentiation and treatment are the main basis of the combination of herbal pairs, and pertinence and flexibility are the key points in clinical application. All mentioned above are expected to provide theoretical guidance for the clinical use and modern research of herbal pairs.

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